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MEDICINES FOR EUROPE

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Medicines for Europe represents generic, biosimilar and value-added medicines companies supplying the largest share of medicines across Europe.

Lobbying Activity

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

29 Jan 2026 · CMA + Health policy

Meeting with Tiemo Wölken (Member of the European Parliament)

28 Jan 2026 · Urban Waste Water Treatment Directive

Meeting with Patrick Child (Deputy Director-General Environment)

16 Jan 2026 · PFAS letter /UWWT study

Meeting with Jessica Polfjärd (Member of the European Parliament, Shadow rapporteur) and Acumen Public Affairs

15 Jan 2026 · Health Policy

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

26 Nov 2025 · Review of the EU General Pharmaceutical Legislation

Meeting with Ulla Schwager (Head of Unit Competition)

24 Nov 2025 · Discussion on the practical implications of the environmental risk assessment

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

23 Oct 2025 · Critical Medicines Act

Meeting with Olivér Várhelyi (Commissioner) and Richter Gedeon Nyrt.

15 Oct 2025 · Competitiveness of EU generic pharma industry

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

14 Oct 2025 · Pharmaceutical legislation

Medicines for Europe urges new state aid exemption for critical medicines production

6 Oct 2025
Topic — EU regulation governing state aid exemptions for sectors deemed compatible with internal markets.
Message — The organization requests introducing a new exemption category under the General Block Exemption Regulation specifically for aid granted to producers of critical medicines. They argue current State aid frameworks are unsuitable for supporting off-patent medicines production and that the GBER should evolve to align with new EU policy priorities recognizing pharmaceuticals as a strategic sector.123
Why — This would simplify and accelerate access to state aid, reducing compliance burdens and eliminating unpredictable obligations.45
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Meeting with Olga Solomon (Head of Unit Health and Food Safety) and European Federation of Pharmaceutical Industries and Associations 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.

Meeting with Ondřej Knotek (Member of the European Parliament, Shadow rapporteur)

16 Sept 2025 · To discuss Critical Medicines Act

Meeting with Ingeborg Ter Laak (Member of the European Parliament)

16 Sept 2025 · Critical Medicines Act

Medicines for Europe urges integration of generic drugs in cardiovascular plan

15 Sept 2025
Topic — EU plan to improve prevention, detection and treatment of cardiovascular disease.
Message — The organisation requests explicit integration of off-patent medicines as the backbone of cardiovascular care, recognition of secondary prevention as a priority, support for value-added medicine innovation, proactive measures for future biosimilar competition, and improved procurement practices to ensure supply sustainability.12345
Why — This would protect their market position and expand opportunities for biosimilar and value-added medicines.6789
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Meeting with Paul Speight (Head of Unit Environment)

15 Sept 2025 · REACH and Universal PFAS restriction

Meeting with Aurelijus Veryga (Member of the European Parliament)

10 Sept 2025 · Shaping the Future of EU Pharmaceutical Legislation

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

10 Sept 2025 · Revision of the EU Pharmaceutical Directive

Meeting with Sebastian Everding (Member of the European Parliament)

4 Sept 2025 · Critical Medicine Act Report

Meeting with Oliver Schenk (Member of the European Parliament, Rapporteur for opinion)

3 Sept 2025 · European Health Policy - Critical Medicines Act

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

3 Sept 2025 · Critical Medicines Act / generic, biosimilar and value added medicines

Meeting with Margarita De La Pisa Carrión (Member of the European Parliament)

2 Sept 2025 · Pharma Package

Meeting with Tilly Metz (Member of the European Parliament, Shadow rapporteur)

2 Sept 2025 · Critical Medicines Act

Meeting with Pierre Jouvet (Member of the European Parliament)

24 Jul 2025 · critical medicines

Meeting with Viktória Ferenc (Member of the European Parliament)

8 Jul 2025 · Exchange of views on Critical Medicines Act

Response to Critical Medicines Act

4 Jul 2025

Medicines for Europe welcomes the proposal for a Critical Medicines Act and its objectives. Building on the proposal and the growing need for health security, we underline the importance of market reforms, a partnership for investment in manufacturing and the need for EU solidarity. Demand-side measures for off patent medicine, Including pricing and reimbursement, have successfully stimulated competition in Member States, mostly once the reference product loses exclusivity. However, these national policies have failed to stimulate long-term competition and availability. There is overwhelming evidence that market policies purely focusing on lowest prices have led to the consolidation of critical and essential medicine supply chains, which increases the risk of shortages. Therefore, we commend the European Commission for including the mandatory use of criteria other than price, and for mandating that the Member States establish programmes supporting security of supply of critical medical medicinal products which includes multi-winner approaches. However, as many critical medicines are not purchased through procurement, should be strengthened by mandating the inclusion of pricing and reimbursement measures into national programmes. Additionally, the Articles on collaborative procurement are not sufficiently clear or detailed to function in practice. Collaborative procurement should not conflict with national procurement or established market arrangements, to avoid market disruptions that could lead to shortages. In line with the Critical Medicines Alliance strategic report, an ambitious European investment plan is needed to strengthen production capacities for critical medicines in Europe.To encourage private sector investment in medicine manufacturing in Europe, the EU should allocate 4 billion to medicine manufacturing in the upcoming MFF.This could support upgrades for security of supply or environmental improvements to 150 production sites in Europe and could facilitate the reshoring of a limited number of molecules of national security interest to the EU. The accompanying state aid guidelines to the Act do not reflect the need for EU strategic autonomy. They should allow investment in production, environmental upgrades and digitalisation to improve the reactivity of production to variability in demand to support the critical medicines industry to mitigate geopolitical risks. They should also support relevant operational costs such as skill upgrades to develop a competitive edge for EU manufacturing. Building on the EMA extended mandate legislation to mitigate shortages, the Act should address national stockpiling mandates, as they often constitute a quantitative restriction on trade, threaten the availability of medicines in other Member States, and must therefore be proportionate to their public health objective. While the Commissions proposal requires stockpiling obligations to be proportionate and compatible with solidarity, it should be added that the Commission will assess stockpiling mandates upon request to ensure that these principles are adhered to. Stockpiling should be based on rolling reserves, companies should be compensated for the additional burden, and there should be regulatory flexibility to respond to market fluctuations. Securing robust medicines supply chains is essential for Europe to maintain a continuous and stable provision of medical products, both domestically and globally, especially during crises. The Act rightly underlines the need for diversification of supply chains through international partnerships to strengthen supply security. Additionally, free trade agreements should include health security chapters to address export restrictions, facilitate coordination in a health crisis, and enhance regulatory cooperation. The EU should consider exploring new Mutual Recognition Agreements and expanding provision of existing MRAs with partners that have appropriate standards.
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Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur)

4 Jul 2025 · Pharma Package

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

26 Jun 2025 · exchange with the Medicines for Europe Executive Committee

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

26 Jun 2025 · to follow

Meeting with Oliver Schenk (Member of the European Parliament)

25 Jun 2025 · Resilient Health Union

Meeting with Mohammed Chahim (Member of the European Parliament, Shadow rapporteur for opinion) and European Federation of Pharmaceutical Industries and Associations and

25 Jun 2025 · Roundtable Critical Medicines Act

Meeting with Tilly Metz (Member of the European Parliament, Shadow rapporteur)

19 Jun 2025 · Pharmaceutical package

Meeting with Barry Cowen (Member of the European Parliament, Shadow rapporteur)

17 Jun 2025 · Meeting with Medicines for Europe

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

Medicines for Europe urges major biotech investment to secure EU biosimilar leadership

11 Jun 2025
Topic — Future EU regulation to accelerate biotechnology innovation and market adoption across Europe.
Message — The organization requests substantial public investment in biosimilar R&D and manufacturing capacity, regulatory streamlining to waive default comparative efficacy studies, reformed procurement practices allowing multi-winner tenders, and harmonized IP rules including clarification of the Bolar exemption and ban on patent linkage.1234
Why — This would reduce their development costs by eliminating expensive comparative efficacy studies and enable faster market entry and export opportunities.567
Impact — Originator pharmaceutical companies lose extended market exclusivity periods and face increased competition from biosimilars.8910
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Meeting with Ruggero Razza (Member of the European Parliament) and MUST Partners

11 Jun 2025 · Incontro con gli amministratori locali siciliani

Meeting with Florika Fink-Hooijer (Director-General Health Emergency Preparedness and Response Authority) and Laboratorios Farmacéuticos Rovi, S.A.

