EU health ministers remain divided over a proposal to extend market protection for certain innovative medicines, as Brussels seeks to balance industrial competitiveness with patient access and healthcare affordability.
The proposal, part of the wider Biotech Act package, would grant an additional year of exclusivity under Supplementary Protection Certificates for selected treatments. These would apply to medicines containing new active substances, those with different mechanisms of action compared with existing therapies, products tested in more than two EU member states, and drugs with at least one manufacturing step carried out within the bloc.
The European Commission argues the measure is necessary to attract biotech investment, strengthen domestic manufacturing, and prevent pharmaceutical innovation from shifting to other global markets. EU Health Commissioner Olivér Várhelyi defended the proposal, saying that without stronger incentives, many new treatments would not reach Europe until after patent expiry elsewhere.
He also rejected concerns over cost implications, suggesting that greater investment in preventive healthcare could offset long-term spending pressures on national health systems.
However, several member states raised strong objections, warning that longer exclusivity periods could delay the entry of cheaper biosimilar alternatives and increase strain on public healthcare budgets. Critics also questioned whether the proposal sufficiently considers unequal access to medicines across the EU.
Malta highlighted stark disparities in availability, noting that it had access to only 17 innovative medicines approved between 2020 and 2023, compared with more than 150 in Germany and over 140 in Italy. Officials warned that extending monopoly rights could deepen such inequalities.
Estonia echoed these concerns, stressing the need for a balanced approach that considers affordability, accessibility, and the long-term sustainability of national health systems.
Other delegations, including Poland and France, questioned whether the Commission had provided enough evidence to justify the policy shift. Some ministers pointed out that the proposal was not accompanied by a standalone impact assessment and relied instead on broader pharmaceutical sector analysis.
Despite disagreements, there was broad agreement on the need to simplify clinical trial procedures, reduce administrative burdens, and avoid regulatory overlap. Many countries also emphasised the importance of strengthening biosimilar markets, which are seen as critical to lowering drug costs and improving patient access across the EU.
France and several other member states argued that biosimilars play a key role in ensuring system resilience and affordability, particularly for smaller healthcare systems.
The debate reflects a broader fault line in EU industrial policy: how to encourage innovation without undermining access and cost control.
As negotiations continue, attention is shifting to Ireland, which will assume the Council of the EU presidency next. Irish Health Minister Jennifer Carroll MacNeill urged member states to accelerate discussions, citing increasing global competition in biotechnology.
She said the external environment makes rapid progress essential and confirmed that Ireland will prioritise clinical trial reform and measures to strengthen Europe’s biomanufacturing capacity.
MacNeill added that Europe must streamline regulatory frameworks to remain competitive, warning that delays could allow other regions to pull further ahead in biotech innovation.
