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European Confederation of Pharmaceutical Entrepreneurs

EUCOPE

EUCOPE represents over 2,600 small and medium-sized pharmaceutical, biotech and medical device companies across Europe.

Lobbying Activity

Pharmaceutical entrepreneurs call for EU health crisis plan with targeted financial support

28 Oct 2025
Topic — EU plan for coordinated prevention, preparedness and response to cross-border health threats.
Message — The organization requests the Plan streamline regulatory and financial initiatives, provide end-to-end funding for research and development, and establish push-pull incentives for antimicrobial resistance. They emphasize small companies need targeted support to develop medical countermeasures that cannot recoup costs through market sales alone.1234
Why — This would unlock public funding for their members to develop medical countermeasures without viable commercial markets.56
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Meeting with Maya Matthews (Head of Unit Health and Food Safety) and European Federation of Pharmaceutical Industries and Associations

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

Meeting with Olivér Várhelyi (Commissioner) and

16 Oct 2025 · Situation of medium sized innovative pharma sector

European pharma entrepreneurs demand medical device regulation reform

6 Oct 2025
Topic — EU revision of medical device and in vitro diagnostic regulations.
Message — The organization requests harmonized timelines for clinical trial reviews, standardized documentation procedures, and clarification of rules for device-drug combinations. They argue current processes are complex, inconsistent, and delay studies by 6-12 months.123
Why — This would reduce approval delays and enable faster clinical research in Europe.45
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European pharma entrepreneurs urge innovation-friendly policies for competitive healthcare sector

3 Oct 2025
Topic — EU framework to strengthen innovation ecosystem and attract investment for innovative companies.
Message — EUCOPE requests comprehensive innovation-friendly policies that address fragmented regulatory frameworks, reduce administrative burdens, improve access to capital, and protect intellectual property rights. They emphasize the need for sector-specific solutions recognizing pharmaceutical industry's unique characteristics and call for alignment with upcoming EU Biotech Act.123
Why — This would enable their members to sustain high-risk R&D investments and maintain competitive position in global pharmaceutical markets.456
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Meeting with Olivér Várhelyi (Commissioner) and

2 Oct 2025 · All pressing portfolio topics

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

23 Sept 2025 · Critical Medicines Act

EUCOPE urges EU to include vaccination in cardiovascular health plan

15 Sept 2025
Topic — The European Commission is seeking feedback on a new plan to address cardiovascular disease.
Message — EUCOPE calls for integrating vaccination into cardiovascular prevention and cardiology care pathways. They also recommend prioritizing investments in point-of-care diagnostics and screening for rare cardiovascular diseases.12
Why — Mandating these diagnostics and vaccines would expand the market for the group's innovative member companies.3
Impact — National health budgets may face increased pressure from the requested diagnostic and vaccination investments.4
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EUCOPE urges bespoke small mid-cap definition for biopharma sector

28 Jul 2025
Topic — This consultation addresses burden reduction and competitiveness for small mid-cap enterprises.
Message — The organization calls for a sector-specific definition for biopharmaceutical small mid-caps that accounts for high research costs and long development cycles. They propose using criteria like global annual revenue, staff headcount, and the number of centrally approved medicines.12
Why — Mid-sized biopharma firms would gain access to tailored regulatory simplifications and financial support currently unavailable to them.34
Impact — Large pharmaceutical companies may face increased competition from mid-sized firms receiving targeted regulatory and financial benefits.5
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Response to Burden reduction and simplification for competitiveness of small mid-cap enterprises - Omnibus Directive

28 Jul 2025

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), representing predominantly small to mid-sized innovative pharmaceutical companies, backs the European Commissions initiative to create a small mid-caps (SMC) category, as established by its Recommendation on the definition of small mid-caps. This category will foster targeted policies to support companies that are at the backbone of innovation in key industrial sectors across the EU, including biopharmaceuticals. While the introduction of a SMC definition by the amendments at the present Directives 2014/65/EU and (EU) 2022/2557 will benefit SMCs across the EU, EUCOPE encourages the European Commission to extend the applicability of the definition to further legislative initiatives, mirroring all advantages currently benefiting the SMEs category. EUCOPE urges the Commission to apply the definition to legislations with specific impact to the biopharmaceutical sector, e.g. the respective Directive and Regulation of the so-called Pharma Package. This will allow the biopharmaceutical companies which fall under the current proposed definition to equally benefit from targeted policy support, in line with the intentions of the Commissions initiative. Additionally, whereas the recommended criteria standards seek to provide a cross-sectorial definition for SMCs, as a result, it restrains access to targeted policy support to a large number of SMCs in the biopharmaceutical sector. Unlike other industries, biopharmaceutical companies often face large R&D operations, long product development cycles, and extensive regulatory hurdles, such as clinical trials and marketing authorisation processes. These factors require substantial risk investments and specialised expertise, differentiating them from other sectors. In the biopharmaceutical sector, most SMC companies focus on highly innovative technologies, which will often result in higher revenues and staff headcount than other sectors and exceed the SMC thresholds. Yet, they still lack the capability to conduct or attract high risk investments at the scale of larger companies in this sector. This creates a significant challenge: many can no longer qualify as an SME and find themselves in a gap, lacking resources or regulatory support to compete with large pharmaceutical companies. It is therefore vital for the SMCs definition to account for the differences of the biopharmaceutical sector, and the specific challenges pertaining to it. This will allow for proportionate policies that acknowledge the sectors distinct operational dynamics and specific challenges. If the Commissions objective with the new definition is to enable more companies to benefit from tailored regulatory simplification and boost competitiveness in the EUs industrial sector, it is crucial to adapt the definition to the biopharmaceutical distinctiveness. Therefore, EUCOPE calls on the Commission to adopt a sector-specific biopharmaceutical SMCs definition that qualifies companies meeting at least two of the three following criteria: global annual revenue; number of centrally approved medicinal products; or staff headcount. These criteria, when viewed through the lens of the biopharmaceutical sector, best reflect this industrys specific challenges and characteristics. By qualifying for additional benefits, many companies will be better positioned to expand their innovative activities, and gain the flexibility needed to invest in company growth, contributing to the EUs competitiveness ambitions. EUCOPEs full recommendations for a definition for SMCs in the biopharmaceutical sector is attached.
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Meeting with Angelika Niebler (Member of the European Parliament)

24 Jul 2025 · EU Health Care Policies

Meeting with Pascal Arimont (Member of the European Parliament)

14 Jul 2025 · APA Training on CBRN Threats

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

9 Jul 2025 · Health policy

Response to Critical Medicines Act

4 Jul 2025

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) acknowledges the European Commission's proposal for the Critical Medicines Act (CMA). Initially expected to focus solely on shortages of critical medicines (also in light of the work within the Critical Medicines Alliance), the scope of the CMA has been broadened to address access to medicines of common interest. These are distinct issues and require separate solutions. To effectively address current challenges related to shortages of critical medicines, it is crucial to focus on the actual issues at hand, without conflating them with access. EUCOPE urges caution regarding proposals related to collaborative procurement mechanisms for medicines of common interest. Such measures fail to address the underlying issues that contribute to access barriers. Additionally, they introduce significant practical challenges to innovative companies, in particular small and mid-sized ones, and risks for therapies, especially rare disease treatments and advanced therapies. Access to innovative medicines can be improved only by assessing and tackling root causes contributing to access delays and market failures at national level, while better exploiting available tools (e.g., implementing timelines for national P&R decisions in the Transparency Directive). Attached is EUCOPEs detailed feedback on the Critical Medicines Act.
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Meeting with Ann-Sofie Ronnlund (Cabinet of Commissioner Ekaterina Zaharieva)

3 Jul 2025 · Life sciences

Meeting with Olivér Várhelyi (Commissioner) and

17 Jun 2025 · EU biotech policy

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

EUCOPE demands tailored support for small and mid-sized biotech companies

11 Jun 2025
Topic — The consultation explores measures to create an enabling environment for EU biotechnology innovation.
Message — EUCOPE requests a sector-specific approach for healthcare biotech through a dedicated agency. They propose streamlining regulatory procedures and updating definitions for small and mid-sized companies. Finally, they advocate for easing GMO restrictions on advanced therapies to boost innovation.12
Why — Proposed changes would lower administrative costs and improve access to funding for smaller innovators.3
Impact — Groups advocating for strict GMO oversight might oppose exemptions for biotech medicinal products.4
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Response to EU Strategy on medical countermeasures

8 May 2025

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) supports the objectives of the EU Strategy to support medical countermeasures against public health threats, which will be a pillar of EU efforts to develop a common and coordinated approach to enhance preparedness and its capacity to respond to health threats, crises and emergencies. In a rapidly evolving geopolitical context, it is essential to catalyse the availability and development of crisis-relevant medical countermeasures (MCMs), enhancing the EUs strategic autonomy and promoting wider access to MCMs. Given the global nature of health threats, EU efforts should be coordinated with reliable international partners to ensure aligned development, manufacturing and equitable access to MCMs. The Strategy should offer a comprehensive approach to the availability and development of MCMs, supporting the health objectives of the Preparedness Union Strategy. It also represents an opportunity for streamlining and aligning the interaction of financial, regulatory and political initiatives at EU and Member State levels, decreasing administrative burdens, promoting a robust industrial ecosystem and boosting competitiveness on health security in support to the wider economy. The Strategy should prioritise MCMs tackling the high priority threats outlined by the Health Emergency and Preparedness Authority (DG HERA): pathogens with high pandemic potential, Chemical, Biological, Radiological and Nuclear (CBRN) threats, and antimicrobial resistance (AMR). A holistic approach should propose measures to expand MCMs manufacturing capacities, encourage the development of new MCMs, and allocate adequate budget for an EU-coordinated approach to MCMs stockpiles, matched by related national measures (e.g., minimum level of local and EU supplies, where applicable), in line with the upcoming EU Stockpiling Strategy. The allocation of end-to-end financial support for R&D activities is essential, and the promotion of flexible technologies will increase the EUs ability to rapidly respond to future threats. This is particularly relevant to small and mid-sized companies that strongly benefit from targeted financial support to develop innovative MCMs. Certain MCMs are only needed in amounts that are too small to recoup development/manufacturing costs. Additional capital provided by e.g. public-private partnerships may help to make development feasible, while in other cases future market guarantee may be necessary. Considering the urgent need of addressing AMR, it is important to work with Member States to develop a coherent framework of financial push and pull incentives. Ensuring the availability of sufficient revenues will improve development of and access to MCMs, which by their nature are only needed on rare occasions or in emergencies. Overall, a risk-sharing approach and flexibility in contractual commitments are required to address uncertainties on future MCM solutions. The availability of additional funding will also contribute to boosting competitiveness in the EUs life sciences sector, supporting objectives of the Competitiveness Compass, Life Sciences Strategy and further initiatives. EUCOPE appreciates the Strategys objective to harness tools such as joint procurements and stockpiling in the specific context of ensuring wide access to MCMs tackling CBRN threats, for which deployment needs to be rapid. In general, when limited to MCMs, these tools are valuable to foster coordination across the EU and are crucial for effective preparedness against threats that are needed quicker than they can be produced or imported during an outbreak. Addressing these priorities will substantially contribute to a better prepared EU amid increased security risks, while positioning the EU among world leaders in health security. It will also support competitiveness in the health security sector, improving access to lifesaving MCMs in the event of future health emergencies.
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Response to Communication on the EU Stockpiling Strategy

