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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

1138859

	registered interest
	date	15/07/2019
	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, with reference to the Clinical Advisory Group for Genomics, if he will set out (a) its terms of reference, (b) when it will first meet, (c) how patient voice will be incorporated into its work, (d) who it will report to and (e) when the (i) Commissioning Policy for Preimplantation Genetic Diagnosis review and (ii) other work of its predecessor, the Clinical Reference Group for Medical Genetics, will be completed; and if he will make a statement.
	tabling member constituency	Hornsey and Wood Green
	tabling member printed	Catherine West
	uin	277243
	answer	answer is ministerial correction date of answer 23/07/2019 answer text <p>NHS England has paused the recruitment for the clinical genetics clinical reference group to ensure the right advisory groups are in place to provide clinical advice across the breadth and depth of the future NHS Genomic Medicine Service.</p><p>These new arrangements will need consider clinical genetics and genetic counselling, but also wider implications of genomics for the National Health Service. Any future arrangements will have appropriate representation, including patient and public voices.</p><p>NHS England is progressing the clinical commissioning policy for Preimplantation Genetic Diagnosis (PGD). This work will include assessment of the treatment pathways for existing PGD services and consideration of the ethical issues. NHS England will continue to seek input from clinicians and patients throughout this work.</p> answering member constituency Gosport answering member printed Caroline Dinenage question first answered 23/07/2019 16:06:02 answering member 4008 label Biography information for Dame Caroline Dinenage
	tabling member	4523 label Biography information for Catherine West

1135183

	registered interest
	date	27/06/2019
	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 the National Genomic Test Directory directly replaces the NHS Directory of Genetic Disorders/Genes for Diagnostic Testing.
	tabling member constituency	Sheffield South East
	tabling member printed	Mr Clive Betts
	uin	270282
	answer	answer is ministerial correction date of answer 05/07/2019 answer text <p>During 2019, the National Health Service will begin to offer whole genome sequencing (WGS) as part of clinical care for:</p><p>- Seriously ill children likely to have a rare genetic disorder;</p><p>- People with one of 21 rare conditions where current evidence supports early adoption of WGS as a diagnostic test; and</p><p>- People with specific types of cancer for which there is likely to be the greatest patient benefit from using WGS – children with cancer, sarcoma and acute myeloid leukaemia.</p><p> </p><p>WGS will only replace existing diagnostic tests once the testing is demonstrated to be clinically safe to replace existing diagnostic testing. Initially, existing diagnostic testing will continue to be performed alongside WGS testing where clinically appropriate. This will continue until WGS is able to fully support clinical decision making within clinically appropriate timescales.</p><p>Current testing for blood cancers includes a number of diagnostic tests, the current expectation is that WGS will not be used to replace tests that require very fast turnaround times (under 24 hours) or high sensitivity.</p><p>WGS and non-WGS testing that will be available as part of clinical care is outlined in the National Genomic Test Directory at the following link:</p><p> </p><p><a href="https://www.england.nhs.uk/publication/national-genomic-test-directories/" target="_blank">https://www.england.nhs.uk/publication/national-genomic-test-directories/</a></p><p> </p><p>The UK Genetic Testing Network (UKGTN) published the NHS Directory of Genetic Disorders/Genes for Diagnostic Testing, which evaluated and recommended genetic tests for rare and inherited disorders for the National Health Service across the UK. However, there was not an equivalent for cancer genomic testing. The National Genomic Test Directory specifies which genomic tests are commissioned by the NHS in England, the technology by which they are available, and the patients who will be eligible to access to a test.</p><p>The National Genomic Test Directory will be updated on an annual basis and NHS England will implement a clear and transparent process, supported by a Clinical and Scientific Expert Panel, to determine which tests are available within the NHS. This will include reviewing any tests that may be retired or replaced by more modern technology, such as WGS. As the price of WGS falls and the clinical evidence improves, we envisage that it will be extended to more conditions and therefore more patients.</p><p> </p><p><strong> </strong></p><p><strong> </strong></p> answering member constituency Gosport answering member printed Caroline Dinenage grouped question UIN 270281 270283 question first answered 05/07/2019 09:24:02 answering member 4008 label Biography information for Dame Caroline Dinenage
	tabling member	394 label Biography information for Mr Clive Betts

1123240

	registered interest
	date	25/04/2019
	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, what steps he is taking to increase (a) access and (b) referral rates for genetic services.
	tabling member constituency	Mid Derbyshire
	tabling member printed	Mrs Pauline Latham
	uin	247678
	answer	answer is ministerial correction date of answer 02/05/2019 answer text <p>Building on the 100,000 Genomes Project and existing genetic services, NHS England announced in October 2018 that over the next 18 months, work to mobilise the NHS Genomic Medicine Service (GMS) would get underway, providing consistent and equitable care for the country’s 55 million population.</p><p>Investment for genomics was included as part of the NHS Long Term Plan, setting out commitments over the next five years to:</p><p>- Sequence 500,000 whole genomes by 2023/24, as part of a Government commitment to sequence 1 million whole genomes;</p><p>- Extend the use of molecular diagnostic testing and routine offering whole genome sequencing to seriously ill children who are likely to have a rare genetic disorder, children with cancer, and adults suffering from certain rare conditions or specific cancers;</p><p>- Link and correlate genomics, clinical data and data from patients, providing routes to new treatments, diagnostic patterns and information to help patients make informed decisions about their care; and</p><p>- Increase the number of people identified with familial hypercholesterolaemia (inherited high cholesterol) from 7% to 25% over the next five years.</p><p>The NHS Genomic Medicine Service will be supported by an informatics system that is being developed in partnership with Genomics England. When fully operational, the informatics system will enable NHS England to monitor the number of genomic tests being carried out across the country and benchmark activity.</p> answering member constituency Gosport answering member printed Caroline Dinenage question first answered 02/05/2019 14:47:05 answering member 4008 label Biography information for Dame Caroline Dinenage
	tabling member	4025 label Biography information for Mrs Pauline Latham

