Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what assessment his Department has made of the cost to the public purse of replicating the relevant functions of the European Medicines Agency after the UK leaves the EU.

Our overall aim in the negotiations is to ensure that patients in the United Kingdom and across the European Union continue to be able to access the best and most innovative medicines while being assured that their safety is protected. We are committed to continue a close working relationship with the European Medicines Agency (EMA), and the exact nature of this relationship will be determined through our negotiations.

The UK already has substantial capacity and expertise to regulate and evaluate the safety of our medicines. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) directly assesses the vast majority of medicines used by patients within the UK. The MHRA is globally recognised for its expertise and they typically undertake between 20 – 35% of the EMA’s licensing and vigilance work, including a significant proportion of pharmacovigilance work and safety referrals.