Speeches made during Parliamentary debates are recorded in Hansard. For ease of browsing we have grouped debates into individual, departmental and legislative categories.
These initiatives were driven by Baroness Finlay of Llandaff, and are more likely to reflect personal policy preferences.
The provisions of the Bill were ultimately enacted through the Online Safety Act 2023.
A Bill to require OFCOM to establish a unit to advise the Secretary of State regarding the use of social media platforms to encourage or assist serious self-harm and activities associated with risk of suicide; and for connected purposes
A Bill to make provision for equitable access to palliative care services; for advancing education, training and research in palliative care; and for connected purposes
A bill to make provision for NHS service commissioners to ensure that persons for whom they have responsibility for commissioning physical and mental health services have access to specialist and generalist palliative care and support services; to enable hospices to access pharmaceutical services on the same basis as other services commissioned by a clinical commissioning group; and to make provision for treatment of children with a life-limiting illness
A Bill to make provision for equitable access to palliative care services; for advancing education, training and research in palliative care; and for connected purposes.
Baroness Finlay of Llandaff has not co-sponsored any Bills in the current parliamentary sitting
The UK currently applies the UK Global Tariff of 20% to imports of tuna from the Maldives. This rate is also applied to imports from all other trading partners where preferential arrangements are not in place.
The Government continues to explore pragmatic opportunities to enhance bilateral trade relations with the Maldives in areas of mutual interest, including fishing.
Ministers and officials from Her Majesty’s Government and the Welsh Government meet regularly to discuss a range of issues including the safety and management of coal tips. In addition, the UK Coal Authority has been working alongside the Welsh Government on its programme of tip risk assessments and inspections.
We are aware of the enormous pressures that the pandemic has had on researchers and doctoral student’s ability to conduct their research. The Government has made available £280 million of funding to sustain UKRI and National Academy grant-funded research and fellowships affected by COVID-19 through costed grant extensions and other measures.
UKRI has made over £62 million of financial support available to students most impacted by the pandemic. It is estimated that this funding is available for up to 12,000 students. This will go some way in ensuring students at the beginning of their academic career will obtain their doctorates in good time and stead.
Most research environments have now adapted to the pandemic, adjusting data-collection plans for their projects, and also operating in a covid-safe way for staff on site. We understand some researchers have been disrupted more than others, and we expect institutions and funders to work with them on a case-by-case basis.
We will continue to monitor the impacts of COVID-19 and UKRI continues to listen and respond carefully as the situation evolves.
Gambling advertising and sponsorship, including around sport, must be socially responsible and must not be targeted at children. The government assessed the evidence on advertising in its Review of Gaming Machines and Social Responsibility Measures, the full response to which can be found at: https://www.gov.uk/government/consultations/consultation-on-proposals-for-changes-to-gaming-machines-and-social-responsibility-measures.
Since then, in March this year, the charity GambleAware has published the final report of a major piece of research into the effect of gambling marketing and advertising on children, young people and vulnerable people. That study found that exposure to advertising was associated with an openness to gamble in the future amongst children and young people aged 11-24 who did not currently gamble. It also found that there were other factors that correlated more closely with current gambling behaviour amongst those groups, including peer and parental gambling. It did not suggest a causal link between any of these and problem gambling in later life.
The government takes concerns raised about loot boxes in video games very seriously. On 23 September 2020 we launched an 8 week call for evidence which includes a focus on whether loot boxes cause harm and, if so, the nature of the harm. This will put us on the best footing to take any action that is necessary. We expect to publish a Government response to the call for evidence early next year.
Ministers and officials regularly engage with stakeholders on a wide range of issues. Ministers have not recently received representations from either the gambling or the sports sectors about gambling advertising or sponsorship of professional sports teams. The House of Lords Select Committee on the Economic and Social Impact of the Gambling Industry and Gambling Related Harm All Party Parliamentary Group have made recommendations to Ministers in both these areas.
