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Medicine Access: EU Health Union Promises Equitable Distribution

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Medicine access has been significantly advanced with the formal establishment of the European Health Union, marking one of the key milestones of the current European Commission mandate on health. Prompted by the need for coordinated action during the pandemic, the Health Union aims to improve access to medicines, ensuring they are available, accessible, and affordable.

The generic, biosimilar, and value-added medicines industry provides 70% of the medicines dispensed in Europe and 9 out of 10 critical medicines. Equitable access to essential off-patent medicines relies on several critical factors:

  • Timely conclusion of the revision of the pharmaceutical legislation
  • Establishment of a Critical Medicines Act to ensure the security of medicine supply
  • Continued investment in health challenges, including medicines manufacturing, timely off-patent medicines competition on Day-1 after IP expiry, fighting antimicrobial resistance (AMR), embracing digital tools, and pragmatic regulatory flexibilities

Commenting on the establishment of the European Health Union, Adrian van den Hoven, Director General of Medicines for Europe, said, “The EU Health Union was built on some of the very hard-learned lessons during the EU response to COVID-19. We commend this initiative and call on the EU to level it up by improving equitable and timely access to medicines for those who need it most in the Pharma review. Through the Critical Medicines Alliance, we will work for a Critical Medicines Act to strengthen manufacturing and reduce shortages, which we hope to be prioritized in the first 100 days of the next Commission mandate.”

The European Health Union is built on the principle of ensuring that all EU citizens have equitable access to essential medicines. This initiative is a response to the vulnerabilities exposed during the COVID-19 pandemic, where coordinated action was critical in managing the crisis. The establishment of the Health Union marks a significant step towards a more resilient and integrated health system in Europe.


Medicine Access: Key Pillars of the European Health Union’s Strategy for Equitable Distribution

1. Pharmaceutical Legislation Revision: The timely revision of pharmaceutical legislation is crucial to adapt to the evolving needs of the healthcare sector. This includes updating regulations to ensure that medicines are safe, effective, and available to all who need them. The revision process aims to address the challenges posed by new health threats and to streamline the approval and monitoring of new medicines.

2. Critical Medicines Act: The proposed Critical Medicines Act is aimed at securing the supply of essential medicines. This legislation would ensure that critical drugs are always available, reducing the risk of shortages. The act would also promote local manufacturing and reduce dependency on non-EU suppliers, thereby enhancing the resilience of the European healthcare system.

3. Investment in Health Challenges: Continued investment is essential to tackle various health challenges. This includes supporting the manufacturing of medicines, ensuring that off-patent medicines are available immediately after intellectual property (IP) expiry, combating antimicrobial resistance (AMR), and leveraging digital tools for better health outcomes. Pragmatic regulatory flexibilities will also be necessary to adapt to new challenges quickly.

Medicines for Europe, representing the generic, biosimilar, and value-added medicines industries across Europe, plays a crucial role in this initiative. The organization is committed to providing sustainable access to high-quality medicines based on five important pillars: patients, quality, value, sustainability, and partnership. Its members employ 190,000 people across over 400 manufacturing and 126 R&D sites in Europe, investing up to 17% of their turnover in R&D.

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The organization’s manifesto, “Levelling up the European Health Union,” outlines its vision for the future of healthcare in Europe. By focusing on equitable access to medicines and improving health outcomes, Medicines for Europe aims to support the goals of the European Health Union.

The establishment of the European Health Union marks a significant step towards ensuring equitable access to medicines for all EU citizens. By addressing key challenges in pharmaceutical legislation, securing the supply of critical medicines, and investing in health challenges, the Health Union promises to deliver a more resilient and fair healthcare system. As the initiative progresses, continued collaboration and investment will be essential to realizing its full potential and improving health outcomes across Europe.

Resoruce: Medicine for Europe, May 30, 2024

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