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1037067

	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	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, with reference to the voluntary scheme for branded medicines pricing and access: heads of agreement, published on 23 November 2018, whether NHS England’s commissioning support programme will be discontinued.
	tabling member constituency	Newton Abbot
	tabling member printed	Anne Marie Morris
	uin	205950
	answer	answer is ministerial correction date of answer 15/01/2019 answer text <p>It is expected that the commissioning support programme, which provides support for service development relating to medicines, as well as medical devices or other sorts of intervention, will continue for 2019/20. The new voluntary scheme for branded medicines pricing and access includes new commitments to the National Institute for Health and Care Excellence (NICE) appraisals for medicines; any implications will be considered through implementation of the new scheme.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 15/01/2019 16:01:48 answering member 4067 label Biography information for Steve Brine
	tabling member	4249 label Biography information for Anne Marie Morris

1046996

	registered interest
	date	23/01/2019
	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	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, with reference to the informal consultation with stakeholder representative bodies on changes to the Human Medicines Regulation 2012 to ensure the continuity of supply of medicines (including in a no deal Brexit), which stakeholders his Department approached for response to that consultation; and what the selection criteria were for those organisations.
	tabling member constituency	Newton Abbot
	tabling member printed	Anne Marie Morris
	uin	211775
	answer	answer is ministerial correction date of answer 31/01/2019 answer text <p>The Department consulted stakeholder representative bodies representing pharmacists, doctors, patient groups and the pharmaceutical industry and asked those bodies to share the consultation as they saw fit. A total of 47 responses were received.</p><p> </p><p>The main benefit of a serious shortage protocol is that patients continue to have access to treatment without undue delays. In addition, the Department expects that where a protocol is in place, it will reduce pressure on general practitioners because they do not have to see all patients to issue a new prescription. For pharmacists, whilst a protocol would likely increase their workload, it would also reduce pressure as pharmacists would not need to liaise with GPs every time they get a prescription. Protocols for therapeutic or generic equivalents will not be suitable for all medicines and patients. A protocol will therefore free up GP time to spend for the patients who most need it.</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 211777 question first answered 31/01/2019 16:20:28 answering member 4067 label Biography information for Steve Brine
	tabling member	4249 label Biography information for Anne Marie Morris

1046997

	registered interest
	date	23/01/2019
	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	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, with reference to the informal consultation with stakeholder representative bodies on changes to the Human Medicines Regulation 2012 to ensure the continuity of supply of medicines (including in a no deal Brexit), what the (a) process and (b) governance arrangements will be for protocols to be developed and signed off centrally by clinicians.
	tabling member constituency	Newton Abbot
	tabling member printed	Anne Marie Morris
	uin	211776
	answer	answer is ministerial correction date of answer 31/01/2019 answer text <p>The Department has well-established governance processes and arrangements for managing medicine shortages in collaboration with manufacturers and suppliers, clinicians and the National Health Service and the Medicines and Healthcare products Regulatory Agency (MHRA). A serious shortage protocol is only one of the tools that can be used to manage shortages. This protocol would only be introduced in case of a serious shortage, if it would help manage the supply situation and if clinicians think it is appropriate, after discussion with the manufacturer and/or marketing authorisation holder when other mitigation measures have been exhausted. Work on operationalising the serious shortage legislation, including the governance processes is ongoing, including the creation of a national, clinically-chaired group advising Ministers and national oversight at senior doctor level. The operation of the serious shortage protocol legislation will be reviewed one year after the first protocol has been issued.</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 211778 question first answered 31/01/2019 16:17:42 answering member 4067 label Biography information for Steve Brine
	tabling member	4249 label Biography information for Anne Marie Morris

