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.