2 Jun 2025 · Breakfast on the margins of HERA Industry Days

Response to EU Strategy on medical countermeasures

9 May 2025

Medicines for Europe welcomes the opportunity to provide feedback on the European Commissions Strategy to support medical countermeasures (MCMs) against public health threats. The Commissions commitment to strengthening Europes resilience through coordinated preparedness mechanisms is appreciated. Better anticipation, planning, and solidarity among Member States are critical to enhancing Europes security of supply. The off-patent pharmaceutical sector emphasises the importance of a resilient, competitive, and agile environment for the development, manufacturing, and supply of MCMs. Given the essential role of off-patent medicines in public health preparedness, their specific characteristics, such as interconencted global supply chains and regulated pricing, must be fully recognized. We urge the Strategy to acknowledge and include the following considerations: 1) Importance of off-Patent medicines: Off-patent medicines, including antibiotics, IV fluid infusions and injectable anesthetics, are crucial for public health preparedness. These medicines have complex global supply chains and are often subject to regulated pricing and tender-based markets. 2) Stockpiling and supply security: Ensure national stockpiling mandates are consistent with the internal market and notified under relevant EU procedures with options to relocate products where needed. Focus stockpiling efforts on medicines with verified supply vulnerabilities to prevent widespread disruptions. Develop an EU-wide impact assessment framework to evaluate the consequences of national stockpiling measures on regional supply. 3) Procurement: Prioritize supply security and diversification in tender design by incorporating mandatory MEAT (Most Economically Advantageous Tender) criteria and dividing tenders among multiple suppliers. Ensure joint procurement tools focus on small volume medicines with actual market constraints and introduce regulatory flexibilities. Avoid overlaps with ongoing national procurement processes and honor existing commercial obligations. 4) Regulatory processes: Simplify and shorten approval and variation processes, ensuring submission predictability. Move towards broader adoption of multi-country packs and labeling harmonization. Transition to electronic product information (ePI) to ensure real-time updates and support the digital transition in healthcare. 5) Financial allocation: Foresee dedicated budget supporting off-patent innovation and investments in manufacturing and supply chain resilience under the current and forthcoming Multiannual Financial Framework. 6) Alignment with existing and forthcoming initiatives: Ensure legal clarity and consistency by aligning this strategy with existing and upcoming legislative and non-legislative initiatives. Please refer to the attached document for additional information and further details.
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Response to Communication on the EU Stockpiling Strategy

9 May 2025

Medicines for Europe welcomes the Commissions initiative to develop a comprehensive EU stockpiling strategy as part of a stronger European preparedness framework. However, to be effective, this strategy must be grounded in evidence, built on coordination, and fully aligned with the realities of pharmaceutical manufacturing and supply. The off-patent medicines sector, which provides over 70% of prescription medicines across Europe, including most antibiotics, intensive care injectables, and chronic disease medicines, is at the core of public health resilience. Yet, recent years have shown that fragmented and disproportionate national stockpiling obligations have introduced significant systemic risks, including market fragmentation, reduced supply chain agility, and pressure on the economic sustainability of essential medicines. An EU stockpiling strategy will only succeed if it addresses, not reinforces, these vulnerabilities. We therefore call for the following principles to guide the development of this strategy: · First, alignment and proportionality are essential. Uncoordinated national stockpiling rules have already created duplicative and often contradictory requirements, which impede the ability of manufacturers to reallocate supply where it is most needed during shortages. Stockpiling should not lead to artificial barriers within the internal market, nor should it compromise solidarity between Member States. · Second, sustainability of supply must be preserved. Off-patent medicines are produced under highly regulated price schemes and frequently awarded through tender-based procurement. Imposing rigid, not remunerated, or high-volume stockpiling obligations on suppliers that operate on tight margins and long production lead times may trigger market exits and reduce the number of suppliers, especially for older or lower-volume products that are critical for care continuity. · Third, data-driven planning and rapid response based on better use of existing data should be prioritised. The European Medicines Verification System (EMVS), routinely used to prevent falsified medicines, offers a unique opportunity to track medicine availability across Member States in real time. This tool can support data-driven planning and rapid response to shortages, particularly when combined with regulatory flexibilities in labelling and pack sizes to facilitate cross-border distribution. · Lastly, industry should be recognised as a central actor in preparedness. Stockpiling obligations that are misaligned with production realities, shelf lives, and actual demand forecasts risk generating waste and delay rather than resilience. Instead, joint planning based on real-world data, coordinated procurement models that incorporate supply security criteria, and voluntary solidarity mechanisms offer more viable alternatives for safeguarding medicine availability. We urge the Commission to design a strategy that differentiates between types of products, recognises supply chain constraints, and avoids imposing counterproductive burdens. The goal must be to strengthen not strain the capacity of the European pharmaceutical system to deliver affordable, reliable access to essential medicines. We stand ready to contribute with data, technical expertise, and practical solutions to ensure this initiative delivers on its promise of a more resilient Europe.
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Meeting with Aurelijus Veryga (Member of the European Parliament)

6 May 2025 · Implications of environmental policy on pharmaceutical access

Meeting with Ruggero Razza (Member of the European Parliament) and European Federation of Salaried Doctors

6 May 2025 · Scambio di opinioni in materia di Salute

Meeting with Ondřej Knotek (Member of the European Parliament)

6 May 2025 · Urban Waste Water Directive

Meeting with Olivér Várhelyi (Commissioner) and

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

Medicines for Europe urges recognition of off-patent innovation in life sciences strategy

17 Apr 2025
Topic — EU strategy to boost competitiveness and innovation in European life sciences sector.
Message — The organization requests that the EU strategy recognize off-patent innovation, reduce regulatory complexity, support competitive market dynamics, and create investment incentives for generic and biosimilar manufacturers. They emphasize expanding the definition of innovation to include manufacturing processes supporting green and digital transitions.123
Why — This would unlock state aid and funding for their manufacturing investments and reduce compliance costs.456
Impact — Innovative pharma companies lose if competition and market entry are prioritized over IP protection.789
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Meeting with Tomislav Sokol (Member of the European Parliament)

1 Apr 2025 · Health policy

Meeting with Dolors Montserrat (Member of the European Parliament)

28 Mar 2025 · Urban Waste Water Treatment Directive

Meeting with Marta Temido (Member of the European Parliament)

25 Mar 2025 · Critical Medicines Act

Medicines for Europe calls for MDR overhaul to reduce regulatory burden

21 Mar 2025
Topic — EU evaluation of Medical Device Regulation's effectiveness for patient safety and market competitiveness.
Message — The organization requests clearer classification rules for drug delivery devices, defined notified body timelines, and streamlined evaluation processes to avoid duplication. They propose device master files similar to those for pharmaceutical ingredients and a coordination group for devices used with medicines.123
Why — This would reduce their compliance costs and development time by eliminating duplicate assessments.45
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Meeting with Christian Doleschal (Member of the European Parliament, Shadow rapporteur)

20 Mar 2025 · Revision der Vergaberichtlinien

Meeting with Piotr Müller (Member of the European Parliament, Rapporteur)

20 Mar 2025 · Evaluation of the Public Procurement Directives

Meeting with Olivier Chastel (Member of the European Parliament)

14 Mar 2025 · Politique de santé de l'Union européenne

Meeting with Pierre Jouvet (Member of the European Parliament, Shadow rapporteur)

13 Mar 2025 · marchés publics

Meeting with Ruggero Razza (Member of the European Parliament)

