The EU has agreed on major reforms to its 20-year-old pharmaceutical rules.
The changes strengthen competitiveness and innovation while keeping strict safety standards in place.
The European Council and the European Parliament have reached an agreement on the ‘pharma package’, a new set of rules that aims to increase patients' access to medicine and make the EU’s pharmaceutical sector fairer and more competitive.
It also seeks to boost the competitiveness of the pharmaceutical industry by cutting regulatory burdens and strengthening the security of supply chains to prevent and manage drug shortages.
The new legislation should lead to the following improvements:
- increased access to medicines for patients across Europe
- streamlined procedures and lessened red tape, speeding up supply chains and decreasing time-to-market for new medicines
- boosted innovation, through stronger incentives for novel products and secure testing environments for breakthrough therapies
- better monitoring and coordination to tackle medicine shortages, plus clearer patent exemptions that support timely entry of generics.
Why this matters
Together, these reforms are designed to strengthen the EU’s strategic autonomy while supporting a more competitive, innovative pharmaceutical sector and ensuring patients have timely access to high-quality medicines.
The agreed framework preserves strong incentives for innovation through eight years of data protection and a baseline year of market exclusivity, with the potential for extension for qualifying innovative products, while also addressing medicine availability by allowing member states to require a sufficient supply of protected products to meet patient needs.
At the same time, the clarified Bolar exemption is intended to accelerate generic and biosimilar entry once intellectual property rights expire, including for public procurement.
The package also introduces a targeted incentive to address antimicrobial resistance, offering an additional year of market protection via a transferable exclusivity voucher, while safeguards such as the ‘blockbuster clause’ aim to limit budgetary impact on national healthcare systems.
Sophie Løhde, Danish Minister for the Interior and for Health, said: "The deal demonstrates the EU’s commitment to both innovation and to ensuring that patients in Europe have access to the medicines they need."
"The package marks a crucial step towards making a more resilient and dynamic life science sector in Europe and it shows that Europe can make the necessary decision to protect European interests."
The provisional agreement now needs to be endorsed by both the Council of the European Union and the European Parliament before being formally adopted and entering into force upon publication in the EU’s Official Journal.