EU negotiators reached a political deal on the reform of the General Pharmaceutical Legislation (GPL) on Wednesday, 10 December. While the final text will only be released in the coming weeks, it’s significantly different from the Commission’s initial proposal from 2023. For example, it will include a decision to keep the current baseline of eight years of exclusivity for new medicines.
The cap on monopoly rights was set at 11 years if companies meet certain conditions, and drugmakers will be able to benefit from a transferable exclusivity voucher (on top of the 11 years) as well as the voluntary subscription model – in an effort to fix the EU’s antimicrobial market.
On the Bolar exemption (traditionally allowing manufacturers of generic medicines to benefit from a patent law exemption in certain circumstances), the GPL includes an IP exemption allowing manufacturers to take the necessary steps to ensure that generic versions of a medicine can be made available on day one after IP rights have expired.
According to MEP Dolors Montserrat (EPP/ES), printed information will remain mandatory on all packaging. However, this paper version will now also need to include a QR code that leads to an online version, which needs to provide the information in all EU languages.
Furthermore, when a country requests that a company make a product available on its market, the company is required to do so. If the company refuses or delays, then a generic version can be brought to market, cancelling market exclusivity in that market.
The Danish Council Presidency is happy to have the file completed with Danish Minister for Health Sophie Løhde, sharing: “The deal demonstrates the EU’s commitment to both innovation and to ensuring that patients in Europe have access to the medicines they need. We are strengthening incentives for priority antibiotics, reducing red tape for the life science industry, and safeguarding the availability of essential medicines.”
The European Parliament has shared that the result of the deal will promote innovation and increase access to medicine, combat antimicrobial resistance, optimise the European Medicines Agency’s structure and improve the monitoring and management of shortages.
The completion of the GPL under the Danish Council Presidency was highly unexpected. However, the move underscores the urgency expressed by Health Commissioner Várhelyi to advance key health files. In terms of next steps, the Directive and Regulation will enter into force on the twentieth day after their publication in the Official Journal of the EU, which is anticipated for 2026. Member States will then have 18 months to adopt the necessary laws, regulations and administrative measures to comply.
