EU membership and UK science Contents

Chapter 2: Regulatory framework

14.We begin with the regulatory framework as it sets the broad context in which UK science and research operate within the EU. The influence of EU regulatory frameworks on UK science and research is vast and spans the spectrum of scientific disciplines. As such, our investigations in this area have been necessarily high-level and heavily influenced by the sectors and subject areas of those who engaged with our inquiry. We have thus explored regulation in a general and overall sense and have only considered specific examples in cases where they were repeatedly highlighted to us.

15.The far-reaching influence of the EU regulatory system was aptly summarised by the Campaign for Science and Engineering (CaSE):

“EU-directed regulation affects the UK research environment in diverse ways, across the breadth of scientific disciplines, from animal research to vacuum cleaner design.”3

The EU regulatory environment

16.The balance of competences4 between the EU and Member States, as set out in the Treaty of the Functioning of the EU (TFEU), means that a large number of EU regulatory frameworks influence UK science and research. These frameworks, termed directives, are constructed at the EU level and it is then for Member State governments to transpose them into national law.

17.However, it was highlighted to us that there have been moves towards the development of over-arching EU regulations, as opposed to directives. We heard from the Wellcome Trust:

“The increasing move away from directives towards regulations within EU legislation can reduce the flexibility of Member States to implement legislation in a manner conducive to their cultural and ethical research environment.”5

18.We are concerned by the apparent trend towards the development of over-arching EU regulations. This move away from the use of EU directives may result in the loss of the flexibility currently afforded to Member States in transposing directives into national regulations.

19.As mentioned previously, a number of EU directives and regulations were repeatedly highlighted to us. The frameworks brought to our particular attention included:

20.We will briefly consider each of these regulatory frameworks in turn. Again, we recognise that our analysis is high-level but, due to time and scope constraints, we could not conduct in-depth investigations.

21.The protection of animals used for scientific purposes directive 2010/63/EU is the regulatory regime that governs animal research across the EU with the aim of harmonising animal research standards and practices. The Academy of Medical Sciences was positive about the influence of this framework and highlighted the UK’s involvement in its development:

“[the UK science community made] substantial efforts across the sector to inform its development and transposition into UK law. A number of Fellows noted the leadership shown by the UK on this issue, and the wider impact it had on animal welfare across the EU.”6

22.The clinical trials framework 2001/20/EC was drawn to our attention a number of times as an area of the EU regulatory environment that has not best served UK science and research. The Association of Medical Research Charities (AMRC) suggested to us that its implementation had resulted in an increased administrative burden on researchers as well as an increase in the cost of running academic trials. They also observed that it has led to a reduction in the number of global trials taking place in Europe.7

23.Professor Angus Dalgleish, representing Scientists for Britain, conveyed strong views regarding the clinical trials directive and asserted that its implementation had resulted in the termination of a successful research programme that he was involved in.8 He did, however, concede that some of the problems stemmed from the UK Government’s transposition of the framework.

24.A new clinical trials regulation has been developed and is expected to come into effect in 2017. AMRC consider this to be a considerable improvement on the current clinical trials directive, citing the introduction of a streamlined applications process and proportionate approach to the monitoring and safety reporting of clinical trials as key developments. They emphasised the UK’s role in influencing the evolution of this new regulation:

“The UK health and research community, including AMRC members, played an important role in influencing these improvements.”9

25.The regulatory framework for data protection was also mentioned repeatedly to us. Data protection and copyright affect a variety of areas of scientific research across a wide spectrum of disciplines. One such area of UK science and research that is affected by data protection regulation is medical research. Parkinson’s UK provided an explanation of the importance of access to patient data for research:

“Personal health records are a valuable resource, revealing the most effective ways of caring for patients and allowing us to better understand the causes and frequency of conditions.”10

Furthermore, they insisted that ineffective regulation in this area would mean that “health and scientific research will be severely threatened.”11

26.A new data protection regulation will replace the protection of personal data directive 95/46/EC. If implemented as first drafted, the new regulation could have significantly inhibited science and research. Universities UK (UUK) suggested that the removal of scientific research from the legitimate exemptions for the processing of personal data, as proposed by the European Parliament, would have had a substantial negative impact on UK research.12 The UK science community played an active role in improving the final version.

27.During the course of our inquiry the regulatory environment for genetically modified organisms (GMOs) was repeatedly highlighted as having had a negative impact on UK science and research. This is an area that we are familiar with from our previous inquiry on genetically modified insects.13

28.The deliberate release directive 2001/18/EC covers all transgenic GMOs including crops and insects. Sense About Science provided a concise summary of the problems associated with this regulatory system:

“The regulations are based on an over-statement of the significance of this particular plant-breeding process. The assessment system is unbalanced. The regulations look only at risks, not at benefits. The end point of the European safety assessment process is not governed by any kind of scientific measure but by political factors … The expensive and complex regulatory system is a barrier to the conduct of research on GM [genetically modified] foods in the UK.”14

29.The registration, evaluation, authorisation & restriction of chemicals (REACH) regulations were another frequently cited regulatory framework. Professor Ric Parker, Director of Research and Technology, Rolls-Royce plc and representative of the Royal Academy of Engineering, suggested that implementation of this framework had been to the “detriment of the competitiveness of some UK companies”.15

30.Felicity Burch, Senior Economist, EEF—The Manufacturers’ Organisation, highlighted the impact of REACH on EEF members’ innovation activities:

“We have had a lot of anecdotal evidence from members saying that, because they are innovating to respond to REACH, they are not able to do as much innovation in other areas as they might like to do, and indeed, we see that more generally with regulation as well. As I have said, innovation is extremely resource-intensive and for businesses there is only so much you can do, particularly at the smaller end. So I think regulations can impact the type of innovation companies do.”16

