As EU health ministers gather in Brussels on 23-24 April to discuss access to critical medicines and formally launch the Critical Medicines Alliance, the European Medicines Agency (EMA) has published its own recommendations to address vulnerabilities in the production and delivery of medicines on the EU’s critical list.

Following the COVID crisis, EMA was given a reinforced role in crisis preparedness and management of medicines to ensure that medicines are available in case of a public health emergency.

EMA’s Medicines Shortages Steering Group (MSSG) is foreseen as having a stronger role in providing advice in the revised Pharmaceutical legislation, and the list of recommendations is made in anticipation of this new role. 

The recommendations will be tailored to the specificities of each medicine on the list and EMA will stop short of making recommendations on industrial policy strategies, including financial incentives.

Nevertheless, there are some concrete proposals particularly for companies, specifically those companies with authorisation to market a medicine in one or more EU countries (Market Authorisation Holders – MAHs).

Companies

MAHs may receive recommendations to propose measures to increase production capacity and meet needs in the EU. There will also be further burdens placed on MAHs in terms of potential obligations to provide shortage prevention plans (SPP).

Stockpiles

The MSSG calls for effective monitoring of stocks to mitigate shortages and supply chains should be tested for robustness, so that they are not beholden to just one producer and there are no geopolitical threats to access.

States should ensure buffer stock is available to protect themselves from fluctuations in demand for medicines and active ingredients. While some states already do this, it is not the case across the board. Ultimately, the EMA may turn to the European Commission to propose stockpiling at the EU level, but this would be a measure of last resort. 

Procurement

One way to ensure availability of medicines across the EU, to countries large and small, would be through joint procurement. This could take many forms: straight forward joint procurement for a particular medicine, or contractual incentives, or capacity reservation contracts. 

Investment in API

A particularly challenging issue is the struggle to maintain the production of Active Pharmaceutical Ingredients (API) in Europe.

These ingredients are often produced much more competitively outside Europe, particularly in China and India, which leaves Europe vulnerable in times of need, as was seen during the COVID pandemic.

EMA says this matter rests squarely in the domain of the Critical Medicines Alliance. Novel tools or new financing mechanisms could be a possibility, but the MSSG is not explicit about what these might be. Alternatively, it could come from some member states acting together or with EU support. 

Cooperation

EMA believes there could be greater cross-border cooperation between regulatory authorities to expedite the authorisation of variations.

The MSSG is focused on developing regulatory and policy recommendations focused on the short- to medium-term. It is complementary to the Critical Medicines Alliance and will focus on long-term measures in the field of industrial policy to address vulnerabilities in the supply chain of critical medicines.

[Edited by Zoran Radosavljevic]

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