The Medicines and Healthcare products Regulatory Agency (MHRA) has “taken steps” to recognise European Medicines Agency (EMA) recommendations on medicines licences for the two years following the end of the Brexit transition period, Lord Bethell, minister for innovation at the Department of Health and Social Care (DHSC), has said.
In a House of Lords debate on the Medicines and Medical Devices Bill, held on 19 October 2020, Lord Bethell said that the MHRA “has already taken steps to recognise for two years future EMA decisions for medicine licences approved through the centralised authorisation procedure from January 2021”.
Bethell was referring to an amendment to the bill put forward by Labour peer, Baroness Thornton, which proposed alignment with the EMA’s medicines regulation processes following the Brexit transition period, which is due to end on 31 December 2020.
Under the central authorisation procedure, pharmaceutical companies submit marketing authorisation applications to the EMA, which then makes a recommendation. However, it is the European Commission which grants marketing authorisations across the EU and the member states of the European Free Trade Association (EFTA). The UK will be a member of neither the EU nor the EFTA from January 2021.
In July 2020, Martin Sawyer, executive director of the Healthcare Distribution Association (HDA), which represents wholesalers, told The Pharmaceutical Journal that the HDA would like the MHRA to “re-confirm publicly” that it will unilaterally recognise EU medicines regulations after the transition period.
The EMA left London and relocated to Amsterdam in March 2019 and, in preparation for Brexit, the UK’s portfolio of medicines was redistributed to other EU member states, which involved transferring more than 370 authorised products to rapporteurs from the EU27 countries, plus Iceland and Norway.
The then health and business secretaries, Jeremy Hunt and Greg Clark, wrote to the Financial Times in 2017 stating their wish for a “special relationship” with the EMA after Brexit.
The MHRA has been contacted for comment.