8 May 2025

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) commands the objective of the EU Stockpiling Strategy (EUSS) to develop an EU-coordinated approach to stockpiling critical medical countermeasures (MCMs). In the context of an uncertain geopolitical landscape that poses increased and diverse threats, it is crucial for the EU to bolster its preparedness and capacity to respond to health threats, crises and emergencies. The EUSS will contribute to better equipping authorities with tools to assure the functioning and wellbeing of societies during unforeseen circumstances. The EUSS should enhance cooperation among all stakeholders, including public authorities, public health experts, civil society, and industry. Open communication with industry is essential particularly to small and mid-sized companies, to find practical solutions on stockpiling needs and prioritise R&D activities aligned with stockpiling demands. Cross-border cooperation is essential to better prepare against public health emergencies, and EU-level efforts should be closely aligned with Member States. There is a need for developing minimum national and regional stockpiles of MCMs, enabling the provision to treat citizens and prevent outbreaks from further spreading. In the realm of health, the EUSS should limit itself to the stockpiling of MCMs, addressing pathogens with high pandemic potential (including vaccines) and Chemical, Biological, Radiological and Nuclear (CBRN) threats. While stockpiling MCMs is essential to ensure rapid and effective response capacities to health emergencies, stockpiling is not a viable solution to innovative medicines, nor to critical medicines targeting shortages. To these, contingency stockpiling can lead to waste and increased costs and complexity for manufacturers, without addressing the root causes of shortages where they exist. This applies especially to innovative medicines e.g. orphan medicinal products (OMPs) and advanced therapy medicinal products (ATMPs), for which stockpiling measures could be unnecessary and counterproductive. Measures to address shortages of critical medicines where they exist should, instead, focus on improving supply chain resilience where appropriate and stronger procurement criteria. To achieve an EU-wide adequate level of preparedness, EUCOPE recommends for the following aspects: 1. MCMs stockpiles should focus on products against identified priority threats that are needed quicker than they can be produced following an incident or during a cross-border outbreak, contributing to factors i.e.: rapid response mechanism; protection of first responders, healthcare professionals and civilians; and mitigation of the spread and impact of a disease or incident in the early stages of a health emergency. 2. The choice of MCMs should be determined by factors such as efficiency and safety of products in relation to costs and time it takes to access the product. Additional relevant topics are time to treat, shelf life, storage temperature, storage conditions and transport limitations. 3. Stockpile locations should be optimal, safe and geographically distributed, which is important particularly in the event of e.g. serious cross border viral threats or chemical attacks. Where applicable, an EU-coordinated approach should be matched by related national measures (e.g. minimum level of local and EU supplies). 4. The allocation of an adequate and substantial budget is essential for the establishment of effective and efficient stocks aligned with HERA priority threats. Long-term and sustainable funding will not only support better preparedness against eventual threats crises but will also provide market certainty to industries conducting R&D activities for MCMs, contributing to a stable policy environment that will attract greater investment and competitiveness to the EUs health security sector. EUCOPEs White Paper on EU-wide stockpiling for MCMs is attached.
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Meeting with Sirpa Pietikäinen (Member of the European Parliament)

8 May 2025 · Health security

Meeting with Laszlo Andrejko (Cabinet of Commissioner Olivér Várhelyi)

29 Apr 2025 · Biotech

EUCOPE urges predictable incentives to boost European life sciences

17 Apr 2025
Topic — The EU is developing a strategy to restore global competitiveness in life sciences.
Message — The confederation calls for maintaining strong and predictable incentives and intellectual property rights. They request streamlined regulatory processes and clinical trials to reduce administrative burdens for developers. Additionally, they propose a specific category for mid-sized companies to address unique barriers.123
Why — Smaller firms would benefit from lower administrative costs and easier research commercialisation.4
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Meeting with Oliver Schenk (Member of the European Parliament)

3 Apr 2025 · Pharmaceutical Industry in the EU

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

27 Mar 2025 · EU HTA regulation

Response to EU Start-up and Scale-up Strategy

14 Mar 2025

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) appreciates the upcoming EU Start-up and Scale-up Strategy. This is an important initiative to reinforce the industrial ecosystem, allowing companies to thrive and promote innovation in the EU, including in the pharmaceutical sector. It will be important to identify and address existing barriers, as well as providing necessary financial and regulatory support. EUCOPE is especially supportive of a whole of government approach, breaking down silos and ensuring legislation is mutually reinforcing and synergistic. The call for evidence has identified many existing challenges and potential solutions. EUCOPE would add a number of recommendations specifically relevant to the biopharmaceutical sector. EUCOPE suggests establishing a dedicated EU Biotech Innovation Fund to support biotech startups and their high-risk R&D projects, covering the entire lifecycle from research to regulatory innovation and biomanufacturing. It is crucial to boost public and private investments in the EU and Member States, ensuring they are tailored to the needs of start-ups and scale-ups. This fund could consist of a mix of grants and loans to support various stages of biotech. This fund should complement existing EU tools (e.g., from the Multiannual Financial Framework, European Investment Bank and European Innovation Council), as well as national funding initiatives, creating a framework for capital inflows. This would ensure stable financing and reducing capital constraints for emerging start-ups and scale-ups, especially those working on treatments for rare diseases and advanced therapies, where market viability may otherwise be challenging. EUCOPE urges the enhancement of existing pharmaceutical hubs across Member States, connect them, and, where gaps exist, support the establishment of new clusters. These hubs should foster public-private partnerships and cross-sector collaborations, facilitate the exchange of best practices, and support research teams in universities and research institutes. This will maximise the potential for spin-offs and start-ups, allowing them to grow or hand-off innovation to other developers. These hubs should also support IP transfer from academia to spin-offs, therefore creating a pan-EU pharmaceutical network to drive innovation and manufacturing. These specialised infrastructures would particularly accelerate research in orphan and advanced therapies. Generally, these hubs would play a crucial role in fostering innovation, economic growth and sustainability. It is equally important to invest in talent development, introducing initiatives to promote STEM education, create and sustain high-quality jobs in the life sciences sector (e.g., through collaborations with educational institutions and industry), as well as life-long learning programmes. This would provide a skilled workforce capable of meeting the sector's evolving needs. A number of horizontal measures should be considered to bolster the scale-ups and start-ups ecosystem: maintaining strong intellectual property rights and regulatory incentives; harmonising clinical trials and simplifying the regulatory framework; exploiting the potential of health data and artificial intelligence to streamline research, reduce costs, and improve the efficiency of clinical trials. Current regulatory fragmentation across Member States creates unnecessary barriers for pharmaceutical start-ups; streamlining approval processes will help bridge the innovation gap between the EU and global competitors. Additionally, recognising pharmaceutical spending as a strategic long-term investment will enable more robust policy support ensuring sustained growth in innovation. The attached EUCOPE-commissioned report provides insights from life sciences investors on the key barriers to investment in the EU.
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Meeting with Tomislav Sokol (Member of the European Parliament) and Acumen Public Affairs

5 Mar 2025 · Health policy

Meeting with Andreas Glück (Member of the European Parliament)

4 Mar 2025 · Health

EUCOPE demands impact assessment for Critical Medicines Act

27 Feb 2025
Topic — This initiative aims to address supply chain vulnerabilities and reduce Europe's medicine dependencies.
Message — EUCOPE urges the Commission to conduct a proper impact assessment before publishing. They argue measures should focus strictly on the Union List of Critical Medicines. Financial incentives are requested to help small companies diversify their manufacturing capacity.123
Why — Small firms would gain financial support and lower administrative costs for production.45
Impact — Patients risk shortages of non-critical drugs if procurement rules are extended too widely.6
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Meeting with Michalis Hadjipantela (Member of the European Parliament)

