Tackling EU supply chain challenges while boosting innovation

As EU Health Ministries approach the final stages of negotiations on the future of Europe’s pharmaceutical rules, Medicines for Europe has called for key actions to ensure medicine supply is protected in the region.

Alongside other actions, the organisation proposed that health is central to all political decisions and to conclude the EU pharmaceutical reform.

“This is not just another technical EU policy,” the organisation argued, but is about ensuring treatment access for patients in Europe, preventing medicine shortages, restoring production to the region, building fairer and more robust health systems, as well as sustainability-focused investment.

According to Medicines for Europe, the European Commission’s proposal provides a solid foundation to:
• Eliminate inequalities for patients and ensure fair medicine access. The reform of regulatory incentives should be a balanced compromise between Member States and allow earlier and more equitable access to off patent medicines.
• Support affordable treatment by boosting market competition on Day 1 following patent expiry
• Prevent medicine shortages via improved EU coordination and digital tools
• Foster smarter and economic innovation on off-patent medicines by also allowing ‘new pharmaceutical forms’ to be considered as a repurposed medicinal product.

Ensuring EU medicine supply amid pharmaceutical reforms

Medicines for Europe emphasised that this reform must be united with determined progress on the Critical Medicines Act (CMA).

The organisation insisted that Europe must plan to restructure its capacity to produce essential off-patent medicines, “via securing funds for critical medicines in the upcoming EU budget and deliver bold state aid reforms for critical medicines and API production”.

“The Draghi Report evidence is overwhelming that competition stimulates productivity, investment and innovation. Now, some companies are shifting production to the US. That is no reason to delay reforms that serve European patients.

“We urge States to support the needed reforms on the CMA and EU Urban Wastewater Treatment Directive (UWWTD) and importantly, to resist pressure to stall negotiations on the pharmaceutical legislation over transatlantic trade tensions,” Medicines for Europe stated.

The industry group further called for the EU to:
• Advocate a US and EU deal for the free passage of pharmaceuticals between markets
• Support the Critical Medicines Act
• Ensure timely entry of generic medicines.

“There is no reason to extend exclusivity periods in Europe, there is actually a strong case to reduce.” Specifically, a reduction from 11 to nine years could save €10 billion annually, Medicines for Europe asserted, specifying that it “would increase access to medicines in Eastern European countries”.

Ultimately, with the industry “rooted in Europe”, the organisation added that appropriate policies are needed, for example, to support security of medicine supply.