11 Mar 2025 · Incontro su CMA - draft report

Response to Evaluation of the Public Procurement Directives

6 Mar 2025

Medicines for Europe welcomes the opportunity to contribute to this call for evidence, as the revision of the Public Procurement Directive 2014/24/EU (PPD) provides a framework for the public procurement of medicines (PPM). The off-patent pharmaceutical sector is operating in a highly regulated pricing framework, which does not allow for the adjustment of prices to increasing costs (e.g. energy, transport inflation, legislation). Moreover, single-winner, price-only tenders exacerbate market consolidation, particularly for EU Critical Medicines (9/10 generics). PPM can ensure timely patient access to off-patent medicines and address shortages, by bolstering competition. To ensure that the revision of the PPD achieves its objectives, it is essential to consider it along with ongoing legislative and non-legislative initiatives on PPM, including the forthcoming Critical Medicines Act and guidance on medicine procurement. This work should be included in the revision of the PPD, by issuing a delegated act to introduce tailored rules for the medicines sector. Medicines for Europe urges the Commission to consider the specific concerns pertinent to the sector of medicines in the revision of the PPD: 1) The PPD should make the application of the MEAT award criteria mandatory in PPM tender design to boost competition in the off-patent sector. Despite the reference to MEAT criteria in the PPD, their actual adoption remains slow. Up to 84% of awarded pharmaceutical contracts are based solely on price, according to the Commission study on best practices in PPM. Mandatory MEAT criteria would incentivise manufacturers to invest in supply security and environmental sustainability and improve the availability of medicines. Exemption to this rule should be possible, with justification provided by contracting authorities. Although environmental criteria are not yet widely used, some countries, such as the Denmark and France have experience. Building a business case for clean production is also in line with the EU Competitiveness Compass. 2) To ensure supply security and prevent the consolidation of manufacturing and supply chains, the PPD should mandate the awarding of contracts to multiple suppliers in the case of PPM. In most countries, contracts are typically granted to a single winner, a practice that renders supply security highly vulnerable to potential disruptions experienced by the sole manufacturer. Furthermore, this approach disincentivizes other suppliers to staying active in the market and step in to address potential medicine shortages. To ensure a smooth roll-out, the exemptions to this rule should be foreseen, taking into account suppliers' ability to deliver, as there may be cases where only one active supplier is present. 3) To maximise participation in PPM tenders and secure viable bids from the off-patent industry, it is crucial to enhance demand predictability and foreseeability in tender design. This requires a lead time of at least six to nine months from contract signature to the first supply date, along with accurate volume estimates and a binding purchase obligation. Disproportionate penalties should be scrutinized and excluded from the bidding process. In addition, the PPD should allow for inflation price adjustment to balance price with supply security. Finally, termination reasons and notice periods should be properly regulated to prevent speculative behavior by either party, which could subsequently disrupt the supply chain or continuity of treatment. 4) While Article 69 of the PPD requires authorities to investigate abnormally low bids, the enforcement and execution of this provision is vague and subject to national implementation. To strengthen fair competition, the provision on investigation should be reinforced, the PPD should establish indicative criteria, on the basis of which contracting authorities assess the price/performance ratio of potential abnormally low bids, including prior tendering experience.
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Meeting with Vilija Sysaite (Cabinet of Executive Vice-President Stéphane Séjourné)

4 Mar 2025 · • Critical Medicines Act • Urban Wastewater Treatment Directive

Meeting with Gabriela Tschirkova (Cabinet of Commissioner Valdis Dombrovskis)

3 Mar 2025 · Urban Waste Water Treatment Directive

Meeting with Ulla Schwager (Head of Unit Competition)

3 Mar 2025 · Exchange of views on the future Critical Medicines Act

Medicines for Europe urges water strategy to protect pharmaceutical manufacturing

28 Feb 2025
Topic — EU strategy to ensure water resilience through management of scarcity and ecosystems.
Message — The organization requests that the Water Resilience Strategy considers the essential nature of pharmaceutical manufacturing and avoids measures that negatively impact medicine availability. They oppose policies like the Extended Producer Responsibility system, arguing it places disproportionate financial burdens on the generic medicines sector.123
Why — This would protect them from costly environmental compliance measures that threaten their business model.45
Impact — Environmental groups lose stronger polluter-pays principles for pharmaceutical wastewater contamination.6
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Medicines for Europe Demands Bold Reforms to Secure Critical Medicine Supply

26 Feb 2025
Topic — EU proposal addressing supply chain vulnerabilities and dependencies for critical medicines.
Message — The organization demands reformed State Aid frameworks to support off-patent medicines, mandatory procurement criteria prioritizing supply security over price, and dynamic pricing mechanisms that adjust for inflation. They call for a European solidarity stock system and strengthened global partnerships.1234
Why — This would unlock investment for their manufacturing facilities and prevent pricing pressures that make products unprofitable.567
Impact — Member states pursuing lowest-price procurement lose flexibility to national healthcare cost-containment strategies.8
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Meeting with Ulla Schwager (Head of Unit Competition)

25 Feb 2025 · Exchange of views on Pharma & IP Legislation Reform & possible anti-competitive practices in the pharmaceutical sector

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

20 Feb 2025 · Preparation of participation of Olga Solomon in the Medicines for Europe Regulatory and Scientific Affairs Conference. Exchange of views on the reform of the General Pharmaceutical Legislation.

Medicines for Europe urges EU-wide reforms to pharmaceutical supply chains

31 Jan 2025
Topic — The consultation concerns developing a single market for global competition and services.
Message — Medicines for Europe proposes strengthening a European Solidarity Mechanism to allow medicine reallocation. They call for a dedicated EU public procurement framework for supply security. The group also urges a review of the SPC manufacturing waiver regulation.123
Why — This would lower operational costs and improve competitiveness against non-European pharmaceutical producers.45
Impact — Patients currently lose out when national rules trap medicines in warehouses during shortages.6
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Meeting with Olivér Várhelyi (Commissioner) and

29 Jan 2025 · Exchange of views on EU health policy

Meeting with Vlad Vasile-Voiculescu (Member of the European Parliament)

28 Jan 2025 · Introductory Meeting

Meeting with Oliver Schenk (Member of the European Parliament)

28 Jan 2025 · European Health Union

Meeting with Tomislav Sokol (Member of the European Parliament) and GSK and

28 Jan 2025 · Health Policy

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

17 Dec 2024 · critical medicines act

Meeting with Tilly Metz (Member of the European Parliament, Shadow rapporteur)

26 Nov 2024 · Pharmaceutical policy

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

24 Oct 2024 · New EU Pharmaceutical Legislation

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

16 Oct 2024 · EU pharmaceutical reform

Meeting with Tomislav Sokol (Member of the European Parliament) and EUROPEAN ORGANISATION FOR RARE DISEASES

17 Sept 2024 · Health policy

Medicines Industry Seeks Flexible MDI Labeling Rules and Extended Timeline

3 Jun 2024
Topic — EU implementing regulation on labeling requirements for products containing fluorinated greenhouse gases.
Message — The organization requests flexible labeling options for metered dose inhalers, allowing information in package leaflets or digital format rather than outer packaging. They seek extended implementation timeline beyond January 2025 and EMA guidance on incorporating fluorinated gas labeling requirements.123
Why — This would avoid space constraints on small MDI packaging and give more time for complex approval processes.45
Impact — Patients lose immediate transparency about greenhouse gases in their inhalers if delays are granted.6
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Meeting with Maurits-Jan Prinz (Cabinet of Commissioner Thierry Breton)

18 Apr 2024 · Supplementary protection certificates

Medicines for Europe and Canadian partners assess CETA pharmaceutical impact

12 Apr 2024
Topic — EU-Canada trade agreement evaluation after five years of provisional application focused on pharmaceuticals.
Message — The organizations support mutual GMP recognition and call for reciprocal acceptance of foreign comparators and joint efforts to advance single development programs. They argue cooperation is crucial to avoid study duplications and cut development inefficiencies.123
Why — This would reduce their development costs by eliminating duplicate clinical studies across jurisdictions.45
Impact — Patients lose timely access to affordable medicines due to extended patent monopolies.6
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Medicines for Europe warns against ECHA control over pharmaceutical data

14 Mar 2024
Topic — EU regulation establishing a common data platform for chemicals safety data.
Message — The organization requests that pharmaceutical safety assessments remain under EMA control, not ECHA. They seek harmonization with ongoing pharmaceutical legislation revisions and clarification on avoiding duplicate submissions. They emphasize protecting proprietary data confidentiality.123
Why — This would prevent duplicate regulatory assessments and protect their proprietary pharmaceutical data.45
Impact — Broader chemical safety oversight loses access to pharmaceutical environmental and toxicity data.6
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Response to Revision of the variation framework for medicines

