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1655857

registered interest
date	01/09/2023
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 document entitled Final impact assessment: statutory scheme to control costs of branded health service medicines, published in March 2020, whether his Department plans to update that impact assessment using data from the Life Sciences Competitiveness Indicators 2023.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	195966
answer	answer is ministerial correction date of answer 07/09/2023 answer text <p>The Government publishes new impact assessments each time the statutory scheme is updated. Further impact assessments were published in respect of updates made to the statutory scheme in 2022 and 2023.</p><p>The Government is currently consulting on updates to the statutory scheme to make sure that the scheme can continue to meet its objectives from 2024 onwards. A consultation stage impact assessment of the proposed updates has been published, and is available at the following link:</p><p><a href="https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1179564/impact-assessment-review-scheme-cost-branded-medicines-updated-21-august-2023.pdf" target="_blank">https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1179564/impact-assessment-review-scheme-cost-branded-medicines-updated-21-august-2023.pdf</a></p><p>An updated impact assessment will be published alongside the response to the consultation and will include the updated Competitiveness Indicators in the evidence base.</p> answering member constituency Colchester answering member printed Will Quince question first answered 07/09/2023 15:02:04 answering member 4423 label Biography information for Will Quince
tabling member	4398 label Biography information for Chris Green

1655861

registered interest
date	01/09/2023
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	Gene Therapies
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 11 July 2023 to Question 192548 on Gene Therapies, how many of the advanced therapeutic medicinal products evaluated by the National Institute for Health and Care Excellence that have been recommended for use were gene therapies appraised through the Single Technology Appraisal pathway.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	195970
answer	answer is ministerial correction date of answer 08/09/2023 answer text <p>As of 5 September 2023, the National Institute for Health and Care Excellence has made positive recommendations on eight out of the nine gene therapy medicinal products it has evaluated using its single technology appraisal process.</p> answering member constituency Colchester answering member printed Will Quince question first answered 08/09/2023 12:02:28 answering member 4423 label Biography information for Will Quince
tabling member	4398 label Biography information for Chris Green

1655862

registered interest
date	01/09/2023
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	Influenza: Vaccination
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, whether his Department makes an estimate of the timescale for manufacturing influenza vaccines to (a) inform its decision on eligibility for the annual NHS influenza immunisation programme and (b) ensure the adequacy of supply of those vaccines across the country.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	195971
answer	answer is ministerial correction date of answer 14/09/2023 answer text <p>The Joint Committee on Vaccination and Immunisation regularly discuss with the vaccine manufacturing industry issues such as the availability of new and existing vaccines, and manufacturing lead in times. Their advice about which flu vaccines are to be used for the coming season is informed by these discussions. An effective programme depends on a reliable supply of vaccine. It takes approximately five to six months for the first supplies of approved vaccine to become available once a new strain of influenza virus is identified and isolated.</p><p>National Health Service providers determine how many seasonal flu vaccines to buy for eligible cohorts each year based on their local populations, as outlined in the annual flu system letter. The letter, published on 25 May 2023, is based on the advice of the JCVI, which reviews the latest evidence on flu vaccines and advises on the type of vaccine to be offered to different age groups and on which vaccines should be prioritised for various at-risk groups.</p><p>General practitioners and community pharmacists are responsible for ordering their own flu vaccines for the adult population from suppliers. These are then used to deliver the national flu vaccination programme, with deliveries phased through the season to help mitigate against risks of wastage, cold chain failure and to adequately cover the peaks and flows of local demand.</p><p>NHS England encourages their contractors to purchase vaccines from more than one manufacturer to mitigate against the risk of supply issues. Regional NHS England commissioners, in partnership with their local systems, also make assessments of the amount of vaccine available in their area to ensure there is enough supply to meet public demand.</p><p>The UK Health Security Agency secures and supplies a sufficient volume of flu vaccines used in the children’s flu programme to ensure that eligible children aged less than 18 years old who present for vaccination can be offered an appropriate vaccine.</p> answering member constituency Lewes answering member printed Maria Caulfield question first answered 14/09/2023 15:27:31 answering member 4492 label Biography information for Maria Caulfield
tabling member	4398 label Biography information for Chris Green

