Reacción a "The European Commission presents its proposal on the Critical Medicines Act to guarantee supply and reduce external dependence"

Possible impact of the CMA

“The measures of the Critical Medicines Act (CMA) are fundamentally designed to increase the security of supply of critical products in the EU, but the budget currently under consideration is very small. The CMA emphasizes the importance of industrial policy measures to promote European pharmaceutical production for 'strategic projects', i.e. selected critical products or elements in the supply chains. In addition, rules are being created for the mandatory use of the Most Economically Advantageous Tender (MEAT) criteria to take greater account of security of supply in the public procurement of critical products – although there is still room for maneuver in the specific implementation. Possible criteria in procurement could include, for example, stockholding obligations, supplier diversification, supply chain transparency, and so on. In certain cases, priority can also be given to medicines produced in the EU.”

“However, the question of financing is problematic. Although EU funding instruments (e.g. Digital Europe, Horizon) are to be opened up for strategic projects, the CMA itself is only budgeted with 88 million euros for the years 2026/27. Moreover, the majority of the budget comes from the EU4Health program. This budget will not go far in building European production, so the ball is in the member states' court, whose budgets are already under severe pressure.”

“Another question mark is the expansion of procurement requirements to include security of supply by the various procurement organizations. There is still a lot of room for maneuver here, and against this background there is also a risk of dilution.”

“The extent to which the CMA draft reduces the structural reduction of European dependence on imports from Asia depends on the funds made available. The budget of the current draft is very limited, and other financing commitments are not yet available.”

Adjustment of drug prices

“Generally speaking, the prices of medicines are not expected to be affected, as the CMA only targets a specific list of critical medicines. Within this group, two mechanisms are particularly relevant to prices. The first mechanism concerns possible adjustments to public procurement when criteria other than price alone become more relevant – in this case, price increases are likely. However, it is not yet clear how the procurement organizations in the member states will implement this. Procurement cooperations, as envisaged by the CMA, can also reduce prices, as market power in purchasing increases. Currently, the decentralized purchasing of the various procurement agencies in the EU tends to hinder the achievement of the lowest possible prices.”

“A second important mechanism is the planned development of European production capacities. Production costs in the EU are higher, and against this background – depending on the funding model – there may also be price pressure on individual pharmaceuticals. This is particularly the case if the purchase or import of cheaper products is to be restricted in the future (e.g. due to procurement requirements for security of supply). However, due to limited budget resources, it can be assumed that there will be no major changes at the moment. At this point in time, it is not yet possible to say what role the strategic projects will play in the individual member states. Currently, major reshoring projects are for example planned France.”

Profitability of EU production

“In many cases, there is a trade-off between resilience and efficiency in supply chain and production structures. The main reason for the current structures and the associated problems is that companies have overemphasized efficient supply chains. This, in turn, is driven by public procurement, which has so far been primarily based on price, while resilience and sustainability aspects have been given little or no consideration. This circumstance, in turn, must be seen against the background of the high pressure on public budgets in general.”

“In other words, the production of pharmaceuticals in the EU is generally more expensive for a variety of reasons. We currently import cheaper off-patent products from Asia, but we also suffer from supply shortages. The idea of reshoring selected production steps to the EU should be seen in this context.”