Executive Vice-President Stéphane Séjourné has committed the European Commission to delivering a report on Regulation (EC) No 816/2006, the EU's compulsory licensing regime for exporting pharmaceutical products to countries with public health problems, which has never been used since it entered into force. The report will focus on four areas: determining remuneration for rights-holders, the application of simplified and accelerated procedures, the effectiveness of anti-diversion requirements, and the regulation's contribution to the Doha Declaration on TRIPS and Public Health. Séjourné stated that the Commission will consult relevant stakeholders and present the report in a timely manner, but declined to pre-empt its findings or commit to proposing amendments.
The answer comes in response to a parliamentary question from Lynn Boylan (The Left), who pressed the Commission on the timeline, stakeholder consultation, and potential amendments. Boylan noted that the review commitment was made during trilogue negotiations on Regulation (EU) 2025/2645 on compulsory licensing for crisis management, after Parliament's position on amending the 2006 regulation was not reflected in the final text. The 2006 regulation was designed to allow EU-based manufacturers to produce generic versions of patented medicines for export to countries lacking manufacturing capacity, but has never been activated, raising questions about its design and utility.
Séjourné's answer outlines a structured review but offers no specific timeline or guarantee of legislative follow-up. The report will examine key technical barriers, including how to set fair compensation for patent holders and whether procedural simplifications are sufficient. The commitment to consult stakeholders, including public health experts and civil society, suggests the Commission is open to understanding why the regulation has remained dormant. However, the absence of a firm deadline or pre-commitment to amendments leaves the outcome uncertain.
The review signals a potential shift in EU intellectual property policy, balancing patent protection with access to medicines. If the report identifies flaws and leads to amendments, it could lower barriers for generic exports, benefiting developing countries and generic manufacturers. Conversely, any changes that reduce patent holder remuneration or weaken anti-diversion measures could face pushback from the pharmaceutical industry. The Commission's cautious approach — promising study but not action — reflects the sensitive trade-offs between innovation incentives and public health needs.