Drug shortages: the measures for EMA to tackle them

Thanks to an EU Regulation, the European Medicines Agency has now the means to strengthen the tools against drug shortages and medical devices shortages. Here are all the news.

The drug shortages are a problem that has afflicted all European countries for several years. With the advent of the pandemic situation from Covid-19 the question has become even more dramatic. To remedy this, the European Parliament and the European Council issued the Regulation (EU) 2022/123. Its aim is to strength the tools of the EMA (European Medicine Agency) to fight the shortage of medicines and medical devices.

The Regulation was published on 31 January 2022 and was became applicable from 1 March 2022. Its main objective is to strengthen the EU’s role in monitoring shortages of both medicines and medical devices, through the establishment of new structures inside EMA. In this way, it will be possible to avoid supply problems even in the event of future health emergencies.

In order to manage the drug shortages and medical devices shortages, the new Regulation brought about the introduction of two steering groups (Medicines Shortage Steering Group and Medical Device Shortage Steering Group), the implementation of a platform for collecting shortage and the activation of an operational task force.

A new introduced by the regulation is the Medicines Shortage Steering Group (MSSG). It is a steering group made up of representatives from each Member State plus one from EMA and one from the Commission. Its aim is to monitor and prevent medicines shortages in each Member State.

A working group made up of representatives from each state’s drug agencies was also established to support the MSSG.

The task of the MSSG is to provide the EU Commission, the Member States, the companies and others, including representatives of healthcare professionals and patients, with recommendations to prevent or mitigate shortages of medicines.

The MSSG also takes care of drawing up the list of critical drugs, that are those medicines necessary for emergency treatment. In the event of an emergency or serious event, the MSSG may require pharmaceutical companies to provide information about these medicines and for pharmacies and wholesalers to provide evidence of actual or potential shortages.

In parallel to the MSSG, the MDSSG, that is the group for the monitoring and management of specific deficiencies of medical devices, was also established.

With the Regulation, the European Shortage Monitoring Platform (ESMP) was introduced, a platform for collecting data on drug shortages.

The ESMP, which must be fully operational by 2 February 2025, will be fed with information from MAHs and national medicines agencies. In the Italian case, given that AIFA, the national competent authority, does not have such information, it is necessary to involve pharmacies and wholesalers in monitoring at the distribution level. This information can also be used to possibly declare a state of emergency or a serious event.

An Emergency Task Force (ETF) was also implemented with the aim of simplifying clinical trials of drugs intended to treat, prevent or diagnose diseases responsible for public health emergencies.

Its duties include reviewing scientific data, making recommendations on the use of unauthorized drugs, coordinating independent studies on vaccine efficacy and safety monitoring, as well as providing scientific advice for the development of medicines intended for use during a public health emergency.

The EU’s network of Single Points of Contact (SPOC), a system used by EMA and national competent authorities to exchange information on deficiencies, is now in charge of supporting the MSSG and providing it with recommendations on:

• monitoring and managing shortages and/or availability issues during a crisis and beyond
• update of the EMA plan for emerging health threats
• definition of the main medicines needed for emergency care, surgery and intensive care, in order to help prepare the lists of essential medicines to respond to public health emergencies or serious events
• Guidance for businesses on the Industry SPOC Network (i-SPOC).