Recommendations for governance and further actions

Public debate

Genome editing has received considerable interest from the scientific media and, to a lesser extent, from the mainstream and news media. There have also been a number of initiatives in recent years to promote public engagement and dialogue on genome editing, either with members of the general public, or with more specific stakeholder groups such as patient organisations. These initiatives have helped to inform debate, and to develop an understanding of public attitudes and reasoning.

It is desirable that work is carried out now to promote and support broad and inclusive societal debate, so that the public interest in heritable genome editing interventions can take shape to inform the development of governance.

Recommendations on supporting public debate

We recommend that broad and inclusive societal debate on heritable genome editing should be encouraged and supported without delay.

In the UK

  • An independent body or commission should be established to promote and coordinate societal debate on genome editing and related areas of scientific and technological development. It should monitor the impact of technological innovation on society and contribute to developing national and international norms for governance.

Internationally

  • Support should be provided for continued international monitoring and dialogue on genome editing, through:
  • a global observatory or international association; and
  • the work of international human rights institutions, such as UNESCO and the Council of Europe.

UK law and regulation  

In the UK, the law does not currently allow the use of genome editing techniques in human embryos or gametes (sperm or egg cells) for use in reproduction. This is prohibited under the Human Fertilisation and Embryology Act 1990, which defines the legal requirements for the use of gametes and embryos outside of the body, for research and in clinics.

The use of embryos and gametes in research and in clinics is licensed and regulated in the UK by the Human Fertilisation and Embryology Authority (HFEA).

Amending the law

There could be a long and complex legislative pathway to follow before any changes could be introduced that would permit heritable genome editing interventions. In the meantime, the law may need to be further amended to address specific potential applications that might not fall within the scope of the current regulatory regime.

Recommendations for UK law and regulation

Guided by our ethical principles of individual welfare and social justice, we make the following recommendations regarding UK law and regulation.

For future consideration of amending the law to permit heritable genome editing interventions: 

We recommend that before any move is made to amend UK legislation to permit heritable genome editing:

  • there should be sufficient opportunity for broad and inclusive societal debate;
  • the likely impacts on people who may be vulnerable to potentially adverse social effects – such as stigmatisation and discrimination – should have been assessed, and any necessary mitigating policies have been developed in consultation with such people; and
  • monitoring and review mechanisms should have been put in place.

In the future, if genome editing were ever to be permitted by law:

We recommend that genome editing should only ever take place under strict regulation and oversight by the HFEA, and that :

  • the risks of adverse clinical outcomes for the individuals involved have been thoroughly assessed;
  • it should be introduced only in the context of clinical studies, including long-term monitoring of the effects on individuals; and
  • it should be licensed on a case-by-case basis.

International law and regulation

There is no specific international treaty that explicitly governs genome editing in humans. However, there are relevant treaties in international law, particularly human rights law:

Universal Declaration on the Human Genome and Human Rights (1997)

This UNESCO Declaration suggests that ‘germ line’ interventions could be contrary to human dignity. In 2015, UNESCO called on states and governments (among other things):

  • To agree a moratorium on germ line editing at least as long as the safety and efficacy of the procedures are not adequately proven as treatments; and
  • To renounce the possibility of acting alone in relation to engineering the human genome and to cooperate on establishing a shared, global standard for this purpose.

Oviedo Convention (1997)

The ‘Oviedo Convention’ is the Council of Europe’s Convention on Human Rights and Biomedicine. It is signed and ratified by 29 of the 47 Member States of the Council of Europe (although not the UK). Under Article 13 of the Convention:

  • Any genome modification (in research or in treatment) may only be undertaken for preventive, diagnostic, or therapeutic purposes.
  • The aim of any genome modification must not be to introduce changes that can be passed on to future generations.

The EU Charter of Fundamental Rights (CFREU) (2000)

The UK did not sign the Oviedo Convention, but as a member of the European Union (at least at present), it is bound by the CFREU, which has provisions closely based on the Oviedo Convention. The Charter does not contain an outright prohibition of genome editing, but on the right to integrity of the person, it prohibits “eugenic practices, in particular those aiming at the selection of persons”.

Other rights and freedoms in international law

As well as the treaties described, a number of other rights and provisions of international law are relevant to the prospect of heritable genome editing interventions. These include:

  • the right to life;
  • the right to physical integrity;
  • the right to health;
  • the right to non-discrimination;
  • the right to the benefits of the scientific progress; and
  • respect for human dignity.

An important recent development in international law is the emergence of a principle of ‘intergenerational equity’, which calls on states to take into account the rights of future generations when undertaking activities that may affect them.

Recommendations for international law and regulation

We recommend that governments in the UK and elsewhere should:

  • work with international institutions such as the Council of Europe, and UNESCO to promote international dialogue and governance with regard to genome editing research and innovation;
  • give consideration to the use of intellectual property rights to promote the public interest in having safe, effective and ethical heritable genome editing interventions; and
  • give consideration to how to how the risks of discrimination on grounds of genetic variation may be best addressed.

Previous work

Contact us

Nuffield Council on Bioethics
28 Bedford Square
London
WC1B 3JS

bioethics@nuffieldbioethics.org

+44 (0)20 7681 9619

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