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891534

	registered interest
	date	25/04/2018
	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	Hereditary Diseases
	house id	1
	legislature	25259 pref label House of Commons
	question text	to ask the Secretary of State for Health and Social Care, what lessons have been learned from the 100,000 Genome Project which will help when deciding what genetic diseases should be screened for at birth.
	tabling member constituency	Bristol North West
	tabling member printed	Darren Jones
	uin	138095
	answer	answer is ministerial correction date of answer 30/04/2018 answer text <p>The 100,000 Genomes Project is focussed on recruiting patients, including children, with rare diseases (and their family members) and those with common cancers. These are areas where whole genome sequencing may offer the best opportunity to diagnose disease. From the Project’s pilot phase we have found actionable findings in 20-25% of rare disease patients.</p><p> </p><p>The scope of the project does not include screening at birth. The Chief Medical Officer, in her annual report Generation Genome, recommended that that the National Screening Committee conducts a systematic evaluation of the opportunities offered by genomics for present and potential screening practices.</p> answering member constituency Gosport answering member printed Caroline Dinenage question first answered 30/04/2018 15:41:08 answering member 4008 label Biography information for Dame Caroline Dinenage
	tabling member	4621 label Biography information for Darren Jones

686170

	registered interest
	date	07/02/2017
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Hereditary Diseases
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, whether his Department funds alternative treatments for mitochondrial disorders that (a) can treat those born with mitochondrial disease and (b) do not involve the creation of genetically modified human embryos; and what plans he has to do so in the future.
	tabling member constituency	Congleton
	tabling member printed	Fiona Bruce
	uin	63365
	answer	answer is ministerial correction date of answer 10/02/2017 answer text <p>The Human Fertilisation and Embryology Authority decided on 15 December 2016 to allow the use mitochondrial donation for risk reduction treatments in certain cases where alternative treatments would be of little or no benefit to mothers at risk of passing mitochondrial disease onto their children. This decision was taken after considering the independent Expert Panel’s fourth report on the latest evidence of safety and efficacy and following a comprehensive and rigorous process of assessment and review of the scientific evidence over the last six years. Before any treatment is offered to affected families, there are still two more licencing processes to be completed. The first to ensure that the clinic meets the required suitability standards and the second a case by case assessment of each individual as required by the Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015.</p><p> </p><p>NHS England is the designated commissioner of the National Health Service service for mitochondrial donation and will fund the treatment costs of the service, alongside an evaluative research project funded by the Wellcome Trust, which will assess and monitor follow-up and outcomes.</p><p> </p><p>Mitochondrial donation does not fit within the definition in law of a clinical trial for the purpose of compliance with the EU Clinical Trial Directive 2001/20/EC. The Directive relates to clinical trials of medicinal products governed by the medicines licensing regime set out in the Medicinal Products Directive and is part of a suite of European measures which set out common rules across the European Union to ensure the free movement of safe medicines.</p><p> </p><p>The Government does not agree with the characterisation of mitochondrial donation as a form of genetic modification. The mitochondrial donation techniques do not involve the germ-line modification of nuclear DNA in the chromosomes that can be passed on to future generations, which is the Chief Medical Officer’s working definition of genetic modification in humans.</p><p> </p><p>NHS England nationally commissions the rare mitochondrial disease service for adults and children, which provides a comprehensive diagnostic service for patients suffering from mitochondrial disease.</p> answering member constituency Oxford West and Abingdon answering member printed Nicola Blackwood grouped question UIN 63363 question first answered 10/02/2017 09:50:02 answering member 4019 label Biography information for Baroness Blackwood of North Oxford
	tabling member	3958 label Biography information for Fiona Bruce