Kristian Vigenin: The Critical Medicines Act has to be flexible and fair to the smaller member states

The Critical Medicines Act is an important initiative for strengthening the resilience of supply chains and protecting patients across the whole European Union, but it must not turn into a new burden for the smaller member states, MEP Kristian Vigenin said during discussions in the European Parliament.

“The Critical Medicines Act has to strengthen the pharmaceutical resilience of Europe, while taking into account the diversity of our health systems. For it to be successful, it has to offer flexibility, fairness and real subsidiarity,” Vigenin stressed.

The legal basis and joint procurement

He drew attention to the fact that the legal basis of the proposal creates uncertainty and insisted on a double basis, articles 114 and 168 of the Treaty on the Functioning of the EU. Vigenin also warned that mandatory additional criteria in public procurement could increase the cost of medicines and limit patient access, which is why these measures should remain optional.

On joint public procurement he stressed that regional cooperation between countries with similar budgets can be useful, but centralised awarding carries risks, the convergence of prices, pressure on national reimbursement systems, the exclusion of smaller producers and contracts that do not fit national realities. In his view the requirement for national programmes within six months is disproportionate and hard to apply, and countries should keep the right to decide for themselves whether and when to introduce such measures.

Vigenin gave an assurance that the efforts to guarantee the availability of vital medicines should be supported, but insisted that the legislation be adapted in such a way that it does not create an additional burden for countries with limited resources.

The draft Critical Medicines Act was proposed by the European Commission on 11 March 2025, with the aim of reducing the dependence of the European Union on imports of vital medication and preventing future medicine shortage crises.