2Priority areas for a science and innovation agreement
7.Our inquiry revisited many of the Brexit priority areas for science that were explored by our predecessor Committee—funding, people, regulation, and collaboration. There are many points that require Government attention, including the UK’s relationship with Euratom,15 the scope for implementing the new EU Clinical Trials Regulation,16 data-sharing,17 and standards-setting. In this Report we have selected a number of priority areas to highlight for particular attention in a UK-EU science and innovation agreement.
Participation in Framework Programme 9
8.Horizon 2020 (or ‘Framework programme 8’) is the EU’s flagship research funding programme. However, it is a time-limited programme, covering the EU’s 2014–2020 budget cycle. The details of the successor programme—’Framework Programme 9’ (FP9), covering 2021–2027—is due to be negotiated soon within the EU. As the UK is currently still a member of the EU it is able to feed in to the EU’s current consultation on the form that FP9 should take, and the Government published its input to this process on 6 March.18 It outlined nine features for the new programme that the Government identify as important to the UK.19 These included a focus on ‘excellence’, and the need for FP9 to “stimulate the creation of markets of the future”, through “support focused on innovation and cross-border-industry-driven collaborative research”. It also highlighted the significance of UK SMEs being able to participate in FP9 in order to contribute to a focus on ‘innovation’. This reflects the CBI’s view that the EU’s “long-term funding, collaborative opportunities and the ability to influence regulations are all valued by enterprises of all sizes”.20
9.We are encouraged to see the Government providing input to the EU’s consultation on the shape of Framework Programme 9, including the emphases it places on excellence and innovation. These are important features for the new programme, and the UK should continue to play a full part in shaping FP9 while it remains a member of the EU, not least to demonstrate the contribution that UK research and innovation can continue to make post-Brexit for the mutual benefit of the UK and EU members.
10.The Government’s Future Partnership paper noted in September 2017 that the terms to be agreed in relation to future participation in FP9 would include “the size of any financial contribution, which the UK would need to weigh against other spending priorities”.21 The Minister told us that there were two tests for the UK’s participation in FP9—a focus on ‘excellence’, and ‘value for money’.22 He told us that “we are not going to participate at any price […] It has to be a realistic deal that works for the UK”.23 We note that our predecessor Committee secured an assurance in 2017 from Jo Johnson MP, then Science Minister, that any future financial contribution to Framework Programme 9 would not be at the expense of the UK Science Budget (i.e. UK participation will not require money to be diverted away from the UK research councils).24
11.The House of Lords Science and Technology Committee has noted previously that while the UK is a net contributor to the EU overall, it is a net receiver of EU funding for research.25 However, whether this will still be possible after Brexit may still be subject to negotiation: a European Parliament motion on the Brexit deal published online in March included a clause stating that the European Parliament could consider UK participation in the EU Research and Innovation Framework Programme “as a third country”, “without permitting net transfer from the EU budget to the UK”.26 This suggests that the EU might not be content for the UK to be an overall beneficiary from FP9 after Brexit. This would not be unusual; the Wellcome Trust’s report quotes the Norwegian Research Council saying that “[this] is without any doubt our country’s most important international partnership within research and innovation”.27
12.The European Scrutiny Committee noted earlier this month that discussion of future participation in FP9 will take place “in parallel to discussions on many other politically sensitive aspects of the post-Brexit EU-UK relationship”, and that participation in FP9 “should therefore not be taken as a given”. It called for the Government to confirm that it would “seek for the UK to become ‘associated’ (or the equivalent term under the future legal framework after 2020) with the next Framework Programme, or, if not, which other ‘options for participating’ the Government is exploring”.28 Calls for the UK to achieve associated status in relation to FP9 have also been made recently by the CBI,29 the Wellcome Trust,30 and several others in written evidence to us.31
13.The recently published European Commission draft negotiating guidelines restate that “nothing is agreed until everything is agreed”.32 The draft guidelines also refer to the UK participating in research and innovation, subject to “the relevant conditions for the participation of third countries to be established in the corresponding programmes in the next Multiannual Financial Framework” (emphasis added).33
14.The Minister emphasised that the Government’s input to the FP9 consultation was “not a commitment to associate with FP9”, but was “a positive vision of what would make the UK excited about FP9”.34 Amanda Dickins, a Deputy Director in the Department of Business, Energy and Industrial Strategy, added that “At this point, it would be unwise to commit oneself to a programme that is yet to be finalised”.35
15.We are concerned that the Government’s default position does not appear to be that the UK will participate in Framework Programme 9. While the details of the Programme have not yet been agreed, the Government should state clearly that it intends to participate unless there is a material unfavourable difference between the new Programme and its predecessor, and that the UK is ready to pay a fair ‘entry fee’ to secure this. If the price is too high, or the focus on excellence is diluted, a change in approach might be warranted, but the Government’s explicitly stated assumption must be to participate fully. Specifically, the Government should state clearly in its response to this Report that it intends to secure Associated Country status for Framework Programme 9.
