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SCIENCE AND TECHNOLOGY COMMITTEE (COMMONS) EU REGULATION OF THE LIFE SCIENCES INQUIRY Submission for the Association of Medical Research Charities

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SCIENCE AND TECHNOLOGY COMMITTEE (COMMONS) EU REGULATION OF THE LIFE SCIENCES INQUIRY Submission for the Association of Medical Research Charities The Association of Medical Research Charities (AMRC) is a membership organisation of the leading medical and health charities funding research in the UK. Working with our members, we aim to support the sector's effectiveness and advance medical research by developing best practice, improving public dialogue about research and science and influencing government to ensure the best research can go ahead and be translated into new treatments. Medical research charities exist because the public choose to donate their money to support research to develop new treatments and cures; 7.6 million people donate in a typical month. In 2014, AMRC members invested over £1.3 billion in health research in the UK. We are grateful for this opportunity to contribute to the Committee’s deliberations on this topic. Introduction Many issues that are important to the medical research community are affected by regulations at EU level. Research is inherently collaborative and cross-border in nature. EU regulations and frameworks impact the UK both directly and indirectly through their impact on other countries in Europe with whom we partner on research. Pan-European rules have the potential to facilitate collaboration by harmonising member countries’ approach to research, and collaboration is vital for medical breakthroughs that make a difference for patients. The single European regulatory framework plays an important part in the UK's attractiveness for inward investment and research by the life sciences industry. This is important to our members and the patients we serve because: 



funders contribute to research at different stages on the translational pipeline. Partnerships between academia, industry and charities ensure that the outcomes of publicly funded medical research are translated into outcomes that benefit UK patients, population and the economy. Funding from actors in the ecosystem is interdependent and additive; reductions in one area can't be compensated or by other funders; a reduction in commercial clinical research activity would reduce early access of UK patients to innovative treatments.

What are the key EU regulations and frameworks that govern/influence the conduct of research and innovation in the UK life sciences? 1.1 The European Clinical Trials Regulation has now been passed, but is not likely to be implemented until 2018. Once implemented this new law should harmonise how clinical trials are approved and conducted across Europe, benefitting research and ultimately patients. 1.2 Once agreed and implemented, the EU Data Protection Regulation will impact how researchers in the UK and the EU conduct research, harmonising a common approach to the use of personal data. It is important that the final text, a positive outcome for the research community, is finalised this year.

1.3 The In Vitro Diagnostic Medical Devices Regulation is currently being revised in order to account for scientific developments and provide a regulatory framework for in vitro diagnostic medical devices that is fit for purpose. 1.4 Rare diseases are an important area in which the EU has played a leadership role. European level legislation in this area includes the EU Regulation on Orphan Medicinal Products, the EU Regulation on Paediatric Drugs (which will be reviewed in 2017), the EU Regulation on Advanced Therapies, the Commission Communication Rare Diseases: Europe's Challenges, the Council Recommendation on a European action in the field of rare diseases, the EU Directive on Patients’ Rights in Cross-border Healthcare, and others. In particular, the UK Strategy for Rare Diseases came about as a direct response to the Council Recommendation on a European action in the field of rare diseases. 1.5 European Directive 2010/63/EU on the protection of animals used for scientific purposes has enhanced animal welfare standards and introduced the concepts of refinement, replacement and reduction (‘3Rs’) across the EU, while ensuring Europe remains a world leader in biomedical research. 1.6 Horizon 2020, the EU framework programme for research and innovation, makes a significant contribution to life sciences in the UK. In financial terms the EU’s contribution to the UK life sciences is significant. The UK receives the second highest financial contribution across all EU Member States from Horizon 2020, after Germany. The financial contribution that AMRC members receive from the EU will vary, although EU funding is an important part of their funding mix. Over the period from 1st January 2012 – 31st December 2014, researchers funded by 13 AMRC member charities received over £260 million in further funding from the European Union, covering disease areas from arthritis to Parkinson’s disease. 1.7 The benefits of long-term research funding programmes, such as Horizon 2020, are more than financial. Such programmes make an important contribution by offering consistent, long-term funding to UK scientists and encouraging collaboration. 1.8 The UK Government and other UK stakeholders are also involved in Joint Actions, for example the Joint Action on rare diseases which bring member states and other stakeholders together to tackle common challenges. In what ways do these EU regulations affect the UK life sciences? What are their benefits and the drawbacks? 2.1 In principle, EU legislation that harmonises rules governing life sciences across member countries is beneficial to UK medical research. By harmonising and streamlining approaches to research, pan EU rules support scientific collaboration. 2.2 There is a vital need for multi-nation involvement to ensure adequate numbers of patients in certain studies, in particular for rare diseases.

