By Sue Tansey with contributions from Dr Mark Flear (Reader in the School of Law, Queen’s University Belfast) and Professor Siobhán O'Sullivan (Professor, Royal College of Surgeons in Ireland, Deputy Chair, European Group on Ethics in Science and New Technologies and Vice-Chair of the Committee on Bioethics in the Council of Europe)
The development and application of biological and medical research is a global endeavour. It is impossible to examine the ethical issues raised by this research without taking international contexts into consideration and engaging with experts and policy makers worldwide.
With ‘exit day’ behind us, the Nuffield Council wanted to explore how Brexit could affect the UK’s relationship with European and global bioethics institutions. Earlier this year, we convened experts in ethics, law, governance, industry and the UK science sector for a horizon scanning exercise to consider what challenges and opportunities Brexit might present for UK policy makers and bioethicists in future.
Here we ask two of those experts – Dr Mark Flear and Professor Siobhán O'Sullivan – to reflect on three key questions on bioethics post-Brexit.
What effect is Brexit having on European and global bioethics?
Brexit is likely to be a short-term issue in terms of UK participation in the development of global bioethics codes and standards.
The UK’s membership of the EU ensured that values and norms underpinned by a commitment to individual autonomy were reflected at the EU level, whereas other values and norms relating, say, to dignity, have been emphasised by other EU member states. Brexit could lead to bioethics within EU fora and the corresponding legal instruments becoming less balanced and rounded in terms of the range of norms and values recognised at the EU-level of governance.
However, a commitment to individual autonomy remains embedded in EU fora such as the European Group on Ethics in Science and Technology. Individual autonomy is also encoded in EU law, including the Charter of Fundamental Rights, and the instruments of secondary law that reference it and global bioethics standards such as the Helsinki Declaration and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines (see below).
In terms of global bioethics, Brexit is unlikely to change the UK’s position in the key global fora for bioethics issues. These include the UNESCO, World Health Organization, World Medical Association and Council for International Organizations of Medical Sciences.
Brexit has changed the UK’s relationship with fora where it was previously represented by the EU as a whole, for example the ICH. The ICH brings together regulatory authorities and the pharmaceutical industry to produce global bioethics standards that are de facto binding through the law of ICH members. Brexit might mean the ICH loses valuable UK experiences, and the UK could lose out on engaging with regulatory processes in key markets for UK products. However, although the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) is currently an observer, there is a process to become a full member. Therefore, the extent to which the UK will continue to shape the ICH’s global bioethics standards seems likely to depend on whether the MHRA becomes a full member and how it exercises its influence. This underscores how, outside the EU, the UK may still be able to take a more proactive role, strategically reposition itself and form new partnerships and alliances to pursue common interests.
It is too early to gauge the effect of Brexit on European and global ethics, and it may take many years for it to become apparent whether the withdrawal of the UK from the EU has had any substantive effect on the leading role the UK has traditionally played in shaping bioethical inquiry and governance.
I would be rather sanguine that the UK will continue to exert its considerable influence in the field, both at the formal intergovernmental level through its participation in the Council of Europe, UNESCO and World Health Organization but also and as importantly on the global stage through the exercise of soft power borne of the considerable bioethics and scientific expertise which resides within the UK.
What effect is Brexit having on how bioethics issues are considered in UK law, regulation and policy?
The UK continues to be represented at the Committee on Bioethics in the Council of Europe, which is tasked with the application of the principles enshrined in the Convention on Human Rights and Biomedicine, the only legally binding instrument on the protection of human rights in the biomedical field.
The Convention draws on the principles established by the European Convention on Human Rights, in the field of biology and medicine. Indeed, the European Court of Human Rights, which is increasingly being called upon to decide upon cases touching on various issues from the bioethical field, frequently refers to texts and instruments developed by the Bioethics Committee. For instance, in its judgment in the case of Lambert v. France (2015), the Court’s Grand Chamber based part of its reasoning on the Guide on the decision‑making process regarding medical treatment in end‑of‑life situations.
The EU-UK Trade and Cooperation Agreement contains a number of provisions which on the face of it confirm the UK’s continued commitment to the European Convention on Human Rights. The UK is an active member at the Committee of Bioethics and has enjoyed regular representation on the Bureau and working groups, which guides the work of the Committee.
In examining the work programmes of other inter-governmental bodies in the field of bioethics, there will be ample opportunities for the UK to be involved in determining the future governance arrangements for emerging, converging and disruptive technologies, in which the UK is heavily invested from both the societal and economic perspective.
There may be an opportunity for the UK to engage with issues of bioethics governance with renewed vigour and to demonstrate its continued leadership outside the EU. As well as participation in global bioethics standard setting fora, relationships with particular markets and trading partners, which are increasingly based on regions such as those in Asia, are a factor in the shaping of bioethics in the UK’s regulatory regime.