1046998

	registered interest
	date	23/01/2019
	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	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, with reference to the explanatory memorandum to the Human Medicines (Amendment) Regulations 2019, what steps his Department took to come to the conclusions that (a) the main benefits of the protocol would be the NHS cost savings associated with GP time and (b) the effect on community pharmacies is expected to be neutral.
	tabling member constituency	Newton Abbot
	tabling member printed	Anne Marie Morris
	uin	211777
	answer	answer is ministerial correction date of answer 31/01/2019 answer text <p>The Department consulted stakeholder representative bodies representing pharmacists, doctors, patient groups and the pharmaceutical industry and asked those bodies to share the consultation as they saw fit. A total of 47 responses were received.</p><p> </p><p>The main benefit of a serious shortage protocol is that patients continue to have access to treatment without undue delays. In addition, the Department expects that where a protocol is in place, it will reduce pressure on general practitioners because they do not have to see all patients to issue a new prescription. For pharmacists, whilst a protocol would likely increase their workload, it would also reduce pressure as pharmacists would not need to liaise with GPs every time they get a prescription. Protocols for therapeutic or generic equivalents will not be suitable for all medicines and patients. A protocol will therefore free up GP time to spend for the patients who most need it.</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 211775 question first answered 31/01/2019 16:20:29 answering member 4067 label Biography information for Steve Brine
	tabling member	4249 label Biography information for Anne Marie Morris

1059824

	registered interest
	date	12/02/2019
	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, with reference to paragraph 3.57 of the 2019 Voluntary Scheme for Branded Medicines Pricing and Access, what criteria will be used to define the five highest health gain categories; whether NHS England has plans to consult on the selection of categories; when he plans to announce those categories; and which comparator countries will be selected for comparison.
	tabling member constituency	Newton Abbot
	tabling member printed	Anne Marie Morris
	uin	220231
	answer	answer is ministerial correction date of answer 18/02/2019 answer text <p>NHS England, working with the National Institute for Health and Care Excellence and officials from the Department, has begun scoping work to support the identification of the five highest health gain categories as part of the implementation of the Voluntary Scheme. NHS England anticipates engaging with interested stakeholders, including the pharmaceutical industry, over the course of 2019.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 18/02/2019 17:21:53 answering member 4067 label Biography information for Steve Brine
	tabling member	4249 label Biography information for Anne Marie Morris

1059822

	registered interest
	date	12/02/2019
	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, with reference to paragraph 3.27 of the 2019 voluntary scheme for branded medicines pricing and access, whether NHS England will issue a public consultation on a proposed new commercial framework.
	tabling member constituency	Newton Abbot
	tabling member printed	Anne Marie Morris
	uin	220230
	answer	answer is ministerial correction date of answer 18/02/2019 answer text <p>NHS England, together with the National Institute for Health and Care Excellence is developing 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. The intention is to publish the framework early in 2019.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 18/02/2019 17:18:40 answering member 4067 label Biography information for Steve Brine
	tabling member	4249 label Biography information for Anne Marie Morris

1047672

	registered interest
	date	24/01/2019
	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	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, with reference to his Department's informal consultation with stakeholder representative bodies on changes to the Human Medicines Regulation 2012 to ensure the continuity of supply of medicines including in a no deal Brexit, published on 14 January 2019, whether any responses to that consultation raised concern about the consultation process; and if his Department will publish the responses to that consultation.
	tabling member constituency	Newton Abbot
	tabling member printed	Anne Marie Morris
	uin	212366
	answer	answer is ministerial correction date of answer 31/01/2019 answer text <p>Whilst there was no statutory obligation to consult on these changes to the Human Medicines Regulations 2012, the Department engaged with stakeholder representative bodies representing pharmacists, doctors, patient groups and the pharmaceutical industry about its proposals. As part of that engagement, it also conducted a short written consultation. Some respondents raised concerns about the short duration of the written consultation. In response, the Department has included a review clause in the legislation, putting an obligation on the Department to review the operation of the legislation, one year after issuing the first protocol. In addition, in the Explanatory Memorandum, the Department has committed to conducting a consultation as part of that review.</p><p> </p><p>The Explanatory Memorandum also reflects the main concerns raised in the consultation. Because the consultation was not a public one, the Department’s response to the consultation has not been published but has been sent to all respondents and is available on request.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 31/01/2019 16:19:22 answering member 4067 label Biography information for Steve Brine
	tabling member	4249 label Biography information for Anne Marie Morris

