Baroness Masham of Ilton

The National Institute for Health and Care Excellence (NICE) is an independent body and is responsible for assessing new medicines and treatments in accordance with its existing methods and processes. NICE’s draft guidance on dupilumab for consultation of 7 May 2021 states that it is not recommended for the treatment of severe asthma. NICE has not yet published its final recommendations on dupilumab and the draft guidance is now open for consultation until 28 May 2021. There will be a further meeting of NICE’s independent appraisal committee in September to consider all comments received during the consultation.

The Government has not made any assessment of the decision of the Scottish Medicines Consortium on dupilumab, as this is a devolved matter.

In 2020/21, the National Health Service Cardiovascular Disease and Respiratory programme has focussed its work on the response to COVID-19. This included bringing forward the implementation of Respiratory Clinical Networks. The networks are vital in promoting an integrated approach to respiratory care during the pandemic and are in parallel supporting delivery of the NHS Long Term Plan priorities.

NHS England and NHS Improvement are working in close partnership with patients and partners, including the British Lung Foundation, to develop and implement policy on provisions of respiratory services in England.

There is no unified record of the number of people with asthma who have contracted Covid-19. While NHS Digital holds data identifying where a patient has both COVID-19 and asthma diagnoses, many cases of asthma will be diagnosed and managed in a primary care setting. Primary care data is not currently linked to data for hospital admissions.

No such assessment has been made.

The content of the Quality Outcomes Framework (QOF) asthma review, which ensures all general practitioner practices establish and maintain a register of patients with an asthma diagnosis, has been amended to incorporate the key elements of basic asthma care positively associated with better patient outcomes and self-management, including:

- An assessment of asthma control;

- A recording of the number of exacerbations;

- An assessment of inhaler technique; and

- A written personalised asthma action plan.

The QOF for 2021/22 has been implemented from April 2021 with these updated indicators for asthma.

The National Institute for Health and Care Excellence’s rapid guidance, on severe asthma during the pandemic recommends using technology to reduce in-person appointments. However, guidance on face-to-face appointments throughout the pandemic has been in line with clinical need.

Work is continuing to recover primary care services, including services for asthma patients, to an appropriate level balance between phone/online and face to face appointments. NHS England and NHS Improvement’s updated practice on standard operating procedures for patient consultations states that although the use of video and remote consultations may be suitable for some people, face to face appointments will be offered.

A wide range of treatments are available for prostate cancer across the National Health Service, depending on both the stage of disease and each individual patient’s preferences, which includes surgery, radiotherapy and chemotherapy. In February 2021, NHS England and NHS Improvement’s specialised commissioning team announced that it would make available external beam radiotherapy to treat hormone sensitive, low volume prostate cancer.

The NHS also made available a range of ‘COVID-19 friendly’ treatments, offering benefits such as fewer hospital visits or a reduced impact on the patient’s immune system. This includes targeted hormone therapies such as enzalutamide for prostate cancer treatment. After treatment, patients will move to a Personalised Stratified Follow-Up pathway that suits their needs and ensures they can get rapid access to clinical support where they are worried that their cancer may have recurred. This stratified follow-up approach was established in all trusts for prostate cancer in 2020.

NHS England is supporting staff to offer personalised care to people affected by cancer, including people with prostate cancer, by promoting awareness and understanding of the personalised care interventions. The NHS Long Term Plan sets a clear ambition that where appropriate every person diagnosed with cancer, including those with prostate cancer, should have access to personalised care to ensure people’s social, emotional, physical and practical needs are identified and addressed at the earliest opportunity. Over the next five years, Cancer Alliances will be embedding personalised care interventions, which will identify and address the changing needs of cancer patients from diagnosis onwards.

Specialist clinical nursing workforce working in urology and prostate cancer is a post-registration qualification and it is the responsibility of individual employers to ensure they have the staff available to provide clinical services.

The Spending Review 2020 provides £260 million to continue to increase the National Health Service workforce and support commitments made in the NHS Long Term Plan, including continuing to take forward the Cancer Workforce Plan - Phase One commitment to expand education and training to increase the number of clinical nurse specialists and develop common and consistent competencies.

This data is not available in the format requested. Referrals for prostate cancer are recorded within the urology specialty but not recorded by urological cancer type.

On 23 March 2021 the Government published Saving and improving lives - the future of UK clinical research delivery. This includes the aim to create a research positive culture in which all health and care staff feel empowered and supported to participate in clinical research as part of their job. To support this vision, we have identified five key themes which underpin the improvements as follows:

- Clinical research embedded in the National Health Service;

- Patient-centred research;

- Streamlined, efficient and innovative research;

- Research enabled by data and digital tools; and

- A sustainable and supported research workforce.

An implementation plan and strategy setting out how the Government will begin to deliver the vision will be published later this year. A copy of Saving and improving lives - the future of UK clinical research delivery is attached.

No such assessment has been made. However, the National Institute of Health Research is funding a study to determine whether using a mixture of re-usable and single-use catheters is as safe and acceptable for intermittent catheterisation as using only single-use catheters.

We are not currently taking any specific steps to ensure patients have access to single use catheters. The decision of which device should be offered to patients remains a clinical one.