People
16.The Government’s future partnership paper states that:
The UK and the EU must ensure that their research communities can continue to access the high-level skills that support innovation in science and technology. The Government has made clear that, although freedom of movement will cease to apply in the UK, the UK will continue to welcome the brightest and best, and as such, migration between the UK and the EU will continue after the UK leaves the EU. This Government wants the UK to remain a hub for international talent and its departure from the EU must be seen in this context.36
17.The importance of ‘people’ to UK science was further underlined by several participants at our summit. Niall Dickson, representing the Brexit Health Alliance, emphasised that there was a need to ensure that scientists continue to see the UK as an attractive place to work:
We have always gone on the principle of immigration of “How do we keep people out of this country?” We need to turn that, in a sense, on its head here. Trying to develop a system that is based on access on one or other characteristics only—be it the skill level, the pay or the region that these people come from—we have to develop a much more flexible system that is based on the needs of this country, and the needs of this country in terms of science and technology have not been sufficiently recognised.
Similarly, Sir Venki Ramakrishnan, the President of the Royal Society, outlined why mobility was important for international competitiveness:
You may ask, “Why is mobility important at all? Why simply couldn’t we grow our own talent and why do we need immigrants?” The reason is that when you have mobility you have a much more rapid exchange of ideas and expertise. That allows you to remain at the cutting edge of, essentially, any science or technology. You cannot in isolation hope to be the leader for ever. You may be the leader temporarily, but then other people will have different ideas. If you do not know them, you are not in good communication and you do not have shared expertise; you have a problem. That is the reason why we must encourage mobility.
Regardless of how much talent we grow here, we will always need talent from abroad, because if you want to be the best in the world you have to recruit from the best. Sports teams know this. It is the same with science.37
Immigration policy and visas
18.Naturally, the UK’s approach to the question of ‘people’ is embodied in its post-Brexit immigration plans, and the details of various schemes. Our attention was drawn to several examples of where current policy is not serving science well.
19.In November 2017 the Government announced an additional 1,000 Tier 1 (Exceptional Talent) visas.38 While this was a helpful measure for ensuring “the brightest and best” can work in the UK, many of the written submissions we received argued that it is not only the ‘exceptional’ researchers who the UK must work to retain, but the technicians, laboratory assistants and others who occupy lower profile but no less essential roles in the UK’s science and innovation sectors. 39 Such people would fall under ‘Tier 2’ (general) of the visa system, rather than benefit from the additional Tier 1 allocation. However, the Home Affairs Committee’s report ‘Home Office delivery of Brexit: immigration’ noted that in January 2018 the cap on Tier 2 visas was reached for the second successive month, causing minimum salary requirements for a visa to jump from £30,000 to over £50,000 a year.40 This would be above the salary of most, if not all, the technicians working in the UK. Forty science and innovation organisations wrote to the Prime Minister earlier this month to highlight the harm being caused by the cap. They pointed out that two-thirds of roles in the ‘shortage occupation’ list were in science, technology and medicine, and called for such posts to be exempt from the restrictions.41
20.There is also an issue about uncertainty surrounding the likely status of some EU researchers if they have not been able to demonstrate a sufficient employment record, perhaps if they have not always been employed because they have been students. The Government has said that EU nationals will be able to apply for ‘settled status’ if they have been resident in the UK for five years. The Home Affairs Committee noted in February 2018, however, a lack of clarity for those EU citizens who have completed five years of continuous residence in the UK but who are temporarily living outside the country. A particular issue is that to apply for permanent residency requires evidence of ‘comprehensive sickness insurance’ (CSI) for people who have not been in employment.42 The Science Minister explained that although EU directives require students to have CSI to qualify for permanent residence, the Government would “not require students living here to prove that they have held such insurance when they apply for settled status”.43 The Home Office, the Minister told us, is developing a ‘Settlement Scheme’ to be launched “in the autumn”.44
