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1139686

registered interest
date	17/07/2019
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	Medical Equipment: UK Notified Bodies
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 adequacy of the number of notified bodies to service medical devices under the terms of the Medical Devices Regulation.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	278523
answer	answer is ministerial correction date of answer 25/07/2019 answer text <p>New European Union Regulations for medical devices (MDR) entered into force in May 2017 and will fully apply from May 2020.</p><p>The new Regulations substantially strengthen the regulatory framework for medical devices and notified bodies are having to make significant changes to meet the enhanced requirements. These changes have the aim of improving the quality, consistency and rigour of notified body assessments, which was one of the Government’s key aims for the new legislation.</p><p>Ministers have met with and received letters from industry representatives who have raised concerns about capacity in the notified body sector across the EU to support the implementation of the MDR. The Government recognises the importance of having competent notified bodies across the EU in place in sufficient time to ensure continuity of supply of products to the United Kingdom market.</p><p>For this reason, at the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council on 14 June, the Parliamentary Under-Secretary of State (Baroness Blackwood of North Oxford) raised the Government’s concerns about the readiness of critical infrastructure required to implement the MDR and the risk that some existing and new to market products will not be available to patients as a result.</p><p>We very much recognise the benefits of the new Regulations and the imperative of full implementation as soon as possible in the interests of patient safety. Therefore, at EPSCO the Government emphasised the importance of finding a coordinated solution at an EU level and we will continue to do what we can to influence these discussions.</p><p>In parallel with this activity, the Medicines and Healthcare products Regulatory Agency (MHRA) has been engaging with its notified bodies on an ongoing basis to ensure that sufficient resources are in place and notified bodies are prepared for the implementation of the new EU legislation. The MHRA is also offering a substantial amount of resource to the EU in order to support and expedite the designation process.</p><p>Through the Office for Life Sciences, the Government plans to work with stakeholders to come to a shared understanding of the issues and discuss what further mitigating action could be taken. Further engagement with industry will therefore take place in the short term.</p><p> </p> answering member constituency Thurrock answering member printed Jackie Doyle-Price grouped question UIN 277763 277764 question first answered 25/07/2019 10:00:04 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	4398 label Biography information for Chris Green

1139219

registered interest
date	16/07/2019
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	Medical Equipment: UK Notified Bodies
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what recent representations he has received from the medical technology sector on the capacity of Notified Bodies to meet the demand for their services under the provisions of the Medical Devices Regulation; and if he will make a statement.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	277763
answer	answer is ministerial correction date of answer 25/07/2019 answer text <p>New European Union Regulations for medical devices (MDR) entered into force in May 2017 and will fully apply from May 2020.</p><p>The new Regulations substantially strengthen the regulatory framework for medical devices and notified bodies are having to make significant changes to meet the enhanced requirements. These changes have the aim of improving the quality, consistency and rigour of notified body assessments, which was one of the Government’s key aims for the new legislation.</p><p>Ministers have met with and received letters from industry representatives who have raised concerns about capacity in the notified body sector across the EU to support the implementation of the MDR. The Government recognises the importance of having competent notified bodies across the EU in place in sufficient time to ensure continuity of supply of products to the United Kingdom market.</p><p>For this reason, at the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council on 14 June, the Parliamentary Under-Secretary of State (Baroness Blackwood of North Oxford) raised the Government’s concerns about the readiness of critical infrastructure required to implement the MDR and the risk that some existing and new to market products will not be available to patients as a result.</p><p>We very much recognise the benefits of the new Regulations and the imperative of full implementation as soon as possible in the interests of patient safety. Therefore, at EPSCO the Government emphasised the importance of finding a coordinated solution at an EU level and we will continue to do what we can to influence these discussions.</p><p>In parallel with this activity, the Medicines and Healthcare products Regulatory Agency (MHRA) has been engaging with its notified bodies on an ongoing basis to ensure that sufficient resources are in place and notified bodies are prepared for the implementation of the new EU legislation. The MHRA is also offering a substantial amount of resource to the EU in order to support and expedite the designation process.</p><p>Through the Office for Life Sciences, the Government plans to work with stakeholders to come to a shared understanding of the issues and discuss what further mitigating action could be taken. Further engagement with industry will therefore take place in the short term.</p><p> </p> answering member constituency Thurrock answering member printed Jackie Doyle-Price grouped question UIN 277764 278523 question first answered 25/07/2019 10:00:04 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	4398 label Biography information for Chris Green

