International cooperation between the competent authorities for medicines and health products is essential. They help ensure the quality, safety and efficacy of medicines and health products in a globalised market and a One World, One Health approach. With this in mind, the FAMHP’s International Relations Unit collaborated on a number of European projects in 2021: from the implementation of a pharmaceutical strategy to the launch of a development cooperation initiative, as well as various projects related to the fight against COVID-19. Charles Denonne, responsible of the International Relations Unit, describes the most important projects in which the FAMHP has been actively involved.
In 2021, the International Relations Unit actively participated in the European Medicines Agency’s project on effectively tackling medicine shortages …
Indeed, the International Relations Unit took part in the negotiation and adoption of Regulation (EU) 2022/123 extending the mandate of the European Medicines Agency. This mandate includes the creation of the European Shortages Monitoring Platform, which should be launched by early 2025.
This platform aims to facilitate the collection of information on shortages, supply and demand of medicines.
The International Relations Unit has also been very busy with the implementation of the European pharmaceutical strategy. What is this project about?
The European Commission’s pharmaceutical strategy is a project that member states have been requesting for a long time. The strategy will be developed in collaboration with the European Medicines Agency and the national competent authorities.
The strategy consist of a number of objectives that have been translated into fifty concrete actions in areas such as the fight against antibiotic resistance, the prioritisation of unmet medical needs, access to medicines, financial accessibility of medicines, attractiveness of Europe for the pharmaceutical industry, innovation and digital transformation, resilience and adaptability of the legislative framework, crisis response, security of supply and the fight against shortages, the quality and safety of medicines, respect for the environment and Europe’s place on the international stage.
In concrete terms, the competent authorities of the member states could, for example, take measures to facilitate the processes following the launch of a clinical trial. Such as granting an authorisation, health technology assessment, health care, health insurance and financing health technology assessment. Many of the strategic goals will result in amendments in the current legislation.
The main objective of this strategy is a proposal to revise the pharmaceutical legislative framework, which is expected by the end of 2022.
A revision of the legislation, that sounds like a lot of preparatory work …
Yes, it is. In 2021 the International Relations Unit mainly did preparatory work for the publication of the European Commission’s legislative proposals. This work consisted mainly of reactions from the FAMHP to the European Commission’s initial impact assessments. For example, we reacted to the analysis of the revision of the legislation on orphan and paediatric medicines and the analysis of the revision of Directive 2001/83 and Regulation 726/2004. We have also actively participated in the workshops and meetings of the Pharmaceutical Committee organised by the European Commission, and we have responded to the questionnaires and interviews organised by its consultant.
We also actively advocated a rapid revision of Regulation (EC) 297/95 on fees payable to the European Agency for the evaluation of medicinal products, considering the needs of the national competent authorities. In this context we took the initiative to send the European Commission a non-paper highlighting a number of essential points for the FAMHP. We have also introduced an argument on this subject in the conclusions of the Trinity Council, adopted by the Employment, Social Policy, Health and Consumer Affairs Council, the EPSCO.
Do you often have to cooperate with the competent authorities for medicines and health products of other member states?
Yes, mainly through various bilateral exchanges and cooperation within the framework of the European Heads of Medicines Agencies (HMA). In 2021, there has been a significant increase in cooperation between national competent authorities with the launch of four joint actions under the European Union Health Programme (EU4Health) in which the FAMHP will actively participate. This trend should continue in 2022.
Europe is obviously central to the work of the International Relations unit. But there are also projects that have an impact on the rest of the world. Could you give us an example?
In 2021, we helped launch a development cooperation initiative as part of the fight against COVID-19. As a first step, the International Relations Unit participated in the first European discussions on vaccine donations through the World Health Organization’s COVID-19 Vaccines Global Access initiative, COVAX which aims to provide fair access to the COVID-19 vaccines vaccination worldwide.
These initiatives have expanded rapidly at the national level in a very natural way, and there is now the desire to contribute to the development of medicine, including vaccines, production capabilities in Africa. This is why the Belgian development cooperation agency, Enabel, took the initiative to discuss Belgium’s added value in strengthening the production capacities of v medicines, including vaccines, and health products. The FAMHP is a valued partner for Enabel in strengthening the regulatory frameworks. So, we took part in those discussions.
Has the fight against the pandemic had a significant impact on your work, as it did in 2020?
For the International Relations Unit, the workload related to managing the coronavirus crisis at national level decreased significantly in 2021. But it has not disappeared completely. The unit continued to keep the FAMHP entities informed by highlighting and circulating relevant international information.
Our unit also coordinated the Belgian position and was actively involved in the meetings of the Task Force for Industrial Scale-up of COVID-19 vaccines. We also played an active role in the preparation of the Belgian position on the European Health Emergency Response and Preparedness Authority, HERA, notably through our participation in the national coordination meetings and the drafting of the Belgian reaction to the Commission’s initial impact assessment of 27 January 2021, and through our involvement in national coordination on the Important Project of Common European Interest in health, the IPCEI.
You are also in charge of a number of transversal dossiers.
The number of these important transversal dossiers for the FAMHP has also increased, particularly with the proposal for legislation on artificial intelligence and the proposal for the NIS2 Directive, which concerns cybersecurity in the European Union.
The adoption of the Regulation (EU) 2021/2282 on health technology assessment, whose implementation will start in 2025, will also have an impact on our work, as will the adoption of the EU4Health Regulation (2021/522).
Within the FAMHP you have also played an important role in relaying information …
The unit ensures that transversality is strengthened and that all FAMHP services are better informed through dynamic distribution lists for each dossier and quarterly information to the Extended Executive Council which brings together all FAMHP managers.