EU pharmaceutical reform: Balancing access, innovation, and concerns

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EU pharmaceutical reform: Balancing access, innovation, and concerns

After much anticipation, some leaks, and several delays, the European Commission has unveiled its latest proposal for a new regulation and directive to replace the existing provisions on medicinal products within the EU. However, the proposal has been met with widespread discontent from major stakeholders, leaving no one truly satisfied. Let’s explore the driving forces behind the proposed reform, its underlying rationale, and the main areas of criticism.

Shaping the new legal framework: The ‘3A’ formula

The EU aims to create a more appealing European market for companies interested in investing in research and development (R&D) related to medicinal products, and a more competitive landscape for the pharmaceutical industry.

This objective is clearly outlined in the Commission communication entitled ‘A Pharmaceutical Strategy for Europe’, adopted on 25th November 2020 and supported by the fourth EU health programme ‘EU4Health 2021-2027’, established through Regulation (EU) 2021/522 on 21st March 2021.

The reform’s numerous objectives include:

  • Fostering pharmaceutical innovation
  • Ensuring accessibility to innovative medicines across all EU member states
  • Promoting economic and environmental sustainability within the pharmaceutical market.

Nevertheless, the goal of this reform remains to improve the health outcomes of European citizens. The Commission believes that all individuals should have the opportunity to access a wide range of available medicinal products at reasonable prices across all 27 EU member states.