The National Institute for Health Research and UK Research and Innovation have jointly commissioned research studies to determine the potential risk to patients and staff from aerosol transmission of COVID-19 and investigate how to mitigate those risks. This includes funding of £433,000 to the AERATOR study at the University of Bristol to investigate aerosolization of COVID-19 and transmission risk at short range from medical procedures.

Additionally, Public Health England have been awarded £337,000 to investigate environmental and airborne transmission routes of COVID-19 including in healthcare settings.

On 13 April, the Joint Committee on Vaccination and Immunisation published their final advice for prioritisation of phase two of the vaccination programme, recommending an age-based approach which the Government has accepted. Phase two will therefore cover all remaining adults aged between 18 and 49 years old. This includes all those disabled people aged 18 years old or over who have not already been included in phase one.

The UK Severe Asthma Registry (UKSAR) has gone from having less than 2000 patients registered to over 8000 patients as a result of work on the asthma pathway. Severe asthma services will continue to participate in the NHS England and Improvement Accelerated Access Collaborative programme to deliver the best healthcare to severe asthma patients. The UKSAR is the world’s largest national severe asthma registry and provides novel insights across a range of research areas as well as enabling annual reporting on performance outcomes for severe asthma services.

Patients added to the shielding list will be under the care of a clinician for their asthma and therefore aware of their diagnosis.

Patients with severe asthma were identified as being (clinically extremely vulnerable (CEV) by two routes. An algorithm was used to identify patients who received high levels of certain asthma medication. Inpatients were also directly added to the CEV list by a clinician in either primary or secondary care following the shielding advice for those with severe respiratory conditions, which was published by the British Thoracic Society in April 2020.

Prioritisation for phase two has not yet been decided. However the Joint Committee on Vaccination and Immunisation’s (JCVI) interim advice recommends an age-based approach, which the Government has accepted in principle.

The JCVI has advised that phase two will include all adults under 50 years old who were not included in phase one, starting with the oldest adults first. The JCVI’s interim advice has not indicated that, as a group, persons paralysed with spinal cord injuries are at higher risk from COVID-19 and therefore they have not been prioritised for the COVID-19 vaccine programme. Final advice on phase two will be published by the JCVI in due course.

Whilst there are no plans to establish national COVID-19 telephone helplines for the public to use to ask questions related to COVID-19 vaccines, the Department and the NHS and PHE are providing advice and information at every possible opportunity to support those who have been prioritised to receive a vaccine and anyone who has questions about the vaccination process. The latest advice and information is available online and our social media channels are regularly publishing fact cards, films and interviews about vaccine safety and answering frequently asked questions about vaccine production. In addition, senior clinicians are giving media interviews and taking part in live question and answer sessions with the public about COVID-19 vaccines.

The Government’s communications plan includes targeted information and advice via TV, radio and social media. This is being translated into 13 languages including Bengali, Chinese, Filipino, Gujarati, Hindi, Mirpur, Polish, Punjabi and Urdu. Print and online material, including interviews and practical advice has appeared in 600 national, regional, local and specialist titles including media for African, Asian, Bangladeshi, Bengali, Gujarati, Jamaican, Jewish, Pakistani and Turkish communities.

Research to evaluate the long-term health and psychosocial effects of COVID-19 is continuing. Major studies include the Post-Hospitalisation COVID-19 study in the United Kingdom and the International Severe Acute Respiratory and emerging Infection Consortium global COVID-19 long-term follow-up study.

Existing United Kingdom vitamin D recommendations are based on advice from the Scientific Advisory Committee on Nutrition (SACN). The SACN carried out an extensive and robust assessment of the evidence on vitamin D and a wide range of musculoskeletal and non-musculoskeletal health outcomes, including fractures and falls which are a consequence of osteoporosis. The SACN recommended a reference nutrient intake of 10 micrograms vitamin D per day for adults and children over the age of one year.

Public Health England (PHE), the SACN and the National Institute for Health and Care Excellence (NICE) concluded that there is currently not enough evidence to support taking vitamin D solely to prevent or treat COVID-19. The expert panel supported current Government advice for everyone to take a daily 10 microgram supplement throughout the autumn and winter for bone and muscle health. NICE, PHE and the SACN are continuing to monitor evidence as it is published and will review and update guidance if necessary.

Multi-grip upper limb prosthetics, which include the Hero-Arm are not currently routinely commissioned in England for upper limb amputees. NHS England and NHS Improvement are in the process of reviewing the policy for commissioning all multi-grip upper limbs and an evidence review has just been completed. It is anticipated that a decision will be made by early summer as to whether the current policy will be revised to allow multi-grip upper limbs to be made routinely available to upper limb amputees.

On 21 January 2021, the Office for National Statistics published data which estimated that, in the week commencing 27 December 2020, there were 301,000 people in England, including children, who were showing post COVID-19 symptoms which had persisted for between five and 12 weeks.

The same data showed that 22.1% of all people testing positive for COVID-19 experienced symptoms for a period of five weeks or longer. For children aged between two and 11 years old, the proportion was lower at 12.9% and 14.5% amongst children aged between 12 and 16 years old.

Children experiencing the long-term effects of COVID-19 should expect to have the same access to school as every other child with a long-term health condition.

The Department for Education’s guidance for schools, Supporting pupils at school with medical conditions: Statutory guidance for governing bodies of maintained schools and proprietors of academies in England, which details statutory duties. This includes Individual Health Plans (IHPs) which schools must maintain to enable children with long term medical conditions to have full access to education. IHPs can include ensuring that children with a medical need to do so, are able to take rest breaks during the school day along with other reasonable adjustments. A copy of the guidance is attached.

