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.
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.
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 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.
In carrying out its reponsibilties, 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 Medicine 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.
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:
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) | |
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Name | Emer Cooke |
Affiliation | European Medicines Agency |
Co-chair (Member States) | |
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Name | Karl Broich |
Affiliation | Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM |
European Commission
Representative | |
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Name | Sylvain Giraud |
Affiliation | European Commission. DG SANTE - Health and Food Safety B4 |
Austria
Representative | |
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Name | Christa Wirthumer-Hoche |
Affiliation | Austrian Agency for Health and Food Safety |
Belgium
Representative | |
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Name | Xavier De Cuyper |
Affiliation | Federal Agency for Medicines and Healthcare Products (FAMHP) |
Bulgaria
Representative | |
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Name | Bogdan Yavorov Kirilov |
Affiliation | Bulgarian Drug Agency |
Croatia
Representative | |
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Name | Siniša Tomić |
Affiliation | Agency for medicinal products and medical devices of Croatia |
Cyprus
Representative | |
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Name | Helena Panayiotopoulou |
Affiliation | Ministry of Health - Pharmaceutical Services |
Czechia
Representative | |
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Name | Irena Storova |
Affiliation | State Institute for Drug Control |
Denmark
Representative | |
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Name | Lars Bo Nielsen |
Affiliation | Danish Medicines Agency |
Estonia
Representative | |
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Name | Ott Laiu |
Affiliation | State Agency for Medicines |
Finland
Representative | |
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Name | Eija Pelkonen |
Affiliation | Finnish Medicines Agency |
France
Representative | |
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Name | Mélanie Cachet |
Affiliation | National Agency for the Safety of Medicine and Health Products |
Germany
Representative | |
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Name | Karl Broich |
Affiliation | Federal Institute for Drugs and Medical Devices |
Greece
Representative | |
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Name | Eleftheria Thomaidou |
Affiliation | National Organization for Medicines |
Hungary
Representative | |
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Name | Zakarias El-Koulali |
Affiliation | National Institute of Pharmacy and Nutrition |
Ireland
Representative | |
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Name | Lorraine Nolan |
Affiliation | Health Products Regulatory Authority (HPRA) |
Italy
Representative | |
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Name | Domenico Di Giorgio |
Affiliation | Italian Medicines Agency |
Latvia
Representative | |
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Name | Sergejs Akulics |
Affiliation | State Agency of Medicines |
Lithuania
Representative | |
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Name | Linas Mažeika |
Affiliation | State Medicines Control Agency |
Luxembourg
Representative | |
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Name | Anna Chioti |
Affiliation | Ministry of Health |
Malta
Representative | |
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Name | Anthony Serracino-Inglott |
Affiliation | Malta Medicines Authority (MMA) |
Netherlands
Representative | |
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Name | Paula Loekemeijer |
Affiliation | Medicines Evaluation Board |
Poland
Representative | |
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Name | Tomasz Lisiewski |
Affiliation | Chief Pharmaceutical Inspectorate |
Portugal
Representative | |
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Name | Rui Santos Ivo |
Affiliation | National Authority of Medicines and Health Products |
Romania
Representative | |
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Name | Razvan Mihai Prisada |
Affiliation | National Authority of Medicines and Medical Devices of Romania |
Slovakia
Representative | |
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Name | Peter Potúček |
Affiliation | State Institute for Drug Control |
Slovenia
Representative | |
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Name | Momir Radulovic |
Affiliation | Agency for Medicinal Products and Medical Devices of the Republic of Slovenia |
Spain
Representative | |
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Name | Maria Jesus Lamas Diaz |
Affiliation | Spanish Agency for Medicines and Health Products |
Sweden
Representative | |
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Name | Bjorn Eriksson |
Affiliation | Swedish Medical Products Agency |
New: 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 Management 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.