Health Committee launches inquiry into regulation of medicines, medical devices and substances of human origin after Brexit

The UK’s withdrawal from the European Union and the European Atomic Energy Community means new regulatory arrangements must be put in place from 29 March 2019 to guarantee the safe and effective supply of medicines, medical devices, medical products and substances of human origin in the UK.

Patients, the NHS and the UK’s life science industry need certainty about what the UK’s regulatory arrangements will be after Brexit and a smooth transition towards them. There are also major implications for the future of medical research and development.

The Health Committee invites submissions on the options available to the UK Government, including the respective opportunities, risks and trade-offs involved.

The Health Committee would like to receive written submissions on the following questions:

· What are the key considerations that arise for companies, healthcare services and regulatory bodies in the UK as a result of the UK’s withdrawal from the EU? Focussing on patients and the public, what needs to be done to ensure that any adverse impact is minimised or eliminated, and that opportunities to enhance services are maximised?

· Following the UK’s withdrawal from the EU, what alternative arrangements for the regulation of medicines, medical devices, medical products and substances of human origin could be introduced? What are the respective opportunities, risks and trade-offs involved?

· How much time is needed to facilitate a smooth transition to new arrangements? Is it possible, or desirable, to move directly to new arrangements post-29 March 2019, or are transitional arrangements needed?

· How will withdrawal from the European Union affect the UK’s ability to influence international standards in life sciences?

· What arrangements are needed to ensure the safe, effective and timely supply of medical radioisotopes over the short, medium and long-term?

· What are the implications for medical research and development, including for the timely patient access to new medicines, technologies and other relevant medical innovations developed within or outside the U.K? How can any adverse consequences be avoided or mitigated and any potential opportunities be enhanced?

The Health Committee is responsible for scrutinising the work of the Department of Health and its associated public bodies. Submissions should therefore address matters for which the Secretary of State for Health is responsible. However, comments are welcome on matters where the Secretary of State for Health may not have lead responsibility, but where the withdrawal negotiations have important implications for the safe and effective supply of medicines, medical devices, medical products and substances of human origin in the UK.

Respondents need not provide responses to all questions. Equally, if there are any crucial issues not captured under the questions we pose, please highlight what they are and explain their salience.

Written submissions should not exceed 3000 words and should be submitted by Thursday 26 October 2017. Public hearings are expected to be held in November and December 2017.

FURTHER INFORMATION:

Committee Membership is as follows: Dr Sarah Wollaston (Con) (Totnes) (Chair), Luciana Berger (Lab) (Liverpool Wavertree), Rt Hon Ben Bradshaw (Lab) (Exeter), Dr Lisa Cameroon (SNP) (East Kilbride, Strathaven and Lesmahagow), Rosie Cooper (Lab) (West Lancashire), Dr Caroline Johnson (Con) (Sleaford and North Hykeham), Diana Johnson (Lab) (Kingston upon Hull North), Johnny Mercer (Con) (Plymouth, Moor View), Andrew Selous (Con) (South West Bedfordshire), Maggie Throup (Con) (Erewash), Dr Paul Williams (Lab) (Stockton South)