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1001918

	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	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, whether officials in his Department have had discussions with the Scottish Government on the (a) Patient and Clinician Engagement system, (b) its effect on approval rates for new rare disease medicines in Scotland and (c) potential lessons from that system for NHS England.
	tabling member constituency	Bury North
	tabling member printed	James Frith
	uin	188233
	answer	answer is ministerial correction date of answer 14/11/2018 answer text <p>Officials have had no such discussions. Health is a devolved matter and the availability of medicines for the treatment of rare diseases in Scotland is an issue for the Scottish Government.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 14/11/2018 11:21:33 answering member 4067 label Biography information for Steve Brine
	tabling member	4637 label Biography information for James Frith

1001919

	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	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, with reference to paragraph 4.12 the UK Rare Diseases Strategy, what assessment his Department has made of whether the National Institute for Health and Care Excellence’s Single Technology Appraisal Programme meets the ambition of suitability for assessing rare disease treatments.
	tabling member constituency	Bury North
	tabling member printed	James Frith
	uin	188234
	answer	answer is ministerial correction date of answer 12/11/2018 answer text <p>Where a company is willing to set a fair price for a drug, the National Institute for Health and Care Excellence (NICE) technology appraisal process has been proven to be suitable for the assessment of drugs for rare diseases. NICE has been able to recommend a number of drugs for patients with rare diseases through its technology appraisal programme; recent examples include dinutuximab beta for neuroblastoma and daratumumab for relapsed and refractory multiple myeloma.</p><p> </p><p>With the aim of improving the lives of all those affected by a rare disease, the United Kingdom Government published the UK Strategy for Rare Diseases in 2013, a high-level framework containing 51 commitments which sets out a seven-year strategic vision (2013-2020). The Government is committed to implementing the Strategy’s commitments and has, in January 2018, published Implementation Plans setting out its actions for England.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 12/11/2018 17:23:30 answering member 4067 label Biography information for Steve Brine
	tabling member	4637 label Biography information for James Frith

1020384

	registered interest
	date	05/12/2018
	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	NHS: Drugs
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, when NHS England plans to publish the commercial framework referred to in the policy paper of 5 December 2018 entitled Voluntary scheme for branded medicines pricing and access.
	tabling member constituency	Bury North
	tabling member printed	James Frith
	uin	199471
	answer	answer is ministerial correction date of answer 12/12/2018 answer text <p>NHS England, with input from the National Institute for Health and Care Excellence, will develop a ’commercial framework’ setting out the parameters for the commercial approach for medicines in the health service in England. This framework will be tested with and informed through consultation with stakeholders once the voluntary scheme is operational. The intention is to publish the framework early in 2019.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 12/12/2018 15:03:23 answering member 4067 label Biography information for Steve Brine
	tabling member	4637 label Biography information for James Frith

1023166

	registered interest
	date	11/12/2018
	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, pursuant to the Answer of 12 November 2018 to Question 188234 on Rare Diseases: Drugs, whether NICE can make a conditional recommendation for treatment for rare diseases that do not qualify for conditional recommendation through the cancer drugs fund.
	tabling member constituency	Bury North
	tabling member printed	James Frith
	uin	201214
	answer	answer is ministerial correction date of answer 19/12/2018 answer text <p>The National Institute of Health and Care Excellence can make a conditional recommendation for treatment for rare diseases that do not qualify for conditional recommendation through the cancer drugs fund. For example, it has recommended the use of belimumab for the treatment of lupus subject to the conditions of a managed access agreement.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 19/12/2018 12:03:22 answering member 4067 label Biography information for Steve Brine
	tabling member	4637 label Biography information for James Frith

1023167

	registered interest
	date	11/12/2018
	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, with reference to his policy paper of 5 December 2018 entitled Voluntary scheme for branded medicines pricing and access, whether NICE plans to review the suitability of its technology appraisal methods for rare disease treatments that do not qualify for the highly specialised technologies programme.
	tabling member constituency	Bury North
	tabling member printed	James Frith
	uin	201215
	answer	answer is ministerial correction date of answer 19/12/2018 answer text <p>The National Institute for Health and Care Excellence (NICE) is not yet able to advise what will be included in the scope of the review of its technology appraisal methods. NICE will begin scoping the planned review in 2019/20 with the involvement of industry and other relevant stakeholders.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 19/12/2018 12:04:06 answering member 4067 label Biography information for Steve Brine
	tabling member	4637 label Biography information for James Frith

1028635

	registered interest
	date	19/12/2018
	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, pursuant to the Answer of 19 December 2018 to Question 201214 on Rare Diseases: Drugs, on how many occasions NICE has made a conditional recommendation for a rare disease treatment that do not qualify for conditional recommendation through the cancer drugs fund; and what criteria NICE uses to determine whether such treatments are eligible for conditional recommendations.
	tabling member constituency	Bury North
	tabling member printed	James Frith
	uin	203975
	answer	answer is ministerial correction date of answer 07/01/2019 answer text <p>The National Institute for Health and Care Excellence (NICE) is able to take into account the commercial terms offered by a manufacturer during a NICE appraisal through a mechanism known as a commercial access agreement. On two occasions NICE has issued optimised recommendations to make rare disease medicines routinely available for the appropriate group of National Health Service patients that are conditional on it being supplied in accordance with the terms of the commercial access arrangements. These were Sorafenib, for advanced hepatocellular carcinoma, and ibrutinib for relapsed or refractory mantle cell lymphoma.</p><p> </p><p>This is different from the process of a conditional recommendation for use within the Cancer Drugs Fund (CDF) for oncology drugs, where there is significant remaining clinical uncertainty which needs more investigation through data collection. In these cases funding is provided from the CDF for a time-limited period to allow patient access whilst this data is collected, before guidance is then reviewed again for routine commissioning.</p><p> </p><p>NICE does not have any particular criteria to determine whether treatments are eligible for conditional recommendations. However, the process guide for patient access schemes and commercial access agreements and the CDF can be found at the following link:</p><p><a href="https://www.nice.org.uk/process/pmg19/chapter/patient-access-schemes-commercial-access-agreements-and-flexible-pricing" target="_blank">https://www.nice.org.uk/process/pmg19/chapter/patient-access-schemes-commercial-access-agreements-and-flexible-pricing</a></p> answering member constituency Winchester answering member printed Steve Brine question first answered 07/01/2019 13:32:56 answering member 4067 label Biography information for Steve Brine
	tabling member	4637 label Biography information for James Frith

