Executive Steering Group on Shortages and Safety of Medicinal Products

The role of the European Medicines Agency's (EMA) Executive Steering Group on Shortages and Safety of Medicinal Products is to ensure a robust response to medicine supply issues caused by major events or public-health emergencies. It coordinates urgent actions within the European Union (EU) to manage medicine supply issues and issues related to the quality, safety and efficacy of medicines.
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EMA established this group in March 2022 in accordance with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123). For more information, see Crisis preparedness and management.

The group is also known as the 'Medicine Shortages Steering Group' or MSSG.

Responsibilities

The group's responsibilities include:

  • establishing lists of the main therapeutic groups of human medicines that are being used in emergency care, surgeries and intensive care;
  • establishing lists of critical medicines that need to be monitored for supply issues during a major event or a public-health emergency;
  • monitoring the supply and demand of critical medicines (included on the lists of critical medicines for a major event or public health emergency) to identify any potential or actual shortages of these medicines;
  • providing recommendations and coordinating activities that aim to prevent shortages or mitigate their effects;
  • advising the European Commission on whether medicine shortages and other ongoing or imminent events should be recognised as 'major events';
  • evaluating information on the quality, safety and efficacy of medicines affected by public-health emergencies and other major events, and consider the need for urgent and EU coordinated actions;
  • providing recommendations on actions to be taken at EU level relating to medicine shortages and the quality, safety and efficacy of medicines, to the European Commission and to EU Member States.
  • overseeing a voluntary solidarity mechanism (information is available in the Working groups section on this page) that enables EU and European Economic Area (EEA) Member States to seek help from one another in obtaining medicines during critical shortages.
  • providing recommendations to address vulnerabilities in the supply chain of medicines included in the Union list of critical medicines.
  • cooperating with the Critical Medicines Alliance to discuss long-term measures to address vulnerabilities.

Information is available on the types of recommendation that the group can make to help tackle critical shortages of medicines and to address vulnerabilities in the supply chain of critical medicines, respectively:

For more information, see the 'Working groups' section on this page.

How the group works

In carrying out its responsibilities, the group may consult EMA's scientific Committees, their working parties, and other expert groups, including the Emergency Task Force (ETF).

When a major event or public health emergency may lead to medicine shortages, the group is supported by EMA's Medicines Shortages Single Point of Contact (SPOC) Working Party.

During major events affecting the efficacy, safety or quality of medicines, the work of the group is supported by EMA's scientific committees, their working parties, expert groups or the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) / Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products (CMDv).

The European Commission or EU Member States can also raise issues of concern to the group for advice on urgent and coordinated EU action.

Composition

The members of the Executive Steering Group include:

  • representatives of EU Member States;
  • one representative of the European Commission;
  • one EMA representative.

It also includes one observer from EMA’s Patients’ and Consumers’ Working Party (PCWP) and one from its Healthcare Professionals’ Working Party (HCPWP).

The group is co-chaired by EMA and by a representative of one EU Member State.

More information on the group's responsibilities, composition, procedures and activities is available in this document:

Members

Below (in alphabetical order of the country they represent) are the current members of the Executive Steering Group on Shortages and Safety of Medicinal Products. The members' declarations of interests are available in the European expert list.

Co-chair (EMA)

Emer Cooke

Affiliation

European Medicines Agency

Co-chair (Member States)

Karl Broich

Affiliation

Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM

European Commission

Representative

Bruno Gautrais

Affiliation

European Commission. DG SANTE - Health and Food Safety D2

Austria

Representative

Günter Waxenecker

Affiliation

Austrian Agency for Health and Food Safety

Belgium

Representative

Hugues Malonne

Affiliation

Federal Agency for Medicines and Healthcare Products (FAMHP) 

Bulgaria

Representative

Bogdan Yavorov Kirilov

Affiliation

Bulgarian Drug Agency 

Croatia

Representative

Siniša Tomić

Affiliation

Agency for medicinal products and medical devices of Croatia

Cyprus

Representative

Helena Panayiotopoulou

Affiliation

Ministry of Health - Pharmaceutical Services

Czechia

Representative

Jakub Velik

Affiliation

State Institute for Drug Control

Denmark

Representative

Merete Hermann

Affiliation

Danish Medicines Agency

Estonia

Representative

Ott Laius

Affiliation

State Agency for Medicines

Finland

Representative

Eija Pelkonen

Affiliation

Finnish Medicines Agency

France

Representative

Guillaume Renaud

Affiliation

National Agency for the Safety of Medicine and Health Products

Germany

Representative

Karl Broich

Affiliation

Federal Institute for Drugs and Medical Devices

Greece

Representative

Theoni Kousteni

Affiliation

National Organization for Medicines

Hungary

Representative

Zakarias El-Koulali

Affiliation

National Institute of Pharmacy and Nutrition

Ireland

Representative

Lorraine Nolan

Affiliation

Health Products Regulatory Authority (HPRA)

Italy

Representative

Domenico Di Giorgio

Affiliation

Italian Medicines Agency

Latvia

Representative

Sergejs Akulics

Affiliation

State Agency of Medicines

Lithuania

Representative

Linas Mažeika

Affiliation

State Medicines Control Agency

Luxembourg

Representative

Anna Chioti

Affiliation

Ministry of Health

Malta

Representative

Anthony Serracino-Inglott

Affiliation

Malta Medicines Authority (MMA)

Netherlands

Representative

Aimad Torqui

Affiliation

Medicines Evaluation Board

Poland

Representative

Tomasz Lisiewski

Affiliation

Chief Pharmaceutical Inspectorate

Portugal

Representative

Rui Santos Ivo

Affiliation

National Authority of Medicines and Health Products

Romania

Representative

Razvan Mihai Prisada

Affiliation

National Authority of Medicines and Medical Devices of Romania

Slovakia

Representative

Roman Dorčik

Affiliation

State Institute for Drug Control

Slovenia

Representative

Momir Radulovic

Affiliation

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia

Spain

Representative

Maria Jesus Lamas Diaz

Affiliation

Spanish Agency for Medicines and Health Products

Sweden

Representative

Joakim Brandberg

Affiliation

Swedish Medical Products Agency

Observers

Iceland

Representative

Runa Hauksdóttir Hvannberg

Affiliation

Icelandic Medicines Agency

Lichtenstein

Representative

Vlasta Zavadova

Affiliation

Office of Health

Norway

Representative

n/a

Affiliation

Norwegian Medical Products Agency

Patients' and Consumers' Working Part (PCWP)

Representative

Nikos Dedes

Affiliation

European AIDS Treatment Group E.V.

Healthcare Professionals' Working Party (HCPWP)

Representative

Piera Polidori

Affiliation

European Association of Hospital Pharmacists

Working groups

A Solidarity Mechanism Working Group advises the Executive Steering Group on setting up a voluntary solidarity forum for EU and European Economic Area (EEA) Member States to seek help from one another in obtaining medicines in case of critical shortages in their own country. 

The voluntary solidarity forum supports member countries in exceptional circumstances when they cannot restore medicine supply in case of critical shortages through other measures. 

It was set up in July 2023.

A European Shortages Management Platform Working Group advises on implementing the European Shortages Monitoring Platform (ESMP). It is responsible for:

  • developing the technical and functional specifications of the ESMP, including a data exchange mechanism with national systems and the data format for electronic submission;
  • strengthening cooperation with the European medicines regulatory network.

It was set up in September 2022. 

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