First Report - Direct-to-consumer genomic testing

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.

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.

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.

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.

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.

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 practice from private clinics can be transferred.

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 feasibility of implementing this recommendation in the longer term with relevant bodies.

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 the recommendation under review and explore with the ICO if further guidance is necessary.

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 recommendation.

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.

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.

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.