Gambling advertising and sponsorship, including around sport, must be socially responsible and must not be targeted at children. The government assessed the evidence on advertising in its Review of Gaming Machines and Social Responsibility Measures, the full response to which can be found at: https://www.gov.uk/government/consultations/consultation-on-proposals-for-changes-to-gaming-machines-and-social-responsibility-measures.
Since then, in March this year, the charity GambleAware has published the final report of a major piece of research into the effect of gambling marketing and advertising on children, young people and vulnerable people. That study found that exposure to advertising was associated with an openness to gamble in the future amongst children and young people aged 11-24 who did not currently gamble. It also found that there were other factors that correlated more closely with current gambling behaviour amongst those groups, including peer and parental gambling. It did not suggest a causal link between any of these and problem gambling in later life.
The government takes concerns raised about loot boxes in video games very seriously. On 23 September 2020 we launched an 8 week call for evidence which includes a focus on whether loot boxes cause harm and, if so, the nature of the harm. This will put us on the best footing to take any action that is necessary. We expect to publish a Government response to the call for evidence early next year.
Ministers and officials regularly engage with stakeholders on a wide range of issues. Ministers have not recently received representations from either the gambling or the sports sectors about gambling advertising or sponsorship of professional sports teams. The House of Lords Select Committee on the Economic and Social Impact of the Gambling Industry and Gambling Related Harm All Party Parliamentary Group have made recommendations to Ministers in both these areas.
My right hon. Friend, the Secretary of State for Education and my hon. Friend, the Minister of State for Universities have regular meetings with Welsh ministers, and ministers from all the devolved administrations, about higher education issues. These discussions have included the development of student number controls policy. The department’s officials also have regular meetings and discussions with their counterparts.
Student number controls are a direct response to the COVID-19 outbreak. They are designed to minimise the impact to the financial threat posed by COVID-19 and they form a key part of the package of measures to stabilise the university admissions system.
These controls are a temporary measure and will be in place for one academic year only. Student number controls for institutions in the devolved administrations only apply to the number of English-domiciled entrants who will be supported with their tuition fees through the Student Loans Company. They are set at a level which will allow every institution to take more first year English students than they took last year. The funding of English-domiciled students is not a devolved matter and it is right and fair that this policy should apply as consistently as possible wherever they are studying in the UK.
Ministers will continue to work closely with the devolved administrations on strengthening and stabilising the higher education system following the COVID-19 outbreak.
No representations have been made to Her Majesty’s Government in relation to the proposal by the Office for Students (OfS) to make savings to teaching grant funding, including for some pre-registration clinical courses.
The OfS consulted on their proposals, which include a proposal to make additional budget provision for providers in a small number of high-cost and high-priority areas, to reflect additional students on pre-registration courses in medicine, nursing, midwifery and allied health professions. Providers and other interested parties have therefore had an opportunity to make representations. The OfS will conclude the consultation in due course.
No representations have been made to Her Majesty’s Government in relation to the proposal by the Office for Students (OfS) to make savings to teaching grant funding, including for some pre-registration clinical courses.
The OfS consulted on their proposals, which include a proposal to make additional budget provision for providers in a small number of high-cost and high-priority areas, to reflect additional students on pre-registration courses in medicine, nursing, midwifery and allied health professions. Providers and other interested parties have therefore had an opportunity to make representations. The OfS will conclude the consultation in due course.
The Government does not have any plans to introduce default 20mph speed limits in England around schools, university entrances or hospitals.
Local authorities have the power to set 20mph speed limits where people and traffic mix; they are best placed to determine the speed limits for their areas, based on local knowledge and the views of the community. They are asked to have regard to the Department for Transport’s guidance ‘Setting Local Speed Limits’, which is designed to make sure that speed limits are appropriately and consistently set while allowing the flexibility to deal with local circumstances. The final decision is for the traffic authority, working with the police who would carry out any enforcement.
The number of deaths, serious injuries, and other injuries, which were suffered by pedestrians, and cyclists in England in each year since 2016, broken down by the speed limit can be found in the attached table.
