Polpharma Group Supports Urgent EU Action to Safeguard Access to Medicines and Strengthen European Pharmaceutical Sovereignty

As a member of Medicines for Europe, Polpharma Group joins industry leaders in calling on EU Prime Ministers to adopt a 5-Point Pharmaceutical Action Plan to protect patients, boost manufacturing, and ensure fair competition

AMSTERDAM, June 05, 2025 (GLOBE NEWSWIRE) -- Polpharma Group, a leading European pharmaceutical manufacturer, has joined fellow members of Medicines for Europe in signing an open letter addressed to the Prime Ministers and Ministers of Health of all 27 EU Member States. The letter calls for urgent political action to adopt a targeted Pharmaceutical Action Plan that will protect patient access to medicines and support a competitive, sustainable pharmaceutical industry in Europe.

The letter, signed by CEOs and senior executives from across the European off-patent medicines sector, focuses on the need to:

1. Accelerate the adoption of the EU pharmaceutical legislation, with a strong emphasis on:

• Maintaining the current 11-year regulatory exclusivity period to avoid unnecessary healthcare costs.
• Strengthening and harmonizing the Bolar exemption, enabling generic and biosimilar medicines to enter the market immediately after patent expiry, ensuring faster access for patients and savings for healthcare systems.
  

The threat of U.S. tariffs should not justify extending Europe's intellectual property (IP) protection, which is already the most generous in the world. Any IP extensions would strain public health budgets and fail to prevent production shifts abroad, as already announced by several originator companies. The letter also stresses that EU countries spent €20 billion on just 5 top medicines in 2024. The simulation, based on the originator extension claims (13 to 18 years), for only 15 molecules shows that the costs for healthcare budgets would be between €20 billion and €100 billion.

2. Avoid harmful legislative overlaps, such as those in the Urban Wastewater Treatment Directive (UWWTD), which-if not amended-could unintentionally disrupt medicine supply and increase costs for patients.

For example, in the Netherlands alone, the cost of diabetes medicine metformin is expected to increase by up to 875%, and the antibiotic amoxicillin up to 400%.

3. Support critical medicines production, through initiatives like the Critical Medicines Act (CMA), which should be aligned with industrial and health security goals.

98% of on-patent investment is going to the US, while only 1% is going to the EU.

Markus Sieger, CEO of Polpharma Group, commented:
"Europe must act now to protect its patients and its pharmaceutical sovereignty. The off-patent industry is investing in Europe, but we also need a stable, competitive, and innovation-friendly environment to continue doing so. The 5-Point Action Plan is a pragmatic and urgent roadmap to ensure that essential medicines remain accessible, affordable, and manufactured in Europe."

Polpharma Group remains committed to working with EU institutions and national governments to build a resilient, sustainable, and patient-focused pharmaceutical ecosystem in Europe.

Source: Polpharma Group

Beata Zdunczyk-Goledzinowska Corporate Communications Head M: [phone] [e-mail] Grazyna Stachowska Corporate PR Content Expert M: [phone] [e-mail]