UK parliament steps up plans for medicines access post Brexit

 The UK parliament has published contingency legislation to ensure continuity of medicines access and clinical trials in the event of a no deal Brexit.

In planning for the possibility of exiting the European Union without a deal on 29th March 2019, the UK parliament is implementing contingency legislation to allow continued access to medicines and medical devices, and the operation of clinical trials in the UK.

Three pieces of legislation have been drafted to address this:

  • The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

  • The Medical Devices (amendment) (EU exit) Regulations 2019

  • The Medicines for Human Use (Clinical Trials) (amendment) (EU exit) Regulations 2019

The proposed legislation will allow the UK Medicines and Healthcare Regulatory Agency (MHRA) to take on the regulatory processes for human medicines and medical devices that are currently undertaken by the European Medicines Agency and other bodies, if there is no withdrawal agreement in place when the UK leaves the EU.

The draft regulations include the power of enforcement for marketing authorisation and ongoing supervision of medicines (for human use). They also provide a framework for the manufacture, import, distribution, sale and supply, labelling, advertising and pharmacovigilance of these products.  

The draft regulations now require approval by the UK parliament, before coming in to force after 29th March 2019.

Andrew Satherley