The Government has had no such specific discussions.

The noble Lord Carter of Coles published a report last year on the provision of aseptic medicines, including some critical care medicines, in England. Recommendations included setting up a network of hub and spoke facilities to prepare ready to administer medicines, providing guidance on standard injectable medicines, and training for aseptic pharmacy staff. NHS England and NHS Improvement are setting up a National Health Service aseptic services transformation implementation board to co-ordinate the implementation of these recommendations.

The recommended changes will improve patient safety by reducing errors in compounding and administering these medicines. Errors in these medicines are not currently specifically tracked but the report recommends that the NHS begins tracking and reducing them.

The creation of regional hub and spoke services could release the equivalent of over 4,000 whole time equivalent nurses each year. This is based on the time taken for nurses to prepare the 14 most commonly used aseptic medicines. The development of a hub and spoke system will offer opportunities for production at scale, relieving pressure on hospital pharmacies.

Local vaccination services coordinate and deliver vaccinations to people who are unable to attend a vaccination site. This includes visiting care homes, the homes of housebound individuals and other settings such as residential facilities for people with learning disabilities or autism and prisons and to reach vulnerable groups such as those who are experiencing homelessness.

The data is not collected in the format requested.

The National Health Service Serious Incident framework of 2015 describes the criteria and definitions that providers and commissioners should apply when considering whether an event in healthcare should be investigated as a serious incident.

The decision to declare a Serious Incident should be informed by the potential for an investigation into the event to generate new insight into preventing future risks, as well as the impact of the event on those involved.

The framework discourages the use of prescriptive lists of types of event to identify serious incidents as this leads to automatic investigations into events that offer little new learning.

No direct assessment has been made.

No assessment has been made.

The National Bladder and Bowel Health (NBBH) project was paused at the start of the COVID-19 pandemic in line with some other national programmes and membership of the project’s panels and timescales for the next phases of the project are not confirmed at this time.

Sue Doheny, Chief Nurse NHS England, is the Senior Responsible Officer for the Excellence in Continence Care Programme which oversees the NBBH project. The project includes representatives from across the health and care profession – patients and carers, suppliers and procurement.

Our ambition is to ensure there are no tariffs, fees, charges or quantitative restrictions on trade in goods between the United Kingdom and the European Union at the end of the transition period through a Free Trade Agreement. We therefore do not expect the UK Global Tariff to apply to EU imports. We are currently in an intense phase of negotiations with the EU and we are working hard to achieve that.

The information is not held in the format requested.

Data is not available in the format requested.

The safety of United Kingdom plasma is reviewed periodically. A comprehensive review of the safety of immunoglobulins produced from fractionated UK plasma was conducted by the Medicines and Healthcare products Regulatory Agency (MHRA) during 2020 and is now under consideration by the Department and the devolved administrations.

The Department will work with the devolved administrations, NHS England and NHS Improvement, the MHRA and NHS Blood and Transplant to consider the implications of any decision on the UK supply of plasma for immunoglobulin.

The safety of United Kingdom plasma is reviewed periodically. A comprehensive review of the safety of immunoglobulins produced from fractionated UK plasma was conducted by the Medicines and Healthcare products Regulatory Agency (MHRA) during 2020 and is now under consideration by the Department and the devolved administrations.

The Department will work with the devolved administrations, NHS England and NHS Improvement, the MHRA and NHS Blood and Transplant to consider the implications of any decision on the UK supply of plasma for immunoglobulin.

The Department commissioned Lord Carter of Coles to look into the provision of aseptic medicines, including some critical care medicines, in England. The noble Lord published his report on 29 October 2020. He made a number of recommendations, including setting up a network of hub and spoke facilities to prepare ready to administer medicines, providing guidance on standard injectable medicines, and training for aseptic pharmacy staff.

NHS England and NHS Improvement are setting up an NHS Aseptic Services transformation implementation board to co-ordinate the implementation of these recommendations.

The National Respiratory Programme is a sub-programme of the wider Cardiovascular Disease and Respiratory programme. The Cardiovascular Disease and Respiratory Programme was allocated NHS Long Term Plan funding as follows:

- 2019/20 - £8.4 million

- 2020/21 - £15 million

General practitioners and their teams have played and continue to play a crucial role in our response to the COVID-19 pandemic and in ensuring that people can get the care they need - between March and August 122.8 million appointments took place in general practice. They have remained open for all patients, including respiratory patients to attend, be that face to face, via telephone or online.

Through national and regional campaigns, the National Health Service continues to urge to the public to come forward with any health concerns they have and to reassure them that the NHS is here for them. A national campaign to encourage the public to seek help when necessary began in October 2020.

Respiratory disease is a national clinical priority in the NHS Long Term Plan and increasing access to pulmonary rehabilitation is part of this. NHS England and NHS Improvement working in close partnership with patients and partners, including the British Lung Foundation, are developing and implementing policy on provisions of pulmonary rehabilitation services in England.

The National Respiratory Programme is part of the wider Cardiovascular Disease and Respiratory programme which was allocated £15 million of NHS Long Term Plan funding for 2020/21.