2.3 EU regulations can also raise standards across Europe. EU regulations can raise the bar in some Member States where standards lag behind, improving the overall quality of the EU’s research output.

2.4 There have been EU regulations that have not best served UK life sciences. An example of this is the 2004 European Clinical Trial Directive (CTD). The CTD significantly increased the administrative burden and cost of running academic clinical trials; it also saw a reduction in the number of global trials taking place in Europe. The new Clinical Trials Regulation, expected to come into effect in 2018, is a considerable improvement on the CTD, introducing a streamlined approvals process and proportionate approach to the monitoring and safety reporting of clinical trials. The UK health and research community, including AMRC members, worked together with partners in Europe to inform these improvements. 2.5 The sector has expressed concerns with the amendments adopted by the European Parliament to the proposed In Vitro Diagnostics Regulation, which could have damaging effects on the provision of genetic tests for patient benefit and could potentially limit the uptake of new healthcare innovations. 2.6 EU and international researchers both contribute to the quality of UK life science. Importantly, existing free movement rules mean that is easier for researchers from the EU to enter the UK, easier for EU students to undertake exchanges and easier for EU researchers to collaborate without the need for visas. Numbers of non-EU researchers are limited, for example, through the existing points-based system and pay thresholds for new entrant and experienced workers. Researchers from the EU make up a significant proportion of the workforce across the UK. For example, in Cancer Research UK’s Beatson Institute, roughly 50% of the researchers are from the EU, compared to 20% from the UK and 28% from the rest of the world. 2.7 Beyond regulation, EU frameworks and programmes encourage collaboration between scientists in member countries, which is vital for making progress. 2.8 Ensuring scientific evidence is integrated into EU regulation is an ongoing challenge. Balancing differing cultural and ethical approaches across 28 member states can mean that European legislation can at times result in proposals that do not match the UK’s approach to medical research. A robust mechanism for embedding scientific evidence into policymaking is crucial for mitigating the impact of these cultural differences (please see response to question below on the importance of a sound evidence base in EU policymaking processes). How transparent, consultative and evidence-based are EU policy-making processes? 3.1 The EU policy-making process is consultative; stakeholders have various opportunities to feed in. The AMRC and its members engage with and feed into EU legislation at various points in the policy-making process. 3.2 At the start of the policy-making process the European Commission actively seeks views via stakeholder consultations. These are published in a transparent way and respondents are given realistic timelines, although the wording of the questions could at times be more accessible. The onus is then mainly on stakeholders who can feed in as appropriate by monitoring legislative files and engaging directly with relevant parties in the EU institutions (European Parliament, European Commission, and the European Council).

3.3 The decision-making process could be more transparent for stakeholders who are not expert in the EU policy-making process. After the initial stakeholder consultation that takes place at the start of the process, it becomes harder to identify how to feed in, who are the key players and where to find updates on the process. Of course, these challenges are not unique to the EU consultation process. 3.4 The EU’s institutions vary in terms of their transparency and openness to stakeholder consultation. AMRC’s members have a good working relationship with the UK Representation in Brussels and relevant Government departments working on EU issues. The European Parliament is also open, and Members of the European Parliament, in particular UK members, are keen to engage. However, identifying the appropriate unit to engage with in the European Commission on specific policy issues can be a challenge. More transparency about how to engage and who to engage with in the European Commission would be beneficial. 3.5 The process of ‘trilogue’ talks between the three institutions, which can go on for a number of months, can be opaque. On the EU Data Protection Regulation, for example, no formal information was given to the UK life sciences sector between the Council position agreement in June 2015 and the publication of the final text in December that year. 3.6 Science and research organisations have always worked hard to ensure evidence-based arguments are fed into the policy-making process and work with equivalent organisations across EU member countries to ensure a pan-European sector approach. 3.7 The AMRC and its membership were supportive of the post of a Chief Scientific Adviser (a similar model to the UK) to the European Commission President, and welcomed the contribution of Anne Glover. We will monitor carefully the new model for scientific advice to assess its effectiveness, although we do have initial concerns that none of the sevenstrong scientific panel has a life sciences background. We are keen to ensure measures that guarantee the mechanism’s transparency and accountability. 3.8 European Citizens’ Initiatives allow one million EU citizens to participate directly in the development of EU policies. They can run counter to scientific evidence, and we urge caution in how they are dealt with by the institutions. To what extent is the UK able to shape regulatory processes at the EU level that affect the life sciences? 4.1 The UK is well placed to shape regulation that affects the life sciences. The UK government has a seat at the table of Council discussions and there are some strong UK Members of the European Parliament, in different groups, that have a solid track record of steering research-related laws through the regulatory process. Both the UK government and UK Members of the European Parliament (as well as MEPs from other countries) are keen to hear from the AMRC and its membership and, often, actively seek views.

