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McKesson Europe fully supports the European Commission’s (EC) evaluation of the General Pharmaceutical Legislation. We strongly believe that the EU’s General Pharmaceutical Legislation is overdue a comprehensive review. The EC needs to utilize this opportunity and make General Pharmaceutical Legislation more effective for European patients.

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 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…

McKesson Europe fully supports the European Commission’s initiative “Digital health data and services – the European health data space”. We would like to use this opportunity to contribute to the ongoing roadmap consultation and flag areas where EU policy action can further be improved.

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) 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.

McKesson Europe fully supports EMA’s extended role in addressing public health emergencies including their new role in monitoring medicine shortages. We also support EMA’s definition of medicine shortages as defined in Art. 2 / (d) of the regulation ( “shortage” means that supply of a medicinal product for human use or a medical device does not meet demand for that medicinal product or medical device”).

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.