31.Common to all of the EU regulatory frameworks discussed above is evidence of UK influence in mitigating some of the potentially detrimental aspects of the frameworks. Dr David Hughes, Global Head of Technology Scouting in Syngenta, highlighted this and issued a warning regarding the loss of this influence:

“The real key for us [Syngenta] is that, if Britain went its own way in Europe, we would lose the most powerful, most influential, significant voice pushing for a rational, science-based regulatory system governing our technologies. If Britain went its own way, Europe would be in a pretty desperate situation, from our point of view. The chances of actually achieving a continent-wide, rational, functioning regulatory system for our technologies would be distant.”17

32.Some witnesses suggested that problems with the development of EU regulation were exacerbated by “interference” in technical matters by the European Parliament. Professor Kurt Deketelaere, Secretary-General, League of European Research Universities (LERU), was one of the proponents of this viewpoint. In reference to the development of the data protection regulation he asserted:

“It went completely wrong when a number of people in the European Parliament—in a very maniacal way, I must say, because of this discussion with the United States on privacy—came up with all kinds of amendments changing the text and introducing all kinds of obstacles to research. Obviously, at the end of the day the lesson is that perhaps we have to elect better people to send to Brussels and to Strasbourg. In that case, the problem was not in the European Commission.”18


33.Although witnesses highlighted several grievances with the EU regulatory environment, the majority of evidence suggested that the regulatory harmonisation brought about by the EU was of benefit to the UK. Such harmonisation can provide a strong platform for collaboration and commercialisation in science and research. The Academy of Medical Sciences (AMS) corroborated this perspective and suggested that the collaborative potential brought about by harmonisation warrants the “burden” of engaging with regulatory processes.19

34.The Royal Academy of Engineering noted the value in widely recognised standards for businesses and suggested that it is important that the UK plays a role in determining them:

“In emerging fields of strategic importance to the UK it is vital to ensure first mover advantage in the creation of standards. For UK companies to not lose out against international competitors the UK needs to play a leadership role in developing international standards.”20

35.Of course, regulatory harmonisation is detrimental when the regulations being harmonised are ineffective. Dr David Hughes expressed such a perception in relation to the EU’s regulatory systems that govern agricultural biotechnologies. He stressed that Syngenta agree with the principle of regulatory harmonisation but that:

“I think in our particular case the argument is more nuanced, because for agricultural technologies—at least, some of them—the regulatory systems that are defining those technologies in Europe are not fit for purpose. They are non-scientific, scientifically unjustifiable and dysfunctional. It is a bit of a mess, quite frankly.”21

36.Juergen Maier, Chief Executive Officer, Siemens UK, indicated that Siemens view regulatory harmonisation as advantageous. However he outlined the difficulty often encountered in achieving this harmonisation:

“Of course, regulation and trying to get 28 countries to achieve a common standard, whether in electromagnetic field regulation or whatever it might be, is going to be difficult, but when you have achieved it, it makes processes in design and manufacture a lot simpler.”22

37.The increasingly global nature of science and business means that international harmonisation is becoming more relevant. Arguably, moves towards global harmonisation could override the need for EU-level harmonisation. However, in this scenario, Professor Siegfried Russwurm told us that the EU acts as an “aggregator” rather than a “transmitter” and boosts the role of Member States in the development of global standards.23

38.The opposite of regulatory harmonisation is, of course, the development of individual national frameworks. The submission from the Royal Society of Chemistry warned against this and highlighted reservations made by their members:

“The ability for the UK to set its own regulation was not viewed positively due to the perception that businesses would still need to comply with EU regulation, as well as any newly-developed UK regulation.”24

39.Despite some EU regulatory frameworks clearly having a detrimental effect on UK and EU science, we see value in the harmonisation of regulatory frameworks across Member States. In areas where regulation has had a negative effect, or the development of new regulations has had the potential to have such an effect, the UK has often played a key role in working to improve and formulate more appropriate frameworks. We view the development of the new clinical trials regulation and data protection regulation to be prominent examples of this.

3 Written evidence from the Campaign for Science and Engineering (EUM0047)

4 Competences refer to the balance of powers between the EU and Member States. The EU may only act within the limits of the competences conferred upon it by Member States in the Treaties to attain the objectives provided therein. Competences not conferred upon the EU in the Treaties remain with Member States. The Treaty of Lisbon clarifies the division of competences between the EU and Member States. These competences are divided into three main categories: exclusive competences; shared competences; and supporting competences. See Division of competences within the European Union: EUR-Lex Access to European Union Law, Division of competences within the European Union (January 2016): [accessed 12 April

5 Written evidence from the Wellcome Trust (EUM0034)

6 Written evidence from the Academy of Medical Sciences (EUM0029)

7 Written evidence from AMRC (EUM0052)

8 Q 128 (Prof Angus Dalgleish)

9 Written evidence from AMRC (EUM0052)

10 Written evidence from Parkinson’s UK (EUM0003)

11 Written evidence from Parkinson’s UK (EUM0003)

12 Written evidence from Universities UK (EUM0054)

13 Science and Technology Committee, Genetically Modified Insects (1st Report, Session 2015–16, HL Paper 68)

14 Written evidence from Sense About Science (EUM0073)

15 Q 38 (Prof Ric Parker)

16 Q 84 (Felicity Burch)

17 Q 71 (Dr David Hughes)

18 Q 8 (Prof Kurt Deketelaere)

19 Written evidence from the Academy of Medical Sciences (EUM0029)

20 Written evidence from the Royal Academy of Engineering (EUM0066)

21 Q 71 (Dr David Hughes)

22 Q 98 (Juergen Maier)

23 Q 101 (Prof Siegfried Russwurm)

24 Written evidence from the Royal Society of Chemistry (EUM0051)

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