EPF Statement on The  Pharmaceutical Legislation

Renewed support to the ambitious objectives of the pharmaceutical package

The European Commission's proposal to revise the EU pharmaceutical legislation after 20 years of implementation is an initiative that has been widely welcomed by the patient community. We especially applauded the objectives of improving access to medicines and promoting their affordability and availability, particularly as they were supported by concrete and ambitious measures.The proposals for a directive and a regulation were then further enriched and improved in many respects by the European Parliament. In particular, it included a number of provisions to strengthen patient involvement across the regulatory lifecycle and introduced an innovative mechanism to improve transparency and promote equitable access to medicines across Europe.

Speed vs. Patients outcomes: Finding the right balance

The objective of reaching an agreement between the European Parliament and the Council before 10 December is perfectly legitimate. After 2.5 years of negotiations since the European Commission’s proposal, it is indeed necessary to finalise the legislative process soon, considering that the full implementation of the new framework will require approximately 18 months. As further revisions to this colossal legislative package will not be feasible for many years, it is essential to get it right now, ensuring that every measure is assessed through the lens of its direct impacts on patients and public health.

Therefore, we strongly urge the EU institutions to ensure that this potentially final trilogue keeps patients’ needs at its core and avoids any outcome that may prove inadequate due to insufficient deliberation. The framework to be discussed next week must be robust enough to uphold the ambition and vision of the proposal. It should be built to meet the needs of today’s patients while remaining able to respond to those of tomorrow.

Key principles that the final agreement must preserve

• Intellectual property: Modulation of the duration of protection to strike a balance between supporting public health objectives, such as addressing patients’ unmet needs (defined with patients) and conducting R&D in Europe, while promoting equitable access. To ensure a competitive market that facilitates the timely entry of generics and biosimilars, the total duration of data and market protection should not be extended.
• Shortages: Maintain a high level of protection for patients against shortages, including the maintenance of shortage prevention plans for all medicines as well as meaningful patient involvement in the reporting and management of shortages.
• Access: Measures to mandate the submission of an application for pricing and reimbursement in all Member States that request it to promote effective and timely patient access. To ensure that all parties negotiate in good faith, clear deadlines accompanied by well-defined and effective sanctions must be established. This is all the more important in view of the potential impacts of U.S measures on companies’ launch strategies. We further call for complementary approaches under other EU pieces of legislation, including an effective joint procurement mechanism under the Critical Medicines Act.                                          
• Transparency: Maintenance of all provisions proposed by the European Commission and the European Parliament on transparency, particularly regarding public funding received for the development of new medicines. The European Parliament’s proposal for an EU Access to Medicines Notification System should be supported.
• Patients’ access to objective and reliable information: Paper leaflets should remain available, alongside electronic formats. The package leaflet should be better tailored to the needs of patients and include a key information section, information on disposal and, where possible, on the environmental footprint to support the choice of less polluting alternatives.
• Participation: Preserving the effective and cross-cutting participation of patient representatives, in accordance with the proposals of the Commission and the European Parliament, including the maintenance of their representation and voting rights within the Committee for Medicinal Products for Human Use (CHMP).

The acceleration and accumulation of legislative processes is detrimental to the democratic debate

In parallel with the negotiations on the pharmaceutical package, the publication of the proposed regulation on critical medicines in March 2025, with the aim of reaching compromises for both the European Parliament and the Council before the end of the year, has put considerable pressure on patient organisations, institutional actors and other stakeholders.

At the same time, the number and pace of legislative proposals in the health field continues to grow. A first regulation on biotechnology, the EU Cardiovascular Health Plan, and the revision of the regulations on medical devices are expected to be published by the European Commission on 16 December. The urgency with which these texts are drafted and presented, often without a proper impact assessment, carries significant risks that the proposed measures will be inadequate to address patients’ needs, difficult to enforce and/or ineffective.

The reduction in the time allowed for discussion of proposals in the European Parliament and in the EU Council limits democratic debate. It also makes it difficult for civil society organisations to actively represent the interests of European citizens. Patient and public health organisations are even less able to operate in a constant state of emergency since the European Commission cut their operating grants in 2025. This decision has significantly reduced the resources they can allocate to participation in EU policy-making processes that directly affect the communities they represent.

As end-users of the healthcare systems, patients are essential partners in the development of EU health policy and legislation. To be truly involved, however, we need sufficient time and resources. We therefore call for the preservation of participatory and democratic processes. Building a European health framework that responds to the needs of EU citizens is our priority and must be strongly defended.