The European Commission has welcomed the political agreement reached between the Council of the European Union and the European Parliament on a comprehensive reform of the EU’s pharmaceutical legislation. This agreement marks a significant step toward modernising the regulatory framework governing medicines across the European Union, replacing rules that have been in place for more than two decades.
The reform is designed to strengthen innovation and investment in the EU pharmaceutical sector while maintaining high standards for the safety, quality, and effectiveness of medicines. At its core, the new framework seeks to ensure that patients across Europe have timely and equitable access to essential therapies.
Improving Access and Availability of Medicines
Under the agreed reform, the EU’s robust, science-based system for the assessment and authorisation of medicines will remain central to regulatory decision-making. At the same time, procedures will be streamlined to increase efficiency, helping medicines reach patients more quickly while preserving the highest safety standards.
By simplifying regulatory processes and improving coordination, the new rules aim to enhance the availability of medicines across Member States and reduce disparities in patient access.
Faster Supply Chains and a Stronger Role for the EMA
The agreement introduces measures to accelerate pharmaceutical supply chains by reducing administrative burdens for companies and shortening evaluation timelines for new medicines. A reformed role for the European Medicines Agency (EMA) is also envisaged, strengthening its capacity to support faster market entry and improved access to therapies, particularly in areas of unmet medical need.
These changes are expected to improve the responsiveness of the EU pharmaceutical system and support more efficient delivery of innovative treatments.
Boosting Innovation and Competitiveness
A key objective of the reform is to position the European Union at the forefront of global pharmaceutical innovation. The new framework introduces enhanced incentives for innovative products and establishes regulatory sandboxes, providing a secure environment to test truly novel medicines.
In addition, the legislation introduces more adaptable regulatory pathways for non-standard treatments, including personalised therapies. Strong recognition is given to the development of medicines addressing unmet medical needs, reinforcing the EU’s commitment to innovation that delivers tangible benefits for patients.
Supporting Generic Medicines and Market Competition
The reform also facilitates timely market entry for generic medicines by clarifying the application of the Bolar exemption. This provision allows certain development and regulatory activities to take place during the patent protection period, without undermining international agreements. By improving legal clarity, the new rules aim to support competition and long-term affordability of medicines.
Addressing Medicine Shortages Across the EU
Medicine shortages are a growing concern across Europe, and the reform establishes a dedicated EU-level framework to monitor and mitigate supply disruptions. The EMA will assume a stronger coordination role, while pharmaceutical companies will face enhanced obligations to anticipate and prevent shortages.
An EU list of critical medicines will be introduced, alongside vulnerability assessments to identify and address risks within supply chains. These measures are intended to strengthen resilience and safeguard continuity of care for patients.
Strengthening Strategic Autonomy in Healthcare
Together, the proposed measures are expected to significantly reinforce a sector that is vital to the EU’s strategic autonomy. Reform of the pharmaceutical legislation is a central element of the European Commission’s broader agenda to ensure access to high-quality medicines while supporting a competitive and innovative healthcare ecosystem.
The reform complements other key initiatives, including the proposed Critical Medicines Act, the Life Sciences Strategy, the upcoming Biotech Act, and the targeted revision of medical device regulations.
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Written by Nare Hovhannisyan, MD