A fine line between health and industrial policy.

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.