29 Feb 2024

Medicines for Europe welcomes the opportunity to comment on the EC proposal to revise the Variations Regulation 1234/ 2008. The current regulatory framework for maintaining products on the market needs to continue evolving to better reflect scientific progress and operational efficiency to reduce administrative burden for companies and authorities. We welcome some improvements in efficiency and in streamlining of regulatory processes but at the same time we have identified some issues with the proposal not leading to optimisation. Medicines for Europes main recommendations to amend the EC draft proposal (detailed contribution in the Annex) include: 1. Reporting of Type IA variations: o No support for mandatory Annual report for type IA variations if not submitted together with other variations. o It shall be still allowed to submit a stand-alone Type IA variation (not only as a part of annual report, grouping or super-grouping) - Possible exemptions are very unclear and will trigger a lot of unnecessary interactions/ discussion with CAs on granting/ non-granting this exemption o Implementation of change prior to a Type IA variation submission shall not be obligatory but shall be an option. Type IA Variations could be notified before, up to 12 months, or later if duly justified, following implementation. 2. Mandatory Worksharing for the Applicant o We understand the CMDh/ NCAs position in favour of mandatory worksharing due to resources management. However, if worksharing is mandatory for the applicant, it shall be also mandatory for the NCAs to accept the role of the RMS to avoid delays in the worksharing procedure. Companies have already experienced difficulties in receiving positive replies from some MSs. Possibility for a MS to refuse the role of RMS will create an additional step for the applicant to search for MS who is willing to accept a leading role in worksharing procedure. o All NCAs should accept to be the lead RMS (if requested) and availability of a lead RMS should not delay the start of the worksharing procedure. 3. For type IA variations, in case of minor issues identified in the documentation, the applicant shall be able to provide any minor amendments or minor documents to the application up to day 25. This flexibility ensures that minor issues do not lead to rejection of variation including the impact on implemented changes and unnecessarily delay the variations process. - Possibility to group variations when these are consequential to the leading variation or related to the same section of the dossier, to be covered as one single type II umbrella variation shall be added. - The current 45-day timeline for issuing a recommendation in accordance with Art. 5 for unforeseen changes should be kept. - In order to reduce administrative burden, variations impacting only one member state should only be submitted and assessed by the member state concerned. After approval, the other member states included in the procedure will be informed. - Digitalisation - although we fully understand that full digitalisation of the variations process will be only possible after the revision of the main Pharmaceutical legislation, the on-going revision of the Variations Regulation shall not exclude a possibility to use SPOR OMS to limited extend. It should be an open possibility in the legislation to submit changes via database once the system is ready to be used (e.g. like in case of QPPV or PSMF changes possible already via Article 57 - database). The decision about moving in this direction will be anyway taken by the Competent Authorities thus, there is no risk for authorities but an opportunity to take advantage of a database like SPOR at the earliest possibility (if possible) and open the regulation for extended database usage in the next revision after the Pharma Review is finalized. Annex II some suggestions are proposed in a detailed document attached to the submission
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Meeting with Dolors Montserrat (Member of the European Parliament)

16 Feb 2024 · Revision of the pharmaceutical legislation

Meeting with Adam Jarubas (Member of the European Parliament) and European Federation of Pharmaceutical Industries and Associations and

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

Meeting with Nicola Danti (Member of the European Parliament)

25 Jan 2024 · Revisione pacchetto farmaceutico

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and Novo Nordisk A/S and EuropaBio

22 Jan 2024 · Directive on Medicinal products for human use

Meeting with Aldo Patriciello (Member of the European Parliament)

29 Nov 2023 · Pharma strategy

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

13 Nov 2023 · Pharmaceutical Package (Regulation)

Meeting with Adrián Vázquez Lázara (Member of the European Parliament, Shadow rapporteur)

8 Nov 2023 · Unitary SPC

Meeting with Deirdre Clune (Member of the European Parliament) and Novartis International AG

7 Nov 2023 · Pharmaceutical Package

Meeting with Dolors Montserrat (Member of the European Parliament) and Novartis International AG

6 Nov 2023 · Revision of the pharmaceutical legislation

Meeting with Stelios Kympouropoulos (Member of the European Parliament)

27 Oct 2023 · discussion on the General Pharmaceutical Package revision

Meeting with Sirpa Pietikäinen (Member of the European Parliament)

27 Oct 2023 · Pharmaceutical Package

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

27 Oct 2023 · Directive on Medicinal products for human use

Meeting with Tiemo Wölken (Member of the European Parliament)

25 Oct 2023 · Pharma Revision (staff level)

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

25 Oct 2023 · Medicines

Meeting with Tiemo Wölken (Member of the European Parliament) and BioNTech SE and Moderna, Inc.

18 Oct 2023 · Pharma Revision - Directive (staff level)

Meeting with Mohammed Chahim (Member of the European Parliament)

16 Oct 2023 · Pharmaceutical Strategy

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

6 Oct 2023 · SPC Medicinal Products (staff level)

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

5 Oct 2023 · Meeting with Medicines for Europe on tackling medicines shortages.

Meeting with Sirpa Pietikäinen (Member of the European Parliament)

4 Oct 2023 · Pharmaceutical package

Response to Evaluation and revision of the general pharmaceutical legislation

29 Sept 2023

Medicines for Europe, representing manufacturers of generic, biosimilar and value added medicines across Europe, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe covering 80% of therapeutic areas, we fully share the goals of ensuring that all patients across the EU have timely and equitable access to safe, effective and affordable medicines, through better competition, a more efficient regulatory system and a framework conducive e to manufacturing and continuous innovation. Focusing on the provisions of the Regulation, we would stress the importance of: 1. Ensuring predictability and legal certainty to prevent delays in access to generic and biosimilar medicines, by rejecting the proposed transferable exclusivity vouchers for novel antimicrobials. The vouchers would lead to the extension of monopolies on the most profitable blockbuster drugs, thus breaking the founding principle of the relationship between innovation and reward, unduly delaying patient access to the more affordable off-patent products and dramatically increasing costs for healthcare budgets. To address the AMR challenge, instead of transferring the costs of funding antimicrobials to patients with already limited and unequitable access to blockbuster drugs, Europe should establish a Union multi-country pull incentive scheme to improve innovation, development and access to both novel and existing antibiotics, such as the revenue guarantee mentioned both in the December 2021 and June 2023 EPSCO Council Conclusions. 2. Establishing a clear European strategy to prevent and mitigate shortages. We support the proposed harmonised definitions of shortages and critical medicinal products, but are concerned about extending shortage notifications from 2 to 6 months which would lead to shortage false alarms as happened in Italy and Canada. Instead, a single digitalised and automated reporting system would allow marketing authorisation holders to report shortages as soon as they are aware, without placing an unnecessary burden on either them or the competent authorities. We support the introduction of shortage prevention plans with a risk-based approach, based on a single coherent list of critical medicines or essential medicines with no alternatives to avoid the generation of countless resource-intensive and unnecessary reports, instead allowing manufacturers to focus their resources on preventing and mitigating actual shortages. 3. Ensuring an efficient regulatory system that delivers on medicine availability. While the proposal already foresees several key provisions to optimise regulatory operations, including a shortened marketing authorisation (MA) procedure from 210 to 180 days, it would be critical to ensure the possibility for generic, hybrid and fixed dose combination products marketing authorisations applicants to choose between the centralised and the decentralised procedure. Moreover, removing the requirement for generic and biosimilar manufacturers to duplicate packaging and brand names for use patents by better adapting labelling to the use patent landscape and avoiding confusion among patients due to duplicate MA applications. We are ready to continue the dialogue with the co-legislators, the Commission, patients and other stakeholders to improve medicines availability, accessibility and affordability and achieve an open strategic autonomy in healthcare.
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Response to Evaluation and revision of the general pharmaceutical legislation

29 Sept 2023

Medicines for Europe, representing manufacturers of generic, biosimilar and value added medicines across Europe, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe across 80% of therapeutic areas, we fully share the goals of ensuring that all patients in the EU have timely and equitable access to safe, effective and affordable medicines, through better competition, an efficient regulatory system and a framework conducive to manufacturing and continuous innovation. Focusing on the Directive, we would stress the importance of: 1. Ensuring predictability and legal certainty to prevent delays in access to generic and biosimilar medicines, by: a) clarifying the Bolar provision to allow immediate day-1 competition after IP expiry, through the inclusion of the supply of EU produced APIs for obtaining marketing authorisations (API supply, offer, export, manufacturing) and all necessary regulatory and administrative steps (MA/P&R list/tender bids); b) modulating market protection rather than data protection, to ensure that in case the originator manufacturer does not supply the product to all EU markets, generic or biosimilar medicines would be approved in time to supply the underserved markets; c) ensuring the cumulative data and market protection period does not exceed the current 11-year cap. 2. Establishing a clear European strategy to prevent and mitigate shortages, by: a) increasing the visibility and transparency of the supply chain through a single interoperable reporting system, leveraging existing data sources like the European Medicines Verification System; b) allowing faster pan-European implementation of electronic product information, starting with hospital products, thus enabling faster reallocation of medicines across Member States. 3. Ensuring an efficient regulatory system that delivers on medicine availability. The proposal already foresees several key provisions to optimise regulatory operations but we still see areas where optimisation can go further to ensure faster patient access to affordable treatments by: a) avoiding limiting the mutual recognition procedure within a year of MA granting b) offering a pragmatic path for the national competent authorities to opt-in national procedures by allowing them to recognise for public health reasons the MA procedure within 5 days after the procedure has been closed c) ensuring a greater flexibility in choosing the marketing authorisation route d) adjusting the ownership of the ASMF to the legal entity that has ultimate responsibility for the ASMF. 4. Adopting a science-driven and risk-based environmental risk assessment (ERA) to reduce the environmental footprint while safeguarding patient access. We support the development of a streamlined process for referencing originator ERA for generic, biosimilar and fixed-dose combination products in order to avoid unnecessary duplication of efforts and delays in access to medicines. In addition, we recommend: a) ensuring that post-MA ERA condition is sufficient for authorisation of products where ERA is not (yet) available b) adopting AMR-related measures for products with a confirmed high risk of developing resistance. 5. Supporting affordable innovation to address patient needs via a clear pathway for value added medicines. The proposal recognises the importance of repurposed value added medicines with a non-cumulative 4-year data protection. We recommend including in the scope all relevant changes which deliver significant benefit to patients, such as repositioning, reformulation and complex combinations, while ensuring the article is not misused for evergreening practices. We are ready to continue the dialogue with the co-legislators, the Commission, patients and other stakeholders to improve medicines availability, accessibility and affordability and achieve an open strategic autonomy in healthcare.
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Meeting with Catherine Amalric (Member of the European Parliament, Shadow rapporteur)

