On 24 October 2023, the European Commission issued a communication setting out short-term and medium/longer-term actions to prevent or mitigate critical shortages at EU level, with a particular focus on the most critical medicines for which supply needs to always be assured in the EU.
Actions to be taken in the short term include the following:
- The immediate deployment of a voluntary solidarity mechanism to support member states experiencing shortages. This scheme will allow member states to flag needs for a given medicine in critical shortage at national level to obtain supplies from other member states with available stock.
- The publication of a Union list of critical medicines that are essential to ensure the continuity of care and guarantee a high level of public health protection. The first version of this list will be available by the end of 2023. The Commission will analyse a first tranche of critical medicines by April 2024 to identify vulnerabilities in their supply chain and consequent remedial actions.
- The acceleration of the pharmaceutical reform, which, as already noted on this blog, provides for several measures aimed at improving supply chain continuity, including placing new responsibilities on companies. Elements of the new pharmaceutical legislation that could be anticipated comprise, among others, the earlier notification of the risk of a shortage and the adoption of related prevention plans by companies, as well as facilitating the transfer of marketing authorisations to third parties to limit the impact of medicines’ withdrawals from the market.
- The launch in 2024 of a joint action on regulatory flexibilities as a tool to manage and mitigate shortages of critical medicines. This includes measures to facilitate the quick authorisation and rollout of alternatives, the upscaling of production or approval of alternative suppliers of raw materials or finished products, and temporarily extending the shelf life of medicines.
- EU guidance on procurement focusing on procurement practices that can directly contribute to security of supply and availability. Examples of such practices could include awarding contracts to multiple winners to reduce the risk of supply disruptions, including supply security and production in the EU/EEA as award criteria and using joint procurement to overcome access challenges of smaller market sizes.
In the medium/longer-term, the Commission intends to set up a Critical Medicines Alliance by early 2024, allowing national authorities, the industry, EU agencies and the Commission itself to develop coordinated actions at EU level against the shortages of medicines, taking the vulnerability analysis of critical medicine supply chains included in the Union list as a starting point.
The Commission will also (i) launch a study by the end of 2023 to assess a legislative initiative for an EU Critical Medicines Act to enhance security of supply of the most critical medicines; (ii) develop a common strategic approach to medicine stockpiling with member states, to be completed by June 2024; and (iii) conclude strategic partnerships with third countries for production of critical medicines, reflecting both local demand and needs at the EU and global level.
With a note published on 26 October 2023, EFPIA announced that it shares the objectives set out in the Commission’s communication and particularly welcomes the structural measures to address the industrial dimension of medicine shortages in the medium and long term, including the initiative for the EU Critical Medicines Alliance.
As highlighted by EFPIA in its note, including the industry in the design and implementation of new processes and sharing information on the likely demand for medicines by EU institutions and competent authorities are of paramount importance to fully deliver the actions included in the communication. We hope the Commission and competent authorities will take that into account when implementing the actions to fight against shortages.