As part of our concerted national efforts to respond to the COVID-19 outbreak, we are doing everything we can to ensure patients continue to have access to COVID-19 test equipment and medicines in all scenarios. This includes holding stockpiles of a variety of medicines currently and potentially used in treating patients with COVID-19, to help ensure there is uninterrupted supply over the coming months.

The Department has well-established procedures to deal with shortages and works closely with industry, the National Health Service and others in the supply chain to address supply disruption events that arise, regardless of the cause.

The National Health Service and the wider scientific community are currently working to better understand the disease course of COVID-19 infection, including the prevalence, severity and duration of symptoms, and how best to support recovery. The Department invests £1 billion per year in health research through the National Institute for Health Research (NIHR). Together with UK Research and Innovation, the NIHR has invested £8.4 million in the Post-HOSPitalisation COVID-19 study (PHOSP-COVID), led by the University of Leicester. The Government is currently considering options for future work in this area.

The research currently underway will continue to help define the long-term effects of COVID-19, which will support the formal recognition of people who are experiencing the long-term effects.

The Department, in consultation with the devolved administrations and Crown Dependencies, are working with trade bodies, suppliers, and the health and care system to make detailed plans to help ensure continued supply of medicines and medical products, including incontinence products, at the end of the transition period.

As set out in the attached letter from the Department to industry of 3 August, we are implementing a multi-layered approach, that involves asking suppliers to get trader ready, consider alternative routes away from potential disruption and stockpiling to a target level of six weeks on United Kingdom soil where this is possible.

The Department recognises that The Urology Foundation has designated September 2020 as Urology Awareness Month.

To raise awareness of urological health and diseases, National Health Service trusts and commissioners are sharing patient stories and carrying out social media activity and webinars.

NHS England and NHS Improvement have established the National Bladder and Bowel Health Project to improve continence care across the whole public health and care system. It has also published ‘Excellence in Continence Care’ a practical guide for leaders and commissioners. This guidance is currently being updated and a revised version will be published in due course.

As Health and Safety Executive guidance for the general public states, which is in line with the World Health Organization (WHO) guidance, alcohol does not have to be ‘active ingredients’ to be effective in hand sanitizer. The WHO recommends that hand sanitiser should contain a minimum of 60% alcohol, but non-alcohol based sanitisers can also be effective when combined with other social distancing measures.

All healthcare workers have access to occupational health assessment and are referred for assessment and treatment in the event of developing skin complications. Using the guidelines, recommendations made by occupational health are followed by National Health Service providers as part of risk assessment and mitigation for the individual and the patient.

As Health and Safety Executive guidance for the general public states, which is in line with the World Health Organization (WHO) guidance, alcohol does not have to be ‘active ingredients’ to be effective in hand sanitizer. The WHO recommends that hand sanitiser should contain a minimum of 60% alcohol, but non-alcohol based sanitisers can also be effective when combined with other social distancing measures.

All healthcare workers have access to occupational health assessment and are referred for assessment and treatment in the event of developing skin complications. Using the guidelines, recommendations made by occupational health are followed by National Health Service providers as part of risk assessment and mitigation for the individual and the patient.

The British Standards Institution Kitemark is a quality scheme that is available for certain industries and sectors where there is a market for it. Products marked with the Kitemark are assessed against a particular standard. The Government has no plans to develop a kitemark of minimum standards for hand sanitisers.

Hand sanitiser for use in clinical settings is treated as personal protective equipment and is therefore regulated by the Health and Safety Executive (HSE).

As HSE guidance for the general public states, and in line with the World Health Organization (WHO) guidance, alcohol does not have to be ‘active ingredients’ to be effective in hand sanitiser. The WHO recommends that hand sanitiser should contain a minimum of 60% alcohol, but non-alcohol based sanitisers can also be effective when combined with other social distancing measures.

The British Standards Institution Kitemark is a quality scheme that is available for certain industries and sectors where there is a market for it. Products marked with the Kitemark are assessed against a particular standard. The Government has no plans to develop a kitemark of minimum standards for hand sanitisers.

Hand sanitiser for use in clinical settings is treated as personal protective equipment and is therefore regulated by the Health and Safety Executive (HSE).

As HSE guidance for the general public states, and in line with the World Health Organization (WHO) guidance, alcohol does not have to be ‘active ingredients’ to be effective in hand sanitiser. The WHO recommends that hand sanitiser should contain a minimum of 60% alcohol, but non-alcohol based sanitisers can also be effective when combined with other social distancing measures.

National Health Service patients are benefitting from an unprecedented partnership with private hospitals as we battle the COVID-19 outbreak. The Department and NHS England and NHS Improvement have worked with the independent sector to secure all appropriate inpatient capacity and other resource across England. The addition of around 6,500 additional beds has increased NHS capacity and ensured that facilities are available for patients diagnosed with COVID-19 whilst ensuring continuity of service for non-COVID-19 patients requiring elective activity, including cancer and other urgent treatment. The latest collected information shows that over 215,000 patient contacts had taken place under the contract.

Independent providers have continued to provide urgent operations for their private pay or insured patients as well as for NHS patients. From the middle of May 2020, independent providers have also been able to provide more routine elective work to private pay or insured patients and where this has been agreed locally with the NHS.