However, the scope for continued collaboration with EU member states is jeopardised by the European Union (Withdrawal Agreement) Act 2020, which permits UK ministers to decide to diverge UK law from EU law without the need for parliamentary scrutiny to remedy ‘deficiencies’. This regulatory freedom for product standards is the case for medicines (a category which includes vaccines), medical devices and equipment, as much as for other products.
Regulatory divergence is already taking place within the UK, in Northern Ireland. The Northern Ireland Protocol means that rules for medical devices, for example, are those applicable in the EU’s single market and, thus, different from those elsewhere in the UK. The UK rules for some medical devices for Covid-19 testing have been revised using powers under the Medicines and Medical Devices Act 2021. This provides for UK ministers to change almost all aspects of regulation in this area through secondary legislation. In respect of Covid-19 testing, the legislation has been used to provide an extra requirement on top of CE marking (gradually being replaced by UKCA marking), and thus a higher standard than under EU law.
It remains unclear to what extent the UK will align with EU standards or even help to shape them outside the law-making institutions, for instance, through lobbying or participation in research projects funded under EU programmes. The UK may decide to diverge from EU standards where, for example, it provides a competitive advantage over other countries. UK divergence does not necessarily mean to lower standards – as in the case of Covid-19 testing, this divergence may be to higher standards in the UK. On the face of it, such products may not face a barrier to markets with (currently) lower standards such as the EU’s single market (since lower standards should already have been met). Divergence may be more of a problem where it leads to lower standards in the UK, thus creating barriers to markets with higher standards. Of course, if the UK continues to abide by global bioethics standards, such as those produced by the ICH, which applies to medicines (including vaccines) and is commonly followed in respect of medical devices, only limited divergence would be possible.
What challenges and opportunities do you foresee in the next 5 years?
Ensuring UK standards facilitate innovation while maintaining access to participation in research studies based in the UK and EU, and market access for any products developed through them, will prove a challenge. Obtaining crucial EU recognition of UK standards (and vice versa) while trying to innovate to gain market share in other regions will require further delicate balancing.
Human germline editing is one example. The UK, like other countries, has already permitted modification of cells in humans that are not heritable, and modifications in gametes (sperm and eggs) and embryos for research purposes only. However, the UK may decide to permit modification of the human germline to prevent children being born with heritable diseases and disabilities once the authorities are satisfied safeguard conditions are met (see the Nuffield Council’s work on genome editing in human reproduction).
Some UK-based researchers may welcome such a change, seeing this as an opportunity, particularly in respect of clinical studies that can take place in the UK alone. At the same time, much research in basic science and technological development tends to involve international collaboration. As such, there are strong incentives to support continued alignment with EU standards. These include those relating to clinical trials, which provide that no clinical trials may be carried out which result in modifications to the subject’s germline genetic identity (ie which are heritable), and there is to be no EU funding of such research activity. Alignment would help to keep funding opportunities open to UK-based researchers and facilitate research studies involving sites in the UK and EU member states.
There are several ethical fora within the EU in which the UK can continue to be involved. The degree of involvement is unclear and evolving and depends as much on UK as EU willingness.
For example, the European Commission hosts a European National Ethics Committee Forum, of which the Nuffield Council on Bioethics has been an active and influential member. Council reports clearly feed into the thinking of national ethics committees who are advising their own policy makers. The European Commission also hosts the International Dialogue on Bioethics. Undoubtedly the UK will continue to be a valued representative at these meetings.
As a result of the manner in which bioethics has evolved in the UK, it is not always clear who the appropriate interlocutor is for inter-governmental bodies to engage with. The Nuffield Council on Bioethics is exceptionally well regarded in the field and has a global reputation, especially in relation to its horizon scanning ability. There are statutory regulators in the UK which have competence in bioethics such as the Human Fertilisation and Embryology Authority, Human Tissue Authority and Health Research Authority. There is also bioethics expertise within the Department of Health and Social Care. The issue of appropriate bioethics representation in international fora is an issue which predates Brexit, but which may come into sharper focus as time goes on and longstanding personal relationships established by UK experts with EU colleagues and beyond become more distal.
The UK may have left the EU institutions, but it is still part of Europe and must continue to play an active and leading role in deliberating upon our collective challenges in the bioethical sphere.
In conclusion, despite Brexit, there are some key global fora in which the UK will continue to participate whereas for others, such as the ICH, there are the means for the UK to re-establish itself as a full member to avoid losing influence. On the other hand, we wait to see how the need to comply with the EU’s ethical framework to facilitate the UK’s ongoing participation in international research involving EU member states will be balanced by the opportunities for innovation the UK may wish to exercise by setting its own UK ethical standards. At the Nuffield Council on Bioethics, most of our activities have an international dimension to ensure we are well placed to recognise and engage with new developments looking to the future.
EU legislation may not be able to prohibit germline procedures for the same reasons as it may not be able to prohibit MST and PNT. See: MacKellar, C. (2018). Can Maternal Spindle Transfer and Pronuclear Transfer Be Prohibited under eu Legislation?, European Journal of Health Law, 25(1), 57-74. doi: https://doi.org/10.1163/15718093-12460338