14 Jan 2025 · Introductory meeting

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

21 Nov 2024 · EUCOPE’s priorities and the perspective of the smaller innovative pharmaceutical industry

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

23 Oct 2024

EUCOPE welcomes the EU HTA procedure and its aims to provide a transparent and inclusive framework for quality HTA, to reduce duplication for national HTA authorities and industry and to facilitate business predictability and ultimately, to accelerate access of medicines to EU patients. The request windows for JSCs should be announced on a rolling basis at least 2 times per year with a planning horizon of 24 months. In this way both companies and the HTA CG can plan ahead in terms of resources and capacity. The IA should acknowledge scenarios where the discussion meeting takes place in an in-person format, and establish the principle that the meetings should be of an adequate duration to allow proper discussion on the list of issues. The IA should also include the option for follow-up written advice after the JSC meeting, to discuss any later changes in the development plans. To avoid that the selection criteria become a pre-qualifier for JSC it is important that they be used only to prioritise between candidates when slots are limited. If selection criteria are to be used, as listed in the draft JSC template shared with the HTA Stakeholder Network, these should be clarified in a separate guidance document, with a definition for each criterion and how they will be used to choose between applicants. The current draft does not provide clarity regarding the timelines of the JSC process, which prevents companies from being able to plan when the advice will be received, and if it would allow for any changes to the clinical trial design. The draft IA should specify clearly the timelines for the key milestones in the process in ranges (i.e. between XX and YY number of days), including: by when (from date of submission) would companies receive a response to a JSC request, and the deadline for submitting the briefing book package, length of any submission validation period, how long the assessment of the briefing book should be, how many days following submission of the briefing book will the JSC meeting be scheduled and by when (after the JSC meeting) will the final outcome document be provided to companies. Companies should be further involved in the organisation of the JSC meeting to ensure better alignment on the agenda and the topics to be discussed. This should include inviting input from companies on the meeting scope and requiring an alignment between companies and the assessors on the meeting scope to reflect the briefing book. Further, companies should be informed in advance about which experts/patients will be involved in the JSC. For rare diseases and ATMPs it would in many cases be required to have the same assessor and co-assessor for JSC and JCA due to the difficulty in identifying someone with the right expertise for the role. The draft text specifies that the outcome documents of the CG and the CHMP should be exchanged. For parallel EMA SA/JSC, responses to questions common to both the EMA and HTA should be interlinked, i.e. the Outcomes document and the final CHMP Scientific Advice should refer to each other for the common questions so that the company can obtain one aligned response. If the result is two completely separate outcome documents, the parallel advice process will not be useful. A definition should be included of what information is covered under the appropriate information, which according to Recital 7 will be exchanged by EMA and the HTA secretariat to ensure the synchronisation of the advice procedures. The security and confidentiality of the IT platform must be ensured, and the necessity of a need-to-know principle when sharing commercially sensitive and hence confidential information will be critical for ensuring the confidentiality of data shared by companies, and for building trust in the process.
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Meeting with Stine Bosse (Member of the European Parliament, Committee chair) and European Federation of Pharmaceutical Industries and Associations

15 Oct 2024 · European health policy

Meeting with Eszter Lakos (Member of the European Parliament) and Acumen Public Affairs

10 Oct 2024 · Life sciences industry

Meeting with Tiemo Wölken (Member of the European Parliament)

24 Sept 2024 · Generel exchange (staff level)

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

24 Jul 2024

EUCOPE welcomes the EU HTA procedure and its aims to provide a transparent and inclusive framework for quality HTA, to reduce duplication for national HTA authorities and industry and to facilitate business predictability and ultimately, to accelerate access of medicines to EU patients. We believe the scope of the information sharing as laid down in Article 2 (1) is relevant and focused on the purpose of proper planning of JCAs and JSCs. At the same time, the information from eligibility decisions for the centralised procedure is the only product-level information that is relevant and reliable for the purpose of planning JCAs. Any other information covering the time before the eligibility decision, e.g. from 8 21 months prior to MAA and even 3-years pipeline information is not suited for informing the annual work programme since no product-level information will be sufficiently reliable at this point in time. For such early information to be relevant and useful for planning e.g. JSCs, we would propose to instead share this information as aggregate data, that can then be used to estimate the volume of upcoming submissions. The information required for forecasting the number of JSCs or MAAs is conditional on the maturity of data from drug development and is not likely to be available one year prior. For better planning, the company could instead share the appropriate information directly with the Coordination Group or via EMA, on a more regular basis. Since the modality and specific content to be shared would need to be further detailed, we would recommend addressing this in a separate guidance document which could be developed in close collaboration with industry stakeholders. While we understand the need to exchange information required for planning and forecasting JCAs and JSCs between EMA and the Coordination Group, information required for conducting the same can be more efficiently received directly from the company throughout the procedure. If such information is required by the Coordination Group in advance of initiating a JCA for a given product, we would propose to utilise the existing pre-submission meetings between applicants and the EMA/(Co-) Rapporteur when deemed necessary by the applicant, and to also invite the JCA Subgroup to participate in the meeting. Whenever data is exchanged for the purpose of conducting a JSC or JCA in accordance with Article 8, the company must be informed about the information exchanged and the purpose of the exchange, in order to avoid any misunderstandings or delays which could impact the quality of the two separate procedures. Maintaining the separation between the remits of the EMA MAA and JCA procedures will be vital to efficiently and adequately meet the specific requirements and objectives of each process. The protection of confidential information must be ensured, and additional measures should be specified in the draft text, including the possibility of restricting information according to different levels of protection, creating technical requirements, and obligations to inform about potential legal consequences. Any information that is shared via the IT platform and further shared within HTA bodies or with other stakeholders must enjoy the same level of protection. Further, the exchange of general scientific or technical matters described in Article 6 should not reference specific products or involve any confidential information. Finally, the current wording of Article 9 is too vague and does not describe how a breach of professional secrecy is determined nor what the consequences are, does not include a definition of individual expert, whether access to information is granted on a need-to-know basis and if all CDAs have been signed. This article must establish a sufficient disincentive for individuals to share protected information and should describe the legal consequences of breaking confidentiality provisions.
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Response to Health technology assessment – Procedural rules for the assessment and management of conflicts of interest in joint wo

26 Jun 2024

EUCOPE supports the aim of the proposed draft rules for assessing and managing conflicts of interest to ensure access to the relevant expertise for Joint Scientific Consultations and Joint Clinical Assessments (JCA) and agree that the applicable measures in case of a conflict of interest should vary depending on the declared interests and the roles and responsibility of the individual expert. As a general principle, the involvement of the most knowledgeable experts must be ensured, in order to guarantee a high quality JCA. However, we do not believe the draft rules as laid down in Annex II will achieve the right balance between ensuring high-quality assessments and managing potential conflicts of interest, as they are not sufficiently flexible and would lead to the default exclusion of experts in all cases where there is a potential conflict of interest, without further consideration of the nature of the conflict of interest and possible measures to ensure their expertise can be provided in an appropriate manner that ensures impartiality. The proposed rules would not support the highest possible quality of the assessment, since individuals without a potential conflict of interest would be favoured in all cases, without any consideration of their subject matter expertise compared to individuals with a potential conflict of interest. To ensure a more balanced approach to the involvement of experts, we recommend to exclude Annex II from the Implementing Act and to replace it with a guidance document to be developed by the European Commission in consultation with the Coordination Group as well as the HTA Stakeholder Network. This would also allow for a timely adjustment of the rules building on the experiences from the first assessments. We agree that in the case where only experts with conflicts of interests are available, they should be involved in a manner that is appropriate, and that transparency should be ensured when it comes to their selection and involvement. This is especially important for highly specialised areas and technologies such as Orphan Medicinal Products (OMPs) and Advanced Therapy Medicinal Products (ATMPs), where the number of potential experts that could contribute is much more limited. In addition, due to the specificities of the disease areas of these products, patient and clinician testimonies play an even more important role in HTA. We welcome the proposed derogation to the draft rules in Article 7 (3) as it addresses the need to ensure involvement of the most knowledgeable experts in highly specialised areas. However, in its current wording, we understand that there could still be situations where a JSC or JCA would not involve individual experts as the HTA secretariat shall provide the relevant subgroup with a list of available individual experts indicating their conflicts of interests only where considered appropriate by the Commission. To avoid the complete lack of individual expert input in JSC or JCA, especially in disease areas where such input plays an even more important role, we believe the relevant subgroups should in all cases be informed about the list of potential experts by the HTA secretariat, and experts should always be involved from that list, while ensuring it is done in an appropriate manner. Further, to prevent lack of expert input in the area of rare diseases, Annex I section 3 should include an exemption for strategic advisory roles related to orphan medicinal products. Finally, to ensure transparency in the selection of experts, also where no individual expert is free from conflicts of interests, a brief justification of why that individual expert was chosen among the list of potential experts by the relevant subgroup should also be recorded in the summary minutes of the meeting and in the outcome documents.
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EUCOPE Warns Short Timelines Risk Quality of Drug Assessments

2 Apr 2024
Topic — A consultation on rules for joint clinical assessments of new medicines.
Message — EUCOPE demands earlier involvement in scoping meetings to clarify assessment requirements. They also request extending deadlines to allow companies to prepare high-quality clinical data submissions.12
Why — This would help smaller firms manage regulatory costs by providing predictability and clarity.3
Impact — Patients could face delayed medical access if poor quality data compromises clinical assessments.4
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Meeting with Elisabetta Gualmini (Member of the European Parliament)

19 Mar 2024 · Reform of the EU pharmaceutical legislation

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

7 Mar 2024 · Directive on Medicinal products for human use

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

5 Mar 2024 · Revsion of Pharmaceutical package (staff level)

Response to Revision of the variation framework for medicines

29 Feb 2024

Please find attached feedback on behalf of EUCOPE.
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Meeting with Stelios Kympouropoulos (Member of the European Parliament)

15 Feb 2024 · rare diseases

Meeting with Patrizia Toia (Member of the European Parliament)

7 Feb 2024 · Pharmaceutical package

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

17 Jan 2024 · Revision of the Parmaceutical Legislation

Meeting with Frédérique Ries (Member of the European Parliament, Shadow rapporteur) and FIPRA International SRL and

5 Dec 2023 · Revision of the Pharmaceutical Legislation

Meeting with Dolors Montserrat (Member of the European Parliament) and Haleon

28 Nov 2023 · Revision of the pharmaceutical legislation

Meeting with Ondřej Knotek (Member of the European Parliament)

22 Nov 2023 · Pharmaceutical package

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and Rud Pedersen Public Affairs Brussels and

22 Nov 2023 · Directive on Medicinal products for human use

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

15 Nov 2023 · Revision of the Pharmaceutical Legislation

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

10 Nov 2023 · Pharmaceutical legislation

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

20 Oct 2023 · Medicinal products for human use

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

28 Sept 2023 · Pharmaceutical legislation

EUCOPE Urges Reform of Medicine Market Authorisation Changes

26 Sept 2023
Topic — The European Commission is reviewing the procedures for making post-authorisation changes to medicines.
Message — EUCOPE requests that the European Commission embrace risk-based approaches to simplify medicine lifecycle management. They advocate for downregulating biological products and reducing the administrative burden of minor notifications. These reforms aim to facilitate innovation and avoid drug shortages by streamlining technical updates.12
Why — The industry would benefit from significantly lower compliance costs and faster technical implementation.34
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Response to Evaluation and revision of the general pharmaceutical legislation

