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1024698

	registered interest
	date	13/12/2018
	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	Orphan Drugs
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, whether he is taking steps to introduce a revised definition for ultra-orphan medicine.
	tabling member constituency	Linlithgow and East Falkirk
	tabling member printed	Martyn Day
	uin	202090
	answer	answer is ministerial correction date of answer 20/12/2018 answer text <p>Currently, rare diseases are defined as conditions affecting no more than five in 10,000 people in the European Union. The new European Clinical Trial Regulation (Regulation (EU) No 536/2014) will introduce an ‘ultra-rare’ condition and states that clinical trials for the development of orphan medicinal products and those of medicines affecting no more than one person in 50,000 in the EU (ultra-rare diseases) should be fostered, and in such areas, a rapid yet in-depth assessment is of particular importance. The new clinical trials regulation is expected to be implemented in the EU in late 2020. The Government has confirmed that United Kingdom law will remain aligned with the parts of the new EU clinical trials Regulation that are within the UK’s control.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 20/12/2018 17:10:46 answering member 4065 label Biography information for Dame Jackie Doyle-Price
	tabling member	4488 label Biography information for Martyn Day

846086

	registered interest
	date	21/02/2018
	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	Orphan Drugs
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, if he will take steps to ensure that NHS England and NICE revise their appraisal criteria for the NICE Highly Specialised Technologies as a result of the Scottish Medicines Consortium’s review of the definition of orphan and ultra-orphan designation route to include condition prevalence criteria; and if he will ensure that they publish those prevalence criteria.
	tabling member constituency	Linlithgow and East Falkirk
	tabling member printed	Martyn Day
	uin	128793
	answer	answer is ministerial correction date of answer 01/03/2018 answer text <p>The Government and the National Institute for Health and Care Excellence (NICE) have no plans to review the criteria for the selection of topics for referral to NICE’s Highly Specialised Technologies (HST) programme. The topic selection criteria for HST are published at:</p><p> </p><p><a href="https://www.nice.org.uk/about/what-we-do/our-programmes/topic-selection" target="_blank">https://www.nice.org.uk/about/what-we-do/our-programmes/topic-selection</a></p> answering member constituency Winchester answering member printed Steve Brine question first answered 01/03/2018 15:09:31 answering member 4067 label Biography information for Steve Brine
	tabling member	4488 label Biography information for Martyn Day