Recommendations & Conclusions
17 items
1
Recommendation
First Report - Direct-to-consumer genom…
A range of benefits and concerns have been raised regarding the availability of genomic testing for direct purchase and use by consumers. These apply to all types of genomic tests, but are arguably most acute for tests used for medically-related purposes. Despite concerns around direct-to-consumer tests existing for many years, …
Government response. The Government recognises both the opportunities and risks raised by direct-to-consumer genomic tests and is committed to ensuring effective and proportionate regulation. The MHRA is working to develop a robust, world-leading regulatory regime for medical devices that prioritises patient safety. …
Department for Science, Innovation and Technology
2
Recommendation
First Report - Direct-to-consumer genom…
Strong support for genomic testing from the current and previous Governments has helped to make the UK a world-leader in the sector. Although this support has focused on testing in the NHS, it has nonetheless supported the direct-to-consumer genomic testing industry. The Government should continue its support for genomic testing …
Government response. The Government welcomes the Committee’s recognition that the UK is world-leading in genomic testing. The Government will continue to support the UK’s genomic testing industry and recognises that it plays an important role in the UK’s thriving life sciences sector, …
Department for Science, Innovation and Technology
3
Recommendation
First Report - Direct-to-consumer genom…
Most manufacturers of genomic tests sold directly to consumers can self-certify the conformity of their products to performance requirements. The Medicines and Healthcare products Regulatory Agency has suggested that this restricts its ability to ensure that genomic tests on the UK market provide reliable results. The Government should require manufacturers …
Government response. The outcome of MHRA’s public consultation will help to inform future policy on how DTC genomic tests are regulated and in turn, how they are assessed prior to being placed on the UK market.
Department for Science, Innovation and Technology
4
Recommendation
First Report - Direct-to-consumer genom…
The results obtained from genomic tests provided directly to consumers cannot be integrated into Genomics England or NHS records since they do not always meet the standards required of the end-to-end testing and data handling process. Enabling tests that are provided directly to consumers to demonstrate that they meet the …
Government response. The Government acknowledges the critical importance of genomic test results meeting appropriate standards and requirements should they have the potential for use in the NHS. We acknowledge that there are a series of practical challenges relating to data standards and …
Department for Science, Innovation and Technology
5
Recommendation
First Report - Direct-to-consumer genom…
The performance requirements on direct-to-consumer genomic tests under the current regulations focus on a genomic test’s analytical performance, not its clinical performance. For a medically-relevant test, however, clinical performance is fundamental to how the test will be used by a consumer. The Government should extend the scope of the performance …
Government response. Performance requirements for IVDs, including DTC genomic tests, are explored as part of MHRA’s public consultation and will help to inform future policy related to this recommendation. The National Institute for Health Care Excellence (NICE) are also exploring the development …
Department for Science, Innovation and Technology
6
Recommendation
First Report - Direct-to-consumer genom…
As the evidence base for genomic testing develops rapidly, some have expressed criticism of the evidence used by some direct-to-consumer genomic testing companies to justify their tests, or warned of the risk of companies ‘cherry picking’ the most favourable evidence available. Requiring external validation of direct-to- consumer genomic tests, covering …
Government response. MHRA’s public consultation explores the pre-market requirements for devices placed on the UK market.
Department for Science, Innovation and Technology
7
Recommendation
First Report - Direct-to-consumer genom…
Results obtained from genomic testing must typically be considered in the context of an individual’s specific circumstance—including their symptoms, personal and family medical history and ethnicity—in order for the clinical significance of those results to be interpreted correctly. These personal details are also often pertinent to the selection of the …
Government response. MHRA’s public consultation explores requirements around the information provided to users of DTC genomic tests and the outcome of this will help to inform future policy on how the tests are regulated.
Department for Science, Innovation and Technology
8
Recommendation
First Report - Direct-to-consumer genom…
Several contributors to this inquiry expressed concern that the information provided to consumers before and after using a direct-to-consumer genomic test, as well as the advertising used to market direct-to-consumer genomic tests, did not do enough to address public misconceptions of the capability of these tests and clarify the clinical …
Government response. Several areas being explored as part of MHRA’s public consultation, including the potential to introduce new classification rules for IVDs, will help to inform future policy on this recommendation.
Department for Science, Innovation and Technology
9
Recommendation
First Report - Direct-to-consumer genom…
Building on its review of advertising for non-invasive prenatal testing, 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.