The UK was a strong voice on the EU Data Protection Regulation. UK research organisations helped inform the UK government, UK MEPs (as well as supportive MEPs from other countries) of the research sector’s concerns and worked with health and research organisations across Europe to ensure the final text best served patients and research. The law will be finalised later this year. The UK’s medical research sector and the MHRA took a strong role in the revision of the EU Clinical Trials Directive. Many of the activities that MHRA had already brought into play (proportionate review) were added to the new regulation and UK-based organisations were able to forge an important and constructive dialogue with the European Parliament’s rapporteur which played a vital role in the law’s positive outcome. 4.2 UK organisations and UK scientists and patients have a key role to play in ensuring EU regulation fulfils its potential and benefits life sciences in the UK and across Europe and does not create obstacles to research. They are able to, and indeed do, engage with MEPs and Council representatives from outside the UK, but often their natural allies are compatriots, from the UK. 4.3 UK organisations can also galvanise support of Europe’s research sector. By working collaboratively with pan-European organisations and organisations across Europe, UK organisations can rally support, demonstrating a united front as they inform and influence policy processes and policy debate. For example, in recent years, the UK research sector has played a key role in the revised Clinical Trials Regulation and the Data Protection Regulation and continues to play a key role in defending the importance of the European Directive 2010/63/EU on the protection of animals used for scientific purposes. 4.4 Well-respected UK scientists are occasionally invited to participate in high-level events in the EU institutions. These opportunities enable them to share their views and ensure support for their calls on regulation. A recent example would be Professor Michel Coleman, who advocated on behalf of the European research sector at a high-level event on survivorship last year.

Stroke Association “Our experience at Stroke Association and the Stroke Alliance for Europe has been overwhelming positive in terms of participation in EU funded activities. We welcome the fact that the EU funds research across the stroke pathway at a much higher relative rate than do UK funding bodies. This has allowed us to grow capacity in terms of collaborating and assisting other stroke support organisations across the EU. We also welcome the close regulation of clinical trials and the increased reliability and efficacy this has enabled, especially in the treatment of acute stroke.”

Is the UK able to depart from the application, standards or timing of such EU regulation? 5.1 EU law should be applied as written in the law within the prescribed timelines, usually two years. For EU regulation to reap the most benefit for patients and research by cementing cross border harmonisation, it is important that rules are applied uniformly across member

countries. EU regulations are more rigid than directives in terms of how they are applied, although in both instances there is a process of interpretation as the rules are transposed. 5.2 The UK has in the past been prone to ‘gold plating’ EU directives i.e. making then more onerous than is needed. For example, the UK’s stringent transposition of the Clinical Trials Directive inhibited how we set up trials; as other EU countries went less far, they became a more attractive place to conduct trials and this dynamic undermined the UK position. 5.3 The UK research sector envisages that compliance with EU regulation will remain important regardless of changes to the UK’s relationship with the EU, to ensure a harmonised European research sector which is vital for UK and European science. 5.4 Departures from prescribed deadlines on timing happen when more time is needed for transposition. For example, the Clinical Trials Regulation was set to be implemented by 2016. Yet before the Regulation comes into effect the EMA must allocate appropriate resource to develop the necessary IT infrastructure. The timely development of this infrastructure will be crucial to ensure the Regulation is implemented before the end of 2018. 5.5 In some instances, for example, Council Directive 2005/71/EC of 12th October 2005 on a specific procedure for admitting third-country nationals for the purposes of scientific research, the UK has opted out of Directives, meaning EU laws are not applied.

For further information, please contact Aisling Burnand MBE, Chief Executive of the AMRC ([email protected])