Fostering public engagement in the ethical and social implications of genetic technologies

Science and Technology Select Committee publish report on Genomics and Gene-editing

Science and Technology Select Committee has published its report on Genomics and Gene-editing.  

The inquiry on genomics and gene-editing was still underway when a general election was called. Therefore, the report identifies issues that warrant further inquiry should the next Science and Technology Select Committee decide to continue looking in to genomics and gene editing. EthicsAndGenetics submitted written evidence to the inquiry, and also gave evidence at the second session, which was on genomics. It's very encouraging that its report has taken note of several of the concerns we raised. 

Our written evidence can be found here.

Parliamentlive.tv recording of the second session, on genomics, can be found here.

Here is the report in full: 

 

Genomics and genome editing: future lines of inquiry

We launched our inquiry into Genomics and genome editing in November 2016, calling for evidence on the impact of these emerging scientific fields on human health, plants, animals and ecosystems. In February 2017 we announced that the inquiry would be split into two parts, with the first looking at genomics and genome editing as it relates to human health, and the second examining the impact of the technologies on plants, animals and ecosystems. So far we have received 60 written submissions and held three evidence sessions on the first of these two inquiries, and have taken evidence from 19 witnesses. We also appointed Professor Sir John Burn as a specialist adviser and we are grateful for his advice on the issues associated with both genomics and genome editing.

We had planned to hold two further sessions on genomics and genome editing as it relates to human health, but due to the forthcoming General Election in June 2017, we have been unable to conclude this strand of our inquiry. We have also not yet begun taking evidence on plants, animals and ecosystems. We have produced this short report to serve as a stock-take for the next Science and Technology Committee. Should it wish to pursue the matter further, the new Committee will be able to draw on the evidence we have gathered so far—both written and oral—and our interpretation of the pertinent issues for examination.

Genomics 

Genomics England

We began by looking at the formation of Genomics England and its role in delivering the 100,000 Genomes Project. Issues for further consideration include:

  • The rationale for Genomics England’s status as a limited company rather than a more typical arm’s length body.
  • Whether lessons from the Human Genome Project and other similar initiatives have been learned (particularly in relation to stimulating commercial activity).
  • Genomics England’s funding history, projected funding requirements, and how its ongoing performance is being evaluated.
  • Why the 100,000 Genomes Project is behind schedule. Potential reasons include delays in setting up the Project’s physical and digital infrastructure, scientific barriers, low patient recruitment and issues around consent.
  • How the devolved administrations have been involved in the 100,000 Genomes Project and further opportunities for UK-wide expansion.
  • How decisions were reached about the types of cancer and rare diseases that are included in the Project, why the infectious disease arm of the Project was transferred to Public Health England, and the progress in this area since its transfer. 

Implications for healthcare 

We also investigated the NHS’s involvement in the 100,000 Genomes Project, in particular how it is coping with the demands of the initiative, and how its mainstream health service will be integrated with the Project’s infrastructure when it concludes. Issues for further exploration, we believe, include:  

  • Whether the Department of Health and the NHS were prepared for the demands of the Project when it was announced, and what the main drivers were for initiating the Project.
  • Whether the development of the NHS’s genomic medicine capacity will reduce or increase NHS costs, and how that might change in the short, medium and long term.
  • How the NHS and Genomics England have reacted to the initiative’s physical infrastructure requirements, including the creation of 13 Genomic Medicine Centres (GMCs). This includes how services and personnel delivered via the GMCs will be integrated into the NHS at the end of the 100,000 Genomes Project, and the feasibility of maintaining this infrastructure when funding for the central project ceases.
  • How the NHS and Genomics England have responded to the Project’s digital infrastructure requirements, particularly in relation to the creation of a centralised, aggregated and integrated genomic database.
  • Whether the NHS is prepared for the mainstreaming of genomic medicine. This relates particularly to staff training requirements and emerging skills gaps (such as genetic counsellors and informatics specialists), and the level of genomic knowledge held by non-specialist clinicians and frontline health workers.

A further set of issues centres on the 100,000 Genomes Project’s intention to deliver tangible health benefits to patients. Issues for possible further consideration include: 

  • Whether patients could receive faster diagnoses through mainstream NHS genomic services (due to the comparatively longer consent process and sequencing times in the 100,000 Genomes Project), and whether patients are being invited into the 100,000 Genomes Project due to perceived long-term research and commercial benefits, at the expense of more immediate benefits to their health.
  • How NICE and NHS commissioning structures are affecting the availability of suitable genomic diagnostics, and whether the health service is capable of treating patients once diagnosed—particularly those with rare diseases.

