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1084394

registered interest
date	08/03/2019
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, whether he will report to Parliament annually on the operation of the Voluntary Scheme for Branded Medicines Pricing and Access; and whether such reporting will extend to the operation of the statutory pricing scheme.
tabling member constituency	Newton Abbot
tabling member printed	Anne Marie Morris
uin	230052
answer	answer is ministerial correction date of answer 13/03/2019 answer text <p>The Department has agreed that the 2019 Voluntary Scheme for Branded Medicines Pricing and Access will be subject to regular six-monthly reviews and a mid-scheme review with all parties to the agreement expected to attend.</p><p> </p><p>The Department already produces quarterly reports on the operation of the voluntary and statutory schemes and this is set to continue. The relevant statutory scheme regulations require an annual review of the scheme, which will be made available to Parliament on an annual basis.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 13/03/2019 14:17:16 answering member 4067 label Biography information for Steve Brine
tabling member	4249 label Biography information for Anne Marie Morris

1084397

registered interest
date	08/03/2019
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	Voluntary Scheme for Branded Medicines Pricing and Access
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what plans are in place with respect to section 3.54 of the 2019 Voluntary Scheme for Branded Medicines Pricing and Access on UK data infrastructure.
tabling member constituency	Newton Abbot
tabling member printed	Anne Marie Morris
uin	230055
answer	answer is ministerial correction date of answer 13/03/2019 answer text <p>As set out in the Long Term Plan, the National Health Service in England is committed to improving the data infrastructure and data analytics in the NHS in both primary and secondary care over the next 10 years. This will support the improvement of the quality, safety and efficiency of NHS services, as well as providing a world class environment for clinical research. Higher quality data can also enable the NHS to improve the evidence for clinically and cost-effective medicines and support better value for medicines spend, as demonstrated by the Cancer Drugs Fund.</p><p> </p><p>Implementation of the ambitions set out in the Voluntary Scheme for Branded Medicines Pricing and Access, and the NHS Long Term Plan, will build on the work of the Global Digital Exemplars and will be supported by Digital Innovation Hubs.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 13/03/2019 14:14:15 answering member 4067 label Biography information for Steve Brine
tabling member	4249 label Biography information for Anne Marie Morris

1084398

registered interest
date	08/03/2019
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	Voluntary Scheme for Branded Medicines Pricing and Access
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 payments under the 2019 Voluntary Scheme for Branded Medicines Pricing and Access are used to increase access to medicines that are recognised by NICE as (a) cost and (b) clinically effective.
tabling member constituency	Newton Abbot
tabling member printed	Anne Marie Morris
uin	230056
answer	answer is ministerial correction date of answer 13/03/2019 answer text <p>Payments made by companies who are members of the 2019 Voluntary Scheme for Branded Medicines Pricing and Access are made to the Department. The Department then allocates the payments across the National Health Service in the United Kingdom. It is for the NHS in England and the devolved administrations to make decisions in the best interest of their patients to ensure access to the medicines they need.</p><p> </p><p>NHS commissioners are legally required to make funding available for drugs and other treatments recommended in National Institute for Health and Care Excellence (NICE) technology appraisal and highly specialised technologies guidance, normally within three months of the publication of final guidance. This is reflected in the NHS Constitution as a right to NICE approved treatments.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 13/03/2019 14:15:54 answering member 4067 label Biography information for Steve Brine
tabling member	4249 label Biography information for Anne Marie Morris

1064732

registered interest
date	21/02/2019
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, pursuant to the Answer of 12 February 2019 to Question 220230 on NHS: Drugs, whether he has plans to undertake a public consultation on the proposed Framework.
tabling member constituency	Newton Abbot
tabling member printed	Anne Marie Morris
uin	224335
answer	answer is ministerial correction date of answer 28/02/2019 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. In preparation for public consultation in the coming months, NHS England is actively engaging with industry trade bodies and health system partners, in the first instance, to progress the development of the commercial framework, as set out in the 2019 Voluntary Scheme for Branded Medicines Pricing and Access.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 28/02/2019 16:19:39 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

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

1058810

registered interest
date	11/02/2019
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, when each of the NICE methodology reviews for STA and HST are planned (a) to begin, (b) to be consulted upon and (c) to have the findings reported.
tabling member constituency	Newton Abbot
tabling member printed	Anne Marie Morris
uin	219448
answer	answer is ministerial correction date of answer 14/02/2019 answer text <p>The National Institute for Health and Care Excellence (NICE) is in the process of planning how to conduct its scoping of the review of the methods for technology appraisal and highly specialised technologies evaluations. Scoping will involve industry and other relevant stakeholders, including patient organisations and is timetabled in the 2019/20 business year. Additional detail and more information will be made available on the NICE website in due course.</p> answering member constituency Winchester answering member printed Steve Brine question first answered 14/02/2019 17:46:04 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

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