Saturday, April 20, 2024

Advancing Medicine Supply Chain Security and Manufacturing for Enhanced Public Health

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The off-patent medicines industry is a vital contributor to Europe’s healthcare system, providing approximately 70% of the medicines dispensed to patients across more than 80% of therapy areas. Medicines for Europe, a prominent industry association, is firmly committed to collaborating with the European Union (EU) to ensure a stable and secure supply of essential and critical medicines that are essential for public health.

Recently, the European Commission released a significant communication addressing the issue of medicine shortages in the EU. This development represents a pivotal step towards addressing the root causes of medicine shortages and ultimately laying the groundwork for a Critical Medicines Act. To effectively advance these efforts, the following key components should be incorporated:

  1. Legal Guidance on Medicines Public Procurement and Supply Security: Establish clear legal guidelines to govern the public procurement of medicines and ensure the security of supply, which is essential to preventing shortages.
  2. Creation of an EU Reserve of Essential Medicines: Develop a strategic EU reserve specifically dedicated to essential medicines, ensuring that critical pharmaceuticals are readily available during times of need.
  3. Incentivizing Greener and More Secure Manufacturing Processes: Facilitate investments in more environmentally friendly and secure manufacturing processes for essential medicines and active pharmaceutical ingredients (APIs) through EU funds and State aid projects.
  4. Digitalization of Regulatory Systems: Promote the digitalization of regulatory systems, enabling increased transparency and solidarity in the allocation of medicines during shortages. Leveraging data, including information from the European Medicines Verification System (EMVS), can significantly enhance the overall visibility of medicine distribution.
  5. Regulatory Flexibility: Implement regulatory flexibility in terms of harmonizing pack sizes and presentations, thereby reducing unnecessary complexities within the medicine supply chain.

Elisabeth Stampa, the President of Medicines for Europe, hailed the release of the Commission’s communication as a positive initial step towards ensuring the security of medicine supply. She emphasized the commitment of Medicines for Europe to collaborate with the EU in implementing these crucial reforms. By aligning market policies, regulatory frameworks, and state aid strategies, there’s an opportunity to harness private sector investment and manufacturing expertise to restore strategic autonomy in the pharmaceutical sector, a pivotal component of public health.

The adoption of these recommendations would not only enhance the security of the medicine supply but also promote sustainability and innovation in the off-patent medicines industry. This collaborative effort holds the potential to address critical healthcare needs, improve patient access to essential medicines, and bolster the overall public health infrastructure in Europe.

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