EU Pharma Package: Parliament and Council reach agreement to modernize EU pharmaceutical legislation - Key takeaways for pharma

Key Aspects of the Pharma Package

Based on the elements described by the EU legislators on 11 December 2025, key aspects of the final form of the Pharma Package will include:

• Regulatory data protection and market protection: There will be a baseline of eight years of regulatory data protection plus one year of market protection. The market protection period can be extended for up to two additional years if certain criteria are met (e.g., addressing unmet medical needs or adding new indications with significant clinical benefit), leading to a maximum exclusivity period of eleven years. 
• Orphan medicinal products: The Pharma Package will significantly modify the regulatory framework for orphan medicinal products. The baseline market exclusivity will be nine years, while orphan medicinal products addressing diseases with no available medicinal treatment (so-called breakthrough orphan medicinal products) will benefit from an extended eleven-year exclusivity period.
• Transferable exclusivity voucher: One of the main aims of the Pharma Package is to combat antimicrobial resistance. To support this goal, a transferable exclusivity voucher is introduced as an incentive for the development of new priority antibiotics. Such an exclusivity voucher can be used to extend the market protection period for a product of the pharmaceutical company’s choice by one year. However, following the Council’s position, the choice will be restricted so that the voucher cannot be used for products with annual gross sales of more than EUR490 million in the preceding four years.
• Bolar exemption: The Pharma Package clarifies and expands the scope of the Bolar exemption, which allows generic or biosimilar manufacturers to undertake certain activities in preparation for their market entry while patent protection still applies. In the future, the Bolar exemption will cover not only activities to obtain a (generic or biosimilar) marketing authorization but also activities regarding HTA submissions, pricing and reimbursement approvals, and participation in public tenders.
• Measures against shortages and to require supply of medicines: In addition to the establishment of an EU framework to monitor shortages and strengthening EMA`s coordination role, Member States may require marketing authorization holders of medicinal products benefiting from regulatory protection to ensure adequate supply. 
• Competitiveness of the regulatory framework: Finally, the Pharma Package intends to make the regulatory framework more competitive and attractive, inter alia by shortening marketing authorization procedures (from 210 days to 180 days), removing the default initial five‑year limitation on marketing authorizations and introducing regulatory sandboxes for the development and testing of new and innovative therapies.

Next steps

The political agreement remains subject to formal approval by the European Parliament and the Council and at that stage the full details of the reforms will be known. Thereafter, the new directive and regulation will enter into force when published in the Official Journal of the European Union. We expect the new regulatory framework to apply after a transitional period of two to three years, based on previously published draft texts and negotiating positions.

Strategic implications for pharmaceutical companies

Pharmaceutical companies should prepare for the new rules, incorporating the new framework for regulatory protection and the new obligations to prevent shortages in their plans, and should also assess opportunities to make use of newly introduced concepts such as the transferable exclusivity voucher or regulatory sandboxes. Innovators should consider the amended rules of the Bolar exemption in their patent and exclusivity strategies.

In practical terms, this means rethinking strategies across several key areas: 

• Reassess exclusivity strategies: Maximum protection now depends on added clinical benefit and indication expansion—early planning is key.
• Optimize orphan drug portfolios: Breakthrough orphan incentives are attractive but will require meeting stricter definitions.
• Leverage AMR incentives: Transferable vouchers can create significant commercial value.
• Strengthen supply chain compliance: New obligations to prevent shortages demand robust supply strategies.
• Explore innovation opportunities: Regulatory sandboxes offer a fast-track for novel technologies and therapies.