Monday, July 15, 2024

It is time for the European Union (EU) to initiate action by enacting a Medicines Security Act to ensure health security

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The off-patent medicines industry plays a vital role in Europe, providing approximately 70% of the medicines patients receive across more than 80% of therapy areas. These generic, biosimilar, and value-added medicines ensure affordability, accessibility, and availability of treatment options, especially during critical times like the COVID-19 pandemic, where they constitute a substantial portion of ICU medicines.

The “Resilient EU2030” report, released by the Spanish Presidency of the Council of the EU, emphasizes the need to bolster supply chains, manufacturing capacity, and strategic autonomy concerning off-patent medicines and active pharmaceutical ingredients (APIs). Medicines for Europe and its members share these objectives and advocate for the establishment of a Medicines Security Act, in alignment with the Critical Medicines Act proposed by Member States, to realize this vision.

For the initiative’s success, Europe requires:

Market and procurement reforms prioritize the security of medicine supply chains to prevent consolidation and dependency on other regions.
Investment from EU funds and State Aid in eco-friendly and secure manufacturing processes for essential medicines and APIs.
The digitalization of the regulatory system, utilizing databases like the EU serialization system, enhances the prediction and management of medicine shortages through inter-member State solidarity.
A clear intellectual property (IP) system that encourages the day-one launch of off-patent medicines, preventing the outsourcing of their development and manufacturing. This is especially crucial for biosimilar medicines, where Europe has a pioneering role and the potential to enhance equitable patient access.
Increased collaboration with significant international manufacturing partners such as the United States, India, and others.

Elisabeth Stampa, President of Medicines for Europe, expressed anticipation ahead of the European Council meeting and the forthcoming European Commission communication on medicine availability. She highlighted the timeliness of discussions and emphasized the shared priority of increasing investment in API and medicine manufacturing, aiming to secure equitable access and a stable supply of off-patent medicines for millions of patients who depend on them.

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