5 Sept 2023

EUCOPE acknowledges the objectives of the review. While numerous regulatory provisions will streamline the functioning of the market, changes to the incentive framework outweigh these, weakening EU global competitiveness. EUCOPE acknowledges the concept of modulating orphan market exclusivity (OME), but this shouldn't be done on the basis of High Unmet Medical Need (HUMN), instead it should follow the OD Expert Group model. The Commissions approach introduces uncertainty and doesn't address the underlying barriers to OMP development. A HUMN definition would be restrictive and labelling a product as not addressing HUMN will have significant P&R implications, inform the commercial viability of a therapy and jeopardize patient access. Vague concepts such as exceptional therapeutic advancement and meaningful reduction in morbidity or mortality also introduce uncertainty and unpredictability. HUMN doesn't recognise that first-to-market therapies don't necessarily address the needs in the entire patient population. Modulation based on HUMN risks undermining innovation and overlooking certain people living with a rare disease. The cumulative impact of changes to the OMP framework risks creating barriers to innovation for those patients that could still benefit from it. A more restrictive interpretation of significant benefit risks excluding subpopulations. Orphan Drug Designation (ODD) expiring at point of marketing authorisation (MA) undermines national incentives which are linked to ODD, e.g. tax incentives in Belgium and pricing in Spain, which address OMP market failures. A single period of OME for each molecule, which can be extended up to 2 years, discourages incremental and breakthrough innovation as developers aren't incentivized to take the financial risk to conduct research in new indications. Developers should be encouraged to expand on their research and knowledge of disease progression and new technologies, not abandon it. EUCOPE calls for the exclusivity period and the number of extensions to be increased. These changes are additive and will negatively impact the commercial viability of developing OMPs without addressing the challenges to encourage innovation in the 95% of rare diseases with no authorised therapies. EUCOPEs members are committed to making their therapies available as widely as possible. Sometimes launching in all 27 Member States is unfeasible, particularly for ATMP and OMP developers or smaller companies. A launch conditionality (release and continuously supply), where developers only receive their full exclusivity period for launching in all Member States in 2-3 years is punitive and wont address the underlying access challenges. The proposal doesn't appropriately consider the infrastructure requirements, implications of small patient populations, or resource limitations of smaller developers. Developers aren't the sole decision-makers regarding launch (e.g. P&R decisions or national priorities) which isn't appropriately reflected in the proposal. To support access, alternative solutions should be pursued, e.g. cross-border healthcare. Provisions we welcome include: Streamlined EMA structure; Reduced regulatory approval timelines (from 210 to 180 days for CHMP opinion, and from 67 days to 47 days for issuing the MA); Phased review pathway considering that this instrument should be more flexible and broader in scope; Simplification of GMO rules for ATMPs; Enhanced legal framework for Scientific Advice, including for combination products, and the accelerated assessment; Adapted clinical trials, use of RWE and regulatory sandbox; Evolutionary PIPs. Other areas of concern include: Duplication of requirements with shortage prevention plans and prolonged supply notification periods; Restrictive scope of PRIME eligibility; 5-year deferral cap for PIP and provisions in art. 75.1(b); Uncertainty if Mutual Recognition Agreements on GMPs can be continued. Our position paper is attached.
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Response to Evaluation and revision of the general pharmaceutical legislation

5 Sept 2023

EUCOPE acknowledges the objectives of the Pharmaceutical Package, and welcomes maintaining a separate Directive and Regulation for decentralized and central approval processes. While we appreciate streamlining and digitisation of regulatory procedures, we are concerned that other proposed provisions will undermine R&D, innovation, EU competitiveness, and be particularly detrimental for patients and small and mid-sized companies. The proposal introduces more risks and unpredictability into the system, while significantly reducing incentives. The EU should retain a broad common understanding of Unmet Medical Needs (UMN), governed by EMA and involving patients, industry and other key health stakeholders, and not codify this in legislation. The proposed definition of UMN is strict and unclear. This introduces unpredictability into the system which makes it challenging for companies to invest in the development of new therapies and ultimately jeopardizes broader patient access. The strict criteria risk hampering innovation, and risk overlooking some patient populations over other. A legally binding definition of UMN will have unintended consequences at P&R level, by giving products a stamp. This definition will not contribute to a future-proof system, since not all patients and diseases are the same and UMNs evolve over time. UMN should not form the basis of the modulation of incentives, as it will not address the existing challenges, but risks exacerbating them. The proposed modulation of Regulatory Data Protection (RDP) will hinder innovation and make the EU less competitive at global level, undermining what was a competitive advantage for the EU. Any reduction in RDP will disproportionately affect companies, especially small and mid-sized. Conditionalities will increase unpredictability and risk reducing investments in the EU, with knock-on effects on innovation for patients. Many small and mid-sized companies have a limited portfolio of therapies, which means that strong and predictable RDP is imperative to their sustainability within the EU, and for investment and research into complex areas. EUCOPEs members are committed to making their therapies available as widely as possible. Sometimes launching in all 27 Member States is unfeasible, particularly for ATMP and OMP developers or smaller companies. A launch conditionality (release and continuously supply), where developers only receive their full exclusivity period for launching in all Member States in 2-3 years is punitive and wont address the underlying access challenges. The proposal doesn't appropriately consider the infrastructure requirements, implications on small patient populations, or resource limitations of smaller developers. Developers aren't the sole decision-makers regarding launch (e.g., P&R decisions or national priorities) which isn't appropriately reflected in the proposal. To support access, alternative solutions should be pursued, e.g., cross-border healthcare. EUCOPE welcomes the Commissions efforts to provide additional clarity and harmonization regarding the implementation of Hospital Exemption (HE) across the EU. An important exemption to the centralized procedure, we call on further clarity on its use and when it can be used, especially regarding the definition of non-routine use, bringing important predictability to the system, while continuing to protect patient safety. Other areas of concern include: Linking environmental risk assessment (ERA) to obtaining or withdrawing marketing authorization, as this entails the risk of delaying approval and patients access to new treatments; R&D transparency requirements; DCPs/MRP: new Opt-In provisions for national authorities. Other provisions we welcome include: Maintaining the 6-monhth SPC extension as reward for conducting PIP; Increased use of digitisation and electronic processes; Active substance master file certificate and quality master file certificate. Our position paper is attached.
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Response to Unitary Supplementary Protection Certificates (SPC) – creation and granting procedure

28 Jul 2023

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) is the European trade association for small to mid-sized innovative companies active in the field of pharmaceuticals and medical technologies at the European level. The development of new medicines requires extensive research that consumes a considerable amount of time and resources, and the path from basic research to a new authorised medicine is long and involves many uncertainties. In order to deal with these uncertainties, and the long timelines for development and subsequent marketing authorisation, intellectual property rights, such as patents and SPCs, are fundamental. A unitary SPC and grant procedure would benefit the industry, and in particular small to mid-sized companies, by reducing internal time and resources needed for the SPC filings on each product. As long as companies have the ability to choose whether to pursue a national or unitary filing, tailored to their needs, unitary SPCs and a centralised procedure would be beneficial to the industry. The revisions of the SPC legislation should be limited to procedural aspects, leaving the substantive provisions untouched. We urge the Commission to maintain this position during the trilogue negotiations. The SPC system is an important element in compensating for the extensive and time-consuming evidence generation required during the patent period of a medicine to obtain a marketing authorisation and making safe and effective products available to patients. The current SPC system encourages and enables continued investment in research and development, while contributing to EUs global competitiveness. National application procedure: The national grant procedure should remain available as an option where a company finds that route the most appropriate, even where a company holds a European or unitary patent and has a centralised marketing authorisation. In any case, appropriate transitional provisions for the national application procedure and the granting of SPCs are necessary. Third-party opposition: The current proposal provides for third parties to oppose the unitary SPC or unified grant procedure for SPCs, and to invalidate the unitary SPC before the EUIPO when such possibilities already exist before the Unified Patent Court (UPC) or before national courts after the granting of an SPC. The ability for third party observations as included in the proposal provides sufficient opportunities for third parties to submit their comments during the grant process. Such an accumulation of opportunities for challenging the grant of the SPC is unnecessary and fundamentally disproportionate, it could result in abuse with an SPC protection not being granted in time before the expiry of the basic and underlying patent, potentially annulling the function of the SPC system. The possibility for third parties to file an opposition, to comment on and contest an application for a pediatric extension is also unnecessary and inadequate in its design. The pre-grant opposition procedure should be deleted from the proposal. The possibility for third parties to file an application for invalidity of the unitary SPC before the EUIPO would in our opinion infringe upon the UPCs exclusive jurisdiction for such situations and should therefore not be included in this Regulation. Economically linked: The proposal includes a requirement that two parties holding separate patents for the same product cannot by economically linked to obtain an SPC. It needs to be clarified if the requirement also pertain to historical links, which could impact negatively on companies ability to make use of the SPC system. We propose that the text in both Recital 12 and Article 3 (3) of 2023/0130 (COD) and Recital 20 and Article 3 (2) of 2023/0127 (COD) be completed with at the time of filing an SPC application..
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Response to Compulsory licensing of patents

