The UK Government has indicated its intention to continue to play a full role in European regulatory procedures and retain a close working partnership with the EU in medicines regulation post Brexit. The three principles which the Government says will underpin the development of a post-Brexit regulatory system for medicines and devices are: (a) patients should not be disadvantaged; (b) innovators should be able to access the UK market as quickly and simply as possible; and (c) the UK will continue to play a leading role in both Europe and the world in promoting public health.
However, despite the Government’s position, some effects of Brexit are already being felt. The European regulator, the European Medicines Agency (EMA), will relocate to Amsterdam from London no later than 30 March 2019. The EMA is central to the functioning of the single market for medicines in the EU.
Currently there are three routes for getting a marketing authorisation (MA) for a product in the UK: i) the "centralised procedure" by making one application to the EMA (which results in a single marketing authorisation or centrally authorised product (CAP)); ii) the "decentralised procedure" (DCP) by making multiple applications to each individual EU member state where marketing authorisation is sought (separate national authorisations are obtained); iii) the "mutual recognition procedure" (MRP), where a medicine is authorised in one EU member state and a later application is made for this authorisation to be recognised in other member states (separate national authorisations are obtained). After Brexit, the UK will no longer be a part of the centralised, mutual recognition and decentralised procedures. Existing products that received an MA for the UK via the mutual recognition or decentralised procedure routes prior to 29 March 2019 will be unaffected as they already hold a national UK MA.
The EMA is proceeding on the basis that the UK will become a third country as of 30 March 2019. If so, the UK will no longer be able to engage as (co)-rapporteur for new marketing authorisation applications under the centralised procedure. In 2018, in preparation for Brexit, the EU27 and the EMA reallocated the UK’s portfolio of centrally authorised products to rapporteurs outside the UK.
Most new medicines come to market via the centralised procedure. In the event of a no deal Brexit, under the legislation which will come into force on exit day, CAPs will be automatically converted without charge in the UK to UK MAs (a process known as grandfathering). MA holders will have a right to opt out of this process by giving notice to the UK regulator, the Medicines & Healthcare Products Regulatory Agency (MHRA).
In the event of a no deal, centralised procedure applications which have not yet reached a decision on exit day will need to be resubmitted to the MHRA. The UK Government proposes that a transitional provision will be made for MRP and DCP procedures in progress immediately before exit day as these procedures already result in a national MA.
The workload of the MHRA will increase post Brexit, as it inherits work from the EMA. After Brexit, to market a product in the UK, an initial MA application will need to be submitted to the MHRA and will go through a national assessment. The Government has given assurances that the MHRA will take a streamlined approach to approving UKMA applications that places no greater burden on industry and ensures that UK patients can access new medicines at the same time as EU patients.