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


EU negotiating position

46.As noted by the Department for Business, Energy, Innovation and Skills, the UK and the EU have outlined a shared objective in the negotiations to protect patient health, and ensure access to medicines.53 The EU’s guidelines for negotiating with the UK indicate that while the European Council reiterates its wish to have the United Kingdom as a close partner in the future, preserving the integrity of the Single Market excludes participation based on a sector-by sector approach, and negotiations under Article 50 will be conducted as a single package in accordance with the principle that nothing is agreed until everything is agreed, which means that individual items cannot be settled separately.54

UK negotiating position

47.We welcome the statements from the Prime Minister in her 2nd March speech that outlined the Government’s desire to forge the “broadest and deepest possible partnership”55 with the European Union after the UK exits the EU. We are pleased to note in particular the Government’s commitment to a close relationship with the EMA after Brexit through “associate membership”,56 and welcome the Government’s “objective of ensuring that these [medicines and medical devices] products only need to undergo one series of approvals, in one country”.57 These statements are a positive indication of the relationship the UK is seeking to forge with the EU after Brexit. We go on to discuss these commitments, and the obstacles to their realisation, in further detail in paragraphs 88 to 92 of this report.

48.We also welcome the earlier commitments given in the letter from the Secretaries of State for Health, Rt Hon Jeremy Hunt MP, and Business, Energy and Industrial Strategy, Rt Hon Greg Clark MP, of 5 July 2017 to a continued close working relationship with the European Union after UK Exit day in the interests of public health.58 The three principles of the letter were set out as being that

(i) Patients should not be disadvantaged

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

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

(i) Patients should not be disadvantaged

49.We see this as a positive objective, but one which, in its current form, lacks the clarity required to make it sufficiently measurable, against which the Government can be held to account. We consider that protecting patients should involve, but not be limited to:

We comment further on each of those points below.

50.We would also like to see the UK approach the next round of negotiations not just with a focus on issues relating to the health of the UK public, but also with a view to ensuring patients in the EU are not disadvantaged from the UK’s withdrawal from the EU. A failure to do so would undermine a commitment to working together in the future for the benefits of patients on both sides of the negotiations.

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

51.We agree that ensuring innovators are able to get their products into the UK market quickly will be an important measure to ensure businesses continue to see the UK as an attractive market in which to invest and launch their products, and to ensure that patients remain protected both in the UK and the EU. To realise this ambition, the UK Government should look to secure continued regulatory alignment with the EU, to reduce regulatory obstacles for those wishing to invest in the UK both now and in the future, particularly noting the UK Life Science Industrial Strategy’s view that the UK market is too small even with the fastest and most innovative regulatory system in the world to stand alone from a larger decision-making bloc. We agree with the position of the Life Science Industrial Strategy that any divergence from EU systems will only add value to UK life sciences and patients so long as any such divergences do not jeopardise the UK’s ability to participate in European research and regulatory regimes.59 At the same time, and to compensate for the effects of Brexit, the UK must continue to implement measures such as the Accelerated Access Review and Life Sciences Industrial Strategy. Adoption of new medicines in the NHS is a national competence and will not be affected directly by Brexit, meaning the UK can continue with existing efforts to speed up the rate of adoption. We endorse the view expressed by Phil Thomson of GSK in oral evidence that

The [Life Sciences] strategy becomes even more important if there is a hard exit from the European Union … without these points of connectivity, whether it is on regulatory, trade or supply, how the UK then develops itself to be competitive is very important.60

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

52.We welcome the Government’s desire to continue the UK’s influence in the life sciences sector. This objective will be more challenging after Brexit, but a focus on maintaining the attributes that have made the UK an attractive place to develop and launch new medicines and devices will continue to help it to remain at the forefront of the life sciences industry. This should be undertaken alongside a continued commitment to EU and international regulatory systems such as the ICH, where the UK’s influence has been significant so far. We welcome the commitment from both sides of the negotiations that whatever the result of the Brexit talks, the UK’s withdrawal should not result in a detriment to patients on either side of the Channel or the Northern Ireland and Republic of Ireland border. That must translate into a commitment from both sides to put the needs of patients above ideology on ‘red lines’.

53.We note the EU’s guidelines for negotiating with the UK which explain that preserving the integrity of the Single Market excludes participation based on a sector-by sector approach. Although there may be significant life science sector level mutual interest from the UK and EU on reaching agreement between the two negotiating sides, this is insufficient to ensure a deal is reached, either for the short or medium term in the Withdrawal Agreement or in the longer term in an EU-UK trade or other agreement(s).61

54.The ongoing UK Exit negotiations have the potential to fall apart if any area of the negotiations fails to agree terms, meaning Government contingency planning for a ‘no deal’ remains vitally important. The publication of this contingency planning will give much needed security to industry and patients, and allow for planning to be undertaken with a firmer idea of what the UK’s fall-back position may be if the negotiations do not reach the desired result. In the highly technical areas around the safety monitoring and regulation of pharmaceutical products with complex supply chains, extensive public scrutiny of any contingency planning will ensure that all relevant aspects are covered to guarantee the health of UK patients regardless of the Brexit outcome.

55.We welcome the announcement at the Autumn Budget 2017 that HM Treasury is making £3bn of additional funding available over the next two years—£1.5bn in each of 2018/19 and 2019/20—so that departments and the devolved administrations can continue to prepare effectively for Brexit.62 An increase in funding to look to minimise the risks and build on the opportunities that Brexit may provide for health and social care (and wider UK sectors) is a positive step. However, without a detailed breakdown of the distribution of this funding by Government department, and then within each department amongst the many areas of policy that Brexit will affect, this figure is too vague to act as significant reassurance to the life science sector and patients that the concerns they have raised in relation to Brexit are being appropriately addressed.

56.We are encouraged that the UK Government has stated that it is seeking to ensure the UK plays a leading role in public health and preventing patients and innovators from being disadvantaged by Brexit. However, we, industry, and patients need tangible measures against which to evaluate these commitments. A detailed breakdown of the funding allocation for the DHSC from the Brexit funding should be published, and this should be accompanied by specific, detailed action points that look to explain how, and on what timeframe, the Government is looking to deliver on its commitments to the life science sector.

57.Following Brexit, the life sciences sector will need a highly supportive domestic agenda. The Government should implement the Life Sciences Industrial Strategy in full and at pace, with a final deadline of 2023. This should be supported with commitment to other domestic measures such as the Accelerated Access Review.

58.However, we note that because Brexit involves the danger of the UK becoming a less appealing market for life sciences innovations due to the UK’s small market share by comparison to the EU and the USA, these domestic measures will be necessary, but not sufficient, to counteract the negative effects of Brexit for patients.63

60 Q276

63 How will Brexit affect health and health services in the UK? Evaluating three possible scenarios, The Lancet, accessed 5th March 2018

Published: 21 March 2018