
Critical Medicines Act
A fine line between health and industrial policy.
CC – 02/2025
The draft regulation for the Critical
Medicines Act is expected on 11 March. EU Health Commissioner Olivér Várhelyi
had already announced the draft several times and had set himself the goal of
presenting it within the first 100 days of the European Commission's new term
of office. In view of the increased political pressure, Várhelyi is now
honouring this promise. But what exactly can we expect on 11 March?
No impact assessment due to lack of time
According to the exploratory report, the
Critical Medicines Act will be a regulation, but with fewer accompanying
material than usual. Contrary to the principles of "better
regulation", an impact assessment is not carried out for time reasons.
Instead, the draft is based on the Strategic Report of the Critical
Medicines Alliance and an external study on supply reliability in the European
Union (EU). While some criticise this approach as being too hasty, others see
it as quick action in the face of pressing problems.
What content can we expect?
The expected measures include proposals for
the joint procurement of medicinal products, a revision of new EU procurement
criteria and recommendations on the obligations for stockpiling medicinal
products. In addition, a "favourable environment for the establishment and
expansion of production facilities in the EU" is to be created. In
general, it should be a basket of measures, with sufficient flexibility, but
also specific regulations to enhance the supply reliability of medicinal
products in the EU.
Diversification – an industrial policy measure
In their opinion, the DSV welcomes the
proposed Critical Medicine Act as an important step towards ensuring a stable
and needs-based supply of medicines in the EU. It is crucial that the
regulation complements the ongoing reform of European pharmaceutical
legislation, takes national measures into account and ensures the financial
viability of healthcare systems. The DSV is calling for
evidence-based implementation as supply bottlenecks have a variety of causes.
It is therefore crucial to monitor the market and supply situation and analyse
the causes of bottlenecks. Simply relocating production back to Europe would
not guarantee supply reliability. Diversification measures also represented an
industrial policy task. Contributions from statutory health insurance should
not be misappropriated for this purpose.
Efficient public procurement
The Member States are responsible for the
procurement and reimbursement of medicinal products. However, the DSV sees an
opportunity to clarify European public procurement law. It should make it clear
that criteria such as supply reliability, production location and supply chain
stability can be taken into account in addition to price. The stockpiling of
critical medicines should also continue to be regulated at national level.