21.We heard that scientists were being disadvantaged by visa rules which did not recognise the legitimate need for researchers to spend time in other countries for field visits as part of their work. Naomi Weir, from the Campaign for Science and Engineering, explained that “rules currently preventing researchers wishing to obtain indefinite leave to remain from spending more than 180 days [outside the UK] in any 12-month period in the course of their work fail to recognise the nature of work in our sector. […] This situation could easily be resolved by amending indefinite leave to remain rules to permit research activity overseas as part of their rules”.45
22.The Science Minister told us that he envisaged that the science and innovation ‘pact’ that the Prime Minister referred to in her recent Mansion House speech would address issues of immigration policy. He was “very aware” that “it is not just about the framework programmes, but about people. In fact, getting the right people—the brightest and best minds—here is as critical as participating in programmes if we are to succeed in science and innovation”.46 However, he told us that that the Migration Advisory Committee (MAC) was “looking at the evidence on international students, academics coming here”,47 and that BEIS had asked the MAC to report on how the UK’s immigration system should be aligned with the Government’s Industrial Strategy.48 He confirmed that that the MAC was due to report on these points by September 2018.49
23.For the UK to achieve the Government’s stated goal of continuing to welcome the brightest and the best, it is imperative that the migration system for scientists, researchers and scientific technicians recognises the need for mobility, including the benefits for scientists moving between research organisations and taking part in collaborative visits A EU-UK science and innovation ‘pact’ must encompass issues relating to ‘people’. A pact that does not address this fully would be pointless. The Migration Advisory Committee is due to report in September 2018, but the current uncertainty cannot be allowed to continue for another six months. We recommend that the Government ask the Migration Advisory Committee to bring forward its conclusions in relation to the immigration arrangements needed to support science and innovation, and build these into a science and innovation agreement with the EU by October 2018 or earlier if possible. We are concerned that if a people-centred science and innovation pact is negotiated later it risks being less comprehensive due to other negotiation priorities of the wider post-Brexit trade deal. Furthermore, if a pact is not agreed in late 2018 this will increase risks to retaining and attracting the essential talent that our science and innovation sectors need.
Regulation
24.UCL noted that the Government’s Future Partnership Paper “gives little detail on regulation”, and urged the Government to “consider the opportunities for the UK to become a global leader in scientific regulation, particularly in areas such as animal research, biomedical sciences, clinical trials, data protection, and research ethics, using regulation to advance public dialogue and engagement on complex issues around science and regulation, and to drive scientific progress”.50
25.The Prime Minister’s Florence speech in September set out what has since been referred to as the ‘three baskets’ metaphor for assessing where UK regulation should diverge from the EU and where it should be aligned:
In any trading relationship, both sides have to agree on a set of rules which govern how each side behaves. So we will need to discuss with our European partners new ways of managing our interdependence and our differences, in the context of our shared values.
There will be areas of policy and regulation which are outside the scope of our trade and economic relations where this should be straightforward.
There will be areas which do affect our economic relations where we and our European friends may have different goals; or where we share the same goals but want to achieve them through different means.