Regarding future provision of NHS treatment, an invitation to tender will be issued by NHS England and NHS Improvement to the healthcare market in October 2020. It will invite providers of elective care services to put themselves forward to be appointed to a framework and, as such, available to deliver elective services to NHS patients, on a cost-per-case basis, at rates reflecting those paid to providers for the same services pre-COVID-19

As part of preparing for winter, the Government has provided an additional £3 billion to the NHS. This includes additional funding to the NHS to allow them to continue to use additional hospital capacity from the independent sector, and to maintain the Nightingale hospitals, in their current state, until the end of March 2021.

National Health Service patients are benefitting from an unprecedented partnership with private hospitals as we battle the COVID-19 outbreak. The Department and NHS England and NHS Improvement have worked with the independent sector to secure all appropriate inpatient capacity and other resource across England. The addition of around 6,500 additional beds has increased NHS capacity and ensured that facilities are available for patients diagnosed with COVID-19 whilst ensuring continuity of service for non-COVID-19 patients requiring elective activity, including cancer and other urgent treatment. The latest collected information shows that over 215,000 patient contacts had taken place under the contract.

Independent providers have continued to provide urgent operations for their private pay or insured patients as well as for NHS patients. From the middle of May 2020, independent providers have also been able to provide more routine elective work to private pay or insured patients and where this has been agreed locally with the NHS.

Regarding future provision of NHS treatment, an invitation to tender will be issued by NHS England and NHS Improvement to the healthcare market in October 2020. It will invite providers of elective care services to put themselves forward to be appointed to a framework and, as such, available to deliver elective services to NHS patients, on a cost-per-case basis, at rates reflecting those paid to providers for the same services pre-COVID-19

As part of preparing for winter, the Government has provided an additional £3 billion to the NHS. This includes additional funding to the NHS to allow them to continue to use additional hospital capacity from the independent sector, and to maintain the Nightingale hospitals, in their current state, until the end of March 2021.

National Health Service patients are benefitting from an unprecedented partnership with private hospitals as we battle the COVID-19 outbreak. The Department and NHS England and NHS Improvement have worked with the independent sector to secure all appropriate inpatient capacity and other resource across England. The addition of around 6,500 additional beds has increased NHS capacity and ensured that facilities are available for patients diagnosed with COVID-19 whilst ensuring continuity of service for non-COVID-19 patients requiring elective activity, including cancer and other urgent treatment. The latest collected information shows that over 215,000 patient contacts had taken place under the contract.

Independent providers have continued to provide urgent operations for their private pay or insured patients as well as for NHS patients. From the middle of May 2020, independent providers have also been able to provide more routine elective work to private pay or insured patients and where this has been agreed locally with the NHS.

Regarding future provision of NHS treatment, an invitation to tender will be issued by NHS England and NHS Improvement to the healthcare market in October 2020. It will invite providers of elective care services to put themselves forward to be appointed to a framework and, as such, available to deliver elective services to NHS patients, on a cost-per-case basis, at rates reflecting those paid to providers for the same services pre-COVID-19

As part of preparing for winter, the Government has provided an additional £3 billion to the NHS. This includes additional funding to the NHS to allow them to continue to use additional hospital capacity from the independent sector, and to maintain the Nightingale hospitals, in their current state, until the end of March 2021.

Data on National Health Service waiting lists is published by NHS England on a monthly basis, with the next publication due on 13 August 2020. NHS England’s collection and quarterly publication of cancelled elective operations, along with its collection and monthly publication of cancelled urgent operations were both paused as part of the initial response to COVID-19. A date to restart collection and publication of this data has not yet been decided.

Nightingale hospitals have helped the National Health Service to rise to an unprecedented challenge by providing extra capacity to manage surges in demand due to COVID-19.

All of the seven NHS Nightingale Hospitals in England are currently on standby and are ready to be utilised should they be needed in the event of a further wave of COVID-19.

We continue to work closely with the NHS and partners, and guidance has already been issued on restoring urgent non-COVID services safely, whilst ensuring surge capacity can be stood up again if needed, including through the use of Nightingale hospitals.

NHS England and NHS Improvement have been closely monitoring all use of immunoglobulin stock through the national immunoglobulin database and through the sub-regional immunoglobulin assessment panels (SRIAP), ensuring use of immunoglobulin is used for commissioned indications only and at the correct dosage and frequency. There have been no shortages reported since the beginning of 2019 with supplies being managed carefully by SRIAP.

As part of our concerted national efforts to respond to the COVID-19 outbreak, we are doing everything we can to ensure patients continue to access the appropriate medicines.

The Department is working closely with industry, the National Health Service and others in the supply chain to help ensure patients can access the medicines they need, and precautions are in place to reduce the likelihood of future shortages.

The Government is committed to improving the lives of those affected by rare disease and continues to implement the commitments made in the UK Strategy for Rare Diseases.

NHS England and NHS Improvement specialised commissioning are in the process of reviewing all the indications for use in the Clinical Guidelines for Immunoglobulin Use (2011).

NHS England and NHS Improvement have published commissioning criteria which recommend alternative commissioned treatments to immunoglobulin where it is clinically appropriate, for example, the use of rituximab biosimilar agents in the treatment of Myasthenia Gravis.

NHS England and NHS Improvement have also worked to develop policies for alternatives such as Allogeneic Haematopoietic Stem Cell Transplant for Primary Immunodeficiencies (all ages) where a transplant is clinically indicated.

