Two and a half years after the initial proposal, agreement has been reached by the EU institutions on the so-called EU Pharma Package. The Package represents a comprehensive overhaul of the European Union’s pharmaceutical framework for medicinal products, which is currently based on legislation dating back to 2001.
Background
The Package was initiated by the European Commission in April 2023 and proposed a number of amendments to strengthen the strategic and competitive position of the pharmaceutical sector and update and future-proof the framework. The core aims of the Package were to ensure more timely and equitable access to medicines, enhance the competitiveness of the EU pharmaceutical sector, and address supply chain resilience and medicine shortages.
The Commission proposal was followed by positions adopted by the European Parliament in April 2024 and the Council of the European Union in June 2025. Each of the institutions had different proposals for what the new framework should look like, which has led to uncertainty and debate among stakeholders. Since the Council position, the Package has been discussed by the EU institutions and member states within the “trilogues,” three-way negotiations between the EU institutions, with Denmark, as the President of the Council, chairing negotiations.
Agreement
In the early hours of 11 December 2025, the EU institutions reached agreement on the Package. While the text is not yet available, the press releases from the Council and Parliament set out the following headline points:
- Regulatory protection: The most highly contested element of the reforms related to regulatory data protection and marketing protection for innovative medicinal products. The current system provides 8 years of data protection, followed by 2 years of marketing protection, which can be extended by 1 year for new indications. Under the agreement, the baseline period of protection will be 8 years data protection plus 1 year market protection, with additional extensions to the market protection period of up to 11 years in certain circumstances. The exact criteria to be met to obtain the additional period(s) of protection remains to be seen.
- Orphan protection: The current period of orphan exclusivity is 10 years. Under the agreement, the baseline period will be 9 years, with 11 years of protection for a new class of “breakthrough” products. The definition of “breakthrough” and how this is determined will be crucial.
- Supply obligations: The Package is focussed on ensuring that medicines are available across all member states, and various mechanisms have been discussed for how this should take place. Under the agreement, EU countries “have the power” to “require” companies to supply medicines benefiting from regulatory protection in sufficient quantities to meet patient needs, and if this does not take place companies may lose market protection in the relevant member state. Questions have been raised during the legislative process about how the supply obligation will be enforced and how companies can evidence supply, and it is currently unclear how this will operate.
- The “Bolar exemption”: The so-called “Bolar exemption” permits generic/biosimilar developers to undertake testing and prepare for regulatory submissions before patent expiry. The Package expands this concept to allow generic and biosimilar drug manufacturers to prepare pricing and reimbursement applications and submit bids in public tenders during the period of patent protection.
- Shortage: Measures to prevent and mitigate shortages are also strengthened. The Package imposes shortage-prevention plan obligations on marketing authorisation holders for all prescription medicines (and others if necessary) and strengthens reporting and monitoring obligations.
- EMA efficiencies: There are a number of points seeking to increase European Medicines Agency efficiency and streamline processes. This includes a shorter assessment time (reduced from 210 to 180 days), streamlined structures, and the use of regulatory sandboxes.
- Antimicrobial resistance: The Package has introduced a transferable exclusivity voucher mechanism for novel antibiotics, enabling an extra year of data protection if certain criteria are met. Importantly, this can be transferred to any product in the developer’s portfolio or sold to another company. However, this cannot be used on products with annual gross sales of more than €490 million in the preceding 4 years. Other measures to ensure “prudent use of antibiotics” will be introduced, as well as a subscription model to guarantee revenue for companies investing in the development of such products.
The text appears to be a compromise agreement, seeking to balance the different views of the institutions and member states as well as the innovative and generic industries. Based on the public information, the agreement does seem to address some of the concerns raised by the innovative industry, but the scope of changes will not be clear until the text is available.
In terms of next steps, the agreement needs to be endorsed by the Council and the Parliament before being formally adopted. It is likely that the new regime will apply sometime in 2028.