And there will be areas where we want to achieve the same goals in the same ways, because it makes sense for our economies.51
26.Given the breadth of regulations that are relevant to the science and innovation community it was no surprise to us that there were a range of views expressed in evidence on the merits of alignment or divergence in different cases. For instance, the CBI emphasised that “shared regulatory frameworks are the grease that keeps good trading relationships moving”,52 and the Wellcome Sanger Institute argued that “divorcing the UK from EU legislation risks poorer EU legislation and leaves the UK outside the system, or forced to accommodate weak regulation”.53 The Institute suggested that:
It is important to recognise there is a difference between gold-plating regulation and diverging from it. Many of the suggestions around divergence come coupled with complaints about the cumbersome nature of EU regulation, with the implication of deregulating. Deregulation and divergence should be viewed with great caution.54
On the other hand, the Agricultural Biotechnology Council had concerns about the ‘close regulatory alignment’ sought in the Government’s position paper in the context of agricultural biotech, since the EU regulatory regime “has not been based on science and has proved to be a barrier to innovation”.55
27.Reflecting these differences, the Royal Society told us that there was a need for careful case-by-case assessment of regulations in the context of science:
In the long-term, it is critical that we identify areas of regulation where continued alignment with EU rules is most important for the UK to collaborate and trade, while also recognising the opportunities to develop new regulatory approaches. In the short term, mechanisms should be put in place to ensure that the impact of any Regulations made as the UK departs from the EU are thoroughly scrutinised, supported by a transparent and thorough assessment of the possible effects on research.56
28.A particular example of where clarity over future regulation in the UK highlighted during our inquiry relates to clinical trials. Our predecessor Committee’s report on EU regulation of the life sciences noted that a new Clinical Trials Regulation57 had been developed by the EU, to replace an existing Clinical Trials Directive dating from 2001. The existing Directive had been highly criticised by the community, as it had led to “increased burden on academic researchers and a drop in clinical trials conducted in the UK and the EU”.58 The new Regulation, however, has attracted much more support from the community, and the UK has contributed to its development.59 We were told that it was important that the UK aligned with the Regulation once its provisions apply, and worked to secure access to the relevant EU infrastructure that would allow participation in clinical trials to continue, such as the central portal and database being created as part of the new Regulation.60
29.In September 2017 we asked DExEU to clarify the UK’s position in relation to the new Clinical Trials Regulation, since the new Regulation is not expected to be in force until after Brexit. Robin Walker MP explained then that this means that future alignment will be “subject to negotiations”:
The general approach taken in the Repeal Bill (formally known as the European Union (Withdrawal) Bill) is that EU law which applies directly in the UK legal system immediately before exit will be converted into domestic law after exit. […]
Under the Bill, direct EU legislation is only converted and incorporated into domestic law “so far as operative immediately before exit day”. […] We are aware that the implementation of the EU Clinical Trials Regulation has been postponed […] the new Regulation may take effect after we leave the EU and therefore will not be covered by the Repeal Bill and so our future alignment with the new EU Clinical Trials Regulation will be subject to negotiations.
However, as the Secretaries of State for Health and for Business, Energy and Industrial Strategy jointly set out in an open letter in the Financial Times on 5 July, the UK is fully committed to continuing the close working relationship we enjoy with our European partners across the field of medicines regulation that will include any future EU regime on clinical trials.61
30.The Academy of Medical Sciences told us that “Harmonisation to this regulation should be prioritised by the UK Government and urgent clarity is required on how the UK will implement the regulation during the transition period”.62 However, the Science Minister’s response was simply that “the current regulatory approval legislation [i.e. reflecting the existing Clinical Trials Directive, which will be transposed into UK law] will stay in place until such time as any changes are needed so there will be no interruption in UK clinical trials approval”.63 This may well be the case in the period immediately after Brexit and before the Regulation applies in the EU, but his statement does not provide any further clarity on what position the UK will take after that point, or reflect the need to negotiate access to the infrastructure necessary to continue to participate in clinical trials from then on.
31.The Science Minister’s response to us on clinical trials regulation is unsatisfactory. His position that “the current regulatory approval legislation will stay in place until such time as any changes are needed” ignores the fact that work is needed now to ensure that the UK can participate in and lead clinical trials in the future. We recommend that the Government revisit this statement in its response to our report.
Regulatory bodies
32.The Prime Minister’s Mansion House speech in March suggested that the Government was exploring associate membership of regulatory bodies such as the European Medicines Agency:
We will also want to explore with the EU, the terms on which the UK could remain part of EU agencies such as those that are critical for the chemicals, medicines and aerospace industries: the European Medicines Agency, the European Chemicals Agency, and the European Aviation Safety Agency.
We would, of course, accept that this would mean abiding by the rules of those agencies and making an appropriate financial contribution. I want to explain what I believe the benefits of this approach could be, both for us and the EU.
First, associate membership of these agencies is the only way to meet our objective of ensuring that these products only need to undergo one series of approvals, in one country.
Second, these agencies have a critical role in setting and enforcing relevant rules. And if we were able to negotiate associate membership we would be able to ensure that we could continue to provide our technical expertise.