Social and ethical concerns

We also discussed the ethical, consent and data-sharing issues associated with the 100,000 Genomes Project and genomics more generally. We believe that issues for further consideration include:

  • How ethical and social concerns relating to genomics are handled by the Government and UK health bodies, and whether a new body—akin to the Human Genetics Commission (which existed until 2012)—is required.
  • The suitability of the ‘broad consent’ model being employed by the 100,000 Genomes Project, and whether the consent materials and patient recruitment techniques fully inform participants of the potential commercial uses of their data. This is tied to the debate around the nature of genetic data and whether it deserves a privileged status over other forms of personal health data.
  • Whether the Project’s consent model will be adopted by the NHS, and whether this would mean that patients must consent to the commercial use of their data in order to receive genomic diagnoses.
  • Whether the security systems and protocols employed by Genomics England, NHS England, and NHS trusts are sufficient for the volume and nature of the data created by the 100,000 Genomes Project.
  • The situations in which genetic screening is acceptable pre-birth, post-birth, and pre-conception. Furthermore, how to approach the eradication of diseases while considering the views of, and implications for, communities of individuals who already suffer from the diseases in question.
  • The secondary actions that should be taken by the NHS when genetic conditions are diagnosed. For example, whether the relatives of those with genetic diseases have a right to be informed.

Genome editing

Social and ethical concerns

Genome editing processes, technologies and outcomes raise a variety of social and ethical considerations. Issues for further consideration, we believe, include: 

  • Whether there are limits to the conditions that genome editing should be used to treat.
  • Whether human embryo research beyond 14 days (the current legal limit) is beneficial to the study of genetic defects, diseases or conditions in either the mother or child, and whether advancing the field of genome editing increases the number of human embryos required for research.
  • The risk of ‘off-target events’ (where changes are made to genes other than those targeted) and the timeframe in which the UK will have confidence in the safety of genome editing techniques, particularly if they are to be used widely in the NHS.
  • Whether the need for research subjects with genetic similarity to humans has implications for the scale of animal testing and, in particular, whether there is an increased need for testing on primates.
  • The extent to which the therapeutic use of genome editing could lead to future non-therapeutic use, noting public concern about ‘eugenics’, ‘designer babies’, and the potential military applications of genome editing.
  • How to stimulate an open and informed debate about genome editing between scientists, policy makers, patients and the public. 

Regulatory concerns

When looking at the regulatory frameworks surrounding genome editing, we found the following issues to be most in need of investigation:

  • Whether the UK’s approach to the regulation of genome editing should be ‘product’ driven (focused on the results of a particular genetic technique) or ‘process’ driven (focused on the technique itself).
  • How to distinguish between regulation for basic research, germline (causing inheritable genetic changes) and somatic (causing non-inheritable genetic changes) editing, and whether the UK’s current regulation accurately reflects these distinctions.
  • How the UK compares to international competitors in terms of its research environment for genome editing, and the degree to which the UK should align its regulatory standards with international bodies and conventions.
  • The regulatory impact of the UK’s decision to leave the EU, and how the UK can continue to collaborate with European institutions after Brexit given the potential for their respective regulatory environments to diverge. In connection with this, the potential opportunities for regulatory refinement post-Brexit.
  • The increased propensity for ‘health tourism’ that could result from a more liberal regulatory regime, and whether (and how) this should be countered.
  • The extent to which the licensing processes for conducting research are fit for purpose, particularly in relation to working with human embryos.

Implications for the NHS

We also looked at the challenges of embedding genome editing techniques into the NHS, which include:

  • Whether genome editing treatments are more effective (both in health and cost terms) than alternative methods currently available on the NHS. If they are not, how to determine the point at which they may become so in the future.
  • How best to embed somatic (non-inheritable) genome editing into the UK’s healthcare system, and how to bridge the gap between basic research and clinical delivery.
  • How the UK health agencies can best coordinate to deliver the necessary medical infrastructure to deliver widespread genome editing services in the UK. In addition to this, how to ensure there is a stream of skilled clinicians who are capable of doing so.
  • Whether ‘gene drive’ techniques are an effective, safe and ethical way of tackling infectious diseases in the UK and overseas.

Commercialisation and the Industrial Strategy

In the sessions we have been able to hold, we also looked at the commercial opportunities for genomics and genome editing in the UK. Areas that warrant further investigation include: 

  • How genomics and genome editing will fit into the ‘life sciences’ arm of the current Government’s Industrial Strategy.
  • How Genomics England is drawing experience, technology and funding from the private sector.
  • How the Government can encourage UK genomics and genome editing specialists to start-up, roll-out and grow technology and health businesses in the UK, and why UK companies in this sector find it difficult—or choose not—to scale up.
  • Whether patenting and intellectual property issues are limiting the development of commercial genome editing companies, and whether they are hampering scientific discovery more broadly.

Conclusion

Our inquiry has been timely because advances in genomics and genome editing mean that both fields are now being used in our health service, because the 100,000 Genomes Project is approaching its original completion date, and because Brexit will significantly alter the opportunities and challenges in these emerging areas. We believe that the subjects warrant further scrutiny given the opportunities and challenges they both present. We hope that the next Science and Technology Committee will consider taking our incomplete inquiry forward when it considers its work programme after the election.

 

Last modified onMonday, 01 May 2017 17:22
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Edward Hockings, the founder of EthicsandGenetics, is a bioethicist who has campaigned against violations of civil liberties, and published work in this area on the BBC News, the Guardian, the Independent, and the Daily Mail.

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