Polpharma Group Calls for Urgent Action to Protect early equitable access to medicines for European patients

Polpharma Group Joins the Call to Action to Finalize Pharmaceutical Reform and Secure Early and Sustainable Healthcare for European Patients

WARSAW, Poland, May 14, 2025 (GLOBE NEWSWIRE) -- Polpharma Group, a leading pharmaceutical company, urges the European Union to take decisive action to conclude the pharmaceutical reform and strengthen Europe’s capacity to produce essential medicines. We advocate for early access to generics to optimize health payer budgets and enable treatments for more patients. In the face of unprecedented geopolitical uncertainty, it is crucial to place public health at the center of all political decisions.

Commitment to Health Security

Public health is a fundamental right. As EU Health Ministries approach the final stages of negotiations on the future of Europe’s pharmaceutical rules, Polpharma Group emphasizes the need to ensure that every European has access to the medicines they need. This is about avoiding shortages, bringing production back to Europe, and making our health systems more resilient and fair.

Key Recommendations

1. Reduced Periods of Exclusivities = increases healthy Competition

On-patent pharmaceutical companies are pushing for extended exclusivities in Europe as part of the late-stage revision of the EU pharma legislation. This move, spurred by the threat of tariffs, aims to stifle competition from the off-patent medicines industry. The EU already has the longest exclusivity period in the world, and extending it further would only hinder competition and delay access to affordable medicines.

2. Timely Access = Savings to Healthcare Systems

The needs of patients are growing faster than health systems can manage. Extending exclusivities would exacerbate this issue, as health systems in Europe are already struggling with exponential medical care costs. Innovation is happening globally, and what drives access to medicines - it is competition among equivalent medicines after patent expiry, not extended exclusivities. Early entry of off-patent medicines has been proven to save costs for health payers, with significant price reductions observed upon entry from minus 25 up to 75% upon first and multiple entrants.

3. Investment in EU Manufacturing = Security of Supply

Off-patent medicines bring access, competition, and effective savings. It is crucial to ensure these medicines are manufactured in Europe at proximity of patients. The COVID-19 pandemic highlighted the fragility of supply chains, and shorter exclusivities would allow faster sourcing of generics, thus improving medicines security. Recently proposed by EU Commission Critical Medicines Act (CMA) is designed to address this issue. As Polpharma Group large European based manufacturer we strongly advocate to make this act equipped with strong "toolbox” to invest in the European pharmaceutical sector.

Polish Presidency's Aspiration to Close Pharmaceutical Directive position in the Council

The Polish Presidency has been highly ambitious in working towards the alignment of member states position on Pharmaceutical Directive. It is in view of securing early access to medicines for more patients thus increasing the medicines security for Europe. As Polpharma Group we strongly support this ambition. Time is of the essence.

Polish Presidency has set ambitious goals for the safety of European citizens, encompassing not only military, food, and hybrid attack protection but also medicines security. During the Polish Presidency, Critical Medicines Act (CMA) has been presented by Health Commissioner Varhelyi and as significant actions have been taken in the European Parliament to advance legislative process under the SANT Committee leadership. It is critically important to secure dedicated funds for investments under the CMA in the Multiannual Financing Framework for 2027-2032.

Financial Impact of Extended Exclusivities

Extending exclusivities could cost health systems up to €20 billion extra per year. In contrast, generic medicines, which account for 70% of those dispensed in Europe, have saved health systems over €100 billion. Biosimilar medicines have generated €56 billion in savings since 2006. The EU’s system of data exclusivity of 11 years means generics wait up to 11 years to enter the market, compared to just 5 years in the U.S., providing faster access to savings for health payers.

Struggling Health Systems

Off-patent medicines are a crucial lever to support these systems. Early entry of generics has been proven to save costs, with significant price reductions observed upon generic entry. The current IP framework in Europe is delivering on innovation, and there is no evidence that extending exclusivities would drive further innovation.

Polpharma Group Call to Action

Polpharma Group calls on the EU to resist attempts to derail the review of pharmaceutical legislation and back competition for the benefit of patients.

Ensure timely entry of generics to strengthen competition, improve access to medicines, and alleviate the impact on health budgets. A reduction of data exclusivity periods from 8 to 6 years could save up to EUR 10 Bn per year.

A unified Bolar clause to ensure Day 1 entry is essential and would increase access to medicines in Eastern European countries.

Support the CMA to strengthen supply chain resilience and facilitate investment into Europe.

Advocate for a US-EU deal to ensure the free movement of pharmaceuticals, benefiting patients.

Polpharma Group calls on the EU to resist attempts to derail the review of pharmaceutical legislation and back competition for the benefit of patients.

The current review of the Pharmaceutical Directive can rebalance exclusivities, increase competition, and ensure timely access to medicines. It’s time for Europe to take responsibility, finalize the pharmaceutical reform, empower the Critical Medicines Act, and protect patients.

Quote from Markus Sieger, CEO of Polpharma Group:

"In these challenging times, it is imperative that we place public health benefit at the forefront of our political decisions. The Pharmaceutical Directive revision and the Critical Medicines Act are crucial steps towards ensuring that every European has access to the medicines they need and when they need. At Polpharma Group, we are committed to supporting these legal initiative and we are advocating to enhance competition, drive all incremental innovation, and secure the supply of essential medicines for all. The active role of the Polish Presidency in promoting the security and early access to medicines highlights our dedication to the safety and well-being of European citizens."

About Polpharma Group

Polpharma Group is a leading off-patent pharmaceutical company dedicated to improving health and quality of life. With a strong commitment to innovation and sustainability, Polpharma Group continues to drive advancements in the portfolio of essential medicines we offer to patients in Europe and globally.

Source: Polpharma Group

Beata Zdunczyk-Goledzinowska
Corporate Communications Head
M: +48 693 307 630
beata.zdunczyk-goledzinowska@polpharma.com

Grazyna Stachowska
Corporate PR Content Expert
M: +48 885 610 273
grazyna.stachowska@polpharma.com