OpenLobby.EU
Explore

European Federation of Pharmaceutical Industries and Associations

EFPIA

EFPIA represents the biopharmaceutical industry operating in Europe, with a mission to create a collaborative environment that enables its members to innovate, discover, develop and deliver new therapies and vaccines for people across Europe.

Lobbying Activity

Meeting with Jessica Polfjärd (Member of the European Parliament, Shadow rapporteur)

27 Jan 2026 · Health policy

Meeting with Yannis Maniatis (Member of the European Parliament) and Liquid Gas Europe

20 Jan 2026 · Introductory Meeting

Meeting with Veronika Cifrová Ostrihoňová (Member of the European Parliament, Shadow rapporteur)

15 Jan 2026 · cardiovascular health

Meeting with Maria Pilar Aguar Fernandez (Director Research and Innovation) and

15 Jan 2026 · Exchange of views with private members of the Innovative Health Initiative Joint Undertaking (IHI-JU).

Meeting with Carmen Laplaza Santos (Head of Unit Research and Innovation)

11 Dec 2025 · Assessment of micropollutants in wastewater

Response to EU taxonomy - Review of the environmental delegated act

5 Dec 2025

On behalf of the European Federation of Pharmaceutical Industries and Associations (EFPIA), we welcome the opportunity to contribute to the call for evidence in for the review of Climate Delegated Act. EFPIA represents the biopharmaceutical industry operating in Europe, bringing together 36 national associations, 40 leading pharmaceutical companies and a growing number of small and medium-sized enterprises. EFPIA supports the EUs transition to a more sustainable and resilient economy and is committed to reducing emissions, improving circularity, and strengthening sustainability performance across the value chain. We share the EU Taxonomys objective of directing capital toward environmentally sustainable activities and believe it can be a valuable tool if it reflects the scientific and regulatory realities of innovative pharmaceuticals. In the attached paper and annex, EFPIA outlines its concerns and practical recommendations to ensure the framework remains credible, comparable, and investment-enabling for a highly regulated, long-cycle sector. Our key recommendations include: The current TSCs for medicinal products are not adapted to how pharmaceutical innovation and manufacturing operate. As drafted, they can be inapplicable to and risk producing near-zero alignment even where companies deliver substantial and measurable environmental improvements. Certain criteria rely on concepts such as substitutability, product attributes, or disclosures that do not fit regulated medicines, may be outside company control, or could create legal and intellectual-property risks. This undermines predictability and the ability to report consistently. The binary approach of the framework does not adequately capture credible sustainability progress in pharmaceuticals. EFPIA recommends more flexible and proportionate pathways that recognise meaningful environmental gains even when specific criteria cannot be met for legitimate scientific, technical, or regulatory reasons, including the possibility of voluntary or phased reporting where appropriate. DNSH requirements should be streamlined and prioritised to avoid duplication and focus on safeguards that are measurable and relevant to medicines manufacturing. Simplification should start with pollution-related DNSH and extend across other DNSH areas and minimum safeguards. Across the annexed technical comments, EFPIA calls for clearer, implementable guidance, alignment with existing EU regulatory and industrial frameworks, and criteria that are workable for global, multi-site pharmaceutical operations without imposing disproportionate burdens or discouraging investment in Europes life-sciences ecosystem.
Read full response

Meeting with Olivér Várhelyi (Commissioner) and

3 Dec 2025 · Future of European pharmaceuticals sector

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur)

2 Dec 2025 · Pharma Package

Meeting with Ekaterina Zaharieva (Commissioner) and

2 Dec 2025 · Life sciences

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

2 Dec 2025 · Pharmaceutical legislation

EFPIA Urges EU to Slash Foreign Subsidy Reporting Burden

18 Nov 2025
Topic — The European Commission is evaluating its rules for screening distortive foreign subsidies.
Message — EFPIA requests higher notification thresholds and specific exemptions for patent-protected medicines and clinical research. They propose a single yearly notification system to simplify repetitive reporting across different transactions.12
Why — Reducing this burden would lower compliance costs and protect funding for pharmaceutical innovation.3
Impact — EU regulators would lose oversight of foreign subsidies that could potentially distort pharmaceutical markets.4
Read full response

Meeting with Angelika Niebler (Member of the European Parliament)

13 Nov 2025 · EU Pharmaceutical Policy

Meeting with Eero Heinäluoma (Member of the European Parliament)

13 Nov 2025 · Critical Medicines Act

Pharma Industry Urges Greater Health Funding in EU Budget

12 Nov 2025
Topic — EU's long-term budget proposal for post-2027 focusing on competitiveness priorities.
Message — EFPIA requests increased earmarked funding for health and life sciences, flexible rulebook allowing industry in-kind contributions, and support across entire innovation value chain from discovery to healthcare system readiness.123
Why — This would reduce pharmaceutical industry compliance costs and enable more in-kind rather than financial contributions.45
Read full response

Meeting with Romana Jerković (Member of the European Parliament, Rapporteur)

12 Nov 2025 · Cardiovascular Health

Meeting with Marion Walsmann (Member of the European Parliament, Rapporteur for opinion)

12 Nov 2025 · CMA

Pharma industry urges healthcare exemptions in EU circular economy rules

5 Nov 2025
Topic — New EU Circular Economy Act setting requirements for recycled materials and sustainable production.
Message — EFPIA requests sector-specific transition periods reflecting pharmaceutical timelines, regulatory flexibility to ensure safety is not compromised, and harmonized EU-wide standards rather than fragmented national requirements. They emphasize that product changes take years and current timelines conflict with pharmaceutical validation and approval processes.123
Why — This would allow them to avoid costly rapid material substitutions and maintain existing global supply chains.45
Impact — Environmental groups lose stronger circular economy requirements that would reduce pharmaceutical waste and virgin material use.6
Read full response

Meeting with Kilian Gross (Head of Unit Communications Networks, Content and Technology)

4 Nov 2025 · Exchange of views on the AI Act and how it applies to research and development activities

Response to Union prevention, preparedness, and response plan for health crises

29 Oct 2025

The COVID-19 pandemic underscored the need for a robust, agile, and competitive European capacity to develop, manufacture, and deploy medical countermeasures (MCMs). To achieve this Europe must establish an environment that enables innovation, investment, and resilient production capacity, as well as operationalise mechanisms that connect research, regulation, manufacturing, and deployment. To strengthen prevention, preparedness, and response to threats of all kinds, from disease outbreaks to conflicts and disasters, cooperation among EU institutions, Member States (MS), industry, academia, and international partners is essential. 1. Agile regulatory framework and research infrastructure Streamlined regulatory pathways: Introduce fast-track, proportionate routes for MCMs addressing high-priority threats, drawing on lessons from pandemic authorisations. The new EU pharmaceutical legislation already provides accelerated assessment, emergency fast-track mechanisms and electronic product information (ePI). It is essential that these provisions are upheld in the legislative process and effectively deployed to deliver on Europes health-security, simplification and competitiveness goals. Early engagement with developers, ePI, rolling reviews, and accelerated scientific advice should become standard tools in future emergencies. Cross-border and multicountry clinical trials: Establish a seamless framework for adaptive, multicountry trials with harmonised ethics procedures, interoperable data governance, and mutual recognition of authorisations. Multicountry trial authorisations and cross-border access to trials will strengthen Europes capacity to generate high-quality evidence quickly. Connected research and data infrastructure: Reinforce EU-wide research networks and data systems to ensure interoperability between research sites, clinical trial hubs, and real-time surveillance platforms to prevent fragmentation and accelerate activation. 2. Rapid and coordinated deployment of MCMs During crises, fragmented national actions undermine equitable supply. The EU should develop an integrated, transparent system linking supply with patient demand and avoiding duplication between national contingency stock requirements and national- or EU-level stockpiles. This system must be informed by timely, reliable information on epidemiology and demand to enable real-time adaptation of supply, production, and distribution. A clear plan for critical logistics, covering continued research, diagnostics, deployment of MCMs, movement of essential personnel, and real-time data on prevalence and needs, is essential to ensure that resources reach affected areas rapidly. 3. Europe as a global hub for MCM innovation and resilience Given the capital intensity and risk of MCM development, Europe needs a coherent, long-term investment and coordination framework. Sustained publicprivate collaboration should serve as the backbone of preparedness with connecting research, innovation, manufacturing, regulation, and logistics. These partnerships can coordinate priority-setting, joint investment, data sharing, and simulation exercises that test and refine readiness. Bilateral and regular exchanges with industry will enhance the understanding of different needs and objectives from both public and private perspectives. A skilled and mobile workforce underpins this system. The EU should promote mutual recognition of qualifications, flexible mobility for critical health and manufacturing personnel, and investment in scientific, digital, and regulatory skills to ensure expertise can be deployed swiftly across borders. Europe has the scientific excellence, manufacturing base, and regulatory expertise to lead globally in MCMs. Achieving this requires acting decisively to foster innovation, secure supply chains, and enable seamless coordination in emergencies. EFPIA stands ready to partner with the EC, MSs, and stakeholders to turn these priorities into concrete actions.
Read full response

Meeting with Dorota Denning (Cabinet of Commissioner Valdis Dombrovskis) and Bayer AG and SANOFI

28 Oct 2025 · Roundtable on Simplification for Pharmaceutical Innovation

Meeting with Ingeborg Ter Laak (Member of the European Parliament) and Pharmaceutical Group of the European Union

27 Oct 2025 · CMA & Biotech Act

Meeting with Adam Jarubas (Member of the European Parliament, Committee chair)

24 Oct 2025 · EU pharmaceutical policies

Meeting with Aurelijus Veryga (Member of the European Parliament)

22 Oct 2025 · Discussion on the Critical Medicines Act

Meeting with Nicolás González Casares (Member of the European Parliament)

22 Oct 2025 · Critical Medicines Act

Meeting with Maya Matthews (Head of Unit Health and Food Safety) and European Confederation of Pharmaceutical Entrepreneurs

22 Oct 2025 · Exchange of views on joint clinical assessment and joint scientific consultations under the HTA Regulation.

Meeting with Elena Nevado Del Campo (Member of the European Parliament)

21 Oct 2025 · Critical Medicines Act

Meeting with Agnes Mathieu-Mendes (Head of Unit Health and Food Safety) and Les entreprises du médicament

17 Oct 2025 · Leem & Efpia | Request for a meeting - France's medicines shortages regulatory framework & policies

Meeting with Martin Hojsík (Member of the European Parliament)

17 Oct 2025 · REACH revision

Pharmaceutical industry urges clarity on AI research exemptions and data rules

14 Oct 2025
Topic — EU initiative to simplify digital regulations across multiple legislative acts.
Message — The organization seeks clarification that AI used in medicine development is exempt from the AI Act, refinement of health data sharing rules, streamlined international data transfer requirements, and harmonized cybersecurity breach notification rules. They argue current overlapping requirements create legal uncertainty and divert resources from research to compliance.123
Why — This would reduce compliance costs and legal uncertainty for pharmaceutical research and development.456
Read full response

Meeting with Chiara Galiffa (Cabinet of Commissioner Maroš Šefčovič)

9 Oct 2025 · EU – US relations

Meeting with Paul Speight (Head of Unit Environment)

8 Oct 2025 · REACH, latest developments in chemicals

Meeting with Matthias Jorgensen (Acting Director Trade)

7 Oct 2025 · EU-US trade relations

EFPIA urges streamlined EU device rules to end clinical trial delays

6 Oct 2025
Topic — Simplifying medical device and in-vitro diagnostic regulations to reduce burden while ensuring patient safety.
Message — EFPIA requests establishing a single EU accountable body for harmonised oversight, implementing an All-in-One coordination process for combined trials, introducing risk-based evaluation frameworks, and extending exemptions for in-house testing in central laboratories. They seek accelerated pathways for emergency use and early access to companion diagnostics.1234
Why — This would reduce trial delays affecting up to 42,200 patients and accelerate launch of up to 89 therapies.56
Read full response

Meeting with Olga Solomon (Head of Unit Health and Food Safety) and Bayer AG and

3 Oct 2025 · The discussion focused on simplifying Annex II to foster innovation while aligning with ICH guidelines, with ideas for legacy products to gradually transition.

Pharma industry urges EU to strengthen IP protections and simplify regulations

2 Oct 2025
Topic — EU framework to strengthen Europe's innovation ecosystem and attract investment for innovative companies.
Message — The organization requests stronger IP protections, simplified legislation across health and chemical regulations, expanded sandboxes for innovation, and better access to capital for all company sizes. They argue the consultation favors small companies but ecosystems need all actors to translate ideas into patient treatments.1234
Why — This would attract more investment to Europe and help them compete with US and China.56
Read full response

Meeting with Olivér Várhelyi (Commissioner) and

2 Oct 2025 · All pressing portfolio topics

Meeting with Tomislav Sokol (Member of the European Parliament, Rapporteur) and Standing Committee of European Doctors and European Society for Medical Oncology (ESMO)

25 Sept 2025 · Health policy

Response to EU cardiovascular health plan

11 Sept 2025

With more than 13 million new cases diagnosed annually and costs amounting to 282 billion per year, the burden of Cardiovascular Disease on patients, healthcare systems and society is staggering. EFPIA therefore supports a robust and well-resourced EU CVH Plan that sets out actions with clear added value, clear objectives and measurable targets, e.g. the reduction of premature and preventable deaths by 1/3 by 2030. The plan should encompass primary, secondary and tertiary prevention, care and rehabilitation. The primary objective should be to bend the morbidity curve by proactively focusing on prevention, early detection and preventative care, in line with the latest scientific advances and clinical guidelines, taking into account major modifiable risk factors. The Plan should support research and innovation to improve health outcomes across CVDs and cater to unmet health needs and also contributing to European research eco-system and competitiveness. It should scale up already existing initiatives co-funded by the EU, e.g. in the scope of IMI and IHI. As its flagship initiative the Plan should define and support the implementation of Cardiovascular Health Checks to be performed in primary care settings. These checks should include screening for a comprehensive range of cardiometabolic risk factors, to enable prevention and early detection of cardiovascular disease as well as obesity and diabetes which are both major modifiable risk factors for CVDs. These health checks should be automatically included whenever routine bloodwork is ordered in primary care for adults and be performed regularly for individuals from an age set out in the plan (e.g. the age of 40), and for adults (age 18+) who are in high-risk groups (e.g. family history of premature CVD, people with familial hypercholesterolemia, obesity, diabetes and chronic kidney disease). These health checks should increase in frequency for people at risk for developing CVD. It is estimated that more than 1 million fatal CVD events could be avoided in the EU over the next 10 years if 70-% of people living with CVD had their risk factors better managed than today. During those checks, the following can be measured to offer a good understanding of the risk profile of the individual: Family history of premature CVD, Familial Hypercholesterolemia, cardiomyopathies - LDL-C - Blood pressure (heart rate recorded at the time of BP measurement) - Smoking status, harmful alcohol consumption status - Body mass index - HbA1c (glycated haemoglobin, history of hyperglycaemia - Elevated levels of Lipoprotein a - Other red flag symptoms, such as oedema, breathlessness, blood/albumin/protein in the urine and fatigue. Based on the results and the subsequent risk profile assessment, HCPs could further check for: - Abdominal obesity, including waist circumference, waist-to-height ratio, and waist-to-hip ratio - Blood glucose level, including impaired glucose tolerance and impaired fasting glucose - Hypothyroidism - Systemic inflammation - Impaired kidney and renal function - Liver disease The EU should also invest in supporting initiatives such as: (i) immunisation programmes (ii) development of a European network of integrated CVH centres of excellence across the EU Member States to optimise clinical practice and R&D of cardiometabolic conditions through multi-stakeholder collaboration and public-private partnerships; (iii) creating an EU Inequalities Registry for CVD patients, implemented by the Joint Research Centre, to generate data on the impact of CVD on underserved populations and to bring together existing cardiovascular registries in Europe; (iv) supporting Members States to implement treatment adherence programs and drive focus on reaching treatment goals; (v) establishment of a dedicated CVH Research Mission and ensuring financial investment in basic and translational CV research (vi) establishment of a cardiovascular health pilot within the European Health Data Space.
Read full response

Meeting with Olivér Várhelyi (Commissioner) and

11 Sept 2025 · Site visit of UCB factory

Meeting with Olivér Várhelyi (Commissioner) and

11 Sept 2025 · Consumer protection dimension of specific dossiers

Meeting with Mariateresa Vivaldini (Member of the European Parliament, Shadow rapporteur)

10 Sept 2025 · CMA

Meeting with Peter Liese (Member of the European Parliament)

9 Sept 2025 · Austausch

Meeting with Jessika Roswall (Commissioner) and

1 Sept 2025 · To discuss the REACH revision and discuss the IHI PFAS projects.

EFPIA demands harmonised rules and trade secret protection in data strategy

18 Jul 2025
Topic — This consultation seeks to streamline EU data sharing rules and improve legal coherence for businesses.
Message — EFPIA requests aligning the Health Data Space with trade secret laws to protect sensitive commercial information. They urge the EU to harmonise data transfer rules across member states to prevent regulatory fragmentation. They also seek clarity on AI regulation exemptions for pharmaceutical research and development.123
Why — Clearer rules would reduce legal uncertainty, protecting high-cost R&D investments and proprietary trade secrets.45
Impact — Patients and researchers lose the benefits of a unified health ecosystem due to fragmented national rules.6
Read full response

Meeting with Tiemo Wölken (Member of the European Parliament, Shadow rapporteur) and Johnson Johnson and

17 Jul 2025 · Critical Medicines Act

Meeting with Marco Marsella (Director Health and Food Safety) and MedTech Europe and

10 Jul 2025 · EHDS and IHI calls

Response to Critical Medicines Act

4 Jul 2025

EFPIA welcomes the objectives of the Critical Medicines Act (CMA) to reinforce supply chain resilience and improve the availability of medicines for patients across Europe. To achieve these goals effectively and without unintended consequences, the Acts implementation should be targeted, risk-based, and supportive of innovation. It must also align with existing EU and national frameworks, avoiding duplication and unnecessary regulatory and administrative complexity. Article 3(7) should ensure that vulnerability evaluations are based on robust, product-specific criteria such as real-world shortage history, manufacturing complexity, and clinical relevance, rather than misleading indicators like supplier concentration or geographic sourcing. This is essential to avoid incorrectly classifying secure products (especially complex biologics) as vulnerable, which in turn could lead to unnecessary regulatory burdens. Likewise, the definition of medicinal products of common interest (Article 3(5)) should be narrowly applied to situations where persistent and verifiable access issues exist, such as a medicine being unavailable in at least three Member States for four years after marketing authorisation. Joint or collaborative procurement (Articles 21-23) should remain a last-resort measure, used only after national approaches have been fully explored, and must not undermine national pricing or reimbursement frameworks. As addressed in Article 18, public procurement can be a valuable tool to support supply resilience if reoriented toward a value-based, multi-criteria approach that gives due weight to supply chain robustness, sustainability, and clinical value. Article 18 should also recognise trusted international partners such as the UK and Switzerland as equivalent to EU-based suppliers to avoid undermining existing supply networks with similar or equivalent supply security standards. Strategic Projects (Articles 5-12) should explicitly encompass existing manufacturing capacity, investments in digital supply chain tools, and advanced production technologies that enhance flexibility and preparedness. At the same time, the CMAs alignment with broader policy areas is critical. This includes ensuring coherence with environmental and chemical legislation to prevent unintended barriers to manufacturing. Article 20 on contingency stock obligations should be calibrated carefully, applying only to critical products confirmed as vulnerable and based on a coordinated, EU-level framework that replaces fragmented national approaches. Flexibility on stock formats and locations, developed in consultation with industry, is essential to avoid inefficiencies or disruptions. The Critical Medicines Coordination Group (Articles 25 and 26) should function as a technical enabler of multistakeholder dialogue (including industry representation) and implementation, not as a centralised regulatory authority. Data provisions under Article 29 should prioritise leveraging existing platforms like EMVS and ESMP, ensuring that any new requirements are proportionate, harmonised, and focused on closing real information gaps. Finally, Article 27 on international cooperation presents a vital opportunity to secure diversified and resilient global supply chains through strategic partnerships with like-minded countries. Resilience should be defined by flexibility and strength of supply networks among other criteria, not by location alone, thus avoiding protectionist measures that risk fragmenting the internal market. By embedding proportionality, coordination, and stakeholder dialogue throughout its implementation, the CMA can support Europes dual ambition of enhancing medicine availability and maintaining global leadership in pharmaceutical innovation and manufacturing.
Read full response

Meeting with Maya Matthews (Head of Unit Health and Food Safety)

3 Jul 2025 · Discussion on implementation of the HTA Regulation with EFPIA HTA Working Group

Pharma industry urges broader scope for EU decarbonisation act

27 Jun 2025
Topic — European initiative to speed up industrial decarbonisation and boost green technology investments.
Message — EFPIA requests broadening the scope beyond energy-intensive industries to include pharmaceutical companies. They advocate for faster permitting and the promotion of green technologies like carbon capture.12
Why — The pharmaceutical sector would gain access to state-backed funding and simplified infrastructure permits.3
Impact — Energy-intensive sectors may face more competition for limited funds and technical support.4
Read full response

Meeting with Sabine Weyand (Director-General Trade)

25 Jun 2025 · Latest global economic developments.

Meeting with Adam Jarubas (Member of the European Parliament, Committee chair)

25 Jun 2025 · Akt o Lekach Krytycznych

Meeting with Olivér Várhelyi (Commissioner) and

25 Jun 2025 · Exchange of views on the EU pharma policy

Meeting with Mohammed Chahim (Member of the European Parliament, Shadow rapporteur for opinion) and MEDICINES FOR EUROPE and

25 Jun 2025 · Roundtable Critical Medicines Act

Meeting with Sirpa Pietikäinen (Member of the European Parliament)

23 Jun 2025 · Medicine access

EFPIA Urges EU to Prioritize Pharmaceuticals in Bioeconomy Strategy

21 Jun 2025
Topic — EU initiative for a circular and climate-neutral bioeconomy using sustainable biomass.
Message — EFPIA requests prioritizing biomass for high-value sectors like pharmaceuticals due to limited supply. They call for a risk-based regulatory approach and faster approval pathways for new biotechnologies.123
Why — Securing priority access would ensure manufacturing stability and help replace fossil-based materials.45
Impact — Industries with lower perceived societal value would lose access to limited biomass supplies.67
Read full response

Meeting with Dorota Denning (Cabinet of Commissioner Valdis Dombrovskis), Zaneta Vegnere (Cabinet of Commissioner Valdis Dombrovskis)

19 Jun 2025 · Competitiveness and simplification

Meeting with Tilly Metz (Member of the European Parliament, Shadow rapporteur) and Bureau Européen des Unions de Consommateurs and

13 Jun 2025 · Critical Medicines Act

Meeting with Dan-Ştefan Motreanu (Member of the European Parliament)

12 Jun 2025 · Barriers to Accessing and Affording Medicines in Eastern Europe

EFPIA Urges Stronger IP Rules for European Biotech Growth

11 Jun 2025
Topic — The EU is consulting on measures to accelerate biotechnology innovation and competitiveness.
Message — EFPIA calls for reinforced intellectual property rules, including removing the five-year cap on certificates. They also advocate for simplified clinical trial frameworks and incentives for private investment. The group suggests pension reforms to increase liquidity for venture capital and small enterprises.1234
Why — These measures would secure research investments and improve competitiveness against the US and China.5
Impact — Generic manufacturers face high financial penalties and delayed market entry from stricter patent enforcement.6
Read full response

Meeting with Viktória Ferenc (Member of the European Parliament)

5 Jun 2025 · Introduction, exchange of views

Meeting with Sandra Gallina (Director-General Health and Food Safety) and

5 Jun 2025 · EU pharmaceutical regulation and policy

Meeting with Marc Lemaitre (Director-General Research and Innovation) and MedTech Europe and

4 Jun 2025 · 2nd dialogue with representatives from across the life sciences to review the progress of the IHI, to discuss opportunities to optimise the current partnership and to exchange views on the future of EU research and innovation programmes.

EFPIA urges tailored AI skills and biopharma regulatory sandboxes

3 Jun 2025
Topic — The EU's Apply AI Strategy aims to boost industrial AI adoption and competitiveness.
Message — EFPIA requests that the EU align AI training with biopharma needs and create specific regulatory sandboxes for medicine. They also want clear guidance on healthcare AI use and flexibility regarding non-European technologies.123
Why — These measures would solve recruitment challenges and provide legal certainty for pharmaceutical AI tools.45
Impact — Local tech providers could lose out if the EU allows non-European AI to dominate the market.6
Read full response

Pharma Group Demands Clear AI Act Research Exemptions

3 Jun 2025
Topic — A European policy strategy to facilitate AI adoption in scientific research.
Message — EFPIA requests clear guidance on AI Act exemptions for scientific research to ensure predictability. They advocate for sector-specific oversight led by the European Medicines Agency rather than general authorities. Additionally, they call for harmonized rules to prevent national-level legal fragmentation.123
Why — This would reduce the expensive overhead of hiring staff to navigate overlapping regulations.4
Impact — Public transparency suffers if AI models are kept as trade secrets.5
Read full response

Response to Evaluation of the Good Laboratory Practice (GLP) Directives

2 Jun 2025

EFPIA welcomes the opportunity to contribute to the Call for Evidence regarding the Good Laboratory Practice (GLP) framework. From our perspective, the current GLP directive and the existing framework are functioning well and continue to support high-quality non-clinical studies across the EU. EFPIA finds that the GLP principles as defined by the OECD are both relevant and value-adding. They have proven effective in ensuring data integrity, mutual acceptance of data, and alignment across international regulatory systems. In this context, we would like to stress that introducing EU-specific or deviating GLP guidelines risks undermining this alignment and could create unnecessary complexity without clear added value. We believe that the guiding principle for any future considerations should be the pursuit of a globally harmonised and consistent set of GLP standards. This is crucial to avoid unnecessary administrative burden, promote regulatory efficiency, and maintain the EUs position as a competitive and attractive environment for pharmaceutical research and development. We remain committed to supporting a regulatory environment that encourages innovation, ensures high-quality standards, and aligns with global practices.
Read full response

Meeting with Michalis Hadjipantela (Member of the European Parliament)

22 May 2025 · Meeting about PFAS

Meeting with Adam Jarubas (Member of the European Parliament, Committee chair)

20 May 2025 · EU competitiveness agenda opportunities for the European economy and access to healthcare for all EU citizens

Meeting with Ana Maria Blass Rico (Acting Head of Unit Internal Market, Industry, Entrepreneurship and SMEs)

15 May 2025 · Exchange of views on the REACH revision and PFAS

Meeting with Patricia Reilly (Cabinet of President Ursula von der Leyen)

13 May 2025 · Discussion on the pharmaceutical industry Strategic Dialogue

Response to Communication on the EU Stockpiling Strategy

9 May 2025

EFPIA and Vaccines Europe support the Commissions recognition that there is real added value in having a coordinated, cross-sectoral and forward-looking EU approach to stockpiling, pulling resources together and identifying common overall objectives and general principles for EU and Member States. The EUs ambition regarding harmonization, simplification and competitiveness should be reflected in the Strategy. However, medicinal products differ significantly from other types of goods that could be stockpiled. They are diverse, technically complex, and often produced under stringent regulatory and logistical constraints, and even seasonal conditions (e.g. flu vaccines). And while stockpiling is one potential risk mitigation measure against out-of-stock situations, it is not universally applicable and counterproductive. In fact, stockpiling is among the least efficient tools to prevent or mitigate shortages. As highlighted by the EMA, the stockpiling of medicines results in a disrupted supply chain. Stockpiling can prolong the duration of a shortage, precipitate a shortage or result in an inequitable distribution to patients. (EMA, Good practices for industry for the prevention of human medicinal product shortages, 28 February 2023) If imposed, stockpiling of medicinal products should be done through contingency stocks that are proportionate, exceptional, and targeted. It should - be limited to critical medicinal products with vulnerable supply chains and those required for crisis preparedness, and only be used as a last resort, when other, more sustainable measures cannot be applied. Their scale must reflect specific risk profiles and real-world needs. As in other sectors, pharmaceutical manufacturers manage inventories and production to absorb fluctuations in demand and supply (e.g. epidemiology changes, national immunization plan evolution for vaccines, tender markets). However, for medicines produced on a make-to-order basis (such as plasma-derived products, radionuclides, or many ATMPs) and those with a short total shelf life it could be technically unfeasible. A comprehensive EU stockpiling policy in the form of contingency stocks should prioritize coordination across the EU in close consultation with all supply stakeholders. At present, excessive or fragmented national stockpiling obligations exacerbate shortages, disrupt supply chains, and hinder equitable access and solidarity across countries. Hence, should the Commission decide to establish Union-level contingency stocks, it must coordinate with national competent authorities to ensure alignment, covering product-specific ceilings and allowances for semi-finished goods based on a robust vulnerability assessment of critical medicinal products supply chains. Existing systems such as EMVS and ESMP should be leveraged for real-time monitoring of supply, demand, and stock levels. Additionally, EU should streamline procedures to facilitate the redeployment of products with different packaging or labelling across Member States. Introducing multi-country packs and harmonized labelling (including e-leaflet) would allow agile, compliant distribution according to patient needs. The volume and duration of the measure should be duly justified based on retrospective data and actual demand forecasts considering production lead times, stock ownership agreements, and considering other existing stockholdings in the EU. Furthermore, Union-level contingency stock holdings should supersede and not duplicate national contingency stock or stockpiling requirements as this could disrupt supply or fragment markets. We recommend to enhance the Solidarity Mechanism framework to enable coordinated, flexible rotation and redistribution of products in times of crisis. This system would ensure efficient resource use across Member States, mitigate the risk of shortages and allow companies to replenish in a reasonable time without being penalized as a result.
Read full response