The Government has no plans to introduce a mandatory registration scheme for cycle ownership. The costs of doing so would outweigh the benefits, and this would deter many people from cycling particularly if cyclists (including children) had to cover the costs of such a system. There would be many practical difficulties too: registration plates would need to be large enough to be seen by cameras and other road users, and there is not generally enough space on bikes to allow for this.
The Department is running trials of rental e-scooters to assess their safety and wider impacts. Trials e-scooters are required to carry a unique identifier that will aid with enforcement. Privately-owned e-scooters remain illegal during trials. We are carefully considering all future requirements for legal use of e-scooters.
The Health and Safety Executive (HSE) are reviewing the Approved Code of Practice (ACOP) and guidance of the Workplace (Health, Safety and Welfare) Regulations 1992 regarding provision of disposal facilities in workplace toilets only, to ensure they meet the needs of both men and women. There will be a public consultation on any changes in summer 2024 and the updated ACOP and guidance will be published in spring 2025.
HSE is the workplace regulator, therefore the legislation and guidance will only apply to toilets for use by workers in workplaces, made available to them as a place of work.
Workplace health and safety law requires employers to ensure an adequate supply of fresh air in the workplace and this has not changed during the pandemic. It is not the health and safety regulator’s role to identify the benefits of the procurement and deployment of any specific equipment. This should be considered as part of the risk assessment carried out for the workplace. To assist with these assessments, the Health and Safety Executive have issued guidance on ventilation during the pandemic at:
https://www.hse.gov.uk/coronavirus/equipment-and-machinery/air-conditioning-and-ventilation.htm
The consultation response on the proposed amendments to Part IX and the final impact assessment is expected to be released in May 2024, and will outline the Government’s response.
The Department believes that it is currently difficult to identify which devices are broadly comparable, and whether more expensive devices provide added value. The proposed amendments that were consulted on intend to increase meaningful choice, not to decrease choice for clinicians and patients. Comparison between products can increase awareness of different brands amongst prescribers.
These proposals support the Life Sciences Vision, and are designed to increase innovation and alignment between partners in the health and care system. The enhanced assessment process will allow comparison between products based on their merits, increasing transparency and competition, and encouraging new products and small and medium sized businesses to enter the market. The proposed introduction of environmental attributes in social value scoring increases the vision to help the National Health Service meet Net Zero.
The Department is aware that there are some very good devices in use, relied upon by clinicians and patients. Part IX will remain a list of devices available to be prescribed in the community via the FP10 prescription route. Any amendments that are taken forward will happen gradually, with review points and engagement with stakeholders, including industry, patient representatives, clinicians, and NHS organisations. The Department will share a timeline of proposed changes taken forward, in due course.
The consultation response on the proposed amendments to Part IX and the final impact assessment is expected to be released in May 2024, and will outline the Government’s response.
The Department believes that it is currently difficult to identify which devices are broadly comparable, and whether more expensive devices provide added value. The proposed amendments that were consulted on intend to increase meaningful choice, not to decrease choice for clinicians and patients. Comparison between products can increase awareness of different brands amongst prescribers.
These proposals support the Life Sciences Vision, and are designed to increase innovation and alignment between partners in the health and care system. The enhanced assessment process will allow comparison between products based on their merits, increasing transparency and competition, and encouraging new products and small and medium sized businesses to enter the market. The proposed introduction of environmental attributes in social value scoring increases the vision to help the National Health Service meet Net Zero.
The Department is aware that there are some very good devices in use, relied upon by clinicians and patients. Part IX will remain a list of devices available to be prescribed in the community via the FP10 prescription route. Any amendments that are taken forward will happen gradually, with review points and engagement with stakeholders, including industry, patient representatives, clinicians, and NHS organisations. The Department will share a timeline of proposed changes taken forward, in due course.
The National Institute for Health and Care Excellence (NICE) has not yet started its evaluation of tofersen for treating amyotrophic lateral sclerosis caused by SOD1 gene mutations, and has therefore not published any guidance or recommendations on whether tofersen should be available for National Health Service patients. In developing its recommendations, the NICE will follow its published methods for health technology evaluation, which will include a thorough assessment of the available evidence. This takes into account all health-related costs and benefits, including health benefits not only to patients but, where relevant, to other people such as carers. The NICE’s aim is to publish its guidance on tofersen as close as possible to the date it receives its marketing authorisation.