28 Jul 2023

The development of new medicines requires extensive research and considerable time and resources, the path from basic research to a new authorised medicine is long and involves many uncertainties. To deal with uncertainties, and the long timelines for development and marketing authorisation, IP rights are fundamental. Predictable protection and enforcement of IP rights contributes significantly to global competitiveness of the EU and must therefore be maintained to ensure future attractiveness of the region for small to mid-sized companies. Strong and predictable IP rights allow for voluntary partnerships and collaborations, including voluntary licensing as seen recently during the COVID-19 pandemic. Thanks to a well-functioning IP rights system, effective and safe medicines were developed and delivered to EU citizens. EUCOPE views the proposal for an EU-wide union compulsory license (CL) with serious concern since it contributes to undermining IP rights, and negatively impacts the competitiveness of the life sciences industry in Europe. It will profoundly reduce the willingness to invest and commercialise in the EU. The current proposal is unclear on process, lacks independent judicial oversight and has too few control mechanisms to ensure that the proposed union CL is the last resort. We acknowledge that certain aspects of the proposal aim at taking the right holders rights into account. However, these aspects cannot outweigh the negative consequences of framing IP rights as a barrier when in fact other obstacles (e.g. trade barriers, distribution chains and access to raw materials) presented themselves in the past as preventative to an adequate crisis response. A CL scheme already exists at national and global level (via the WTO TRIPS agreement). The current proposal for an EU-wide CL would interfere with these systems. In particular, the following must be addressed: As found in law at Member State level, an accelerated process for independent judicial review by the General Court is needed both prior to granting the CL, to make a determination on the Commission decision, and after to allow for independent review and determination of remedies if the CL is found to have been unlawfully granted. The proposal lacks a clear definition of what is meant by crisis as a trigger for a union CL and provides only limited reference to other EU legislation in the Annex. There is a risk that the lack of clarity and the vagueness of the framework will make the definition and its actual application go beyond its original purpose. It is also not clear when a rights holder should be notified about a union CL procedure. This must be clarified so that the system contains a level of predictability and clarity. We understand the intention is for a union CL to also apply to the period of data and marketing protection. However, it is unclear what is meant by resumption of RDP and its consequences for products marketed under a union CL. We are also concerned that the suspension of RDP would not result in an equal extension of the original duration, resulting in effectively removing rights without compensation. We are also concerned this suspension of RDP would not be TRIPS compliant. The Commission is granted extensive powers to take complementary measures which could be interpreted as including disclosure of confidential/commercially sensitive information. This would infringe upon a companys ability to protect its trade secrets as guaranteed by EU legislation and must be avoided. It is unreasonable to require disclosure of information other than that included in the patent. The proposed remuneration of the rights holder is of an inadequate level. Furthermore, the specified penalty for a rights holder that does not comply or cooperate is set at a level significantly higher than the remuneration.
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Meeting with Sara Cerdas (Member of the European Parliament, Shadow rapporteur) and Standing Committee of European Doctors

7 Nov 2022 · Espaço Europeu de Dados de Saúde

Meeting with Sara Cerdas (Member of the European Parliament)

7 Nov 2022 · Legislação Farmacêutica

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

7 Sept 2022

EUCOPE welcomes the proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application. We welcome the transition of the BTC Directives into one Regulation which will increase regulatory predictability and harmonization. We welcome the continued regulatory delineation between BTCs and pharmaceutical products to increase regulatory predictability. We are concerned about areas in which the SoHO Regulation is not coherent with existing medicinal product regulation. Medicinal products are already regulated to a higher regulatory standard (including Good Manufacturing Principles) that should take precedent in any area of conflict with the SoHO Regulation. Defining the borderlines We welcome the decision to maintain the current definitions and delineation between BTCs and advanced therapy medicinal products (ATMPs) which provides needed predictability. Often the first activities in the manufacturing chain, many BTCs, governed under the SoHO framework, are starting materials for ATMPs and other medical products. Therefore, we welcome the clarity provided by the proposal regarding definitions and the boundary between the SoHO and pharmaceutical legislation. Regrettably, there remain some areas, such as urine-derived products, where more clarity is needed. Sustainability and sufficiency of supply EUCOPE welcomes the EC’s willingness to address issues relating SoHO sustainability. The proposal should encourage MS to develop strategies to ensure availability of SoHOs. Strategies should include implementation of patient blood management (PBM) programs in line with the WHO 3 pillar concept to manage and preserve patient’s own blood, and national plans to increase the availability of plasma for fractionation and reduce reliance on the US. The EC should encourage and harmonise sustainable uptake of SoHOs for Medically Assisted Reproduction (MAR), balancing obligations with support. There is uneven implementation of sperm and egg donation across Europe and this proposal can encourage greater homogenous uptake. There is a need for more clarity regarding the requirements for autologous collection outlined in articles 2.2 and 2.3 which should avoid undue obligations. The SoHO Coordination Board (SCB) Clarity is needed regarding the role of SCB and possible conflicting decisions. The Committee for Advanced Therapies (CAT) is responsible for providing advice on whether a product meets the definition of an ATMP, whereas the SCB shall assist MS including classification of borderline cases. To promote predictability, in cases of classification of borderlines, any decision from the CAT should take precedence. Plasma EUCOPE welcomes differentiation of plasma for fractionation from blood and blood components for transfusion; a foundation for policies that can support increased availability of plasma in Europe. However, we are concerned that plasma donation is described as a “procedure of significant risk” without scientific justification. This classification may discourage plasma donation and impact supply of PDTs. Genetically modified organisms Recital 9 states that the SoHO regulation also applies to genetically modified organisms. As genetic manipulation is considered substantial manipulation, we believe that it should always fall into the realm of the ATMP regulation. Primacy of Pharmaceutical Legislation Under articles 42 -44, developers require a prior importing SoHO entity authorisation. While plasma product manufacturers are exempt, other medicinal product (e.g. ATMP) developers are not and must register as importing SoHO entities. For SoHOs that are raw materials for the production of medicinal products, import and export are already regulated in the GPL, and the SoHO requirements cause undue burden. In order to avoid duplication and unnecessary burden on ATMPs manufacturers, the proposal should exempt the latter from the requirements introduced by articles 42 and 43.
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Pharmaceutical SMEs demand uniform European Health Data Space rules

27 Jul 2022
Topic — A proposal for creating a secure, cross-border European Health Data Space.
Message — The Commission must clarify data protection rules and streamline legislative overlaps to support innovation. Industry stakeholders should be involved in the new governance board to clarify their roles.12
Why — Harmonised standards will lower financial barriers and legal risks for pharmaceutical innovation.34
Impact — National regulators may lose discretion over expanding health data categories independently.5
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Meeting with Giorgos Rossides (Cabinet of Commissioner Stella Kyriakides), Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides)

18 May 2022 · Exchange of views on the upcoming reform of the pharmaceutical legislation

EUCOPE: Compulsory licensing must remain a last resort

28 Apr 2022
Topic — The EU is creating a unified framework for compulsory patent licensing during crises.
Message — EUCOPE argues compulsory licensing must remain a last resort. New rules should respect international agreements and protect data incentives.123
Why — Stronger protections allow companies to secure returns on high-risk medical research.4
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Response to Unitary Supplementary Protection Certificates (SPC) – creation and granting procedure

4 Apr 2022

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) is the European trade association for small to mid-sized innovative companies active in the field of pharmaceuticals and medical technologies at the European level. SPCs, by restoring some of the effective patent term lost up to the grant of a marketing authorisation, are of fundamental importance to ensure sustainable investments into researching and developing new medicines. Out of the 3 options outlined by the European Commission in this consultation, EUCOPE supports Option C (legislative changes combined with non-legislative ones), in particular measures in relation to Policy Option C1. Creating a centralised system for SPC protection in the EU. From the perspective of small to mid-sized companies, we agree that there is a need to create a more harmonised, transparent and efficient application procedure for granting SPCs in order to reduce the high registration and maintenance costs and administrative burden and making the procedure for granting SPCs more predictable. First, a unified SPC grant mechanism leading to “European SPCs” would considerably simplify the administrative process, limiting duplication of work for applicants and national offices (NPOs), thereby allowing better use of resources and expertise. In addition, a unitary SPC being granted on the basis of European Patents with unitary effect could substantially enhance the attractiveness of European patents with unitary effect to biotechnology and pharmaceutical companies. However, this requires coherent safeguards as well as clarifications on questions such as whether remedies for revocation should be brought before national courts with the decision having effect for the whole territory of the Unitary SPC or rather before the Unified Patent Court itself with the decision having effect for selected Member States. Thus, a step-wise approach to gradually uniformise the pharmaceutical patent system in Europe would be preferable. Eventually, a unitary SPC could benefit European industry in reducing internal time and resources needed for the SPC filings on each product but companies must continuously have the freedom to decide where and how to register the SPC, thus following national procedures.
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Response to Cancer Screening Recommendation

22 Feb 2022

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) is the voice of small to midsized innovative companies active in the field of pharmaceuticals and medical technologies. EUCOPE welcomes the update of the 2003 guidance (Council Recommendation) on cancer screening and supports expanding the scope of the recommendation to include new types of cancers as well as the inclusion of new technologies that have been proven effective in order to increase screening and early detection rates. Early detection of cancer allows for more timely treatment selection and leads to significantly improved clinical outcomes for cancer patients. We also support the aim of including less invasive approaches as these have the potential to increase screening rates by reducing barriers for citizens to participate in screening programmes. Certain innovative applications of genomic techniques for diagnostic tests, i.e. advanced diagnostics, have shown promising results for being able to detect some types of cancer at an early stage. Since the field of advanced diagnostics is rapidly evolving, we urge that the new recommendations be more frequently updated, so that for example new blood-based tests that are made available and have demonstrated adequately high-performance in early-stage cancer detection can be considered for inclusion. For further information about advanced diagnostics, please find attached a white paper prepared by the Genomics Working Group of EUCOPE. The group is made up of advanced diagnostics companies that have come together to ensure Europe will be able to draw benefit from the significant advances that have been made in genomic testing.
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Response to Requirements for Artificial Intelligence

