Recommendations & Conclusions
12 items
3
Recommendation
First Report - Direct-to-consumer genom…
Deferred
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 …
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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 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.
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Government response AI summary
The government states that the outcome of MHRA's public consultation will inform future policy on regulating and assessing direct-to-consumer genomic tests, deferring a decision on requiring external assessment.
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Department for Science, Innovation and Technology
5
Recommendation
First Report - Direct-to-consumer genom…
Deferred
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 …
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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 requirements on direct-to-consumer genomic tests to explicitly cover clinical performance as well as analytical performance.
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Government response AI summary
The government defers action, stating that performance requirements for such tests are part of an ongoing MHRA public consultation, the outcome of which will inform future policy. It will keep the recommendation under review following this consultation and facilitate discussions between relevant bodies.
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Department for Science, Innovation and Technology
6
Recommendation
First Report - Direct-to-consumer genom…
Deferred
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 …
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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 clinical as well as analytical performance, could help to address this. In addition to pre-market validation of direct-to-consumer tests, the Government should consider requiring companies offering such tests to regularly update the evidence submitted to the external validation body, and for that body to review this, for example on an annual basis.
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Government response AI summary
The government states that MHRA's public consultation is exploring pre-market requirements for devices, implying that this process will inform future policy on this matter.
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Department for Science, Innovation and Technology
7
Recommendation
First Report - Direct-to-consumer genom…
Deferred
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 …
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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 most appropriate genomic test for an individual. The NHS takes account of these contextual factors through the expert supervision and counselling provided throughout the testing process. In contrast, companies providing genomic testing directly to consumers appear to provide generic tests and depend upon consumers understanding written information provided alongside the test that has not been tailored to their personal situation. The Government should consider 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. Criteria used to determine which tests should require medical supervision could include the severity of the conditions being tested for, as well as the predictive power of the test. Requirements for supervision and genetic counselling should cover the qualifications of the medical intermediary required and minimum requirements on the content and format of the support or oversight provided.
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Government response AI summary
The government states that MHRA's public consultation is exploring requirements for information provided to users of DTC genomic tests, and the outcome will inform future policy on test regulation.
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Department for Science, Innovation and Technology
8
Recommendation
First Report - Direct-to-consumer genom…
Deferred
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 …
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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 utility of the results generated. Even where advertising material has used statistics accurately, the Advertising Standards Authority has ruled that there is still scope for them to provide a misleading impression to consumers. The Government should consider the case for including reviews of the information provided to consumers 52 Direct-to-consumer genomic testing prior to and after taking a direct-to-consumer test within any external validation required to place such tests on the market. This could, for example, include assessment of studies of consumer understanding of the information provided.
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Government response AI summary
The government states that several areas being explored as part of MHRA’s public consultation, including new classification rules for IVDs, will help inform future policy on this recommendation, deferring a direct commitment.
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Department for Science, Innovation and Technology
10
Recommendation
First Report - Direct-to-consumer genom…
Deferred
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 …
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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 ensure comprehension of the result but also to provide balanced, non-directive information about the different options following the test result. Since our predecessor Committee launched its inquiry into direct- to-consumer genomics, there have been several significant developments related to the information and support provided with non-invasive prenatal testing. We hope these will address some of the concerns raised during our inquiry and our predecessor Committee’s inquiry. As the Government considers the requirements that should be introduced on the information provided to consumers using direct-to- consumers genomic tests, it 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.
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Government response AI summary
The government defers immediate action, stating the issue is addressed in MHRA’s ongoing consultation and highlighting CQC’s existing inspection of NIPT services. It commits to working with the UKNSC and MHRA to establish what actions are required and with the CQC to understand if best …
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Department for Science, Innovation and Technology
12
Recommendation
First Report - Direct-to-consumer genom…
Deferred
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 …
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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 to contribute to ongoing efforts to train genetic counsellors within the NHS. The Government should continue to explore, with Direct-to-consumer genomic testing 53 NHS England and NHS Health Education England, the opportunity for companies selling genomic tests directly to consumers to contribute to the costs of training genetic counsellors in the NHS.