The National Neurosciences Advisory Group, supported by NHS England and NHS Improvement, has been working with the Neuro Intelligence Collaborative (NIC) on projects which include investigating the hospitalisation of people with acute neurology and establishing a profile of their interactions and length of stay in hospital. The NIC’s aim is to identify gaps in neurological service and develop recommendations for change.

In addition to this, NHS England works with national bodies such as Public Health England and patient organisations such as the Neurological Alliance, to raise awareness and support improvement in outcomes for people living with neurological conditions. NHS England supports local transformation through their national programmes - NHS RightCare has published a number of intelligence tools and resources to support reduction in unwarranted variation in neurology services.

Departmental Ministers meet with the life sciences sector to discuss a range of issues. Officials in the Department have held discussions with a range of stakeholders, including representatives of the medicine and medical device supply sector, about the Medicines and Medical Devices Bill. As the Bill is primarily an enabling Bill, discussions with stakeholders on aspects of future regulatory change have been limited, as the details of proposed changes are still under development.

The Bill requires that consultation takes place, prior to the making of regulations in Parts 1, 2 and 3 of the Bill and this will include key stakeholders from the medicine and medical device supply sector.

The stockpiles that were used during the initial COVID-19 response were either ‘business as usual’ stockpiles, stockpiles procured in preparation for a potential ‘no-deal’ exit from the European Union, or stockpiles procured specifically for pandemic response.

The Department has been procuring medicines and medical products in preparation for future cases of COVID-19 and as part of its preparations for the end of the transition period.

Respiratory disease is a clinical priority within the NHS Long Term Plan. The respiratory interventions proposed in the NHS Long Term Plan include early and accurate diagnosis of respiratory conditions, which help prevent avoidable emergency admissions for asthma.

The Quality Outcomes Framework (QOF) ensures all practices establish and maintain a register of patients with an asthma diagnosis in accordance with National Institute for Health and Care Excellence guidance. An update to the General Practitioner contract includes an improved QOF asthma domain which incorporates aspects of care positively associated with better patient outcomes and self-management. NHS England also commissions the national asthma audit programme that provides data on a range of indicators to show improvements and opportunities in asthma outcomes. Audit data are then used by providers to assess the quality of their services and to support quality improvement.

Respiratory disease is a clinical priority within the NHS Long Term Plan. The respiratory interventions proposed in the NHS Long Term Plan include early and accurate diagnosis of respiratory conditions, which help prevent avoidable emergency admissions for asthma.

The Quality Outcomes Framework (QOF) ensures all practices establish and maintain a register of patients with an asthma diagnosis in accordance with National Institute for Health and Care Excellence guidance. An update to the General Practitioner contract includes an improved QOF asthma domain which incorporates aspects of care positively associated with better patient outcomes and self-management. NHS England also commissions the national asthma audit programme that provides data on a range of indicators to show improvements and opportunities in asthma outcomes. Audit data are then used by providers to assess the quality of their services and to support quality improvement.

The Department is committed to working in partnership with its arm’s length bodies, agencies and wider Government to improve the lives of those with lung disease.

Respiratory disease is a clinical priority within the NHS Long Term Plan. This has the overarching objective of improving outcomes for people with respiratory disease through earlier diagnosis and increased access to treatments.

No assessment has been made as the information is not held centrally.

Respiratory disease is a clinical priority within the NHS Long Term Plan. The Plan has the overarching objective of improving outcomes for people with respiratory disease, including asthma. Within the Plan, the respiratory interventions include early and accurate diagnosis, medicines optimisation and the development of self-management models to support people with respiratory conditions to manage their condition all of which are applicable for asthma.

The NHS Long Term Plan commitment to reduce death and disability from severe asthma attacks by ensuring timely assessment and treatment has been taken forward within the scope of the Clinical Review of Standards. This was requested by the Prime Minister in June 2018 and is led by Professor Stephen Powis, Medical Director of NHS England.

The review seeks to promote safety and outcomes; drive improvements in patients experience; are clinically meaningful, accurate and practically achievable; ensure the sickest and most urgent patients are given priority; ensure patients get the right service in the right place; are simple and easy to understand for patients and the public; and not worsen inequalities.

An interim report was published in March 2019 and testing at 14 different hospitals began in May 2019. This included a commitment to collect data to examine the feasibility of measuring how fast critically ill or injured patients arriving at accident and emergency receive a package of tests and care developed with clinical experts

All National Health Service and social care staff, including nurses, can apply for a test if they are experiencing symptoms using digital portal. The employer referral portal allows employers to refer essential workers who are self-isolating either because they or member(s) of their household have COVID-19 symptoms, for testing.

Asymptomatic care home staff are now eligible for testing through the ‘whole home’ testing portal.

Decisions about policy on the provision of medical products available from Part IX of the Drug Tariff, including urinary incontinence products, are a matter for local clinical commissioning groups and National Health Service trusts, taking account of the needs of their local populations and national guidance. Clinicians are expected to prescribe products that meet their patients’ clinical needs taking account of local commissioning policies as appropriate.

The Drug Tariff does not apply to NHS trusts who are responsible for selecting the products they wish to use locally.

Government guidance now requires social distancing and to only work in the same location if it is absolutely essential. Tradespeople should therefore be practising social distancing where possible.