1655863

registered interest
date	01/09/2023
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	Influenza: Vaccination
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, whether his Department plans to ask the Joint Committee on Vaccination and Immunisation to update the baseline modelling and assumptions it uses to make decisions on the cost-effectiveness of vaccinating specific age cohorts against seasonal influenza.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	195972
answer	answer is ministerial correction date of answer 08/09/2023 answer text <p>For the Joint Committee on Vaccination and Immunisation to formally revisit the cost-effectiveness of vaccinating specific age cohorts against seasonal influenza, an up-to-date impact and cost effectiveness analysis would be required, and the UK Health Security Agency is in the process of updating the influenza model using more recent data, including accounting for changes due to the pandemic.</p><p>There is currently uncertainty on any longer-term changes because of the pandemic to social contact patterns and the activity of flu in the population for a fully robust update to cost effectiveness analysis in the short term.</p> answering member constituency Lewes answering member printed Maria Caulfield question first answered 08/09/2023 14:16:55 answering member 4492 label Biography information for Maria Caulfield
tabling member	4398 label Biography information for Chris Green

1650374

registered interest
date	05/07/2023
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	Abortion: 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 assessment he has made of the implications for his policies of provision of abortion pills to a woman beyond the legal limit for abortion by the British Pregnancy Advisory Service.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	192546
answer	answer is ministerial correction date of answer 14/07/2023 answer text <p>No assessment has been made of the implications for policies on the provision of abortion pills to a woman beyond the legal time limit for abortion.</p><p>The law on abortion and required standards of medical care are clear. The Department continues to work closely with NHS England, the Care Quality Commission and abortion providers to ensure that abortions in England are performed in accordance with the Abortion Act 1967.</p><p>There are no plans to review Section 3(D) of the Abortion Act 1967. Parliament decided the circumstances under which abortion can legally be undertaken. It would be for Parliament to decide whether to make any changes to the law on abortion. As with other matters of conscience, abortion is an issue on which the Government adopts a neutral stance and allows hon. Members to vote according to their moral, ethical or religious beliefs.</p> answering member constituency Lewes answering member printed Maria Caulfield grouped question UIN 192547 question first answered 14/07/2023 10:44:11 answering member 4492 label Biography information for Maria Caulfield
tabling member	4398 label Biography information for Chris Green

1650375

registered interest
date	05/07/2023
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	Abortion: 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 his Department will make an assessment of the potential merits of reviewing Section 3(D) of the Abortion Act 1967 in the context of potential risks presented to the health and safety of women.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	192547
answer	answer is ministerial correction date of answer 14/07/2023 answer text <p>No assessment has been made of the implications for policies on the provision of abortion pills to a woman beyond the legal time limit for abortion.</p><p>The law on abortion and required standards of medical care are clear. The Department continues to work closely with NHS England, the Care Quality Commission and abortion providers to ensure that abortions in England are performed in accordance with the Abortion Act 1967.</p><p>There are no plans to review Section 3(D) of the Abortion Act 1967. Parliament decided the circumstances under which abortion can legally be undertaken. It would be for Parliament to decide whether to make any changes to the law on abortion. As with other matters of conscience, abortion is an issue on which the Government adopts a neutral stance and allows hon. Members to vote according to their moral, ethical or religious beliefs.</p> answering member constituency Lewes answering member printed Maria Caulfield grouped question UIN 192546 question first answered 14/07/2023 10:44:11 answering member 4492 label Biography information for Maria Caulfield
tabling member	4398 label Biography information for Chris Green

1650376

registered interest
date	05/07/2023
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	Gene Therapies
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, whether the National Institute for Health and Care Excellence’s Single Technology Appraisal pathway is compatible with emerging innovations including gene therapies.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	192548
answer	answer is ministerial correction date of answer 11/07/2023 answer text <p>The National Institute for Health and Care Excellence (NICE) evaluates gene therapies through both its technology appraisal programme and its highly specialised technologies programmes as appropriate. NICE’s processes have been proven to be suitable for the evaluation of advanced therapeutic medicinal products (ATMPs) where companies are willing to price their products in a way that represents value to the taxpayer. NICE has recommended 80% of the ATMPs it has evaluated for use by the National Health Service and they are now available for the treatment of NHS patients, including through the Cancer Drugs Fund and managed access agreements negotiated between the NHS and the manufacturer.</p><p>Most recently, in April 2023, NICE recommended eladocagene exuparvovec, the first and currently only gene therapy for children with an ultra-rare genetic disorder, aromatic L-amino acid decarboxylase deficiency, enabling its use on the NHS in England.</p> answering member constituency Colchester answering member printed Will Quince question first answered 11/07/2023 15:09:38 answering member 4423 label Biography information for Will Quince
tabling member	4398 label Biography information for Chris Green

