On 11 December 2025, it was announced that the Council of the European Union and European Parliament reached an agreement on the EU Pharma Package.

What is the EU Pharma Package?

On 26 April 2023, the European Commission published its proposal for the revision of the pharmaceutical legislative framework, 20 years after the previous major review. 

The proposal consists of replacing the existing pharmaceutical legislation (Directive 2001/83/EC and Regulations 726/2004, 1901/2006, and 141/2000/EC) with a new, modernised Directive and Regulation that, according to the aim of the European Commission, “will support innovation and boost the competitiveness and attractiveness of the EU pharmaceutical industry, while promoting higher environmental standards”.

What are the key changes?

According to the announcement, as the final text has not been published, the following appear to have been provisionally agreed for the EU Pharma Package.

• Regulatory exclusivities – The regulatory data protection period is the timeframe during which applicants for a marketing authorisation for new generic, hybrid, or biosimilar medicinal products cannot reference the dossier of an already authorised reference medicinal product. This is then followed by a market protection period during which marketing authorisation applications for generic, hybrid, or biosimilar products can be accepted, but such medicines cannot be placed on the market. 

  Currently, the regulatory data protection period is 8 years, followed by a basic market protection period of 2 years and a possibly additional 1 year of market protection for a significant new indication. This formula is known as “8+2(+1) years”. Under the new framework, the regulatory data protection period remains 8 years, followed by the market protection period of 1 year, with possible further 1-year extensions for innovative medicines that satisfy two out of three conditions. The new formula will thus be “8+1(+1)(+1) years”. This means that the basic market protection has been decreased to 1 year, but the maximum period of regulatory protection will still be a total of 11 years. 

• Orphan medicinal products – The basis market exclusivity will be 9 years (as opposed to 10 years in the current legislation), with the possibility to extend this period to 11 years for orphan medicines addressing diseases for which there is no available treatment at the moment. 

• Security of supply – To address the growing concern about shortages of medicines and unequal availability, various measures were proposed for the EU Pharma Package to ensure supply chain resilience and sufficient supply to meet patient needs. 

  One such proposal was made by the Council in June 2025, which consists of giving EU Member States the power to require marketing authorisation holders to place medicines on the market and supply it in sufficient quantities and in the presentations necessary to cover the needs of patients in that Member State. This proposal has been agreed between the Council and European Parliament, but with additional safeguards to prevent use of these provisions for parallel trade.

• Bolar exemption – The Bolar exemption allows the use of medicinal products before patent or SPC expiry to conduct “necessary studies and trials” for obtaining marketing authorisations of generics or biosimilars. Currently, the implementation of the Bolar exemption across EU member states is variable, leading to uncertainty. 

  Under the new framework, which attempts to harmonise the Bolar exemption across the EU, the scope has expanded to also include HTA submissions, pricing and reimbursement approvals and submissions for procurement tenders.

• Antimicrobial resistance – The initial European Commission proposalsought to introduce a new voucher system for “priority” antimicrobials, which would provide marketing authorisation holders with a transferrable regulatory exclusivity voucher. The European Parliament proposed a modulated approach for different classes of antimicrobials (6 months for “medium priority”, 9 months for “high priority” and 12 months for “critical), whereas the Council proposed one single 12-month period for “priority” antimicrobials, the definition of which was clarified. 

  Under the agreed new framework, the Council and European Parliament agreed to the single 12-month regulatory exclusivity period for the transferrable voucher, which can only be transferred to products with annual gross sales of more than €490 million in the preceding four years.

What happens next?

The final position on the EU Pharma Package now needs to be formally approved by the Council and European Parliament, then adopted and published in the EU’s Official Journal. Based on the earlier published draft texts, it is likely that the transitional period will be 2 or 3 years, after which the new legislation becomes applicable. 

Once the final text is published, Bird & Bird will conduct a closer review and publish more detailed content on specific topics. Watch this space and sign-up for alerts here.