1139220

registered interest
date	16/07/2019
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	Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
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 plans to seek an extension to the implementation period of the Medical Devices Regulation from the EU.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	277764
answer	answer is ministerial correction date of answer 25/07/2019 answer text <p>New European Union Regulations for medical devices (MDR) entered into force in May 2017 and will fully apply from May 2020.</p><p>The new Regulations substantially strengthen the regulatory framework for medical devices and notified bodies are having to make significant changes to meet the enhanced requirements. These changes have the aim of improving the quality, consistency and rigour of notified body assessments, which was one of the Government’s key aims for the new legislation.</p><p>Ministers have met with and received letters from industry representatives who have raised concerns about capacity in the notified body sector across the EU to support the implementation of the MDR. The Government recognises the importance of having competent notified bodies across the EU in place in sufficient time to ensure continuity of supply of products to the United Kingdom market.</p><p>For this reason, at the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council on 14 June, the Parliamentary Under-Secretary of State (Baroness Blackwood of North Oxford) raised the Government’s concerns about the readiness of critical infrastructure required to implement the MDR and the risk that some existing and new to market products will not be available to patients as a result.</p><p>We very much recognise the benefits of the new Regulations and the imperative of full implementation as soon as possible in the interests of patient safety. Therefore, at EPSCO the Government emphasised the importance of finding a coordinated solution at an EU level and we will continue to do what we can to influence these discussions.</p><p>In parallel with this activity, the Medicines and Healthcare products Regulatory Agency (MHRA) has been engaging with its notified bodies on an ongoing basis to ensure that sufficient resources are in place and notified bodies are prepared for the implementation of the new EU legislation. The MHRA is also offering a substantial amount of resource to the EU in order to support and expedite the designation process.</p><p>Through the Office for Life Sciences, the Government plans to work with stakeholders to come to a shared understanding of the issues and discuss what further mitigating action could be taken. Further engagement with industry will therefore take place in the short term.</p><p> </p> answering member constituency Thurrock answering member printed Jackie Doyle-Price grouped question UIN 277763 278523 question first answered 25/07/2019 10:00:04 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	4398 label Biography information for Chris Green

1138235

registered interest
date	10/07/2019
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	Weather: Health Education
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 his Department has made of the adequacy of the funding allocated to the NHS Help us help you to stay well this winter campaign in the (a) last and (b) next 12 months.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	275776
answer	answer is ministerial correction date of answer 16/07/2019 answer text <p>As for all NHS England campaigns, the adequacy of the funding for the ‘NHS Help Us Help You Winter Pressures’ campaign is measured by the effectiveness of the campaign in achieving it objectives, which are set.</p><p>The independent evaluation research showed that the 2018/19 ‘NHS Help Us Help You Winter Pressures’ campaign successfully achieved 15 of the 18 objectives set before the activity started. The ‘NHS Help Us Help You Winter Pressures’ campaign budget for 2019/20 has been reduced by 7.5% when compared to the budget for 2018/19. However, NHS England expects to deliver similar levels of effectiveness.</p><p> </p><p> </p><p><strong> </strong></p> answering member constituency Wimbledon answering member printed Stephen Hammond question first answered 16/07/2019 16:08:01 answering member 1585 label Biography information for Stephen Hammond
tabling member	4398 label Biography information for Chris Green

1138237

registered interest
date	10/07/2019
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	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, how much funding his Department has committed to spend on campaigns to promote flu vaccination in 2019.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	275777
answer	answer is ministerial correction date of answer 18/07/2019 answer text <p>Public Health England is planning to spend £1,300,000 on a flu vaccination campaign to encourage eligible members of the public and health and social care workers to take up the free vaccine ahead of the winter season. The spend includes expenditure for advertising on television, radio, national and regional press, outdoor, digital, and printing, excluding VAT. Figures provided are provisional and need to be reconciled following the campaign’s conclusion in November.</p><p>Flu marketing resources can be viewed at following link:</p><p><a href="https://campaignresources.phe.gov.uk/resources/campaigns/34-stay-well-this-winter-/resources" target="_blank">https://campaignresources.phe.gov.uk/resources/campaigns/34-stay-well-this-winter-/resources</a></p> answering member constituency South Ribble answering member printed Seema Kennedy question first answered 18/07/2019 09:01:30 answering member 4455 label Biography information for Seema Kennedy
tabling member	4398 label Biography information for Chris Green

