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Brexit: Medicines, Medical Devices and Substances of Human Origin

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Brexit: Medicines, Medical Devices and Substances of Human Origin House of Commons Health and Social Care Committee Brexit: medicines, medical devices and substances of human origin Fourth Report of Session 2017–19 HC 392 House of Commons Health and Social Care Committee Brexit: medicines, medical devices and substances of human origin Fourth Report of Session 2017–19 Report, together with formal minutes relating to the report Ordered by the House of Commons to be printed 13 March 2018 HC 392 Published on 21 March 2018 by authority of the House of Commons Health and Social Care Committee The Health and Social Care Committee is appointed by the House of Commons to examine the expenditure, administration, and policy of the Department of Health. Current membership Dr Sarah Wollaston MP (Conservative, Totnes) (Chair) Luciana Berger MP (Labour (Co-op), Liverpool, Wavertree) Mr Ben Bradshaw MP (Labour, Exeter) Dr Lisa Cameron MP (Scottish National Party, East Kilbride, Strathaven and Lesmahagow) Rosie Cooper MP (Labour, West Lancashire) Diana Johnson MP (Labour, Kingston upon Hull North) Johnny Mercer MP (Conservative, Plymouth, Moor View) Andrew Selous MP (Conservative, South West Bedfordshire) Derek Thomas MP (Conservative, St Ives) Martin Vickers MP (Conservative, Cleethorpes) Dr Paul Williams MP (Labour, Stockton South) The following Members were members of the Committee during the inquiry Dr Caroline Johnson MP (Conservative, Sleaford and North Hykeham) Maggie Throup MP (Conservative, Erewash) Powers The Committee is one of the departmental select committees, the powers of which are set out in House of Commons Standing Orders, principally in SO No 152. These are available on the internet via www.parliament.uk. Publication Committee reports are published on the Committee’s website at www.parliament.uk/hsccom and in print by Order of the House. Evidence relating to this report is published on the inquiry publications page of the Committee’s website. Committee staff The current staff of the Committee are Huw Yardley (Clerk), Seth Roberts (Second Clerk), Laura Daniels (Senior Committee Specialist), Lewis Pickett (Committee Specialist), Juliette Mullin (Clinical Fellow), Cecilia Santi O Desanti, (Senior Committee Assistant), Ed Hamill (Committee Assistant), and Alex Paterson (Media Officer). Contacts All correspondence should be addressed to the Clerk of the Health and Social Care Committee, House of Commons, London SW1A 0AA. The telephone number for general enquiries is 020 7219 6182; the Committee’s email address is [email protected]. Brexit: medicines, medical devices and substances of human origin 1 Contents Summary 2 1 Introduction 4 Our work 4 Existing models of trade with the EU 5 Norway: the European Economic Area and single market integration 5 Canada: a free trade agreement focusing on mutual recognition 6 Options for the UK 6 Brexit and the Department for Health and Social Care’s Single Departmental Plan 10 Our inquiry 11 2 Protecting and enhancing the UK’s position in Europe and globally 13 Global life science industry 13 International Council on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) 14 UK’s position and influence in Europe 15 Medicines and Healthcare products Regulatory Agency 15 Influence of the UK Government, national bodies and institutions in European regulations 16 3 Negotiations 18 EU negotiating position 18 UK negotiating position 18 (i) Patients should not be disadvantaged 18 (ii) Innovators should be able to get their products into the UK market quickly 19 (iii) UK must continue to play a leading role promoting public health 20 4 Aligning with the EU on market authorisation and regulation 22 Regulatory alignment with the EU after Brexit 22 ‘No deal’ risk management 25 Batch testing, QPs and Good Manufacturing and Distribution Practices 27 The UK’s relationship with the EMA 30 5 Continued collaboration in other areas of the life science sector 33 Research and development and clinical trials 33 Current participants in clinical trials 33 Continued participation in clinical trials 34 Regulatory alignment over EU rules for data protection 37 Research and collaboration networks 39 2 Brexit: medicines, medical devices and substances of human origin Free movement of researchers 40 Research and development funding 41 Access to EU pharmacovigilance systems 42 Trade, customs and supply chains 44 Supply chains 45 Stockpiling and time-sensitive supply chains 48 Medical radioisotopes and Euratom 49 Supply chains: conclusions 51 World Trade Organisation (WTO) rules 52 Parallel trade 52 Conclusions and recommendations 54 Formal minutes 60 Appendix 1: Letter to the Secretary of State regarding Brexit transitional arrangements, 15 February 2018 