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226308

	registered interest
	date	10/03/2015
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	NHS: Research
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, pursuant to the Answer of 24 February 2015 to Question 223768, when NHS England plans to publish its revised approach to promoting and taking account of research in the new healthcare system; and what plans NHS England has to hold a formal consultation on that revised approach.
	tabling member constituency	Crawley
	tabling member printed	Henry Smith
	uin	227008
	answer	answer is ministerial correction date of answer 17/03/2015 answer text <p>Since 24 November 2014, there have been no discussions between my Rt. Hon. Friend the Secretary of State for Health and NHS England on its revised approach to promoting and taking account of research in the new healthcare system. However, discussions between senior officials in the Department and NHS England are ongoing.</p><p> </p><p> </p><p> </p><p>NHS England will be setting out high level plans through their Business Plan, which is due to be published on 27 March 2015. NHS England does not routinely consult on business plans and, as such, no formal consultation has been planned.</p><p> </p> answering member constituency Mid Norfolk answering member printed George Freeman grouped question UIN 227007 question first answered 17/03/2015 16:19:16 answering member 4020 label Biography information for George Freeman
	tabling member	3960 label Biography information for Henry Smith

226307

	registered interest
	date	10/03/2015
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	NHS: Research
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, pursuant to the Answer of 24 February 2015 to Question 223768, on which dates since 24 November 2014 he has discussed with NHS England its revised approach to promoting and taking account of research in the new healthcare system; and what the content of those discussions was.
	tabling member constituency	Crawley
	tabling member printed	Henry Smith
	uin	227007
	answer	answer is ministerial correction date of answer 17/03/2015 answer text <p>Since 24 November 2014, there have been no discussions between my Rt. Hon. Friend the Secretary of State for Health and NHS England on its revised approach to promoting and taking account of research in the new healthcare system. However, discussions between senior officials in the Department and NHS England are ongoing.</p><p> </p><p> </p><p> </p><p>NHS England will be setting out high level plans through their Business Plan, which is due to be published on 27 March 2015. NHS England does not routinely consult on business plans and, as such, no formal consultation has been planned.</p><p> </p> answering member constituency Mid Norfolk answering member printed George Freeman grouped question UIN 227008 question first answered 17/03/2015 16:19:17 answering member 4020 label Biography information for George Freeman
	tabling member	3960 label Biography information for Henry Smith

178540

	registered interest
	date	09/02/2015
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	NHS: Research
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, when he expects to publish the results of the consultation for the NHS England Research and Development Strategy.
	tabling member constituency	Crawley
	tabling member printed	Henry Smith
	uin	223768
	answer	answer is ministerial correction date of answer 24/02/2015 answer text <p>The consultation for the NHS England Research and Development Strategy closed in December 2013. NHS England subsequently decided not to publish the results of the consultation at that time, but instead to use the findings to inform a new piece of work which would be developed with the Department which will describe NHS England’s role in promoting and taking account of research in the new healthcare system.</p><p> </p><p> </p><p> </p><p>NHS England is working with the Department to agree a revised approach.</p><p> </p><p> </p><p> </p><p>Delivery of NHS England’s research objective was discussed at the accountability meeting on 14 October 2014. The minutes of this meeting are available at:</p><p> </p><p> </p><p> </p><p><a href="https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/377477/SofS_Accountability_Meeting_oct_2014.pdf" target="_blank">https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/377477/SofS_Accountability_Meeting_oct_2014.pdf</a></p><p> </p> answering member constituency Mid Norfolk answering member printed George Freeman question first answered 24/02/2015 16:49:23 answering member 4020 label Biography information for George Freeman
	tabling member	3960 label Biography information for Henry Smith

