EU regulation of the life sciences Contents

Conclusions and recommendations

1.Given the cautionary example of the Swiss freedom of movement referendum, we urge the Government to conduct a risk analysis of the science and innovation funding and collaboration scenarios in the event of Brexit and put in place immediate contingency plans to protect our science and innovation sector from any adverse consequences and to consolidate any benefits. (Paragraph 4)

2.We do not prejudge the outcome of the forthcoming Referendum on the UK’s membership of the European Union. Nor in this inquiry do we express a view about which outcome would be best for the UK life sciences, less still the UK more generally. Life sciences will clearly not be the determining factor when the British public casts their votes on 23 June. Whatever the result, however, there will need to be action to address a number of concerns about the way the life sciences are regulated in the UK and in the markets it trades with. (Paragraph 8)

Impact of an EU regulatory system

3.The impact of EU-wide regulation of the life sciences can be assessed in terms of the balance between the benefits of harmonised and responsive regulation and the compromises needed to ensure this can be achieved. By harmonising the procedures under which research is conducted, EU regulation can foster cross-border collaborations. These multiple state collaborations are evident at least in the conduct of clinical trials, for example, and setting up such trials through a system where permission needed to be sought country by country would likely introduce even more delay and bureaucracy than the current EU system. Harmonisation in the life science innovations, products, processes and treatments that flow from that research brings with it ready access to the whole EU market, and in the process attracts inward investment into UK life sciences. ... The EU life science regulatory regime may be more costly for researchers and businesses, but provides access to a significantly greater EU-wide market. (Paragraph 17)

4.We are aware of evidence that under Associated Country status UK researchers and innovators could lose out on opportunities to exploit their research under Associated Country scenarios. The extent to which UK scientists could be able to offset this by pursuing greater global (rather than EU) collaborations remains uncertain. We urge the Government to investigate this issue. (Paragraph 18)

5.While the EU regulatory regime has sought a harmonised approach, a failure by some member states to properly implement legislation, or the European Commission to enforce it, has reduced its value. Variations in the way directives are translated into national law can lead, for example, to difficulties for developers of medicinal products. (Paragraph 26)

6.Weaknesses in the 2001 Clinical Trials Directive significantly increased the administrative burden and cost of running academic clinical trials and saw a reduction in trials taking place in Europe. Its replacement Clinical Trials Regulation, expected to come into effect in 2018, appears to be an improvement. (Paragraph 27)

The EU regulatory process: the UK’s influence on it and scope for improvement

7.The UK’s Medicines and Healthcare products Regulatory Agency is widely respected, and has been able to exploit its reputation, leadership and expertise to positively influence the EU medicines regulatory regime. The MHRA should reassess its information channels with medical businesses, however, to ensure that all companies and laboratories, including SMEs, are able to seek to influence the regulatory environment. (Paragraph 39)

8.It is essential that regulation is proportionate in safeguarding patient safety as well as providing a legal environment for the research and development of effective healthcare interventions. Whatever the outcome of the Referendum, there is considerable scope to avoid areas of unnecessary complexity and overlap in EU regulation and to reduce its burden. The costs of a marketing authorisation under the EU system are greater than a national system, but ... it brings wider market access. In the event of the UK leaving the EU, some life science researchers and businesses might seek to have many of the EU regulations either mirrored or continue to be applied by the UK. (Paragraph 49)

9.Every effort must be made to avoid adding unnecessary regulatory burdens to already hard-pressed businesses. The Government must energetically follow up on the EU commitment, secured by the Prime Minister, to “regulatory simplification and burden reduction, including through establishing, where feasible, burden reduction targets in key sectors”. One such ‘key sector’ must be the life sciences. We recommend that the Government, in consultation with industry and whatever the Referendum outcome, draws up a programme for regulatory simplification in life sciences. (Paragraph 50)

10.There is limited evidence that patients in the European Union may benefit from advances in medical technology more quickly than those in Japan and the US. On the other hand, the EU regulatory system often imposes protracted regulatory timescales, including when correcting bad regulation. The new Clinical Trials Regulation, replacing an inflexible and inconsistently applied Directive, coming into force in 2018 represents almost two decades of lost time. (Paragraph 56)

11.The Government and UK regulators must continue to push for shorter timescales in the EU system, to keep pace with a rapidly developing life sciences sector. In order for UK life sciences to retain our competitive advantage we must support them with the most agile and responsive regulatory environment in the world. (Paragraph 57)

12.The Government should explicitly establish a life sciences horizon-scanning group to communicate effectively with universities and businesses about future regulations that could significantly impact on their work. The Group should aim to anticipate technological developments and provide advice to Government and regulators on timely and proportionate legislative and regulatory responses. Such a group could provide a focus for existing horizon-scanning activities in universities, industry and Government. We believe that the EU should also be encouraged to establish more effective horizon-scanning activities across the life sciences. (Paragraph 58)

13.Too often, the precautionary principle has been wilfully misused in the formulation of EU life science policy-making, including perhaps most noticeably in connection with Genetically Modified Organisms. There remains a fundamental need for what the minister called “an enlightened regulatory system on the side of innovation”. In practical terms, an improvement needs to come from a change to a ‘product-based approach’ from the existing unhelpful ‘process-based approach’, and an EU application of the precautionary principle that takes into account the benefits as well as risks and the consequences of not acting as well as acting. The Government should renew its earlier efforts to engender in the European Commission and other member states a far more robust scientific application of the precautionary principle, informed by existing good science evidence. This will be a prerequisite for meaningful and effective international collaboration in life science research. (Paragraph 65)

14.Better-informed input to regulation and policy-making in the EU, along with greater transparency, is needed, not least to tackle instances where the precautionary principle is applied in an overly proscriptive manner. A barrier to an evidence-based regulatory system is a knee-jerk resistance to science by some. The recent establishment of the EU High Level Group of Scientific Advisers, following the Commission’s sacking of its Chief Scientific Adviser and its failure to renew the post, could still provide an opportunity to improve EU regulation. The High Level Group is reviewing vehicle carbon dioxide emission testing and cyber security, but a far sterner test of its influencing capability will come in examining the exploitation of genetic techniques in medicine and agriculture. This is an area in which the EU has not come close to satisfactorily demonstrating an evidence-based approach to policy making. (Paragraph 74)

15.The Government should push for the EU High Level Group of Scientific Advisers to provide a prominent and transparent process for providing independent scientific advice to the EU institutions, to feed into better European regulation of the life sciences. UK science and scientists have a huge opportunity, not to mention responsibility, to help bring this about. The Government must also encourage the Commission to ensure that all the key stakeholders are kept informed at every stage of policy development. (Paragraph 75)

© Parliamentary copyright 2015

8 June 2016