The prospect of Brexit is causing concern to the pharmaceutical sector, as borne out by the report from an experts' meeting that took place on 8 March last. According to this report, many different authorisation documents on the market are still not ready for functioning when the United Kingdom leaves the Union.
The technical meeting brought together around 80 experts from the EU27 and the European Economic Area. The aim of this event, arranged by the European Commission, was to provide information to the network regulatory authorities and to identify the action to undertake before the United Kingdom leaves the Union on 30 March 2019.
At a European level, the United Kingdom is involved in several activities carried out by the European Medicines Agency (EMA), such as centralised authorisation procedures, scientific committees and inspection exercises. According to the figures put forward by the EMA, British participation in centralised procedures would be around 15%.
Overall, the main problem that appears to have been emphasised during the technical meeting focuses on the lack of mobilisation by the pharmaceutical companies. The European Commission describes this as a “wait-and-see approach”, “Despite the awareness activities and targeted communication measures, many Marketing Authorisation Holders have not yet taken the necessary regulatory actions, e.g. marketing authorisations transfers, relocation of QPPV (Qualified Person for Pharmacovigilance) etc. While recognising the complexity of some of these procedures for companies to put in motion, there seems to be also a "wait and see" approach by the MAHs (Marketing Authorisation Holders)”.
The report has also drawn up a balance sheet regarding the medicine situation. With regard to the products authorised in a centralised way, it indicates that the EMA is currently carrying out an analysis that includes an investigation among the pharmaceutical companies, in an effort to identify the products particularly affected by the regulatory impact of the United Kingdom leaving the Union. According to the European agency, the national authorities would like to increase their participation in the centralised procedure but some of them have raised concerns about budgetary constraints and the approval required from health ministers.
For the products authorised at a national level, the Commission has reported that the Heads of the Medicines Agencies (HMA) set up their own Brexit working party in November 2017, due to the difficulties caused by the volume of procedures and their complex nature.
Another technical meeting is planned for the second half of 2018. To see the report from the technical meeting on 8 March please see: https://bit.ly/2Emww7w. (Original version in French by Sophie Petitjean)