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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

1024700

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	Rare Diseases: Drugs
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 ensure that the UK remains a world leader for the treatment of rare diseases after the UK leaves the EU.
tabling member constituency	Linlithgow and East Falkirk
tabling member printed	Martyn Day
uin	202091
answer	answer is ministerial correction date of answer 20/12/2018 answer text <p>The Government is committed to the safe and effective regulation of medicines in the United Kingdom; ensuring patients and the public have fast access to new, innovative medicines, including medicines for rare diseases.</p><p> </p><p>The agreement of an implementation period will ensure that access to medicines continues, and patient safety is maintained, in both the UK and European Union markets. Beyond that, the Political Declaration sets out a plan for a free trade area for goods, underpinned by deep regulatory co-operation, as well as a joint commitment to explore close cooperation with the European Medicines Agency.</p><p> </p><p>The Government also continues to prepare for the unlikely outcome that we leave the EU without any deal in March 2019. The Department has been engaging with all pharmaceutical companies that supply the United Kingdom with pharmacy or prescription-only medicines from, or via, the EU/European Economic Area, on their contingency plans in the event of a no deal EU Exit.</p><p> </p><p>Whatever the exit scenario, we will work to ensure that the UK will remain a world leader for the treatment of rare diseases after the UK leaves the EU, that UK patients are able to access the best and most innovative medicines including medicines for rare diseases and that their safety is protected. The UK life sciences industry has much to offer in creating, developing, trialing and commercialising medicines that will benefit UK patients and strengthen the ability of the UK to compete internationally.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 20/12/2018 17:07:43 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	4488 label Biography information for Martyn Day

937450

registered interest
date	09/07/2018
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	Cervical Cancer: 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 he plans to pilot the self-sampling of cervical screening for women who would prefer to access their screening in that way; and if he will make a statement.
tabling member constituency	Linlithgow and East Falkirk
tabling member printed	Martyn Day
uin	162104
answer	answer is ministerial correction date of answer 17/07/2018 answer text <p>The United Kingdom National Screening Committee is currently reviewing the evidence for human papillomavirus self-sampling as an additional test within the National Health Service cervical screening programme. A public consultation looking at self-screening is due to open in autumn 2018.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 17/07/2018 11:26:25 answering member 4067 label Biography information for Steve Brine
tabling member	4488 label Biography information for Martyn Day

937622

registered interest
date	09/07/2018
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	Antimicrobials: Drug Resistance
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, for what reason Tuberculosis was excluded from the scope of the £10 million Small Business Research Initiative competition on antimicrobial resistance in humans.
tabling member constituency	Linlithgow and East Falkirk
tabling member printed	Martyn Day
uin	162105
answer	answer is ministerial correction date of answer 12/07/2018 answer text <p>The Small Business Research Initiative competition is funded by a Department of Health and Social Care non-Official Development Assistance budget. Research specifically on Tuberculosis (TB) pathogens was deprioritised for this competition as there are established global funds targeting the development of new treatments for TB.</p><p> </p><p>The United Kingdom is contributing to a reduction in drug resistant TB by implementing the Collaborative TB Strategy for England, which parallels and integrates with the aims and actions of the UK Antimicrobial Resistance strategy.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 12/07/2018 11:45:18 answering member 4067 label Biography information for Steve Brine
tabling member	4488 label Biography information for Martyn Day