Third, associate membership could permit UK firms to resolve certain challenges related to the agencies through UK courts rather than the ECJ.64
On the European Medicines Agency, the Prime Minister said that membership would mean:
investment in new innovative medicines continuing in the UK, and it would mean these medicines getting to patients faster as firms prioritise larger markets when they start the lengthy process of seeking authorisations. But it would also be good for the EU because the UK regulator assesses more new medicines than any other member state. And the EU would continue to access the expertise of the UK’s world-leading universities.65
33.It remains to be seen whether the ambition of ‘association’ will be realised through the negotiations. In the draft negotiating guidelines published by the Council of the European Union on 7 March, the Council stated that “the Union will preserve its autonomy as regards its decision-making, which excludes participation of the United Kingdom as a third-country to EU Institutions, agencies or bodies” (emphasis added).66 This suggests that there may still be some doubt that a formal ‘Associate Member’ status will be possible in this context, with the assumption that the UK will be a ‘Third Country’ instead.
15 Qq98–101. See also, for instance, Business, Energy and Industrial Strategy Committee, Second Report of Session 2017–19, Leaving the EU: implications for the civil nuclear sector, HC 378, and Euratom, Commons Briefing Paper CBP8036.
16 See paras 27–30
17 See, for instance, Digital, Culture, Media and Sport Committee, Second Report of Session 2017–19, The potential impact of Brexit and the creative industries, tourism and the digital single market, HC 365, paras 105–120
18 Department for Business, Energy and Industrial Strategy, UK position paper on the Ninth Framework Programme for Research and Innovation (6 March 2018)
19 Q6
20 CBI, Collaborate to innovate: Developing UK access to Framework Programme 9 (March 2018)
21 HM Government, Collaboration on science and innovation: future partnership paper (6 September 2017)
22 Q7
24 Oral evidence taken on 17 October 2017, HC (2017–19) 438, Q34
25 House of Lords, EU membership and UK science, Second Report of the Science and Technology Committee, Session 2015–16, HL Paper 127, para 105
26 Motion for a resolution to wind up the debate on the framework of the future EU-UK relationship (5 March 2018), para 35
27 Wellcome Trust, Building a strong future for European Science: Brexit and beyond (February 2018), p8
28 European Scrutiny Committee, EU Research Funding: Interim evaluation of Horizon 2020 (39425), 5271/18, COM(18) 2, para 10.12
29 CBI, Collaborate to innovate: Developing UK access to Framework Programme 9 (March 2018), p1
30 Wellcome Trust, Building a strong future for European Science: Brexit and beyond (February 2018), p1
31 See, for instance, Universities UK (BSI 19), University of Bristol (BSI 50) para 3.3ii, ELIXIR and ELIXIR UK (BSI 52), National Physical Laboratory (BSI 57), Samsung UK and Ireland (BSI 64) para 2.8, Johnson Matthey (BSI 79).
32 European Council, Article 50 (23 March 2018) Draft guidelines (7 March 2018), para 1
33 European Council, Article 50 (23 March 2018) Draft guidelines (7 March 2018), para 8
34 Q6
35 Q9
36 HM Government, Collaboration on science and innovation: future partnership paper (6 September 2017)
38 Gov.uk, ‘Government doubles exceptional talent visa’, 15 November 2017
40 Home Affairs Committee, Third Report of Session 2017–19, Home Office delivery of Brexit: immigration, HC 421, para 49
41 Campaign for Science and Engineering, ‘CaSE calls on Prime Minister to revise current visa restrictions’, 8 March 2018
42 Home Affairs Committee, Third Report of Session 2017–19, Home Office delivery of Brexit: immigration, HC 421, paras 15, 32
46 Q27
47 Q28
48 Q36
49 Q38
51 Gov.uk, ‘PM’s Florence speech: a new era of cooperation and partnership between the UK and the EU’, 22 September 2017
57 Council Regulation (EC) No.536/2014
58 Science and Technology Committee, First Report of Session 2016–17, EU regulation of the life sciences, HC 158, para 23
59 House of Lords, EU membership and UK science, Second Report of the Science and Technology Committee, Session 2015–16, HL Paper 127, para 24
60 Association of Medical Research Charities (BIS 32). See also Regulating clinical trials, POSTnote 561, Parliamentary Office of Science and Technology, 2 October 2017
61 Correspondence from Robin Walker MP dated 21 September 2017
63 Department for Business, Energy and Industrial Strategy (BSI 86)
64 Gov.uk, ‘PM speech on our future economic partnership with the European Union’, 2 March 2018
65 Gov.uk, ‘PM speech on our future economic partnership with the European Union’, 2 March 2018
66 Council of the European Union, European Council (Art.50) (23 March 2018)—Draft guidelines (7 March 2018)
Published: 21 March 2018