EMA group calls for multi-prong measures to tackle shortages
The European Medicines Agency’s (EMA) Medicines Shortages Steering Group (MSSG) has recommended a series of actions that Member States and marketing authorization holders (MAHs) can take to strengthen supply chains and avoid shortages of critically needed medicines.These recommendations were issued on Tuesday following endorsement by the MSSG last week.
MSSG was established in March 2022 under Regulation (EU) 2022/1233 to bolster the EU’s role in monitoring shortages of medicines through the establishment of new groups within EMA to coordinate such actions to manage supply chain issues. The group includes representatives of EU Member States, the European Commission, and the EMA. (RELATED: Euro Roundup: EMA plans new bodies to manage tasks created by extended mandate, Regulatory Focus 3 March 2022)
The EU’s recently adopted pharmaceutical reform legislation also “foresees additional reinforcement of the role of the MSSG, including a provision that the MSSG may provide recommendations on appropriate security of supply measures of medicines included in the Union list to Marketing Authorisation Holders (MAHs), the Member States, the Commission or other entities. This document is drafted in the context of the anticipation of this new role.”
Some of the group’s eight recommendations include the following:
- MAHs should set up mechanisms to increase production capacity and increase supply to fulfill the needs of Member States;
- MAHs should diversify the number of suppliers in the supply chain and add alternative manufacturing sites in the regulatory dossier to reduce dependence on one supplier. MAHs should also assess geopolitical risks when choosing suppliers of critical raw materials, active substance, intermediates, and finished product; such risks include sites that are subject to travel restrictions, conflict zones, or trade barriers;
- MAHs and the EU/EEA should have systems in place to manage inventory and monitor available stocks for supply and demand. The paper states that such monitoring of demand “is essential for correct adjustments in the manufacturing and distribution to avoid or at least mitigate the impact of shortages.” Past shortages or back orders can also be used to forecast demand trends;
- Competent Authorities should provide assistance to small and medium-sized enterprises (SMEs) to address supply chain weaknesses;
- Supply chain partners should maintain contingency stock to serve as a buffer in the event of short-term shortages; the paper notes that this provision has already been implemented in several Member States;
- MAHs put in place a shortage prevention plan (SPP) for medicinal products placed on the Union list of critical medicines; and
- The EU should have a joint procurement mechanism to facilitate central negotiation or joint purchase of medicines for EU/EEA Member States. The paper states that such public procurement would “ensure availability for all patients regardless of where they live.”
The guide notes that in case of critical shortages of medicinal products, MAHs and Competent Authorities should consult its MSSG Toolkit. (RELATED: Euro Roundup: Commission proposes ‘regulatory flexibilities’ against drug shortages, Regulatory Focus 26 October 2023)
MSSG recommendations
