To ask Her Majesty's Government what assessment they have made of the impact a no-deal Brexit would have on access to new medicines.
25 February 2019
The Government continues to prepare for the outcome that we leave the European Union without a deal in March 2019.
Regarding access to medicines, the Department and the Association of the British Pharmaceutical Industry have a voluntary agreement to control the prices of branded drugs sold to the National Health Service. The 2019 Voluntary Scheme for Branded Medicines Pricing and Access will bring benefits to patients, the NHS and the life sciences industry. Patients will benefit from faster adoption of cutting-edge and best value drugs, so they can gain access to them up to six months earlier. We do not anticipate any need to make changes to the Voluntary Scheme in light of EU exit, whatever the outcome of negotiations.
Regarding the United Kingdom’s regulatory system, in a ‘no deal’ scenario the UK’s participation in the European medicines regulatory network would cease and the Medicines and Healthcare products Regulatory Agency (MHRA) would take on the functions currently undertaken by the EU for human medicines on the UK market. On 4 January the Government published an online-only detailed proposal for how the MHRA would regulate medicines in the event of a ‘no deal’ scenario, which included the new licensing routes that we would offer in order to make sure UK patients are still able to access the best and most innovative medicines.
The Government values the strong collaborative partnerships that we have across the European Union in the areas of science, research and innovation, and as part of Exit negotiations is working to ensure that we have the best possible environment in which to support access to new medicines after we leave the EU.