27 Sept 2023 · Reform of the EU pharmaceutical legislation

Medicines for Europe Urges Slashing Red Tape in Pharma Rules

26 Sept 2023
Topic — This consultation reviews procedures for post-authorisation changes to medicines for human use.
Message — They propose streamlining the variations system by grouping related changes and introducing silent approvals. The industry also requests that minor changes affecting one state be handled solely by that country.12
Why — These changes would lower compliance costs and prevent medicine shortages caused by bureaucratic delays.34
Impact — National regulators may lose direct oversight of changes that no longer require their explicit prior approval.5
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Medicines for Europe calls for safeguards in new SPC system

18 Sept 2023
Topic — Regulation on supplementary protection certificates for plant protection products and pharmaceuticals.
Message — The organization requests a 14-year maximum exclusivity period, qualified examiners, pre-grant opposition proceedings, and transparent SPC registers. They emphasize preventing litigation strategies and ensuring access to affordable medicines.123
Why — This would reduce their litigation costs and enable earlier generic market entry.45
Impact — Originator pharmaceutical companies lose extended monopoly periods and face earlier generic competition.67
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Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and Bundesverband der Pharmazeutischen Industrie e.V.

6 Sept 2023 · Directive on Medicinal products for human use

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

31 Jul 2023 · Revision of the Pharmaceutical Legislation (staff level)

Medicines for Europe urges voluntary licensing over compulsory measures

28 Jul 2023
Topic — EU proposal to harmonize compulsory patent licensing procedures for crisis management.
Message — The organization requests that compulsory licensing remain exceptional and be used only as a last resort. They advocate for strengthening voluntary licensing mechanisms and adding provisions to address anticompetitive behavior that delays generic market entry.123
Why — This would preserve their voluntary licensing deals while enabling intervention against patent holders blocking generic competition.456
Impact — Patent holders lose leverage if anticompetitive patent practices can trigger compulsory licensing.78
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Meeting with Tomislav Sokol (Member of the European Parliament, Shadow rapporteur)

18 Jul 2023 · Pharmaceutical legislation

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

14 Jul 2023 · Pharma legislation

Meeting with Daphne Von Buxhoeveden (Cabinet of Commissioner Stella Kyriakides), Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides)

13 Jul 2023 · Meeting with Medicines for Europe on critical medicines

Meeting with Beatrice Covassi (Member of the European Parliament)

5 Jul 2023 · Drug accessibility and European health industrial policy

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur) and Eli Lilly and Company and

7 Jun 2023 · Medicines

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

7 Jun 2023 · Medicines Security Act

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

7 Jun 2023 · Unitary SPC - SPC Revision (staff level)

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

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

Medicines for Europe accepts pharmacovigilance fee increase amid inflation pressures

16 May 2023
Topic — Adjustment of EMA pharmacovigilance fees to reflect 2022 inflation rates.
Message — The organization accepts the fee increase while emphasizing that generic medicine manufacturers also face severe inflation. They argue that price adjustments for generic medicines are urgently needed to sustain supply.12
Why — This acknowledges their cost pressures while positioning them for future pricing negotiations.34
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Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

15 May 2023 · Medicines

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

2 May 2023 · Pharma legislation

Meeting with Pietro Fiocchi (Member of the European Parliament, Shadow rapporteur)

19 Apr 2023 · Packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC

Meeting with Tiemo Wölken (Member of the European Parliament) and GSK

3 Apr 2023 · EU-Health Policy (staff level)

Meeting with Stelios Kympouropoulos (Member of the European Parliament)

20 Mar 2023 · Upcoming pharmaceutical legislation

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

20 Mar 2023 · Pharma legislation

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

17 Mar 2023 · Revision of the Pharmaceutical legislation

Pharmaceutical Industry Opposes Transfer of Water Pollutant List Powers to Commission

14 Mar 2023
Topic — EU proposal to amend water quality directives and update surface and groundwater pollutant lists.
Message — The industry requests maintaining current legislative co-decision procedures rather than transferring power to adopt delegated acts to the Commission. They demand close collaboration between ECHA and EMA on pharmaceutical assessments and continued stakeholder involvement in working groups. They also request removal of the proposed groundwater standard for total pharmaceuticals.12345
Why — This would preserve their influence over pharmaceutical pollution standards and prevent stricter monitoring requirements.678
Impact — Environmental and public health advocates lose stronger protections against pharmaceutical pollution in water sources.9
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Response to Revision of the Urban Wastewater Treatment Directive

14 Mar 2023

Medicines for Europe, representing generic, biosimilar and value-added medicines industries across Europe, which supply 70% of dispensed medicines in Europe and cover 80% of the therapeutic areas, welcomes the opportunity to provide feedback on the proposal to revise the Urban Wastewater Treatment Directive (UWWTD). Our sector is engaged in efforts to reduce the environmental and climate footprint of the pharmaceutical industry through a science-based approach covering the entire lifecycle of medicine while ensuring equitable patient access to safe, effective and high-quality treatments. European Union policies to address pharmaceutical residues in the environment should be proportionate, based on scientific evidence, consider the public health impact and otherwise comply with European laws and principles. As outlined in the attached position paper, we believe that the proposal to revise the UWWTD fails to meet these requirements given that: the proposed extended producer responsibility (EPR) system is inconsistent with the established legal principles of conferral, subsidiarity and proportionality and further it does not address the established position that pharmaceutical legislation has prevalence over general legislation to ensure a high level of public health protection and the quality, safety and efficacy of authorised medicines; proportionality has not been properly assessed, since the scope of medicines that will be required to contribute to the EPR and the financial contribution to the water industry are undefined. This uncertainty makes the measure impossible to quantify; it does not cover other industrial sectors, despite acknowledgement within the feasibility study that other sectors also contribute to the presence of micro-pollutants in wastewater. The responsibility and financial burden for establishing additional wastewater treatment (quaternary treatment) and to stimulate an environmentally friendly environment has to be distributed between all relevant actors. The proposal should not have been based on a discriminatory and arbitrary selection of sectors; it is based on a feasibility study and impact assessment with clear methodological flaws, due to: the inaccurate and limited scientific evidence of environmental impact from the pharmaceutical sector and other industrial sectors, the absence of an assessment on the feasibility of replacing current medicines with alternative molecules (no evidence is presented to demonstrate that there are alternatives available to replace active pharmaceutical ingredients (APIs) without compromising safety and efficacy) and the vastly underestimated effect on the off-patent pharmaceutical industry, which supplies life-saving products in high volumes and at low-profit margins. As medicine prices are strictly regulated on the Member State level in the EU, manufacturers are not at liberty of introducing price increases even if the cost of manufacturing rises. Therefore, the proposals suggestion for the recuperation of EPR costs through increasing the product price is irrelevant; it will jeopardise patient access to critical, safe and affordable medicines by threatening the viability of manufacturing several generic molecules, which can potentially lead to withdrawals of products from the market. Therefore, Medicines for Europe calls on the EU Council and Parliament to re-evaluate the legal basis of the proposal and the associated economic and public health impact before moving forward with any discussions. All alternative options for supporting the set-up and the operations of the quaternary treatment by distributing the responsibility and financial burden among all relevant actors should be explored and measures that consider the specificities of the pharmaceutical sector, particularly off-patent manufacturing, should be applied to avoid unintended consequences on patient access to safe and affordable medicines.
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Meeting with Cristian-Silviu Buşoi (Member of the European Parliament, Rapporteur)