Response to EU Strategy on medical countermeasures

9 May 2025

EFPIA & Vaccines Europe support the ECs initiatives for further acceleration of development, availability and accessibility of medical countermeasures (MCM) to ensure EU preparedness and response against public health threats. To reach success in preparedness in Europe, we believe that the EC needs to develop fit-for-purpose funding tools within HERA to become a comprehensive end-to-end research and innovation authority that can support late-stage product development and manufacturing for pandemic-relevant MCM. An end-to-end approach entails a single entity, such as HERA, which can provide monitoring, coordination and/or funding support throughout product development, manufacturing and bringing MCM to the market. The respective steps of these processes include risk assessment, early and late developments, regulatory pathways, manufacturing, purchasing and proportionate stockpiling, and liability. Improvement of existing funding tools and/or establishment of innovative mechanisms should be one of the main priorities in the upcoming Strategy. Public funding of MCM should be designed in a way that supports the business cases based on an end to end approach (from early R&D to post-market surveillance) taking in consideration risks inherent to preparedness and crisis phases. Funding mechanisms should include more flexibility into the (public-private) contracts/commitments via joint governance structures, risk sharing, protection of IP ownership, use of stage-gate process, and allowing entrance of new players or exit strategies without the need to launch entirely new procedures (e.g. OTA contract used by BARDA). There is a need for a significantly higher budget in the next multiannual financial framework (MFF). The current small-scale grants and loans are not suitable to achieve outcomes in late-stage development as this requires significant capital. Furthermore, more predictability is necessary. This involves long-term contracts and reducing market uncertainty through sharing of threat assessments and their methodology, with clear early market commitments and guarantees of acquisition of reserved and/or procured MCMs volumes and realistic lead times. Procurement and contracting processes should be tailored to support specific innovations rather than simply transposing criteria applicable to pandemic situations to endemic ones. Forecasting for MCMs, both proportionated stockpiled materials in the preparatory phase, as well as increased production volumes required in crisis mode, is important to understand at early stage so that new and existing manufacturing processes and facilities can be scaled appropriately. Rapid high-volume production of the desired MCMs will require timely access to the appropriate raw materials, facilities, equipment, and trained personnel. It is currently considered that reserving this capacity at the original manufacturer might be difficult and comes with a cost, which must be factored in, but working more closely with a range of well-supported European-based subcontractors (including CMOs) with relevant and diverse capabilities is helping to leverage capacity in times of crisis. A clear division of funding responsibilities between European institutions and EU Member States is essential to prevent overlaps, which waste resources and weaken EU-level MCM strategies. Clarity will improve transparency and coordination. Several Member States already have strong R&D, manufacturing facilities, robust warehouse/distribution networks, and scientific expertise - with some having strengths in one area and others across several - that can be used during crises and in preparation phases. However, this work needs to be done in partnership with industry including pharmaceutical, device, and diagnostic companies, as well as subcontractors and distributors. Close coordination and collaboration will be key to successfully carrying out the plans being developed by the European Commission and other EU stakeholders.
Read full response

Response to New comprehensive strategic approach towards India

8 May 2025

The Draghi Report on European Competitiveness and the Economic Security Strategy underscores the importance of strategic partnerships in reinforcing the EUs leadership in the pharmaceutical sector, an industry essential to EU innovation, strategic autonomy, public health and economic growth. EFPIA supports a truly strategic approach to a partnership with India that strengthens regulatory trust, patient safety, intellectual property protection and ensures supply chain resilience. India represents a significant growth opportunity for our industry, driven by its expanding economy, large population, and increasing demand for innovative healthcare solutions. Yet, current trade figures reveal that EU pharmaceutical exports to India remain limited. In 2023, EU pharmaceutical exports to India reached 5.5 billion (imports: 2,6 billion). In contrast, EU pharmaceutical exports to China and the U.S. were 21.3 billion and 92 billion, respectively (Eurostat). Pharmaceuticals rank only 11th among EU exports to India, compared to 1st and 4th for the U.S. and China respectively (Trading Economics). Key barriers to the introduction of innovative medicines in India include weak IP protection, strict price controls and regulatory delays. Between 2012 and 2021, India ranked 18th among G20 countries in the launch of new medicines (phrma.org/resources/global-access-to-new-medicines-report). The strategic partnership provides the opportunity to create more jobs and investment as well as improved patient access to innovative medicines. Conversely any trade agreement with India that fails to include meaningful provisions for pharmaceuticals risks undermining the EU's overarching strategy for diversification of trade partners, which is critical for innovative pharmaceuticals as a highly export driven sector in Europe. The strategic approach needs to build on the finalisation of a comprehensive FTA that includes strong IP protection and equal level playing field and sets a basis for regulatory collaboration with regulatory harmonization as a goal (see attached). EFPIAs recommendations: - Ensure strong IP protection: currently India provides no TRIPS-compliant regulatory data exclusivity and protection, lacks regulatory provisions on transparency for making market authorizations public, has no trade secrets protection law, lacks patent enforcement and has restrictive patentability criteria. Any agreement with India needs to include a meaningful IP chapter, with Indias TRIPS commitments at a minimum, and set up ongoing dialogue on its enforcement. - Commit to annual High-Level Dialogues on IP, Trade, and Health & Pharmaceuticals, with industry participation. - Collaborate with India to fight counterfeit and illegal medicines. - Build on the Trade and Technology Council, use the strategic partnership as a vehicle to initiate regulatory dialogue and incremental alignment. India should be encouraged to become actively engaged at the ICH (currently observer) and to seek PIC/S membership. Ultimately, the regulatory collaboration could lead to MRA discussions. - Support India in developing a globally aligned clinical trial system that effectively reduces local study requirements. Streamlined regulations can also be applied to include drugs with similar mechanisms or prior precedent to support patient safety, innovation, and regulatory trust benefiting both sides. - Ensure tariff exemption on health products, including finished therapeutics and vaccines, as well as active pharmaceutical ingredients, raw materials, chemicals, other inputs, including specialty equipment used to invent, manufacture, and deploy them. - Further elaborate a pharmaceuticals and health-centric EU-India digital partnership under the TTC, including industry involvement. Key elements: trusted cross-border data flows, alignment on AI governance, digital health interoperability, regulatory digitalisation, cybersecurity, IP protection, and pharmaceuticals supply chain visibility.
Read full response

Meeting with Hildegard Bentele (Member of the European Parliament)

7 May 2025 · EU Water Policy

Meeting with Aurelijus Veryga (Member of the European Parliament)

6 May 2025 · Balancing environmental goals and pharmaceutical access in EU policy

Meeting with Aura Salla (Member of the European Parliament)

6 May 2025 · Clean Industrial Deal, chemicals and pharmaceutical industry

Meeting with Olivér Várhelyi (Commissioner) and

30 Apr 2025 · Exchange of views on the EU pharma policy

Meeting with Andreas Glück (Member of the European Parliament, Shadow rapporteur for opinion)

28 Apr 2025 · Critical Medicines

EFPIA urges EU strategy to restore pharmaceutical industry leadership

17 Apr 2025
Topic — This consultation aims to boost Europe's life sciences competitiveness and reduce global dependencies.
Message — EFPIA calls for a dedicated EU Office for Life Sciences to coordinate governance. They demand stronger intellectual property protections and streamlined clinical trial approvals to foster innovation.123
Why — Simplified regulations and robust patents would lower compliance costs and increase investment.45
Impact — Environmental groups lose safety protections if restrictions on hazardous substances are bypassed.6
Read full response

Meeting with Vilija Sysaite (Cabinet of Executive Vice-President Stéphane Séjourné)

14 Apr 2025 · - potential U.S. tariffs on Pharma - upcoming REACH revision and PFAS - European environmental legislation

Meeting with Kerstin Jorna (Director-General Internal Market, Industry, Entrepreneurship and SMEs) and

10 Apr 2025 · Impact of US tariffs

Meeting with Stéphane Séjourné (Executive Vice-President) and

10 Apr 2025 · Impact of US tariffs

Meeting with Tomislav Sokol (Member of the European Parliament)

7 Apr 2025 · Health policy

Meeting with Maurice Whelan (Head of Unit Joint Research Centre), Tobias Wiesenthal (Head of Unit Joint Research Centre) and

4 Apr 2025 · Scientific roundtable discussion between the European Commission’s Joint Research Centre and the pharmaceutical industry on the topic of leveraging health data and data sciences for innovation

Meeting with Morten Løkkegaard (Member of the European Parliament, Shadow rapporteur)

3 Apr 2025 · Biotechnology & Simplification

Meeting with Susanne Appel (Cabinet of Commissioner Maria Luís Albuquerque)

3 Apr 2025 · Financing challenges for small enterprises

Response to Foreign Subsidies Guidelines

2 Apr 2025

The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomes the opportunity to submit feedback on the Foreign Subsidies Guidelines. The FSR aims to subject subsidies granted by non-EU countries to the same sort of scrutiny as applies to EU Member State subsidies under EU State aid rules. In doing so, the Commission is required to respect its obligations under international law, and to adopt implementing rules which take the utmost account of the goal of limiting the administrative burden imposed on undertakings. The Commission Implementing Regulation on detailed arrangements for the conduct of proceedings by the Commission pursuant to the FSR only partially limited the administrative burden imposed on undertakings which remains in many cases disproportionate. In the overwhelming majority of the FSR notifications that are not problematic, companies nonetheless have had to allocate scarce resources to collate the data necessary for the filing (and in many cases beyond in response to RFIs) that is a manual and time-consuming process, running counter to the new Commissions broader objective of reducing drastically the regulatory and administrative burden and making EU administrative processes simpler, faster, and lighter". It is imperative that in addition to providing guidance on the assessment of distortion of competition, the application of the balancing test, and the power to call-in below threshold transactions, the Commission introduces additional measures to decrease the administrative burden on companies. In addition, it is imperative the Commission introduces additional measures to decrease the administrative burden on companies in the context of its proposed legislative updates which are due by 14 July 2026. EFPIA has compiled consolidated feedback in consultation with its members to respond to this consultation. Please find this as an attachment hereto.
Read full response

EFPIA pushes for simpler and more flexible EU Taxonomy rules

26 Mar 2025
Topic — Amending EU Taxonomy rules to make sustainability reporting simpler and more cost-effective.
Message — EFPIA calls for greater clarity on materiality thresholds and partial alignment classifications. They recommend making operating expense disclosures voluntary and removing restrictions on hazardous chemicals. They also suggest updates be published earlier to provide sufficient implementation time.123
Why — This would lower administrative burdens and reduce costs of complex data collection.4
Impact — Environmental groups lose protections as the industry seeks to remove chemical restrictions.5
Read full response

Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation

21 Mar 2025

EFPIA welcomes the European Commissions initiative to evaluate the IVDR and MDR. In the context of a possible revision of these legislations, EFPIA strongly supports targeted amendments to establish a proportionate, risk-based, and EU-coordinated regulatory framework. Both Regulations, while aiming to ensure availability of high-quality devices, have created regulatory complexity, increased administrative burdens and introduced misalignment with the Clinical Trials Regulation, resulting in delays in patient access to innovation. These challenges discourage investment in Europe and impact patient access to advanced therapies. To address these issues, EFPIA proposes the following key revisions for the IVDR and MDR. A more detailed explanation for these revisions is provided in the attached document in annex. Improve governance: Establish a single, integrated accountable body ensuring an EU harmonized interpretation of requirements based on scientific rationale, a process for dispute resolution, a better oversight and harmonisation of NBs. Also ensure closer coordination between the medicines pathway and MDs/CDx pathways and establish a process for consolidated scientific and regulatory advice covering combined trials involving medicinal products, integrated device combination products and IVDs. Accelerate full EUDAMED deployment to support coordinated assessment of PS and CI, data-sharing, and efficient approval for combined trials. Ensure there is an appropriate pathway in place for breakthrough innovation, orphan MDs/IVDs, accelerated review within the device and diagnostics regulations, and early access for CDx, coordinated with relevant pathways in the medicinal product legislation. Improve coordination between MDRIVDR & CTR: Implement an All-in-One coordination process, building on the COMBINE project, to centralise and integrate the submission and assessment process for CI/PS and CT applications. Also ensure coordination of Ethics Committees. Establish appropriate scientific advice procedures with the involvement of all relevant stakeholders, including EMA, NCAs, expert panels and/or NBs, as appropriate, to facilitate development programs using integral drug-device /diagnostic combined products. Introduce a risk-based approach for CI/PS applications for low-risk MDs/IVDs to avoid unnecessary regulatory burdens on study sponsors, regulators and other stakeholders. Also remove PSA requirements for CE-marked IVDs used according to their intended purpose. Update Art 5.5 on in-house testing to also cover devices manufactured and/or used in central laboratories or clinical research organisations when such devices are used only in the context of investigational medicinal product trials. Reduce regulatory burdens in IVDR and MDR: - Delete Art 58.2 and limit regulatory scrutiny to performance studies meeting Art 58(1) criteria - Delete Art 70.1 and refine Art 70.2 to ensure that regulatory requirements focus on IVDs undergoing clinical validation rather than routine diagnostic use. - Ensure that the requirements for CDx are more proportionate (flexible interpretation of the intended use within clinical trials). -Ensure a proportionate approach for certification of legacy devices, avoiding excessive evidence requirements for well-established devices. -Clearly state in MDR which of its requirements apply to products where a device is combined with a drug and the PMOA is a therapeutic effect. -Clarify application of Art 13/14 and 16 for co-packaged medicinal products. -Revise Art 74 to create a new category of studies which are conducted on devices that do not bear a CE-marking or are used outside of their intended use, but which are not intended to assess the safety or performance of a device. -Remove Art 82.2 and the option to have national provisions for clinical investigations -Revise rule 11 risk classification for MedDev SoftWare to adopt a truly risk-based approach as per IMDRF principle
Read full response

Meeting with Sander Smit (Member of the European Parliament) and Association of the European Self-Care Industry

21 Mar 2025 · ENVI-general

Meeting with Olivér Várhelyi (Commissioner) and

20 Mar 2025 · Exchange of views on the EU health policy

Meeting with Patricia Reilly (Cabinet of President Ursula von der Leyen)

20 Mar 2025 · Competitiveness of the EU pharmaceutical industry

Meeting with Maroš Šefčovič (Commissioner) and

20 Mar 2025 · Global trade developments and challenges

Meeting with Vytenis Povilas Andriukaitis (Member of the European Parliament)

19 Mar 2025 · EU Health Policy

Meeting with Dolors Montserrat (Member of the European Parliament, Rapporteur) and Novo Nordisk A/S

19 Mar 2025 · New EU Pharmaceutical Legislation

Meeting with Roxana Mînzatu (Executive Vice-President) and

19 Mar 2025 · Topical issues for the pharmaceutical industry, including competitiveness and skills.

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur)

18 Mar 2025 · SPC, Compulsory Licensing, Pharma Package

Response to EU Start-up and Scale-up Strategy

17 Mar 2025

The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomes the Commission consultation on an EU startup and scaleup strategy to foster an innovation friendly environment that makes it simpler and faster for European innovative startups to grow and scale up in the Single Market. EFPIA would like to propose below concrete actions that are needed from the EU and/or Member States to address hurdles related to financial, regulatory and administrative burdens. Due to the limited space for feedback, these concrete actions are developed further in the annex attached to the summary response. 1 Improve access to finance Europe needs to catch up with the US and Asia and create policies and funding streams to support startups and scaleups evolving in the biopharmaceutical sector. EFPIA would like to propose three main recommendations which can help retain and grow Europes startups and scaleups footprint: a) Pension funds reform: Increase flexibility of pension funds in favour of venture capital (VC) and startups / scaleups / SMEs investment to boost sector growth b) Euronext needs to be enhanced and used more widely to attract more domestic and international investors, to compete against the US Nasdaq c) Establish a 1 billion guarantee fund for limited partners to reduce risk sharing. 2 Reduce regulatory and bureaucratic burdens EFPIA proposes a list of legislations that have an important impact on startups and scaleups in Europe and would benefit from a revision to foster innovation and competitiveness (more details in the annex document). - Urban Wastewater Treatment Directive - Classification, Labelling and Packaging of substances and mixtures Regulation - Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation - Ecodesign for Sustainable Products Regulation - EU Taxonomy Regulation - European Health Data Space Regulation - AI Act - Clinical Trials Regulation - Cell and gene therapies legislation - Safe and Sustainable by Design framework - TiO2 and other colorants legislation - General Data Protection Regulation - General pharmaceutical legislation currently being reviewed. 3 Improve access to EU market In relation to the HTA Regulation 2021/2282 there is a need for further strengthening obligations on Members States to use the outputs of the EU process (and not duplicate); the capacity for Joint Scientific Consultations needs to be immediately scaled up to support SMEs. 4 Improve access to research and technology infrastructure and programmes, knowledge (e.g. patents) and support services (business acceleration services, coaching and networking) a) Need to Strengthen European Research Infrastructure Access. References in the annex to Horizon Europe, EIC, European Research Infrastructure Consortiums, Biohubs b) Need to enhance knowledge transfer, IP accessibility and regulatory science support. References in the annex to Technological Transfer Offices, national patent offices, IP licensing, EPO c) Need to improve access to business support services, clinical trial networks and R&I programmes References in the annex to European Biomedical Innovation network, Startup Europe initiative, closer industry-academia collaboration, targeted incentives, Horizon Europe FP10, dedicated fund for biomedical corporate-startup collaborative incubators d) Need to reduce fragmentation and ensure regulatory and data protection clarity. References in the annex to Digital Innovation Hubs, startup visa, scale up support mechanism, united VAT for startups scaling up across borders.
Read full response

Meeting with Sirpa Pietikäinen (Member of the European Parliament)

14 Mar 2025 · Cancer and ontology

Meeting with Kristoffer Storm (Member of the European Parliament)

12 Mar 2025 · Pharmaceutical Federation

Meeting with Nicolo Brignoli (Cabinet of Commissioner Valdis Dombrovskis)

11 Mar 2025 · taxonomy

Response to Evaluation of the Public Procurement Directives

7 Mar 2025

The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomes the opportunity to submit feedback on the effectiveness of the EU public procurement directives. Recourse to the public procurement of medicines has increased in recent years as payers across the EU struggle to balance constrained healthcare budgets and increasing demand. Yet the practical application of the procurement rules varies widely across EU Member States in ways that are not always aligned, effective, or compliant with the spirit or the letter of the core provisions of Directive 2014/24/EU. The procurement of healthcare goods and services should respect fundamental procurement principles guaranteeing an open, transparent, objective, nondiscriminatory award procedure leading to the selection of the most economically advantageous offer based on the best price-quality ratio. EFPIA has developed a list of 10 recommendations to ensure that procurement procedures, including joint procurement, deliver high quality medicines for patients in the right quantities, and at the right time. These recommendations, along with EFPIA's call for the adoption of best practice guidance for effective procurement are contained in the attached White Paper on the Effectiveness of Public Procurement of Medicines in the EU. Please consider this White Paper as a material part of EFPIA's submission to this evaluation.
Read full response

Meeting with Adam Jarubas (Member of the European Parliament, Committee chair)

6 Mar 2025 · Pharmaceutical strategy for Europe

Meeting with Aurelijus Veryga (Member of the European Parliament)

5 Mar 2025 · The Future of Oncology Research in Europe: Challenges and Opportunities

Pharma group urges balanced EU water resilience strategy

1 Mar 2025
Topic — A multi-annual cross-sectoral plan to achieve a water resilient Europe by 2040.
Message — The federation requests balanced policies and a risk-based approach that supports innovation and patient access. They urge the Commission to streamline processes and ensure involvement from the European Medicines Agency.123
Why — Flexible and streamlined regulations would protect the industry's competitiveness and reduce potential financial burdens.45
Impact — Patients may face reduced medicine availability if disproportionate costs are imposed on the pharmaceutical sector.6
Read full response

EFPIA urges innovation-focused Critical Medicines Act with streamlined rules

26 Feb 2025
Topic — This consultation addresses supply chain vulnerabilities and dependencies for critical medicines in Europe.
Message — EFPIA calls for an act that promotes innovation and avoids rigid targets for local production. They recommend replacing national stockpiling with EU-level coordination and streamlining regulatory processes using digital data.123
Why — The industry would avoid fragmented regulations and reduce costs through streamlined manufacturing authorizations.45
Impact — Smaller EU countries lose medicine access if large markets implement separate stockpiling requirements.67
Read full response

Meeting with Vytenis Povilas Andriukaitis (Member of the European Parliament)

19 Feb 2025 · Medicines shortages and critical medicines act

Meeting with Elisa Roller (Director Secretariat-General)

18 Feb 2025 · Competitiveness of the innovative pharmaceutical sector, with specific focus on clinical trials and biotech act.

EFPIA calls for unified EU pharmaceutical regulations

31 Jan 2025
Topic — The consultation aims to remove regulatory barriers within the European single market.
Message — The group wants a single approval process for trials across multiple countries. They also request harmonized criteria for evaluating the value of new medicines.12
Why — Harmonized rules would decrease administrative expenses and attract more research investment.3
Impact — National authorities would lose control over their unique medicine pricing and reimbursement processes.4
Read full response

Meeting with Jorge Vitorino (Head of Unit Trade)

31 Jan 2025 · Discussion on the international aspects of IP policy affecting the pharmaceutical industry

Meeting with Maurice Whelan (Head of Unit Joint Research Centre), Tobias Wiesenthal (Head of Unit Joint Research Centre) and

27 Jan 2025 · Exploit interest in a scientific roundtable between the European Commission’s Joint Research Centre and the pharmaceutical industry on the topic of leveraging health data and data sciences for innovation

Meeting with Marco Marsella (Director Health and Food Safety), Rainer Becker (Director Health and Food Safety)

24 Jan 2025 · AI in medicinal products’ life cycle

Meeting with Stine Bosse (Member of the European Parliament)

17 Jan 2025 · European chemical regulation

Response to Performance of pharmacovigilance activities for human medicines ( update of Implementing Regulation (EU) 520/2012)

15 Jan 2025

The European Federation of Pharmaceutical Industries and Associations (EFPIA), representing the biopharmaceutical industry operating in Europe, welcomes the Commissions initiative to update IR_EU_520-2012 and appreciates the opportunity to provide comments. The proposed removal of the MAH's obligation to continuously monitor Eudravigilance (EV) and to inform the Agency and national competent authorities when a signal is identified in EV is a highly welcomed change. Additionally, in many instances, the proposed updated text provides helpful clarity, such as the requirements outlined for subcontracted PV activities. However, EFPIA members are concerned that the proposed updates regarding the conduct of audits will place an additional burden on all parties involved. EFPIA would like to emphasise the importance of maintaining the established principles of a risk-based audit approach to ensure efficiency and safeguard patients and public health.
Read full response

Meeting with Andrea Wechsler (Member of the European Parliament)

15 Jan 2025 · EU Health policy

Meeting with Axel Hellman (Cabinet of Commissioner Jessika Roswall), Jan Ceyssens (Cabinet of Commissioner Jessika Roswall), Vita Jukne (Cabinet of Commissioner Jessika Roswall)

14 Jan 2025 · Chemical Regulation & Water Treatment Directive

Meeting with Teresa Ribera Rodríguez (Executive Vice-President) and

14 Jan 2025 · Meeting with EFPIA’s Board members on the objectives of the new Commission to build a cleaner and more competitive Europe.

Meeting with Olivér Várhelyi (Commissioner)

11 Dec 2024 · Priorities and initiatives concerning pharma industry

Meeting with Peter Van Kemseke (Cabinet of President Ursula von der Leyen)

11 Dec 2024 · health policies -priorities

Meeting with Adam Jarubas (Member of the European Parliament, Committee chair)

10 Dec 2024 · Pakiet Farmaceutyczny Akt o Lekach Krytycznych Polska Prezydencja

Meeting with Radan Kanev (Member of the European Parliament)

26 Nov 2024 · Sustainability and strategic autonomy of the pharmaceutical sector

Meeting with Mariateresa Vivaldini (Member of the European Parliament) and Meta Platforms Ireland Limited and its various subsidiaries

20 Nov 2024 · Meeting conoscitivo

Meeting with Tilly Metz (Member of the European Parliament)

12 Nov 2024 · Pharmaceutical policy

Meeting with Stine Bosse (Member of the European Parliament, Shadow rapporteur)

5 Nov 2024 · European health policy

Response to Health technology assessment – Joint scientific consultations on medicinal products for human use

29 Oct 2024

EFPIA welcomes the possibility to comment on this implementing act (IA) aiming to establish the basis for a unified EU level approach to Joint Scientific Consultations (JSC) - a critical component of the EU HTA Regulation. EFPIA would call on the HTA Secretariat, the Member States Expert Group on HTA and the Coordination Group to consider the following recommendations, which we consider essential to fully leverage the benefit of JSCs. Request periods should be aligned as close as possible to a rolling system, and secure adequate capacity that can meet and foster the demand from HTDs and exclude the need for the application of selection criteria. This would then ensure the predictability allowing HTDs to plan in advance and include the request for advice/consultation into their development plans and to secure the best possible alignment and synchronization with regulatory scientific advice. JSC and JCA procedures should be considered as a continuum, with the JSC dialogue informing the generation of evidence that would support the JCA submission and assessment. The implementing act should clarify, according to the HTA Regulation, that, all assets under development in any disease area are eligible to JSC and to have a JSC request duly considered, independently of the development phase. Only when demand exceeds maximum capacity, prioritization criteria established by the HTA Regulation may apply. Information asked to HTD in the JSC request should not result in restrictions based on study phase or design, against HTA Regulation principles. There is a need for further guidance on JSC and parallel JSC/EMA procedures allowing the HTD to navigate the process with a well-defined timeframe, and a streamlined exchange of information. When conducted in parallel with EMA, the procedure needs also synchronized timing, coordinated submission of documents and coordination of the overall advice process. EFPIA also supports the meaningful involvement of patients, patient organisations, clinical societies and other relevant experts at the appropriate time to fully leverage their feedback and expertise and recommends that sufficient mechanisms be developed to ensure their input is meaningfully integrated. The JSC procedure should aim at enabling HTA bodies to align on the recommendation/advice, and at including all Member States from the Coordination Group in the elaboration/endorsement of the outcome document. The outcome document should be the result of a consolidated advice, with only highlighting exceptional national divergencies, if any, which can be part of an actionable advice, rather than be a compilation of individual countries specificities. The consolidation process shall also be explained and justified in a transparent manner in the outcome document. In order to achieve the benefits of the JSC system, the JSC outcome should be actionable, i.e. provide the HTD with focused, timely, and realistic recommendations in view of the JCA submission. EFPIA takes the opportunity to highlight the importance of securing adequate resources and capacity to meet the demand for JSCs within the new EU HTA framework, including the option for follow-up/pre-submission advice. EFPIA would like to re-iterate that the security and confidentiality of the IT Platform, and the necessity of a need-to-know principle when sharing commercially sensitive and hence confidential information, are paramount for building trust into the process and for ensuring that the confidentiality of the HTD data is maintained. The protection of confidential information should therefore be strengthened by ensuring an equivalent level of protection as EMA, limiting shared information to HTA-relevant contents, adding sanctions for non-compliance with professional secrecy and inserting a reference to national criminal prosecution Additional feedback including proposed amendments to the draft implementing act is available in the attachment.
Read full response

Meeting with Victor Negrescu (Member of the European Parliament) and MedTech Europe and

16 Oct 2024 · European Health Policies and their Impact on CEE Countries and Romania event

Meeting with Stine Bosse (Member of the European Parliament, Committee chair) and European Confederation of Pharmaceutical Entrepreneurs

15 Oct 2024 · European health policy

Response to Commission Roadmap to phase out animal testing

14 Oct 2024

EFPIA (innovative pharmaceutical industry) welcomes this call for evidence. Medicines developers are required to demonstrate that potential new and commercialised medicines, therapeutics and vaccines are effective and safe in humans, relying on many different technologies to support the most appropriate testing strategies, which include in vitro assays, in silico methods and at a late stage, animals in preclinical development. We are committed to the science-based phase-in of methods to replace the use of animals for scientific purposes and the deletion of animal tests that are nowadays identified to be obsolete or redundant, but still required through some regulatory bodies. EFPIA companies aim to lead progress on this by engaging in a wide range of practical activities to help drive the development, uptake and promotion of non-animal technologies (NATs) and new approach methodologies (NAMs) so that these can be phased-in as soon as it is scientifically possible to do so. Since 2011, EFPIA has published reports giving extensive overviews of actions on putting animal welfare principles and the 3Rs into action: https://www.efpia.eu/about-medicines/development-of-medicines/animal-use-and-welfare/. Furthermore, there are numerous actions on 3Rs as part of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (https://www.sciencedirect.com/science/article/pii/S0273230024001247). EFPIA requests to be included as a relevant stakeholder in the planned targeted consultations as part of the roadmap development. In parallel, EFPIA is supporting the creation of the European roadmap to reduce reliance on animal testing in the pharmaceutical industry. While there is no single replacement for animal testing, and various tests are required by legislation, we want to work together with all the stakeholders involved and drive forward phasing out animal testing where scientifically feasible. For the roadmap to be ambitious yet practical, it must be based on comprehensive information about the current situation based on scientific, available solutions, and ongoing developments keeping human safety as a priority. To this end, we are engaging our members to sort the animal testing into three categories: Basket 1: Animal testing for which alternative technologies to replace current animal testing already exist from a scientific perspective. It also includes animal tests that the company conducting them considers having no or not enough added scientific benefit to justify them, but which are required to conduct for regulatory reasons. This basket also includes all animal testing that will become superfluous through a combination of other available tests that are not carried out on animals and/or the use of weight of evidence-based approach, if regulatory approval on the combination of alternatives was available. Strong political support is needed here at a global level to stop these mandated animal tests and procedures completely and as quickly as possible. Basket 2: Such animal testing purposes for which there are no technologically mature or validated alternatives or for which there is no scientific proof non-animal methods can replace animal tests, but for which there are already concrete ideas and hypotheses as to which alternative methods could be developed to replace them. EFPIA wishes to engage the Commission and regulators to further foster the development of these alternatives. Basket 3. Animal tests for which there is still no concept or hypothesis as to how non-animal methods could replace them and where we do not yet have a method to provide safe and effective medicines without animal testing. Here the science still needs to be more developed, and in the future hypotheses and techniques will emerge as to how animal testing can be dispensed with. EFPIA will further work with all stakeholders and will provide the Commission with our recommendations to feed into their action plan
Read full response

Meeting with Eszter Lakos (Member of the European Parliament) and EuropaBio

25 Sept 2024 · Public health

Response to Health technology assessment – Cooperation with the European Medicines Agency

