European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)

EUCOPE welcomes the European Commission's targeted revision of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), recognising it as a timely opportunity to improve predictability, reduce unnecessary regulatory burdens, and strengthen Europe's competitiveness.

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) represents small to mid-sized innovative companies in pharmaceuticals, biotechnology, and medical technologies across Europe. EUCOPE welcomes the European Commissions initiative to revise the MDR and IVDR to ensure a more predictable, proportionate, and innovation-friendly framework.

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 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…

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.

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.

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), representing predominantly small- and mid-sized innovative pharmaceutical companies, views Part I of the European Commissions proposed European Biotech Act as a timely and promising initiative.

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) supports the European Commissions initiative to develop a Biotech Act and its overarching objective to reinforce the biopharmaceutical research and innovation ecosystem, allowing companies to thrive in the EU.

The European Biotech Act Part I contains several welcome healthcare policy measures. To fully realise its objectives, EUCOPE has identified a set of additional recommendations for the Biotech Act Part II: Reframe biopharmaceutical spending as strategic investments; Promote uptake of biotechnology; Enhance biomanufacturing cooperation with international partners; Scale-up genome sequencing capability and newborn…

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) supports the European Commissions initiative to develop a European Innovation Act, and its overarching objective to reinforce the EUs innovation ecosystem and close the innovation gap with its global competitors.

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) welcomes the proposal on the European Health Data Space (EHDS). It recognises the importance of EU-level data collection standards and the promotion of data interoperability and exchange protocols. However, such a domain-specific common data space is expected to face challenges. Therefore, we submit the following recommendations.

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.

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) is the voice of small to mid-sized innovative companies active in the field of pharmaceuticals, biotechnologies and medical technologies at the European level.

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.

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…

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.

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.

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 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 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 European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) welcomes the draft Commission Implementing Regulation setting out the technical requirements, interoperability, and operational framework for HealthData@EU under Regulation (EU) 2025/327.

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) represents small and mid-sized innovative companies in the pharmaceutical, biotechnology and medical technology sectors across Europe. EUCOPE welcomes the opportunity to comment on the draft implementing regulation setting out minimum metadata elements and their characteristics for dataset descriptions required from health data holders under Article…

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.

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).

EUCOPE, the European association with a strong focus on small to medium-sized companies active in pharmaceuticals and biotechnologies, welcomes the Commission’s proposal for a regulation 2020/0321 to reinforce the role of the European Medicines Agency (EMA) in crisis preparedness and management for medicinal products and medical devices.

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 2020/0322 within the framework of better cross-border crisis preparedness and management.