8 Mar 2023 · EMA Fees Regulation

Response to Revision of EMA fees

7 Feb 2023

Medicines for Europes comments of the EMA fees regulation. Medicines for Europe supports a cost-based EMA fee system with a simpler fee structure. For generic medicines with very low margins, regulatory costs can be critical to maintain older products (with low to zero profitability) or supply products to small markets. Generic medicines fees must remain reasonable and affordable to avoid withdrawals of older essential medicines from the market due to regulatory costs. Key requests of Medicines for Europe: - Ensure adequate distribution of fees between the EMA and National Competent Authorities (NCAs). While Industry can hardly assess how fair a fee sharing proposal between the EMA and NCAs is, we support a fair distribution of funds, accounting for the time and expertise NCAs provide to EMA activities. Moreover, the EMA's fee system should not harm the allocation of NCAs resources to national regulatory processes (i.e. DCP/MRP) and should not transfer the cost of missing income from EMA fees onto fees at the national level. - Reduction of scientific advice fees is welcomed but should not negatively impact its quality/accessibility and the NCAs experts motivation to engage in advising. The right distribution of fees between the EMA and NCAs is therefore crucial. - Maintain initial generic application fees at the proposed level The initial generic medicine application fees (141k) seem to adequately reflect the actual workload involved in assessing generics compared to NCEs/full dossiers, and therefore the cost-based principles. The EC Pharma package should simplify the assessment of generic medicines, reducing assessors time. - Reduce the generic medicines Pharmacovigilance annual fees from current 20% to minimum 50% The too high (2,5-fold) increase in annual PhV fees despite no recent notable increase in PhV activities will lead to significant and disproportionate increase in fees for generic medicines producers. It is also unjustified: a cost-based fee system requires a clear breakdown of these costs, detailing what these annual PhV fees will fund, and the revision of PhV should legally be based on transparent and independent evaluation. If the massive PhV fees increase will fund investments in IT infrastructure and/or in the analysis of real word/health data to enable better decision-making process and support innovation, it should be a separate category of fees, funded proportionally by the main beneficiaries users (not mainly by generic medicine companies). - Clarify financing of investments in IT infrastructure, data analysis, and regulatory optimisation activities (I.e. SPOR-IDMP and interoperable IT systems across the Network) - Adjust biosimilar medicine application fees Initial biosimilar medicines application fees significantly increase (200k to 575k: nearly 3-fold increase). The move towards abandoning comparative clinical trials/extensive clinical data package should adjust biosimilar medicine application fees to a level of 450k (closer to fixed dose combination than to New entity) if clinical comparability studies are provided and reduced to around 400k where the data package no longer includes any extensive comparative study. - Other The EMA fee regulation should be part of a larger systemic reform towards regulatory optimization, based on streamlined, time-efficient and less resource consuming regulatory processes for EMA, NCAs and companies, which we trust the new Pharma Package to address appropriately. EU contribution to public health should lead to an increased contribution from the EU towards the EMA budget, notably to cover expenses of the EU Network functioning unrelated to products/procedures. EMA and NCAs expectations of a mechanism taking account of inflation should go together with indexation of medicines prices at MS level out of the scope of this regulation, but support from NCAs and EMA in discussions with payers would be welcome.
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Meeting with Dolors Montserrat (Member of the European Parliament, Rapporteur)

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

Meeting with Maurits-Jan Prinz (Cabinet of Commissioner Thierry Breton)

10 Nov 2022 · will follow

Meeting with Maurits-Jan Prinz (Cabinet of Commissioner Thierry Breton)

10 Nov 2022 · EU strategic autonomy for the production of active pharmaceutical ingredients

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

9 Nov 2022 · Exchange of views on the pharma reform

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

9 Nov 2022 · Pharma strategy

Medicines for Europe urges trade reforms to boost generic drug access

16 Sept 2022
Topic — EU developing a renewed global health strategy to strengthen leadership in global health.
Message — The organization requests increased regulatory harmonization through mutual recognition agreements and single development programs for generics. They want balanced intellectual property rules in trade negotiations and cooperation to strengthen supply chain resilience.123
Why — This would reduce duplicative studies and facilitate faster market access for their products.45
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Medicines for Europe calls for customs rules protecting generic medicine flow

14 Sept 2022
Topic — Reform of EU customs legislation to address e-commerce, risk management and internal market protection.
Message — The organization requests protection for legal generic medicine transit and coordination during crises. They want green lanes for pharmaceutical freight and harmonized application of medicine exemptions from sanctions.123
Why — This would ensure their products continue flowing across borders without delays or confusion with counterfeits.45
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Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur) and Biogen

30 Jun 2022 · Generics

Meeting with Margaritis Schinas (Vice-President) and

30 Jun 2022 · Pharma strategy

Meeting with Maurits-Jan Prinz (Cabinet of Commissioner Thierry Breton)

27 Jun 2022 · Health industrial ecosystem and supply chains

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

12 May 2022 · Generics

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

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

Medicines for Europe opposes inflation-linked fee increases for generics

28 Apr 2022
Topic — Adjustment of EMA pharmacovigilance fees to account for 2020-2021 inflation rates.
Message — The organization opposes adjusting monitoring fees in line with inflation, arguing that off-patent medicine prices cannot be raised accordingly due to strict price regulations and price-driven tendering.12
Why — This would prevent additional cost burdens while their product prices remain fixed.34
Impact — EMA and national authorities lose funding needed to maintain pharmacovigilance capacity.
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Medicines for Europe Urges Priority for Voluntary Patent Licensing

27 Apr 2022
Topic — EU initiative to harmonize compulsory patent licensing procedures for cross-border crisis management.
Message — The organization believes voluntary agreements are the best way to tackle health crises. They argue that compulsory licensing should remain an exceptional, last-resort measure used primarily for anti-competitive practices.12
Why — This would allow their members to secure industrial incentives and EU funding for manufacturing.3
Impact — Public health authorities might find it harder to mandate drug production during emergencies.4
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Meeting with Stella Kyriakides (Commissioner) and

26 Apr 2022 · Meeting with representatives of Medicines for Europe

Meeting with Margaritis Schinas (Vice-President) and

26 Apr 2022 · Pharma Strategy

Meeting with Maurits-Jan Prinz (Cabinet of Commissioner Thierry Breton)

24 Apr 2022 · Supply security & production capacity for critical medicines and ingredients

Medicines for Europe urges centralized SPC litigation to cut costs and delays

4 Apr 2022
Topic — EU reform of supplementary protection certificates for pharmaceuticals and agrochemicals.
Message — The organization demands that any SPC reform must prioritize eliminating multiple national litigation and conflicting court decisions. They call for a unified litigation system before the Unified Patent Court, pre-grant opposition mechanisms, and strict safeguards including accountability measures for granting bodies. They argue the current reform proposal ignores the core problem of fragmentation in enforcement.123
Why — This would reduce litigation costs and enable faster market entry for generic and biosimilar medicines.45
Impact — Patients in eight EU countries lose earlier access to affordable treatments currently available at patent expiry.67
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Generic medicine industry seeks pricing reforms to combat antibiotic shortages

23 Mar 2022
Topic — EU Council recommendation on strengthened actions against antimicrobial resistance.
Message — The industry requests pricing and procurement reforms to ensure sustainable antibiotic supply, incentives for environmentally responsible manufacturing, and recognition of value-added innovation in existing antibiotics. They strongly oppose transferable exclusivity vouchers that would extend monopolies and delay generic access.123
Why — This would protect their market position and prevent price erosion from extreme cost-containment measures.45
Impact — Healthcare systems lose potential savings from delayed generic entry on profitable blockbuster medicines.67
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Generic drug industry backs EU measures for Northern Ireland medicine supply

15 Mar 2022
Topic — EU regulation changes to maintain medicine supplies to Northern Ireland post-Brexit.
Message — The organisation requests approval of measures allowing manufacturers to continue supplying medicines to Northern Ireland from Great Britain, maintain single packaging, and choose between EU and UK authorisation procedures. They emphasise the importance of MHRA issuing UK-wide marketing authorisations and clarity on packaging requirements.12
Why — This would avoid costly relocation of testing facilities and separate packaging for different markets.3
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Medicines for Europe backs EU derogations for Northern Ireland supply

15 Mar 2022
Topic — Directive amending rules for medicines supplied to Northern Ireland and dependent EU markets.
Message — The organization supports EU measures allowing continued medicine supply from UK to Northern Ireland with single packaging. They seek automatic extension of derogations if the Northern Ireland Protocol is extended.12
Why — This avoids costly facility relocation and separate packaging for different UK regions.34
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Meeting with Sandra Gallina (Director-General Health and Food Safety)

21 Jan 2022 · Exchange of views on the role of the generic and bio-similar industry under the EU pharmaceutical strategy.