24 Jul 2024

<p> EFPIA thanks the European Commission for the opportunity to comment on the proposed draft implementing act on the cooperation of the Coordination Group and the European Commission with the European Medicines Agency in the form of exchange of information for JCAs and JSCs. EFPIA recognizes the many positive elements in the text and takes this opportunity to highlight some principles that are important to be further reflected in this implementing act. <p> <i> -- The type of information covered by the implementing act is mainly generated and exchanged prior to the submission of a Marketing Authorization Application. Such information is highly sensitive for health technology developers competing to launch their products in Europe. It is imperative that the EU holds strict measures on commercially confidential information to ensure competitiveness and attractiveness of the region, in full respect of the rights of the health technology developers over the information they generate, own and share in the regulatory and JCA/JSC processes.<i> <p> -- (a). The health technology developers should remain responsible for sharing the information they generated with different authorities or stakeholders, in response to specific questions and for appropriate and relevant purposes. Information on specific medicinal products preceding a Marketing Authorization Application, including indication and target filing date, is of critical competitive nature. As the HTD shares product information directly and in confidence with regulators to allow better planning, resourcing, and learning, the HTD should be responsible for sharing this information directly with the HTA secretariat as well. This would enable the HTDs to submit the confirmation of eligibility for centralized procedure the same way they share their Letter of Intent to submit, providing the only reliable and timely information for JCA planning. This information should not be published in the Annual Work Plan at such a level that it can be re-engineered to identify the source data (e.g. target filing date). <p> -- (b). For the Annual Work Plan, it should be possible for regulators to share other early product information that HTD made available to them (e.g. portfolio information) as aggregate information once per year or quarterly as this would still enable the estimation of the volume of upcoming submissions and allow resource forecast. If combined with the information that HTDs made public until that point in time in their communication to other stakeholders, it should be sufficient for capacity forecast. <p> -- (c). On the same note, EFPIA is concerned about information generated by HTD for regulators being shared and used for a different purpose i.e. for the public report on Emerging Health Technologies, which has a different remit beyond JSC and JCA planning leaving the use, the level of protection, and the final distribution and publicity of that HTDs information unknown and unclarified. This risks to undermine the trust that constitutes the foundation of this information sharing practice between HTD and the EMA and may negatively jeopardize the willingness of the HTD to share such information with the Agency from the get-go. This is why EFPIA highlights that for the purpose of the EHT report, the subgroup should rely on public data sources, inviting HTDs to agree upon and provide data directly and on a voluntary basis. <p> -- (d). The present implementing act governs also the information that EMA shares through the IT system and the information if shared within HTA bodies or with other stakeholders should enjoy a similar level of confidentiality. The sanction proposed for breaches of confidentiality is negligible and EFPIA and its members are not convinced the approach will guarantee sufficient disincentive for individuals not to share the information. We request a more stringent sanctions for individuals breaking the confidentiality provisions.
Read full response

Meeting with Tom Berendsen (Member of the European Parliament) and European Chemical Industry Council and

23 Jul 2024 · Industrial policy

Meeting with Christian Ehler (Member of the European Parliament) and European Chemical Industry Council and

23 Jul 2024 · Industrial policy

Meeting with Laurent Castillo (Member of the European Parliament)

18 Jul 2024 · Europe de la Santé

Meeting with Lukas Sieper (Member of the European Parliament) and GSMA Europe and

16 Jul 2024 · Introductory meeting at networking event

Response to Health technology assessment – Procedural rules for the assessment and management of conflicts of interest in joint wo

26 Jun 2024

EFPIA shares the objectives and principles outlined in Regulation 2021/2282 (EU HTA Regulation) which include, among broader objectives on patient access, the impartiality of the assessors and experts, the transparency regarding their potential conflicting interests, and the necessity to involve external experts such as patients and clinicians, to guarantee the best quality for the joint work. However, EFPIA is concerned that the operationalization of these principles via the proposed draft implementing act risks creating situations of de facto unilateral exclusions/bans of the available external experts from participating in the joint work. By introducing rigidity that could unnecessarily limit participation of the right experts, the implementing act risks producing unintentional delays and reducing the quality the work of the HTA Coordination Group and subgroups. EFPIA would therefore recommend that the involvement of the best available expertise be prioritized as the main objective of the implementing act, while mandating transparency and disclosure of possible conflicts. The quality of the joint work and the ultimate benefit of patient access to innovative treatments are contingent on this involvement. As such, the implementing act should avoid imposing a straitjacket for expert involvement which may prohibit future adaptations to the needs of the EU system and instead should articulate general principles for the definition of future guidance, for the benefit of both representatives and individual experts. EFPIA is concerned with the introduction of a decision matrix (operating as inclusion/exclusion mechanistic algorithm) within the framework of the implementing regulation. EFPIA considers the system will be better served by clarifying how to handle possible conflicts of interest in a specific guidance, which can more easily be amended based on observed practice. EFPIA would like to articulate several principles to guide the development and finalization of the implementing act: a) Conflict of interest framework fit for the joint scientific work as designed by the EU HTA Regulation b) Transparency of possible conflicts of interest over de facto exclusion c) Use of best instrument to address and govern detailed involvement procedures, such as decision of inclusion and exclusion (guidance rather than implementing regulation) d) Patient-centricity along medicine development and across the EU HTA Regulation life-cycle e) Alignment with European Medicines Agency best practices f) Due consideration to the context of medicine development, the specificities of complex technologies and small populations g) Flexibility around clearance periods and financial thresholds h) Involvement of experts organisations (i.e. patient organisations, medical societies, civil society etc.) Additional detailed considerations and proposals are listed in the annex of this response. EFPIA stands ready to meaningfully contribute to the success of the EU HTA Regulation for the benefit of EU patients.
Read full response

Response to Update of format of F-gas labels

4 Jun 2024

EFPIA welcomes the opportunity to comment on the draft implementing regulation. EFPIA supports comments of the International Pharmaceutical Aerosol Consortium (IPAC) which focus on labelling formetered dose inhalers (MDIs) for which extensive product labelling is required through medicinal product regulations. Their comments are reiterated below. MDIs present specific challenges and careful considerations with regard to adding F-gas labelling. The European Medicines Agency (EMA), respectively, the National Competent Authorities (NCA), who receive applications for the changes to MDI labelling will play an important role in reviewing and approving F-gas labelling before it can be added to MDIs for placing on the market. We welcome the legislative proposal and believe it takes a pragmatic approach that achieves the intent of the F-Gas Regulation whilst balancing implications for patients, and understanding unique challenges for labelling of MDIs. Managing the timeframe for implementing the labelling continues to be a critical issue to ensure uninterrupted supply of life-saving medicines for European patients suffering from serious respiratory disease. We therefore request an approach that allows necessary time for EMA and NCA guidance and requisite formal regulatory procedure to enable changes to MDI labelling in an efficient manner. We call for clarifying guidance reassuring that product supply and patient access to MDIs will not be negatively impacted due to the short time period that remains. Detailed Comments We welcome the clarification that labels on the outer packaging and package leaflet will assure compliance with Regulation (EU) 2024/573. It is, however, important to note that further detailed guidance is needed on the precise content and location of the F-gas labelling text to be added to package leaflet, to ensure consistency across MDIs and approvability with short timelines by EMA and Member States, respectively. Changes to labelling on outer packaging and leaflets require EMA approval in case of medicines that were centrally authorised by the EMA. Most MDIs currently marketed within the EU are not centrally authorised but are approved via national or decentralised procedures and the relevant changes in labels should be submitted nationally. EFPIA notes the 2023 EMA guidance EMA/477469/2023 Section 3.6 which states that, for the introduction of new, low GWP propellants, Inclusion of statements such as HFC free on the label: As a general principle, the Summary of Product Characteristics (SmPC) is the basis of information for healthcare professionals on how to use the medicinal product safely and effectively. There is no ground or need to include additional information on elements which are not included in a medicinal product (i.e., absence of a component in the product or in a container), as the information may become extensive and confusing. Therefore, such promotional statement is not allowed Article 1 (10) proposal for adding a digitally readable link does not appear to be an option for MDIs which are medicinal products for which there are specific rules and restrictions for how digital links can be approved on labelling. Article 1 (11) states that the indication Contains fluorinated greenhouse gases should be included in the labelling. However, we suggest that this be changed to Contains a fluorinated greenhouse gas as MDIs do not contain multiple fluorinated gases. We consider the Act is missing a clarification specific for MDIs in relation to the requirements of Article 12 (16) of the Regulation 2024/573 and F- gas. Adding F-gas labelling to advertising of MDIs that is not directly related to the medicines properties may not be aligned with the Medicinal Product Directive (2001/83/EC) and its restrictions for advertising content of medicinal products. A clarification is therefore considered necessary.
Read full response

Meeting with Pernille Weiss-Ehler (Member of the European Parliament)

21 May 2024 · General discussion

EFPIA Demands Data Protection for Medicines in Chemicals Platform

3 Apr 2024
Topic — Proposal for a common data platform to improve chemical safety assessments.
Message — EFPIA demands that the European Medicines Agency leads medicinal risk evaluations. They request strict confidentiality for business studies and a full impact assessment.123
Why — These protections prevent the disclosure of sensitive drug research to global competitors.45
Impact — Public research institutions face higher burdens to provide raw data and experimental protocols.6
Read full response

Response to Health technology assessment - Joint clinical assessments of medicinal products

2 Apr 2024

The EU HTA Regulation represents a step-change in the assessment of clinical evidence of new technologies at EU level and has the potential to accelerate and improve access to innovative therapies for patients with the declared goals to reduce inefficiencies and duplications, goals that the pharmaceutical industry shares. In 9 months time, national HTA bodies, health technology developers (HTDs) as well as patients and clinicians are expected to actively participate in the first JCAs. The success of the EU HTA Regulation is contingent on the ability of the system to deliver timely high-quality JCA reports which provide added-value to national decision-makers. In order to be achievable, the JCA process needs to: i.facilitate early, actual engagement with the health technology developer (HTD), to ensure a timely and optimally informed start of the process and to enable the systematic exchange of relevant information with the HTD. ii.provide participants with all the necessary information and evidence for the scoping and assessment. iii.secure sufficient time for HTDs to conduct the relevant analyses required to prepare high quality clinical evidence for JCA submission dossiers. iv.ensure appropriate protection of commercially confidential information. EFPIA is concerned about several provisions in the draft JCA implementing act, especially regarding the insubstantial involvement of the HTD in the scoping process and the insufficient time allocated to the HTD for the development of the dossier before submission. Simply put, the proposals in the implementing act undermine the capability of the HTD to provide a high-quality submission dossier. The lack of early visibility on the scope of the JCA also means that HTDs will not have the time to prepare and deliver the full set of evidence expected by the JCA subgroup. This will negatively impact the final JCA output & its relevance & usability/uptake at national level. It is difficult to understand why the implementing act doesnt build on HTDs expertise to facilitate the definition of the most appropriate assessment scope as is generally the case in regulatory and national HTA submissions. This is particularly pertinent in light of the expected size &amp; complexity of evidence and analyses required in the submission, driven from a mechanistic need to satisfy all Member States. Addressing this would help rebalance the time dedicated between scoping, content development and assessment. EFPIA strongly believes that JCAs can be successful if the process builds on the ability of key stakeholder to provide input, establishes the necessary procedural prerequisites, and provides sufficient time for the HTD to develop timely a high-quality dossier in line with respective remits and obligations. Among others this means that the HTD: should have at least 135 days to prepare a high-quality submission dossier which can be achieved by reducing the time available to define the policy questions that guide the development of this dossier to at most, 90 days. should have the opportunity to contribute all relevant information, evidence, and knowledge as a key input into the definition of the assessment scope at the time of the application for the marketing authorisation. should have an opportunity to meet and discuss with the assessor/co- assessor its views on the consolidated assessment scope proposal. should have visibility on the consolidated assessment scope proposed by the assessor/co-assessor at the earliest possible stage, to inform the development of a high-quality submission dossier. These procedural changes are the most important ones to secure the workability of the future JCA system & its ability to result in timely & high quality JCA dossiers & consequently reports. Additional detailed considerations and proposals are listed in the annex of this response. EFPIA stands ready to meaningfully contribute to the success of the EU HTA Regulation for the benefit of European patients.
Read full response

Meeting with Matthias Ecke (Member of the European Parliament) and GSK

28 Mar 2024 · Pharmapaket

Meeting with Katherine Power (Cabinet of Commissioner Mairead Mcguinness), Patricia Reilly (Cabinet of Commissioner Mairead Mcguinness)

21 Mar 2024 · Sanctions

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur)

11 Mar 2024 · Directive on Medicinal products for human use

Response to Revision of the variation framework for medicines

29 Feb 2024

EFPIA/Vaccines Europe fully support revision of the EU variations framework and agree with the stated aim of this first step to streamline procedures and ensure better handling based on a science and risk-based approach. We are encouraged to see the inclusion of the following changes: Removal of the default type II classification for quality/manufacturing changes for biological products, including advanced therapies; formalisation of the legal basis for use of existing additional regulatory tools; extension of influenza vaccines approaches to coronavirus vaccines; and reference to annual updates for minor variations whilst retaining the flexibility of immediate submission in some cases, which is critical. These proposals are encouraging steps to a more efficient framework which may be fully realized after the update to the general pharmaceutical legislation. Following review of the draft regulation, EFPIA/VE offers feedback on the following points, with some additional details included in the separate appendix: 1) Classification guideline review: the proposal for annual reports by the Agency is generally welcomed and offers the opportunity for more regular adaptations. However, it is unclear how quickly the EC will implement the changes to the guideline and whether the scope includes changes to accommodate scientific and technical progress other than new recommendations under Article 5. We encourage the EC to be ambitious here and aim for clear, regular updates that broadly encompass all necessary revisions. Ultimately, our view is that EMA/HMA should have full accountability for managing and updating the classification guideline. 2) Additional regulatory tools: The wording in Article 6a is unclear and could be expanded to enable the introduction of Established Conditions and PLCM as further regulatory tools. We suggest additional qualification to the Article as follows specific regulatory tools e.g., design space, post approval change management protocols and others as science and technology progresses. 3) Super-grouping: The introduction of this concept into the regulation is fully supported, but the related proposed revision to Article 7(2) lacks clarity. Since this Article now appears to apply only to minor/type IA variations for single marketing authorisations (MA) under the same MA holder it could be revised to where multiple minor variations to the terms of the same marketing authorisation owned by the same holder.... 4) Worksharing: this now appears mandatory for certain cases (Article 20(1)) but MA holder choice may be warranted e.g., in justified cases. Regarding the annexes, we believe the proposed change to Annex I, point 1(c) is unclear and would keep the wording in the original Annex I (efficacy and/or safety). Generally, for Annex II we believe that there is an opportunity to move much closer to the aims of ICHQ12 by replacing the detailed text describing the classification of variations with general principles, and that this should actively be considered at step 1. However, should this not be possible, we offer the following feedback: 1) Introduce additional text at the start of Annex II A variation whose classification is not determined by a product lifecycle document agreed by the relevant authority shall be classified as follows: 2) Clarify changes for point 1(f) which appears to be unchanged. 3) Revise point 2(f), to only reference introduction of a design space as a type II variation where this may have a significant impact on the quality, safety or efficacy of the medicinal product. 4) Revise points 1(g) and 2(n) to clarify their application to changes in medical devices that impact the use of medicinal products, whilst in vitro diagnostics follow a separate process and should be excluded. Finally, under Annex III, further amendments could be made to allow grouping of parallel (i.e., concurrent but non-consequential) type IB and type II variations, to the same Module 3 section.
Read full response

Meeting with Peter Liese (Member of the European Parliament)

23 Feb 2024 · Austausch

Response to Review of the Health Emergency Preparedness and Response Authority (HERA)

19 Feb 2024

Since its establishment, HERA strived to fill a critical gap in pandemic preparedness and response, having an ambitious agenda to establish or strengthen essential tools and infrastructures for an end-to-end approach. To ensure its success in achieving the 100-day goal of responding to health emergencies, it is crucial to have an appropriate level of flexibility, expertise, resources, and budget to ensure the implementation of the activities established in its work plans. The tools and strategies employed, such as threat assessment, intelligence gathering, advanced R&D promotion, and timely provision of medical countermeasures (MCMs) should be both suitable and effective. Several areas that need special attention are the following: a) Budget: HERA needs adequate funding tools and the ability to fund itself. A higher budget needs to be allocated in the next financial cycle. HERA should be able to combine its own resources with resources from other funding instruments to manage unexpected crises. Available resources should be allocated to key priorities. b) Research funding: funding tools for late-stage development of MCMs should be accessible to companies of all sizes and new funding tools could be piloted by tweaking existing instruments or by setting up a new instrument combining key features of existing tools. c) Intellectual property: HERA should have a reliable, predictable, and flexible IP framework, that protects privately funded IP, and incentivises the industry to develop and commercialise MCMs. d) Scenario planning: Early risk identification and prioritisation are crucial for understanding needed MCMs. JICF should prioritise discussions on scenario mapping and threat prioritisation for effective technology and compound evaluation. e) Manufacturing: Shift the conversation from European manufacturing capacity to allocation for European markets, emphasising the need to address regulatory bottlenecks and maintain open supply chains for a quick and flexible production ramp-up. f) Stockpiling: Targeted stockpiling limited to emergency situations can only be considered in very specific cases as one element of a broad strategy. The need for stockpiling should be assessed jointly by authorities and manufacturers and the process should take into consideration the time needed for planning, the costs and the shelf-life limitations. g) Procurement: Joint procurement should be limited to situations where the purchase and supply of MCMs cannot be ensured by other means. Collaboration with industry is key to ensuring fair competition, timely access, and reliable supply. h) Liability protection: establish an EU compensation fund to financially support no-fault compensation systems in all Member States. i) Seamless decision-making: ensuring there is no duplication between HERA and EU Member States, EU bodies (EMA, ECDC), or other Commission services and that existing infrastructures are leveraged (e.g., EMVS). j) Global: HERA is expected to show EU leadership in the field of pandemic preparedness and response and therefore to play an active role in shaping the Pandemic Treaty negotiations through internal coordination within the EC. Additionally, HERA should play a leading role in an effective and coherent international approach to ensure immediate and unhindered sharing of pathogens and associated information. k) Equity: Policies and structures should ensure more equitable access to MCMs for priority populations around the world. l) Continuous dialogue with industry: Any measure potentially affecting industry operations should be subject to pre-consultation and continued dialogue for lessons learned and adjustments. To achieve its mission, HERA needs more budget flexibility, expertise, and autonomy, and its governance model and organisational set-up should reflect these needs. The industry remains committed to further collaborating with HERA and engaging in more operational workstreams with subject matter experts.
Read full response

Meeting with Josianne Cutajar (Member of the European Parliament)

19 Feb 2024 · The Pharmaceutical Package

Meeting with Riho Terras (Member of the European Parliament)

19 Feb 2024 · Reform of pharmaceuticals legislation

Meeting with Frédérique Ries (Member of the European Parliament, Shadow rapporteur)

8 Feb 2024 · Revision of the Pharmaceutical Legislation

Meeting with Tomislav Sokol (Member of the European Parliament, Shadow rapporteur)

6 Feb 2024 · Pharmaceutical legislation

Meeting with Adam Jarubas (Member of the European Parliament) and MEDICINES FOR EUROPE and

31 Jan 2024 · EU pharmaceutical roundtable - the EU institutions’ representatives and the stakeholder's dialogue

Meeting with Peter Liese (Member of the European Parliament) and AbbVie and Deutscher Caritasverband e. V.

22 Jan 2024 · Austausch

Meeting with Laura Ballarín Cereza (Member of the European Parliament, Shadow rapporteur for opinion)

17 Jan 2024 · Pharmaceutical Legislation (Regulation)

Meeting with Ondřej Knotek (Member of the European Parliament)

13 Dec 2023 · Pharmaceutical package

Meeting with Christel Schaldemose (Member of the European Parliament) and Novo Nordisk A/S

13 Dec 2023 · EU General Pharmaceutical Legislation

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and Bayer AG and

12 Dec 2023 · Directive on Medicinal products for human use

Meeting with Henna Virkkunen (Member of the European Parliament, Rapporteur for opinion)

12 Dec 2023 · Medicinal products for human use

Meeting with Tomislav Sokol (Member of the European Parliament, Shadow rapporteur)

5 Dec 2023 · Pharmaceutical legislation

Meeting with Javier Zarzalejos (Member of the European Parliament, Shadow rapporteur)

5 Dec 2023 · Meeting with the European Federation of Pharmaceutical Industries (EFPIA) to discuss the Supplementary protection certificates (SPCs) package

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and Bayer AG

10 Nov 2023 · Directive on Medicinal products for human use

Meeting with Javier Zarzalejos (Member of the European Parliament, Shadow rapporteur)

8 Nov 2023 · Meeting with the European Federation of Pharmaceutical Industries (EFPIA) to discuss the Supplementary protection certificates (SPCs) package

Response to Revision of the Union Customs Code

7 Nov 2023

The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomes the opportunity to comment on the revision of the Customs Union Code. EFPIA represents the biopharmaceutical industry in Europe. Please find an explanation of our position attached. EFPIA supports the objectives of the revision and wishes to highlight a few elements that require further explanation. Will the new strategic approach aimed to implement targeted and coordinated customs action prioritize certain industries or products i.e., the pharmaceutical sector? The implementation of a simpler customs process via the EU Customs Data Hub, is welcomed however, we are concerned that further simplification may inadvertently facilitate criminal activities. Information collected in the Data Hub will be utilized for risk analysis and will gradually replace the current customs IT systems, transitioning from multiple systems in each Member State to a more centralized environment. The use of this centralized approach will be mandatory. What is the timeline for this new system and can Member States opt to reject it? EFPIA supports the utilization of existing sources of risk information, including the IPEP. The proposal introduces new Union-level risk management activities, including common risk analysis and the issuance of corresponding Union control recommendations to customs authorities. What is the origin of the Union-level data and what are the parameters on which the analysis will be based? Will the data include small parcels in addition to large containers/truck shipments? How will pharmaceuticals risk analysis be conducted, are parameters such as country of origin, consignee, weight, and declaration, etc., considered? A cooperation framework is suggested involving market surveillance, law enforcement and Union agencies. What changes will be implemented in this form of cooperation to ensure its success? The roles of individuals accountable to customs, such as declarants and carriers, will be modified to assign compliance responsibility to importers and exporters. How will due diligence be conducted for non-compliant importers, exporters, or non-existing parties? Who will be responsible for verifying this information? What actions will Customs take if an exporter/importer is not EU registered and the goods are claimed to be in transit but instead, are unloaded within the EU? How will Customs follow up on such cases? In Recital 13, a notable statement is made: "The persons responsible for the goods entering and exiting the customs territory of the Union are liable for any risks posed by the goods to the safety, security, health, life, environment, or consumers." Who determines if a risk to human, animal, or plant health is present? What if the exporter/importer claims to have no knowledge of such infringement and how will this be proven? Does this "risk" include intellectual property infringement? Will pharmaceuticals be treated differently, considering the higher risk of patient safety through falsification? The regulation establishes Union customs infringements and non-criminal sanctions. With minimum sanctions outlined, what confidence is there that these sanctions will be a sufficient deterrent to prevent illegal imports and false declarations? What are the implications associated with Recital 8 which addresses prohibitions and restrictions on goods that can be justified, including those related to the protection of industrial or commercial property and goods infringing certain intellectual property rights? EFPIA would welcome additional explanation how article 76(2) will take effect for pharmaceuticals, given that the MoH is on most occasions the party handling the seized medicines. EFPIA remains available to work with legislators to revise and rework the proposal to improve its practical implications.
Read full response

Meeting with Erik Poulsen (Member of the European Parliament) and AbbVie and GSK

30 Oct 2023 · Pharmaceuticals legislation

Meeting with Laura Ballarín Cereza (Member of the European Parliament, Shadow rapporteur for opinion) and European Patients' Forum (EPF) and

23 Oct 2023 · Pharmaceutical Package (Regulation)

Meeting with Henna Virkkunen (Member of the European Parliament, Rapporteur for opinion) and Novartis International AG and European Confederation of Pharmaceutical Entrepreneurs

20 Oct 2023 · Medicinal products for human use

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and Vaccines Europe

20 Oct 2023 · Directive on Medicinal products for human use

Response to Revision of the variation framework for medicines

25 Sept 2023

EFPIA/Vaccines Europe (VE) fully support the need to revise the EU variations framework. We believe such a revision must be extensive and enable a science- and risk-based approach to lifecycle management, allowing the future framework to keep pace with innovation and ensure a sustainable supply of medicines throughout the product lifecycle. We believe that despite the constraints of the current pharmaceutical legislation, significant progress can be made in the next 12 months and we encourage the EC to keep the broader goal in mind when considering all changes needed. More details are included in the Annex but the immediate priorities are: 1) Apply the same principles to change categorization (science-and risk-based) to all technologies including biologicals, vaccines, ATMPs, drug-device combinations, and IVDs. 2) Remove from Annex II of Reg 1234/2008 items 2(e) "variations related to modifications in the manufacturing process or sites of the active substance for a biological medicinal product and 2(f) variations related to the introduction of a new design space or the extension of an approved one. 3) Apply risk-based approaches to the submission of variations that have an impact on the Product Information. 4) Accommodate innovation, emerging science, and sustainability through classifications which consider ICHQ12 tools and principles in the following way: allow a flexible/expanded use of Post Approval Change Management Protocols (PACMPs), and other structured protocol-driven changes; remove default Type IB classification for biologicals and immunologicals from B.I.e.5(c) and B.II.g.5(c) (2013/C 223/01); facilitate multi-product protocols to support changes across similar product types and use of existing grouping and worksharing procedures for change; ensure the flexible use of PACMPs to enable proposing all types of change, including those affecting multiple sites/products to be managed under a company pharmaceutical quality system (PQS) with no regulatory submission; include Established Conditions and Product Lifecycle Management as per ICHQ12 (in 2013/C 223/01) and utilize the regulatory sandbox concept to gain greater understanding of these new tools. 5) Expand the EU Masterfile system (within the general pharmaceutical legislation) to include the option of a Platform Technology Master File (PTMF) and revise the Variation framework to fully enable an efficient lifecycle management of any new types of master file. 6) Adopt new technologies, such as model-based process controls, allowing the management of changes to control variables as notifications or under the PQS, where justified (aligned with the planned revisions of EMA/CHMP/QWP/63699/2014). 7) Expand the use of existing IT solutions to maintain administrative information associated with the Marketing Authorisation, thereby removing the requirement to submit minor changes for review whilst evaluating advances in cloud-based technology to enable real-time oversight of the dossier by regulators. 8) Include accelerated assessment procedures and timelines for variations associated with major public health interest or significant therapeutic innovation e.g., new indication. 9) Refine and expand existing concepts such as work-sharing procedures and grouping to reduce time for review/approval of the change and its implementation, especially where the same change affects multiple products and procedures. 10) Consider including the concept of worksharing and regulatory reliance/alignment with other regulatory agencies outside the EU. EFPIA and VE believe a comprehensive revision of the variation framework is necessary to realise the potential for a streamlined, future-proof framework. To enable success, there needs to be full commitment and collaboration to undertake all necessary revisions in the context of both the current and future legislative framework for medicines in a timely manner. We will continue to do all we can to advance this topic with all stakeholders.
Read full response

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur)

22 Sept 2023 · Directive on Medicinal products for human use

Meeting with Margrete Auken (Member of the European Parliament, Shadow rapporteur)

22 Sept 2023 · Pharma legislation

Meeting with Catherine Amalric (Member of the European Parliament, Shadow rapporteur) and European Public Health Alliance and France Assos Santé

18 Sept 2023 · Reform of the EU pharmaceutical legislation

Response to Unitary Supplementary Protection Certificates (SPC) – creation and granting procedure

15 Sept 2023

EFPIA supports the stated aims for the SPC revisions. Central SPC issuance for classical European patents and Unitary Patents will improve IP framework efficiency, bringing innovative medicines to patients in a timely manner via reliable protection. EFPIA welcomes the recognition of SPCs as vital via the decision to maintain the current SPC term, which is the last-to-expire protection for over half of innovative medicines in the EU. Lastly, concerns remain regarding some provisions, like pre-grant oppositions. With a range of recent legislative initiatives that seek to erode IP protection in the EU, it is critical that SPC protection remains stable. The SPC framework encourages R&D investment to bring the latest therapies to European patients, maintaining EU competitiveness globally: a decisive factor in the industrys positive contribution to the EU trade balance. Any substantive change to the SPC model would create unpredictability. As to specific provisions: Pre-Grant Opposition: Allowing any 3rd party to oppose SPCs pre-grant is inherently open to misuse and is inefficient from a cost and system view, where validity of the vast majority of SPCs is undisputed. The impact assessment does not justify this, nor assess its effects. Central examination already allows 3rd party observations and will achieve harmonization. The pre-grant timing is concerning: it will inevitably lead to cases where an SPC is not granted before the underlying patent expires, leaving a gap during which no legal certainty exists: either for the generic or the rights-holder on whether to respect the SPC term. The proposed pre-grant opposition is not time-limited and can be followed by 3 appeals, making this likely. Neither the US nor Japan has oppositions for Patent Term Extension (PTE), their SPC equivalent. Australia has pre-grant oppositions for PTEs, but a rights-holder can enforce a pending application, avoiding the gap. In Europe, pre-grant oppositions for patents were considered but firmly rejected when the European Patent Convention was created, as they could lead to undue delays. In India, where 3rd-party pre-grant oppositions are routinely filed, the patent system is ineffective. Pre-grant oppositions would only harm EU competitiveness while the innovation gap widens. Invalidity before EUIPO: Invalidity actions for uSPCs before EUIPO ignore the UPCs exclusive jurisdiction over all uSPCs and should be rejected. Timelines: Several examination stages have defined timelines, but many do not, raising questions as to the effectiveness of the new system. Examination Expertise: Given SPC matter complexity, experts at each process step will be fundamental to provide reliable outcomes; only experienced examiners should be involved. Transitional provisions: The proposal lacks suitable transitional provisions, given the goal of closing the national SPC route. Adding them would allow users to gain confidence in the system before it is mandatory. Paediatric extensions: The opportunity for 3rd-party observations to challenge paediatric extension applications is unnecessary for a formal procedure. Economically linked: It is suggested that more than one SPC can only be granted if the holders of the underlying patents are not economically linked. However, this is ambiguous; it should refer to SPC holders who are not part of the same undertaking at the time of application filing. If uncorrected, universities and SMEs will be most negatively affected, with some products becoming commercially unviable. CJEU Codification: Certain Recitals seeking to codify CJEU case law require revision to ensure accurate jurisprudence capture. EFPIA urges holding true to the proposals spirit, honing implementation while preserving the core of substantive SPC protection. Increased legal certainty will increase confidence in the EU IP framework and contribute to efficient SPC administration, helping close the gap globally and bring the latest innovative therapies to patients.
Read full response

