11 DECEMBER 2025 – The European Parliament and the Council of the European Union have reached a provisional political agreement on a comprehensive reform of the EU pharmaceutical legislative framework (the “pharma package”). This reform represents the most significant overhaul of EU pharmaceutical legislation in over 20 years, aiming to improve patient access to medicines, strengthen the competitiveness of the EU pharmaceutical sector, and enhance security of supply across Member States [1][2].

The agreement covers a new Directive and a new Regulation, replacing and modernising large parts of the existing EU pharmaceutical framework, including Regulation (EC) No 726/2004 and Directive 2001/83/EC. Formal adoption by both co-legislators is still required before the legislation enters into force [1][2].

Key Objectives of the Pharma Package

According to both institutions, the reform seeks to [1][2]:

• • • Ensure timely and equitable access to safe, effective, and affordable medicines across the EU.
    • Strengthen competitiveness and innovation within the EU pharmaceutical sector.
    • Improve security of supply and shortage prevention, particularly for critical medicines.
    • Modernise regulatory incentives while supporting public-health priorities, including antimicrobial resistance.

Key Elements of the Political Agreement

1. 1. Revised Regulatory Data and Market Protection Framework: This revised framework aims to balance incentives for innovation with earlier access to generics and biosimilars. Under the agreed compromise, new medicinal products will benefit from [1][2]:

• • • • • Eight years of regulatory data protection
        • One year of market protection
        • Conditional extensions linked to specific public-health objectives (e.g. unmet medical need, additional indications), with a maximum combined protection period of 11 years.

1. 1. Expanded Bolar Exemption: The Bolar exemption — which allows manufacturers to undertake certain activities during the protection period without infringing intellectual-property rights — has been clarified and broadened to support earlier entry of generics and biosimilars. The revised text allows generic and biosimilar manufacturers to carry out preparatory activities during the protection period, including regulatory submissions, pricing and reimbursement procedures, and participation in procurement and tendering processes. This is intended to support “day-one” market entry following expiry of exclusivity [2].
   2. Incentives for Priority Antimicrobials: To address antimicrobial resistance (AMR), the package introduces a transferable exclusivity voucher for developers of priority antibiotics. The voucher provides a one-year extension of market protection for another medicinal product, subject to safeguards designed to limit financial impact on health systems [2].
   3. Supply Security and Shortage Management: The reform strengthens obligations related to availability and supply continuity, enabling Member States to require marketing authorisation holders to ensure adequate supply of medicines and improve early notification and management of shortages [1][2].

RWR CONTEXT: Why This Reform Matters for Real-World Research

The reform of the EU pharmaceutical legislation is of direct and strategic importance for real-world research (RWR). As outlined in our EU | Reform of the EU Pharmaceutical Legislation (RWR Regulatory Updates, April 2023), this reform represents the first time that the role of real-world data (RWD) and data analytics is explicitly embedded in EU pharmaceutical law.

In the most significant legislative shift in two decades (20 years), the European Commission and the European Medicines Agency (EMA) have formally recognised that regulatory decisions on the development, authorisation, and supervision of medicines may be supported by real-world data generated outside of clinical trials. Both the European Health Data Space (EHDS) and DARWIN EU® (the Data Analysis and Real World Interrogation Network) are explicitly referenced in the proposed new Directive and Regulation, underlining their central role in future regulatory decision-making.

For RWR stakeholders, the reform strengthens the legal foundation for:

• • • Regulatory decision-making supported by RWD and advanced data analytics, including structured access to individual patient data.
    • Lifecycle evidence generation, enabling post-authorisation observational studies, registries, and secondary data analyses to inform benefit–risk assessments.
    • Regulatory sandboxes, allowing innovative, data-driven approaches (including AI and digital technologies) to be tested in controlled real-world environments under regulatory supervision.
    • Data-driven updates to product information, where emerging real-world safety or effectiveness data may trigger updates to the Summary of Product Characteristics (SmPC).
    • Collection and use of data from compassionate use programmes, explicitly to inform regulatory benefit–risk decisions

While the reform does not fundamentally alter the existing legal framework for post-authorisation safety studies (PASS), it broadens the context in which non-interventional studies and real-world evidence are expected to support regulatory oversight. As a result, robust RWR governance, data quality, and methodological rigour will become increasingly critical for sponsors, CROs, and marketing authorisation holders operating in the EU.

Overall, the pharma package establishes a more data-driven, lifecycle-based regulatory system, positioning real-world research as a core component of EU regulatory science rather than a supplementary evidence source.

Next Steps

The provisional agreement will now proceed to formal adoption by the European Parliament and the Council. Once adopted and published in the Official Journal of the European Union, the new Directive and Regulation will enter into force following applicable transitional periods [1][2].

References

1. European Parliament – Press Release – Deal on comprehensive reform of EU pharmaceutical legislation (11 December 2025)

Link: https://www.europarl.europa.eu/news/en/press-room/20251209IPR32110/deal-on-comprehensive-reform-of-eu-pharmaceutical-legislation

2. Council of the European Union – Press Release – Pharma Package: Council and Parliament Reach a Deal on New Rules for a Fairer and More Competitive EU Pharmaceutical Sector (11 December 2025)

Link: https://www.consilium.europa.eu/en/press/press-releases/2025/12/11/pharma-package-council-and-parliament-reach-a-deal-on-new-rules-for-a-fairer-and-more-competitive-eu-pharmaceutical-sector/