1047000

	registered interest
	date	23/01/2019
	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	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, with reference to his Department's informal consultation with stakeholder representative bodies on changes to the Human Medicines Regulation 2012 to ensure the continuity of supply of medicines (including in a no deal Brexit), published on 14 January 2019, what (a) formal processes and (b) governance arrangements will be in place to ensure that any serious shortage designation has been reached in a robust manner.
	tabling member constituency	Newton Abbot
	tabling member printed	Anne Marie Morris
	uin	211778
	answer	answer is ministerial correction date of answer 31/01/2019 answer text <p>The Department has well-established governance processes and arrangements for managing medicine shortages in collaboration with manufacturers and suppliers, clinicians and the National Health Service and the Medicines and Healthcare products Regulatory Agency (MHRA). A serious shortage protocol is only one of the tools that can be used to manage shortages. This protocol would only be introduced in case of a serious shortage, if it would help manage the supply situation and if clinicians think it is appropriate, after discussion with the manufacturer and/or marketing authorisation holder when other mitigation measures have been exhausted. Work on operationalising the serious shortage legislation, including the governance processes is ongoing, including the creation of a national, clinically-chaired group advising Ministers and national oversight at senior doctor level. The operation of the serious shortage protocol legislation will be reviewed one year after the first protocol has been issued.</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 211776 question first answered 31/01/2019 16:17:42 answering member 4067 label Biography information for Steve Brine
	tabling member	4249 label Biography information for Anne Marie Morris

1015151

	registered interest
	date	26/11/2018
	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	Diabetes: Medical Equipment
	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 NHS England's News story of 14 November 2018, NHS to provide life changing glucose monitors for Type 1 diabetes patients, what plans NHS England has to make available nationally (a) AccuChek Expert, (b) Dexcom G6 and (c) EversenseXL; and if he will make a statement.
	tabling member constituency	Newton Abbot
	tabling member printed	Anne Marie Morris
	uin	195657
	answer	answer is ministerial correction date of answer 29/11/2018 answer text <p>NHS England has recently announced plans to enable consistent national availability of the Freestyle Libre Flash Glucose Monitoring device according to published guidance.</p><p>Clinical commissioning groups (CCGs) can purchase any available blood glucose monitoring which has been approved for sale on the open market. The availability of AccuChek Expert, Dexcom G6 and Eversense XL products is a matter for CCGs who are primarily responsible for commissioning diabetes services, to meet the requirements of their population. In doing so, they need to ensure that the services they provide are fit for purpose, reflect the needs of the local population, are based on the available evidence and consider national guidelines. NHS England engages with technology companies developing products that may be of significant benefit to those with diabetes to seek to increase their availability to patients where appropriate.</p><p>The Department does not collate data on the number of patients using these devices nationally or by clinical commissioning group.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 29/11/2018 17:24:34 answering member 4067 label Biography information for Steve Brine
	tabling member	4249 label Biography information for Anne Marie Morris

1015152

	registered interest
	date	26/11/2018
	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	Diabetes: Medical Equipment
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, which blood glucose monitoring systems the NHS makes available; and how many people are using each such system (a) nationally and (b) in each clinical commissioning group area.
	tabling member constituency	Newton Abbot
	tabling member printed	Anne Marie Morris
	uin	195658
	answer	answer is ministerial correction date of answer 29/11/2018 answer text <p>NHS England has recently announced plans to enable consistent national availability of the Freestyle Libre Flash Glucose Monitoring device according to published guidance.</p><p>Clinical commissioning groups (CCGs) can purchase any available blood glucose monitoring which has been approved for sale on the open market. The availability of AccuChek Expert, Dexcom G6 and Eversense XL products is a matter for CCGs who are primarily responsible for commissioning diabetes services, to meet the requirements of their population. In doing so, they need to ensure that the services they provide are fit for purpose, reflect the needs of the local population, are based on the available evidence and consider national guidelines. NHS England engages with technology companies developing products that may be of significant benefit to those with diabetes to seek to increase their availability to patients where appropriate.</p><p>The Department does not collate data on the number of patients using these devices nationally or by clinical commissioning group.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 29/11/2018 17:43:51 answering member 4067 label Biography information for Steve Brine
	tabling member	4249 label Biography information for Anne Marie Morris