Response to Unitary Supplementary Protection Certificates (SPC) – creation and granting procedure

15 Sept 2023

EFPIA supports the stated aims for the SPC revisions. Central SPC issuance for classical European patents and Unitary Patents will improve IP framework efficiency, bringing innovative medicines to patients in a timely manner via reliable protection. EFPIA welcomes the recognition of SPCs as vital via the decision to maintain the current SPC term, which is the last-to-expire protection for over half of innovative medicines in the EU. Lastly, concerns remain regarding some provisions, like pre-grant oppositions. With a range of recent legislative initiatives that seek to erode IP protection in the EU, it is critical that SPC protection remains stable. The SPC framework encourages R&D investment to bring the latest therapies to European patients, maintaining EU competitiveness globally: a decisive factor in the industrys positive contribution to the EU trade balance. Any substantive change to the SPC model would create unpredictability. As to specific provisions: Pre-Grant Opposition: Allowing any 3rd party to oppose SPCs pre-grant is inherently open to misuse and is inefficient from a cost and system view, where validity of the vast majority of SPCs is undisputed. The impact assessment does not justify this, nor assess its effects. Central examination already allows 3rd party observations and will achieve harmonization. The pre-grant timing is concerning: it will inevitably lead to cases where an SPC is not granted before the underlying patent expires, leaving a gap during which no legal certainty exists: either for the generic or the rights-holder on whether to respect the SPC term. The proposed pre-grant opposition is not time-limited and can be followed by 3 appeals, making this likely. Neither the US nor Japan has oppositions for Patent Term Extension (PTE), their SPC equivalent. Australia has pre-grant oppositions for PTEs, but a rights-holder can enforce a pending application, avoiding the gap. In Europe, pre-grant oppositions for patents were considered but firmly rejected when the European Patent Convention was created, as they could lead to undue delays. In India, where 3rd-party pre-grant oppositions are routinely filed, the patent system is ineffective. Pre-grant oppositions would only harm EU competitiveness while the innovation gap widens. Invalidity before EUIPO: Invalidity actions for uSPCs before EUIPO ignore the UPCs exclusive jurisdiction over all uSPCs and should be rejected. Timelines: Several examination stages have defined timelines, but many do not, raising questions as to the effectiveness of the new system. Examination Expertise: Given SPC matter complexity, experts at each process step will be fundamental to provide reliable outcomes; only experienced examiners should be involved. Transitional provisions: The proposal lacks suitable transitional provisions, given the goal of closing the national SPC route. Adding them would allow users to gain confidence in the system before it is mandatory. Paediatric extensions: The opportunity for 3rd-party observations to challenge paediatric extension applications is unnecessary for a formal procedure. Economically linked: It is suggested that more than one SPC can only be granted if the holders of the underlying patents are not economically linked. However, this is ambiguous; it should refer to SPC holders who are not part of the same undertaking at the time of application filing. If uncorrected, universities and SMEs will be most negatively affected, with some products becoming commercially unviable. CJEU Codification: Certain Recitals seeking to codify CJEU case law require revision to ensure accurate jurisprudence capture. EFPIA urges holding true to the proposals spirit, honing implementation while preserving the core of substantive SPC protection. Increased legal certainty will increase confidence in the EU IP framework and contribute to efficient SPC administration, helping close the gap globally and bring the latest innovative therapies to patients.
Read full response

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur) and Eli Lilly and Company and

7 Sept 2023 · Revision of the Pharmaceutical Legislation (staff level)

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur)

4 Sept 2023 · Directive on Medicinal products for human use

Response to Compulsory licensing of patents

28 Jul 2023

In its Compulsory Licensing (CL) proposal, the European Commission (EC) posits a new EU-wide CL for crisis response. This harms IP rights and is a dramatic expansion of the ECs role into Member State (MS) remit, where viable CL provisions already exist. CLs are a last resort, all attempts at voluntary licensing having failed. CLs undermine IP and prevent the choosing of preferred partners to rapidly bring goods to market. Undue willingness to employ CLs erodes investor confidence in IP, harming innovation pipelines, and impeding voluntary measures speed to bring goods to the public in times of crisis. Little in the proposal, however, limits CLs to measures of last resort. The lessons from COVID are clear: CLs were not needed. Voluntary models launched vaccines in a year and rapid scale-up made supply quickly exceed demand. Vaccine delivery challenges were related to trade, eg export bans, or issues of logistics and uptake. CLs would have only diverted scarce resources, hampering supply. The proposal fails to provide compelling evidence for an EU-wide CL, despite the clear request from the RSB for both concrete examples and impact on future R&D investment. It disregards the public consultation, which favors a coordinating role for the EC. There is no reason for why this was rejected nor a showing of MS CL provisions as inadequate. An EU-wide CL is simply not required, as coordination is preferable and achieves better harmonisation: it employs existing MS CL practice with EC oversight, channeling communication and evidence among MS facing a crisis. It avoids legal pitfalls facing the EC proposal and allows agile response to crises affecting limited numbers of MS. It sends the wrong signal globally, incorrectly implying that IP is a barrier in a crisis. This is already having negative effects on global IP discourse, harming the ability to address the actual, multifaceted issues impeding crisis response. It faces broad legal hurdles: TRIPS: The ability to ignore the: 1) ID of the rights-holder, 2) ID of patents, 3) assessment of alternatives, and 4) negotiation with the rights-holder, violates Art. 31(a)&(b). Broad additional measures without safeguards, possibly including know-how transfer, violate Art. 39. Extension to patent applications violates Art. 31. A remuneration cap at 4%, divorced from a true economic value analysis violates Art. 31(h). Lack of a clear, thorough legal redress violates Art. 31(i)&(j). EU Law: An EU-wide CL interferes with the Right to Property under Art. 17 of the EU Charter of Fundamental Rights. Legislation must limit interference to what is proportionate and strictly necessary. By failing to include safeguards, eg by extending CLs to include know-how, allowing CL issuance without: 1) ID of or negotiating with rights-holders, 2) ID of the relevant patents, or 3) providing adequate remuneration or rights of appeal, the proposal fails proportionality and violates Charter Art. 17, 41 & 52. Lack of clarity also renders the framework impractical, likely to impede crisis response. Problems include: No clear crisis definition, only limited references to other legislation; Inadequate rights-holder CL notification; An EC trigger for the CL procedure, with an unclear licensee role; No clear process for first negotiating voluntary licences; Unclarity of advisory body composition, the effect of its recommendation, and scope of rights-holder consultation; Overbroad CLs can apply to all rights attached to a product, without clear ID, including pending rights; Broad EC powers for complementary measures, which may lead to forced disclosure of know-how/trade secrets; Limited judicial review of a CL, precise avenues for/scope of redress unclear; Remuneration capped too low to be adequate, cooperation penalties capped far higher, exceeding those in the General Pharmaceutical Legislation. These issues call for meaningful stakeholder discussion, with serious reflection on proposal purpose and legality.
Read full response

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur)

19 Jul 2023 · SPC and Complsory licensing (staff level)

Meeting with Tomislav Sokol (Member of the European Parliament)

11 Jul 2023 · COVI report

Pharma group calls for harmonized and flexible sustainability reporting

7 Jul 2023
Topic — New European standards for mandatory corporate reporting on environmental, social, and governance factors.
Message — EFPIA requests that international and US standards be considered equivalent to avoid duplicative reporting. They also suggest prioritizing the most meaningful topics to minimize the administrative burden on companies.12
Why — International harmonization would reduce the resources required for companies to meet different legal regimes.3
Impact — SME suppliers lose transparency on payment timelines if requirements to disclose invoice data are deleted.4
Read full response

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and AbbVie

13 Jun 2023 · Directive on Medicinal products for human use

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur) and SANOFI and BioMarin UK Limited

7 Jun 2023 · Revision of Pharmaceutical Legislation (staff level)

Meeting with Tomislav Sokol (Member of the European Parliament, Shadow rapporteur)

23 May 2023 · Pharmaceutical legislation

Meeting with Karsten Lucke (Member of the European Parliament)

17 May 2023 · R&D

Pharmaceutical lobby warns against unfair singling out in EU taxonomy

2 May 2023
Topic — The consultation defines sustainable economic activities for investment purposes under EU environmental objectives.
Message — The industry requests that these rules be delayed and refined until other manufacturing sectors are also included. They specifically ask to remove requirements for testing drug metabolites, which they claim are currently unachievable.123
Why — Proposed changes would prevent companies from being unfairly classified as non-green due to unattainable data requirements.45
Impact — Sustainable investors lose clarity because they cannot distinguish between environmentally responsible and unsustainable pharmaceutical companies.6
Read full response

EFPIA warns pharmaceutical safety requires specific packaging exemptions

21 Apr 2023
Topic — The Commission is reviewing packaging requirements to support waste prevention and increase recycling.
Message — EFPIA asks that the regulation accounts for the decade-long process to change medical packaging. They seek exemptions for labelling and recyclability to protect product stability and safety.12
Why — Maintaining current packaging avoids a massive bureaucratic burden and complex regulatory re-approvals.3
Impact — Circular economy initiatives lose because pharmaceutical plastic waste will likely remain non-recyclable.4
Read full response

Meeting with Patricia Reilly (Cabinet of Commissioner Mairead Mcguinness)

3 Apr 2023 · Review of EU pharmaceutical regulations

EFPIA warns chemical labelling changes could hinder pharmaceutical innovation

30 Mar 2023
Topic — The European Commission is revising rules for classifying, labelling, and packaging hazardous chemical substances.
Message — EFPIA calls for substance definitions to remain consistent with existing REACH regulations to avoid confusion. They oppose automatically classifying chemicals based on other environmental laws and request simpler labelling for research samples.123
Why — Maintaining current rules would prevent over-classification of substances and lower administrative compliance costs.45
Impact — Regulatory agencies lose efficient tools for automatically synchronizing hazard classifications across different environmental laws.6
Read full response

Meeting with Deirdre Clune (Member of the European Parliament, Shadow rapporteur) and European Environmental Bureau and

29 Mar 2023 · Stakeholder Consultation on Urban Waste Water Treatment Directive

Meeting with Despina Spanou (Cabinet of Vice-President Margaritis Schinas), Maria Luisa Llano Cardenal (Cabinet of Vice-President Margaritis Schinas)

21 Mar 2023 · Revision of the pharmaceutical legislation

Meeting with Kevin Keary (Cabinet of Executive Vice-President Valdis Dombrovskis)

17 Mar 2023 · competitiveness, intellectual property protection, FTAs

Meeting with Anthony Whelan (Cabinet of President Ursula von der Leyen)

16 Mar 2023 · Boosting competitiveness and productivity in the EU pharmaceutical industry

Pharma industry warns against less transparent EU water rules

14 Mar 2023
Topic — This consultation covers updates to EU lists identifying chemical pollutants in surface and groundwaters.
Message — The industry opposes shifting powers to the Commission and demands closer agency collaboration. They also want the removal of generic limits for total pharmaceuticals in groundwater.123
Why — These changes would protect manufacturing permits and prevent new restrictions on production facilities.4
Impact — European lawmakers would lose influence over standards because of the shift to delegated acts.5
Read full response

Response to Revision of the Urban Wastewater Treatment Directive

14 Mar 2023

EFPIA, representing the innovative pharmaceutical industry, is aware that medicinal products have been detected in European Surface Waters. We are supportive of the Urban Wastewater Treatment Directive Proposals objective to protect the environment and human health from the adverse effects of urban wastewater discharges and are committed to play our part in achieving this objective in a fair and equitable way. We believe that, to achieve this objective, every stakeholder concerned must play its fair part, including the people generating discharges to urban wastewater treatment facilities. The responsibility lies not only with the pharmaceutical manufacturing industry, which is already driving initiatives to evaluate and reduce the environmental impact using well established risk-based methodologies. The pharmaceutical industry shows efforts in reducing environmental emissions through Effluent Management Programs and EPR programs for pharmaceutical solid waste and supporting the MedsDisposal campaign. Any further measures taken to reduce pollution must be balanced, proportionate, based on sound data, and consider all stakeholders contributing to micropollutants and therefore must be part of any solution towards ensuring cleaner water. It should also consider the healthcare and social benefits from the use of products that are currently targeted as containing environmental concerning substances. However, we have serious concerns that the EPR scheme for micro-pollutants as proposed in the revised UWWTD proposal is neither fair, nor proportionate nor based on sound scientific evidence. Critically, it neglects to adequately apply the polluter-pays principle, a foundational principle underlying EU environmental policy, by failing to consider all stakeholders contributing to micropollutants in urban wastewaters, since only two sectors are under the scope of the directive: pharmaceutical industry and cosmetics. One of the stated aims of the EPR system is to incentivise the development of greener products. In the case of pharmaceuticals, however, it is critical to consider their societal and health benefits alongside environmental impacts. Access to medicines is a fundamental component of the full realisation of the right to health, therefore, human medicines cannot be considered as any other commodities. This fact calls for a different policy approach than the one being considered for other goods or chemicals. Furthermore, the complexity of medicines for human use and the limits of the current scientific and technological progress must be considered. Changing the design of a pharmaceutical compound (e.g., make it more biodegradable) could reduce the pharmacological efficiency. EFPIA would also point to the conclusion in Section 9.4 in the EPR Feasibility Study accompanying the Impact Assessment that states an EPR Scheme is unlikely to significantly incentivise the substitution of pharmaceuticals. Please refer to the attached joint document prepared by AESGP and EFPIA for detailed feedback evidencing the shortcomings of the Commission Impact Assessment and Feasibility Study. Pharmaceutical associations and companies were not previously consulted for the impact assessment and during other developments. Moreover, we would like to highlight that the scope of the feasibility study targeted only pharmaceutical and cosmetic products, having a narrowed range of research and not providing a whole and balanced overview across sectors. On many aspects, this study lacks clarity. The 92% contribution of pharmaceuticals and personal care products to the total toxic load is not scientifically supported. We therefore challenge its conclusions in the document attached. The pharmaceutical Industry remains committed to working with all partners along the value chain of medicines and the EU institutions, to address environmental concerns while responding to patient needs and to ensuring access to medicines.
Read full response

EFPIA calls for reduced administrative burdens in foreign subsidy rules

6 Mar 2023
Topic — Procedures for notifying and investigating foreign subsidies that might distort the internal market.
Message — EFPIA demands a simplified notification process and exemptions for subsidies governed by international trade agreements. They also seek clearer reporting waivers and improved rights of defense for investigated companies.12
Why — Streamlining these rules would reduce the immense logistical and financial costs of global compliance.3
Impact — Public health systems lose out if excessive regulation discourages pharmaceutical companies from bidding on contracts.4
Read full response

Meeting with Antoine Kasel (Cabinet of Commissioner Nicolas Schmit)

10 Feb 2023 · employment aspects of the upcoming Pharmaceutical legislation

Meeting with Patricia Reilly (Cabinet of Commissioner Mairead Mcguinness) and Eli Lilly and Company and

10 Feb 2023 · Discussion of upcoming pharmaceutical package; value of predictability (IP), EU pharmaceutical product approval process, competitiveness, unmet medical needs.

Meeting with Caroline Boeshertz (Cabinet of Executive Vice-President Valdis Dombrovskis), Kevin Keary (Cabinet of Executive Vice-President Valdis Dombrovskis)

9 Feb 2023 · Pharma package, competitiveness

Meeting with Kyriacos Charalambous (Cabinet of Commissioner Johannes Hahn)

8 Feb 2023 · Presenting the industry’s point of view on the upcoming pharmaceutical package and on the wider competitiveness, global positioning and resilience aspects.

Response to Revision of EMA fees

6 Feb 2023

EFPIA welcomes the opportunity to comment on the EU Commissions EMA fees proposal. EFPIAs comments reflect those of its members in the innovative industry which extensively remit EMA fees. Exacerbated by the COVID crisis and the impact of Brexit, the EU regulatory system is experiencing significant resourcing challenges that hinder its ability to achieve optimal efficiency and sustainability. Delays in decisions and scientific advice as well as variation in the quality of medicines assessments are current symptoms. EFPIA considers it essential to the viability of the EU regulatory system that these resourcing constraints (funding, capacities and capabilities) be promptly and comprehensively addressed. EU needs a system that can adapt rapidly to emerging technology and needs of our healthcare systems. Appreciating its critical role in patient health, public monies should contribute a significant portion to achieving a well-resourced, robust system at both EMA and National Competent Authorities (NCAs) levels. This revision is an opportunity to help improve the EUs global competitiveness by becoming faster, more efficient, predictable and flexible. Funding and financials are one part of the challenge along with many other contributors: recruiting technical expertise in cutting edge fields, retaining experienced talent, complexity of activities, and process redundancies. Improving the EMA fees system coupled with the review of the general pharmaceutical legislation offers a once in a generation opportunity. Summary: EFPIAs views on EMA fees proposal In its proposal, the EC seeks to streamline the fees system and to simplify its structure, to contribute to providing a sound financial basis to regulatory operations, and to make the system future-proof. These objectives are well aligned with EFPIAs position (https://www.efpia.eu/media/676843/efpia-position-paper-on-ema-fees.pdf). EFPIA recognises significant advances in the ECs proposals following the 2019 Inception Impact Assessment (IIA) and 2021 Impact Assessment (IA). Importantly, EFPIA observes numerous references to its underlying principles for the EMA fees system: Transparency, Fairness & Proportionality, Sustainability, Simplicity and Flexibility. EFPIAs views are aligned with key proposals: - Adopting IAs Option 3 light cost-based system, including minor variations in the new annual fee, will streamline administrative processes for regulators and companies - Integrating a more agile EMA fees system with flexibility to accommodate subsequent and timely adjustments should future-proof the system and help support implementation of EMAs Regulatory Science Strategy - Introducing a new fee for the assessment of pre-submission data packages on an on-going basis will support advances in regulatory and data sciences, and timelier new and innovative medicines for EU patients EFPIA suggests several enhancements: - KPIs and triggers for fees changes (increase or decrease) should incorporate measures of performance (e.g., adherence to statutory procedure timelines), in addition to cost and resource information described in Annex VI, and have sufficient transparency. - Establishing a platform for ongoing consultation with stakeholders, including the pharmaceutical industry, to capture inputs necessary when the structure and level of fees are being reviewed or revised to support the agility objective. - While not offering input on distributions between EMA and NCAs, EFPIA believes the system should be fair and proportionate to the service and resources provided, to encourage NCA participation in procedures. EFPIA wishes to ensure sufficient flexibility to optimise the use of resources within the EU Regulatory Network e.g., by using Multi-National Assessment Teams. Through ongoing improvements to the EMA fees, the regulatory system should be better enabled for viability today and vibrancy tomorrow. EFPIA is pleased to offer its detailed views in the attachment.
Read full response

Meeting with Patricia Reilly (Cabinet of Commissioner Mairead Mcguinness)

1 Feb 2023 · Discussion of the upcoming pharmaceutical legislative package

Meeting with Sara Cerdas (Member of the European Parliament, Shadow rapporteur)

20 Jan 2023 · Espaço Europeu de Dados de Saúde

Meeting with Sara Cerdas (Member of the European Parliament)

20 Jan 2023 · Preparatory call for Rethinking the Future of Cancer Care

Response to Extension of the transition period for medical devices

18 Jan 2023

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe. EFPIA appreciates the opportunity to provide comments on the Proposal for an Extension of the Transitional Provisions for Certain Medical Devices and In Vitro Diagnostic Medical Devices (IVDs), issued on 6 January 2023. EFPIA commends the European Commission for its efforts to protect access to on-market devices and IVDs. We believe it is critical to preserve patient access to safe and effective medical devices and IVDs. EFPIA would also encourage the Commission to consider the general points raised below related to the In Vitro Diagnostic Regulation (IVDR): EFPIA recommends introducing amendments that would delay the application of the IVDR to newly developed IVDs that are being used in clinical trials, because amendments proposed to date do not address this gap. Neither the extension of the transitional period for IVDs that was issued in January 2022, nor the currently proposed amendment address this issue. As a result, clinical trials of novel therapies for which no IVD exists in the market to identify patients must comply with the IVDR as of May 2022. Unfortunately, the critical infrastructure for a smooth process and a coordinated approach to authorising studies with IVDs under the IVDR are not yet available. This results in a complex and fragmented review process for clinical trials with the potential of divergent assessment by Member States. In the absence of a streamlined process and suitable infrastructure and guidance, the implementation of the IVDR is having a critical negative impact on clinical research in Europe, particularly for innovative personalised medicines. As noted in EFPIAs recent statement ( https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/efpia-statement-on-the-concerning-impact-of-the-in-vitro-diagnostic-regulation/) , the IVDR implementation is leading to delays in clinical trials that are in turn delaying access for European patients to these trials. This is particularly true for studies of novel targeted agents for cancer, which rely on diagnostic testing to enroll patients into the trial. Hundreds of trials and thousands of patients are already impacted, per recent industry data collected by EFPIA. Additionally, delayed clinical research could result in delayed launch of novel therapies in Europe, many of which are for patients with life-threatening diseases in areas of unmet need. The current challenges may also push large companies to rethink the inclusion of European sites in their upcoming trials and divert their investment in R&D outside of Europe, until these challenges are resolved. Introducing a delay to the application of the IVDR to IVDs used in clinical trials would alleviate these issues until sufficient infrastructure and processes for efficient assessment of IVDs are available. We thank you for considering our proposal and hope that our comments will help to inform the final amendments. We are available to provide further input or clarify any of our comments, as appropriate. Respectfully yours, EFPIA
Read full response

Meeting with Tomislav Sokol (Member of the European Parliament, Rapporteur)

13 Dec 2022 · European Health Data Space - EHDS

EFPIA warns new liability rules will stifle pharmaceutical innovation

11 Dec 2022
Topic — The consultation seeks to update product liability rules for the digital age.
Message — EFPIA argues the proposal shifts the burden of proof onto companies and introduces overly broad definitions of damage. They want to maintain existing liability thresholds and avoid confusing regulatory compliance with product defects.12
Why — Maintaining existing rules would lower legal costs and prevent expensive speculative litigation settlements.34
Impact — Patients could face higher medicine prices and reduced access to new pharmaceutical treatments.5
Read full response

Response to Fitness check of how the Polluter Pays Principle is applied to the environment

8 Dec 2022

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe. The pharmaceutical industry is committed to positively impact the lives of patients while operating sustainably and fully supports the European Green Deal. Hence, we continuously evaluate the development and the manufacturing of the medicines to minimise unintended environmental effects of medicinal products. We are actively mitigating climate change by reducing waste, energy consumption and emissions and increasing focus on transitioning to circularity. In this framework fits the polluter-pays principle (PPP): a key element underpinning the European environmental policy. However, it does not yet clearly define who is a polluter and what is a pollutant. In any case, the PPP should use a risk-based approach and require a clear causal link between the damage and the pollutant. Medicines have a unique value to public health and society at large and are vital for our wellbeing. Access to medicines is fundamental for the full realisation of the human right to health. They cannot be considered as any other commodity, nor can they be easily replaced by others (I.e., environmentally more friendly) without reducing their pharmacological efficiency. The Extended Producer Responsibility (EPR) is based on the PPP and is applied to pharmaceuticals. In some EU countries this is realized in the form of take-back schemes for unused and expired medicines, devices and packaging. Some of these schemes were established and financed by the different stakeholders of the medicines value chain manufacturers, wholesalers, and pharmacies under their social and environmental responsibility programs, by setting up initiatives for Producer Responsibility Organizations (PROs). PPP/EPR policies have the key feature to prevent waste, improve reusability and recycling. According to OECD (2001), EPR provides incentives to producers to take into account environmental considerations when designing their products, and according to this call for evidence, (Ares (2022)7789078 - 11/11/2022), applying the principle provides an incentive to avoid damaging the environment at source. Within the PPP, pollution control is assigned to the polluters, who can absorb costs without compromising their or others interests. It is unclear that having medicines manufacturers pay (e.g., for the treatment or urban wastewater) meets this condition as these provisions will induce external costs burdening health systems and patients. Additionally, large extent pharmaceuticals are already efficiently managed by existing best practice WWTs. Finally, the EPR policy option has originally been applied to tangible products or materials, and its use at the molecular level is questionable, and gives room for free-riders. An alternative is the user-pays principle, a variation of the PPP that calls upon the user of a natural resource to bear the cost. Governments worldwide adopted it in relation to many public services. The principle states that the actual user should pay for the service. This principle promotes more responsibility and accountability in relation to the environment and the consumption of increasingly scarce resources. EFPIA would appreciate an open and transparent dialogue, involving all relevant stakeholders, to have a constructive and targeted approach to define responsibilities and financial contributions of all polluters. This could balance our shared ambition for clean water and circularity with the pharmaceutical industrys mission of securing access to health for all. EFPIA will participate in the public consultation on PPP announced by EU COM in 2023 and would appreciate any further involvement.
Read full response

Meeting with Dolors Montserrat (Member of the European Parliament, Rapporteur)

7 Dec 2022 · Lessons learned on impact of COVID-19 pandemic

EFPIA warns AI liability rules will stifle pharmaceutical innovation

28 Nov 2022
Topic — New EU rules establishing liability for damages caused by artificial intelligence systems.
Message — EFPIA urges the EU to maintain procedural safeguards requiring claimants to demonstrate fault and causation. They argue the current proposal creates a de facto reversal of the burden of proof. They also request that evidence disclosure be limited to readily available information.123
Why — This would reduce their compliance costs and protect them from expensive litigation.4
Impact — Patients face higher drug prices and limited access to new medical therapies.5
Read full response

Meeting with Margrete Auken (Member of the European Parliament, Shadow rapporteur)

24 Nov 2022 · Recast of the UWWTD

Pharma trade group warns CLP labels could disrupt medicine supplies

18 Oct 2022
Topic — The European Commission proposal introduces new chemical hazard classes under the CLP Regulation.
Message — The industry calls for hazard definitions based on causal relationships rather than correlation. They also propose consecutive transition periods to avoid supply chain disruptions for medicines.12
Why — Stricter evidence requirements and staggered timelines would lower their regulatory compliance costs.3
Impact — Environmental groups lose as narrower hazard definitions make it harder to restrict chemicals.4
Read full response

Meeting with Pierre Delsaux (Director-General Health Emergency Preparedness and Response Authority)

17 Oct 2022 · EFPIA/EC catch-up on HERA Next meeting of the Joint Cooperation Industrial Forum

Meeting with Kurt Vandenberghe (Cabinet of President Ursula von der Leyen)

10 Oct 2022 · Conc. Commission proposals to revise the entire EU pharmaceutical legislation by the end of the year

EFPIA Urges Protection of Medicine Supply in ECHA Reform

7 Oct 2022
Topic — New proposal to update governance and financing of the European Chemicals Agency.
Message — EFPIA demands the European Medicines Agency be consulted to align chemical rules with medical needs. They argue ECHA should not interfere with the risk-benefit assessments performed by the EMA. An impact assessment is requested to prevent shortages of chemicals used in healthcare.123
Why — This protects pharmaceutical supply chains and prevents new regulatory burdens on medicine manufacturers.45
Impact — Patients face risks if new chemical rules restrict the availability of essential medicines.6
Read full response

Response to Revision of the Union legislation on blood, tissues and cells

8 Sept 2022

The proposed Substances of Human Origin(SoHO) Regulation intends to harmonize measures for Member States and organizations involved in activities related to SoHOs for human application, facilitating cross-border exchange and continuity of supply in the EU. EFPIA supports these aims but is concerned about areas of the SoHO Regulation that appear incoherent with medicinal product regulation. Article 2(3) clarifies the application of the regulation is limited to specific activities for SoHOs used to manufacture products regulated under other Union legislations (e.g. medicinal products and advanced therapy medicinal products (ATMPs)). Yet certain provisions remain unclear. Human plasma included in a plasma master file is explicitly exempt in Art. 42 from importing SoHO entity authorisation. We ask Art. 42 and recital 11 be clarified so all SoHO import/export intended for manufacture of medicinal products (incl. ATMPs) are clearly exempt from SoHO entity authorization. Import and export of SoHOs intended for manufacture medicinal products are regulated under the Pharmaceutical Legislation according to GMP principles for supplier qualification, and applying additional SoHO entity requirements causes undue burden. Recital 9 states the SoHO regulation applies to genetically-modified organisms. This is inconsistent with Art. 2 as genetic manipulation is considered substantial manipulation, and should always fall into the realm of the ATMP regulation. No reference is made in the SoHO Regulation to medicinal products produced under Clinical Trials Regulation 536/2014. Art. 2(3) and Recital 11 should include this reference to clarify that starting material used in production of investigational medicinal products are included. Regarding borderline cases, Recitals 24 & 39 and Article 14 of the proposed SoHO regulation state when there is doubt about the regulatory status of a substance, product or activity, SoHO competent authorities shall consult with the relevant authorities responsible for other regulatory frameworks and may request an opinion from the SoHO coordination board (SCB) who will keep a compendium of decisions taken. The EU Commission is also empowered to decide on the regulatory status under the SoHO Regulation upon request or on its own initiative. In general, we welcome measures to ensure clarity and harmonization of borderline cases across the EU. The ATMP classification procedure defined in Regulation 1394/2007 is established at EMA based on the scientific recommendation of the Committee for Advanced Therapies (CAT). A more robust approach is needed to ensure the borderline classifications by CAT, Member States and SCB do not lead to divergent outcomes. The approach in Art. 14 aims to reduce potential divergency, however, the need to consult with CAT should be clearly reflected. Recital 40 and Article 68(1) notes the need for SCB to collaborate with EMA in relation to authorisation of plasma but should encompass guidelines impacting ATMP production. The complex interplay proposed in Art. 14 may create additional hurdles that could delay the development and patient access to novel therapies. We strongly believe that in conjunction with the Pharma revision a clear hierarchy on classification of borderline products should be defined at a centralized EU level. Given the reliance on a new SCB and technical expert bodies EDQM and ECDC to adapt requirements to scientific progress, we underline the importance of leveraging subject matter expertise, including in industry, through structured dialogue and transparent consultation with all stakeholders when updating or developing technical guidelines. In conclusion, EFPIA welcomes the potential benefits of harmonization offered by the draft Regulation and calls on policy makers to ensure the final version addresses the remaining issues highlighted, notably, clearer delineation of SoHO and pharmaceutical activities and appropriate definitions for classification.
Read full response

