Author: Sebastian Vinzens, Senior Medical Writer, Germany
On 11 March 2025, the European Commission (EC) proposed the Critical Medicines Act (CMA). The CMA aims to address medicine shortages by reducing supply chain vulnerabilities, reducing the EU’s dependence on non-EU suppliers and improving access to medicines of “common interest”. To the surprise of industry, it also includes the possibility of future EC-led EU Joint Procurement for innovative products of common interest that have undergone a Joint Clinical Assessment (JCA). While the EU HTA came into force at the beginning of this year, the CMA brings further ambiguity and significant uncertainty to the European market access of novel medicines, which could present both risks and opportunities. Here is a first look:
Articles 22, 23 and 24 of the proposed CMA introduce the concept of European Joint Procurement:
a) For critical medicines for which a vulnerability assessment has identified a weakness in the supply chain (generic medicines); and –
b) For medicinal products of common interest (innovative therapies) for which a joint clinical evaluation (or even a clinical evaluation carried out in the framework of voluntary cooperation between Member States) has been carried out. If nine or more Member States so request, the Commission may procure on their behalf or in their name, acting as a central purchasing body, and other Member States may opt in under the conditions defined by the CMA.
This raises different questions about the implications for pricing and market access strategies and the relevance of Joint Procurement initiatives not only for generics but also for ‘medicinal products of common interest’.
Potential Relevance and Scope for EU Joint Procurement
Article 3(5) of the Act defines medicinal products of common interest as non-critical products for which the functioning of the market in three or more Member States does not sufficiently ensure availability and accessibility for patients in those Member States. This could be interpreted to mean that Joint Procurement is a means of actually achieving the EU HTA Regulation’s objective of achieving equitable patient access to innovative therapies in Europe. It is interesting to note that the EC can only decide to pursue the procurement if it is exclusive to the member states or if they agree to binding minimum quantities. The CMA cites orphan drugs or novel antimicrobials as examples of products of common interest. As the vast majority of innovative medicines are not available or accessible in all Member States, and often are not available in more than three Member States, it is questionable which products could be defined as being of common interest – and how availability and accessibility are defined in this specific context.
Although the strategic outlook for joint purchasing of innovative therapies remains largely elusive, as there is currently no clear understanding of what such a process might actually look like from a strategic and operational perspective, current joint HTA/purchasing initiatives such as BeNeLuxA and the Joint Nordic HTA Bodies (JNHB) provide a first glimpse of the effectiveness and influence of the concept.
With a potential impact on pricing and market access activities the EU Joint Procurement raises a number of issues that may offer opportunities, but also risks, such as: Regulatory requirements and prerequisites for Joint Procurement initiatives, relevance and interconnection with national HTA processes, engagement and influence on existing buying collaborations (i.e. BeNeLuxA, JNHB), importance for countries with highly developed HTA processes (e.g. France, Germany), benefits for countries with less defined HTA processes (e.g. Serbia, Latvia etc.), implications for strategic price setting mechanisms such as international reference pricing and managed entry agreements.
Kintiga are closely monitoring all relevant legislative developments and consider them directly in our day-to-day projects with our clients. If you would like to discuss the potential impact and potential strategic opportunities for your product, please contact us – we are look forward to an exciting discussion!
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