846084

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	Rare Diseases
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 his Department's policy paper, UK strategy for rare diseases: implementation plan for England, published on 29 January 2018, what steps he is taking to increase cross-border collaboration (a) within the UK and (b) between the UK and the EU in developing approaches to treatment and management of rare diseases.
tabling member constituency	Linlithgow and East Falkirk
tabling member printed	Martyn Day
uin	128792
answer	answer is ministerial correction date of answer 01/03/2018 answer text <p>The activities described in the Department’s ‘UK Strategy for Rare Diseases: implementation plan for England’ are those that are shared between the Department and a number of partner organisations in implementing the UK Strategy for Rare Diseases. This implementation plan applies to England only.</p><p> </p><p>The UK Rare Disease Policy Board, which has representation of all four United Kingdom nations, oversees the implementation of the UK Strategy for Rare Diseases across the UK. The UK Rare Disease Policy Board publishes on a biennial basis an update on the implementation activities across the whole of the UK. The next report was published on 28 February 2018 and will highlight, in greater detail, initiatives and achievements across the four nations over the past two years, as well as look at UK-wide developments and challenges in the rare diseases landscape that will be important in the forward look to 2020.</p><p> </p><p>The UK is involved in European Reference Networks, virtual centres of knowledge, skills and expertise in the field of rare diseases and complex conditions, which provide a platform to create partnerships between healthcare providers. The UK participates in 23 out of the 24 networks (involving 113 separate UK groups) and leads six networks.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 01/03/2018 15:08:15 answering member 4067 label Biography information for Steve Brine
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

846144

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	Patients: Death
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what guidelines his Department has in place for medical staff dealing with hospital deaths where the deceased has requested to be preserved using cryonics.
tabling member constituency	Linlithgow and East Falkirk
tabling member printed	Martyn Day
uin	128838
answer	answer is ministerial correction date of answer 28/02/2018 answer text <p>The Department has not issued guidance to medical staff dealing with hospital deaths where the deceased has requested to be preserved using cryogenics. There are no current plans to amend the Human Tissue Act or bring forward legislative proposals in this area.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price grouped question UIN 128839 128840 question first answered 28/02/2018 14:53:51 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	4488 label Biography information for Martyn Day

846145

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	Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018
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 amend the draft Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 to include the regulation of cryopreservation of (a) complete bodies and (b) heads.
tabling member constituency	Linlithgow and East Falkirk
tabling member printed	Martyn Day
uin	128839
answer	answer is ministerial correction date of answer 28/02/2018 answer text <p>The Department has not issued guidance to medical staff dealing with hospital deaths where the deceased has requested to be preserved using cryogenics. There are no current plans to amend the Human Tissue Act or bring forward legislative proposals in this area.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price grouped question UIN 128838 128840 question first answered 28/02/2018 14:53:51 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	4488 label Biography information for Martyn Day

846146

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	Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018
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 make it his policy to bring forward legislative proposals for the regulation by the Human Tissue Authority on the removal of (a) bodies and (b) heads for cryopreservation.
tabling member constituency	Linlithgow and East Falkirk
tabling member printed	Martyn Day
uin	128840
answer	answer is ministerial correction date of answer 28/02/2018 answer text <p>The Department has not issued guidance to medical staff dealing with hospital deaths where the deceased has requested to be preserved using cryogenics. There are no current plans to amend the Human Tissue Act or bring forward legislative proposals in this area.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price grouped question UIN 128838 128839 question first answered 28/02/2018 14:53:51 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	4488 label Biography information for Martyn Day

845522

registered interest
date	20/02/2018
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	WHO Framework Convention on Tobacco Control
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, when the Government plans to (a) ratify the WHO Framework Convention on Tobacco Control and (b) deposit the instrument of ratification at the UN in New York.
tabling member constituency	Linlithgow and East Falkirk
tabling member printed	Martyn Day
uin	128494
answer	answer is ministerial correction date of answer 23/02/2018 answer text <p>The United Kingdom ratified the World Health Organization Framework Convention on Tobacco Control (WHO FCTC) on the 16 December 2004. The WHO FCTC adopted the Protocol to Eliminate Illicit Trade in Tobacco Products on 12 November 2012. The Government is fully committed to the Protocol. It is current UK Government policy that international treaties will not be ratified until all the legislation required for implementation has been passed by Parliament. A Command Paper setting out the UK’s plans to ratify the World Health Organization Protocol to Eliminate Illicit Trade in Tobacco Products now needs to be laid before Parliament. Preparations, led by HM Revenue and Customs, are underway and they expect to proceed shortly.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 23/02/2018 12:17:57 answering member 4067 label Biography information for Steve Brine
tabling member	4488 label Biography information for Martyn Day