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

26 Oct 2021 · Exchange of views on the upcoming revision of the pharmaceutical legislation and the Health Union

Meeting with Margaritis Schinas (Vice-President) and

8 Oct 2021 · Pharma Strategy

Response to Commission Implementing Regulation on EUDAMED

21 Jun 2021

We thank you for the opportunity to provide comments in this public consultation Please find our detailed feedback as comments in the attached file.
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Meeting with Margaritis Schinas (Vice-President) and

16 Jun 2021 · Supply chains for medicines

Meeting with Stella Kyriakides (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

7 Jun 2021 · VTC meeting - Access to Medicines

Response to Evaluation and revision of the general pharmaceutical legislation

22 Apr 2021

Medicines for Europe represents manufacturers of off-patent medicines supplying close to 70% of dispensed prescription medicines in Europe. The pharmaceutical legislation should foster access to follow-on off-patent medicines on day-1 after IP expiry by extending the scope and harmonising the Bolar exemption to cover API supply and all administrative steps needed to effectively launch generic/biosimilar medicines. The legislation should also ban patent linkage – a major cause of generic/biosimilar entry delays, which the EC considers anti-competitive and “unlawful”. While incentives have generated some success, they should not go beyond their legally defined public objective and abuses/misuses that delay generic/biosimilar competition should be tackled. To encourage competition, access and sustainable innovation, there should be incentives and regulatory reforms to encourage the development of follow-on orphans and off-patent paediatric products. In addressing AMR, there should be market reforms to ensure the availability of critical older off-patent antibiotics and encourage value added innovation. Value added medicines (VAM) are an opportunity for continuous innovation on off-patent molecules for unmet medical needs, e.g. reformulation of off-patent antibiotics to tackle AMR, repurposing in oncology. To encourage this innovation, the pharmaceutical legislation should recognise VAM as a separate category of innovation with proportionate incentives. The regulatory system needs to be updated to keep a resilient off-patent sector by: • The use of telematics tools for regulatory efficiency • short and predictable timelines • adapting to new digital or technological developments Single global development is a key enabler of efficient generic drug development and the unethical duplication of studies in humans. It is important to tailor regulatory pathways for maintenance, approvals and regulatory learnings as well as enabling multi-source competition at loss of exclusivity of the reference drug. Amendments to the Variations Regulation and Variations Classification guidelines are needed to reflect the science and telematics tools to optimise the regulatory process, avoid duplication and enable a faster reaction to shortages or emergencies (via Target Operating Model). Current limitations to broader use of the CP, DP and RUP should be removed. To prevent continued consolidation of the market and manufacturing, supply chain resilience should be strengthened via procurement reform that includes criteria other than price and encourages multiple manufacturers to supply the market. Imposing stronger obligations to supply and subsequent penalties will increase demands on manufacturers with no reward thus increasing consolidation. Any stockpiling of medicinal products must be done rationally: clear demand, financing and management of the stockpile, preventing strain on manufacturing capacities and potential wasteful disposal of unused medicines. Uncoordinated national stockpiling demands should be rejected as this will fragment the internal market, increase costs and undermine EU solidarity. To address the environmental impact of medicines manufacturing and disposal, policies should look at the life cycle of the medicine. Establishing a central EMA ERA database containing all available ERA data submitted by MAHs can identify missing environmental data gaps considering science and risks, and prevent unnecessary duplication. Beyond medicines manufacturing, introduction of e-Pi would bring not only environmental benefits but also greater supply flexibility in a crisis.
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Meeting with Salvatore De Meo (Member of the European Parliament)

19 Apr 2021 · Various

Meeting with Stella Kyriakides (Commissioner) and BUSINESSEUROPE and European Federation of Pharmaceutical Industries and Associations

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

Medicines for Europe seeks seat on HERA Board and supply chain reforms

24 Feb 2021
Topic — Proposal to establish European Health Emergency Response Authority for coordinated health crisis response.
Message — The organization requests industry representation on the HERA Board and legal framework for voluntary cooperation during shortages. They call for improved data analysis, robust modeling for inventory planning, and a structured process to assess emergency medicines lists. They demand financial incentives for manufacturing capacity and regulatory reforms encouraging maintenance of older medicines.1234
Why — This would reduce their compliance burden and secure financial incentives for maintaining idle manufacturing capacity.56
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Medicines for Europe Warns Against Joint Procurement for Generic Medicines

2 Feb 2021
Topic — EU regulation on cross-border health threats and emergency medicine procurement mechanisms.
Message — The organization opposes joint procurement for generic medicines, citing COVID-19 ICU medicine procurement failures. They request exclusivity clauses, transparent tender processes, and volume commitments. They also call for a coordinated EU medicine reserve with clear cost responsibilities and rolling reserves to prevent waste.1234
Why — This would prevent inventory blockage and reduce financial risks from unused stockpiles.56
Impact — Patients risk medicine shortages when parallel procurement creates supply chain stress and volatility.78
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Medicines for Europe urges stronger ECDC coordination on medicine supply forecasting

2 Feb 2021
Topic — Reform of the European Centre for Disease Control mandate following COVID-19 response.
Message — The organization requests that ECDC provide useable epidemiological forecasts to help pharmaceutical companies plan manufacturing and supply capacities for medicines. They emphasize the need for strengthened coordination between Member States, EU institutions, agencies, and industry stakeholders during health crises.123
Why — This would enable them to avoid conducting their own costly epidemiological research during crises.45
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Medicines for Europe calls for harmonized EU shortage reporting system

2 Feb 2021
Topic — EU regulation strengthening the European Medicines Agency's role in health crisis management.
Message — The organization requests a harmonized digital reporting system for medicine shortages across EU member states, built on common definitions and data fields. They want reporting at national level with aggregated data shared to EMA, compliance with ISO IDMP standards, and active collaboration between agencies and manufacturers during crises.123
Why — This would reduce their administrative burden by avoiding duplicate manual reporting and human errors.45
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Medicines for Europe seeks limits on orphan drug monopolies

21 Dec 2020
Topic — EU review of incentives for medicines treating rare diseases and children.
Message — The organization requests preventing companies from combining orphan and paediatric incentives to delay competition. They want explicit exclusion of generics and biosimilars from orphan 'similar product' definitions after ten years. They also seek pull incentives for off-patent paediatric medicines and oppose transferrable exclusivity vouchers.1234
Why — This would allow their generic and biosimilar products to enter markets faster after exclusivity periods expire.567
Impact — Originator pharmaceutical companies lose extended monopoly periods and additional exclusivity protections for orphan drugs.8910
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Meeting with Kim Jorgensen (Cabinet of Executive Vice-President Margrethe Vestager)

13 Nov 2020 · Upcoming Pharmaceutical strategy, links to digital technologies, data and competition.

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 Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides)

6 Nov 2020 · Covid-19

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

6 Nov 2020 · COVID-19

Medicines for Europe: Greek pharma reforms failed to boost generics

29 Oct 2020
Topic — Ex post evaluation of Greece's economic adjustment programmes from 2010 to 2018.
Message — The organization argues that pharmaceutical reforms failed to achieve objectives like increasing generic penetration and controlling spending. They highlight that extreme price cuts and clawback mechanisms drove affordable medicines out while newer expensive products entered, and call for structural reforms addressing prescription control and unnecessary consumption of new medicines.123
Why — This would reduce their clawback payments and create a more predictable business environment for generic manufacturers.45
Impact — Patients face higher out-of-pocket costs as affordable generics exit and expensive medicines dominate the market.67
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Meeting with Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides)

27 Oct 2020 · Medicines for Europe - Exchange of views on the upcoming Pharmaceutical Strategy.

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

27 Oct 2020 · Pharma Strategy

Meeting with Giorgos Rossides (Cabinet of Commissioner Stella Kyriakides), Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides) and European Federation of Pharmaceutical Industries and Associations