The National Institute for Health and Care Excellence (NICE) has not yet started its evaluation of tofersen for treating amyotrophic lateral sclerosis caused by SOD1 gene mutations, and has therefore not published any guidance or recommendations on whether tofersen should be available for National Health Service patients. In developing its recommendations, the NICE will follow its published methods for health technology evaluation, which will include a thorough assessment of the available evidence. This takes into account all health-related costs and benefits, including health benefits not only to patients but, where relevant, to other people such as carers. The NICE’s aim is to publish its guidance on tofersen as close as possible to the date it receives its marketing authorisation.
Stakeholders will be kept updated on the progress of the in-service evaluation (ISE) for newborn screening for spinal muscular atrophy (SMA) via the UK National Screening Committee’s blog, which is available in an online only format. The most recent update was published on 24 January 2024, and detailed the progress of the SMA ISE, which is available in an online only format.
A total of 587 valid clinical trial authorisation applications were received and assessed during the period of July 2022 to June 2023. Out of the 587, 100 applications were assessed within 30 days (17.04%).
The Government takes obligations to protect public policy from the commercial interests of the tobacco industry under the Framework Convention on Tobacco Control very seriously. The ‘Guidance for government engagement with the tobacco industry’ was published on 19 June 2023 to support Government Departments and public bodies to adhere to Article 5.3 and remind them of their commitments. This document builds on established measures that the Department has put in place internally to limit interactions with the tobacco industry and ensure the transparency of the interactions that do occur. A copy is attached.
The NHS Long Term Plan made a commitment to ensure that children and young people with a learning disability and/or autism in special residential schools have access to sight checks in school. To fulfil that commitment, NHS England commenced a proof-of-concept programme in 2021, piloting sight testing and the dispensing of glasses in special schools.
NHS England are currently considering the evaluation of this special school programme, to determine how services to meet the eye care needs of children with learning disabilities in school settings should be commissioned and will set out next steps shortly.
The NHS Long Term Plan made a commitment to ensure that children and young people with a learning disability and/or autism in special residential schools have access to sight checks in school. To fulfil that commitment, NHS England commenced a proof-of-concept programme in 2021, piloting sight testing and the dispensing of glasses in special schools.
NHS England are currently considering the evaluation of this special school programme, to determine how services to meet the eye care needs of children with learning disabilities in school settings should be commissioned and will set out next steps shortly.
NHS England has actively increased its support to local commissioners to improve the accessibility, quality and sustainability of palliative and end of life care for all. This has included the publication of statutory guidance and service specifications, with further resources available on the FutureNHS Collaboration Platform. Copies of these documents are attached.
In addition, NHS England has funded the establishment of a palliative and end of life care Strategic Clinical Network in every NHS England region, which work closely with local commissioners regarding the development of accessible, high quality and sustainable services.
No specific assessment has been made. Palliative and end of life care is commissioned at a local level by integrated care boards (ICBs) in response to the needs of their local population. NHS England has published statutory guidance and service specifications to support ICBs in commissioning a range of palliative and end of life services, including inpatient beds, that meet local needs and preferences.
In addition, NHS England has funded the establishment of a palliative and end of life care Strategic Clinical Network in every NHS England region to work closely with local commissioners on the development of accessible, high quality and sustainable services.
In July 2019, a pilot was launched to develop and test a ‘subscription-style’ evaluation and payment model for antibiotics in England, which would pay pharmaceutical companies for access to antibiotics based on the value to the National Health Service, rather than the volume used. This model aims to incentivise pharmaceutical companies to develop new, novel antimicrobials which can be used appropriately, including those to treat chronic lung disease in people with cystic fibrosis.
