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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

1139222

registered interest
date	16/07/2019
answering body	Department for Business, Energy and Industrial Strategy
answering dept id	201
answering dept short name	Business, Energy and Industrial Strategy
answering dept sort name	Business, Energy and Industrial Strategy
hansard heading	Research: Finance
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Business, Energy and Industrial Strategy, what assessment he has made of the equity of the distribution of research and development spending for areas with poor health outcomes.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	277765
answer	answer is ministerial correction date of answer 22/07/2019 answer text <p>I refer the hon. Member to the answer I gave the hon. Member for Newcastle upon Tyne Central (Chi Onwurah MP) on 9 May 2019 to Question <a href="https://www.parliament.uk/business/publications/written-questions-answers-statements/written-question/Commons/2019-04-30/249283/" target="_blank">249283</a>. Further to that answer, on 11 July 2019 the Government announced £135 million of funding to support National Institute for Health Research (NIHR) Applied Research Collaborations (ARCs). The NIHR ARC scheme will support high-quality applied health and care research to make tangible improvements for patients, the public and to health and care services. NIHR ARCs will work with local partners and patients and the public from across the local communities they serve, and particularly with Academic Health Science Networks, to tackle local health and care priorities.</p> answering member constituency Kingswood answering member printed Chris Skidmore question first answered 22/07/2019 15:18:24 answering member 4021 label Biography information for Chris Skidmore
tabling member	4398 label Biography information for Chris Green

1139223

registered interest
date	16/07/2019
answering body	Department for Business, Energy and Industrial Strategy
answering dept id	201
answering dept short name	Business, Energy and Industrial Strategy
answering dept sort name	Business, Energy and Industrial Strategy
hansard heading	Research: Finance
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Business, Energy and Industrial Strategy, what steps he plans to take to ensure that the Government's target of increasing research and development funding to 2.4 per cent of GDP benefits the areas with the poorest health outcomes, particularly parts of the north of England.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	277766
answer	answer is ministerial correction date of answer 22/07/2019 answer text <p>The 2.4% R&amp;D Roadmap will set overall direction for how we can achieve the 2.4% R&amp;D ambition by 2027, and 3% in the longer term, through the use of strategic public funding to leverage private R&amp;D investment.</p><p>It aims to transform R&amp;D intensity across all sectors of the economy, supporting the development of new technologies, industries, and products that bring growth, good jobs across the UK, and social improvements for all.</p><p>The 2.4% R&amp;D Roadmap will bring together Government, academia, and industry to collaboratively focus their efforts on increasing R&amp;D investment. In the area of health, this includes the Department of Health and Social Care and NHS R&amp;D activity, and work with industry in taking forward the Life Sciences Sector Deal. The 2.4% R&amp;D Roadmap will also align closely with the Industrial Strategy’s Grand Challenges. This includes the Ageing Society Grand Challenge which will create new demands for technologies, products and services for an ageing population, and the AI and Data Grand Challenge which will use data, artificial intelligence, and innovation to transform the prevention, early diagnosis, and treatment of diseases like cancer, diabetes, heart disease, and dementia by 2030.</p><p>In order to achieve the 2.4% R&amp;D target, we need to accelerate the growth and build on R&amp;D strengths across the UK. The Government has put in place a number of initiatives to support every part of the UK to identify and leverage their R&amp;D strengths, from Science and Innovation Audits to the Strength in Places Fund. The Strength in Places Fund (SIPF) is investing £237m up to 2021-22 in growing new and existing centres of excellence for research and innovation across the UK.</p><p>We are working with Local Economic Partnerships as they develop Local Industrial Strategies to identify science and innovation strengths and the action needed to unlock R&amp;D growth in places across the country.</p> answering member constituency Kingswood answering member printed Chris Skidmore question first answered 22/07/2019 15:15:15 answering member 4021 label Biography information for Chris Skidmore
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

1122385

registered interest
date	23/04/2019
answering body	Department for Business, Energy and Industrial Strategy
answering dept id	201
answering dept short name	Business, Energy and Industrial Strategy
answering dept sort name	Business, Energy and Industrial Strategy
hansard heading	STEM Subjects: Research
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Business, Energy and Industrial Strategy, whether he has plans to increase Government funding to support the STEM research sector; and what recent assessment he has made of the effect of such Government funding on changes in the number of highly skilled people working in that sector.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	246536
answer	answer is ministerial correction date of answer 29/04/2019 answer text <p>Through our modern Industrial Strategy we have committed to the highest R&amp;D increase on record. We have announced increases in public R&amp;D spending worth £7bn up to 2021/2022, and we are working with UK Research and Innovation and other key partners to develop a roadmap that sets out how government and industry will work together to reach our target of increasing R&amp;D investment to 2.4% of GDP by 2027, which would be the highest recorded level, and 3% in the longer-term.</p><p> </p><p>The Government recognises that to make best use of this increased level of investment in science we will need to increase the number of researchers and strengthen the pipeline leading to research careers. Though it is too early to assess the impacts of these new programmes we are addressing this need through such programmes as UK Research and Innovation’s £900m Future Leaders Fellowship which aims to attract the best researchers from the UK and from around the world.</p><p> </p> answering member constituency Kingswood answering member printed Chris Skidmore question first answered 29/04/2019 15:24:40 answering member 4021 label Biography information for Chris Skidmore
tabling member	4398 label Biography information for Chris Green