29 Jul 2021

Representing small and medium-sized companies active in life sciences, EUCOPE acknowledges the Commission’s efforts in proposing a legal framework for Artificial Intelligence (AI). We particularly welcome the commitment from the Commission to strive for a balanced approach, as stated in the explanatory memorandum of the proposal. For AI to realise its potential, a key prerequisite is the establishment of a balanced and fit-for-purpose regulatory framework ensuring trust and adhesion of the European citizens. Many of the AI-based solutions used in healthcare and by the health sector will be classified as medical devices (MD) or in-vitro diagnostic (IVD) medical devices, and therefore already covered by the Medical Devices Regulation (MDR) 2017/745 and the IVD Regulation (IVDR) 2017/746. We understand from Article 47.6 from the proposal that those devices will be exempted from an additional ex-ante conformity assessment, as, indeed, they would have already gone through a substantial conformity assessment most often via a Notified Body, before entering the market. We understand that this single Notified Body assessment will address conformity with the MDR or IVDR, whichever is applicable, as well as the AI regulation. EUCOPE would welcome, however, more clarity on the interplay between the Commission proposal and Regulations 217/746 and 217/746 in that sense, as well as on the obligations for serious incidents reporting (Article 62.3 of the proposal) on what exactly the Commission intends as breach of obligations under Union law intended to protect fundamental rights. To avoid disconnects when sponsors attempt to comply with the different regulations, we call on the Commission to ensure good collaboration with its Medical Devices Coordination Group (MDCG) to discuss and iron out the interplay challenges between the different set of laws. We suggest that linkage between the various provisions of these regulations is explicit, so this interplay is clear. We similarly suggest that the linkage between the AI regulation provisions and the General Data Protection Regulation (GDPR) provisions is explicit and clear, so that our industry can assess potential impacts of the interplay between these two regulations. We acknowledge the suggestions laid out by the Commission in Recital 68 and Article 47 of the proposal to allow for exceptional derogation from conformity assessment procedure. Such regulatory flexibility is crucial to cover for any emerging and urgent crisis, as demonstrated by the COVID-19 pandemic where the flexibility showed by the Commission and the EMA proved essential in developing vaccines or continuing clinical trials in Europe. We would also welcome more information on the relationship between the database as mentioned in Article 60 of the proposal and the newly established EUDAMED database for devices, as per the new devices Regulations. Also, we ask the Commission to take into account the administrative burden faced by small and medium-sized companies when different legal frameworks have so close connection. Any duplication of efforts should be avoided. Finally, we would welcome more clarity on the annexes of the proposal and the definition of high risk, in particular confirmation that AI-based solutions used in healthcare and medical product development are not considered high-risk AI systems. We would also suggest that the Regulation considers the potential for unforeseen consequences to the health care system, as well as scientific research and development of new and innovative pharmaceuticals and medical devices, when evaluating the AI regulation. As the regulation is broad in nature and attempts to address the use of AI across all sectors, there is the potential for unanticipated impacts that could hinder scientific research and development. To avoid these unintended consequences, we respectfully ask that the Commission consider our industry when reviewing and revising the proposed regulation.
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Meeting with Cyrus Engerer (Member of the European Parliament)

13 Jul 2021 · Pharmaceutical Strategy

Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

EUCOPE is the voice of small to midsize innovative companies active in the field of pharmaceuticals and medical technologies at the European level. The COVID-19 pandemic has again made the vital importance of the European pharmaceutical sector apparent, and while regulatory simplification is welcomed, broader business incentives should also be considered to address the EU’s competitiveness. EUCOPE supports the ‘targeted approach’ pursued by the European Commission for the revision of the pharmaceutical legislation. For the sake of legal certainty and regulatory efficiency we suggest conducting the revision on the basis of the existing legal acts, and maintaining the coexistence of both a general Regulation and a general Directive. Feedback on the proposed solutions: a) EUCOPE supports the Commission’s aim to reach a common understanding of UMN including in the area of AMR. A definition however runs the risk of overlooking the needs of diverse populations and disease areas. UMN is highly dependent on the scope and the value framework in which it is used based on different stakeholder needs and responsibilities. Thus, coming to a common understanding of UMN should be considered within the broader value framework of each stakeholder (e.g. patient, HCP, societal). b) Simplification is welcomed and particularly important for small to midsize companies. This should include reducing approval times and costs. It is not clear to us what is meant by “provide regulatory authorities the possibility to adapt on their own initiative terms of marketing authorisations”. In any case, such processes must only take place after a profound consultation with MAHs. A strengthened cooperation between EMA and national HTA bodies is vital in order to further streamline the evidence requirements for authorisation and HTA procedures. c) EUCOPE supports the introduction of incentives that complement the existing framework, in particular in areas of highest medical need. Incentives must not be linked to an obligation to launch: Market launch depends on the structure and requirements of each individual Member State. For smaller and midsize companies it is particularly difficult to navigate the different systems in a given time frame due to their operational and financial restrictions. Linking incentives to more transparency of R&D costs will prove unfeasible: Developing products is a complex process with a high failure rate, and methodologies are unlikely to capture the true R&D costs and investments. Further, R&D costs do not reflect the value of innovation and are not the correct link for incentives that aim to reward it. Consequently, linking the incentives system to the beforementioned obligations would substantially weaken the EU’s ability to attract and promote innovation. e) Streamlined regulatory processes and expedited pathways (e.g. COVID-19 expedited approval and rolling review, PRIME), with earlier and more interactions with developers, early assurance of accelerated assessment and decreased regulatory burden could prove effective incentives. g) It is important to maintain regulatory incentives and IP rights for innovation. Any weakening or disbalance will reduce predictability and undermine R&D investments. Market uptake of medicines, including generics, is determined by Member States’ policies and therefore does not fall within the EU legislators’ competence. i) Rather than introducing further obligations for supply and transparency, the efficient use of existing obligations will enhance the level of security. As learned from COVID-19 a constant and solution-oriented dialogue between the EU institutions and manufacturers enhances security while not imposing additional obligations on the MAH which might be impossible to achieve, in particular for small to midsize companies. Any reform of the existing system should therefore be linked to incentives that encourage advanced manufacturing capabilities for certain critical products.
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Response to Evaluation of patient rights in cross-border healthcare

11 Feb 2021

EUCOPE gives voice to small and mid-sized biopharmaceuticals and devices companies. Many of our member companies are developing Orphan Medicinal Products (OMPs) and Advanced Therapy Medicinal Products (ATMPs), including gene and cell therapies, bringing solutions to people living with rare diseases in Europe. The ability to cross borders to receive treatment bears a significant importance for rare diseases patients and their carers, who often do not have access to highly specialised treatment center in their home country. Whilst the Directive, in that sense, sheds lights on the necessity to facilitate access to healthcare abroad for many patients, we believe it does not efficiently operate in practice. In the case of rare diseases, and even more so in the case of ATMPs, the complex nature of their delivery limits the number of physicians and hospitals capable of providing these treatments and proper disease management. Only a small number of highly specialised centers have the expertise to administer ATMPs, which causes countries without such centers to send patients abroad. Cross-border healthcare for ATMPs may occur through three legal paths: a parallel agreement between two countries; the Directive; and the EC Social Security Regulations 883/2004 and 987/2009 (S2 route). Whilst the evaluation assesses the cross-border healthcare Directive, we encourage the Commission to examine the current and future needs of patients in cross-border healthcare with the Directive and S2 route in mind. With the Directive foreseeing a pre-payment by the patients, this is not a viable option in the case of ATMPs, where treatment and related costs (travel, accommodation, multiple visits to the center of treatment) can be an obstacle for patients and carers. As highlighted in the 2019 Special Report of the European Court of Auditors on EU actions for cross-border healthcare, it would not be reasonable to ask patients for an upfront payment and then subsequently ask for reimbursement. To address the issue of prior authorization, the Commission should consider encouraging Member States to implement the Directive’s mechanism of financial compensation, introducing direct billing between health institutions, removing the burden of upfront payments. Consequently, the S2 route remains the most used pathway for ATMPs, as it does not require pre-payment by the patients. Yet, the S2 model also presents some flaws that can impede patients’ access: including, for instance, processing timelines for prior authorisation using the ‘S2 Form’ varying from one country to another. Obtaining authorization will often be dependent on the inclusion of the therapy in the home country’s basket of care. The shortcomings of the S2 route can be partially addressed by, for instance, Commission guidelines setting acceptable and harmonized review and approval timelines to expedite time-to-treatment in the EU and leveraging existing joint HTA assessment initiatives, such as EUnetHTA, to supplement S2 applications and to enable broader access to cross-border healthcare. In that sense, the Directive does not meet the specific needs of rare diseases patients, especially in the case of ATMPs, and still poses a number of administrative hurdles in access to healthcare abroad or seeking reimbursement thereafter. Another critical shortcoming in the implementation of the Directive is the level of awareness of the relevant stakeholders. As shown by a 2018 Commission survey, patients’ awareness on their rights and possibilities to access health services abroad and on the use of National Contact Points is still low, hindering the use of cross-border healthcare in the EU. Patients often have to rely on the work of patient organisations or other stakeholders to relay the necessary information. We, therefore, recommend the establishment of a European one-stop-shop and unified single source of reliable, accessible information to increase process transparency and navigate the CBHC framework.
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Response to A European Health Data Space

3 Feb 2021

EUCOPE welcomes the opportunity to participate in the evaluation process of the European Commission proposal for a European Health Data Space (EHDS). Representing small and medium-sized companies active in pharmaceuticals, biotechnologies and medical technologies, EUCOPE shares the Commission’s ambition to see the EU becoming a leader in digital innovation. One of the key prerequisites is the establishment of a safe area where data can be accessible, of sufficient quality, and where its use for health and/or research purposes is embedded in a balanced regulatory framework ensuring trust and adhesion of the European patients. As highlighted in our recent White Paper on Artificial Intelligence (AI), the fight against COVID-19, has demonstrated the potential of AI to drive change and improve efficiency and accessibility in healthcare. From compounds design in medicines development to faster, more accurate patient screening and diagnosis to hospital management (to name but a few applications), AI-based solutions can help upgrade our healthcare systems towards more sustainability, while helping to address patients’ unmet needs. The ambitious plan of the Commission on creating an EU Health Data Space is certainly a move in the right direction. It builds on existing or emerging initiatives such as the eHealth Network, Digital Service Infrastructure, the Beyond 1+ Million genomes initiative, the ERNs and the EMA’s DARWIN. We urge the Commission to work closely with the EMA and to involve all stakeholders in the design and implementation of DARWIN. These infrastructures should support better decision-making throughout the product life-cycle. It is important the consultation process ensures a fit-for-purpose regulatory framework. Only a balanced environment will enable safe data-sharing, accelerate the rollout of personalised medicine and diagnostics solutions, and drive innovation in AI and digital health. We agree with most of the problems stated by the Commission in the inception impact assessment. Indeed, AI relies critically on the availability of rich data. High quality, reliable and interoperable data is the sine qua non condition of any solution utilizing artificial intelligence. Despite the vast amounts of data available in healthcare institutions, or generated in a non-medical context, the majority is either not accessible, or usable, making the development of AI healthcare solutions extremely challenging. Also, very often, when data is available, the dataset is not viable, with systems not able to synthesise data, communicate with and use information from different systems. Interoperability and unified standard format are among the main barriers to the adoption of digital health services, or use of data for research purposes. Due to the fragmented landscape, the data, when available, can be of disparate quality and complexity. Curating this information and evaluating its appropriateness requires a lot of skills, resources and time, which is beyond the scope for smaller biotechnology and medtech companies ,as well as other health solutions developers. To that end, EUCOPE recommends the adoption of EU-level data collection standards that promote data interoperability and exchange protocol, based on the experience of ERNs. We understand the Commission is considering various policy options to address the problems identified by the inception impact assessment. We recognise the need for an appropriate legal and governance framework to cover the access to and exchange of health data for healthcare provision, research, policy-making and regulatory activities, as stated by the Commission. A multi-level governance approach is vital to make the EHDS a success. It is imperative to streamline regulations and guidance documents so that they can act as accelerators to stimulate innovation, to the benefit of the EU competitiveness, and ultimately, to the benefits of European patients.
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Response to Proposal for a Regulation establishing a European Centre for Disease Prevention and Control (ECDC)