The National Health Service is issuing guidance regularly to all parts of the health service on infection prevention and personal protective equipment (PPE). Regularly updated guidance is available online on GOV.UK.

This guidance includes advice on how to keep staff and patients safe and we would expect any healthcare organisation to inform visiting tradespeople of any specific extra measures that need to be taken in the location they are visiting.

People working in health and care settings should be supplied with any PPE equipment that is clinically required for the job that they are doing or the setting that they are in. Regularly updated guidance is available online on GOV.UK.

Government guidance now requires social distancing and to only work in the same location if it is absolutely essential. Tradespeople should therefore be practising social distancing where possible.

The National Health Service is issuing guidance regularly to all parts of the health service on infection prevention and personal protective equipment (PPE). Regularly updated guidance is available online on GOV.UK.

This guidance includes advice on how to keep staff and patients safe and we would expect any healthcare organisation to inform visiting tradespeople of any specific extra measures that need to be taken in the location they are visiting.

People working in health and care settings should be supplied with any PPE equipment that is clinically required for the job that they are doing or the setting that they are in. Regularly updated guidance is available online on GOV.UK.

There continues to be adequate supply in line with Public Health England recommended use and the European Union exit and pandemic influenza stockpiles have been released. We have now moved to providing substantial extra deliveries and support will be available 24 hours a day, seven days a week.

Services across the National Health Service are urgently being sent stocks of personal protective equipment to help them manage cases and potential cases of COVID-19 and keep staff safe.

The Government’s response is built around protecting those who are most vulnerable in our society. Testing is a crucial part of the United Kingdom’s response to the COVID-19 pandemic and we are working on multiple fronts to deliver additional testing capacity into the system.

As we have moved from ‘contain’ and into the ‘delay’ phase of COVID-19, Public Health England, together with NHS England and the Department, has agreed we will need to prioritise testing for those most at risk of severe illness from the virus. Our aim is to save lives, protect the most vulnerable, and relieve pressure on the National Health Service.

As a result, tests will primarily be given to:

- all patients in critical care for pneumonia, acute respiratory distress syndrome (ARDS) or flu like illness; and

- all other patients requiring admission to hospital for pneumonia, ARDS or flu-like illness

The Government is looking at wider testing for those in less critical states. As announced on 27 March, the Government is working with industry, philanthropy and universities to significantly scale up testing.

On 30 March the Government updated their online guidance on GOV.UK for the clinically extremely vulnerable. This group is advised to shield until at least the end of June 2020. Expert doctors in England identified specific medical conditions that, based on what we knew about the virus so far, place someone at greatest risk of severe illness from COVID-19.

There are around 2.2 million clinically extremely vulnerable patients that have been identified. Each patient identified nationally receives a letter, a text message if their mobile phone details are known and is entitled to use the Cabinet Office shielded patient service. The letter provides specific advice about their circumstances.

On 25 March a new coronavirus Bill was given Royal Assent and is now an Act of Parliament. The Coronavirus Act 2020 aims to protect public health, increase National Health Service’s capacity, strengthen social care and support the public to take the right action at the right time.

On 27 March the Care Quality Commission published interim guidance on Disclosure and Barring Service and other recruitment checks, for providers recruiting staff and volunteers to health and social care services in response to COVID-19.

This guidance represents an interim change in expectations to support the health and social care system. It will only apply for the period the Coronavirus Act 2020 remains in force and will be kept under review during this time. These regulations are effective from 27 March 2020.

On 15 April the Action Plan for Adult Social Care was published. The Government’s number one priority for adult social care is for everyone who relies on care to get the care they need throughout the COVID-19 pandemic. Millions of people rely on this care and support every day. As the pandemic progresses, these vital services must remain resilient and the challenges of COVID-19 go far beyond anything we have previously experienced. The Government’s approach in the action plan is made of four pillars:

- Controlling the spread of infection;

- Supporting the workforce;

- Supporting independence, supporting people at the end of their lives, and responding to individual needs; and

- Supporting local authorities and the providers of care.

This action plan sets out all settings and contexts in which people receive adult social care. This includes people’s own homes, residential care homes and nursing homes, and other community settings – it applies to people with direct payments and personal budgets, and those who fund their own care. It supports the response services for the people who rely on technology-enabled care and monitoring services. The action plan will support care providers, the care workforce, unpaid carers, local authorities and the NHS in their ongoing hard work to maintain services and continue to provide high quality and safe social care to people throughout the pandemic. While this action plan applies to England only (as adult social care is a devolved matter) the Government of course continues to collaborate across the United Kingdom, to share learning and ensure all nations can benefit from new initiatives where possible.

Work is underway to develop and test an innovative model for the evaluation and purchase of antimicrobials. The United Kingdom continues to promote this project internationally to encourage other countries to test similar models which, together, achieve the right incentives to stimulate investment in antimicrobial research and development.

New antimicrobial products not being tested through this project will be purchased and prescribed in line with established practice. The National Institute for Health and Care Excellence (NICE) supports stewardship of current and new antimicrobials through its Managing Common Infections antimicrobial prescribing guidelines for all care settings. NICE also produces Evidence Summaries of the best available information on an antimicrobial to guide decision-making, both nationally within NHS England and locally, for example within a clinical commissioning group, a National Health Service trust, or across a local health economy.