EFPIA calls for impact assessment on chemical data sharing

10 Aug 2022
Topic — The initiative seeks to improve access to chemical data for safety assessments.
Message — EFPIA requests an impact assessment to prevent negative effects on medicine availability. They demand that data sharing rules respect regulatory data protection and keep company details confidential. They also call for alignment with pharmaceutical legislation revisions.123
Why — Maintaining data protection would safeguard their research investments and ensure market exclusivity.4
Impact — Researchers and private groups lose access to raw data due to confidentiality restrictions.5
Read full response

Meeting with Kathleen Van Brempt (Member of the European Parliament, Committee chair) and Vaccines Europe

14 Jul 2022 · The current situation of the pandemic and the work of the COVI Committee

Meeting with Stella Kyriakides (Commissioner)

29 Jun 2022 · Exchange of views on the upcoming pharmaceutical legislation

Meeting with Margaritis Schinas (Vice-President) and

29 Jun 2022 · Pharma Strategy

Response to Labelling requirements for unauthorised medicinal products used in Clinical Trials

28 Jun 2022

EFPIA comments to Art. 70 EU CTR 536/2014 Draft Delegated Regulation on Annex VI General comments 1. Efpia welcome the changes in Annex VI for the inner pack expiry date omission when displayed on an outer pack label. This change should be implemented as soon as possible. We would like to point out one of the original points of the Efpia position on this from 2014. That is Annex VI limits / blocks future technologies. We would respectfully request that future further changes to Annex VI remain an open possibility as technology moves forward with appropriate risk-based implementation 2. At the time the legislation will come into force, labelling of available IMPs will already include the expiry date on the immediate packaging. It would be helpful to have guidance, perhaps in the Q&A on Regulation (EU) 536/2014, on whether the expiry date can be removed without the need for notification to the regulatory authorities. This would seem a reasonable approach given the rationale for making such a change Specific comment on the Explanatory Memorandum of the Draft Delegated Regulation We suggest amending the Explanatory Memorandum by adding in paragraph (3): ‘by opening protective packaging’ in the sentence: “One such potential risk may be damages stemming from the need to open the packaging by breaking tamper evident seals, by opening protective packaging and disassembling the multilayer kit.” Specific comment on Annex VI of the Draft Delegated Regulation Proposal to add the following text in bullet point 7 for better clarification of the reference to Article 67 (2): 7. Where additional labelling for authorised investigational medicinal products is required in accordance with Article 67(2), the following ...
Read full response

Meeting with Véronique Trillet-Lenoir (Member of the European Parliament)

16 Jun 2022 · pharmaceutical strategy

Pharmaceutical group calls for tighter protections on sensitive data

13 May 2022
Topic — This initiative aims to facilitate data access and review database rules.
Message — EFPIA requests robust protections for proprietary data to safeguard pharmaceutical innovation. They also want clearer definitions for government data requests during emergencies.12
Why — Stronger rules would help firms keep their competitive commercial strategies private.3
Impact — Public sector bodies could lose easy access to private data during crises.4
Read full response

Meeting with Giorgos Rossides (Cabinet of Commissioner Stella Kyriakides), Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides)

11 May 2022 · Exchange of views on the upcoming pharmaceutical strategy.

Response to A New European Innovation Agenda

10 May 2022

Research-based industries rely on a thriving research ecosystem, strong capability and a sustainable policy environment. This is particularly true for the innovative pharmaceutical industry that is Europe’s most research-intensive sector, investing 15.4% of its turnover in R&D. Currently, EU pharmaceutical innovators are still strong and internationally competitive in developing, producing and exporting innovative and high value-added medicines. However, during the last few decades, Europe has been falling behind other regions in terms of translating basic research into innovative products and services: while 25 years ago, approximately 50% of medicines were discovered and developed in Europe, today it is 22%. This presents strong challenges for Europe’s strategy autonomy in health, making us increasingly dependent on innovation happening elsewhere. The New European Innovation Agenda is an opportunity to reverse that trend, and we welcome many of the points addressed in the Roadmap. Indeed, breaking the existing silos within the European research ecosystem is imperative to maintain a competitive edge. Having an open, cross-functional approach, relying on dynamic partnerships to accelerate research, including between the public and private sectors is key. Such a collaborative research ecosystem must be embedded in a policy environment that is conducive to innovation. To achieve this, it is essential to ensure coherence in EU policies: while this initiative could help improve research in the EU, measures discussed in the Pharmaceutical Strategy may unintentionally negatively impact research efforts. We hence respectfully call on the Commission to look into the potential interplay. The international competitiveness of EU innovative pharmaceutical industry is a strong asset for the EU to achieve open strategic autonomy. As competition on innovation is increasing global, attractiveness for research is key. Vibrant research is the first step in the development cycle of innovation. It is the catalyst for the discovery of new treatments, vaccines and technologies that benefit European society and economy. To realise its full innovation potential, the EU needs a framework in place to increase pharmaceutical companies’ ability to invest in R&D and modern production capacities in Europe in the future. That means: Robust enablers for private R&D, including intellectual property protection, adapted to the long and risky process of pharmaceutical R&D; A research infrastructure that helps deliver the next generation of health innovation, including academic collaborations, an educated health workforce, clinical trial networks and a fit-for-purpose health data and digital health infrastructure; A strong, future-proof, agile centralised regulatory framework that allow for the timely and effective authorisation of medical innovation; A value-based market access environment where the pricing and reimbursement of innovation is based on the value that new therapies bring to patients, health systems and societies; A consistent EU policy framework avoiding barriers to operate. In addition, the European innovation eco-system could be strengthened through targeted and clearly defined complementary initiatives that address identified gaps and removing barriers for collaborations between public and private sectors to optimise impact. We therefore support measures such the Innovative Health Initiative, the Health Emergency Preparedness and Response Authority and the establishment of Important Projects of Common European Interest (IPCEIs) in the health domain. European-level life science funds backed up by institutions such as the EIB to provide late-stage funding for Small and Medium-Sized Enterprises in biotech and life science could play an important role. European biotech SMEs have today lesser opportunities to get sufficient funding compared to the US, which is a clear gap in the European health innovation eco-system.
Read full response

Meeting with Werner Stengg (Cabinet of Executive Vice-President Margrethe Vestager)

6 May 2022 · European Health Data Space, Data Act, Data Governance Act

Response to Streamlining EU scientific and technical work on chemicals through the EU agencies

12 Apr 2022

EFPIA response to the Commission Call for Evidence on Chemicals – making best use of EU agencies to streamline scientific assessments The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe. It is essential for EFPIA that any actions on implementation of the One Substance One Assessment (OSOA) concept as part of the EU chemicals strategy for sustainability, which aim to simplify the current set up and reduce administrative burden, duplication, and optimize resources, do not have a negative impact on ensuring the access of safe, efficient medicines and vaccines to citizens in Europe. It is important to note that the EU Fitness check of all chemical legislations referred to in the Call for Evidence excluded pharmaceuticals from scope. Therefore, the clear functioning and impact of the proposed OSOA concept on medicines and vaccines is unknown. While there is foreseen to be no economic, social and environment impact from the implementation of the OSOA concept, our sector has significant concerns over the availability and supply of safe medicines and vaccines to citizens in Europe. Overall, regulatory frameworks and processes within Europe on chemicals, food, and environment must also be tailored to enable innovation and continuous global supply of medicines. While EFPIA supports a single assessment to identify the hazards of any chemical, it is important to note that an assessment of the risk to patients will differ strongly depending on the dose/amount/formulation of the medicinal product. For example, from an environmental risk standpoint, hazardous materials used in the production of medicinal products may present a very low environmental risk, since amounts used may be low and the controls inherent in manufacture and waste disposal satisfactory to ensure 100% containment of materials and their waste and appropriate waste treatments. From a toxicological risk standpoint, the impact on health of any hazardous chemical will depend upon the exposure (e.g. the amount to which a subject is exposed and the duration and frequency of that exposure). Hence, hazardous chemicals present in uncontrolled levels in, e.g. food may present a high risk to health, whereas regulated controls (on levels within a product and on dosing amount and frequency) may mean that the risk in medicines is far lower, thus the benefit outweighs the risk. As such, whilst one hazard identification for chemicals is a desirable approach, OSOA will need to ensure an appropriate and tailored approach of related risk assessments for the respective use, such that considerations of benefit/risk in the specific context of medicinal products, which are adequately reflected already (eg in Directive 2001/83/EC), are still provided. The impact of this strategy, notably the simplification of the EU regulatory framework for hazard identification, risk assessment and management of chemicals, is difficult to assess but is reasonably expected to result in the removal and replacement of chemicals also used in healthcare products e.g., for excipients, packaging materials or even as Active Pharmaceutical Ingredient (API). If this impact is not properly anticipated and managed, the OSOA strategy may have a negative impact on the quality and availability of healthcare products and medicines in the EU/EEA in the longer term, hence conflicting with other Commission’s strategies and the overall Sustainable Development Goals (SDGs). Medicines are developed for patients to use worldwide and authorised in multiple countries or regions, following guidelines of the International Council for Harmonisation (ICH). Due to the expected impact on our sector, EFPIA would like to express interest to be part of the planned targeted consultation with relevant stakeholders.
Read full response

Response to Proposal for a Council Recommendation on long-term care

29 Mar 2022

Spending on long-term care in OECD countries has seen the highest growth compared to other areas of healthcare. A European Care Strategy should take a lifespan approach to healthy ageing, aiming at reducing and delaying the need for long-term care, especially noting the growing ageing population. This would free up resources to enable access to high-quality and people-centered long-term care services to those that need them, when they need them. Tackling non-communicable diseases (NCDs) would be a key part of this strategy - today almost one-third of people over 65 years are living with two or more chronic diseases such as Alzheimer’s Disease, cardiovascular disease, cancer, diabetes or respiratory diseases. NCDs and co-morbidities require complex and costly healthcare, long-term care and social care interventions. In this perspective, a European Care Strategy should focus on commonalities and potential for broad interventions that impact multiple conditions simultaneously, and keep Europeans living with chronic disease in a good state of health for as long as possible. A European Care Strategy should also account for the considerable impact that an ageing population and growing prevalence of NCDs have on informal and unpaid carers, most of which are women. In the case of Alzheimer’s disease, women are disproportionately impacted both as patients and caregivers: 2/3 of individuals diagnosed with AD in Europe are women and they also constitute 2/3 of informal caregivers. In addition to enormous unpaid effort (estimated 15.3 billion hours of unpaid help in 2020), this also puts women at risk of poor health outcomes and economic hardship – in fact, almost 19% of women had to stop working due to the burden of caregiving or to become a full-time caregiver. As an integrated part of a European Care Strategy EFPIA calls on the European Commission to support the efforts to transform the lives of people living with chronic diseases through: 1. Screening, early detection and prevention. 2. Data Registries and Electronic Health Records (EHR) . 3. Health systems reform. These actions should be complemented with promoting health literacy and adherence to treatment. Unfortunately, nearly half of Europeans have inadequate (12%) or problematic (35%) health literacy skills. Improving health literacy, including the Commission's commitment to increase digital literacy, by integrating it into health policies and targets will contribute to better health outcomes and more efficient use of health resources. Please see the attached file for further details and supporting references.
Read full response

Meeting with Despina Spanou (Cabinet of Vice-President Margaritis Schinas), Maria Luisa Llano Cardenal (Cabinet of Vice-President Margaritis Schinas)

29 Mar 2022 · access to medicines online portal

Response to Recommendation for strengthened actions against antimicrobial resistance

23 Mar 2022

EFPIA welcomes the European Commission’s initiative to issue a proposed Council Recommendation on AMR. EFPIA supports the need for coordinated, effective and efficient “One Health” EU action to tackle AMR, focusing on high-impact areas, such as addressing market failures that have resulted in an innovation pipeline insufficient to protect patients from antimicrobial-resistant bacteria. While AMR is more widespread in LMICs, AMR is an increasing concern in the EU too, and governments need to respond robustly to the threat. Our industry is proposing a series of tangible measures to fight against AMR. As part of the AMR Industry Alliance (https://www.amrindustryalliance.org/), EFPIA is uniting efforts with other industry sectors to reduce the development of AMR, invest in R&D and improve access to medical countermeasures. Also, launched in 2020, the AMR Action Fund (https://www.amractionfund.com/) is a ground-breaking partnership from over 20 leading biopharmaceutical companies, supported by the WHO, the EIB and the Wellcome Trust. Created as a bridging mechanism, while new pull incentives are implemented in the EU and beyond, the Fund seeks to invest US$1 billion to support bringing 2-4 novel antimicrobials to the market over the next 10 years. The EU and Member States have a critical role to play in fighting AMR, for example by promoting better prevention via vaccination, and strengthening surveillance and prudent use of antimicrobials; by improving awareness and understanding of AMR; by implementing a package of push and pull incentive mechanisms at EU and national level to foster antimicrobial R&D, and promoting HTA and reimbursement reforms of antimicrobials, to ensure market sustainability for these products; as well as by adapting the regulatory framework, and addressing environmental concerns. Robust policies are needed to establish an economic environment that incentivises sufficient long-term investment in antimicrobial R&D, while fostering access and reliable supply, and antimicrobial stewardship. In this regard, EFPIA believes that a package of different measures should be urgently implemented. Notably, a new EU pull economic incentive would represent a much-needed signal to the private sector to invest in R&D at the level needed to build a sustainable antimicrobial pipeline. The innovative pharmaceutical industry, including companies of all sizes, calls for a novel EU pull incentive in the form of transferable exclusivity extension (TEE). TEE would be the most appropriate and valuable tool to incentivise antimicrobial R&D, while promoting good stewardship. The developer of a qualifying antimicrobial would be awarded a TEE for a specified period of additional exclusivity. This exclusivity could be applied to another product within the portfolio of the company that developed the new antimicrobial or sold to another company. TEE should be designed so that it provides an appropriate reward to incentivise R&D, whilst aligning the value of the TEE with the broader societal value of the antimicrobial. A TEE would offer significant advantages in the EU and would demonstrate EU leadership in the fight against AMR. In addition, more needs to be done to increase the value that EU societies and healthcare systems place on antimicrobials, which is still too low, considering the high unmet need behind AMR and the “safety net” role of antimicrobials for healthcare systems. Local HTA processes do not assess the unique attributes of novel antimicrobials or consider the full range of benefits antimicrobials bring to patients, healthcare systems and society. Appropriate HTA, and national pricing and reimbursement reforms are therefore needed to ensure that the antimicrobial market is more sustainable and patients can get access to the most appropriate antimicrobials. EFPIA is committed to EU and global efforts to fight AMR and looks forward to further dialogue with the European Commission, Member States and all stakeholders.
Read full response

Meeting with Sandra Gallina (Director-General Health and Food Safety)

16 Mar 2022 ·  EU Pharmaceutical Strategy

Meeting with Stella Kyriakides (Commissioner) and

14 Mar 2022 · Meeting with EFPIA, Medicines for Europe and European Fine Chemical Group to discuss the security of supply of medicines

Response to Cancer Screening Recommendation

22 Feb 2022

The EFPIA Oncology Platform (EOP)1 welcomes the European Commission's intentions to update the European Council Recommendation on cancer screening based on the latest evidence. Screening is a critical step in reducing the burden of cancer, as early detection of cancer contributes to improved patient outcomes. It is crucial to continually and regularly align screening with innovation. Research, diagnostics tools and evidence for screening evolve rapidly, and a clear governance and timely review process is needed to assess the latest evidence, technological innovations and implementation practices to support the updating of screening recommendations. Continuous reviews (e.g. every 3-5 years)2 should be part of the process. Monitoring of screening programmes will ensure their continuous improvement. A robust and comprehensive EU-wide monitoring framework, linked to the Cancer Inequalities Registry, would support assessment against predetermined performance indicators. Such a framework could be used to support the rapid adoption of innovation and quality improvement across Member States. The EOP has been working with the ECO and the ECPC3 to define indicators for cancer care including screening and early detection and would welcome the opportunity to share insights on indicators for this monitoring framework, which should consider public awareness of cancer symptoms and available screening programs, as well as implementation and participation rates. The main goal of screening is to improve cancer care and outcomes – therefore follow-up pathways need to be established. Following a positive screening result, it is crucial to provide rapid access to diagnostic procedures and the most appropriate psychological support, treatment and care plan. It is important not to ignore the need for improvement of diagnosis and treatment for cancer types for which there is no evidence for screening. It is therefore important to ensure that Clinical Practice Guidelines & Quality Assurance Schemes for every part of the care pathway are developed by the Knowledge Center on Cancer for all cancer types. As recognised in Europe’s Beating Cancer Plan, personalised medicine has a key and growing role in cancer diagnosis and treatment decision-making. With the help of biomarkers, healthcare practitioners can identify genomic alterations that drive cancer growth and identify the best treatment option for each patient, at each given time. Therefore, it is important to ensure that every person living with cancer has their tumour tested before treatment decisions are made – a step that can be incorporated in the validation of positive screening findings. We welcome guidance from the European Commission on ensuring that genomic testing becomes part of routine clinical practice within the next 5 years, via EU recommendations on Genomic Tumour Testing. Finally, we call on the European Commission to support the coordination of cancer screening efforts across the EU. The development of screening guidelines must be paired with robust implementation and delivery. This requires clear follow-up, implementation of Artificial Intelligence where applicable, and use of Real-World Data and digital technologies. These efforts can be linked to action around the European Health Data Space. In addition, the Commission should encourage programmes aimed at decreasing cancer care inequalities between Eastern and Western Europe, to ensure equal access to quality cancer care across the EU. 1. https://www.efpia.eu/about-medicines/use-of-medicines/disease-specific-groups/fighting-cancer/ 2. https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21557 3. https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/cancer-experts-patients-and-industry-applaud-europe-s-beating-cancer-plan-and-reemphasise-the-importance-of-measuring-success/ Additional reading: https://www.efpia.eu/media/589727/unlocking-the-potential-of-precision-medicine-in-europe.pdf
Read full response

Meeting with Caroline Boeshertz (Cabinet of Executive Vice-President Valdis Dombrovskis), Elina Melngaile (Cabinet of Executive Vice-President Valdis Dombrovskis), Kevin Keary (Cabinet of Executive Vice-President Valdis Dombrovskis) and

26 Oct 2021 · Pharmaceutical sector – trade related issues

Response to Requirements for Artificial Intelligence

30 Jul 2021

EFPIA applauds the Commission for launching the first ever legal framework on AI that elaborates on a European approach for AI with an aim to promote Europe’s innovation and industry capacity in AI that could bring benefits to entire healthcare system. We welcome a risk-based approach to AI with an oversight proportionate to the intended use and led by defined risk categories. Healthcare is one of the most regulated industries with strict ethical and governance rules and evidence-based regulatory decision-making. EFPIA supports the Commission’s approach to regulate AI based on risk, overall acknowledging CE marking system for high-risk applications in healthcare which is already addressed by MDR/IVDR. We would welcome an alignment of the risk levels described in the proposal with MDR for consistency. Under a risk-based regulatory system and in consideration of the scope of use, some AI-driven software may be categorised as low or intermediate risk under the MDR, whereas the draft proposal appears to classify all such devices as high risk. A generalised approach can decrease the competitiveness on the market due to providers having difficulty in fulfilling market access regulations and therefore jeopardising the uptake of AI-driven solutions by operators. AI has a broad application in the pharma supply chain including R&D, manufacturing, launch, post marketing surveillance as well as opportunities across the patient journey. To incentivise the investments in AI solutions in Europe, we recommend a thorough assessment of the proposed requirements versus the support offered to providers to navigate through the new rules. To assure high quality AI solutions and to safeguard the EU’s competitiveness in the international AI marketplace, easy yet compliant access to a significant amount of high quality and representative data will be prerequisite to ensuring highest levels of safety and robustness of AI and reducing bias, discrimination. Industry invests (e.g. via IMI) and supports the “FAIR-ification” of data to build up on existing sources and to make the machine-readable metadata findable for automated discovery. The Commission’s plans to create a EHDS promise to unlock the power of data for AI-enabled healthcare and a well-functioning EHDS should incentivise data sharing and harmonise applicable rules to remove barriers to the collective benefits across Europe. In order for all stakeholders, including providers and operators, to train, test, develop and apply a trustworthy, reliable and ethical AI system, clear rules favouring industry data access and processing within EHDS should be laid out; and full benefit should be made of all measures in support of innovation such as AI regulatory “sandboxes” which may involve the further processing of personal data for a limited period of time under well-defined conditions. Emerging AI methods involving the decentralised development of machine learning algorithms would enhance user and stakeholder privacy and should be investigated. We should avoid fragmented implementation. Therefore, we welcome the creation of a European AI Board tasked with coordination of collaboration on AI across the EU. We emphasise that the evolving positive ecosystem of AI must be built together. EFPIA wishes to underline the importance of all key stakeholders being engaged in this initiative at the highest level and encourages early agreement on public-private platform to allow for structured dialogue with the Board. Co-creation would empower regulators and policymakers to gain vital insight as much as it would encourage stakeholders to gain ownership of the process and its effectiveness.Finally, we call the EU policymakers to engage with international partners throughout the legislative process to take into consideration how the rules would apply internationally. Any regulation should ensure an equal playing field for both local and global players while not stepping away from core European values.
Read full response

Meeting with Cyrus Engerer (Member of the European Parliament)

22 Jul 2021 · Pharmaceutical Strategy

Response to Data Act (including the review of the Directive 96/9/EC on the legal protection of databases)

25 Jun 2021

Thank you for the opportunity to respond to the Inception Impact Assessment on the Data Act. Please find attached the response of EFPIA
Read full response

Meeting with Margaritis Schinas (Vice-President) and

21 Jun 2021 · Pharmaceutical strategy

Meeting with Margaritis Schinas (Vice-President) and

16 Jun 2021 · Supply chains for medicines

Meeting with Stella Kyriakides (Commissioner) and MEDICINES FOR EUROPE and

7 Jun 2021 · VTC meeting - Access to Medicines

Response to Revision of EU legislation on hazard classification, labelling and packaging of chemicals

31 May 2021

EFPIA, the research-based pharmaceutical industry is supportive of the European Commission initiatives related implementation of the Green Deal, specifically the chemicals strategy for sustainability, which sets out a number of actions that require a targeted revision of the Regulation on the classification, labelling and packaging of chemical substances and mixtures. We welcome the analysis of various options for revision based on an impact assessment, followed by legislative proposals for a revision of both the enacting terms of and the annexes to that Regulation. It has to be noted that pharmaceutical industry applies all required steps to comply with worldwide classification and labelling regulations. In the IIA, a number of measures have been mentioned that will be examined through options with different ambition levels as examples. EFPIA comments on those examples: Introduce new hazard classes (such as endocrine disruptors) and corresponding criteria: • The CLP Regulation is the core piece of Union legislation for the hazard assessment of chemicals, stemming from the United Nations’ global standard (GHS). It is the basis for hazard classification of chemicals and how to communicate those hazards to consumers and workers. From a hazard communication perspective it would be advisable to keep the alignment of CLP with GHS, therefore our proposal is to implement the new criteria with the global agreement (eg. UN GHS Purple Book). Introduce an obligation to provide information of some hazards on the label for products currently outside the scope of CLP: • It is unclear what is the impact on pharmaceuticals – especially in the final dosage form (FDF). We are currently only impacted in case of handling and transporting API and bulk FDF. It would be advisable to continue to utilise Patient Insert Leaflet (PIL)/SmPC for communication purposes of FDF, as up to now. Clarify the obligations to classify mixtures and some complex substances: • FDF should be kept excluded as up to now, since they are covered by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Introduce specific rules for online sales: • Currently we are not aware of these rules Introduce the possibility to submit proposals for and set harmonised environmental and safety values for some substances: • We have previous experiences with harmonisations, specifically harmonisation is a possibility for generic APIs. We are supporting this activity, as well as more sharing of preclinical and environmental studies used as the basis of classification. Require importers and downstream users to submit information on substances classified for physical effects or health hazards to poison centres and clarify obligations for distributors to submit such information, through an only representative or other means: • This point is not fully clear as for any potential impact as the requirement for imported and hazardous mixtures to be notified is already included in CLP. Introduce a mandate for Commission to request ECHA to develop new harmonised classification and labelling (‘CLH’) dossiers: • As mentioned before, we agree with harmonisation and consider this is a reasonable proposal. Allow multilingual fold-out labels: • For sustainability reasons we support digital labels. Introduce tailored labelling rules where there is not enough space on packaging: • We support this proposal. Tailored labelling is a feasible option for small containers (e.g. laboratory scale, clinical trial material). For sustainability reasons we support digital labels. Introduce a prioritisation mechanism for harmonising the classification of certain chemicals: • We support risk based prioritisation with classification criteria that are scientifically grounded. Simplify and reduce unnecessary administrative costs: • Simplification and reduction of administrative costs is fully supported.
Read full response

Response to Revision of EU legislation on registration, evaluation, authorisation and restriction of chemicals

31 May 2021

EFPIA, the research-based pharmaceutical industry, supports the Commission’s objective to revise, improve and simplify the REACH regulation. We welcome the opportunity to be recognised as a key stakeholder to develop and implement better chemical regulations. Chemicals are essential in the development & delivery of innovative and high-quality pharmaceuticals, and as such the pharmaceutical industry can play a key role as a driver in achieving the ambitious goals of the Commission towards a toxic-free environment, e.g. reducing the industry’s carbon and environmental footprint and developing greener manufacturing technology. Any change to the regulation shall align with the initial principles of REACH: to ensure a high level of protection of human health and the environment from effects of hazardous chemicals, while avoiding unnecessary testing on animals and enhancing competitiveness and innovation in Europe. At all time, the best option for risk management should be assessed and identified through predictable and transparent procedures, with involvement of relevant stakeholders. The goals of the Chemical Strategy for Sustainability and planning certainty should be achieved primarily within the framework of existing legislation. Options should not exclude the use of hazardous substances from the outset but should allow an open-ended evaluation. Understanding that this is only the beginning of a long dialogue to shape the future of chemicals policy, EFPIA wishes to provide preliminary considerations on the different topics laid out in the IIA from the Commission: - Current data requirements shall not be increased for low volume substances & intermediates (key to drive innovation). Information requirements on environmental footprint goes beyond REACH and shall be discussed and developed through a larger forum. - We encourage the digitalisation of information communicated along the supply chain. - We are concerned that allowing authorities to commission studies, without agreed criteria nor involvement from the registering companies, would lead to unplanned cost for the industry (through direct or indirect fees), and no predictability as to which type of testing and endpoints would be required for the substances, discouraging R&D. - The revision of the authorisation process should secure a more agile & predictable process & establish legal timelines. It should permit simplified procedure for small amounts, and derogation for the use of SVHC in R&D (above 1 t/y), in the spirit of boosting innovation and competitiveness for EU. Provision should be added to allow authorities to give time-limited derogations from the authorisation procedure in situations where there is a threat to public health, eg art. 55(1) of the Biocidal Products Regulation. The proposal to allow national authorisation for smaller applications could have unintended consequences, discrepancies and inconsistencies between member states could develop, thus creating an uneven playing field across the EU. -The current restriction procedure allows for balanced risk management & focuses on phasing out only the unacceptable uses. Grouping approach might become problematic if it is not based on robust science. The implementation of generic approach to risk management for professional uses would be disproportionate, as professional users (e.g. healthcare workers) have specific qualifications & are informed about measures to mitigate the risks during corresponding activities, & the current restriction procedure allows for selective restriction of uses. - The operationalisation of the “Essential Use” concept shall consider the features of the pharma industry. This will require multi-agency engagement by the Commission to ensure that the CSS does not have any adverse impact on the reliability and robustness of medicinal product supply chains. - We are supportive of a more robust and consistent enforcement EU wide, addressing both manufacturers and importers equally.
Read full response

Meeting with Caroline Boeshertz (Cabinet of Executive Vice-President Valdis Dombrovskis), Cristina Rueda Catry (Cabinet of Executive Vice-President Valdis Dombrovskis), Michael Hager (Cabinet of Executive Vice-President Valdis Dombrovskis)

17 May 2021 · EU vaccine policy

Response to Pact for Research and Innovation in Europe

12 May 2021

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the research-based biopharmaceutical industry operating in Europe. Our mission is to create a cooperative environment that enables our members to innovate, discover, develop and deliver new therapies and vaccines for people across Europe, as well as contribute to the European economy. The research-based pharmaceutical industry aims to turn fundamental research into innovative treatments that are widely available and accessible to patients. In 2018, the pharmaceutical industry invested more than € 36,300 million in R&D in Europe, a continual increase from € 17,849 million in 2000. However, Europe is now facing increasing competition from economies with rapid growth in their market and research environments such as US, Brazil and China who are contributing to the move of economic and research activities to non-European markets that offer stronger incentives for R&D and investments. EFPIA supports the vision to align the European Research Area around commonly agreed values and principles (including freedom of research, integrity of research, gender balance, etc.). The Pact for R&I has the potential to enable an attractive innovative ecosystem aligned with Europe’s R&D, innovation, resilience and competitiveness ambitions including: - accelerating science; - enabling partnerships and collaborations across sectors and disciplines; - fostering deployment of assets, infrastructures and knowledge generated through research programmes. This can be achieved through: - R&D budgets comparable to those of other regions (min 3% GDP investments in R&I); - openness to the world to attract and harness best science and capabilities to provide solutions to European citizens/consumers/patients; - flexible mechanisms that allow new forms of collaboration, as innovation comes from unexpected directions; - robust IP frameworks which guarantee certainty for all players; - access to research data as open as possible, as closed as necessary to both accelerate progress and protect academia and big and small companies’ competitiveness; - financing the deployment and scaling up of results generated in research programmes - pan-European and regional infrastructures that go beyond single institutions; - the role of tech transfer offices as enablers and nodes in the large innovation ecosystem; - mobility of researchers between countries, but also between public and private sectors; - consistent approach to excellence and geographical inclusiveness: whereas R&I actions should be based on scientific excellence and impact, those R&I Member States with lower engagement should be supported via e.g. a Forum for transition and specific networking actions.
Read full response

Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

EFPIA supports an agile regulatory framework and a strong incentives’ system that embrace and encourage advances in science, technology & medicines. This evaluation is an opportunity to implement learnings from COVID-19 and ensure a competitive, world-class regulatory system in Europe supporting a globally competitive research-based industry at a critical time. Companies aim to bring products to as many patients as quickly as possible, across all countries. However, the legislation cannot solve issues around access & affordability, which are national competences. We believe that a solid analysis of the current regulatory framework and root causes of unavailability and access delays is important and EFPIA is ready to engage in an open dialogue with relevant stakeholders to support this common goal. We propose these priorities for legislative change to equip the regulatory framework to respond quickly to patient needs: Reinforce expertise-driven assessment and enable a more agile centralised authorisation framework by removing unnecessary interfaces between EC, EMA & Committees Enhance expedited pathways framework supporting innovation Expand the role of EMA in the assessment of drug-device/diagnostic combination products Replace the paper patient information leaflets with electronic versions It will be crucial to enable future innovative approaches to medicines R&D eg by ensuring the acceptance of RWE in medicines evaluation both pre & post-authorisation and to further strengthen EU’s leadership towards global regulatory convergence especially as new technologies emerge. Revision of the Variations Regulation is a must to simplify and modernise the EU post-approval framework. Fast-paced developments in medicine, devices, data & digitalisation will lead to more personalised healthcare solutions. The legislation framework must set out the principles, whilst allowing for policy adaptations at a later point without the need for further legislative revision. Updates to existing policy & guidance documents can help to: Encourage the use of novel clinical trial designs Ensure ongoing scientific dialogue throughout product development Enhance security, transparency & oversight of supply chains through a targeted stakeholder approach and incentives driven reforms based on facts. EFPIA calls for using the data stored in the interoperable network of national repositories (Falsified Medicines Directive) to provide additional intelligence in monitoring shortages Support environmental risk assessments to cover product lifecycle and address sustainability via initiatives like #Medsdisposal The stability and predictability of the existing European incentives’ framework has enabled industry to invest in R&D and to deliver new medicines to patients, healthcare systems and society. For areas where there is a lack of a viable market (eg antimicrobials) and where the current framework has not yet covered all needs (eg OMP/Paediatrics), novel incentives adapted to the specific challenges of particular disease areas should be considered. Guided by science, EFPIA members are working both to address unmet need in diseases where there are no treatments and where the existing treatments do not sufficiently meet patient needs. To attract investment in Europe it is important that incentives are predictable and do not change late in development. Since market access is dependent on mostly national & health system related factors as well as market dynamics and cannot be predicted early in development, linking incentives to access could jeopardise the objectives of incentivising & improving access to innovation in the EU. Commitment from national governments to identify and remove outstanding barriers and to address the negative effects of international reference pricing is needed. The industry is committed and EFPIA continues to call for a High-Level Forum on Access to Health Innovation to address these issues, to the benefit of all patients in the EU
Read full response

Meeting with Margaritis Schinas (Vice-President) and

8 Apr 2021 · Health Union

Response to Digital Services Act: deepening the Internal Market and clarifying responsibilities for digital services

31 Mar 2021

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe. Through its direct membership of 36 national associations, 39 leading pharmaceutical companies and a growing number of small and medium-sized enterprises (SMEs), EFPIA’s mission is to create a collaborative environment that enables our members to innovate, discover, develop and deliver new therapies and vaccines for people across Europe, as well as contribute to the European economy. EFPIA welcomes the publication by the European Commission of the proposal for a Regulation on a Single Market for Digital Services. Beyond the numerous provisions already outlined in the European Commission’s proposal, EFPIA believes there are additional targeted measures needed to be taken to guarantee the protection of EU citizens against illicit/counterfeit medicines. Please find attached our detailed proposal.
Read full response

Meeting with Despina Spanou (Cabinet of Vice-President Margaritis Schinas), Maria Luisa Llano Cardenal (Cabinet of Vice-President Margaritis Schinas)

25 Mar 2021 · Biopharmaceutical CEO Roundtable

Meeting with Stella Kyriakides (Commissioner) and BUSINESSEUROPE and MEDICINES FOR EUROPE

5 Mar 2021 · VC Meeting discussion on COVID-19 vaccines export authorisation scheme.

Response to European Health Emergency Response Authority

23 Feb 2021

COVID-19 has demonstrated the need for the EU to ensure a robust, resilient and agile ecosystem to anticipate and effectively manage pandemics and their consequences. EFPIA and Vaccines Europe (VE) welcome the European Commission’s ambition to create a Health Emergency and Response Authority (HERA) to strengthen the EU’s approach to pandemic preparedness and response. What is needed most for effective emergency preparedness and response is a system that is connected, responsive and collaborative, as innovation and opportunities to address health threats may come from unexpected areas. In such a system, building on existing actors, their contributions and needs, HERA would take the role both of central actor as well as systems designer, together with the key public stakeholders (including health authorities) and private stakeholders. EFPIA and VE believe that the baseline scenario and option 1 lack the necessary ambition and clear funding line to address the gaps identified whereas we consider that options 2 & 3 contain several promising elements. EFPIA and VE support the ambition to set up clear structures to address the existing gaps in supporting late-stage development and manufacturing of medical countermeasures. We welcome the suggested end-to-end approach and single-entry point for stakeholders to bring more certainty, limit complexities end redundancies and allow the pooling of resources to fund at the magnitude needed to make a difference. In addition, HERA should be able to execute projects with single entities, and it should be staffed with subject-matter experts who have extensive industry and regulatory knowledge. To stimulate innovation in areas of health security threats, HERA should have a flexible, collaborative and agile setup. EFPIA and VE welcome the intent of a more streamlined approach but would like to highlight that a complex structure implies hurdles, which might reduce the speed of decision-making. Therefore, it will be crucial to set up a new and fit-for-purpose framework together with tools to eliminate redundant bureaucratic procedures and guarantee the necessary flexibility and speed to act, specifically in times of emergencies. These factors will be critical for the attractiveness, overall performance and success of the authority. HERA must have a strong mandate with a clearly defined scope and responsibilities (including control of the financial and operational instruments related to counter-measures at EU level), with a multi-annual budget aligned with the ambitions of its scope. It is important that the focus of HERA is clearly defined while remaining flexible to tackle unexpected threats. The new authority should be embedded in the existing EU R&I ecosystem and have strong ties with other EU and international agencies such as ECDC, EMA, WHO, or BARDA to avoiding unnecessary competition and overlaps, explore collaboration possibilities and align on areas of work. To work effectively, HERA will need to be designed to collaborate in all of its efforts with all types of organizations (public and private, European and global) and to support global needs. Overall, EFPIA and VE call for a clear definition of HERA’s scope, for a mechanism to support a sustainable and dedicated funding stream, for the removal of all potential bureaucratic hurdles and the assurance of HERA’s ability to act and take decisions quickly in close and effective collaboration with existing public and private actors. HERA should plan, coordinate and build an ecosystem of private and public capabilities serving EU and global needs in case of health emergencies. The attached document outlines the proposed key principles that we believe would make HERA a success. An urgent initiative on COVID-19 and its variants should serve as a first step towards building the authority.
Read full response

Meeting with Sandra Gallina (Director-General Health and Food Safety)

12 Feb 2021 · Phone call with EFPIA

Response to Evaluation of patient rights in cross-border healthcare

9 Feb 2021

The evaluation roadmap for the Cross-Border Healthcare Directive raises some important points for in-depth review. Regarding the scope of the Directive, there are opportunities to broaden it to clearly include access to diagnosis and access to treatment centres for European patients. There is also a gap in the Directive concerning cross-border access to clinical trials, for which the legislation remains suboptimal. A recent EFGCP & EFPIA study (see attachment) reveals that cross-border participation in clinical trials only occurs very rarely despite a high need expressed by study respondents. There is a need for reliable and accessible information regarding practical aspects of cross-border access to clinical trials. Secondly, better efforts are needed to ensure timely and effective patient access to Advanced Therapy Medicinal Products (ATMPs) across Europe, both through adapting the framework and by facilitating more coordinated implementation by Member States. For instance, the Directive should include clear guidance on patient pathways for cross-border access to gene therapies. It should provide standard guidance on prior authorisation for all Member States with clarification on the process, and clear timelines for decision making and reimbursement. Moreover, the Directive should fully consider the specificities of rare diseases, including rare cancers. Rare disease patients rely on a limited number of specialised treatment centres, sometimes restricted to a few countries. EU-wide interconnected networks of qualified centres for rare diseases and the European Reference Networks are particularly meaningful from a patient perspective. The ERNs help to empower patient groups and they enable homogeneity of care across Member States. Their potential should be further leveraged by strengthening the collaboration with stakeholders, including industry. The ERNs play a particularly important role in collecting outcomes data. They should be provided more actions to collect and aggregate data from countries. The poor number of patients and the lake of data in the R&D area play in favour of supra-national registries. Nevertheless, too many registries are still being developed at the country level, without thinking about the harmonisation and interoperability of data and systems. More generally, the Directive should provide sufficient guidance to support data sharing across countries to support systematic monitoring and data management. The Directive’s effectiveness is further impeded by concerns over security of payment or reimbursement. Cross-border treatments entail significant administrative work for the treatment centres, sometimes rendering the activity without profit. For treatments with a high upfront cost, like ATMPs, the viability of the current reimbursement-based system is uncertain. Treatment centres tend to be cautious as they may need to wait several months to get paid or reimbursed, resulting in some treatment centres charging more for cross-border patients. Innovative payment models should be considered to ensure patient access is not restricted due to reimbursement delays and challenges. Finally, increased awareness is needed to ensure a good functioning of the Directive. Policies, initiatives and community-led pilots should increase awareness of the options available for cross-border healthcare among clinicians, patient advocacy groups, policymakers, academia, charities and others. For example, physicians sometimes lack sufficient knowledge to request funding for cross-border treatments. Even more importantly, patients need better information about the reference pathways and available options when seeking for care. A standardised approach to collecting and making transparent data on health outcomes and other important indicators at a provider level would be important to fully empower patients to use the rights enshrined to them by the Directive, and also drive care quality improvement throughout Europe.
Read full response

Response to Proposal for a Regulation on serious cross-border threats to health

2 Feb 2021

EFPIA fully supports the EU’s goal to enhance its health emergency preparedness and response capacity. We welcome the proposed Regulation strengthening Europe’s preparedness against serious cross-border health threats, and believe that it can be improved further to ensure it delivers on its objectives. The new mechanisms and governance structure created, should build on the COVID-19 lessons learned, and provide for clear procedures and allocation of responsibilities. They should aim to ensure free movement of medical countermeasures and essential workers in emergency situations, and should support sustained supply of active pharmaceutical ingredients and finished products, by reinforcing coordinated actions by Member States, and by avoiding unilateral and uncoordinated decisions. Continued and proactive dialogue between EU authorities and manufacturers during the pandemic has proven successful in, among others, detecting challenges related to the supply of medical countermeasures, as well as identifying policy options to address such challenges. EFPIA, therefore, believes that to enhance informed decision-making and improve EU-wide coordination, the Health Security Committee (art. 4) and the Advisory Committee on public health emergencies (art. 24) should be allowed to consult stakeholders, including manufacturers, on specific topics relevant to the Committees’ activities and decisions. This could be done, for example, via the creation of a dedicated stakeholder group, and in coordination with the upcoming Health Emergency Response Authority. The COVID-19 crisis has led to important challenges in relation to patient access to diagnosis, testing, consultation and treatment management services. EU and national preparedness and response plans (art. 5-10) should explicitly cover provisions to ensure the continuity of healthcare services for chronic, degenerative and life-threatening diseases (e.g., neurology, oncology). The topic of service continuity should also be included in the curriculum for training of public health staff (art. 11). EFPIA welcomes clearer rules to recognise emergency situations (art. 23). The Regulation should be equally clear in defining under which circumstances mechanisms such as joint procurement of medical countermeasures (art. 12), as well as stockpiling, should be allowed. If imposed with very short notice and under non-viable conditions, these have the potential to hamper supply, eventually jeopardising product choice and increasing the risk of shortages. Hence, the Regulation should include specific provisions to prevent such unintended effects, e.g., by clarifying that the mechanisms foreseen would apply for a time-limited period and under well-defined circumstances (i.e., during emergency situations as formally recognised by the Commission). As shown during the pandemic, improved product demand forecast is critical to ensure timely and effective crisis response, and dialogue between EU authorities and pharmaceutical manufacturers has been one of the cornerstones of the resilience of the system, allowing well-informed authorities to take the necessary decisions to ensure the continuity of supply. When it comes to epidemiological surveillance (art. 13-17), while the proposal provides for permanent communication between the Commission, the ECDC and national authorities, we regret that it does not foresee a mechanism to ensure that manufacturers are made aware, in a timely fashion, of epidemiological data, modelling and response scenarios developed by EU authorities, which would greatly help ensure the right allocation of supply, and strengthen industrial capacity preparedness and response for new products. Such communication could be ensured, for example, via the digital platform for surveillance (art. 14). EFPIA is ready to work with the EU institutions and all stakeholders to ensure that the proposed Regulation is taken forward in a successful manner.
Read full response

Response to Proposal for a Regulation on a Union framework addressing public health emergencies (EMA)

2 Feb 2021

EFPIA fully supports the EU’s goal to enhance its health emergency preparedness and response capacity by, among others, extending the mandate of the EMA. The current crisis has shown the importance of close dialogue between EU authorities and the industry, to address medicines’ shortages. It is therefore crucial that manufacturers and other supply chain stakeholders are involved on a permanent basis in the work of the Medicines Steering Group (art. 3). From a governance perspective, the Committees set up by the Regulation should be incorporated into the EMA’s system in a way which clearly shows their responsibilities and how they work in relation to the CHMP, which should retain sole responsibility for benefit-risk assessments. The Regulation should provide for a consistent, EU-harmonized definition of shortages, based on actual patients’ needs (art. 2(d)), and for agreed standardised reporting requirements via a single platform. For optimum decision making, data regarding the sub-national (hospital level) medicine supply and demand situation should be available, and existing systems should be leveraged, such as the European Medicines Verification System. The definition of major event (art. 2(f)) should be further clarified, to ensure full transparency on the circumstances under which the mechanisms set up by the Regulation would be triggered. Lists of critical products in case of major events should be harmonised across Member States. The scope and legal nature of the Steering Group’s recommendations in case of a major event (art. 8(3)) should be better defined and focus on regulatory solutions to address shortages. In setting up new requirements, the Regulation should better acknowledge the multiple drivers of shortages, and therefore the roles and responsibilities of all stakeholders across the supply chain, including but not limited to manufacturers. Reporting requirements for marketing authorisation holders (art. 10) should be justified and proportionate, and cover clearly defined critical products and timeframes. The proposed permanent iSPOC system should complement, not duplicate, current reporting procedures. EFPIA is concerned over the risk of increased, ineffective and unjustified reporting burden on manufacturers, as the Regulation’s requirements would come on top of the obligations set in Directive 2001/83/EC. Confidentiality provisions should also be strengthened, including to address the risk of cybersecurity attacks. Accelerated and free of charge scientific advice, through the establishment of the Emergency Task Force, and advice on clinical trial protocols, will facilitate development and faster regulatory assessment. Providing an option for CHMP opinions on emergency use of products, i.e., conducting the compassionate use and art. 5(2) assessments centrally, similar to the US emergency use authorization, is a welcomed improvement to the EU regulatory framework. Integrating the EMA into the future European Health Data Space’s IT infrastructure and enabling the EMA to access or query real world data (RWD) for evidence, will address some of the longer-term aspirations to make better use of RWD. EFPIA supports an agile governance of the EMA and the EU Medicines Regulatory Network, pooling best experts. This will be key for adopting an integrated EU pathway for the assessment and delivery of innovative technologies. New EMA Expert Panels on high-risk medical devices should support this objective. The proposed reforms should only be a first step in future-proofing the EU regulatory framework. Beyond the specific issues of pandemic preparedness, and to deliver on the objectives of the Pharmaceutical Strategy, the regulatory network needs further strengthening, to achieve the goals identified in the EMA’s Regulatory Science Strategy to 2025, and needs the necessary means to ensure that Europe has a regulatory framework that is predictable, adaptable, effective and globally competitive.
Read full response

Response to Proposal for a Regulation establishing a European Centre for Disease Prevention and Control (ECDC)

2 Feb 2021

EFPIA fully supports the EU’s goal to enhance its health emergency preparedness and response capacity by, among others, reinforcing the mandate of the ECDC. It is critically important that as part of its extended missions and tasks (art. 3), the ECDC can get full and immediate access to all epidemiological data from Member States. In this respect, EFPIA welcomes the intention to further develop digital platforms and applications to support epidemiological surveillance as provided by art. 5 and by the proposed Regulation on Cross-Border Health Threats. These platforms should become part of the European Health Data Space’s IT infrastructure. The Agency should have the internal capacity to provide robust monitoring, surveillance, risk assessment and forecasting on epidemiological trends, health system capacities and demand for treatment in relation to serious cross-border health threats. It is equally important that the Agency has the ability to share relevant data with manufacturers, allowing them to adapt their shortage prevention strategies, to cover patients’ demand. There are currently no formal opportunities for regular interactions between the ECDC and the pharmaceutical industry. While fully supporting the ECDC’s institutional independence, and all efforts to continue guaranteeing such independence, EFPIA believes that the agency could greatly benefit from the industry’s knowledge and state-of-the-art expertise in many areas related to the ECDC’s mandate, e.g., the identification of population groups at risk, and of research needs and priorities. The Regulation is an opportunity to provide the framework for an institutionalised dialogue between the ECDC and the industry, delimited by stringent standards regulating stakeholder engagement with public institutions, to avoid any conflicts of interest. This has been successfully achieved by the WHO (https://www.who.int/about/partnerships/non-state-actors) and the US Centers for Disease Control and Prevention (https://www.cdc.gov/partners/partnering.html). The extension of the ECDC’s mandate provides also a chance to optimise the functioning of the Agency and restructure its governance and ways of working, following the principles of efficiency, transparency and accountability. This includes avoiding future overlaps between mandates and competencies of the ECDC on one hand, and of other EU agencies such as the EMA, the upcoming Health Emergency Response Authority, as well as international bodies such as the WHO Regional Office for Europe, on the other hand. In terms of the ECDC’s governance, EFPIA believes that a revision of the Agency’s decision-making process should also be part of the Regulation, addressed by relevant modifications to art. 18 of Regulation (EC) No 851/2004, to guarantee that the ECDC can take decisions autonomously, via its management team, according to its endorsed strategic roadmap and extended mission. The role of the Advisory Forum should be consistent with art. 18 of the ECDC Regulation (“support the director in ensuring the scientific excellence and independence of activities and opinions”) and should not overlap with the role of the ECDC management team or of the Management Board. Art. 3 mandates the ECDC, among others, to “provide […] evidence-based communication messages to the public on communicable diseases, on the threats to health posed by them and on the relevant prevention and control measures”. Considering that there is still limited public awareness of the ECDC and its role, and limited access to its communications materials, EFPIA believes that Member States should be involved in the dissemination of such messages via dedicated campaigns targeting national audiences, and to be co-developed with stakeholders. This could go a long way in improving public awareness on health threats and the acceptability of the ECDC’s work and new mandate.
Read full response

Response to Legislative framework for the governance of common European data spaces

29 Jan 2021

EFPIA • Welcomes the Data Governance Act as an important milestone in the delivery of the EU’s Data Strategy • Hopes the act will address fragmentation in the implementation and interpretation of GDPR and underpin the agreed flexibilities of GDPR in relation to scientific research • Believes that the new data intermediation entities have the potential to improve data access for researchers but must operate consistently and efficiently across the EU • Emphasises the importance of societal trust in the use of data and the need to ensure that citizens understand how their data is used and how they can exercise control over its use Please see attached statement
Read full response

Response to Revision of the EU legislation on medicines for children and rare diseases

6 Jan 2021

EFPIA members are committed to ensuring that unmet needs are addressed and that available treatments reach all European patients. Children and rare disease (RD) patients have greatly benefited from the progress achieved through the Paediatric and Orphan Regulations. The Paediatric Regulation is meeting best-case expectations from its impact assessment (IA) conducted in 2004. The Orphan Regulation has incentivised the pharmaceutical sector to deliver treatments for up to 6.3M patients in the EU. Any revision of the rewards and incentives should be designed to keep and improve Europe’s strong basis for innovation and should avoid measures aimed to address affordability issues which are best dealt with elsewhere. We agree that new incentives, in addition to dedicated research funding and accelerated regulatory pathways, can stimulate R&D in areas of unmet need. For many diseases, scientific knowledge and diagnostic capabilities must be built, and clinical endpoints developed. Any process to identify unmet needs must build on a multi-stakeholder discussion and include inter alia patients and their caregivers. Said system must also spill over to and be recognised by downstream decision-makers, ie HTA bodies and payers. Reducing rewards for fulfilling the PIP obligations or reducing incentives to focus only on ultra-RD where no treatment exists or on first in class innovation fail to understand the science behind biopharmaceutical research. Such measures will not redirect R&D into areas of needs but rather risk undermining Europe’s attractiveness as a region for innovation. Limiting the RD-designation criteria to less prevalent diseases risks leaving out significant numbers of pathologies and patients; reducing prevalence thresholds or using a cumulative prevalence criterion fails to recognise the importance of follow-on innovation to achieve meaningful patient outcome. Developing medicines for children and RD patients only provides a very marginal economic case, which is why these areas are not attractive to generic and biosimilar developers. The concept of overcompensation is not established: the staff working document (SWD) showed that only 14% of OMPs have yearly turnover of >€100 million. Making rewards and incentives conditional on launch obligations fails to understand the economics behind biopharmaceutical research and the complexities of launching medicines across the EU. We call on the Commission to work with stakeholders and urgently identify the root causes of access differences to find targeted solutions. Root causes are multifactorial and cannot be reduced to company decisions. Any access solutions will require a close collaboration of national healthcare systems (eg HTA and P&R bodies) on issues such as pan-European evidence generation, meaningful joint clinical assessments, and novel pricing and payment models. They require solidarity between Member States (MS), a recognition that wealthier EU MS should not benefit from the lower prices that ought to be available, in the interest of patient access, to poorer MS. We welcome the Commission’s intention to keep pace with scientific and technological developments and to ensure that procedures remain efficient. Regulatory authorities should be entrusted to ensure that the system works and keeps up with global regulatory and scientific developments. Key scientific and procedural developments can be consolidated in guidance, eg on issues such as biomarker-defined conditions, or class waivers for paediatric development. We call on the Commission to consider all options through a thorough IA, including those identified as ‘baseline’ and to acknowledge that their SWD is based on data up to 2017, which neither reflects the actions agreed in the 2018 EC-EMA paediatric action plan, nor the Commission notice 2016/C 424/03 on the Orphan Regulation or scientific and regulatory progress. EFPIA stands ready to work with the Commission to ensure future development of medicines.
Read full response

Response to Green Paper on Ageing

14 Dec 2020

EFPIA welcomes the European Commission’s work on a Green Paper on Ageing aiming at fostering solutions to one of Europe’s most pressing issues: demographic change. Ageing has drastic social, economic, and healthcare implications which should be tackled in a holistic way. Keeping the ageing population in good health is imperative to ensure sustainable health and social systems, economic growth and population health and wellbeing. Our healthcare systems require increased funding and deep reforms that must last well beyond COVID-19. As Europeans grow older, they develop more chronic diseases like diabetes, cardiovascular disease, Alzheimer’s disease or cancer, and face a surge in comorbidities. Around 37% of people aged 65 and older have been diagnosed to have at least two chronic conditions. By 2030, the number of Europeans with diabetes is expected to rise from 60 to 66 million, while the prevalence of Alzheimer’s disease will increase from 10 to 14 million. The number of newly diagnosed cancer cases in Europe has also steeply increased from 2.1 million to 3.1 million cases between 1995 and 2018. The result is a growing burden on patients, their families, social and healthcare systems, and the economy. Chronic diseases already account for 70-80% of our healthcare spending and lead to additional hundreds of billions in informal care and non-medical costs. To meet the impact of this demographic evolution on societies and to optimise patient outcomes, urgent reforms are needed to our health and social care systems. Members States should ensure access, uptake and adherence to the best available innovative therapies, in order to improve patients’ health outcomes while reducing long-term healthcare and societal costs. Investments in digitalisation and data management will also be needed to empower patients and ensure health systems are able to face the unprecedented challenges posed by an ageing population and the rise of chronic diseases. Smart spending will bring more value to systems (attachment). The European Semester and the Recovery and Resilience Plans can play a pivotal role in guiding Member States’ spending to mitigate the impact of ageing. Members States should also ensure that both primary and secondary prevention of chronic conditions is prioritised to reduce overall health and care expenses. Furthermore, our health systems are lacking the procedures and tools to enable early diagnosis of conditions like Alzheimer’s disease or cancer. Early diagnosis is especially important in light of potential new treatments for Alzheimer’s disease that are currently in development and that are targeting early stage patients. Efficient diagnostics like biomarkers and brain images are often not well established in care settings, or they are insufficiently reimbursed. Without early detection of the disease, a strengthening of infusion capacities in care settings, and good monitoring of the disease progression and treatment effectiveness, the potential of new treatments is lost. Additionally, in the future, people with chronic conditions will need to take an active role in managing their own health. Conditions like diabetes already require active self-management, which is a stressful and demanding round-the-clock task. Adopting a patient-centric approach and fostering health literacy also implies an increased focus on primary and community care. Health systems must be redesigned by integrating care and funding across the patient pathway, reinforcing primary through tertiary care, and aligning healthcare budgets. Recent research demonstrates that less than half of EU Member States have integrated diabetes funding in place, and a smaller number provides incentives to encourage financial integration. This situation has to improve. Finally, management of non-communicable diseases requires better measurement and comparison of outcomes data. The creation of an EU outcomes observatory could be a first but important step towards this goal.
Read full response

Response to Revision of the Union legislation on blood, tissues and cells

11 Dec 2020

Revision of the Blood, Tissues & Cells (BTC) Legislation offers an important opportunity to ensure regulatory standards safeguarding patient safety and public health keep pace with technical and scientific advances, legal certainty and risk-based flexibility to facilitate innovation, and sustainability of supplies across EU for both therapeutic need and producing products derived from BTC. Keeping pace with science •The current environment is witnessing a rapid pace of technological and scientific advances rendering current technical aspects of Directive 20016/17 and 2002/98 obsolete or outdated •Policy options reinforcing adoption of technical standards developed by ECDC and EDQM and leveraging EURO GTP I and II will ensure a dynamic system that can more easily adapt to changes in the current state of science •New standards governing the safety, quality, availability and use of BTC should be patient-centred and seek synergies between certification, audit, and technical expertise bodies with competent authorities •Policy options that reinforce the risk-based principles in inspection and control processes will facilitate a proportional and efficient approach to oversight Legal certainty and flexibility •Divergent approaches across Member States (MS) cause unequal levels of safety and quality as well as complexities and uncertainties that disincentivize investment in innovation in Europe •A streamlined and rational EU-level framework could provide legal certainty and consistency across MS •Policy options that include an EU level mechanism for product classification should be more than advisory, enforceable and leverage, not duplicate or create a parallel pathway to, existing mechanisms for borderline issues (e.g. EMA CAT classification) •Such a mechanism would allow flexibility to adapt to future innovation, facilitate streamlined procedures, and ensure adherence to a common European standard for quality and safety Sustainability •Maintaining self-sufficient supplies of blood, tissues and cells is essential but the current legislation does not provide adequate measures •Shortages of blood and blood-derived products during COVID-19 have reinforced the risks of supply interruption •Policy options should reinforce adoption of guidance that ensures sustainability of BTC supply, promoting best practices in managing existing supplies. These could include Patient Blood Management, an approach optimising care of patients who might need a blood transfusion while reducing the amount of blood needed, and plasmapheresis, as an efficient mechanism to collect more plasma. Patient blood management is valuable in the surgical setting and medical care for chronic diseases (including cancer), as around 2/3 of red blood cell transfusions are used in medical care of chronic diseases •BTCs can be used as starting materials for ATMPs. Policy options should strike a fair balance ensuring innovation is promoted equally across EU without jeopardising patient needs for blood components Medicinal products and devices based on BTC •In the interest of patient safety, it is important that medicinal products and devices based on BTC continue to be regulated as medicinal products; BTC regulation must not be exploited to offer medicinal products without seeking EU marketing authorization. Coordinated EU support is needed for multi-stakeholder expert networks to disseminate best practice across MS between authorities and practitioners to ensure impact of EU-level actions on the ground. European initiatives for training of inspectors and controllers (Eustite, CATIE, VISTART) must also be maintained with more participation from MS. A holistic approach to revision of BTC Legislation considering the Pharmaceuticals Strategy is welcomed. EFPIA and its members look forward to working with the Commission and other stakeholders to build solutions that support continued innovation in the life sciences to improve patient outcomes and safeguard public health.
Read full response