1 Feb 2021

EUCOPE, the European association with a strong focus on small to medium-sized companies active in pharmaceuticals and biotechnologies, welcomes the proposal for a regulation 2020/0320 that aims at enforcing the mandate of the European Centre for Disease Prevention and Control (ECDC). Providing the ECDC with the right tools and resources will be key to ensure Europe's preparedness, resilience and readiness to face current and future cross-border health threats. We would also like to recall the importance of monitoring and exchanging information between the EU and Member States to effectively address the impact of communicable diseases and cross-border health threats on vulnerable patient groups, including cancer and rare disease patients and those with life-threatening or chronically debilitating conditions. The ECDC has greatly contributed to this endeavour during the pandemic, and we believe that additional resources and a robust legal framework will be key to continue ensuring timely cooperation in this area.
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Response to Revision of the EU legislation on medicines for children and rare diseases

6 Jan 2021

EUCOPE’s represents 130 small to medium-sized companies playing a key role in the European pharmaceutical environment, many focused on rare diseases. Some of them have unique profiles due to their highly specialised product portfolio, no or limited revenues to date and/or significant risky R&D investments. For these companies, incentives are crucial to sustain (re)investments and planning cycles required to foster research in rare and paediatric diseases. We emphasise the need to tackle the incentives’ evaluation in a holistic and inclusive manner, involving the entire rare disease and paediatric community. We take part in and co-lead multi-stakeholders’ initiatives to advocate for this approach. The most recent is the Expert Group on OD Incentives, which brings together representatives of the rare disease community, including researchers, academia, patient representatives, members of the investor community and industry. These experts are working together to develop recommendations aimed at improving the European environment for the development of orphan medicines (1). With regard to the options proposed by the Commission: Firstly, they all require a clear understanding of unmet needs. There is no agreed common definition of this concept. While crucial, the absence of any treatment is not the only unmet need to consider. Disease severity, burden of illness and impact on the quality of life of patients, families and carers are also essential elements. We need a common understanding that considers all these components and the views of and benefits for all relevant stakeholders. Secondly, to assess unmet needs we need a comprehensive way to appropriately and timely identify rare disease patients in Europe. To achieve this, important pre-requisites include harmonised EU clinical diagnosis guidelines, full implementation of the ORPHA CODES and interoperability of disease registries. Such provisions are also key to reduce diagnostic delays. Thirdly, we note that curtailing incentives could risk significantly lower numbers of OMPs and Paediatric Medicines being developed, or in some cases threaten the survival of companies which solely produce them (2) and further affect the attractiveness of Europe as a region for innovation. Thus, we call for considering further measures to strengthen the incentives ecosystem. This approach should be coherent with the recently published EU IP Action Plan, which rightly takes into account the role of a strong, coherent and predictable IP framework in fostering competitiveness and innovation. Fourthly, with regards to paediatric, the way the current legislation has been implemented led to barriers to development of paediatric products. The criteria in the proposed options might further discourage innovation in the development of paediatric medicines, creating different speeds of development. Regarding the baseline options, we believe there is room for strengthening the current system by improving and streamlining the regulatory and HTA requirements for the authorisation of OMPs e.g. through more acceptance of Real-World Evidence (RWE) and Artificial Intelligence (AI); fostering closer European collaboration on HTA; closer alignment on requirements from EMA committees; evaluation and increased capacity building of PRIME scheme. The review of the Regulations will not directly provide solutions to improve access and affordability of paediatric and orphan medicines. To tackle these issues, cooperation and dialogue structures need to be established, involving Member States, medical and research community, biopharmaceutical industry and patients. In the attached document we elaborate on our proposed framework to strengthen the whole EU environment for the development of OMP and Paediatrics and we outline some recommendations to enact this holistic approach. (1) https://od-expertgroup.eu (2) https://www.eucope.org/study-economic-financial-challenges-of-developing-omps/
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Response to Revision of the Union legislation on blood, tissues and cells

14 Dec 2020

EUCOPE, the voice of small to mid-sized innovative companies active in the field of pharmaceuticals, bio- and medical technologies at the European level, shares the Commission’s views that the Blood Directive 2002/98/EC and the Tissues and Cells Directive 2004/23/EC (the BTC legislation) does not provide adequate measures for self-sufficient supplies of blood, tissues and cells and that divergent approaches at national level prevent exchange and utilisation of BTC. Also, as identified by the 2019 consultation it cannot cater for all the new scientific and technical developments that have taken place since its adoption. Amongst the three policy options we favour ‘option 3’ which would provide an adequate response to the inconsistencies of the regulatory framework. Technical standards should however still be maintained outside of legislative frameworks to ensure an easier adaptation to future technological advancements. The lack of harmonisation of evaluation at national level due to multiple authorities implementing the legislation, including for licensing and inspections leads to an unclear situation. Binding technical rules and specifications from the ECDC and EDQM should be based on best practices, inter alia Patient Blood Management (PBM) strategies, which help optimise delivery of blood to patients in both acute and chronic settings. For that reason, we call on the Commission to define Patient Blood Management in the context of the Blood Directive and to instruct ECDC and/or EQDM to develop PBM standards and to monitor their implementation at country level through regular audits. Concerned by the reliance on other geographies for plasma collection, EUCOPE asks the Commission to consider legislative and non-legislative options as well as risk-based regulatory flexibility to help Member States collect more plasma for fractionation to manufacture life-saving plasma-derived medicinal products (PDMPs). The Tissues and Cells Directive should clarify minimum requirements for collection, labelling, testing and storage/transport when tissues and cells are starting materials for ATMPs or non-viable tissue-derived products. Currently situations arise where ATMPs have been considered as medicinal products in one country but not in another and clarification of which legal framework is applicable at each stage of production that rely on BTC for manufacture is required, including for cross-border starting material transportation. Any EU-level mechanism on classification should not diverge from existing mechanisms or create a parallel system to ensure consistency in decision making, but rather use existing systems like the EMA Committee for Advanced Therapies. The lack of harmonised tissue authorisation licenses should be addressed with provisions for how a licensed medical product manufacturing site can procure, store and test cells and tissues from outside the single market. Further, there is a need for clear definition of rules for cells export and coding systems considering that cells are used for starting materials for the production of medicinal products. A risk proportionate approach should be reinforced where donor testing for tissues and cells collected for autologous use is proportionate to the risk posed to either donor or patient. Similarly, a risk proportionate approach to donor testing for non-viable tissues products for allogeneic use should be applicable where methods of processing can ensure the elimination of risks, such as virus inactivation. It should be clarified whether the Blood Directive can apply to starting materials for ATMPs since Article 3 of the ATMP Regulation 1394/2007 treats products containing cells and tissues as covered by the Tissues and Cells Directive while in practice some ATMP starting materials fall within the definition of Blood and Blood components. For clinical effectiveness meanwhile, it should be clarified that cell products fall under the ATMP framework where such matters are covered.
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Response to Details for the application dossier for the authorisation of a veterinary medicine

8 Dec 2020

Please find attached the comments of the European Confederation of Pharmaceutical Entrepreneurs AISBL (EUCOPE).
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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 Stella Kyriakides (Commissioner) and

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

Response to Intellectual Property Action Plan

13 Aug 2020

As the European trade association for innovative, often family-owned, small to medium-sized healthcare and life sciences companies located all over Europe, many of which are active in the field of rare diseases, EUCOPE endorses an exclusivity rights system that provides the predictability and certainty that is needed for these companies to partner up, compete successfully and accelerate the launch of new products. The suite of IP protection offered by the EU provides stability and predictability over time and is critical to incentivising high risk investments in medical R&D and thus fostering innovation. In fact, as far as small to medium-sized companies are concerned, one of the most important assets for them is the IP generated in those businesses. These companies usually hold a greater share of their value in the form of IP than larger competitors because they are less likely to own a significant base of tangible assets. The success of these businesses, and therefore of the development and distribution of innovative therapeutic solutions for patients, depends largely on the protection and growth of their IP assets. EUCOPE therefore welcomes the Commission’s aim to decrease the complexity and costs associated with the EU IP system. Yet it is important that flexible choices remain for owners to decide how to best obtain, utilise and enforce their IP rights in accordance with their field of technology, the size of the company and their business goals. The introduction of a unitary European SPC as an option based on the Unitary European Patent would thus contribute to improving the EU IP framework. EUCOPE welcomes efforts to increase access to information and advice on IP for small to medium-sized companies. Furthermore, some of our members propose for the Commission to strengthen its incentives framework in order to encourage industry-academia collaboration to facilitate knowledge transfer between the public and private sectors. Harmonisation of intellectual property and tech transfer policy could help further commercialise EU-funded research and innovation and generate value locally. We welcome the aim to harness the EU’s capacity to act as a global standard setter and promote global fair play. In this regard, AI technologies play a key role to many of our members and some would like to see the Commission carry out multilateral discussions, particularly in WIPO, with meaningful industry participation in order to enhance predictability and adaption of the existing patent system to emerging technologies, including AI. Policies that promote free cross-border exchange of data with robust patient information and IP safeguards should be considered to support the EU digital agenda and adoption of AI, advanced analytics and cloud computing. For EU industries to remain competitive and resilient it is key to have a solid framework in place which allows industry to continuously adapt and innovate while also ensuring innovations benefit the digital and green economy. An innovation-friendly environment, which contributes to the creation and growth of pharmaceutical- biotechnology- and medical device companies, and to the increased competitiveness of this European industry at large is essential to ensure that the most novel and innovative therapies are made available to patients across Europe. It is therefore important that the aims of the intellectual property action plan is implemented in a coherent way that is also carried forward across the whole range of Commission initiatives proposed under ‘A New Industrial Strategy for Europe’, including the pharmaceutical strategy for Europe and the review of the Paediatric and OMP Regulations.
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

