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The European Commission has proposed new rules aimed at strengthening the security of supply and availability of critical medicines, prioritising EU-based suppliers in public procurement.
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The EU executive included a new 'Buy Europe' mechanism with its long-awaited proposal for a Critical Medicines Act, unveiled on Tuesday, a key piece of health legislation for this term. The proposal came just in time to meet Health Commissioner Olivér Várhelyi's self-imposed deadline of 100 days in office.
This accelerated timeline for the proposal has sparked controversy due to the lack of a comprehensive impact assessment and limited stakeholder feedback, but the Commission said the proposal was urgently needed in view of ongoing medicine shortages.
The Act aims to secure stable and reliable supply chains within the EU, ensuring a high level of public health protection and security.
'The Critical Medicines Act ensures that EU patients have access to the medicines they need, when and where they need them at an affordable price. In the current geopolitical context this has become an even bigger priority,' said Várhelyi.
The proposal establishes the security of supply and availability of critical medicines as a strategic EU objective. Achieving this requires a coordinated approach at both national and European levels, the Commission acknowledged.
The Act primarily targets critical medicines included in the EU's list of critical medicinal products drafted by the European Medicines Agency (EMA) in 2023, focusing on drugs used to treat serious conditions or those with limited alternatives.
What's the issue about
The proposal seeks to tackle severe medicine shortages in the EU, particularly for essential drugs such as antibiotics, insulin, and painkillers. Many of these medicines have become difficult to obtain due to reliance on a limited number of manufacturers or countries.
The Commission acknowledges the EU's heavy dependence on foreign suppliers for active pharmaceutical ingredients (APIs) and the risks posed by export disruptions. The COVID-19 pandemic exposed these vulnerabilities, underscoring the need for a more resilient supply chain.
While pharmaceutical companies are responsible for ensuring sufficient medicine supply, individual EU member states oversee distribution within their territories. Most shortages are currently managed at the national level.
'Buy European' is the solution
The new proposal aims to boost investment in manufacturing essential medicines and key ingredients within the EU, reducing external dependencies.
A key measure is a sort of 'Buy European' principle, which introduces public procurement award criteria that prioritise the security of supply over price alone.
In practice, when a vulnerability in supply chains and dependence on a single third country is identified, EU contracting authorities will, where justified, apply procurement requirements favouring suppliers that manufacture a significant portion of these critical medicines within the EU.
These measures will be implemented in compliance with the Union's international commitments. 'This is about increasing EU production capacity and diversifying supply chains to make them more resilient, while also leveraging demand,' an EU official explained.
"The Act will have a positive impact on EU's competitiveness by fostering a more stable and predictable market environment," said Commissioner Olivér Várhelyi in Strasbourg.
European Union - Valentine Zeler
A joint procurement scheme?
The proposal also introduces a novelty, a category of medicines under close review: medicines of common interest. These include medicines with little availability and accessibility in at least three EU member states, such as are used for treatments for rare diseases.
For these medicines, the Commission proposes coordinated procurement mechanisms with member states to prevent inequalities and supply gaps.
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This could be seen as an attempt to put into practice a much-awaited joint procurement of medicines at the EU level, with the involvement of the European Commission supporting member states in the use of different collaborative procurement tools for critical medicines and other medicines of common interest.
Additionally, the proposal introduces the concept of strategic projects, aimed at bolstering the EU's capacity to manufacture and develop critical medicines.
These projects, located within the EU, will benefit from incentives such as fast-tracked permitting, streamlined environmental assessments, administrative and scientific support and potential EU funding.
Lack of ambition (and money)
Commenting on the proposal, Luxembourgish Green MEP Tilly Metz called for bolder initiatives to reshore medicine production in Europe. 'Joint procurement and just accelerating the processes is not enough,' she told Euronews.
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Meanwhile, Romanian liberal MEP Vlad Voiculescu welcomed the proposal as a positive step toward greater access to affordable medicines.
'It's a beginning. We hope to see it backed by funding, budgets, and national legislation as soon as possible,' Voiculescu told Euronews.
Concerns remain over financing. Others fear that the proposal's indicative budget of €83 million for 2026-2027, primarily through the EU4Health program, will be insufficient.
Ahead of the proposal's presentation, 11 EU health ministers advocated expanding the scope of the upcoming EU defence funding scheme to include critical medicines. Belgian Health Minister Frank Vandenbroucke, one of the signatories, urged the Commission to integrate the Act into Europe's security and defence framework.
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'Medicine security is just as important as defence or energy security. Our collective safety depends on it,' he pointed out.
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