Asked by: Alison Thewliss (Scottish National Party - Glasgow Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the debate of 4 July on Human-specific medical research techniques, Official Report columns 293WH to 304WH, what assessment he has made of the capability of the UK’s regulatory system to support the (a) development and (b) use of human-specific technologies in medical research.
Answered by Will Quince
As the regulator of medicines, medical devices and blood components for transfusion in the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) keeps abreast of advances in human-specific technologies in medical research that are relevant to the development of medicines and medical devices. The MHRA is aware of human-specific techniques, such as organ-on-chip technologies used to better identify potential toxicity of novel medicines, and has engaged with other organisations active in this space such as the National Centre for the Replacement, Refinement & Reduction of Animals in Research who have hosted meetings on this theme. The MHRA has also provided scientific advice on the use of this technology to support proof of concept for a new medicine. That said, the MHRA does not identify those with whom it may have had discussions who are active commercially in this space.
In relation to human-specific technologies, some medicines have been developed which only have activity in humans, such as eculizumab (Soliris), tebentafusp (Kimmtrak) or CAR T cell products (for instance, Kymriah, Yescarta and Tecartus). These medicines were developed using human specific methods, however, versions of these medicines that were active in animals were, in some cases, also used. The MHRA supports the developers of these products by its offer of scientific advice services, the Innovation Office and the Innovative Licensing and Access Pathway.
Asked by: Rachael Maskell (Labour (Co-op) - York Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure that families on low incomes have access to adequate sun protection products; and if he will ensure that free sun protection products are available to people who are exempt from paying for prescriptions.
Answered by Neil O'Brien
Sun protection products are not classified as medicines or medical devices. Products which are not medicines or medical devices may be prescribed by clinicians, taking into account appropriate national and local guidance on clinical and cost effectiveness. For example, NHS England guidance states that sun protection should not routinely be prescribed in primary care as the condition is appropriate for self-care. However, Advisory Committee on Borderline Substances (ACBS) approved sun protection products for the indication of photodermatoses are listed in part XV of the Drug Tariff and are appropriate for being prescribed for this purpose, the list available at the following link:
https://www.england.nhs.uk/wp-content/uploads/2018/03/otc-guidance-for-ccgs.pdf
It is for the general practitioner or other responsible clinician to work with their patient and decide on the course of treatment, with the provision of the most clinically appropriate care for the individual always being the primary consideration. Clinicians are accountable for their prescribing decisions, both professionally and to their service commissioners.
Almost 89% of prescription items in England are already provided free of charge, including to those in receipt of qualifying benefits or tax credits. For those not exempt from charges, prescription pre-payment certificates can be used to cap costs at around £2 a week for regular prescriptions. People on low incomes can apply for help with their health costs through the NHS Low Income Scheme. The Scheme provides income related help to people who are not automatically exempt from charges but who may be entitled to full or partial help if they have a low income and savings below a defined limit.
Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 5 June 2023 to Question 186946, on Yellow Card Scheme, when data collection began on medical devices which will be made available in a format similar to that of the Innovative Devices Access Pathway.
Answered by Will Quince
In 2015, the Medicines and Healthcare products Regulatory Agency (MHRA) simplified its medicine and device incident report systems by extending the Yellow Card scheme to collect reports on medical device incidents in addition to suspected adverse drug reactions (ADRs). The MHRA's interactive Drug Analysis Profiles contain listings of all suspected ADRs reported through the Yellow Card scheme for medicines. MHRA is currently working to improve the Yellow Card reporting site and this work includes enhanced data visualisations of incident reports, and this will be rolled out across all medicinal products, including medical devices. This work will continue through 2023.
Asked by: Lord Hunt of Kings Heath (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what has been the increase in each year since 2000 in the number of UK regulated independent online providers offering (1) Care Quality Commission regulated prescribing, and (2) General Pharmaceutical Council regulated dispensing services, to the public.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The requested information is not held centrally. The Care Quality Commission does not have a regulated activity of prescribing or dispensing.
The General Pharmaceutical Council (GPhC) regulates pharmacists, pharmacy technicians and pharmacies in England, Scotland and Wales. The Pharmaceutical Society of Northern Ireland regulates pharmacists and pharmacies in Northern Ireland.
All pharmacies in Great Britain, including those providing internet services, must be registered with the GPhC. The Department does not hold information on the number of independent online providers offering GPhC regulated dispensing services.
Medicines and medical devices are not ordinary consumer goods and their supply is tightly controlled in the United Kingdom. All service providers must adhere to high standards when prescribing and supplying medications to patients, particularly if the patient’s journey is not face to face.
The regulation of providers delivering general practitioner consultations over the internet and providers prescribing medications in response to online forms is the responsibility of Care Quality Commission. General Pharmaceutical Council sets standards for professional practice for all registered pharmacies, including non-NHS distance selling pharmacies. The Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK.
To ensure remote supply of medicines to patients is safe, regulators have issued guidance for online providers on how to comply with the legislation and meet expected standards of services and provided guidance for patients about the importance of checking that services they access are statutory regulated. The regulators are working together to address various concerns about remote practice.
The decision about data collection required to support these regulatory activities is at the discretion of the regulatory bodies.
Asked by: Lord Hunt of Kings Heath (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government for what reasons UK-regulated independent online providers in England are permitted to issue and dispense prescriptions without any requirement for pseudonymised prescribing and dispensing data to be collated.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The requested information is not held centrally. The Care Quality Commission does not have a regulated activity of prescribing or dispensing.
