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.

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 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.

How the group works

    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.

    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) 
    NameEmer Cooke

    Affiliation

    European Medicines Agency

     

    Co-chair (Member States) 
    NameKarl Broich
    AffiliationBundesinstitut für Arzneimittel und Medizinprodukte - BfArM



    European Commission

    Representative 
    NameSylvain Giraud
    AffiliationEuropean Commission. DG SANTE - Health and Food Safety B4


    Austria 

    Representative 
    NameChrista Wirthumer-Hoche
    AffiliationAustrian Agency for Health and Food Safety


    Belgium

    Representative 
    NameXavier De Cuyper
    AffiliationFederal Agency for Medicines and Healthcare Products (FAMHP) 


    Bulgaria

    Representative 
    NameBogdan Yavorov Kirilov
    AffiliationBulgarian Drug Agency 


    Croatia

    Representative 
    NameSiniša Tomić
    AffiliationAgency for medicinal products and medical devices of Croatia


    Cyprus

    Representative 
    NameHelena Panayiotopoulou 
    AffiliationMinistry of Health - Pharmaceutical Services 


    Czechia

    Representative 
    NameIrena Storova
    AffiliationState Institute for Drug Control


    Denmark

    Representative 
    NameLars Bo Nielsen
    AffiliationDanish Medicines Agency


    Estonia

    Representative 
    NameOtt Laiu
    AffiliationState Agency for Medicines


    Finland

    Representative 
    NameEija Pelkonen
    AffiliationFinnish Medicines Agency


    France

    Representative 
    NameMélanie Cachet
    AffiliationNational Agency for the Safety of Medicine and Health Products


    Germany

    Representative 
    NameKarl Broich
    AffiliationFederal Institute for Drugs and Medical Devices


    Greece

    Representative 
    NameEleftheria Thomaidou     
    AffiliationNational Organization for Medicines


    Hungary

    Representative 
    NameZakarias El-Koulali
    AffiliationNational Institute of Pharmacy and Nutrition


    Ireland

    Representative 
    NameLorraine Nolan
    AffiliationHealth Products Regulatory Authority (HPRA)


    Italy

    Representative 
    NameDomenico Di Giorgio
    AffiliationItalian Medicines Agency


    Latvia

    Representative 
    NameSergejs Akulics
    AffiliationState Agency of Medicines


    Lithuania

    Representative 
    NameLinas Mažeika
    AffiliationState Medicines Control Agency


    Luxembourg

    Representative 
    NameAnna Chioti
    AffiliationMinistry of Health

     

    Malta

    Representative 
    NameAnthony Serracino-Inglott
    AffiliationMalta Medicines Authority  (MMA)


    Netherlands

    Representative 
    NamePaula Loekemeijer
    Affiliation

    Medicines Evaluation Board


    Poland

    Representative 
    NameTomasz Lisiewski
    AffiliationChief Pharmaceutical Inspectorate


    Portugal

    Representative 
    NameRui Santos Ivo
    AffiliationNational Authority of Medicines and Health Products


    Romania

    Representative 
    NameRazvan Mihai Prisada
    AffiliationNational Authority of Medicines and Medical Devices of Romania


    Slovakia

    Representative 
    NamePeter Potúček
    AffiliationState Institute for Drug Control


    Slovenia

    Representative 
    NameMomir Radulovic
    AffiliationAgency for Medicinal Products and Medical Devices of the Republic of Slovenia


    Spain

    Representative 
    NameMaria Jesus Lamas Diaz
    AffiliationSpanish Agency for Medicines and Health Products


    Sweden

    Representative 
    NameBjorn Eriksson
    AffiliationSwedish Medical Products Agency

    Working groups (new)

    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 PDF icon 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.