Government response. The Government has sought information from the Advertising Standards Authority (ASA), the UK’s independent advertising regulator who ensure that advertising is legal, decent, and truthful. The ASA respond to concerns and complaints raised by the public, assessing them against relevant …
Department for Science, Innovation and Technology
10
Conclusion
First Report - Direct-to-consumer genom…
The potential for results from non-invasive prenatal testing to influence decisions made on terminating pregnancies raises specific issues not encountered by most other genomic tests offered to consumers. Several submissions highlighted the importance of the information and other support provided to those receiving results from such tests to not only …
Government response. This issue is addressed in MHRA’s consultation, as the information provided alongside such tests is a crucial part of their regulation. There may be a role for the UK National Screening Committee (UKNSC) in providing advice on regulation of prenatal …
Department for Science, Innovation and Technology
11
Recommendation
First Report - Direct-to-consumer genom…
Many submissions to this inquiry expressed concern that direct-to-consumer genomic testing could increase pressure on the NHS due to consumers consulting their GP following a test result. Although there is not yet strong evidence of this happening, some companies providing tests directly to consumers recommend that their customers consult genetic …
Government response. The Government agrees that it is important to gather more information on the impact of DTC genomic testing in the NHS. An NHS Genomics Workforce Survey, aimed at doctors initially, was launched on the 23 August 2021 across the NHS …
Department for Science, Innovation and Technology
12
Recommendation
First Report - Direct-to-consumer genom…
Concern was raised with us that companies providing genomic tests directly to consumers could profit from supplying the tests while leaving the NHS to deal with consumers and their results following the test. Addressing this issue, representatives of several major direct-to-consumer testing companies indicated to our predecessor Committee their willingness …
Government response. Genomic counsellors play a key role in the genomic pathway and are an important but limited resource whose roles are first and foremost focused on activity commissioned by the NHS, covering referrals from NHS clinicians. As noted above, patients presenting …
Department for Science, Innovation and Technology
13
Recommendation
First Report - Direct-to-consumer genom…
Various concerns related to privacy and consent regarding data generated by direct- to-consumer genomic tests were raised during this inquiry. Many of these were similar to concerns that have been expressed regarding personal data more generally, although the relevance of an individual’s genomic data to that individual’s relatives was raised …
Government response. The Government agrees that it is important to have a strong data protection framework governing genomic data in the UK. The Information Commissioner’s Office (ICO) is the regulator for the UK’s data protection law and it must be adhered to …
Department for Science, Innovation and Technology
14
Recommendation
First Report - Direct-to-consumer genom…
Although there is potential for the results of a genomic test to be upsetting, this is not a sufficient reason to prevent consenting adults from using these tests. However, a range of submissions to our inquiry and our predecessor Committee’s inquiry highlighted a potential need for restrictions on direct-to-consumer genomic …
Government response. Under the UK Medical Device Regulations 2002, the MHRA could only take action against the use of certain genomic tests if a compliance or safety issue associated with the device had arisen. The MHRA proactively investigate and review adverse incident …
Department for Science, Innovation and Technology
15
Recommendation
First Report - Direct-to-consumer genom…
Prenatal genomic testing could influence decisions on terminating fetuses, leading to specific concerns in addition to the issues concerning other types of direct-to- consumer genomic testing. The Government should consider if any restrictions should be placed on the conditions that prenatal genomic tests provided directly to consumers are able to …
Government response. Under the UK Medical Device Regulations 2002, the MHRA could only take action against the use of certain genomic tests if a compliance or safety issue associated with the device had arisen. The MHRA proactively investigate and review adverse incident …
Department for Science, Innovation and Technology
16
Recommendation
First Report - Direct-to-consumer genom…
The Government should consider requiring any manufacturer making genomic tests available to consumers in the UK to register a legal representative in the UK, with responsibility for ensuring that products supplied to consumers in the UK meet all relevant UK regulatory requirements.
Government response. MHRA’s public consultation explores the registration of medical devices in the UK and the outcome of this will help to inform future policy on this recommendation.
Department for Science, Innovation and Technology
17
Recommendation
First Report - Direct-to-consumer genom…
As well as companies offering products to consumers that combine genomic testing with analysis of the genomic data obtained through the test, some companies offer secondary analysis of genomic data obtained through a previous genomic test from a different company. There is a potentially increased risk that the testing process …
Government response. MHRA’s public consultation explores the scope of medical device regulations in the UK and the outcome of this will help to inform future policy on this recommendation.
Department for Science, Innovation and Technology