61 Witnesses 63 Published written evidence 64 List of Reports from the Committee during the current Parliament 67 Brexit: medicines, medical devices and substances of human origin 3 Summary The United Kingdom’s withdrawal from the European Union (EU)—“Brexit”—will affect many aspects of the provision of health, social care and the wider life sciences sector, both in the UK and the EU. In order to minimise harm to their citizens both sides should look to secure the closest possible regulatory alignment as a priority in the next round of negotiations. We welcome the Government’s stated intention to maintain regulatory alignment with the European Medicines Agency (EMA). The UK, with the expertise and capacity of the Medicines and Healthcare products Regulatory Agency (MHRA), has a great deal to offer its European partners. We believe this is in the interests of patients, citizens and governments on both sides of the negotiations. The entire supply chain of pharmaceuticals, from research and development, timely licensing, production, quality control, through to the product being launched and available on a pharmacy shelf, will be adversely affected by regulatory divergence and seriously so in the event of a ‘no deal’ Brexit. However, while the European Council has reiterated its wish to have the UK as a close partner in the future, it has also set out that preserving the integrity of the Single Market excludes participation based on a sector-by-sector approach. As negotiations under Article 50 will be conducted as a single package, any provisions which are put in place for continued co-operation between the EU and the UK in the life sciences are dependent on similar agreements being made across the whole of the negotiations. We heard evidence from witnesses that their preferred option was Britain’s continued membership of the Single Market and Customs Union or retaining a Norway type EFTA/EEA relationship. We note that the Government has ruled those options out. In the absence of a change in the Government’s approach, we believe it is not just prudent, but essential, that scrutiny is undertaken of the Department of Health and Social Care’s (DHSC) contingency planning for a ‘no deal’ situation. For the benefit of patients, particularly those living with rare conditions, on both sides of the Channel, it is vital that the UK life sciences sector is able to continue to participate in Europe-wide clinical trials. If the UK does not adopt the new clinical trials regulations and is unable to access the infrastructure that has been developed within the EU to underpin them, a variety of difficulties for patients and the life science industry could emerge both in the short and medium to long term. The UK should seek to continue to be a member of EU Research and Development (R&D) funding and research mechanisms such as Horizon 2020 after leaving the EU, if possible on the same terms as it currently enjoys. The UK should also seek mutual recognition of pharmacovigilance mechanisms by the MHRA and the EMA as a priority in the next round of negotiations. This should include ensuring that all UK pharmacovigilance organisations continue to be members of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), as the failure to do so could affect patient safety both in the UK and the EU. It is also in the best interests of patients for the UK to continue membership of all of the major EU pharmacovigilance systems and databases, including the European Database on Medical Devices (EUDAMED) and Eudravigilance. 4 Brexit: medicines, medical devices and substances of human origin We support the case for free and frictionless trade with the EU. The Government should assess the impact of the loss of parallel imports. We also recommend that the Government undertake further contingency planning on the impact on the supply chain in the event of failure to achieve free and frictionless trade in pharmaceutical products. We heard a consistent and repeated message during our inquiry that to minimise the risks to all stages of the development and timely supply of medicines and devices, the Government should seek the closest possible regulatory alignment with the EU. Brexit: medicines, medical devices and substances of human origin 5 1 Introduction Our work 1. The UK’s withdrawal from the European Union—“Brexit”—will affect many aspects of the provision of health and social care in the United Kingdom. This report is the second phase of our work on Brexit, Given the range and complexity of the questions associated with the impact of Brexit on health and social care, our predecessor Health Committee in the last Parliament focused the first phase of its inquiry on the immediate issues faced by people, including the health and social care workforce as well as citizens who rely on reciprocal healthcare arrangements.
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