On Tuesday 11 March, the European Commission adopted a proposal for a Regulation on critical medicinal products aimed at boosting Europe’s production capacity, in particular by diversifying supply chains and reducing the EU’s dependencies.
These measures should provide Europe with a more stable supply of critical medicinal products. They should also help to improve access and availability of other medicines of common interest (to treat rare diseases), where there are disparities between countries.
“This proposal is very much needed to ensure security of supply and availability of critical medicines, as well as accessibility of other key medicines where the market is not delivering”, said Commissioner for Health Olivér Várhelyi.
He explained that the proposed text will facilitate investment for companies that create or increase production capacity for critical medicinal products in the EU. These projects can be identified as strategic projects. “This will give them easier access to funding and fast-track administrative, regulatory, and scientific support”.
The Commission has also published guidelines on State aid to help Member States support these strategic projects or projects with similar objectives.
The Act will strengthen the resilience of supply chains. “Procurers will have to use criteria other than only the price in their procurement procedures. For instance, these criteria could be the use of diversified suppliers or contractual clauses on timely delivery”, according to Olivér Várhelyi. There are also provisions for critical medicinal products that are highly dependent on supplies from one or a limited number of countries outside the EU. In this case, procurers will also be required, where justified, to “favour suppliers that manufacture a significant proportion of these critical medicines in the EU, as long as they comply with the Union’s international commitment”, said the Commissioner.
In addition, the Commission will offer Member States the possibility of using “aggregated demands”. If they so wish, EU countries will be able to ask the Commission to help them use different collaborative procurement tools to facilitate access to the medicines they need, “building on the experience of jointly procuring medical countermeasures”, said the Commissioner. Finally, the Commission will seek to establish new international partnerships to diversify the supply chains for these critical medicinal products.
Speaking to the press (https://aeur.eu/f/fvq ), Commission Vice-President Teresa Ribera stressed that the proposal also aimed to ensure that the production framework was modernised in order to attract investment.
The budgetary impact of the proposal is €83 million for the period 2026-2027. This amount will be used to finance investment in the manufacturing sector and production capacity. These funds will be redeployed within the EU4Health programme envelope.
The proposal establishes a series of industrial policy measures, including the designation of strategic projects aimed at creating, increasing or modernising production capacities for critical medicinal products in the Union. These strategic projects would benefit from certain incentives. Access to EU funding will be facilitated for projects aimed at addressing supply chain vulnerabilities through the ‘Strategic Technologies for Europe Platform’ (‘STEP’ initiative).
The Act proposes measures relating to public procurement to encourage secure supply chains and make markets more attractive to manufacturers, while guaranteeing Member States a stable supply of medicines.
For critical medicinal products, public purchasers will have to include a broader set of requirements in their tendering procedures (diversification of raw material sources, monitoring of supply chains).
In the event of heavy dependence on a single country or a limited number of countries, and where justified, they will also have to apply procurement requirements favouring the production of critical medicinal products in the EU. This will also be possible for other medicines of common interest in certain circumstances.
The law describes how Member States can request assistance from the Commission to use different collaborative public procurement tools, such as joint public procurement, between themselves. This can create economies of scale and reduce disparities in access and availability.
The law focuses mainly on the critical medicinal products on the EU list (see below). This covers a wide range of medicines, from antibiotics and antithrombotics to cancer treatments and cardiovascular drugs. The law on critical medicines also covers certain other medicines of common interest that are experiencing market failures. For example, medicines for rare diseases.
Link to the proposal: https://aeur.eu/f/fv1 (Original version in French by Lionel Changeur)