Payments from NHS England to two pharmaceutical companies involved in the pilot commenced on 1 July 2022. Officials are considering how the new frameworks for the evaluation and payment of new antimicrobials can be developed, including through consultation with domestic and international stakeholders. The consultation process will continue until spring 2023.
Findings from the pilot have been shared online via the National Institute for Health and Care Excellence and at international conferences. The Government has also advocated for such models internationally, including during the United Kingdom’s G7 Presidency in 2021, to jointly explore incentives to bring new antimicrobials to market.
We continue to work with G7 partners to implement commitments made on antimicrobial resistance (AMR), including those secured during the United Kingdom’s 2021 presidency. The UK Special Envoy on AMR, Professor Dame Sally Davies, also recently attended the Third High-level Ministerial Conference on AMR in Oman. In November 2022, the Government issued a call for evidence to seek expert contributions to the next five-year AMR national action plan, which has been shared with international counterparts.
This information is not held in the format requested. NHS Digital publishes online only data on monthly sickness absence rates for staff working in hospitals and integrated care systems and the reason for the absence, collected via the Electronic Staff Record. However, data on the duration of the absence and the proportion of staff absent due to a specific illness is not currently centrally validated.
Local National Health Service leaders have been asked to consider the health and wellbeing of all staff as a priority and establish a preventive approach to health and wellbeing. A national growing occupational health and wellbeing programme has been launched to ensure a preventive, organisation-wide approach to health and wellbeing. In addition, all NHS staff have access to a free confidential text service and to the online Headspace and Unmind platforms until 31 December 2023.
The NHS sickness absence toolkit provides advice to managers to support staff to return to work, including considering reasonable adjustments and discussing the direct causes of absence. For winter 2022/23, NHS organisations will support staff to prevent the transmission of respiratory illnesses and all frontline healthcare workers will be offered free COVID-19 and flu vaccines.
The majority of care workers are employed by private sector providers which set pay and terms and conditions, independently of central Government. We are encouraging adult social care providers to invest in mental health and wellbeing services for staff. We will continue to work with the sector to ensure that wellbeing resources and best practice advice are available.
The General Medical Council (GMC) is the independent regulator of all medical doctors practising in the United Kingdom which sets and enforces the standards all doctors must adhere to. In order to practise medicine in the UK, doctors are required to hold registration with a licence to practise.
The Department does not hold the information requested as this is collected independently by the GMC.
The General Medical Council (GMC) is the independent regulator of all medical doctors practising in the United Kingdom which sets and enforces the standards all doctors must adhere to. In order to practise medicine in the UK, doctors are required to hold registration with a licence to practise.
The Department does not hold the information requested as this is collected independently by the GMC.
The NHS Long Term Plan committed to ensure that children and young people with a learning disability, autism or both in special residential schools have access to eyesight, hearing and dental checks. NHS England commenced a proof-of-concept programme in 2021 to pilot and evaluate a potential service model in residential schools. Once the evaluation is complete, NHS England will develop a model specification for use in special residential schools. The evaluation may result in recommendations for future service provision in day schools. Children in day schools who are unable to attend high street opticians can currently access eye tests in their homes through existing domiciliary services.
From 2018 to March 2022, the Department was involved in tripartite negotiations between employers, the British Medical Association (BMA) and the Hospital Consultants and Specialists Association to reform local clinical excellence awards. However, the proposal was rejected by the executive committees of the trades unions and the negotiations concluded without agreement.
National Health Service trusts are therefore reverting to the arrangements in Schedule 30 of the consultant contract, agreed with the BMA in 2018. This does not alter the funding and eligibility position for clinical academics and represents a continuation of existing provisions.
Following the 2021 Spending Review, we are increasing the number training posts in dermatology in England by 15, with doctors in postgraduate training in post from August 2022. The National Health Service is also ensuring that patients can access specialist care through dermatology outpatient services. This focuses on a personalised approach for patients waiting for outpatient appointments, improving waiting times and offering choice for patients at the point of referral. Pharmacies can offer clinical advice and over-the-counter medicines for many skin conditions and where appropriate pharmacists can advise the patient to consult a general practitioner (GP), nurse or other healthcare professional.