1128437

registered interest
date	23/05/2019
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 (a) NICE and (b) NHS England take into account the availability of medicines under the Early Access to Medicines Scheme when assessing those same medicines for approval as new medicines.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	257759
answer	answer is ministerial correction date of answer 07/06/2019 answer text <p>The National Institute for Health and Care Excellence takes into account the availability of medicines through the Early Access to Medicines Scheme (EAMS) in terms of scheduling its assessments, however the process followed in assessing the technology is the same as for non-EAMS technologies.</p> answering member constituency South Ribble answering member printed Seema Kennedy question first answered 07/06/2019 14:54:05 answering member 4455 label Biography information for Seema Kennedy
tabling member	4398 label Biography information for Chris Green

1127772

registered interest
date	21/05/2019
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, whether the review of the methods for the NICE Technology Appraisal Programme referred to in the 2019 voluntary scheme for branded medicines pricing and access will include support for earlier patient access to innovative medicines.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	257056
answer	answer is ministerial correction date of answer 30/05/2019 answer text <p>The National Institute for Health and Care Excellence (NICE) is in the process of scoping the review of the methods for technology appraisal and highly specialised technologies evaluations. Scoping will involve patient organisations and other relevant stakeholders, including industry. The Voluntary Scheme for Branded Medicines Pricing and Access sets out the Department’s expectation that that any future changes to NICE methods and processes would support faster adoption of the most clinically and cost effective medicines. Additional detail and more information will be made available on the NICE website in due course.</p><p>The 2019 Voluntary Scheme also states that NICE will adopt the principle of appraisal timelines for non-oncology treatments matching the faster timescales for oncology treatments, subject to the evidence base for the product being sufficiently developed to enable a NICE appraisal with the same level of rigour and certainty as would be expected currently.</p> answering member constituency South Ribble answering member printed Seema Kennedy question first answered 30/05/2019 10:52:06 answering member 4455 label Biography information for Seema Kennedy
tabling member	4398 label Biography information for Chris Green

1121864

registered interest
date	18/04/2019
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	Medicine: Research
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 encourage the National Institute for Health Research and the Clinical Research Network to diversify their research portfolios to include a greater proportion of commercially funded research and clinical trials.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	245817
answer	answer is ministerial correction date of answer 30/04/2019 answer text <p>Through the National Institute for Health Research (NIHR), including the NIHR Clinical Research Network, the Government is increasing the volume of clinical trials and other well-designed studies undertaken, and increasing the proportion of commercially funded research.</p><p>In 2017 the Government announced more than £950 million investment in research infrastructure in the National Health Service including Biomedical Research Centres (BRCs), Clinical Research Facilities, Experimental Cancer Medicine Centres (funded in partnership with Cancer Research UK and the devolved administrations) and Medtech and In vitro diagnostics Co-operatives. These centres and facilities conduct and support translational research to transform scientific breakthroughs into life-saving treatments for patients.</p><p>In 2017-18, the NIHR’s research infrastructure generated over £231 million of industry research investment, and the NIHR’s BRCs supported over 1,770 industry collaborative and contract research studies, filed 199 patents, and created five spin-out companies.</p> answering member constituency Gosport answering member printed Caroline Dinenage question first answered 30/04/2019 09:40:02 answering member 4008 label Biography information for Dame Caroline Dinenage
tabling member	4398 label Biography information for Chris Green

