Policy may directly govern how research is conducted, or it may influence the rapid and safe realisation of potential future applications.
A number of areas that are within the EU’s competence to make policy can influence research, for example the use of animals in research, the governance of clinical trials, data protection, patents and copyright.
Policy that influences research can be divided into two types:
Both types may influence research in a number of ways. Policy may directly govern how research is conducted, or it may influence the rapid and safe realisation of potential future applications. For example, if the development of commercial applications of research is restricted, this may discourage further investment in research.
Research is highly collaborative. In 2015 over half of the UK’s research output was the result of an international collaboration and while the US continues to be UK based researchers’ single most frequent partner country, the number of UK based researchers collaborating with EU partners is increasing at a faster rate.Consistent implementation of policy that supports science can facilitate these cross-border collaborations. However poorly designed policy can be damaging whether applied consistently or inconsistently.
The following case studies illustrate the development of EU policy in a number of areas that impact on UK research. They show how scientific evidence and advice has been provided and has influenced the process and where other factors such as social norms, tradition, moral values and global events have influenced the outcome. They illustrate the role of formal mechanisms and more informal engagement through which the scientific community engages with the policymaking process.
Data protection policy regulates the way that personal data are collected and shared across the EU. It is a shared competence between the EU and Member States.
Data protection policy has evolved in the EU since the development of the 1995 EU Data Protection Directive 95/46/EC. In January 2012, the European Commission published a proposal for a General Data Protection Regulation (GDPR) to replace the existing Directive, and noted that while its objectives and principles were sound, the original Directive had not ensured a harmonised system of personal data protection across the EU.
The new Regulation was developed to bring data protection laws in line with rapid technological developments that have transformed the way data are collected, accessed, used and transferred. This aimed to create a single, technologically neutral and future-proof set of rules across the EU.
Throughout the development of the GDPR, the research community engaged with the policymaking process. The original draft of the proposed Regulation set out a proportionate mechanism for protecting privacy, while enabling research using personal data, for example in health and social sciences, to continue through specific exemptions.
During the legislative process, several amendments were proposed that would have negative consequences for research. For example, the amendments would mean that, while Member States could pass a law permitting the use of pseudonymised health data (i.e. data that cannot be attributed to a particular individual) for research purposes without consent, the criteria for allowing this would be very narrow and restrictive. The use of fully identifiable health data without consent would have been prohibited.
In practice, this would have made it problematic to use data concerning health, for example from large cohort studies, biobanks and disease registries, without specific consent, which could have prevented valuable health research that is currently legal and already tightly regulated.
The research community across the EU established campaigns, urging EU institutions to find a compromise position to enable vital research to continue. Activity included interaction with MEPs and the Council of Ministers, through briefings and meetings as well as articulating positions through statements and open letters.
The European Commission held a number of conferences and consultations on the use and protection of personal data, which gave stakeholders the chance to express their views formally.
After considerable input from the European research community, the final text of the new GDPR did not include the proposed amendments and ensured that the legislation maintains a proportionate balance between facilitating research and ensuring safeguards to protect individuals.
As a Regulation, the GDPR will apply directly in all 28 Member States, however, some aspects, such as safeguards and exemptions for research are delegated to Member States.
It is difficult to assess the impact of this Regulation on UK research, as it has not yet been applied into UK law. The European research community is confident that this will not prevent research which accesses personal data from going ahead. However, this will be dependent on exactly how different Member States implement the Regulation in research and how this approach varies across the EU.
There is rapid technological development in the handling and analysis of data meaning that it is likely that this legislation will need regular review to ensure governance practices are fit for purpose.
Policy to regulate clinical trials in the EU aims to ensure high and harmonised standards for conducting clinical trials across the EU. However, the introduction of the Clinical Trials Directive (CTD) 2001/20/EC in 2001 did not achieve the harmonisation sought, and furthermore the legislation made it particularly difficult to perform certain clinical trials in several Member States (see below). In the UK, the number of clinical trials dropped by 22% between 2007 and 2011.
In 2012, the Commission proposed a revised Clinical Trials Regulation EU No 536/2014, which entered into force in 2014. As a Regulation, this must be implemented in the same way by all Member States. The Regulation aims to simplify authorisation procedures, creating a more favourable environment for conducting clinical trials, with the highest standards of patient safety in all EU Member States.
Recognising problems with the implementation of the 2001 Clinical Trials Directive, the European Commission ran consultations on plans to revise it. During this period, organisations representing the medical research community in the UK and other Member States strongly articulated the need for legislation that would create a supportive environment for conducting research involving clinical trials. In the UK, sixteen organisations including Cancer Research UK, the Wellcome Trust and the Academy of Medical Sciences produced a statement welcoming the revision of the Clinical Trials Directive. The Commission and the European Medicines Agency held a conference to facilitate a dialogue on clinical trials legislation between the Commission and stakeholders from industry and academia.
The new Clinical Trials Regulation has now been adopted and came into effect in May 2016. This is considered by the scientific community to be a considerable improvement on the Clinical Trials Directive, addressing many of the previous problems. The fact that the new proposal is a Regulation rather than a Directive means that the new legislation will automatically become law across all Member States, reducing the potential for inconsistent interpretation.