Response to Sustainable Products Initiative

14 Nov 2020

EFPIA, the research-based pharmaceutical industry is supportive of the European Commission initiative to increase product sustainability as indicated in the roadmap for the Sustainable Products Initiative. We would like to contribute to the policy debate with recommendations that aim at safeguarding the future access to care for patients and at improving human health. For the pharmaceutical industry patient safety is paramount. This is key when manufacturing pharmaceutical products and medical devices. A sustainability approach that calls for e.g. reparability, recyclability, reuse and the use of secondary raw materials may in some cases conflict with the quality standards of pharmaceuticals and if pursued ineffectually may compromise patient safety. The industry recognises the need to move away from traditional linear business models, where possible, and to adopt circular economic principles in development and addressing sustainability challenges. Due to the complex and lengthy regulatory approval process for pharmaceuticals, sustainability should preferably be used as a design principle in the development phase, as any innovative post approval change to established manufacturing processes is very complicated, lengthy and expensive to implement. Therefore, the introduction of new sustainable products and processes should ideally not conflict with pharmaceutical regulation. Increasingly, the industry is looking to sustainable options that can be implemented within existing manufacturing processes that may not have a regulatory impact, e.g. through use of renewable energy, sourcing of sustainable materials, optimising resources (e.g. water) and minimising waste (1). While the industry is keen to adopt a comprehensive sustainable products approach, it is still bound by a rigid regulatory landscape. The sustainable products initiative should clearly define sustainability criteria while balancing the potential impact of different sustainability parameters against each other, e.g. would a process based on green chemistry principles but making use of virgin raw materials due to high quality requirements, be considered sustainable or not? We would also suggest that the sustainable products initiative supports the development of guidelines and standards for assessment of environmental impacts of sustainable products to ensure a consistent approach. Environmental impacts may arise throughout the entire life cycle of a pharmaceutical product – manufacturing, distribution, use, recycling/recovery where possible and final disposal. Impacts from pharmaceutical residues in the environment, and possible effects on resistance development from antibiotic substances in the environment, needs to be addressed by all actors along the value chain of the products. Industry has taken several initiatives (e.g. Eco-Pharmaco-Stewardship (2) and AMR Industry Alliance (3) framework for antibiotic manufacturing) to prevent the occurrence of unacceptable releases during the manufacturing of products. Actors down-stream (e.g. users in healthcare and waste-water treatment plant operators) need to take additional measures to address potential releases in their operations. Additionally, consideration of how the pharmaceutical industry can better address hazardous and biological materials in waste streams needs to be addressed in waste directives / regulation in order to support sustainability. Recycling of product materials in the pharmaceutical sector requires a broader definition of recyclability involving other sectors that can support product and materials recovery and reuse. (1) https://www.efpia.eu/media/554663/circular-economy.pdf (2) https://www.efpia.eu/media/25628/eps-a-holistic-environmental-risk-management-program.pdf (3) https://www.amrindustryalliance.org/
Read full response

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

6 Nov 2020 · Videoconference with Pharmaceutical Industry Associations to discuss shortages of medicines and medical devices including diagnostic tests in the context of COVID-19 pandemic

Meeting with Szabolcs Horvath (Cabinet of Commissioner Olivér Várhelyi)

23 Oct 2020 · Stronger “European health union”

Meeting with Giorgos Rossides (Cabinet of Commissioner Stella Kyriakides), Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides) and MEDICINES FOR EUROPE

22 Oct 2020 · Exchange of views on the upcoming pharmaceutical strategy

Meeting with Despina Spanou (Cabinet of Vice-President Margaritis Schinas), Maria Luisa Llano Cardenal (Cabinet of Vice-President Margaritis Schinas)

20 Oct 2020 · Pharmaceutical strategy

Meeting with Astrid Dentler (Cabinet of Vice-President Dubravka Šuica), Mattia De' Grassi (Cabinet of Vice-President Dubravka Šuica)

15 Oct 2020 · Conference on the Future of Europe Health and industrial policies

Meeting with Nele Eichhorn (Cabinet of Executive Vice-President Margrethe Vestager)

6 Oct 2020 · Pharmaceuticals strategy, Industrial strategy and trade policy issues

Meeting with Stella Kyriakides (Commissioner) and

30 Sept 2020 · Call with pharmaceutical and medical device supply Chain on COVID-19

Meeting with Kurt Vandenberghe (Cabinet of President Ursula von der Leyen)

23 Sept 2020 · EU pharmaceutical strategy and the general approach to IP in pharmaceuticals

Meeting with Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides)

23 Sept 2020 · Meeting on the upcoming Pharmaceutical Strategy.

Meeting with Eszter Batta (Cabinet of Commissioner Thierry Breton)

18 Sept 2020 · Pharmaceutical strategy

Response to Intellectual Property Action Plan

13 Aug 2020

EFPIA welcomes the Commission’s recognition of the importance of innovation and intangible assets as cornerstones of today’s economy. A strong and predictable IP framework is the foundation for a successful EU industrial strategy and recovery, promoting sustainable innovation to meet the needs of patients, healthcare systems and society and driving EU’s competitiveness in an increasingly competitive economy. As a research-based industry relying heavily on the availability and enforceability of patents, EFPIA supports the EU’s efforts to upgrade and further harmonise the EU IP framework. We particularly await the entry into force of the Unitary Patent (UP) system and further support the creation of a unitary SPC (uSPC): one SPC for the EU rather than one SPC by country. This can simplify the application procedure, reduce duplication and facilitate a consistent application of the SPC Regulation across the EU. As the timeline for the UP system remains unknown, EFPIA commends the EC reflection to provide an intermediate solution. A single application portal and a unified grant mechanism can be helpful steps towards a uSPC. Also, while we support the EU’s ambition to be a trusted leader in the digital/AI economy, notably by exploring options, including in the IP framework, to best incentivize voluntary data sharing, it is important that any European approach to IP in relation to AI proceeds in coordination with its major trading partners. We also appreciate DG GROW’s collaboration with WIPO. In response to the COVID-19 crisis, the pharmaceutical industry has been collaborating with the research and healthcare communities to test, research & develop more than 1000 potential treatments and vaccines, and has publicly committed to working with governments to ensure that any potential vaccines/treatments are available and affordable to those that need them. This work and unprecedented response by industry build on products, knowledge and research capacity developed over many years relying on a robust IP framework. We are not aware of a situation where IP has been or will be an impediment to an effective response to the current pandemic, showing that the current system is best suited to meet public health needs. In our industry, the availability of meaningful and reliable IPR enforcement measures is essential. We welcome the plan to continue monitoring the application of IPRED, especially to ensure effective enforcement and appropriate remedies are available. The principle of proportionality, which is embedded in EU law and specifically mentioned in IPRED Art 3.2 and 2017 Guidance, provides the flexibility to strike the necessary balance of interests. To ensure this balance as it relates to our industry, we had further proposed to increase transparency of key medicines patents to facilitate early resolution of patent disputes, sufficiently in advance to increase legal certainty for all stakeholders (https://www.efpia.eu/media/219818/efpia-official-proposal-for-an-erm.pdf). Falsified medicines represent a threat to patients’ health and safety. Health authorities have reported a recent surge in fake medicines, as criminals are taking advantage of the COVID-19 pandemic. As there can be no tolerance for such acts, EFPIA welcomes the willingness to step up the fight against counterfeiting, including by strengthening the responsibilities of online platforms and by furthering cooperation between manufacturers, supply chain operators, intermediaries and law enforcement authorities. This can only strengthen the arsenal put in place by the Falsified Medicines Directive, notably concerning online sales. Finally, promoting a robust global level playing field for high standards of IP protection and enforcement should be core to the EU’s trade strategy. This is critical to ensuring the success of Europe’s IP-intensive industries on a global scale and for our industry to remain a world leader in innovation.
Read full response

Response to Legislative framework for the governance of common European data spaces

31 Jul 2020

EFPIA reply to the consultation for the impact assessment on the legislative framework for the governance of common European data spaces EFPIA welcomes the proposal to create a horizontal legislative framework aiming to unlock the value of data, support the use of data, lower the cost of data use and transaction cost and support the development of sectoral data spaces. In the health sector, a strong European Health Data Space (EHDS) would improve the research and innovation health eco system and support value-based healthcare. Data Access is the key challenge. The impact of existing EU and national legislation should be explored and in particular its contribution to supporting data access. The framework should consider the need for incentives to ensure interoperability and the curation and sharing of high-quality data-sets. The framework should aim to create clarity among possible consumers and contributors of data and provide guidance on the right safeguards and governance models to avoid abuses and distortions, including by defining the roles and responsibilities of data intermediaries. It should also establish general principles for data governance, while providing scope for elaboration of specific regimes in different sectors, with particular reference to established legal and ethical governance approaches and the regulatory requirements of each sector. The Governance Framework should apply regardless of technologies. EFPIA is committed to being a partner in this data ecosystem and the creation of a EHDS, to improve health outcomes. EFPIA's response to the Data Strategy is attached for further information on our position
Read full response

Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

3 Jul 2020

The EU Pharmaceutical Strategy has the potential to support Europe’s medical research eco-system, enhance the region’s resilience to global health threats, address our on-going health challenges as well as be a key driver for the EU’s economic recovery. EFPIA welcomes the Commission’s recognition of the importance of the sector in the Roadmap and is committed to working with the EU and Member States to ensure that patients in Europe have access to the medicines they need and, learning the lessons from the COVID-19 crisis, creating the policy environment in which the industry in Europe can be a world leader in medical innovation. Unfortunately, the Roadmap does not contain the necessary drivers of innovation to realise its own ambition of supporting the industry in Europe to be a world leader in innovation. In our response to the EU Industrial Strategy we have outlined the steps needed to recover the ground lost to other regions of the world in medical innovation, including alignment to the EU’s industrial and trade strategies. Europe needs a research and manufacturing infrastructure that delivers the next generation of vaccines and treatments. That means developing clinical trial networks, biobanks and data banks, building a European health data space, delivering public-private collaboration mechanisms to accelerate bringing health solutions to patients and encouraging innovative manufacturing. To place the EU at the forefront of pharmaceutical innovation, Europe needs a world-class IP framework to attract investment into the development of future treatments for the benefit of patients, including for patients with rare and paediatric diseases. Developing incentives to further address unmet medical needs and seize advances in science is critical to tackling issues like AMR and pandemic preparedness. SPC harmonisation and strong IP systems can increase certainty and predictability for innovators and investors alike. Europe needs a regulatory framework that is stable but adaptable, fast, effective and globally competitive. We need; development support and regulatory approval times on par with other regions, EU regulators delivering world class scientific expertise in collaboration with global partners, simplification of the EU regulatory network, and connected regulatory oversight of drug-device/diagnostic combinations. To be able to deliver on its related 2025 regulatory science strategy, the EMA needs further strengthening. We share the concern over inequalities of access to new treatments and vaccines across Europe. Faster, more equitable access for citizens is a shared goal. The root causes of these issues are multi-factorial; including late start of market access assessment, duplicative evidence requirements, national pricing and reimbursement policies and companies’ behaviours responding to these and other factors. They can only be addressed by stakeholders working together. By creating a High-Level Forum on Better Access to Health Innovation we can identify multi-stakeholder solutions for introducing new technologies that can broaden access, reduce delays and mitigate the impact of shortages. This collaborative dialogue must be evidence-based, requiring an EU-led analysis of the root causes and drivers of access, supply and shortage issues. EFPIA has proposed potential solutions utilising novel pricing and payment models, which could be more broadly implemented across European healthcare systems. By concluding the HTA Regulation negotiations we can address the misalignment on evidence between industry, regulators and HTA bodies; one of the most prominent and complex delays to access. What is clear, is that access issues will not be addressed by tampering with the regulatory and incentives framework, integral to Europe’s ambition to be a world leader in medical innovation. EFPIA and its members stand ready to work with all stakeholders to create medical innovation and facilitate sustainable access for all.
Read full response

Meeting with Stella Kyriakides (Commissioner)

3 Jul 2020 · VC meeting : Exchange of views on the forthcoming Pharmaceutical Strategy

Response to Digital Services Act: deepening the Internal Market and clarifying responsibilities for digital services

30 Jun 2020

EFPIA (the European Federation of Pharmaceutical Industries and Associations), representing research-based pharmaceutical manufacturers in Europe, welcomes the recently launched proposal for a new Digital Services Act package, which aims to modernise the current legal framework for digital services. Notably, we welcome the combined evaluation roadmap/inception impact assessment report as we fully agree with the European Commission in its identified risks for the safety of citizens online as “online platforms continue to play a significant role in the spread of illegal goods”. The spread of illegal goods via online platforms poses a particularly acute health and safety risk when it comes to medicines, and more specifically highly innovative medicines. A recent EUIPO/OECD report showcased the increased sophistication of counterfeiters as they move from a more ‘traditional’ focus on painkillers or sexual dysfunction treatments towards highly specialized medicines such as cardiovascular and cancer treatments. Pharmaceutical manufacturers never sell their medicines online in Europe, nor do they ship direct to patients via post/courier/small consignments. Taking this into account we welcome the Commission’s ‘option 2’ proposal, looking at a more comprehensive legal intervention, updating and modernizing the rules of the e-Commerce Directive. Notably we believe obligations such as ‘know-your-customer’, proper ‘notice-and-action’ systems or transparency of algorithmic systems would be particularly encouraging for the pharmaceutical industry to better collaborate with online platforms towards combating the proliferation of illegal medicines online. In addition to what is outlined by the inception impact assessment, we believe the following measures would further reinforce the aims of the initiative: Obligation for platforms to proactively monitor, identify and remove illegal content – platforms should take all steps they can in order to prevent the appearance of illegal medicines on their platforms. Obligation for platforms to inform consumers when they have been exposed to illegal goods – if an illegal medicine is found on a platform then platforms/online intermediaries should inform consumers once they find out. When it comes to illegal medicines, patients should be the very first ones to be informed about their purchase so that they immediately discontinue their use. Creation of a dedicated governing body with oversight to act as an arbitrator – we believe there is a risk that national implementation of the requirements will result in variations in how the measures are implemented as well as the extent to which they are enforced by national agencies and upheld by national courts. In conclusion, EFPIA supports the adoption of the measures outlined in ‘option 2’ as the most adequate to address the points above.
Read full response

Meeting with Stella Kyriakides (Commissioner) and

29 Jun 2020 · Call with pharmaceutical and medical device industry associations on COVID-19

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

29 Jun 2020 · Videoconference with Pharmaceutical Industry Associations to discuss shortages of medicines and medical devices including diagnostic tests in the context of COVID-19 pandemic

Response to Chemicals strategy for sustainability

19 Jun 2020

EFPIA response to Commission’s Sustainable Chemicals Strategy roadmap Sustainable solutions which are resource-efficient, circular and climate-neutral, are a key value driver for EFPIA. Our member companies are committed to making a positive impact on the lives of patients while operating sustainably, and in particular to transition to a more circular economy with changes throughout the value chains, from product design to new business and market models, from new ways of turning waste into resources, prolonging life of products and to new models of customer behaviour. EFPIA supports the Commission’s need to develop a strategy and to promote research & development for the sustainable transformation of the chemical industry and the creation of green and sustainable manufacturing capacity in Europe. We welcome that the Commission recognises the essential use of chemicals in the production of pharmaceutical products, which are critical to the health of society. EFPIA´s goal is to drive innovative, evidence based and sustainable chemicals management for our industry and society in Europe, while safeguarding access to innovative medicines for patients. The pharmaceutical sector The area of pharmaceuticals is one of the most regulated sectors in Europe and the world, with e.g. pre-approval of manufacturing plants, clinical trials and marketing authorisations. Therefore, activities that involve chemicals, necessary for the research and manufacturing of innovative medicines, are required to also pass through strictly regulated pharma processes and this should be considered when implementing and interpreting some elements of chemical legislation. The use of instruments like the Risk Management Option Analysis (RMOA) are essential to evaluate appropriate risk management measures before considering the integration of chemicals, which are critical in innovation, authorisation and restriction processes. Due to the global operation of our companies and increasing number of countries with emerging chemical legislation, it is crucial collaborations take place between industry and regulators globally. In the pharmaceutical sector there are many compounds designed to interact with the endocrine system of patients. As for all pharmaceuticals, the assessment of these compounds is based on an extensive characterisation of their primary and secondary pharmacology, followed by studies of their toxicity. As for any active substance, the principles of risk-benefit assessment apply, and “endocrine active” substances present are intended to result in beneficial effects in patients. Likewise, other properties such as toxicity or persistence may also be necessary for an efficacious medicine & these are considered, in total, during the regulatory review process. Innovation through collaboration We support measures to foster research into the feasibility of greener products, and industry has been increasingly developing greener manufacturing methods bearing in mind that the safety and efficacy of the medicines we produce must remain the primary objective. Public private partnerships are important drivers in the innovation of sustainable chemicals. IMI’s CHEM21 project dealt with the sustainability of drug manufacturing processes, aiming to reduce the industry's carbon and environmental footprint. It generated a range of methods to make the drug development process more environmentally friendly and developed a metrics Toolkit to measure the sustainability of chemical and biochemical reactions. While highlighting that 76% of the active pharmaceutical ingredients used in the manufacture of innovative medicines in Europe are sourced in the EU, EFPIA welcomes dialogue with policy makers on how to best address calls for strategic resilience and global interdependencies of supply chains, while supporting the Commission’s zero pollution ambition for a toxic-free environment.
Read full response

Meeting with Giorgos Rossides (Cabinet of Commissioner Stella Kyriakides), Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides)

10 Jun 2020 · Webex meeting upon EFPIA’s request to discuss the forthcoming Pharmaceutical Strategy, the evaluation of the EU Orphan Medicinal Products and Paediatrics regulations and the proposed HTA regulation

Meeting with Despina Spanou (Cabinet of Vice-President Margaritis Schinas), Maria Luisa Llano Cardenal (Cabinet of Vice-President Margaritis Schinas)

8 Jun 2020 · Exchange of views on the new pharmaceutical strategy for Europe

Meeting with Anne Bucher (Director-General Health and Food Safety)

5 Jun 2020 · pharmaceutical strategy of the Commission, SWD on the Orphan and Paediatric Regulation

Meeting with Stella Kyriakides (Commissioner) and MEDICINES FOR EUROPE and

29 May 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Virginijus Sinkevičius (Commissioner) and

19 May 2020 · To discuss EU Pharmaceutical Strategy and EU Chemical Strategy and cooperation on green agenda.

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

15 May 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and MedTech Europe and

8 May 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

8 May 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Kerstin Jorna (Director-General Internal Market, Industry, Entrepreneurship and SMEs)

5 May 2020 · courtesy call and presentation by EFPIA of their concerns due to COVID crisis and the future of pharmaceutical industry

Response to Report on the application of the General Data Protection Regulation

29 Apr 2020

EFPIA has provided general responses to Commission questions on GDPR implementation through the GDPR Stakeholder Group during 2019. This response focuses on international transfers of data to support scientific research. The attached paper, though dating from 2017, remains accurate in its description of the data flows ,the implications of their being restricted and the highly-regulated environment within which such flows take place. EFPIA sees the following priorities in relation to international data flows: · The basis on which personal data is shared with EU Medicines Regulatory Agencies for medicines approval and pharmacovigilance purposes is reasonably clear with respect to transfers within the EU. Though both activities have clear societal benefits and require that personal data be shared more widely, the legal basis for international transfers is not laid out in GDPR or in the EDPB’s Guidelines 2/2018 on derogations of Article 49 under Regulation 2016/679. · In March 2019, EFPIA submitted a proposal to the Commission to elaborate Sectoral Standard Contractual Clauses for the Life Sciences sector. These would provide a basis for the transfer of data to research partners and data processors in the context of clinical research. EFPIA believes that these clauses could usefully complement any general clauses that the Commission might develop as part of its planned review. We wonder whether it would now be possible to take this proposal forward · EFPIA noted the Commission’s plans to engage with further countries to secure alignment in data protection practices. EFPIA would prioritise dialogue with Australia, Brazil, Chile, Mexico, Singapore, South Africa, South Korea, Turkey and Thailand. · Following the UK’s departure from the EU, and considering the deep scientific links between the two, prioritisation should be given to consider the UK as an adequate country or find another alternative with the same effect. The Commission has confirmed that the forthcoming report will address other issues beyond chapters V & VII GDPR. In relation to scientific research, there have been a number of significant developments, particularly the publication of the European Data Strategy (and the proposal for a European Health Data Space) and the White paper on AI. The Commission is consulting on both documents at present and both have significant implications for data protection. At the same time, the EDPB’s Guidelines 03/2020 on the processing of data concerning health for the purpose of scientific research in the context of the COVID-19 outbreak propose a specific approach to international data transfers based on article 49 and justified by the seriousness of the situation. For EFPIA, this raises two issues. The data flows needed to combat Covid are not entirely exceptional – they are just more pressing and perhaps indicative of the flows that we should expect in the future, in terms of the breadth of sharing that will be characteristic of research and healthcare. Covid has exposed what wasn’t working under normal conditions of international data transfers for research purposes and indeed in relation to data-sharing within the EU. We also ask that the EU prioritise regulatory alignment in the area of data protection for scientific research in its trade negotiations. Second, EFPIA asks that the Commission carry out full consultation with stakeholders when developing the Data strategy and seek alignment with the Board on the questions that it intends to address in developing its “further and more detailed guidance for the processing of health data for the purpose of scientific research”. EFPIA remains concerned that the combination of divergent or absent national legislation, together with efforts to restrict the scope of the GDPR’s flexibilities for scientific research may undermine the EU’s strategic goals for Digital Europe. An approach to consultation that addressed the needs of both institutions would be very beneficial.
Read full response

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

29 Apr 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and MEDICINES FOR EUROPE and

29 Apr 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Jean-Eric Paquet (Director-General Research and Innovation)

24 Apr 2020 · Covid-19

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

23 Apr 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and MEDICINES FOR EUROPE and

23 Apr 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Response to Action Plan on the Customs Union

21 Apr 2020

EFPIA (the European Federation of Pharmaceutical Industries and Associations), representing research-based pharmaceutical manufacturers in Europe, welcomes the Action Plan “Taking the Customs Union to the next level“ concerning the future of the customs union. EFPIA would like to stress the need to further focus the Action Plan on Intellectual property rights (IPR) as fighting more efficiently against IP infringements would ensure security and safety of citizens and the internal market as well as better protect revenues. To achieve these objectives, we believe cooperation between customs authorities and private actors is crucial. Over the years, pharmaceutical manufacturers observe a continuous increase in counterfeit medicines both at EU level and worldwide, and this is clearly a safety issue. At the same time, they observe a further decrease in the quantity and granularity of information received from customs authorities when a seizure is made. This can be partly explained by the different legal instruments which empower customs authorities to seize shipments of potentially counterfeit medicinal products, in addition to Regulation 608/2013, Article 52b of the Falsified Medicines Directive and non-compliance with local pharmaceutical legislation (lack of Marketing Authorisation, package and leaflet in an inappropriate language, or other). In addition, with the advent of the internet and the internationalisation of global commerce and, more recently, with the proliferation of social media platforms (such as Facebook groups, Instagram, Twitter and WhatsApp etc.) we notice an increase in worldwide trade of illicit and counterfeit medicines which transit borders in small consignments. This should automatically be a red flag for the pharmaceutical industry and customs authorities as pharmaceutical companies do not ship direct to patients via post/courier/small consignments. The current COVID-19 pandemic further exacerbates the trend outlined above and the dangers of counterfeit medicines as various restrictions to individual moment lead more and more patients to procure their medicines from (sometimes questionable) online sources. Huge increases in demand for medicines in such times and changes in patient behaviour in buying medicines are coupled with increased creativity of criminal networks operating across borders to create a perfect storm. EFPIA members wish to be active partners in investigations of cases of potential counterfeit medicines. They can provide valuable additional information to the authorities based on their expertise and knowledge of criminal networks operating worldwide. Furthermore, they are ready to complement the efforts of the authorities in this respect. EFPIA members can react quickly and can draw upon information which may not be available to authorities, considering that usually authorities have only their territory in scope but EFPIA members are global companies, with their own internal global security departments. We believe this will lead to better information exchange, allowing a broader (global) perspective and local intelligence led activities (better profiling of shipments) which support Customs operations and help support the achievement of Customs KPIs (Key Performance Indicators). In addition, pharmaceutical manufacturers are always willing to train customs officers and law enforcement agencies and would like to have more opportunities to do so. Such training activities already take place in various Member States and are yielding concrete results in targeting seizures of counterfeit medicines and improved reporting to rights holders, which is then fed back to customs authorities allowing for better profiling of shipments. This reinforced a virtuous loop of information exchange. We have proposed several concrete amendments to the roadmap, in the annex attached, in order to strengthen the messages above. We stand ready to provide any additional information you may require.
Read full response

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

17 Apr 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and MedTech Europe and

9 Apr 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

9 Apr 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and MEDICINES FOR EUROPE and

3 Apr 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and MEDICINES FOR EUROPE and

3 Apr 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Anne Bucher (Director-General Health and Food Safety)

2 Apr 2020 · update on Pharma Strategy

Meeting with Thierry Breton (Commissioner) and MEDICINES FOR EUROPE and

27 Mar 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and MEDICINES FOR EUROPE and

27 Mar 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and MEDICINES FOR EUROPE and

20 Mar 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and MEDICINES FOR EUROPE and

20 Mar 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and MEDICINES FOR EUROPE and

13 Mar 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss possible shortages of medicines and medical devices for the Covid-19 outbreak

Response to Europe’s Beating Cancer Plan

3 Mar 2020

The research-based pharmaceutical industry remains committed to improving cancer prevention, diagnosis, treatment and quality of life of patients. The last two decades have seen great progress in treatment innovation allowing people affected by cancer to live longer and more productive lives. With an ageing population and growing incidence of cancer (50% since 1995) controlling it will require a multi-stakeholder effort, investment of substantial resources and effective coordination of national policies. Mortality increased at much lower pace (20% since 1995) due to progress in the whole cancer journey: prevention, better diagnosis and better treatment. But spending on cancer care remains static during the same period (4 to 7% of total health expenditure yearly) in Europe. Society is not yet investing in tackling cancer according to the burden of disease or citizen expectations. Significant progress is being made, but beating cancer will require broad political support, new initiatives to boost innovation and continued investment. There are significant differences across Europe in the level of overall healthcare spend/cancer specific investment as well as the organization, delivery, and quality of care. Europe’s Beating Cancer Plan should complement Member State activities with the objective to a) set clear European cancer targets in incidence, mortality, 5-year survival and quality of life; b) improve the availability and the sharing of data, c) support Member States to achieve the goal of beating cancer. Activities: • Undertake a detailed situational assessment and set European objectives (cancer care targets) to be achieved under the Plan • Support initiatives already at the disposal of Member States (cancer registries, data infrastructure) • Promote a patient-centric understanding of the whole cancer journey, including focus on patient empowerment, patient-relevant outcomes, cancer literacy and the benefits for society overall • Mitigate the extent and effect of workforce shortages • Implement Key Performance Indicators (poss. using existing mechanisms like the European Semester) Ways to do it: • Create a European platform with all relevant stakeholders to identify synergies and facilitate the sharing of best practices, integrating patient perspectives • Establish a structure of federated national databases KPIs (European Cancer Outcomes Dashboard): • Clinical: Incidence, mortality, 5-year survival, disability adjusted life years gained, recurrence • Financial: Public expenditure/investment in oncology, efficiency of screening/diagnosis, technology in different stages, diagnostics, treatment & care, cost-effectiveness of public spend, % of access to innovative oncology treatments • Patient: Time from first referral to treatment, patient experience of care, return to work rates, improved capacity of reintegration into society, palliative care, patient-reported outcomes • Healthcare system efficiency & national cancer plans The plan should take a comprehensive approach by going beyond access to the medicine/treatment itself and also consider prerequisites for access, e.g. access to molecular diagnostics and quality biomarker testing. A vision for investment in pathology capacity is needed and cohesion funds could be used to address unequal access to laboratory infrastructure. Continued development and access to innovations for rare, paediatric and neglected cancers requires a coordinated approach across a number of European policy initiatives, budget priorities and a stable and predictable, pro-innovation legislative framework. The EU incentives framework for rare and paediatric medicines should continue to support the development of oncology treatments in these populations. Adapted HTA and access frameworks, including acceptance of surrogate endpoints as appropriate, coverage with evidence development and novel pricing and payment models will support timely patient access while ensuring value for payers.
Read full response

Meeting with Renaud Savignat (Cabinet of Commissioner Jutta Urpilainen)

28 Feb 2020 · EFPIA requested a meeting to present their ongoing work

Meeting with Kasia Jurczak (Cabinet of Commissioner Janez Lenarčič)

11 Feb 2020 · Health In humanitarian aid and in crisis management

Meeting with Olympia Neocleous (Cabinet of Commissioner Stella Kyriakides)

11 Feb 2020 · Pharmaceutical strategy

Meeting with Marlene Rosemarie Madsen (Cabinet of Commissioner Elisa Ferreira)

6 Feb 2020 · Medical innovation & Reform policies

Meeting with Dermot Ryan (Cabinet of Commissioner Phil Hogan)

23 Jan 2020 · presentation EFPIA's manifesto

Meeting with Astrid Dentler (Cabinet of Vice-President Dubravka Šuica)

23 Jan 2020 · Integrated health solutions, active ageing, sustainability and quality of healthcare systems, long-term visions on healthcare

Response to A new Circular Economy Action Plan

20 Jan 2020

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. Through its direct membership of 36 national associations and 39 leading pharmaceutical companies, EFPIA's mission is to create a collaborative environment that enables our members to innovate, discover, develop and deliver new therapies and vaccines for people across Europe, as well as contribute to the European economy. Our vision is for a healthier future for Europe. A future based on prevention, innovation, access to new treatments and better outcomes for patients. The Pharmaceutical Industry are supportive of the Roadmap for a Commission New Circular Economy Action Plan and see synergies with our aspiration to safeguard the future supply of pharmaceuticals for patients. We welcome the opportunity to be part of the solution by working collaboratively with the EU in shaping the legislative framework and within our organisations to mitigate our impacts. The pharmaceutical industry’s approach to circularity builds on our long experience in sustainability and aligns with the EU approach whilst recognising the constraints, especially on speed of transition, from operating in a highly regulated industry. Due to the approval process for pharmaceuticals it is currently very challenging to introduce innovative changes to the product manufacturing processes post-approval. Innovation which will enable circularity will drive new opportunities for growth, greater resource productivity, and a more competitive economy and reduce pollutants however, it cannot be done without consideration of wider influences on our sectors activities for example on use of secondary materials in manufacturing.
Read full response

