On 28 September 2026, the Council of the European Union (Council) formally adopted the EU Pharma Package, a major reform of EU pharmaceutical legislation and the most significant revision of the framework since 2004.
The package introduces important changes to regulatory protection, incentives for innovation, medicine shortages and market access.
The Council’s adoption follows political agreement on the package reached in December 2025 after extensive negotiations between the EU institutions. The final legislative texts were subsequently published in March 2026, which gave stakeholders their first detailed view of the reforms that are set to shape the future EU pharmaceutical framework.
The reforms seek to address longstanding challenges facing the sector, including unequal access to medicines across Member States and concerns about medicine shortages, while maintaining incentives for pharmaceutical innovation and facilitating earlier entry of generics and biosimilars.
The European Parliament must adopt the package before it can enter into force following publication in the Official Journal of the European Union. Nevertheless, the Council’s adoption provides a clear indication of the framework pharmaceutical companies can expect to operate under in the coming years. It offers greater clarity regarding the future direction of pharmaceutical regulation within the EU.
We have summarised the key changes below:
Changes to Regulatory Protection
Perhaps the most closely scrutinised aspect of the reform concerns the regulatory protection framework.
Under the new regime, innovative medicinal products will benefit from eight years of regulatory data protection, followed by one year of market protection. In broad terms, this means that competitors will be prevented from relying on an originator’s data for a defined period and will be unable to place competing generic or biosimilar products on the market during the period of market protection.
Additional periods of protection may be available where specified conditions are met, including circumstances involving comparative clinical trials, certain EU-focused development activities and products addressing unmet medical needs. Depending on the circumstances, the total period of protection may reach eleven years and, in certain cases involving a transferable exclusivity voucher (see below), twelve years.
The final compromise places greater emphasis on linking additional exclusivity to specific policy objectives, rather than relying solely on a fixed period of protection. Pharmaceutical companies will therefore need to assess these incentives at an earlier stage when developing clinical and regulatory strategies.
New Incentives for Antimicrobial Innovation
The package also introduces a new mechanism to stimulate the development of novel antimicrobials.
The commercial challenges associated with antibiotic development are well documented. Significant research and development investment is required, yet the commercial returns are often more limited than those for medicines used over the long term. Against that backdrop, the legislation introduces a transferable exclusivity voucher that may be awarded to companies developing qualifying priority antimicrobials. The voucher provides an additional year of protection for a medicinal product and may be transferred to another company.
The introduction of the voucher system is one of the more novel features of the package. It demonstrates a willingness among EU policymakers to explore alternative methods for incentivising innovation in areas of strategic public health importance.
At the same time, concerns about the potential impact on healthcare expenditure have led to limitations on the use of these vouchers, including restrictions on products that exceed specified sales thresholds.
Revised Framework for Orphan Medicinal Products
Companies developing medicines for rare diseases will also be closely examining the new regime.
Under the package, orphan medicinal products will generally benefit from nine years of market exclusivity. Additional protection may be available for certain breakthrough therapies, potentially increasing the exclusivity period to eleven years. The intention is to continue supporting investment in areas where patient populations are often small and development costs remain significant.
The reforms suggest that legislators remain committed to maintaining targeted incentives for rare disease research, while also seeking to ensure that those incentives are directed towards products that deliver meaningful therapeutic advances.
For companies active in the orphan medicines space, the details of the revised framework are likely to form an important part of future portfolio and lifecycle management decisions.
More Efficient Approval Process
The package also includes measures to streamline the EU medicines approval process and reduce regulatory burdens on applicants.
In particular, the reforms seek to improve the efficiency of procedures operated by the European Medicines Agency (EMA) and facilitate faster access to medicines across the EU. The package also provides for greater patient involvement in the scientific assessment process by including patient representatives on the EMA’s main scientific committee.
A more streamlined authorisation process could reduce timelines and administrative complexity, although the practical impact of these changes will become clearer once the new framework is implemented.
A Greater Focus on Security of Supply
The package also reflects the increasing prominence of medicine shortages as a policy issue across Europe.
Supply chain vulnerabilities, highlighted during and after the COVID-19 pandemic, have led regulators to place a greater emphasis on resilience and continuity of supply. The new legislation introduces measures to strengthen the EU’s ability to monitor, anticipate, and respond to medicine shortages. Manufacturers will face enhanced obligations regarding shortage notifications and prevention measures, particularly for critical medicines.
Of particular note is the ability of Member States to require pharmaceutical companies benefiting from certain regulatory protections to supply medicines in quantities sufficient to meet patient needs. While safeguards have been included, the provision demonstrates the growing importance of supply obligations as a feature of pharmaceutical regulation within the EU.
For pharmaceutical companies, compliance considerations are therefore likely to extend beyond traditional regulatory approval and market access issues to encompass broader supply chain planning and risk management.
Expansion of the Bolar Exemption
From an intellectual property perspective, another noteworthy development is the revised Bolar exemption.
The exemption allows generic and biosimilar manufacturers to undertake certain studies, trials and related activities before the expiry of relevant intellectual property protections, enabling them to seek regulatory approval in advance of market entry.
While the Bolar exemption already permits certain studies and trials conducted for regulatory approval, the package broadens and clarifies its scope. In particular, it extends the exemption to a wider range of activities related to obtaining market access, including procurement procedures, to facilitate the launch of generic and biosimilar medicines immediately following the expiry of relevant intellectual property rights.
The expanded exemption is likely to be of particular interest to generic and biosimilar manufacturers, as it may further reduce barriers to market entry following loss of exclusivity.
Looking Ahead – Key Takeaways
The adoption of the Pharma Package marks a significant development for companies operating in the pharmaceutical sector. The reforms preserve many of the core incentives that underpin pharmaceutical innovation, while introducing a stronger emphasis on unmet medical needs, antimicrobial development, medicine availability and faster access to competition.
For innovative pharmaceutical companies, the new rules will require careful consideration of development, regulatory and exclusivity strategies. Generic and biosimilar manufacturers, meanwhile, will be assessing the opportunities created by the revised regulatory framework and the expanded Bolar exemption.
While the practical impact of many of these reforms will only become apparent once the new regime is implemented, the package provides the clearest indication yet of the EU’s vision for the future of pharmaceutical regulation: one that seeks to support innovation while placing increasing emphasis on patient access, security of supply and public health priorities.
For more information about the topics discussed above, please contact Laura Scott or Colette Brady.
