European medicines regulatory network working on a common strategy

The EU Heads of Medicines Agencies (HMA) convened on 18–20 September in Helsinki for the first HMA meeting held during Finland’s presidency of the Council of the EU. The agenda included, among other things, future outlook for the network, common strategy work for the upcoming strategy period, and matters of current interest concerning human and veterinary medicines. In addition to the heads of medicines agencies, the meeting participants included management representatives from the European Medicines Agency and representatives of the European Commission.

The discussion on HMA’s strategy, commenced in the preceding presidency of Romania, was continued in Helsinki. The meeting participants divided into six sub-working groups that focused on challenges identified as central from the strategy point of view. The purpose of the work is to create a common strategy for the European medicines regulatory network formed by the Member States, the EMA and the EU Commission for the upcoming period of 2021–2025. The work will continue under Finland’s direction in the HMA II meeting to be held in November.

Brexit and the new legislation on veterinary medicines as the most important matters of current interest

The meeting also addressed a number of topics of current interest, the most important of which were the status of the preparations for the United Kingdom’s exit from the European Union and the implementation of the new EU legislation concerning veterinary medicines. The medicines regulatory network has previously initiated preparations in view of a no-deal Brexit. The majority of the preparations have been brought to completion according to schedule. The different operators within the medicines regulatory network will monitor the situation closely and take the necessary actions within their mandate to safeguard the future availability of medicines to European patients. The current deadline for the UK’s exit from the EU is 31 October 2019.

The preparation of the implementation of the new EU legislation concerning the regulation of veterinary medicines has started well. A number of Commission Regulations requiring scientific advice and recommendations from the EMA are currently under preparation. The implementation of the legislation also requires the setting up of a new database. The implementation of veterinary medicines legislation will call for significant additional resources from all the operators involved in the medicines regulatory network.

Pharmaceutical innovations and biosimilars addressed as themes raised by Finland

In the meeting, Finland raised as a separate topic the Health Sector Growth Strategy and the means for promoting pharmaceutical innovations. The joint strategic project of three ministries and Finland’s strengths were presented by Liisa-Maria Voipio-Pulkki of the Ministry of Social Affairs and Health. Genomes and individualised medicine are also among the topics to be addressed in the event held in Brussels in October during Finland’s presidency.

The HMA meeting was preceded by a stakeholder meeting in which the use of biosimilar medicines and the promotion of their use in Europe were discussed. The EU is the leader in the uptake of biosimilars on the global market, but the sale of biosimilars still only accounts for about 5 % of the total sale of biological medicines in Europe. The uptake of biosimilars is hampered by the competitive framework and the lack of trust and motivation towards biosimilars felt by medicine prescribers and users. With the strategy work of the network currently being in progress, the potential medicines regulatory network’s common guidelines and support for making the use of biosimilars more effective will await further consideration.

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HMA: Highlights of the 97^th meeting 18–20 September 2019