Czech Deputy Health Minister Jakub Dvořáček has told Euractiv that while the Critical Medicines Act could improve access to medicines across the bloc, there are still key issues to be resolved for it to be effective.
While welcoming the initiative, Dvořáček warned that uncertainty around investment, unclear definitions of European-made medicines, and a lack of coordination between member states could undermine its impact.
“In terms of safety and the provision of key medicines, the material is not bad at all,” said Dvořáček, who co-chairs the first working group in the Critical Medicines Alliance.
However, he stressed that the proposal needs clearer rules to ensure long-term security of supply, prevent fragmented investments, and support the launch of medicines in smaller member states.
The European Commission’s proposal aims to strengthen Europe’s pharmaceutical supply chains by reducing reliance on third-country suppliers and addressing medicine shortages.
A key element is the Union List of Critical Medicines, which will be regularly updated to prioritise essential medicines for EU-wide support.
The Act also includes provisions for investment incentives and joint procurement, allowing member states to combine purchasing power to secure better access to medicines.
Medicines definitions needed
Dvořáček acknowledged the importance of these measures but pointed to several concerns regarding their implementation. One of his main issues is the time required for investments to translate into actual drug production.
“From the decision to invest to the launch of production, and the final product reaching the market, the process takes three to four years. There is no guarantee that the drug won’t fall off the list of critical medicines in the meantime,” he pointed out.
The unpredictability of which medicines remain on the list presents a risk for investors, potentially discouraging participation in strategic projects. There is also no clear definition of what constitutes a European-made medicine.
“Only such medicines can be considered strategic, but we need to clarify what part of the drug must originate from Europe, whether it applies only to the active substance and other related aspects,” Dvořáček said.
He also pointed out the risk of uncoordinated investments. If each country pursues its own projects without coordination, multiple states could end up investing in the same medicines, such as penicillin, rather than distributing resources efficiently across different types of critical medicines.
Joint procurements crucial
The Act introduces joint procurement mechanisms, which could help smaller EU countries access medicines more easily.
At present, pharmaceutical companies tend to prioritise larger markets, making new medicines available in countries like Germany and France first before expanding to smaller states. This results in delayed patient access to medicines in less economically attractive markets.
Dvořáček sees potential in the joint purchasing system, which should cover not only “critical” medicines but also those of “common interest.”
“It finally creates the conditions for joint negotiations and European purchases on a larger scale than I had originally thought - because they are working with common-interest products, not just critical ones. That made me happy,” he said.
Joint purchasing could improve negotiation conditions for smaller countries, ensuring that medicines are introduced more evenly across the EU. “The European Commission is preparing the capacity to assist with this. It is moving in the right direction,” Dvořáček said.
Finish Pharma Package first
The proposal does not explicitly include measures against uncoordinated national stockpiling of medicines – an issue which was highlighted by Czechia recently – but the issue is mentioned in the Critical Medicines Act recital.
Dvořáček welcomed these references but noted that they should be incorporated into the EU’s pharmaceutical package – another EU legislation which is in a more advanced stage of negotiations.
According to Dvořáček, measures against uncoordinated stockpiling should apply not only to critical medicines but to all medicines where availability could become limited.
Dvořáček also stressed that the Act’s alignment with the broader pharmaceutical legislation is necessary to avoid contradictions. “We have to finish the work on the pharmaceutical package first and then work on the Critical Medicines Act so that they reflect each other and do not contradict one another,” he said.
Czech industry calls for quick action
From the perspective of the Czech pharmaceutical industry, the Critical Medicines Act represents an important opportunity, but only if the country acts quickly.
Filip Vrubel, Executive Director of the Czech Association of Pharmaceutical Companies, emphasised that the Act will not only create competition between EU manufacturers and third-country suppliers but also between different EU member states.
“The Commission’s effort to bring pharmaceutical manufacturing back to Europe is an opportunity we must not miss. The Critical Medicines Act can help reverse the current unfavourable situation, but its success will depend on how individual states use its tools,” Vrubel said.
He warned that some countries, such as France, are already preparing strategic investments, and unless the Czech Republic formulates its own clear strategy, it risks losing out to other EU states with more developed support mechanisms.
[Edited by Vasiliki Angouridi, Brian Maguire]