1650377

registered interest
date	05/07/2023
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	Gene Therapies
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 his Department has taken to implement the commitment in the National Institute for Health and Care Excellence’s methods and processes review to accept a greater degree of uncertainty in the evaluation of innovative new health technologies, including emerging cell and gene therapies.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	192549
answer	answer is ministerial correction date of answer 11/07/2023 answer text <p>The National Institute for Health and Care Excellence (NICE) is an independent body and is responsible for the methods and processes that it uses in the development of its guidance. NICE made a number of changes to its health technology evaluation manual in January 2022 following a comprehensive review of its methods and processes, including to clarify its committees’ additional flexibility in considering uncertainty when evidence generation is difficult. NICE’s technology appraisal and highly specialised technology committees are now using the updated health technology evaluation manual for all new evaluations which began after 1 February 2022, including evaluations of cell and gene therapies.</p> answering member constituency Colchester answering member printed Will Quince question first answered 11/07/2023 15:07:23 answering member 4423 label Biography information for Will Quince
tabling member	4398 label Biography information for Chris Green

1650378

registered interest
date	05/07/2023
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	Gene Therapies
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, whether his Department has made an assessment of the potential effect of NHS England’s Budget Impact Test on single-dose gene therapies.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	192550
answer	answer is ministerial correction date of answer 11/07/2023 answer text <p>No assessment has been made.</p><p>The Budget Impact Test is an integral part of the National Institute for Health and Care Excellence (NICE) evaluation process for new interventions, including gene therapies. It assesses the financial implications of introducing a new therapy by considering factors such as patient eligibility, treatment costs, and the impact on National Health Service resources. NICE undertakes a Budget Impact Test for each individual single-dose gene therapy as part of standard NICE process.</p> answering member constituency Colchester answering member printed Will Quince question first answered 11/07/2023 09:10:32 answering member 4423 label Biography information for Will Quince
tabling member	4398 label Biography information for Chris Green

1645682

registered interest
date	19/06/2023
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	Clinical Trials
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, how many participants were recruited to industry-sponsored clinical trials in each of the National Institute for Health and Care Research's Local Clinical Research Networks in 2022-23.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	190128
answer	answer is ministerial correction date of answer 22/06/2023 answer text <p>A total of 32,328 participants were recruited into industry sponsored clinical trials in England in 2022/23 which were supported by the National Institute for Health Research and Clinical Research Network (CRN). The following table shows a breakdown of the number by Local CRN.</p><p> </p><table><tbody><tr><td><p>Local CRN</p></td><td><p>2022/23</p></td></tr><tr><td><p>East Midlands</p></td><td><p>1716</p></td></tr><tr><td><p>East of England</p></td><td><p>2,579</p></td></tr><tr><td><p>Eastern</p></td><td><p>0</p></td></tr><tr><td><p>Greater Manchester</p></td><td><p>3,449</p></td></tr><tr><td><p>Kent, Surrey and Sussex</p></td><td><p>847</p></td></tr><tr><td><p>North East and North Cumbria</p></td><td><p>2,571</p></td></tr><tr><td><p>North Thames</p></td><td><p>2,723</p></td></tr><tr><td><p>North West Coast</p></td><td><p>1,840</p></td></tr><tr><td><p>North West London</p></td><td><p>3,216</p></td></tr><tr><td><p>South London</p></td><td><p>2,255</p></td></tr><tr><td><p>South West Peninsula</p></td><td><p>1,807</p></td></tr><tr><td><p>Thames Valley and South Midlands</p></td><td><p>1,432</p></td></tr><tr><td><p>Wessex</p></td><td><p>1,692</p></td></tr><tr><td><p>West Midlands</p></td><td><p>2,507</p></td></tr><tr><td><p>West of England</p></td><td><p>1,262</p></td></tr><tr><td><p>Yorkshire and Humber</p></td><td><p>2,432</p></td></tr><tr><td><p>Total</p></td><td><p>32,328</p></td></tr></tbody></table><p> </p> answering member constituency Colchester answering member printed Will Quince question first answered 22/06/2023 15:56:13 answering member 4423 label Biography information for Will Quince
tabling member	4398 label Biography information for Chris Green