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1676390

registered interest
date	07/12/2023
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Genetics: Screening
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, whether her Department has made an assessment of the potential implications for management of donor information of commercial direct-to-consumer genetic testing.
tabling member constituency	Jarrow
tabling member printed	Kate Osborne
uin	5893
answer	answer is ministerial correction date of answer 14/12/2023 answer text <p>The Government asked the Human Fertilisation and Embryology Authority (HFEA) in 2021 to undertake a review and public engagement about priorities for modernising the Human Fertilisation and Embryology Act. HFEA published its report on 14 November 2023, which is available at the following link:</p><p><a href="https://www.hfea.gov.uk/about-us/modernising-the-regulation-of-fertility-treatment-and-research-involving-human-embryos/" target="_blank">https://www.hfea.gov.uk/about-us/modernising-the-regulation-of-fertility-treatment-and-research-involving-human-embryos/</a></p><p>HFEA’s report notes the rapidly developing field of genetic testing, including direct to consumer testing, and includes proposals about access to donor information. The Government is considering the issues raised in the report and will respond in due course.</p> answering member constituency Lewes answering member printed Maria Caulfield question first answered 14/12/2023 09:21:24 answering member 4492 label Biography information for Maria Caulfield
tabling member	4783 label Biography information for Kate Osborne

1666274

registered interest
date	19/10/2023
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Genetics: Screening
house id	2
legislature	25277 pref label House of Lords
question text	To ask His Majesty's Government what assessment they have made of Nolan and Ormondroyd’s systematic review published on 30 March in Clinical Genetics, setting out the consequences for consumers and health services of direct-to-consumer genetic testing and how it relates to equitable healthcare; and what assessment they have made of the regulation of direct-to-consumer genetic testing.
tabling member printed	Baroness Bennett of Manor Castle
uin	HL10676
answer	answer is ministerial correction date of answer 25/10/2023 answer text <p>Whilst no specific assessment has been made of Nolan and Ormondroyd’s systematic review published in March 2023 or Emma Wilkinson’s article published in October 2022, the Government recognises both the opportunities and risks raised by direct-to-consumer genomic tests and is committed to ensuring effective and proportionate regulation.</p><p>In consideration of the regulation of direct-to-consumer genetic and health testing, the Medicines and Healthcare products Regulatory Agency is working to develop a robust, world-leading regulatory regime for such medical devices that prioritises patient safety.</p> answering member printed Lord Markham grouped question UIN HL10677 question first answered 25/10/2023 11:20:51 answering member 4948 label Biography information for Lord Markham
tabling member	4719 label Biography information for Baroness Bennett of Manor Castle

1666275

registered interest
date	19/10/2023
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Genetics: Screening
house id	2
legislature	25277 pref label House of Lords
question text	To ask His Majesty's Government what assessment they have made of Emma Wilkinson’s article published in October 2022 in The BMJ on the impact of direct-to-consumer testing on the public and the NHS, and of how this relates to the regulation of direct-to-consumer health testing.
tabling member printed	Baroness Bennett of Manor Castle
uin	HL10677
answer	answer is ministerial correction date of answer 25/10/2023 answer text <p>Whilst no specific assessment has been made of Nolan and Ormondroyd’s systematic review published in March 2023 or Emma Wilkinson’s article published in October 2022, the Government recognises both the opportunities and risks raised by direct-to-consumer genomic tests and is committed to ensuring effective and proportionate regulation.</p><p>In consideration of the regulation of direct-to-consumer genetic and health testing, the Medicines and Healthcare products Regulatory Agency is working to develop a robust, world-leading regulatory regime for such medical devices that prioritises patient safety.</p> answering member printed Lord Markham grouped question UIN HL10676 question first answered 25/10/2023 11:20:51 answering member 4948 label Biography information for Lord Markham
tabling member	4719 label Biography information for Baroness Bennett of Manor Castle