The European Medicines Agency EMA has published a so called “MSSG Toolkit on recommendations on tackling shortages of medicinal products“, a guidance document for use by the MSSG to facilitate identification of recommendations on critical shortages of medicinal products.
Regulation (EU) 2022/1231 (the Regulation) established the Executive Steering Group on Shortages and Safety of Medicinal Products (the ‘Medicine Shortages Steering Group – MSSG’) to ensure a robust response to major events or public health emergencies, including through provision of advice and
recommendations on the necessary actions to safeguard the quality, safety and efficacy of medicinal products as well as to safeguard the supply of medicinal products and to ensure a high level of human health protection.
The Regulation provides a framework to be deployed by the Agency in preparation for and during public health emergencies and during major events, as defined in the Regulation, to enhance the Union’s capacity to react quickly, efficiently, and in a coordinated manner to such emergencies.
The role of the MSSG is to ensure a robust response to major events/public health emergencies, and to coordinate urgent actions within the Union in relation to the supply of medicinal products. The MSSG also has a role in monitoring critical shortages2 that could lead to a major event or public health
According to the Regulation, the MSSG shall provide recommendations to the Commission and Member States on any appropriate action that it believes needs to be taken at Union level on the medicinal products concerned in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004. The
MSSG, on its own initiative or at the request of the Commission or a Member State, may also provide recommendations on measures that the European Commission (EC), Member States, marketing authorisation holders and other entities, including representatives of healthcare professionals and of
patients, could take to prevent or mitigate actual or potential shortages of medicinal products or to ensure preparedness for dealing with actual or potential shortages of medicinal products.
The MSSG is supported by a working party comprised of single points of contact related to shortages from national competent authorities for medicinal products, the so-called Medicine Shortages SPOC Working Party (SPOC WP).
The SPOC WP is responsible for monitoring and reporting events that could affect the supply of medicines in the European Union. The SPOC WP may escalate availability events to the MSSG that are likely to lead to a major event or a public-health emergency.
This document is built on the experience gained by the European Medicines Regulatory Network during the COVID-19 pandemic, the experience acquired by dealing with critical shortages escalated by the SPOC WP since the MSSG was set up, and guidelines issued by the European Commission during the
pandemic3. It enlists the main types of actions that MSSG should on a case-by-case basis consider recommending in order to tackle critical shortages that have been escalated to this forum. It includes both frequently-applied measures for tackling medicine shortages, as well potential measures that may
only be appropriate in exceptional critical-shortage situations (i.e. would not need to be considered or applied for majority of cases that are managed at national or SPOC WP level). It is not, however, exhaustive and MSSG may also identify other recommendations that may be appropriate for the
particular shortage situation.