6 Jul 2020

EUCOPE welcomes the European Commission’s ambition to create a holistic, patient-centred and forward-looking environment for pharmaceuticals and medical devices in Europe with its Pharmaceutical Strategy. With the COVID-19 crisis, the pharmaceutical sector demonstrated the potential for being a driving force for economic recovery and a key factor for healthcare systems’ resilience. EUCOPE’s members, a wide range of small to medium-sized companies active in pharmaceuticals, biotechnologies and medical technologies, play a key role in the European pharmaceutical environment. Some of them have unique profiles due to their highly specialised product portfolio, no or limited revenues to date, significant and continuously risky R&D investments, including on rare diseases and technologies such as OMPs and ATMPs. EUCOPE notes a disconnect between the identified issues and the actions proposed in the roadmap, which currently lacks concrete plans to promote the EU’s competitiveness, (re)investment in innovative therapies, and incentivise industry in adopting green technologies. The EU’s objective of ensuring greater access, availability and affordability should go along with enabling innovation by means of a strong incentive ecosystem. Adaptable yet clearer and faster regulatory pathways will be key to harness the potential of new technologies, such as ATMPs, nanotechnologies and digital applications for medical devices. On this, Real Word Evidence can support reduction of evidential uncertainty in R&D and contribute to faster patient access. In addition, there is room for strengthening cooperation among key stakeholders putting forward a robust HTA framework. Next to the need for supporting ground-breaking innovation, certain issues related to specific established medicines need ad hoc solutions as in the case of Antimicrobial Resistance. On reducing dependence on manufacturing from non-EU countries, rather than focus on reshoring, the EU should strengthen its existing production capabilities, seek regulatory convergence and reduce trade barriers to ensure diversity of supply sources. Appropriate regulatory frameworks and policies, which facilitate the availability of starting materials, such as human plasma to manufacture medicinal products, could support this. EUCOPE supports promoting administrative and regulatory simplification to be developed in a collaborative manner between industry and regulatory bodies in respect of EU and national division of competence. This would contribute to make Europe an attractive region for new technologies. EUCOPE welcomes the Commission’s intention to reinforce the European Medicines Agency via the Next Generation EU instrument, as we believe this will have a positive impact on the efficiency of EU regulatory activities. EUCOPE’s members are committed to ensure medicines availability in the entire EU. However, it needs to be borne in mind that, once marketing authorisation (MA) is obtained, there are substantial differences among Member States in terms of length, processes and evidence requirements preceding a national product launch. Thus, it would be very difficult to provide launch intention plans from a logistical and confidentiality perspective already at MA phase. This is particularly true for SMEs with their limited staffing and financial resources. EUCOPE acknowledges that joint procurement can be a useful tool in exceptional cases of cross-border threats as laid down in Decision 1082/2013/EU. However, it remains an undesirable approach when treated simply as a cost-containment tool due to the differences between Member States’ health systems. Where there is a real patient benefit in joint price negotiations and joint procurements, a holistic approach centred on the value of the medicine and health outcomes should apply. EUCOPE welcomes non-legislative measures to ensure coordination among Member States on innovation, supply of products, administrative simplification and transparency.
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Meeting with Stella Kyriakides (Commissioner) and

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

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

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

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

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

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

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

Meeting with 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

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

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

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

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

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

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

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

3 Apr 2019 · Key aspects of current EU files related to health

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

3 Apr 2019 · EUCOPE’s presentation and discussion about ongoing EU health files

Meeting with Vytenis Andriukaitis (Commissioner) and

15 Jun 2018 · HTA

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

7 Feb 2018 · Supplementary protection certificate; HTA

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

8 Jan 2018

EUCOPE, the European trade association for innovative pharmaceutical and biotech small to mid-sized and family-owned companies, welcomes the opportunity to provide feedback on the Roadmap published by the EU Commission on 11 December 2017 for the planned evaluation of the legislation on medicines for children and rare diseases. EUCOPE would first stress the recognised positive effects of the two Regulations on the development of medicines for children and for rare diseases. The EU Paediatric Regulation, based on a set of obligations and rewards, has proven beneficial with the authorisation of over 230 new paediatric medicines since its imple-mentation, the inclusion of paediatric development in companies’ product development processes and the substantial knowledge growth. Providing an incentives-based framework, the Orphan Medicinal Products (OMPs) Regulation has also proven highly successful in encouraging the development of new therapies for rare diseases from eight - before the adoption of the OMP Regulation - to 143 today and in increasing the prioritisation of rare diseases at national level. However, barriers to patient access remain at the national level. Acknowledging the complexities of implementing the Paediatric Regulation which may hinder further paediat-ric medicines’ development, EUCOPE has prescribed the use of non-legislative guidance, as outlined in its April 2017 Position Paper . However, EUCOPE would like to warn against the signal that this evaluation and any subsequent changes or potential proposals for revision might send outside the EU and internationally, at times when other similar legislations in other countries are under increased scrutiny. Furthermore, EUCOPE would welcome clarifications on the following: 1. Intended objectives of the EU Regulations on OMPs and on Paediatric medicines 2. The mentioned purposes and ultimate goal of conducting such an evaluation 3. The proposed methodology Attached, you will find EUCOPE's full feedback on the EU Commission Roadmap. About EUCOPE: The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) gives voice to small-to-medium sized innova-tive companies in the field of pharmaceuticals, biotechnologies and medical devices. EUCOPE represents 900+ mid-sized innovative pharma and biotech companies, directly and via national trade associations such as British EMIG, French France Biotech, German BPI or Swedish IML. EUCOPE membership includes innovative family-owned compa-nies such as B.Braun, Ferring, Grifols or Norgine as well as innovative companies active in the field of biotechnology and rare diseases. These consist of Achillion, Actelion, Aegerion, Akcea, Alexion, Alnylam, Amicus, Biogen, BioMarin, Blue-bird Bio, Celgene, Celsion, CSL Behring, Cytokinetics, Grifols, Horizon, Incyte, Intercept, Kite Pharma, CTRS, Medac, Miltenyi Biotech, Nordic Nanovector, Onxeo, Orphan Europe, Ovid, Prothena, PTC, Santhera, Santen, Sarepta, Shire, Sobi, Takeda, Tesaro, Vertex, Vifor Pharma, Zealand Pharma and Zogenix. For more information, please contact: Dr. Alexander Natz Delphine Roulland Secretary General Manager Public Affairs +32 (0) 2 842 69 82 +32 (0) 2 842 69 81 natz@eucope.org roulland@eucope.org
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Response to Definition of the concept "similar medicinal product"

27 Nov 2017

1. General Comments The European regulatory framework, the incentives as defined in the Orphan Medicinal Product Regulation (EC) 141/2000 and the accompanying Commission Regulation EC 847/2000 have successfully stimulated research and development of orphan medicinal products. Until 2000, research for therapies treating rare diseases was scarce due to the complexities of research and the limited commercial attractiveness linked to the small number of patients per disease. As a positive result of the Regulation, 141 orphan medicinal products have been authorised providing patients with treatments for a variety of severe and life threatening rare diseases. EUCOPE would like to stress the vital importance of maintaining a favourable regulatory environment to continue to see progress in treating rare diseases. While we understand assessment of similarity will always be done on a case by case basis it would be useful to have specific examples demonstrating the interpretation of the text in each category. This can also be done in a separate complementary guideline or Q&A. The complementary guideline or Q&A should be released at the same time as the final regulation to avoid a period of uncertainty in implementing the revised definition. 2. Article 1 (2.1) Biological medicinal products - proteinaceous substances: The draft Regulation defines similar monoclonal antibodies (mAB) based on their “mechanism of action” as it refers to “binding” to epitopes, whereas the remaining definitions throughout the Regulation are based on the “principal molecular structural features”. The definition for mAB should also be based on the concept of the “principal molecular structural features” to provide better clarity and certainty to developers of mABs and also to be harmonized with the remaining definitions in the Regulation. In particular, the similarity assessment for monoclonal antibodies should be based on the Complementary Determining Region (CDR) sequences or the additional structural elements relevant for function of the mAB, which are both elements of the molecular structural features of monoclonal antibodies. We therefore believe that Article 1 (2.1) last paragraph should be amended as follows: “Two monoclonal antibodies, monoclonal antibody conjugates or fusion proteins could be determined to be non-similar if different Complementary Determining Region (CDR) sequences of the antibody or the additional structural element of the conjugated or fused monoclonal antibody, or other functionally relevant sequences significantly affects the biological and functional characteristics of the substance” 3. Article 1 (3) Advanced Medicinal Products We appreciate the addition of the section on advanced therapy medicinal products and support the general principle of reliance on differences biological and functional characteristics when similarity cannot be established on the basis of principle structural molecular features. However, further elaboration on what is considered a "significant impact" and clarity on the level of evidence expected is needed to establish a consistent implementation of the revised definition. It is also important that this concept is not confused with 'significant benefit,' which must be demonstrated in case two products are found to be similar. This can be done in a complementary guideline or Q&A from the EC and EMA. Clarification on how non-similarity will be established on the basis of manufacturing differences is also needed. Manufacturing details are highly confidential and it may be difficult for applicants to make meaningful comparisons with other products. Further guidance on methodology that can be used to demonstrate non-similarity on the basis of manufacturing differences is to be provided in complementary guidelines.
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Meeting with Rolf Carsten Bermig (Cabinet of Commissioner Elżbieta Bieńkowska)

5 Oct 2015 · new off-lable rules in France

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

13 Apr 2015 · Off-label use of medicines