Agreement Reached on EU Pharma Package

Our Life Sciences Regulatory team outlines the key features of the recently negotiated Pharma Package and explain the next steps in the ongoing revision of the legislative framework for pharmaceutical products in the EU.

What you need to know

• The ‘Pharma Package’ refers to the major revision of the current legislative framework for the EU’s pharmaceutical industry.
• Negotiations have been ongoing following the European Commission’s publication of the first draft of the Pharma Package in April 2023.
• An agreement was reached between the Council and Parliament regarding the Package on 11 December 2025.
• The Pharma Package is now expected to be adopted in full in the coming months.

An agreement has been reached between the EU Commission, Parliament and Council on the EU’s Pharma Package, marking a significant development towards planned reform of the EU’s pharmaceutical regulatory rules. The agreement follows over two years of negotiations to overhaul the EU’s current framework for pharmaceuticals. The EU Pharma Package will consist of a new Regulation and Directive designed to improve the accessibility and affordability of medicines on the EU market while also supporting the competitiveness of the EU’s pharmaceutical sector.

Key Features

Data and market protection: medicinal products will benefit from eight years of data protection, during which product data cannot be accessed, followed by an additional year of market protection, during which generic or biosimilar products cannot be sold. The agreed upon version of the Pharma Package allows for extensions on market protection, up to a maximum of 11 years, if various conditions can be satisfied:

• The product addresses an unmet medical need
• An approval is obtained for a new therapeutic indication with significant clinical benefit
• The product contains a new active substance, satisfies various trial conditions, and introduces a marketing authorisation application within 90 days of submission of a first marketing authorisation application outside of the EU

Orphan medicinal products: orphan medicinal products, or ‘breakthrough’ medicines, which meet unmet medical needs, will enjoy market exclusivity for a reduced baseline period of nine years. However, orphan medicinal products for diseases with no pre-existing medicinal treatment can be granted an extended exclusivity period of 11 years.

Availability of medicines: in order to ensure the availability of key medicines, Member States will be empowered to require marketing authorisation holders of medicinal products under regulatory protection to ensure adequate supply to meet patient needs.

‘Bolar exemption’: added clarity on, and extensions to, the application of the bolar exemption, which allows manufacturers of generic or biosimilar medicines to engage in certain activities to prepare for market entry while a medicinal product remains under patent protection.

Antimicrobial resistance: a transferable exclusivity voucher, or "TEV", has been introduced to encourage the development of priority antibiotics. This will grant companies an additional year of market protection for small volume priority antimicrobials. However, this extension will not apply to products earning a figure exceeding €490 million in annual gross sales in the preceding four years.

Modernised regulatory processes: the Pharma Package will introduce several initiatives to streamline and update regulatory processes, including:

• The reduction of EMA review periods from 210 to 180 days
• The introduction of regulatory sandboxes
• A requirement to notify anticipated supply shortages
• The use of QR codes as an alternative or supplement to paper product information materials

Next Steps

In order to progress, this version of the Pharma Package will now require formal adoption by the European Parliament and the Council. Once adopted, the legislation will be published in the Official Journal of the European Union, triggering the beginning of the timeline for implementation. It is anticipated that the final text will be agreed within the next few months, with the incoming legislation starting to apply from the mid-2028.

For more information and expert advice, contact our Life Sciences Regulatory team.

The content of this article is provided for information purposes only and does not constitute legal or other advice.