Health ministers from across the European Union gathered in Luxembourg on 16 June for a first formal discussion of the European Commission's proposed Biotech Act. The session, chaired by the Cypriot presidency, revealed deep divisions over a central element: an additional year of market exclusivity for certain innovative medicines.
The measure, known as a Supplementary Protection Certificate (SPC), would apply to treatments that contain a new active substance, operate through a different mechanism of action from existing therapies, have undergone clinical trials in at least two EU member states, and include at least one manufacturing step—such as packaging or quality testing—within the Union. The Commission argues that this incentive is necessary to keep biotech investment, research, and production on European soil.
EU Health Commissioner Olivér Várhelyi defended the proposal at a press briefing, stating that without such protection, “most likely these products will never enter Europe, only once the patents have expired.” He dismissed concerns about the financial burden, urging member states to focus on prevention to free up budgets for cutting-edge therapies.
Divergent Views Among Member States
Spain’s health minister, Mónica García Gómez, voiced support, telling fellow ministers: “We support the idea of incentivising technology in Europe and we support the idea to extend the protection certification system.” However, several delegations expressed reservations, questioning whether the extension would ultimately benefit patients.
Christopher Farrugia, Malta’s deputy representative to the EU, warned that the proposal could exacerbate existing inequalities in access to medicines. “We are … reluctant to direct taxpayer money into an industry which refuses to supply small markets or that expects us to pay substantially higher prices than large member states with a higher GDP,” he said, noting Malta’s “reservations” on the SPC extension. According to industry data, Malta had access to only 17 innovative medicines approved between 2020 and 2023, compared with 156 in Germany and 142 in Italy.
Estonia echoed these concerns, urging “balance” in discussions on protection periods. “We want to be very clear about the need for balance,” the Estonian delegation stated, emphasising that affordability, access to medicines, and the sustainability of healthcare systems must be taken into account.
Several countries also questioned the evidence base for the measure. The proposal was not accompanied by a dedicated impact assessment, relying instead on analysis carried out for broader pharmaceutical legislation. Katarzyna Kacperczyk, Poland’s deputy health minister, noted: “It is still not clear whether this instrument will be fit to the goals of the industrial and biotech policies of the EU. The Commission's analysis shows that the solution may have significant economic effects and consequences, may affect competition, public spending, and may affect medicinal products availability.”
Despite the disagreements on exclusivity, ministers broadly agreed on the need to simplify multinational clinical trials, streamline regulatory processes, reduce administrative burdens, and avoid overlaps with existing legislation. Multiple delegations—including those from Hungary, Czechia, Poland, Estonia, Greece, France, Latvia, and Malta—highlighted the importance of strengthening support for biosimilars. France’s deputy permanent representative, Cyril Piquemal, said: “The support measures for biosimilars should, in our view, be reinforced.” Kacperczyk called biosimilars “key for the security and safety of patients in the EU.”
Irish Presidency Pushes for Speed
The incoming Irish presidency of the Council of the European Union signalled its intention to accelerate negotiations. Irish health minister Jennifer Carroll MacNeill urged member states to adopt positions early, citing the urgency of the external competitive environment. “Because of the external environment, [we] need to move speedily on this particular Act. And ahead of the upcoming Presidency, I'd urge all of you to take your positions as early as possible with that urgency in mind,” she said.
MacNeill emphasised that advancing Europe’s biotech sector is “time sensitive for industry, time sensitive for patients,” noting that competitors are already gaining ground. She has appointed a dedicated Irish presidency team to work “in an expeditious and streamlined manner with a view to negotiating the Act as quickly as possible.” The presidency will initially focus on clinical trials, aiming to “progress measures aimed at strengthening the EU's industrial bio-manufacturing capacity and simplifying procedures to create legislative frameworks that are conducive to innovation.”
The debate over the Biotech Act comes amid broader discussions on European competitiveness and health security. As the EU seeks to reduce dependence on non-European suppliers and foster homegrown innovation, the balance between incentivising research and ensuring affordable access remains a contentious issue. The outcome of these negotiations will have significant implications for patients, healthcare systems, and the biotech industry across the continent.
