Asked by: Martyn Day (Scottish National Party - Linlithgow and East Falkirk)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether his Department is taking steps to support small businesses through the voluntary scheme for branded medicines pricing and access.
Answered by Will Quince
The voluntary scheme for branded medicines pricing and access (VPAS) includes strong commercial incentives in the form of freedom of list pricing and exemptions from payments for medicines containing a new active substance. Smaller companies are specifically supported through payment exemptions for those with under £5 million sales and a taper for companies between £5 million and £25 million sales.
Asked by: Martyn Day (Scottish National Party - Linlithgow and East Falkirk)
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 potential impact of the Voluntary Scheme for Branded Medicines Pricing and Access on access to medicines in the UK.
Answered by Will Quince
The voluntary scheme for branded medicines pricing and access (VPAS) includes strong commercial incentives to launch new products in the form of freedom of list pricing and exemptions from payments for medicines containing a new active substance. In addition, the scheme made commitments to improve the access environment for medicines which has been done through the publication of NHS England’s Commercial Framework for New Medicines, a review of the National Institute for Health and Care Excellence’s methods and processes and improved horizon scanning capabilities.
These incentives and commitments have contributed to VPAS driving significant improvements in patient access to clinically and cost-effective medicines, whilst ensuring sustainable and predictable spend growth for the National Health Service and industry during a period of economic uncertainty. This is demonstrated by data published in April 2023, by the U.S. industry body, PhRMA ranked the UK third in the G20 for availability of new medicines from 2012 to 2021.
Asked by: Martyn Day (Scottish National Party - Linlithgow and East Falkirk)
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 potential merits of establishing a fund for ultra-orphan medicines.
Answered by Will Quince
The National Institute for Health and Care Excellence (NICE) has been able to recommend medicines for very rare diseases for NHS funding through its established processes. These are now available to NHS patients in England, including gene therapies for metachromatic leukodystrophy (Libmeldy), spinal muscular atrophy (Zolgensma) and inherited retinal dystrophies (Luxturna).
In June 2022, the Government launched the Innovative Medicines Fund that will support NHS patients in England, including those with very rare diseases, to get early access to the most innovative and effective new treatments, where further data is needed to support a NICE recommendation on routine funding. The IMF is a managed access fund that provides a route for earlier patient access to the most promising new medicines while further evidence is collected to inform a long-term commissioning recommendation.
NICE’s independent committee may consider managed access if it cannot make a recommendation for routine commissioning but believes that further evidence collection during a period of managed access will sufficiently support the case for such a recommendation in the future.
Asked by: Martyn Day (Scottish National Party - Linlithgow and East Falkirk)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether he has had discussions with his counterpart in the Scottish Government on the lessons learned from the implementation of Scan4Safety in Scotland.
Answered by Will Quince
The NHS Mandate 2023 sets out the requirement for the National Health Service to adopt digital scanning. By March 2024, all trusts should adopt barcode scanning of high-risk medical devices and submission to the national, mandatory Medical Device Outcome Registry (MDOR) either directly or via a supporting electronic health record (EHR) or inventory management system that can support registry data submission. The registry will be used to improve patient safety and outcomes in procedures that use high risk medical devices.
MDOR has native barcode scanning, including Unique Device Identifier (UDI) barcodes, so will result in the whole of England having an available UDI scanning solution without having to implement a separate system. The registry was launched in May 2023 and will accept bulk uploads from existing providers’ solutions, including Scan4Safety, that meet the data quality and completeness requirements. The Outcomes and Registries programme will support provider adoption of digital solutions that enable medical device traceability on the electronic patient record.
The Secretary of State has exchanged letters with the Scottish Government setting out the UK Government’s commitment to delivering the recommendation of the Independent Medicines and Medical Devices Safety Review and on the approach for MDOR. The intention is that each Devolved Administration has the option to ‘opt in’ to existing or future technical registry developments in MDOR, building on the different data programmes and local approaches to traceability and patient outcome monitoring being taken at Devolved Administration levels.
Asked by: Martyn Day (Scottish National Party - Linlithgow and East Falkirk)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if his Department will conduct an inquiry into potential reforms to clinical research and trials to (a) scale up, (b) speed up and (c) increase the number of such trials in (i) Scotland and (ii) the UK.
Answered by Will Quince
The Department has no plans to conduct an inquiry into clinical research reforms as work in this area is already in progress. The Government's vision for clinical research delivery, set out in ‘Saving and Improving Lives: The Future of UK Clinical Research Delivery’ (2021), aims to create a patient-centred, innovative, and digitally enabled environment. This includes improving study set-up, speed and efficiency, increasing the participation of patients within clinical trials and integrating clinical research within health and social care practice.