The 2019 Voluntary Scheme for Branded Medicines Pricing and Access is designed to help ensure the affordability of branded medicines to the NHS, whilst supporting innovation and improved access to and uptake of cost-effective medicines, including new antimicrobials, for the benefit of patients.

Carbapenemase-producing Enterobacteriaceae (CPE) are carbapenem-resistant infections with the ability to transfer resistance to different bacterial species. Public Health England conducts monitoring and surveillance of these infections and publishes toolkits to support acute and non-acute organisations to prevent and control the spread of CPE.

The Government recognises that identifying where carbapenemase-producing Gram-negative infections occur, and acting to prevent them, is essential to maintain the effectiveness of our most important antibiotics. Work is underway to add these infections to the list of notifiable diseases as part of our national action plan for antimicrobial resistance.

NHS England and NHS Improvement continue to work to reduce the burden of all healthcare-associated infections and is tasked with delivering the Government’s ambition to halve all healthcare associated Gram-negative blood stream infections by 2023-24.

Work is underway to develop and test an innovative model for the evaluation and purchase of antimicrobials. The United Kingdom continues to promote this project internationally to encourage other countries to test similar models which, together, achieve the right incentives to stimulate investment in antimicrobial research and development.

New antimicrobial products not being tested through this project will be purchased and prescribed in line with established practice. The National Institute for Health and Care Excellence (NICE) supports stewardship of current and new antimicrobials through its Managing Common Infections antimicrobial prescribing guidelines for all care settings. NICE also produces Evidence Summaries of the best available information on an antimicrobial to guide decision-making, both nationally within NHS England and locally, for example within a clinical commissioning group, a National Health Service trust, or across a local health economy.

The 2019 Voluntary Scheme for Branded Medicines Pricing and Access is designed to help ensure the affordability of branded medicines to the NHS, whilst supporting innovation and improved access to and uptake of cost-effective medicines, including new antimicrobials, for the benefit of patients.

Local authorities in England are mandated to provide comprehensive open access sexual health services including access to the full range of contraception and sexually transmitted infection testing and treatment. The Government provides funding to local authorities for their public health responsibilities, including sexual health services, through the public health grant. It is for individual local authorities to decide their spending priorities based on an assessment of local need, including the need for sexual health services taking account of their statutory duties. Consultations at sexual health services increased by 15% between 2014 and 2018 (from 3,101,960 to 3,561,548).

Work on the development of a new national sexual and reproductive health strategy is underway with the Department working with Public Health England, NHS England and NHS Improvement, local government and other partners. Initial engagement has already taken place and we are considering the response to the Green Paper Advancing our health: prevention in the 2020s along with suggestions for priority areas for the new strategy we received through the consultation process. Details of the strategy’s scope and objectives will be announced in due course.

There are currently no plans to reintroduce the mandatory 48 hour access guideline for sexual health services in England.

Local authorities in England are mandated to provide comprehensive open access sexual health services including access to the full range of contraception and sexually transmitted infection testing and treatment. The Government provides funding to local authorities for their public health responsibilities, including sexual health services, through the public health grant. It is for individual local authorities to decide their spending priorities based on an assessment of local need, including the need for sexual health services taking account of their statutory duties. Consultations at sexual health services increased by 15% between 2014 and 2018 (from 3,101,960 to 3,561,548).

Work on the development of a new national sexual and reproductive health strategy is underway with the Department working with Public Health England, NHS England and NHS Improvement, local government and other partners. Initial engagement has already taken place and we are considering the response to the Green Paper Advancing our health: prevention in the 2020s along with suggestions for priority areas for the new strategy we received through the consultation process. Details of the strategy’s scope and objectives will be announced in due course.

There are currently no plans to reintroduce the mandatory 48 hour access guideline for sexual health services in England.

Local authorities in England are mandated to provide comprehensive open access sexual health services including access to the full range of contraception and sexually transmitted infection testing and treatment. The Government provides funding to local authorities for their public health responsibilities, including sexual health services, through the public health grant. It is for individual local authorities to decide their spending priorities based on an assessment of local need, including the need for sexual health services taking account of their statutory duties. Consultations at sexual health services increased by 15% between 2014 and 2018 (from 3,101,960 to 3,561,548).

Work on the development of a new national sexual and reproductive health strategy is underway with the Department working with Public Health England, NHS England and NHS Improvement, local government and other partners. Initial engagement has already taken place and we are considering the response to the Green Paper Advancing our health: prevention in the 2020s along with suggestions for priority areas for the new strategy we received through the consultation process. Details of the strategy’s scope and objectives will be announced in due course.

There are currently no plans to reintroduce the mandatory 48 hour access guideline for sexual health services in England.

The 2020/21 Commissioning for Quality and Innovation scheme for urinary tract infections will include specific reference to catheter-associated urinary tract infections, aligned to the National Institute for Health and Care Excellence antimicrobial prescribing guidance NG113.

As part of the English surveillance programme for antimicrobial utilisation and resistance, Public Health England collects surveillance data on antibiotic resistance in bacteria isolated from urine.

Among all bacterial isolates from urinary tract infection samples, decreases in the proportion resistant were observed for trimethoprim (34.9% to 31.0%), fosfomycin (11.6% to 7.9%), and pivmecillinam (12.1% to 9.9%) between 2015 and 2018.