The European Parliament and Council have reached a provisional agreement on the Critical Medicines Act (CMA), introducing measures to diversify supply chains, boost EU-based manufacturing, and facilitate joint procurement among member states. Salud por Derecho welcomes the priority given to these negotiations and the speed with which they have been concluded — medicine shortages are an urgent public health crisis in Europe, as demonstrated by recurrent stock-outs of rifampicin-based treatments for tuberculosis patients disrupting continuity of care across the WHO European Region, and by persistent shortages of essential oncology medicines, including the critical shortage of intravenous ifosfamide and cyclophosphamide, with nearly 70% of European countries having experienced shortages of cancer medicines in recent years.
Salud por Derecho welcomes concrete progress, including the reduction of the threshold of countries needed to trigger a joint procurement request — from nine to five — and the inclusion of orphan medicines within the law’s scope. Pooled procurement must go beyond securing availability — it must become a tool for member states to collectively push back against unaffordable prices, while avoiding using confidentiality clauses by leveraging joint negotiation power. However, until the full text is published, the deal’s position on a central civil society demand remains unknown: whether public financial support for strategic projects will be tied to binding affordability and transparency obligations.
On the “EU preference” approach to manufacturing, concerns raised by other civil society actors deserve attention. As we have warned, a significant surge in EU demand and stockpiling could drive up global commodity prices, making medicines unaffordable in the Global South. Likewise, if reshoring of EU manufacturing is done without having Global Health commitments in the planning process, the EU may inadvertently undermine efforts to build pharmaceutical manufacturing capacity in other regions — an initiative strongly championed in several multilateral fora, such as the G20.
These are risks the CMA’s implementation must actively seek to mitigate. We call on both institutions to ensure, through the formal adoption process and subsequent implementing acts, that no public investment under this framework is made without a clear public return — including equitable and affordable access to end products.
“Today’s deal is a starting point, not a finish line. The CMA will only fulfil its promise if affordability obligations are binding, if joint procurement can be used to secure fair prices, and if the ‘Buy European’ drive does not come at the expense of health equity globally. Civil society will remain watchful through the formal adoption process,” said Jaime Manzano, researcher and advocacy manager at Salud por Derecho.