Lord James O’Shaughnessy was appointed by Government to conduct an independent review into the United Kingdom commercial clinical trials landscape. The Review, published 26 May, makes 27 recommendations, with an emphasis on speed of delivery, transparency of clinical research data and easier recruitment for UK clinical trials. The Government welcomes the recommendations set out in Lord O'Shaughnessy's independent review and in its response makes five headline commitments to improve the commercial clinical trials system.
No centralised information is available for clinical trials in Scotland, and the Department cannot provide a response on behalf of the Scottish Government.
Asked by: Martyn Day (Scottish National Party - Linlithgow and East Falkirk)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what progress his Department has made on the roll-out of the Scan4Safety initiative.
Answered by Will Quince
The NHS Mandate 2023 sets out the requirement for the National Health Service to adopt digital scanning. By March 2024, all trusts should adopt barcode scanning of high-risk medical devices and submission to the national, mandatory Medical Device Outcome Registry (MDOR) either directly or via a supporting electronic health record (EHR) or inventory management system that can support registry data submission. The registry will be used to improve patient safety and outcomes in procedures that use high risk medical devices.
MDOR has native barcode scanning, including Unique Device Identifier (UDI) barcodes, so will result in the whole of England having an available UDI scanning solution without having to implement a separate system. The registry was launched in May 2023 and will accept bulk uploads from existing providers’ solutions, including Scan4Safety, that meet the data quality and completeness requirements. The Outcomes and Registries programme will support provider adoption of digital solutions that enable medical device traceability on the electronic patient record.
The Secretary of State has exchanged letters with the Scottish Government setting out the UK Government’s commitment to delivering the recommendation of the Independent Medicines and Medical Devices Safety Review and on the approach for MDOR. The intention is that each Devolved Administration has the option to ‘opt in’ to existing or future technical registry developments in MDOR, building on the different data programmes and local approaches to traceability and patient outcome monitoring being taken at Devolved Administration levels.
Asked by: Martyn Day (Scottish National Party - Linlithgow and East Falkirk)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what lessons from the covid-19 pandemic his Department is applying to its policy on clinical trials.
Answered by Will Quince
The United Kingdom’s clinical research ecosystem is actively learning from the successful COVID-19 research response. The UK Government published its vision in ‘Saving and Improving Lives: The Future of UK Clinical Research Delivery’ in March 2021. The vision sets out the ambition to create a patient-centred, pro-innovation, and digitally enabled clinical research environment. This includes the prioritisation of the improvement in study set-up speed and efficiency by expediting costing, contracting, and approvals. Implementing the vision will unleash the true potential of our clinical research environment to improve health, capitalise on our renowned research expertise, and make the UK one of the best places in the world to design and deliver research.
Asked by: Martyn Day (Scottish National Party - Linlithgow and East Falkirk)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the recommendations of the Law Commission in its report on Building families through surrogacy: a new law and the proposals in its draft Surrogacy Bill, whether he plans to bring forward legislative proposals to protect the rights and interests of surrogate mothers.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The Law Commissions of England & Wales and Scotland published a full report of their review of surrogacy legislation, with a draft bill, on 28 March 2023. The Government is considering the report and will publish a response in due course.
Asked by: Martyn Day (Scottish National Party - Linlithgow and East Falkirk)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether he has made an assessment of the effectiveness of legislation on surrogacy at preventing the coercion of women; and whether he plans to introduce legislative proposals to help prevent such coercion.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The Law Commissions of England & Wales and Scotland published a full report of their review of surrogacy legislation, with a draft bill, on 28 March 2023. The Government is considering the report and will publish a response in due course.
Asked by: Martyn Day (Scottish National Party - Linlithgow and East Falkirk)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what progress his Department has made on implementing the recommendations made by the Liver Advisory Group in 2020 on liver transplantation for the treatment of perihilar cholangiocarcinoma and intra-hepatic cholangiocarcinoma.
Answered by Neil O'Brien
The Liver Advisory Group, on behalf of NHS Blood and Transplant (NHSBT), are exploring pilot programmes for selected patients with both small intra-hepatic cholangiocarcinoma and perihilar cholangiocarcinoma (pHCCa) with underlying primary sclerosing cholangitis.
The pathway for intrahepatic Cholangiocarcinoma is now live and there is an offering process in place which should ensure they receive a timely named patient offer. The protocol for pHCCa remains in development and will soon be live in the third quarter of this year. Additionally, in collaboration with NHS England, NHSBT are developing the pHCCa as a commissioning evaluation for the neoadjuvant pathway of proton beam therapy which is a ground-breaking intervention that is being evaluated in this clinical transplant pathway.