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Government response AI summary
The government states the NHS does not currently wish to seek contributions from DTC companies for genetic counsellor training, arguing DTC tests are unlikely to directly increase demand for NHS services. However, it commits for the Health Education England Genomics Education Programme to explore the …
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Department for Science, Innovation and Technology
13
Recommendation
First Report - Direct-to-consumer genom…
Deferred
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 …
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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 as a particular feature of genomic data. Despite data protection legislation and voluntary agreements such as the Code on Genetic Testing and Insurance, the complexity and uncertainty of future uses of genomic data may challenge current procedures for obtaining informed consent. Further, consumers may not benefit from this data protection if they transfer their data or genetic samples out of the UK for processing. As technologies develop and more consumers use direct-to- consumer genomic tests, existing data safeguards may become less effective and the consequences for privacy more significant. The Government should aim for the data protection framework governing genomic data in the UK to be world-leading. It should review the adequacy of the UK’s data protection framework for direct-to-consumer genomic testing, including the risks and opportunities presented by technological developments and growing numbers of consumers using direct-to-consumer genomic tests. The Government should aim for the data protection framework governing genomic data in the UK to be world-leading. It should review the adequacy of the UK’s data protection framework for direct-to-consumer genomic testing, including the risks and opportunities presented by technological developments and growing numbers of consumers using direct-to-consumer genomic tests. The Government should also consider the case for requiring companies providing direct-to-consumer genomic tests to inform consumers, at the point of sale, of the potential consequences of genomic test results for their relatives.
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Government response AI summary
The government agrees a strong data protection framework is important and asserts existing UK data protection law, regulated by the ICO, is robust and technology-neutral. It states the law already requires clear data processing purposes and restricts data transfer outside the UK. It will keep …
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Department for Science, Innovation and Technology
14
Recommendation
First Report - Direct-to-consumer genom…
Deferred
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 …
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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 testing of children. Professional bodies in the UK and internationally have recommended that genomic tests are not provided directly to consumers for the testing of asymptomatic children for adult-onset conditions for which no intervention can be made during childhood. 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.
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Government response AI summary
The government explains the MHRA's current regulatory powers are limited to compliance or safety issues, not the broader scope of the recommendation. It commits to encouraging and facilitating future discussions between the UK National Screening Committee and MHRA to advise on policy relating to this …
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Department for Science, Innovation and Technology
15
Recommendation
First Report - Direct-to-consumer genom…
Deferred
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 …
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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 test for. (Paragraph 99) 54 Direct-to-consumer genomic testing
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Government response AI summary
The government states that current MHRA regulations limit action to compliance or safety issues. It will encourage and facilitate future discussions between MHRA and UKNSC regarding policy but does not commit to the government actively considering restrictions itself.
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Department for Science, Innovation and Technology
16
Recommendation
First Report - Direct-to-consumer genom…
Deferred
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.
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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.
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Government response AI summary
The government defers action, stating that MHRA’s public consultation is currently exploring the registration of medical devices, and its outcome will inform future policy on this recommendation.
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Department for Science, Innovation and Technology
17
Recommendation
First Report - Direct-to-consumer genom…
Deferred
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 …
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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 used to obtain the genomic data is unsuitable for the analysis performed by a company offering secondary analysis. Despite this, the current regulation may not apply to companies providing secondary analysis of genomic data if their product is not deemed to include the use of physical equipment. The Government should consider extending the definition of products covered by the regulation of genomic tests to include software and other services offering analysis and interpretation of genomic test results obtained from third parties. (Paragraph 104) Direct-to-consumer genomic testing 55
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Government response AI summary
The government states that MHRA's public consultation is exploring the scope of medical device regulations in the UK, and the outcome will inform future policy on extending the definition to include secondary analysis software/services.
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Department for Science, Innovation and Technology