The Council of the European Union, composed of the ministers of the European Union’s (EU) 27 member states, took a step forward this week (June 4, 2025) on pharmaceutical policy reforms, by agreeing to its position on the European Commission’s so-called “pharma package,”  the largest reform to the EU’s laws on medicines in more than 20 years. This now setting the stage for negotiation by the Council and European Parliament to reach a final agreement on the reforms.  

This is the latest step in what has become a multi-year process for EU pharmaceutical reform. The European Commission began the process for the proposed reforms in November 2020 by issuing its Pharmaceutical Strategy for Europe. The strategy kick-started a revision of current pharmaceutical legislation that sought to respond to current challenges faced in the EU’s pharmaceutical sector. In April 2023, the European Commission published its “pharma package” with several major goals, including improving access to affordable medicines, enhancing security of supply and mitigating drug shortages, increasing the competitiveness of the EU’s pharmaceutical industry, and mitigating the environmental impact of pharmaceuticals. With the Council agreeing to is position on the pharma package this week ( June 4, 2025), the Council and the European Parliament now have to reach an agreement on the final shape of the new rules. 

The Council’s position 
The Council’s mandate for negotiations with the European Parliament introduces several key amendments to the proposed legislation as outlined below.  

Regulatory data protection: Under the Council’s mandate, companies producing innovative medicines will be able to prevent competitors from accessing the data used to develop those medicines for eight years. 

Regulatory market protection: In addition, under the Council’s mandate, producers of innovative medicines will benefit from one year of regulatory market protection, extendable to two years if certain pre-defined key objectives are achieved. 

Obligation to supply: The Council is adding a new measure to give EU member states the power to oblige the marketing authorization holder of a medicinal product to make that product available in sufficient quantities to cover the needs of patients in the member state. 

Transferrable exclusivity voucher: The Council has introduced a new clause stipulating that a transferred voucher can only be used in the fifth year of the regulatory data protection period, and only if the marketing authorization holder demonstrates that the annual gross EU sales of the product have not exceeded EUR 490 million ($561 million) in any of the preceding four years. 

Intellectual property exemption for generic medicines: In order to support earlier market entry of generic and biosimilar medicinal products, the Council’s mandate further clarifies the scope of the so-called ‘Bolar exemption’ and expands it to include submissions for procurement tenders.  

Industry response 
Both the innovator drug industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the generics and biosimilar industry, represented by Medicines for Europe issued statements this week (June 4, 2025) on the pharma packing. EFPIA was largely critical of the proposed reforms while Medicines for Europe broadly supported the action with certain specific issues of concern.  

“[The] announcement from the EU Council of Ministers on the revision of the General Pharmaceutical Legislation represents a missed opportunity to position Europe’s life sciences sector at the forefront of global competition, said EFPIA in a June 4, 2025, press statement. “In the face of a highly disruptive and unpredictable global environment, Europe needs clarity, stability, and a future-proof regulatory framework to support pharmaceutical innovation. While a significant number of EU member states have acknowledged the urgency of reinforcing Europe’s competitive edge, the text falls short of delivering the bold action Europe needs.” 

EFPIA was specifically critical of measures to reduce execlusivity. “The choice to reduce intellectual property protections for pharmaceutical companies makes Europe less attractive, discouraging investment and jeopardizng the development of innovative treatments in Europe without addressing the underlying barriers and delays to patient access,” said EFPIA in its June 4, 2025, statement.  

It also raised concerns over overall competitiveness for the EU’s pharmaceutical industry. “As the legislative process enters its final phase, EFPIA urges EU decision-makers to consider the long-term consequences,” said EFPIA, in its statement. “If Europe is to remain competitive and continue to deliver cutting-edge healthcare solutions, it must provide a predictable and globally competitive environment for research, development and manufacturing.” 

Meanwhile, Medicines for Europe, which represents generics and biosimilar companies and manufacturers in Europe, issued broad support for the package, but raised specific issues it considered important. “Medicines for Europe supports this reform provided it can truly deliver on equitable access to medicines for all Europeans and it contributes to increasing the security of supply of medicines,” said the association in a June 4, 2025, statement.  

In its statement, Medicines for Europe highlighted several issues of particular interest and concern as outlined below.  

Exclusivity provisions. The association said it “would oppose attempts to extend incentives and intellectual property rights” which it says “already provide the longest monopoly protections in the world. “ 

Security of supply. The association is calling to Increase harmonization of rules for better access and security of supply for patients in all EU member states. It is also calling for the pharmaceutical package to align with the objectives of the European Medicines Agency’s  extended mandate legislation to facilitate the use of digital tools to prevent and mitigate medicine shortages. 

EU investment. Medicines for Europe is also calling for regulatory and market incentives to ensure there is more investment in Europe and that more patients benefit from access to innovation in all member states.  

Repurposing of drugs. The association also said that the repurposing clause should be extended to ensure more investments in major public health needs, such as antimicrobial resistance and the EU’s upcoming cardiovascular strategy.   

Active pharmaceutical ingredients (APIs). The association is calling for the Bolar exemption to be harmonized to encourage API development in Europe and to stop unnecessary and anti-competitive delays to generic or biosimilar competition at loss of exclusivity.  

Regulatory reform. Medicines for Euorpe is also calling for tegulatory measures to increase European competitiveness globally such as single global development, timely generic and biosimilar marketing authorization procedures and clear deadlines for setting up a system for electronic product information to  improve access to medicines.  

Source: The Council of the European Union, EFPIA, and Medicines for Europe