Many dermatology departments in England now offer a rapid access Teledermatology Advice and Guidance service for GPs to seek advice from a specialist prior to a referral being made. The use of technology, such as digital images, reduces unnecessary face-to-face appointments and provides flexibility for patients when booking outpatient appointments.
A Teledermatology Roadmap for 2020-21 v1.0 provides recommendations on optimising teledermatology triage and specialist advice, including establishing a working group of multidisciplinary clinical leads and other stakeholders. A copy of the Roadmap is attached. The two-week wait skin cancer pathway: innovative approaches to support early diagnosis of skin cancer as part of the NHS COVID-19 recovery plan also includes a new virtual pathway using teledermatology. A copy of the guidance for the skin cancer pathway is attached.
The Government has announced its intention to consult on whether to introduce mandatory calorie labelling on pre-packed alcohol and alcohol sold in on-trade businesses such as pubs and restaurants. The consultation will also seek views on whether the provision of the United Kingdom Chief Medical Officers’ low risk drinking guidelines should be mandatory or continue on a voluntary basis. Respondents to the consultation can also suggest additional labelling requirements for consideration, such as ingredient listing.
Individuals from lower socioeconomic groups are more likely experience greater levels of alcohol-related harm compared to higher socioeconomic groups, including alcohol-related hospital admissions and deaths. Through the 10-year drug strategy, the Government has invested £532 million into rebuilding local authority commissioned substance misuse treatment services in England. All local areas will receive additional funds through a phased approach according to need, with 50 of the most deprived areas receiving a greater share of the funding in 2022/23. As part of the NHS Long Term Plan, we have invested £27 million to establish specialist Alcohol Care Teams in the 25% of hospitals with the highest rates of alcohol-mortality and deprivation.
Since 2020/21, the Government has also provided £50.4 million to provide substance misuse treatment services for people sleeping rough through the Rough Sleeping Drug and Alcohol Treatment Grant. The Government will provide additional investment of up to £186.5 million during the current Spending Review period, including £15 million announced through the cross-Government drugs strategy.
Access to the local clinical excellence award scheme is a contractual entitlement for all consultants employed on the 2003 terms and conditions. The central funding for awards is calculated on this basis. Clinical academics hold honorary contracts with the National Health Service and therefore have no contractual right to the scheme. However, employers continue to be encouraged to include clinical academics in the awards process.
NHS England and NHS Improvement have established a workstream for urinary tract infections (UTIs) to reduce the prevalence by trialling and implementing interventions which could prevent infections in older people. This includes a series of hydration pilots in England which will evaluate and improve our understanding of which interventions best increase fluid intake in older people and reduce the risk of UTIs. The collection of data within the workstream will enable evaluation of the effectiveness of interventions.
The Medicines and Healthcare products Regulatory Agency recently undertook a consultation on changes to the Medicines for Human Use (Clinical Trials) Regulations 2004, including Schedule 1. The responses to the consultation are currently being analysed and the response will be published in due course.
The General Medical Council and the Royal College of Surgeons are developing a cosmetic surgery credential. The credential will set out the expectations of doctors working in this area of practice and strengthen regulation and patient protection by ensuring surgeons have appropriate training, qualifications and experience.
The cosmetic surgery credential will not be mandatory. However, we expect the cosmetic surgery industry to embrace the credential as a way of demonstrating that doctors have the relevant skills and knowledge to deliver safe care to patients. We anticipate the cosmetic surgery credential will be completed in 2023.
The General Medical Council and the Royal College of Surgeons are developing a cosmetic surgery credential. The credential will set out the expectations of doctors working in this area of practice and strengthen regulation and patient protection by ensuring surgeons have appropriate training, qualifications and experience.
The cosmetic surgery credential will not be mandatory. However, we expect the cosmetic surgery industry to embrace the credential as a way of demonstrating that doctors have the relevant skills and knowledge to deliver safe care to patients. We anticipate the cosmetic surgery credential will be completed in 2023.