The General Pharmaceutical Council (GPhC) regulates pharmacists, pharmacy technicians and pharmacies in England, Scotland and Wales. The Pharmaceutical Society of Northern Ireland regulates pharmacists and pharmacies in Northern Ireland.
All pharmacies in Great Britain, including those providing internet services, must be registered with the GPhC. The Department does not hold information on the number of independent online providers offering GPhC regulated dispensing services.
Medicines and medical devices are not ordinary consumer goods and their supply is tightly controlled in the United Kingdom. All service providers must adhere to high standards when prescribing and supplying medications to patients, particularly if the patient’s journey is not face to face.
The regulation of providers delivering general practitioner consultations over the internet and providers prescribing medications in response to online forms is the responsibility of Care Quality Commission. General Pharmaceutical Council sets standards for professional practice for all registered pharmacies, including non-NHS distance selling pharmacies. The Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK.
To ensure remote supply of medicines to patients is safe, regulators have issued guidance for online providers on how to comply with the legislation and meet expected standards of services and provided guidance for patients about the importance of checking that services they access are statutory regulated. The regulators are working together to address various concerns about remote practice.
The decision about data collection required to support these regulatory activities is at the discretion of the regulatory bodies.
Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the level of awareness of (a) health professionals and (b) the general public of the Adverse Events Yellow Card System; and what steps is he taking to increase awareness of that system among those groups.
Answered by Will Quince
The Medicines and Healthcare products Regulatory Agency (MHRA) recognises the importance of both public and healthcare professional understanding of, and access to the MHRA Yellow Card scheme, so that they can promptly report any concerns they have about the safety of healthcare products. The MHRA monitors the number of reports it receives from members of the public and healthcare professionals and strives to keep improving understanding and awareness of the reporting system. The MHRA continually works to encourage reporting of any safety concerns to the Yellow Card scheme and help improve the safe use of medicines and medical devices for everyone.
A sharp increase in reporting, mainly from patients, has been seen due to better awareness of the scheme following significant communications activity at the start of the COVID-19 vaccination campaign.
Asked by: Rachael Maskell (Labour (Co-op) - York Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will conduct a review into (a) the adequacy of the level of public understanding of the Medicines and Healthcare products Regulatory Agency's Yellow Card reporting system and (b) any changes needed to help increase public understanding of that reporting system.
Answered by Will Quince
The Medicines and Healthcare products Regulatory Agency (MHRA) recognises the importance of public understanding of and access to the MHRA Yellow Card scheme, so that any member of the public is able to promptly report any concerns they have about the safety of healthcare products. The MHRA monitors the number of reports it receives from members of the public and strives to keep improving the public understanding of the reporting system. The MHRA continually works to encourage reporting of any safety concerns to the Yellow Card scheme and to help improve the safe use of medicines and medical devices for everyone.
A sharp increase in reporting, mainly from patients, has been seen due to better awareness of the scheme following significant communications activity at the start of the COVID-19 vaccination campaign. MHRA works with key partners to include information about the Yellow Card scheme to be given to recipients of medical products, coupled with MHRA campaigns and outreach work that generates media coverage.
Asked by: Virendra Sharma (Labour - Ealing, Southall)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he is taking to maintain the supply of medical devices in the UK in light of increased financial and regulatory pressures for manufacturers.
Answered by Will Quince
The Government recognises challenges faced by suppliers relating to financial pressures and regulatory changes. The Department and NHS Supply Chain (NHSSC) have robust measures in place to monitor supply chains, working closely with suppliers within the bounds of contractual agreements to secure value for money for taxpayers and maintain access to devices and clinical consumables.
Similarly, the Government remains committed to providing sufficient time for industry to transition to any new regulatory requirements, following its response to the Medicines and Healthcare products Regulatory Agency’s future medical device regulations consultation in June 2022. The latter outlined changes supporting innovation in the United Kingdom’s life sciences and access to medical devices.
Asked by: Angus Brendan MacNeil (Independent - Na h-Eileanan an Iar)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he is taking to help ensure that an adequate number of medical devices are available on the UK market.
Answered by Will Quince
The response to the future medical device regulations consultation, published in June 2022, outlined changes supporting innovation in United Kingdom’s life sciences and access to medical devices.
The Government is fully committed to protecting the continuity of supply of medical devices and providing sufficient time for industry to transition to any new requirements.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has confirmed that devices “Conformité Européene” marked under the most recent European Union regulations can continue to be placed on the Great Britain market for up to five years from July 2024, when the new UK regime is planned to take effect.
MHRA is developing a world-leading regulatory framework for the UK that will ensure the ongoing availability of adequate numbers of medical devices.
Asked by: Lord Taylor of Warwick (Non-affiliated - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the effects of the UK's departure from the EU on the National Health Service.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
As part of our reforms following the United Kingdom’s departure from the European Union (EU), provisions within the Medicines and Medical Devices Act 2021 enable us to overhaul medical devices and clinical trial frameworks so patients can get access to new lifesaving medicines and medical devices more quickly. The Department closely monitors National Health Service and adult social care staffing levels in England, with data showing that since leaving the EU we have seen an increase in EU/EEA staff working in the NHS.
We are also working closely with suppliers, NHS England, the Medicines and Healthcare products Regulatory Agency, the devolved governments, and other stakeholders to ensure patients continue to have access to the treatments they need.