Immediate and short-term measures
The Commission recognizes that more needs to be done to secure the medicine supply chain in the EU. Therefore, the Commission introduces a set of initiatives such as the launch of a European Voluntary Solidarity Mechanism for medicines, which was introduced in October. This mechanism facilitates the communication of one Member State’s medicine needs to other Member States, enabling a faster redistribution of medicines. Also, an EU list of critical medicines will be made available by the end of 2023, to show where additional measures to protect the supply chain will be needed. Moreover, the Commission will issue EU Guidance on procurement by early 2024, to support Member States in their procurement practices.
Mid- and long-term measures
For the longer term, the Commission prepares the way for an EU ‘Critical Medicines Act’ to strengthen the security of medicines supply in novel legislation. Also, a ‘Critical Medicines Alliance’ is intended to be set up by early 2024. This alliance will introduce an industrial policy dimension to the European Health Union, facilitating collaboration between national authorities, industry stakeholders, civil society representatives, the Commission, and EU agencies to address medicine shortages and vulnerabilities within the supply chains. The alliance will identify a targeted number of critical medicines with the highest risk of shortages, and will endeavor to diversify global supply chains, boost innovation and manufacturing capacity and create a common strategic approach to better leverage and align EU and national funding.
New EU pharmaceutical law package
The actions as presented by the Commission cannot be viewed separately from pharmaceutical reform that was announced in April 2023. The proposed reform would revise and replace the existing general pharmaceutical legislation. Among other things, the proposals in the EU Pharmaceutical Law Package introduce requirements for marketing authorisation holders to have a Shortage Prevention Plan in place and introduce more extensive notification requirements for marketing authorization holders to inform the European Medicines Agency (EMA) about supply disruptions, marketing suspensions and product withdrawals. The new actions aim to complement the proposed reform by further boosting the anticipation and operationalization of the proposed measures and provide additional policy tools to ensure the security of supply of critical medicines in the EU.
Next steps
As stated above, the coming period will see many developments in the pharmaceutical field within the European Union. Our teams regularly provide updates on pharmaceutical developments in the EU. Please contact the authors or the Hogan Lovells attorneys with whom you regularly work for additional information.
Authored by Milan Tuijp and Hein van den Bos.