The National Health Service (Appointment of Consultants) Regulations 1996 do not prevent NHS trusts from seeking alternative members to contribute to the process of appointing consultants. The Regulations do provide discretion to involve these Royal Colleges where appropriate and do not apply to foundation trusts, which comprise the majority of trusts.
We are considering the merits of amending the Regulations to include additional Colleges and will provide further details in due course.
The National Health Service (Appointment of Consultants) Regulations 1996 do not prevent NHS trusts from seeking alternative members to contribute to the process of appointing consultants. The Regulations do provide discretion to involve these Royal Colleges where appropriate and do not apply to foundation trusts, which comprise the majority of trusts.
We are considering the merits of amending the Regulations to include additional Colleges and will provide further details in due course.
NHS England and NHS Improvement publish the number of patients spending more than 12 hours in accident and emergency (A&E) from the time of arrival in the annual summary report of hospital accident and emergency activity. In 2020/21, 302,784 patients spent over 12 hours in A&E from arrival.
The NHS Standard Contract for 2022/23 includes a 12-hour standard from time of arrival as a national quality indicator. NHS England is currently considering when data against this standard can be published and expects to confirm in due course.
An assessment regarding the impact of the COVID-19 Test Device Validation Approval process (CTDA) on multiplex tests is ongoing. A public consultation ended on 30 September 2021 and a response will be published later this year. As the approval process safeguards consumers and has been determined by scientists, we have no current plans to amend it for multiplex tests.
The Department plans to recruit more full-time scientific advisors to meet clinical demand and accelerate CTDA approvals. We anticipate the recruitment campaigns will be concluded shortly. However, the speed of the approval process is also dependent on manufacturers submitting the correct data at the application stage.
The online only guidance COVID-19 test approval: how to apply advises testing manufacturers on the validation process for new devices. The guidance sets out the process from submitting an application; the desktop review; how payment can be made; the outcome reporting on tests which have passed; how to make a complaint; and where an application is unsuccessful, how the manufacturer can request a review of the decision.
For updates to products while an application is being considered, applicants must inform the COVID-19 Test Device Validation Approval processes (CTDA) administration team and provide the updated Instructions for Use. For updates to approved products, manufacturers are encouraged to contact the CTDA administration team. Guidance for such updates is currently being developed.
The CTDA team aim to have the results of the application review within 20 working days of submission, subject to the application being complete. This process may take longer where there is a high volume of applications and if there are additional queries on the data submitted.
The current supply of Ronapreve is limited globally and the clinical policy prioritises the most vulnerable patients for whom this treatment will have the largest beneficial impact. The use of Ronapreve is being monitored and the interim clinical policy will be updated if supported by the latest evidence.
The number of patients treated by Ronapreve will depend on the infection rate over the next year; the degree of vaccine protection; the availability of Ronapreve and other products; and on National Health Service clinical policy. To date, the evidence has most strongly supported treatment indications, but the evidence on prophylactic use will continue to be actively reviewed.
The forthcoming Spending Review will set out the Government’s spending plans for health and social care for future years. On 6 September, we announced an additional £5.4 billion to support the COVID-19 response over the next six months - a total of more than £34 billion this year. This includes £2 billion to tackle the elective backlog and reducing waiting times for patients, including disabled children.
We are working with the Department for Education and NHS England and NHS Improvement to improve the provision of health and care services for disabled children, including access to therapies and equipment. In 2020, NHS England and NHS Improvement made clear that the restoration of essential community services must be prioritised for children and young people with special educational needs and disabilities aged up to 25 years old and who have an Education Health and Care Plan in place or are going through an assessment. We are supporting access to appropriate disability equipment via the NHS Supply Chain, which maintains a framework contract for the supply of rehabilitation and disabled services equipment, such as paediatric wheelchairs.
The Getting It Right First Time (GIRFT) National report on dermatology was completed in 2020 but has not yet been published, therefore we have not made this assessment. The report will be published later this year, once NHS England and NHS Improvement have reviewed the recommendations.