1037139

	registered interest
	date	07/01/2019
	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	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, what steps he is taking to ensure the availability of treatments for patients with rare diseases since the introduction of the Orphan Medical Product Regulation 2000.
	tabling member constituency	Bury North
	tabling member printed	James Frith
	uin	206027
	answer	answer is ministerial correction date of answer 15/01/2019 answer text <p>The Government is committed to improving the lives of all those affected by a rare disease. Implementation plans by NHS England and the Department were published jointly in January 2018 and describe the actions and framework in place to deliver this commitment to improve the lives of those affected by rare disease, as defined in the UK Strategy for Rare Diseases.</p><p> </p><p>Through its technology appraisal and highly specialised technologies programmes, the National Institute for Health and Care Excellence (NICE) plays an important role in ensuring that patients, including patients with rare diseases, are able to benefit from effective new treatments. NICE has recommended a number of drugs for rare diseases through these programmes that are now routinely funded by the National Health Service for eligible patients.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 15/01/2019 16:13:10 answering member 4067 label Biography information for Steve Brine
	tabling member	4637 label Biography information for James Frith

1131207

	registered interest
	date	11/06/2019
	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	NHS: 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 the availability of medicines after the UK leaves the EU.
	tabling member constituency	Bury North
	tabling member printed	James Frith
	uin	263234
	answer	answer is ministerial correction date of answer 19/06/2019 answer text <p>The Government remains committed to leaving the European Union with a deal. However, as a responsible Government, we will continue to prepare to minimise any disruption to the supply of medicines and medical products in a potential ‘no deal’ scenario.</p><p>We are continuing to work with trade bodies and other stakeholders to carefully review the implications of the extension to the Article 50 period until 31 October at the latest before sharing further guidance with industry at the earliest opportunity. On 26 April we wrote to suppliers advising that, until further guidance is provided, all no-deal measures, including stockpiles and plans to route away from the short straits, should remain in place but on hold.</p> answering member constituency Wimbledon answering member printed Stephen Hammond question first answered 19/06/2019 15:27:39 answering member 1585 label Biography information for Stephen Hammond
	tabling member	4637 label Biography information for James Frith

1037137

	registered interest
	date	07/01/2019
	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	Orphan Drugs: Regulation
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, when his Department plans to publish its consultation on the regulation of orphan drugs after the UK leaves the EU.
	tabling member constituency	Bury North
	tabling member printed	James Frith
	uin	206025
	answer	answer is ministerial correction date of answer 16/01/2019 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 Medicines and Healthcare products Regulatory Agency (MHRA) launched in October 2018 a consultation on the regulation of medicines in the event of a ‘no deal’ exit, which included the proposed UK approach to the regulation of orphan medicines post-exit, including on incentives to encourage such medicines onto the UK market. Following this consultation, the MHRA, on 3 January 2019, published guidance on the UK proposed arrangements for the regulation of orphan medicines, in the event of a ‘no deal’ exit. This can be accessed at the following link:</p><p> </p><p><a href="https://www.gov.uk/government/publications/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal" target="_blank">https://www.gov.uk/government/publications/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal</a></p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 16/01/2019 17:20:56 answering member 4065 label Biography information for Dame Jackie Doyle-Price
	tabling member	4637 label Biography information for James Frith

1131208

	registered interest
	date	11/06/2019
	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	NHS: 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 tackle shortages of (a) Adalat, (b) Nifedipine and (c) other common medicines.
	tabling member constituency	Bury North
	tabling member printed	James Frith
	uin	263235
	answer	answer is ministerial correction date of answer 19/06/2019 answer text <p>The vast majority of medicines are not subject to supply problems and every day over 2 million prescription items are successfully dispensed in England.</p><p>Where problems do occur the Department’s Medicines Supply Team has well established procedures to deal with medicine shortages and works closely with all stakeholders to help prevent shortages and to ensure that the risks to patients are minimised when they do arise.</p><p>We are aware of ongoing supply issues with the Adalat range of the drug nifedipine due to manufacturing capacity constraints. We have been working closely with all suppliers of generic and other brands of nifedipine to maintain overall supply of this medicine to patients and have provided regular updates about the situation to the National Health Service.</p><p>We will continue to work closely with all manufacturers of nifedipine preparations to monitor the overall supply situation to ensure supplies continue to remain available.</p> answering member constituency South Ribble answering member printed Seema Kennedy question first answered 19/06/2019 14:22:30 answering member 4455 label Biography information for Seema Kennedy
	tabling member	4637 label Biography information for James Frith