Brexit: medicines, medical devices and substances of human origin Contents

Contents

Summary

1 Introduction

Our work

Existing models of trade with the EU

Norway: the European Economic Area and single market integration

Canada: a free trade agreement focusing on mutual recognition

Options for the UK

Brexit and the Department for Health and Social Care’s Single Departmental Plan

Our inquiry

2 Protecting and enhancing the UK’s position in Europe and globally

Global life science industry

International Council on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH)

UK’s position and influence in Europe

Medicines and Healthcare products Regulatory Agency

Influence of the UK Government, national bodies and institutions in European regulations

3 Negotiations

EU negotiating position

UK negotiating position

(i) Patients should not be disadvantaged

(ii) Innovators should be able to get their products into the UK market quickly

(iii) UK must continue to play a leading role promoting public health

4 Aligning with the EU on market authorisation and regulation

Regulatory alignment with the EU after Brexit

‘No deal’ risk management

Batch testing, QPs and Good Manufacturing and Distribution Practices

The UK’s relationship with the EMA

5 Continued collaboration in other areas of the life science sector

Research and development and clinical trials

Current participants in clinical trials

Continued participation in clinical trials

Regulatory alignment over EU rules for data protection

Research and collaboration networks

Free movement of researchers

Research and development funding

Access to EU pharmacovigilance systems

Trade, customs and supply chains

Supply chains

Stockpiling and time-sensitive supply chains

Medical radioisotopes and Euratom

Supply chains: conclusions

World Trade Organisation (WTO) rules

Parallel trade

Conclusions and recommendations

Formal minutes

Appendix 1: Letter to the Secretary of State regarding Brexit transitional arrangements, 15 February 2018

Witnesses

Published written evidence

List of Reports from the Committee during the current Parliament




Published: 21 March 2018