A European Perspective #1
On 6 March 2026, the Council of the European Union published the final compromise texts of the EU “Pharma Package”, following the political agreement reached between the Council, the European Parliament and the European Commission during trilogue negotiations on 11 December 2025. The Committee of Permanent Representatives of the Member States (COREPER I) has since endorsed the trilogue outcome. As a result, the two core legislative instruments forming the basis of the reform have now been formally released:
With a total volume exceeding 1,000 pages, the reform represents the most farreaching revision of EU pharmaceutical legislation in more than twenty years. The package aims, inter alia, to improve patient access to medicines, strengthen incentives for innovation, address antimicrobial resistance and modernise regulatory procedures within the EU pharmaceutical framework.
Key aspects of the Pharma Package:
- Regulatory Exclusivity: One of the central elements of the reform concerns the restructuring of the regulatory exclusivity framework. The current “8+2(+1)” model is replaced by a more flexible and incentive-based system. Under the new Directive, medicinal products will benefit from a baseline period of 8 years of regulatory data protection, followed by 1 year of regulatory market protection. During the data protection period, generic or biosimilar applicants may not rely on the originator’s data, while the subsequent market protection period prevents the placing on the market of competing products. The framework allows for additional exclusivity extensions under defined conditions. In particular, 1 additional year of market protection may be granted if the medicinal product obtains a marketing authorisation for a new therapeutic indication demonstrating significant clinical benefit during the data protection period. A further 1-year extension may be available where certain development-related criteria are fulfilled, such as the conduct of comparative clinical trials or the timely submission of the marketing authorisation application in the EU, overall leading to the 8+1(+1+1) rule.
- Orphan Drugs: The reform also substantially revises the incentive framework for orphan medicinal products. Under the current regime, orphan products benefit from a uniform ten-year market exclusivity period. The new Regulation introduces a more differentiated system of orphan market exclusivity. In particular: 11 years of exclusivity will apply to breakthrough orphan medicinal products, i.e. products addressing an indication without existing authorised treatment and demonstrating a clinically relevant reduction in morbidity or mortality. 9 years will apply to other orphan medicinal products. The existing exclusivity period may be extended by one year if the marketing authorisation holder obtains authorisation for an additional orphan indication at least two years before the expiry of the exclusivity period. Such a prolongation may be granted twice (thus, a maximum extension of 2 years), if the new therapeutic indications are each time for different orphan conditions. At the same time, the Regulation allows the submission and assessment of applications for similar medicinal products during the final two years of the exclusivity period, enabling generics or biosimilars to enter the market immediately upon expiry of the orphan exclusivity.
- New Exclusivity Voucher: In order to address the growing challenge of antimicrobial resistance, the reform introduces a new incentive mechanism in the form of transferable exclusivity vouchers for so-called priority antimicrobials. Where a company successfully develops such an antimicrobial product, it may obtain a voucher granting 1 additional year of regulatory data protection. This voucher may subsequently be transferred to another medicinal product, thereby providing a potentially significant commercial incentive to invest in antimicrobial research and development. The Parliament has also agreed to maintain the Council’s proposed “blockbuster clause” by stipulating that the transferrable voucher cannot be used on products with annual gross sales of more than € 490 million in the preceding four years.
- Bolar Exemption: The reform also addresses the longstanding issue of divergent national implementations of the “Bolar” exemption across Member States. The new Directive aims to harmonise and clarify the scope of this exemption by explicitly providing that certain activities conducted during the term of a patent or Supplementary Protection Certificate (SPC) will not constitute infringement. These include activities necessary for obtaining a generic, biosimilar, hybrid or bio-hybrid marketing authorisation, conducting health technology assessments, obtaining pricing and reimbursement approvals, as well as submitting and application on procurement tenders (to the extent that the submission of an application on procurement tenders does not entail the sale or offering to sale during the term of protection). The exemption also covers a wide range of related activities, including the manufacture, supply, import, storage or use of medicinal products for the above purposes, including activities carried out by third-party service providers. This clarification is intended to ensure greater legal certainty and facilitate earlier market entry of generics and biosimilars once relevant protection periods expire.
Key Takeaways | What’s next?
From a strategic perspective, the revised framework introduces more fragmented and conditional regulatory exclusivity periods, which will require pharmaceutical companies to adopt a more integrated and forward-looking exclusivity strategy. In particular, decisions regarding comparative clinical trials, the geographic scope of clinical development, the timing of EU marketing authorisation applications and the sequencing of additional indications will play an increasingly important role in maximising regulatory protection. Regulatory exclusivity planning will therefore need to be more closely aligned with patent strategies, market access considerations and broader lifecycle management approaches.
The legislative process is not yet fully concluded. The European Parliament’s Committee on Public Health (SANT) has approved the key trilogue agreements on the overhaul of the EU’s pharmaceutical legislation on 18 March 2026, representing an important procedural step. Following a linguistic review, final adoption by both the European Parliament and the Council is currently expected in autumn 2026, after which the acts will be published in the Official Journal of the European Union. The new Regulation is expected to become applicable in 2028, two years after its publication, while the Directive must be transposed into national law by the Member States within the same timeframe. Transitional provisions ensure that the current regulatory exclusivity regime continues to apply to marketing authorisation applications submitted before the new framework becomes applicable.