1121865

registered interest
date	18/04/2019
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	Medicine: Research
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what proportion of medical research is (a) commercially funded and (b) funded by grants and non-commercial sources.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	245818
answer	answer is ministerial correction date of answer 30/04/2019 answer text <p>The best estimates that we have is that the proportion of commercial and non-commercial funded medical research is 48% and 52% respectively. This is taken from analysis produced by the UK Clinical Research Collaboration (UKCRC) published in 2014 which estimated total health research and development (R&amp;D) funding in the United Kingdom was £8.5 billion.</p><p>The figures for commercial research come from a variety of sources. The 2014 UKCRC analysis draws on the Office for National Statistics Business Enterprise Research and Development (ONS BERD) survey which was used to provide private sector data where relevant research is categorised as ‘pharmaceuticals’. This will under-estimate private sector investment as other product groups may be relevant to health research and the private sector will fund research outside of the business, for example, in academia. In 2014, pharmaceuticals R&amp;D totalled £4.1 billion. The more recent ONS BERD survey of 2017 indicated that this has increased to £4.3 billion.</p><p>For the 52% of non-commercial funded medical research in 2014, approximately £4.4 billion, this was made up of funding predominantly from the Medical Research Council (MRC), the National Institute for Health Research (NIHR), other research councils and from medical research charities.</p><p>In 2016/17, Government funding for medical research was mainly distributed by the MRC, now part of UK Research and Innovation (UKRI), and the NIHR, funded by the Department, which invested £0.8 billion and £1.0 billon in medical research respectively. Other UKRI research councils also contribute to medical research in addition to funding from other Government departments and the devolved administrations.</p><p>In 2016, the Association of Medical Research Charities’ members invested £1.6 billion into medical research.</p> answering member constituency Gosport answering member printed Caroline Dinenage question first answered 30/04/2019 09:56:33 answering member 4008 label Biography information for Dame Caroline Dinenage
tabling member	4398 label Biography information for Chris Green

1110547

registered interest
date	09/04/2019
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	Medicine: Research
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 encourage the NHS and GP practices to increase participation in commercial research.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	242860
answer	answer is ministerial correction date of answer 16/04/2019 answer text <p>Through the National Institute for Health Research (NIHR), the Government is investing in the infrastructure, skills and facilities that the National Health Service and general practitioner (GP) practices need to participate in commercial research.</p><p> </p><p>In 2017 the Government announced more than £950 million investment in research infrastructure in the National Health Service including Biomedical Research Centres (BRCs), Clinical Research Facilities, Experimental Cancer Medicine Centres (funded in partnership with Cancer Research UK and the Devolved Administrations) and Medtech and In vitro diagnostics Co-operatives.</p><p> </p><p>These centres and facilities conduct and support translational research to transform scientific breakthroughs into life-saving treatments for patients. In 2017-18, NIHR research infrastructure has generated over £231 million of industry research investment, and the NIHR BRCs have supported over 1,770 Industry collaborative and contract research studies, filed 199 patents, and created five spin-out companies.</p><p> </p><p>The NIHR Clinical Research Network (CRN) supports the delivery of clinical research trials and other studies in the NHS to quality, time and target, providing world-class health service infrastructure, for example research support staff such as clinical research nurses; and research support services such as pharmacy, pathology and radiology, to support clinical research in the NHS in England.</p><p> </p><p>In 2017-18 the NIHR CRN achieved record levels of recruitment with over 725,000 people taking part in clinical research studies supported by the Network. Of these, over 50,000 participants were recruited to studies sponsored by the life sciences industry, including 24 global first patients. Around 10,000 of these participants were recruited in primary care, primarily through GP practices.</p><p> </p><p>The NIHR CRN has the ambition to increase the proportion of NHS trusts and GP practices involved in delivering commercial clinical research. In 2017/18 99% of NHS trusts and 32% of GP practices were actively engaged in clinical research, and 82% of NHS trusts and 2% of GP practices recruited patients into commercial contract research studies.</p><p> </p><p>The Life Sciences Industrial Strategy and Sector Deals confirm the United Kingdom’s commitment to life sciences research. Life Sciences Sector Deal 2 announced a suite of measures to make our clinical research environment faster, more efficient, streamlined and innovative. The NIHR has committed to work closely with industry and NHS trusts to investigate workforce resource challenges in commercial contract research, and to identify opportunities to recognise and incentivise NHS trusts and GP practices acting as participant identification centres.</p><p> </p><p>The NHS Long Term Plan recognises that increased research participation leads to improved healthcare performance and that research and innovation are important for the UK economy, confirming that the NHS endorses and will play its full part in delivering the Life Sciences Sector Deals. In addition, the Long Term Plan commits to increase the number of people registering to participate in health research to one million by 2023/24, and to continue to make it faster, cheaper and easier to undertake research in England through simpler standardised trial set-up processes and prices, initiated as part of NHS England’s 12 Actions to Support and Apply Research in the NHS.</p> answering member constituency Gosport answering member printed Caroline Dinenage question first answered 16/04/2019 14:28:33 answering member 4008 label Biography information for Dame Caroline Dinenage
tabling member	4398 label Biography information for Chris Green