New Critical Medicines Alliance starts work to address shortages
The EU has faced recent shortages of various critical drugs, including paracetamol and some antibiotics, due to a range of supply-chain issues, from low production capacity to shortages in key raw materials combined with a rise in demand across the bloc.
During the launch of the Alliance in Brussels (24 April), Health Commissioner Stella Kyriakides said that though shortages are not a new phenomenon, they have been exacerbated by the COVID-19 pandemic and geopolitical challenges.
“We have to be able to anticipate possible disruptions for the future, to boost our strategic autonomy and also ensure diversified supply chains,” she added.
The Critical Medicines Alliance is part of a wider plan to tackle medicine shortages published in a Communication in October 2023, which also touted extending the mandate of the European Centre for Disease Prevention and Control and the reform of current pharmaceutical legislation.
The Alliance will have a mandate of five years and focus only on industrial policy, leaving other regulatory topics for the new pharmaceutical rules.
It will work to strengthen manufacturing capacities by leveraging EU and national funding and using market incentives such as capacity reservation contacts or joint procurement, and is set to issue its first recommendations in a Strategic Plan envisioned for the end of the year.
The consultation body comprises 250 members and includes representatives from the European Commission, member states, the pharmaceutical industry, patients and other healthcare professionals.
Belgian Health Minister Frank Vandenbroucke said that during the last 20 years, production has shifted away from Europe to countries such as China or India, adding to the risk in case of supply problems.
The group will also work to diversify the international supply chain of the medicines identified as most critical and will develop joint projects and strategic partnerships with third countries.
The Alliance will also work on the Union List of Critical Medicines published by the Commission and the European Medicines Agency in December 2023.
The first version of this list contained more than 200 medicines for human use that are considered critical and whose shortages could be a threat to public health.
The Commission then launched a pilot exercise to analyse the vulnerabilities in the supply chains of an initial set of 11 substances from this list that will be the baseline for the Alliance’s work.
Paving the way for a Critical Medicines Act
The Alliance will build on the model of similar industrial initiatives such as existing European Alliances on critical raw materials and semiconductors, which led respectively to the European Raw Materials Act and the European Chips Act, and is also expected to result in legislation.
"We need a battery of instruments which is also a battery of legal instruments. We need a Critical Medicines Act,” said Vandenbroucke.
Last year, 23 member states published a non-paper asking for an act as a first step to a more structural, long-term approach.
The new Alliance considers that its work could “pave the way for a possible Critical Medicines Act in the future” and stated that this would require thorough preparation, including assessing economic aspects.
The Commission launched a study in October 2023 to assess the possibility of such an act, but no concrete timeline has been set for any future action.