174759

	registered interest
	date	20/01/2015
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Bile Duct Cancer
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, what research his Department has commissioned into cholangiocarcinoma.
	tabling member constituency	Crawley
	tabling member printed	Henry Smith
	uin	221396
	answer	answer is ministerial correction date of answer 27/01/2015 answer text <p>The Department has not commissioned any research relating specifically to cholangiocarcinoma. The National Institute for Health Research Imperial Biomedical Research Centre has a £3.6 million gastroenterology and hepatology research theme (2012-17). This includes research on cholangiocarcinoma biomarkers and imaging.</p><p> </p> answering member constituency Mid Norfolk answering member printed George Freeman question first answered 27/01/2015 12:35:01 answering member 4020 label Biography information for George Freeman
	tabling member	3960 label Biography information for Henry Smith

155948

	registered interest
	date	17/11/2014
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Prescription Drugs
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, what steps his Department is taking to encourage flexibility in the licensing process for potential new treatments for rare conditions.
	tabling member constituency	Crawley
	tabling member printed	Henry Smith
	uin	214491
	answer	answer is ministerial correction date of answer 24/11/2014 answer text <p>Most new medicines for rare conditions are licensed by the European Commission.</p><p> </p><p>The European Union offers a range of incentives to encourage the development of these medicines in order to address unmet clinical need. These incentives include a period of 10 years market exclusivity, the provision of Protocol Assistance (scientific advice specifically tailored for orphan medicinal products) and fee reductions and waivers for regulatory procedures.</p><p> </p><p> </p><p> </p><p>Through the Medicines and Healthcare products Regulatory Agency (MHRA), the United Kingdom takes an active role in the decision making process at the European Medicines Agency’s Committee on Orphan Medicinal Products, ensuring applications for Orphan Drug designation of potential drug candidates for rare diseases are appropriately recognised, encouraging companies to develop their products further and recommending use of existing flexibilities such as conditional authorisation, authorisation under exceptional circumstances and accelerated assessment. The UK is actively involved in the European Medicines Agency’s adaptive licensing pilot that is exploring further use of these flexibilities. The MHRA has an Innovation Office that can offer advice and assistance to developers of drugs for rare diseases, including on the use of flexibilities.</p><p> </p><p><strong> </strong></p><p> </p><p>In addition, in the UK, the Early Access to Medicines Scheme aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need.</p><p> </p><p> </p><p> </p><p>We are also commissioning an external review of the pathways for the development, assessment, and adoption of innovative medicines and medical technology. This review will consider how to speed up access for NHS patients to cost-effective new diagnostics, medicines and devices.</p><p> </p><p><strong> </strong></p><p> </p><p><strong> </strong></p><p> </p> answering member constituency Mid Norfolk answering member printed George Freeman question first answered 24/11/2014 17:23:13 answering member 4020 label Biography information for George Freeman
	tabling member	3960 label Biography information for Henry Smith

155953

	registered interest
	date	17/11/2014
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Drugs: Licensing
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, if he will set targets and goals for speeding up the use of off-patent drugs outside their licensed indications, where evidence supports that use.
	tabling member constituency	Crawley
	tabling member printed	Henry Smith
	uin	214424
	answer	answer is ministerial correction date of answer 24/11/2014 answer text <p>We have no plans to set such targets or goals.</p><p> </p><p> </p><p> </p><p>Off-patent drugs are those whose patent period has expired and they are widely used in the National Health Service now. Drugs can also be prescribed ‘off-label’ outside of their licensed indication(s) to individual patients where doctors consider it is clinically appropriate to do so. Prescribing decisions are rightly a matter for clinicians in discussion with their patients.</p><p> </p><p> </p><p> </p><p>We are in the process of setting up a round-table discussion with key stakeholders, including NHS England and the National Institute for Health and Care Excellence to explore opportunities for supporting appropriate use of off-label drugs outside their licensed indications where the evidence supports this.</p><p> </p> answering member constituency Mid Norfolk answering member printed George Freeman question first answered 24/11/2014 17:35:43 answering member 4020 label Biography information for George Freeman
	tabling member	3960 label Biography information for Henry Smith