Nuffield Council on Bioethics welcomes Select Committee report on direct-to-consumer genomic testing

When we pitched this inquiry to the Committee in 2019, our hope was for the Committee to use its convening and investigative powers to take a hard look at the direct-to-consumer genetic testing industry. Today’s report shows the Committee has risen to that challenge by carrying out an in-depth examination of all the issues we raised in our submission and oral evidence to the inquiry, and more.

By taking on board a wide range of views and expertise, the Committee makes a number of important recommendations that, if adopted, will help ensure commercial genomic testing is available ethically and with appropriate safeguards in place.

Danielle Hamm, Director of the Nuffield Council on Bioethics said:

“Today’s timely report draws attention to a world of genomic testing that currently is not being subjected to the same kinds of checks and balances as genomic medicine in the NHS.

“As the direct-to-consumer genetic testing industry continues to expand, we strongly support the recommendations in this report and urge the Government to take positive action in its response.”

Recommendations

We agree with the Committee that the Government’s commitment to establish a “gold standard UK model for how to apply strong and consistent ethical and regulatory standards” in genomic medicine should apply to the private sector as well as to the NHS.

With that in mind, some of the Committee’s important recommendations include:

“The Government should set out a specific timeframe in which it intends to review the case for introducing new regulations for genomic tests provided directly to consumers.”

“The Government should require manufacturers of direct-to-consumer genomic tests to have the performance of their tests assessed by an external body prior to placing their products on the UK market.”

“..’the Advertising Standards Authority should review, within the next year, the marketing materials used by companies offering other genomic tests directly to consumers, focusing in particular on the clinical performance implied by the tests compared with their actual performance.”

“The Government should work with Genomics England and the NHS to define clear technical standards for direct-to-consumer genomic testing that, if met, would enable the genomic data generated by the test to be used and trusted by Genomics England and the NHS.”

Genomic testing in children

Several UK and European bodies, including the Nuffield Council Bioethics, have raised concerns over the past decade about the potential for direct-to-consumer tests to be carried out as a screening test in apparently healthy children.

The Committee recognises those concerns and recommends:

“The Government should consider which, if any, genomic tests for asymptomatic children should be able to be provided directly to consumers, including whether there should be a ban on the provision of genomic tests for use on children that do not meet the criteria of the UK National Screening Committee.”

This recommendation is timely given the Government’s recent commitment to carry out a large-scale research programme to determine whether and how whole genome sequencing should be used in NHS newborn screening, as well as supporting industrial growth for genomics companies in the UK.

Prenatal genomic testing

In 2017, we carried out an inquiry on non-invasive prenatal testing (NIPT) which made recommendations aimed at improving practice in the private sector. We highlighted concerns about the misleading use of statistics, poor provision of information about the tested-for conditions, and a lack of follow-up support for women and couples.

Therefore, we welcome the Committee’s recommendations that the Government should consider:

“specific requirements for prenatal genomic testing to ensure that the information provided is balanced and non-directive, with accurate information on what might be expected from life for a child or adult with the condition being tested for.”

“the case for including reviews of the information provided to consumers prior to and after taking a direct-to-consumer test within any external validation required to place such tests on the market.”

“the case for amending the regulation of genomic tests provided directly to consumers, to require medical supervision or the provision of genetic counselling for at least some types of genomic testing offered directly to consumers.”

Private providers of NIPT can look for guidance to preparations for the evaluative roll-out of NIPT for Down’s syndrome, Patau’s syndrome and Edward’s syndrome in the NHS screening pathway.

Restrictions

The Committee recommends that the Government should consider if any restrictions should be placed on the conditions that prenatal genomic tests provided directly to consumers are able to test for.

This question embodies the tensions that exist between enabling women and couples to make reproductive choices, responsibilities to reduce harm, and the need to consider the wider societal consequences of prenatal testing.

In an attempt to resolve those tensions, in 2017 we recommended that women and couples should be able to access NIPT to enable them to find out, if they wish, whether their fetus has a significant medical condition or impairment that manifests in childhood. Importantly, such tests, we suggested, should only be available if they provide an accurate prediction of whether the fetus has or does not have the condition and if high quality information and support is provided to women and couples.

Wider societal consequences

We also recommended in 2017 that NIPT should only be available when steps are taken to minimise the potential harms of offering NIPT. This, we suggested, includes the Government meeting its duties to provide disabled people with high quality specialist health and social care and to tackle discrimination, exclusion and negative societal attitudes experienced by disabled people.

Although there have been some positive developments, with regular reports of failures in the care of people with learning disabilities, there is an urgent need for further action.