EMA’s new recommendations to strengthen supply chains of critical medicines – a short recap of what and why

On 19 April 2024 it was announced that EMA, through its Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), has developed a set of recommendations to strengthen supply chains of critical medicines. The following is a short recap of what the recommendations are and why they have been developed.

These new recommendations have been developed to ensure a continued supply of medicinal products that are considered to be the most critical to healthcare systems, and whose continued supply is considered a priority in the EU to prevent serious harm to patients and minimize the risk of supply disruptions. The medicinal products in question are defined through what is referred to as the “Union List”, which was developed jointly by the EMA, the European Commission and the Heads of Medicines Agencies.

The recommendations to be adopted by the MSSG will vary depending on the particular situation at hand; they may include advice, for example to marketing authorisation holders (MAHs) to stockpile products, diversify suppliers or increase production capacity when a vulnerability in a supply chain has been identified. Another possibility is to request a MAH to establish a shortage prevention plan for medicines in the Union List. EMA has announced that it will publish guidance and templates for shortage prevention plans in June 2024.

The recommendations will thus depend on and be tailored to possible identified vulnerabilities in the supply chain and the specific intrinsic characteristics of the medicinal product(s) in question. For example, the product’s shelf life will be taken into consideration.

The MSSG may also, for example, recommend that the competent authorities of the Member States provide scientific and regulatory support to address vulnerabilities in the supply chain. This may also include assistance to small and medium-sized enterprises.

While the MSSG will focus on developing short-to-medium term actions to prevent vulnerabilities in the supply chain, the newly launched Critical Medicines Alliance (CMA) will focus on long-term actions in the field of industrial policy. Their work will thus be complementary, and the aim is to maintain close cooperation. The MSSG will also work closely with Member State experts, the industry and healthcare professionals.

Even though the new recommendations of the MSSG are currently not legally binding, this may change once the new pharmaceutical legislation enters into force. This new legislation includes a specific provision concerning the MSSG’s possibility to provide recommendations, for example, to MAHs, Member States and the Commission on appropriate security of supply measures for medicinal products included in the Union List.

Finally, it may be added that the new recommendations are displayed through a living document, hence they will likely be developed and adjusted going forward. Setterwalls is following this matter closely.