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

Meeting with Thierry Breton (Commissioner) and

20 Oct 2020 · Production capacity of generic medicines in the EU

Meeting with Stella Kyriakides (Commissioner) and

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

Meeting with Stella Kyriakides (Commissioner)

17 Jul 2020 · Exchange of views on the upcoming Pharmaceutical Strategy

Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

6 Jul 2020

To deliver equitable patient access to medicines and contribute to healthcare system sustainability, the pharmaceutical strategy should prioritise sustainable economic, regulatory and industrial off patent medicines policies. Generic, biosimilar and value added medicines (almost 70% of EU prescription medicines) are critical to access and to public health, as demonstrated by our industry’s role in dramatically increasing the supply of medicines for Covid-19. To align public health and industrial policy agendas, the strategy will need to be based on a structured dialogue between industry, supply chain actors and the EU Institutions and national authorities. Paying lip service to transparency will not suffice. A sound functioning of the internal market can be achieved by promoting healthy competition, removing barriers that delay off-patent medicines market entry at loss of exclusivity, allowing for rapid and sustainable uptake of medicines with robust policy frameworks. For biosimilar medicines, efforts should target countries or segments where biosimilar uptake is low. In fields of high unmet need such as orphan diseases, the removal barriers to follow-on competition, the need to harmonised rules such as the Bolar Directive and an EU ban on patent linkage are essential to grant access to therapies for more patients. To reinforce the mechanisms for cooperation and coordination between regulatory authorities, it should boost the optimisation of regulatory system to focus finite resources on access. Concretely, this includes the implementation of the European Network telematic strategy; the reduction of redundant administration (amend variations regulation); shifting resources to essential tasks such as regulatory oversight and plant inspections; the implementation of electronic product information and the simplification multilingual packs. Regarding the availability of medicines, the EU should address the root causes of medicines shortages, which are economic (price-only procurement criteria; reference pricing policies; clawback policies; arbitrary price-cuts), high regulatory burden (Falsified Medicines Directive implementation; Brexit), unforeseen surges in demand (as experienced during COVID-19). By securing existing and encouraging new investments in off-patent medicine manufacturing, EU policies should cover public sustainable procurement practices, pharmaceutical regulation, new pricing models and reimbursement (via Transparency Directive) and state aid should secure and incentivise investment in supply reliability and in high-technology medicines manufacturing in Europe at national level while stimulating multi-source medicine competition at expiry of exclusivities.The COVID-19 outbreak has demonstrated the resilience of the European off-patent medicines industry which was able to massively scale up supply to address demand surges. Therefore, the strategy should support the global competitiveness of the industry by building on existing pharmaceutical manufacturing capacity (over 400 off-patent medicines manufacturing sites in EU) to further increase security and resilience of supply. It should also create strong incentives for finished products and API in Europe while rejecting national protectionism that would undermine the Internal Market and European solidarity. Supply chain resilience and regulatory cooperation should also be part of a new medicines trade agenda based on security, access and mutual openness with key trading partners. Advancing single global development of generic and biosimilar medicines is also of critical importance. Finally, the strategy should also recognise value added medicines innovation which is needed to improve treatments for patient with chronic and non-communicable (i.e. cancer) diseases, deliver on high unmet medical need (e.g. repurposing for Covid-19 treatments) at sustainable cost for health systems. The strategy should lay the foundation to sustain this innovation for public health.
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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

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 Federation of Pharmaceutical Industries and Associations 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 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 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 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 European Federation of Pharmaceutical Industries and Associations 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 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 European Federation of Pharmaceutical Industries and Associations 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 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 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 European Federation of Pharmaceutical Industries and Associations 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 European Federation of Pharmaceutical Industries and Associations 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 European Federation of Pharmaceutical Industries and Associations 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 Thierry Breton (Commissioner) and European Federation of Pharmaceutical Industries and Associations 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 Thierry Breton (Commissioner) and European Federation of Pharmaceutical Industries and Associations 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 European Federation of Pharmaceutical Industries and Associations 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 European Federation of Pharmaceutical Industries and Associations 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

Medicines for Europe backs cost-based EMA fee system with simplification

16 Oct 2019
Topic — Review of fees charged by European Medicines Agency for marketing authorizations.
Message — The organization supports a cost-based fee system with simplified structure and flat annual fees to reduce administrative burden. They emphasize fees must reflect actual assessment workload and not become barriers to registering generic and biosimilar medicines.123
Why — This would reduce their administrative burden and prevent excessive costs for generic medicines.45
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Meeting with Timo Pesonen (Acting Director-General Internal Market, Industry, Entrepreneurship and SMEs)

15 Jul 2019 · Introduce themselves and present the manufacturers of generic medicines general position for the future Commission

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

5 Jun 2019 · Next European Commission holistic strategy for access to off patent medicines; future of pharmaceutical policies; regulatory optimisation; biosimilar medicines; international convergence

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

7 May 2019 · EU-US issues, EU trade agreements, FTAs

Meeting with Paulina Dejmek Hack (Cabinet of President Jean-Claude Juncker)

11 Feb 2019 · Supplementary Protection certificate (SPC)

Meeting with Jyrki Katainen (Vice-President)

11 Feb 2019 · SPC manufacturing waiver

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

4 Feb 2019 · Supplementary Protection Certificates

Meeting with Paulina Dejmek Hack (Cabinet of President Jean-Claude Juncker)

20 Nov 2018 · Commission's proposal on a Supplementary Protection Certificate

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

25 Oct 2018 · Supplementary protection certificate

Meeting with Vytenis Andriukaitis (Commissioner) and

17 Jul 2018 · Supplementary protection certificate, pharmaceuticals in the environment, AMR

Meeting with Vytenis Andriukaitis (Commissioner) and

15 Jun 2018 · HTA

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

10 Apr 2018 · SPC

Meeting with Fabrice Comptour (Cabinet of Commissioner Elżbieta Bieńkowska), Tomasz Husak (Cabinet of Commissioner Elżbieta Bieńkowska)

8 Feb 2018 · SPC

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

30 Jan 2018 · Supplementary Protection Certificate Manufacturing Waiver

Meeting with Fabrice Comptour (Cabinet of Commissioner Elżbieta Bieńkowska)

9 Jan 2018 · SPC manufacturing waiver

Meeting with Jyrki Katainen (Vice-President)

21 Nov 2017 · Internal Market's industrial property legal framework relating to supplementary protection certificates (SPC)

Meeting with Filomena Chirico (Cabinet of Vice-President Jyrki Katainen)

23 Nov 2016 · IPR actions in the single market strategy

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

20 Oct 2016 · Follow-up to Council conclusions, AMR

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

5 Jul 2016 · Discuss the next Commission Action Plan on antimicrobial resistance (AMR)

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

20 Jun 2016 · Biosimilars

Meeting with Marika Lautso-Mousnier (Cabinet of Vice-President Jyrki Katainen)

13 Apr 2016 · IP and pharmaceuticals in the EC Single Market Strategy, SPC Manufacturing Waiver proposal

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

10 Dec 2015 · European healthcare policies

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

16 Oct 2015 · Internal Market strategy

Meeting with Elżbieta Bieńkowska (Commissioner) and

11 May 2015 · Introductory meeting

Meeting with Elżbieta Bieńkowska (Commissioner)

11 May 2015 · Meeting with Beata Stępniewska (EGA Deputy Director General )

Meeting with Clara Martinez Alberola (Cabinet of President Jean-Claude Juncker)

24 Mar 2015 · European Union’s policies affecting the pharmaceutical sector

Meeting with Rolf Carsten Bermig (Cabinet of Commissioner Elżbieta Bieńkowska)

6 Mar 2015 · Intro meeting

Meeting with Eveline Lecoq (Cabinet of Commissioner Carlos Moedas)

26 Feb 2015 · Generic medicines and biosimilars

Meeting with Aura Salla (Cabinet of Vice-President Jyrki Katainen)

18 Feb 2015 · Pharmaceutical Industry

Meeting with Vytenis Andriukaitis (Commissioner) and

4 Feb 2015 · EGA manifesto

Meeting with Ladislav Miko (acting Director-General Health and Food Safety)

20 Jan 2015 · Exchange of views regarding the EU strategic plan for 2015-2016 and EGA vision

Meeting with Nathalie Chaze (Cabinet of Commissioner Vytenis Andriukaitis)

18 Dec 2014 · Pharma policy coordination; European semester process; COM 2015 workplan for pharmaceuticals.

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

10 Dec 2014 · Presentation of the association