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HRPRES2020: HALMED hosted the first virtual meeting of the Heads of Medicines Agencies (HMA)


As part of the Croatian Presidency of the Council of the European Union, on 28 May 2020 Croatian Agency for Medicinal Products and Medical Devices (HALMED) hosted the meeting of the Heads of Medicines Agencies (HMA). This marks the most important strategic meeting in the field of medicinal products organised by HALMED during HRPRES2020. It is, at the same time, the jubilee, 100th HMA meeting and the first one held virtually, in line with the unprecedented circumstances related to the COVID-19 pandemic.

The meeting was chaired by Prof Siniša Tomić, PhD, Head of HALMED, who at the beginning welcomed participants and highlighted: "Croatian Presidency slogan - ‘A strong Europe in a world of challenges’ - perfectly describes the importance of our joint action in facing the challenges that the COVID-19 pandemic placed in front of the members of the European Union, as well as the whole world”. Prof Tomić thanked the HMA Management Board for their constant efforts and support dedicated to ensuring the work of the European Medicines Regulatory Network and the HMA Permanent Secretariat on their successful contribution to the continuity of the Network’s activities.

The participants were also welcomed by the representative of the Croatian Ministry of Agriculture, Tomislav Kiš, DVM, Head of Food Safety and Veterinary Public Health Sector.

During the meeting, in line with the current situation, presentations and discussions focused mostly on the functioning of the European Medicines Regulatory Network in the context of the COVID-19 pandemic.

Prof Gudio Rasi, the Executive Director of the European Medicines Agency (EMA), reported on the EMA’s work adjustments directed to ensuring smooth conducting of regulatory procedures and holding of scientific committees and working groups meetings. Moreover, EMA’s activities related to informing patients, healthcare professionals and representatives of scientific institutions and the pharmaceutical industry were stressed out.

Following the introductory presentation on the NCAs experiences and key initiatives in relation to the spread of COVID-19 given by Thomas Senderovitz, MD, chairperson of the HMA Management Group, a fruitful discussion was held aiming at finding appropriate solutions for improving crisis management in future situations.

The European Commission (EC) representative, Andrzej Rys, MD, Director of Health systems, medical products and innovation of the DG SANTE, highlighted a close cooperation of the EC with EMA and Member States in providing EU citizens with access to vaccines and medicines for COVID-19, while also taking into account the availability of existing therapies.

Meeting also included "Tour de table”, moderated by Momir Radulović, MPharm, Head of Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP). In this part of the meeting representatives of all the Member states’ NCAs reported on key experiences gained during the pandemic period and the challenges they encountered, primarily related to ensuring the availability of therapies for COVID-19, but also the availability of medicinal products and medical devices in general. Likewise, they shared their experiences of adapting their work to extraordinary circumstances.

During the meeting participants also exchanged information on the development of therapeutic options and vaccines for COVID-19 disease, as well as on the means of monitoring shortages and market supply of medicinal products and medical devices during pandemic. Additionally, participants discussed topics such as ensuring the business continuity of the Network, clinical trials and the implementation of the new veterinary regulation. Moreover, progress update was presented for the HMA-EMA joint strategy from 2020 to 2025, which had been in a great measure prepared during the Croatian Presidency of the Council of the European Union.

Although held in different circumstances and in virtual format, the meeting was recognised as very successful and extremely important for maintaining the continuity of the HMA.

Approximately 90 members of the HMA attended the meeting, consisting of Heads and other representatives of the National Competent Authorities for medicinal products for human use and veterinary medicinal products in the EEC. Meeting was also attended by esteemed representatives of the European Commission, the European Medicines Agency and the European Directorate for the Quality of Medicines.

HMA gathers the directors of all Member States’ Agencies twice during each Presidency, in order to make crucial decisions regarding patients’ health and public health issues within the EU. Through their joint activities, harmonized work at the EU level is achieved and mutual cooperation between the EU Member States is carried out regarding control and monitoring of the safety of medicinal products usage, as well as ensuring that appropriate therapy is available for patients.