Why is the EU reforming its pharmaceutical framework?
The revision of the EU pharmaceutical framework is part of a broader initiative to modernize and future-proof the regulatory environment for medicinal products. The reform seeks to ensure that patients across all Member States benefit from timely and equitable access to safe, effective and affordable medicines.
At the same time, the legislative package is intended to reduce the administrative burden, improve environmental sustainability, strengthen supply security and streamline the overall efficiency and clarity of the regulatory process. The overarching objective is to ensure that the EU remains an attractive region for pharmaceutical development and investment, while responding to public health needs.
The Council's general approach supports the core structure of the Commission's proposal – published on 26 April 2023 – which consists of two legislative instruments: a new regulation and a new directive. Together, these aim to harmonize and streamline rules governing the authorisation, monitoring and availability of medicines in the EU.
The most prominent changes proposed by the Commission include the regulatory data protection (RDP) period and market protection period for new or innovative products.
Other key changes include additional incentives for medicines targeting antimicrobial resistance (AMR) and for improving availability in small or fragmented markets. Furthermore, the reform includes provisions to reduce the environmental impact of medicinal products and to promote environmentally sustainable pharmaceutical development.
Baseline regulatory data protection
One of the most significant proposed changes relates to regulatory data protection.
As part of the Commission's Pharma Package proposal, it was proposed to reduce the baseline period of regulatory data protection for new branded medicines in the EU from eight years to six years, with possible extensions of up to two additional years, based on variable incentives.
On 10 April 2024, the Parliament then proposed a baseline regulatory data protection period of 7.5 years, which could be extended to a maximum of 8.5 years under certain conditions.
Under the Council's proposal, the eight-year baseline period of regulatory data protection is retained. However, the Council instead supports shortening the period of subsequent market exclusivity from two years to one year, with the possibility of a one-year extension of market exclusivity subject to the fulfilment of the following cumulative criteria:
- Clinical trials must be conducted in more than one Member State
- An evidence-based comparator must be used in the trials
- The initial marketing authorisation application must be submitted in the EU or within 90 days of a submission elsewhere
- The product must address an unmet medical need in the EU
According to the Council, the revised exclusivity model aims to reward innovation while enabling earlier access to affordable medicines, including generics and biosimilars.
Industry responses
The Council's position, like the previous proposals from the Commission and the Parliament, has prompted a range of responses from stakeholders in the pharmaceutical sector. While the focus on access, simplification and competitiveness has been acknowledged, some stakeholders – in particular pharmaceutical innovator companies – have expressed concerns, especially regarding the potential implications of reduced market exclusivity on long-term investment in innovation.
In addition, particular attention has been drawn to the complexity of the conditional model for exclusivity extensions, and the need for regulatory clarity and predictability to support product development within the EU.
The next steps
Although the Council's adoption of its general approach marks a milestone in the legislative process, negotiations are still at an early stage. Attention now turns to the trilogue phase, where the Commission, the Parliament and the Council must work towards a final text for the two proposed pieces of legislation.
On 17 June 2025, the opening trilogue on the Pharma Package took place, in which the Parliament exchanged views with the Council on key political points and the negotiation positions. A second trilogue is expected before the end of 2025.
Plesner is monitoring the legislative process closely.
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