The Regulation has been formally adopted by the EU and is in the process of being implemented in Member States. It is envisaged that the Regulation will have a positive effect on the system of conducting clinical trials in the UK. The UK has been particularly stringent in its implementation of the Clinical Trials Directive compared with other EU Member States, resulting in high standards in the UK but placing the UK at a competitive disadvantage. In the development of the new Clinical Trials Regulation, the research community has been effective in influencing the debate to ensure the administrative burden and increased cost of conducting clinical trials is addressed. Issues arising from the inconsistent interpretation of the current Clinical Trials Directive should be addressed by the fact that the new piece of legislation is a Regulation (see Fact box 2).
Modern biotechnology can use techniques that are not naturally occurring to modify the genetic material of organisms. The EU has established a legal framework which aims to ensure the safe and responsible development of these GMOs across the EU. The framework is intended to establish:
This framework comprises a number of Directives and Regulations supplemented by a number of implementing rules, recommendations and guidelines on more specific aspects.
To take into account scientific and technical developments in biotechnology, the European Commission established a New Techniques Working Group to assess what falls within the scope of EU legislation. Similarly, the European Food Safety Authority (EFSA) has a Scientific Panel on GMOs to provide scientific advice on the safety of GMOs in the food chain such as plants, animals and micro-organisms. This comprises 18 scientists from across Europe, covering wide areas of expertise.
Two reports were prepared between 2009 and 2011 evaluating the EU legislative framework in the field of cultivation of GMOs focusing on GMO cultivation and GM food and feed.
The Joint Research Centre (JRC) also plays a role in the development and implementation of EU GMO legislation. Sitting within the JRC, the EU Reference Laboratory for GM Food and Feed provides the scientific assessment and validation of detection methods for GM Food and Feed as part of the EU authorisation procedure. It also coordinates the National Reference Laboratories for GMOs in the Member States.
When the EU originally adopted legislation to control the use of GMOs in 1990, the precautionary principle was applied due to the absence of evidence at the time regarding the potential risks to human health and the wider environment. The consensus of scientific bodies is that scientific evidence now no longer justifies controlling GMOs based simply on the technology that generated them (i.e. the process-based approach).
Alongside the scientific evidence, public opinion is very important. High levels of public concern over the use of GMOs and different attitudes across EU Member States have limited the number of GMOs authorised for cultivation and food and feed.
To date, one GM crop, a pest resistant variant of maize, is commercially cultivated in the EU. Although this crop has EU-wide approval, it is only grown in five Member States.
The European Commission is currently reviewing whether it should regulate a gene-edited plant that has no foreign DNA, as if it were a genetically modified organism.
How does this impact research in the UK?
The UK has a strong science base in the fields that contribute to the development of GM applications. However, the prohibitive length and cost of obtaining EU regulatory approval for GM products is a factor that may discourage the translation of this research into agricultural applications. This can deter investors and drive research to other countries with more permissive regulation such as the US, Canada or emerging economies like Brazil and China. In the UK, England, Scotland, Wales and Northern Ireland can each choose to restrict or prohibit the cultivation of GMOs that have been approved by the EU. In Autumn 2015 Scotland, Wales and Northern Ireland chose to do so.
At present the use of animals remains the only way for some areas of research to progress. EU policy follows the principle of Three Rs (Replace, Reduce and Refine), which aims to ensure the welfare of animals used for research purposes. EU regulation of this area began in 1986 but inconsistencies in national implementation by Member States led to the publication of a revised Directive in 2010.
The UK Bioscience sector – consisting of a united coalition of academic, industry, small and medium-sized enterprises (SMEs), funding, charity and patient bodies - played an active role in providing evidence and advice to inform the revision of the Directive. For example, the bioscience sector published position statements, responded to consultations of the Home Office and House of Lords European Union Select Committee and provided briefings for Parliamentary debates. This formed a powerful collective voice that shaped the UK’s negotiating position at the Council.
Throughout the process of revising the Directive 86/609, the Commission sought the opinions of Scientific Expert Committees on a number of issues relating to the use of animals in experiments. The Scientific Committee on Animal Health and Animal Welfare (SCAHAW) provided input on the welfare of non-human primates used in experiments and a Technical Expert Working Group (TEWG) was assembled by the European Commission’s Directorate General Environment to include expertise from industry, academia and animal welfare organisations. A public stakeholder consultation on the use of animals in experiments and ways to improve their welfare included both citizen and expert questionnaires.
The UK has one of the world’s strongest regulatory systems in this area. One of the central aims of the revised legislation was to raise standards of oversight and animal use in other Member States, especially those with a poor record of implementing the previous Directive. For the majority of UK researchers there has subsequently been little change to the governance of research using animals.
The UK Bioscience sector has expressed concerns that the Directive is being implemented inconsistently across Member States, and that this could negatively impact on collaboration between Member States and other countries. The Directive will be reviewed in 2017.