1019872

	registered interest
	date	04/12/2018
	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, what recent assessment NHS England has made of trends in the level of uptake of molecular diagnostic tests in England.
	tabling member constituency	Newton Abbot
	tabling member printed	Anne Marie Morris
	uin	198833
	answer	answer is ministerial correction date of answer 12/12/2018 answer text <p>NHS England does not currently hold this data but as part of the NHS Genomic Medicine Service, which is beginning to operationalise, a National Genomics Informatics System (NGIS) is being developed by Genomics England for use by the National Health Service.</p><p> </p><p>When fully operational NGIS will enable NHS England to monitor the number of tests being carried out across the country and benchmark activity.</p> answering member constituency Gosport answering member printed Caroline Dinenage question first answered 12/12/2018 15:38:10 answering member 4008 label Biography information for Dame Caroline Dinenage
	tabling member	4249 label Biography information for Anne Marie Morris

1002034

	registered interest
	date	05/11/2018
	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, what proportion of Clinical Commissioning Groups fund family history clinics.
	tabling member constituency	Enfield, Southgate
	tabling member printed	Bambos Charalambous
	uin	188157
	answer	answer is ministerial correction date of answer 14/11/2018 answer text <p>NHS England does not hold information on the number of family history clinics in operation. As set out in the Manual for Prescribed Specialised Services 2018/19 NHS England commissions genetics services, including genetic testing for inherited cancer through the Genomic Laboratory Hubs and the genetic clinical service through the Regional Clinical Genetics Services.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 14/11/2018 11:31:09 answering member 4067 label Biography information for Steve Brine
	tabling member	4610 label Biography information for Bambos Charalambous

917326

	registered interest
	date	05/06/2018
	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, what assessment (a) his Department and (b) Public Health England have made of the role of (i) genetic testing and (ii) population level genomic data to improve public health.
	tabling member constituency	Strangford
	tabling member printed	Jim Shannon
	uin	150116
	answer	answer is ministerial correction date of answer 13/06/2018 answer text <p>The United Kingdom National Screening Committee recently recommended that the use of Non-Invasive Prenatal Testing should be evaluated as an additional screening test in the antenatal screening programme for Down’s syndrome, Edwards’ syndrome and Patau syndrome. In addition to this, the use of next generation sequencing is currently being evaluated in the diagnostic pathway for babies found to be screen positive for cystic fibrosis.</p><p> </p><p>From October 2018, the National Health Service’s Genomic Medicine Service will, for the first time, be supported by a comprehensive directory of genomic tests for specified cancers and rare diseases that encompasses the entire testing repertoire from Whole Genomic Sequencing to tests for single genes, molecular markers and other functional genomic tests.</p><p> </p><p>This National Genomic Test Directory will be updated on an annual basis to keep pace with scientific and technological advances with a systematic review process in place to ensure continued value through the co-ordinated replacement of older tests with new and emerging approaches.</p><p> </p><p>The Test Directory will be updated annually, following advice from an expert scientific and clinical committee that will be established to operate in accordance with NHS England’s specialised services commissioning processes.</p><p> </p><p>The Chief Medical Officer for England’s annual report ‘Generation Genome’ provided a comprehensive overview of the role of clinical genomic testing and is being taken forward via the Minister-chaired National Genomics Board.</p> answering member constituency Gosport answering member printed Caroline Dinenage question first answered 13/06/2018 15:36:59 answering member 4008 label Biography information for Dame Caroline Dinenage
	tabling member	4131 label Biography information for Jim Shannon

917327

	registered interest
	date	05/06/2018
	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 there are plans in place to undertake a localised population-based genetic research study in England; and if he will make a statement.
	tabling member constituency	Strangford
	tabling member printed	Jim Shannon
	uin	150117
	answer	answer is ministerial correction date of answer 12/06/2018 answer text <p>The United Kingdom has a strong history of conducting cohort studies of this kind. The Department’s National Institute for Health Research welcomes funding applications for research into any aspect of human health, including localised population-based genetic research studies. These applications are subject to peer review and judged in open competition, with awards being made on the basis of the importance of the topic to patients and health and care services, value for money and scientific quality.</p> answering member constituency Gosport answering member printed Caroline Dinenage question first answered 12/06/2018 13:53:59 answering member 4008 label Biography information for Dame Caroline Dinenage
	tabling member	4131 label Biography information for Jim Shannon