Response to Revision of EMA fees

15 Oct 2019

Dear Sir/Madam, Please find attached our response to the EU Commission Inception Impact Assessment on EMA Fees. Best regards, Pär Tellner Director Regulatory, Drug Development and Manufacturing EFPIA
Read full response

Meeting with Miguel Ceballos Baron (Cabinet of Vice-President Cecilia Malmström)

29 Aug 2019 · Trade in the pharma sector

Meeting with Arunas Ribokas (Cabinet of Commissioner Vytenis Andriukaitis)

29 Aug 2019 · EFPIA position on the EU preliminary list of US products considered for countermeasures

Response to EU-Africa Global Health Partnership

27 Aug 2019

EFPIA and Vaccines Europe support the EU-Africa Global Health Partnership as a successor to EDCTP, and as an essential instrument to strengthen research capacity and scientific leadership in sub-Saharan Africa and promote public health in Africa, Europe and around the globe. RATIONALE: Global health challenges are best addressed through international collaboration between stakeholders from all sectors. EFPIA and Vaccines Europe support the continuation of EDCTP’s success in accelerating the development of vaccines, drugs, and health technologies to combat infectious diseases, protect citizens from pandemics and increase global health security. SCOPE: - Building on EDCTP successes, this proposed Partnership should focus on new solutions for which substantial discovery and preclinical work is successfully completed. The focus should not be on discovery projects, but those that could rapidly bring solutions to the populations which need them the most, in particular in sub-Saharan Africa. - Focus on poverty-related and neglected infectious diseases, rather than expanding to include non-communicable diseases, would increase the partnership’s impact. As emerging infectious diseases continue to impact health in sub-Saharan Africa, Europe, and the world, we support the inclusion of emerging diseases in the partnership’s remit (in collaboration with other initiatives such as CEPI, BMGF, or the Wellcome Trust) and the inclusion of other epidemic diseases in low income settings, such as the enteric diseases. Optimisation of existing and novel treatments including development of specific formulations better addressing needs in low income settings should also be considered. - Expanding capacity for infectious disease R&D in sub-Saharan Africa is critical to create the capability not only to generate infectious disease knowledge and develop interventions, but also to implement new interventions in the region. Epidemiology data on many infectious pathogens in sub-Saharan Africa are limited, yet are essential to design and conduct late stage clinical trials, and to prioritize the development of interventions against specific pathogens. The scope should be expanded to include the burden of disease, epidemiological and surveillance studies. - In a globalized world, with climate change impacting intermediate hosts and pathogen transmission, epidemic and pandemic diseases know no barriers or borders. In addition to diseases currently affecting populations in sub-Saharan Africa and Europe, studies should look at other relevant geographies, in particular in view of epidemiological expansion. OPTIONS: EFPIA & Vaccines Europe support policy Option 4, with an extended scope to enable epidemiological studies or clinical trials of shared interest among multiple stakeholders, in sub-Saharan African and other regions impacted by poverty-related and neglected infectious diseases. An appropriate and agile management structure and clear governance representing all funding partners and appropriate expertise would need to be set up. OTHER IMPORTANT ASPECTS: - The EU-Africa and the European Partnership on Innovative Health should have a coordinated strategy and vision on Global Health investments. - The role of private companies investing in GH programmes without actively seeking return on investment as a primary goal should be taken into account when designing calls. A pre-agreed set of Global Health terms or a charter (such as that of the BMGF) would help balance public and private investors interests and create a more collaborative environment. - Irrespective of the legal basis, both in-kind investment from industry and funding for industry should be enabled. - Even if the focus is on diseases affecting Africa, programmes should enable participation of all parties from public and private sectors and all geographies, as long as they deliver solutions adapted to the needs of affected populations, healthcare systems and market conditions.
Read full response

Response to European Partnership for innovative health

27 Aug 2019

EFPIA welcomes the roadmap for a “European Partnership for innovative health” under Horizon Europe, and supports and supports Option 2 (Institutional Partnership under TFEU Article 187) as an enabler to address the challenges, and deliver the expected beneficial impact on society, patients, healthcare systems, academia and the industry. A novel multi-sector Partnership for health research and innovation will be instrumental to break the silos between different industries and their respective stakeholders. This will accelerate the development of safer and more effective healthcare innovation for patients, carers and citizens at large. It will enhance sustainability of both health industries and health systems in Europe. EFPIA supports the proposed Option 2 - Institutionalised Partnership. We would like to emphasize the unprecedented cross-sectorial dimension of such a Partnership, which would provide a new joint pre-competitive multi-sector collaboration platform to deliver better health to patients and more business efficiency. The required level of integration between different public and private sectors and the desired impact on medical practice, health systems and individual patients calls for an Institutionalised Partnership that offers a neutral platform to allow the participation of parties that would not be able to collaborate in other, less institutionalised frameworks. As far as impact is concerned, EFPIA would like to add that such a proposed Partnership, further building on IMI, would continue filling an important gap in translational research in Europe for which funding mechanisms are scarce. It would also accelerate the development of regulatory sciences that reflect the new integrated approaches to R&D and healthcare delivery present today and tomorrow, create new businesses placing Europe at the forefront of cross-sectorial benefits for citizens and patients, and allow for global collaborations and impact. To attract a wide range of industrial players from all sectors and deliver on its objectives, the Partnership would require efficiency and flexibility, i.e.: - Flexible, time and cost-efficient processes to reduce bureaucratic burden as much as possible. A flexible priority-setting and call process to allow a mix of bottom-up and top-down topics while ensuring openness to all stakeholders. - In-kind contribution as the condition for true collaborative projects between public and private participants, by which the industry would bring significant and differential skills, expertise and industrial know-how from which academics and SMEs can benefit. The Partnership should have the ability to attract resources at a global level, in order for Europe to benefit from synergistic collaboration with major industrial players in the pharmaceutical and medical technology sectors operating globally, as well as with international funding organisations and charities. This would enable global input and reach, resulting in excellent science and innovation for the benefit of citizens globally as well as foster international knowledge transfer. Such impact would only be achievable if in-kind contributions from all partners are eligible without limitation, irrespective of their origin. - A flexible legal framework for the management of intellectual property in order to facilitate participation of stakeholders with diverse research & innovation lifecycles and business models. - Mechanisms to ensure synergies & collaborations between Partnerships would be required to avoid overlaps, especially with potential partnerships on EU-Africa Global health, Healthcare systems, Personalised medicines and Rare diseases. EFPIA welcomes engagement with EU institutions and stakeholders to further discuss the potential scope and features of such a Partnership.
Read full response

Meeting with Timo Pesonen (Acting Director-General Internal Market, Industry, Entrepreneurship and SMEs)

23 Jul 2019 · Present their latest Manifesto and introduce the pharmaceutical companies position towards new Commission

Meeting with Vytenis Andriukaitis (Commissioner) and

26 Jun 2019 · Access to medicines, shortages, medicines for rare diseases and children

Meeting with Anne Bucher (Director-General Health and Food Safety)

25 Jun 2019 · development of a High-level Forum on Healthcare; the Commission "outcomes" agenda; EU HTA Regulation proposal

Meeting with Jean-Eric Paquet (Director-General Research and Innovation)

23 Apr 2019 · PPPs in health area

Meeting with Jyrki Katainen (Vice-President)

4 Feb 2019 · Supplementary Protection Certificate Manufacturing Waiver in Europe and EFPIA’s priorities in the context of the 2019 institutional changes

Meeting with Anne Bucher (Director-General Health and Food Safety)

3 Dec 2018 · courtesy visit

Meeting with Jean-Eric Paquet (Director-General Research and Innovation)

7 Sept 2018 · Partnesrhips

Meeting with Vytenis Andriukaitis (Commissioner) and

15 Jun 2018 · HTA

Meeting with Risto Artjoki (Cabinet of Vice-President Jyrki Katainen)

19 Apr 2018 · Competitiveness of the European Pharmaceutical industry

Response to EU cooperation on Health Technology Assessment

30 Mar 2018

EFPIA welcomes the Commission’s proposal for a Regulation on HTA. This proposal presents a unique opportunity to ensure a degree of harmonisation throughout the European Union, thereby leading to faster patient access to new innovative medicines and synergies in clinical evidence generation needs and assessment by Member States. The proposal clearly states that one of its core objectives is to remove existing divergences in the internal market for health technologies caused by differences in joint clinical assessments through harmonization at EU level. Such an approach can only work if the joint clinical assessment that is done at European level by all Member States is effectively used in all the national processes of HTA.This principle forms the core of the proposal and should be safeguarded throughout the legislative approval process. Article 8 of the proposal is very clear in that respect. Scope of the Regulation The scope is rightly limited to an assessment of the clinical evidence available at the moment of the submission for joint clinical assessment. Member States will continue to be solely responsible for drawing conclusions on the overall added value of the assessed health technology based on the joint clinical assessment report and their own non-clinical assessment, i.e. the appraisal which will inform the national reimbursement decision making. Mandatory uptake The European joint assessment has to replace a step in the overall process of HTA at national level to bring added value. Without the safeguards in the proposed EU regulation that guarantee that there is no duplication of jointly conducted work in Member States it will not be possible to meet the Regulation´s objectives. Without clarity and predictability that joint work will be used in Member States, EFPIA considers it a disproportionate burden on manufacturers to invest considerable resources into active participation in joint clinical assessments. Quality criteria EFPIA believes that the jointly conducted work of the envisaged HTA collaboration needs to follow high quality standards. These standards need to be defined in tertiary legislation and should be based on a clear list of general criteria in the primary regulation which is currently missing. This list would include stipulations, amongst others, that make clear that: • procedural rules and clinical assessment methodology should be in line with agreed best practices and clearly link to EUnetHTA achievements, • advances in science should be taken into consideration, • the best available evidence at time of joint clinical assessment should be considered, • confidential data should be protected by confidentiality agreements, • stakeholders’ roles and responsibilities should be clearly defined, • whilst the legislation should propose a framework around process timeline, including a maximum timeline with clearly defined clock stops and the necessity of a scoping meeting, the detail should be left to agreed process and method guides. Appeal mechanism An appeal mechanism for companies is missing in the proposal, such as is the case in most national HTA systems. Given that the jointly produced clinical assessment is to be the basis of subsequent national decision making, an opportunity should be given for an independent review of the assessment. Joint scientific consultations EFPIA welcomes the opportunity for pharmaceutical companies to request a joint scientific consultation on clinical benefit assessment evidence (in parallel with the EMA) in order to discuss data requirements for the regulatory approval process and joint clinical assessment. EFPIA believes that this opportunity should be offered to all medicines that eventually have to undergo joint clinical assessments and not only to a selected few. In this respect, EFPIA considers any selection process aiming at prioritizing among company plans to develop innovative medicines to be counterproductive.
Read full response

Meeting with Michael Hager (Cabinet of Vice-President Günther Oettinger)

21 Mar 2018 · competitiveness of the life science industry in Europe

Meeting with Nils Behrndt (Cabinet of Vice-President Neven Mimica)

19 Mar 2018 · Health in development cooperation

Meeting with Patricia Reilly (Cabinet of Commissioner Tibor Navracsics)

15 Mar 2018 · Research & Innovation policy

Meeting with Maria Asenius (Cabinet of Vice-President Cecilia Malmström), Nele Eichhorn (Cabinet of Vice-President Cecilia Malmström)

8 Feb 2018 · Possible change of EU patent legislation

Meeting with Elżbieta Bieńkowska (Commissioner) and

30 Jan 2018 · Exchange of views on current topics

Meeting with Irena Andrassy (Cabinet of Vice-President Neven Mimica), Nils Behrndt (Cabinet of Vice-President Neven Mimica)

17 Jan 2018 · Role of pharmaceutical industry in development cooperation

Meeting with Xavier Prats Monné (Director-General Health and Food Safety)

12 Jan 2018 · Discussion on AMR

Response to Evaluation of the legislation on medicines for children and rare diseases (medicines for special populations)

21 Dec 2017

EFPIA and EuropaBio welcome the opportunity to comment on the European Commission’s roadmap on the evaluation of the legislation on medicines for children and rare diseases (medicines for special populations). It is to note that both the Orphan Medicines and Paediatric Medicines Regulations have successfully stimulated the development of medicines for special populations, with each addressing specific development challenges. As such, bearing in mind that the aim is to increase the number of therapeutic choices for children and patients suffering from rare diseases, we would caution against too much generalisation. We would like to emphasise the vital importance of maintaining a favourable regulatory environment to maintain the momentum and continue to achieve progress in the fields of paediatric and orphan medicines. We would welcome clarification of the Commission’s intentions regarding the ultimate objective of this joint evaluation, which should be more precisely stated in the roadmap. In this respect the anticipated scope of the additional study on orphan medicinal products legislation that will be launched in 2018 should be explained, in particular the remaining research questions this study is intended to address. The analysis of the impact of the legislation on the availability of treatment options to patients should be put in a broader context, aiming to identify all drivers of investment in research and development in both the areas of orphan and paediatric medicines. It should be driven by the overall objective to improve access of patients to new treatments. Payers, HTA bodies, investors and all other stakeholders involved in the financing, development, manufacturing, reimbursement and commercialisation of orphan and paediatric medicines will provide useful input to help understand the dynamics across the medicinal product’s life. SMEs, often helped by capital provided by specialised investors, have proven to be important players in the development of orphan medicines and understanding the factors conducive to their success in this field is another important consideration. Since development is global, it is very welcome that the Commission considers the experience and developments in the United States. US FDA metrics could be added to the potential data sources. Overall the roadmap constitutes a good starting point but questions remain on the methodology and on the sources that will be used in line with the stated objective. Regarding the financial and cost/benefit aspects of the planned evaluation, it will be important to understand the overlap with the work done in preparation for the 10 year Report on the Paediatric Regulation. In particular, how will data be gathered in an appropriately objective way, and duplication of the paediatric work avoided? More specifically, EFPIA and EuropaBio would welcome further details and clarity on the following: • Whether a separate consultation process is foreseen on the scope of the ‘additional study on orphan medicinal products legislation’ • Methodology and source of data gathering envisaged for this new study • Role of and relationship with the existing Technopolis study on the Paediatric Regulation • The targeted consultation involving Member States and specific interest groups – for example, which aspects the Commission plans to explore more in depth? • In addition to the listed stakeholders, to fully capture the picture of enablers and barriers to address unmet needs in special population, we recommend consulting with pharma investors. We are looking forward to further engage as more information and detail on the roadmap become available. Contacts : EFPIA: François Lamerant (francois.lamerant@efpia.eu) Silvia Garcia (silvia.garcia@efpia.eu) EuropaBio: Davide Marchi (d.marchi@europabio.org)
Read full response

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

15 Dec 2017 · AMR; Pharma

Meeting with Vytenis Andriukaitis (Commissioner) and

29 Nov 2017 · Pharmaceutical incentives, antimicrobial resistance

Meeting with Michel Barnier (Head of Task Force Task Force for Relations with the United Kingdom)

27 Oct 2017 · Meeting with the Task Force for the Preparation and Conduct of the Negotiations with the United Kingdom under Article 50 TEU

Response to Communication on Digital transformation of health and care in the context of the DSM

16 Aug 2017

The European Federation of Pharmaceutical Industries and Associations (EFPIA) representing the innovative pharmaceutical industry welcomes the announcement by the European Commission of the adoption of a Communication on ‘Digital Transformation of Health and Care’ and appreciates the opportunity to give feedback on the Roadmap in the field of Digital Health. The proposals outlined in the Roadmap have the potential to act as a catalyst for wider change contributing to patient welfare and enhanced health system performance. For that wider change to happen, other factors will need to be in place. These include the clarification of legislative and regulatory issues related to the application of EU law, and the availability of funds for investment in patient-centered healthcare, both of which are noted in the Roadmap. Factors also include the mobilisation of multi-stakeholder engagement and public-private partnerships, both to build a wider momentum towards innovative solutions, and also to ensure a full and public debate on the responsible use of health data. The pharmaceutical industry is itself in a process of digital transformation and its future prospects in Europe are closely tied to the success of initiatives such as those being piloted by the Commission. We look forward to working with the Commission and other stakeholders to build the momentum for change. Detailed comments are in the attached pdf.
Read full response

Meeting with Christian Burgsmueller (Cabinet of Vice-President Cecilia Malmström), Maria Asenius (Cabinet of Vice-President Cecilia Malmström)

29 Jun 2017 · Turkey - in breach of rules; Canada - some concerns around implementing legislation.

Response to Strategic approach to pharmaceuticals in the environment

26 May 2017

The European pharmaceutical industry represented by AESGP, EFPIA and Medicines for Europe support the Roadmap objectives of filling knowledge gaps, exploring how to protect the environment and safeguarding patient access to pharmaceutical treatments. The objectives are aligned with our Eco-Pharmaco-Stewardship (EPS) program[1,2,3]. EPS takes a life-cycle approach to PiE management and includes initiatives on managing environmental risks post-authorisation through an extended Environmental Risk Assessment model, providing tools to prioritise environmental testing of legacy pharmaceuticals, improvements in manufacturing effluent management and promoting the safe disposal of expired and unused medicines. EPS also addresses the roles and responsibilities of all parties involved. EPS presents valuable alternatives which should be considered instead of measures that might jeopardise patient access to medicines or require extensive legislative amendments when most pharmaceuticals pose low or insignificant risk. The major source of human pharmaceuticals entering the environment is from patient excretion following their use to address medical conditions. A comparatively smaller, localised contribution stems from manufacturing emissions or incorrect disposal of unused/expired medicines. Available scientific information demonstrates that the vast majority of human pharmaceuticals entering the environment are unlikely to present an appreciable risk to the environment[4,5]. With regard to human risks and drinking water, the WHO reported that "Trace quantities of pharmaceuticals in drinking-water are very unlikely to pose risks to human health..”[6]. Other studies support this conclusion[7,8]. It is worth mentioning that increased use of preventative vaccines and the advancement of personalised medicine will likely result in reductions in the use of traditional APIs[9]. Nevertheless, the occurrence and potency of certain human pharmaceuticals may warrant further environmental investigation. Scientists from academia, government and industry are currently collaborating in an IMI project (iPiE), co-sponsored by the Commission and EFPIA-member companies, to develop state-of-the-art, science-based predictive environmental models that could be used to identify and prioritise any significant environmental risks that might occur from APIs not already evaluated, especially legacy products[10]. The EC Strategic Approach to PiE should leverage the existing regulations to reduce the potential for duplication and conflicting goals that might impact the availability of medicines. Any new policies proposed should be science-based and avoid broad-stroke solutions for topics with significant uncertainties that can be clarified by additional targeted research. Expecting risks from a large number of APIs based on evidence from only a few, and proposing broad management policies would be wasteful of resources. For example, development of antimicrobial resistance (AMR) is a complex problem with a number of factors contributing to the probabilities of occurrence and possible impacts. Industry have initiated several health-based commitments (e.g. Davos Declaration; AMR Alliance) to understand and minimise the potential for AMR, including control of APIs in manufacturing wastewaters. Finally, the Roadmap indicates that no impact analyses will be carried out for the Strategic Approach itself, even though it “could include policy options” and will consider additional options in a supplementary report that is not yet available. The pharmaceutical industry believes that an impact assessment should be done on the Strategic Approach, and any policy options it contains, in order to understand the scope of possible benefits and costs associated with the proposed framework. As responsible stewards of our products, we will continue to develop our life-cycle EPS approach and hope to actively participate in helping achieve the stated objectives of the Roadmap.
Read full response

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

24 Apr 2017 · Follow-up to COUNCIL conclusions: Impact of the incentives on innovation, availability and accessibility of medicinal products

Response to Commission Implementing Directive on GMP for human medicinal products

10 Feb 2017

European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. Through direct membership of 33 national associations and 42 leading pharmaceutical companies EFPIA is the voice on the EU scene of 1,900 companies committed to R&D. EFPIA welcomes the opportunity to provide feedback on this consultation. EFPIA expects that the Commission will ensure that GMP requirements in different sections (or outside) of EudraLex - Volume IV Good manufacturing practice (GMP) Guidelines are consistent and will manage these changes appropriately to avoid divergences in requirements. This is because EFPIA member companies typically operate one quality system covering, for example, both commercial products and investigational medicinal products. This is particularly important for the current proposal for establishing a Regulation for the GMP for investigational medicinal products and a Directive for the GMP for medicinal products. EFPIA recommends that all GMP requirements for different kinds of products - IMPs, ATMPs and commercial medicinal products will be posted in Eudralex Volume IV. A core set of common GMP principles is proposed to be referred to in Part I. Rather than duplicating these core requirements in separate sections (e.g. in part III or Annexes) addressing, for example, IMPs or ATMPs, EFPIA recommends that only the differences in the GMP requirements for these kinds of products and their development phase should be described. Emphasising these core principles will facilitate the common application within the company’s pharmaceutical quality system, and consistency in inspections across these different kinds of products by the different agencies of the member states. EFPIA also expects that during the Directive transposition phase, Member States will interpret the GMP for medicinal products consistently to ensure harmonised requirements across the EU/EEA. EFPIA notes the introduction of wording to clarify the Member State obligations (e.g. “the Member State shall ensure that the manufacturer …” or “be obliged to ensure…”) and requests confirmation that this will not result in new enforcement penalties.
Read full response

Response to Commission Delegated Regulation on GMP for IMPs

10 Feb 2017

European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. Through direct membership of 33 national associations and 42 leading pharmaceutical companies EFPIA is the voice on the EU scene of 1,900 companies committed to R&D. There are critical issues with this final draft Regulation on GMP for IMPs which, if not addressed, will have an impact counter to the intent of Clinical Trials Regulation 536/2014 of making the EU a more attractive region to conduct clinical trials. The current wording does not take into account the complexities and practicalities of clinical trial supply chains. In particular, its focus on ‘the manufacturer’ ignores the way in which developers of new medicines may use a series of manufacturers in the supply chain whilst providing oversight as ‘the sponsor’ and keeping intellectual property under originator’s control. The ways in which requirements for the retention of samples and documents are addressed are over burdensome, inflexible and impractical to implement. In this response we provide a list of key aspects to us. We will be very happy to work further with the Commission to address these issues and ensure that the final regulation results in requirements that are fit for the purposes of safeguarding clinical trial subject safety and data integrity whilst being proportionate and practical for industry to implement. Specific feedback on the text: Although Whereas (4) recognises the importance of cooperation between manufacturer and sponsor and of there being a technical agreement between them, there is no flexibility within the Regulation wording for certain responsibilities to be taken on by either the manufacturer or the sponsor subject to written contract. The following Articles are impacted: Article 8(3) on PSF retain responsibility and retention period tied to the study timelines; Article 10(2) requiring the manufacturer to assure the quality control laboratory compliance, an activity that the sponsor may outsource; Article 11(1) stipulating that samples must be held by the manufacturer with no opportunity for these to be transferred to the sponsor, plus the period of retention wording; Article 12(2) tying the retention of the batch register to the date of trial completion or discontinuation, which the manufacturer may not be privy to; Article 14(2) responsibility for unblinding solely with the manufacturer whereas in practice it is far more likely to be addressed by the sponsor. Process validation: Article 9(3) currently requires validation of the manufacturing process “to the full extent, taking into account the stage of product development.” This wording is too open to interpretation in a way that is not aligned with current regulatory expectations: To avoid issue over interpretation, we strongly recommend an alternative wording: “The manufacturing process is not required to be validated, but should be appropriately controlled and monitored to assure the quality required for the intended use, taking into account the stage of product development. The manufacturer shall identify the process steps that ensure the safety of the subject, such as sterilisation. Those critical process steps shall be validated and regularly revalidated.” Manufacture in third countries: the current wording expects third country manufacturing sites to be ‘entitled’ (Wheras (5)) or ‘authorised’ (Article 3(2)) to manufacture IMPs in that third country. However, not all third countries have specific requirements for the authorisation of IMP manufacturing sites; the USA being a case in point which is very significant in many EU IMP supply chains. If it is not intended that there be any restriction due to a lack of local authorisation requirements, then the wording should be changed accordingly. E.g., continuing the current practice of QP declaration at the time of clinical trial application and QP responsibility for batch certification.
Read full response

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

31 Jan 2017 · Non Communicable diseases

Meeting with Carlos Moedas (Commissioner) and

7 Dec 2016 · Meeting with EPFIA'S President, IMI/Innovation Policy

Response to REACH Regulation - Annex XIV

14 Oct 2016

This joint response is made by EFPIA, Medicines for Europe, Vaccines Europe and IFAH Europe, who together represent the major part of R&D, Generics, Vaccines and Animal Health industry in Europe. Our comments are specific to 4-tert-OPnEO, herein referred as Triton X-100. Authorisation is not the best Risk Management Option to control the use of Triton X-100 in the manufacture of medicines and medical devices; other RMO’s should be explored to achieve the aims of REACH while protecting the safety of patients/Animals and competitiveness of our industry. According to a CRA Report the impact to BioPharma sector could be c. 3.5€ BN. We request that official Patient Safety and Socio-economic Impact Assessments are conducted ahead of REACH Committee vote to place Triton X-100 on Annex XIV. -Patient/Animal Safety: Triton X-100 is used for Viral Inactivation (VI) and also to remove protein impurities from biotech medicinal products/processes to ensure Patient/Animal Safety; the impact of a time limited authorisation or more importantly, the loss of supply of such a critical small volume raw material to public health, would be very significant. The risk of viral contamination is common to all medicinal products derived from mammalian cell lines and plasma sources. Triton X-100 is considered the most widely validated/robust pathogen VI method used today. New and evolving viruses are a significant public health concern; Triton X-100 offers a broad range specificity to inactivate these. Viral safety requirements are laid down in legislation and guidance issued by European Medicines Agency (EMA), US FDA and WHO. It is also used as critical component in the Vaccines production process. -Additional Regulatory Burden: Substituting Triton X-100 in a defined bioproduct manufacturing process is extremely difficult once the medicine has entered development phases. Substitution may require additional animal testing/clinical trials and biophysical characterisation to prove equivalent efficacy and safety. Assuming an alternative is found, amendments to global pharma Marketing Authorisations and extensive revalidation of manufacturing processes at facilities previously approved by the EMA and other Medicinal regulatory authorities, will be required. This could lead manufacturers to source their medicines outside EU and place severe pressure on the supply chain of those medicines. -Impact to Future Investment: Pharma manufacturing is a key part of EU’s agenda for Jobs, Growth, Investment and Competiveness. R&D and manufacture of medicines is a high-risk business which needs regulatory certainty and predictability to support long-term investment in facilities within EU. The uncertainty of Triton X-100 will continue until proposed sunset date late 2020. This unpredictability and the availability of manufacturing capacity outside EU where REACH does not apply is a disincentive to long-term investment in EU manufacturing facilities particularly for pipeline medicines that use Triton X-100. This is the most critical risk to competitiveness of the EU and to multinational Pharma companies who have a choice to invest in EU or not. -Proportionality: There is little evidence of 4-tert-OP being present in EU waters. Other EU regulatory instruments (WFD/EQS for 4-tOP, Urban WWTD) already set appropriate standards/control the discharge/impact of 4-tert-OP. Wide dispersive uses have been overstated. The prioritisation process for 4-tert-OPnEO should be reassessed. -EMA/ECHA Memorandum of Understanding: The MoU requires early exchange of information regarding evaluation and authorisation/restriction of chemicals as relevant for the activities of EMA, which has not taken place in this case. -Long Authorisation for Pharma: Recital 18 doesn’t address the uncertainty that this has generated in our industry on the availability of critical raw materials and certainly doesn’t address the long investment timelines that are required to bring our medicines to market.
Read full response

Meeting with Kevin O'Connell (Cabinet of Commissioner Věra Jourová)

7 Oct 2016 · GDPR

Meeting with Vytenis Andriukaitis (Commissioner) and

15 Jun 2016 · HTA, AMR, Access to innovative medicines

Meeting with Vytenis Andriukaitis (Commissioner) and

3 Jun 2016 · AMR, Situation in Ukraine

Meeting with Günther Oettinger (Commissioner)

24 Feb 2016 · Big Data, ehealth

Meeting with Vytenis Andriukaitis (Commissioner) and

24 Feb 2016 · Access to Medicines, HTA, AMR

Meeting with Cecilia Malmström (Commissioner)

24 Feb 2016 · TTIP, CETA, affordable medicines

Meeting with Nils Behrndt (Cabinet of Vice-President Neven Mimica)

23 Feb 2016 · Access to health care and pharmaceuticals in developing countries

Meeting with Xavier Prats Monné (Director-General Health and Food Safety)

25 Nov 2015 · AMR

Meeting with Maria Asenius (Cabinet of Vice-President Cecilia Malmström), Miguel Ceballos Baron (Cabinet of Vice-President Cecilia Malmström) and Boehringer Ingelheim

19 Nov 2015 · TTIP

Meeting with Arunas Vinciunas (Cabinet of Commissioner Vytenis Andriukaitis)

28 May 2015 · Developments of pharmaceutical industry

Meeting with Jean-Luc Demarty (Director-General Trade)

22 Apr 2015 · Trade relations with US and China

Meeting with Cecile Billaux (Cabinet of Vice-President Cecilia Malmström)

25 Feb 2015 · Trade negotiations and health

Meeting with Antonio Lowndes Marques De Araujo Vicente (Cabinet of Commissioner Carlos Moedas)

10 Feb 2015 · Science and innovation

Meeting with Maria Asenius (Cabinet of Vice-President Cecilia Malmström), Miguel Ceballos Baron (Cabinet of Vice-President Cecilia Malmström)

10 Feb 2015 · TTIP

Meeting with Paolo Berizzi (Cabinet of Vice-President Neven Mimica)

26 Jan 2015 · Anti-biotic resistance within development policy

Meeting with Nils Behrndt (Cabinet of Vice-President Neven Mimica)

23 Jan 2015 · EFPIA engagement in developing countries

Meeting with Giulia Del Brenna (Cabinet of Commissioner Carlos Moedas)

19 Dec 2014 · Innovative Medecines Initiative / Ebola crisis

Meeting with Carlos Moedas (Commissioner)

18 Dec 2014 · European industry’s perspective on the future of EU research and innovation policy