Asked by: Jonathan Reynolds (Labour (Co-op) - Stalybridge and Hyde)
Question to the Department for Work and Pensions:
To ask the Secretary of State for Work and Pensions, whether all assessors at each stage of (a) a personal independence payment assessment and (b) subsequent appeals have access to insight condition reports for fetal valproate spectrum disorder as recommended in the Independent Medicines and Medical Devices Safety Review report.
Answered by Chloe Smith
Both Personal Independence Payment (PIP) assessment providers have a Condition Insight Report (CIR) on Fetal Valproate Spectrum Disorder, which all their Health Professionals (HPs) have access to during the course of the PIP assessment process.
The CIR on Fetal Valproate Spectrum Disorder is a product specifically developed for HPs. It is therefore not shared with DWP Case Managers, who make decisions on entitlement and mandatory reconsiderations, or Her Majesty’s Courts and Tribunals Service (HMCTS), who handle appeals.
DWP Case Managers use the content within the assessment report provided by the HP, and any other available evidence, to make a decision for each claimant. However, HP advice is available throughout the process if a DWP Case Manager requires input following the initial assessment.
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what assessment they have made of reports (1) that UK clinics are selling BGI Group’s tests for genetic conditions such as Down’s syndrome, and (2) that BGI Group is (a) using these tests to harvest the genetic data of millions of women and their unborn children, and (b) storing this data on a gene database funded by the government of China; and what plans they have to ban BGI Group in the UK.
Answered by Lord Bethell
There has been no specific assessment of BGI Group’s tests. Public Health England and NHS England have confirmed they do not use BGI technology in their genomic screening services.
On the information provided, the Medicines and Healthcare products Regulatory Agency (MHRA) would anticipate that this type of device would be classified as a List B In-Vitro Diagnostic, which requires the oversight of a conformity assessment body before being placed on the United Kingdom market. The device must comply with the Medical Devices Regulations 2002 No.618. The MHRA understand BGI genetic screening tests are currently available for sale in the UK. These devices do not appear to have been registered with the MHRA at this time, however, due to their risk classification, registration will be required from 1 September 2021 in order to continue placing the products on the market.
Access to health data is controlled by the Data Protection Act 2018 (which incorporates GDPR in UK domestic law) and the common law duty of confidentiality and we have no plans to change these. The Government is clear that health and care data should only ever be used and/or shared where used lawfully, treated with respect, held securely and where the right safeguards are in place. The UK’s high standards of data protection will be maintained and enforced.
As outlined in the Genome UK strategy, all our genomic data systems will continue to apply consistent high standards around data security and our intention is that the UK model will be recognised as being the gold standard for how to apply strong and consistent ethical and regulatory standards that support rapid healthcare innovation, adhere to legal frameworks, and maintain public and professional trust.
There are no grounds to prevent BGI Groups operating in the UK provided they comply with UK legislation and regulatory requirements.
Asked by: Lord Risby (Conservative - Life peer)
Question to the Foreign, Commonwealth & Development Office:
To ask Her Majesty's Government what support they have provided to British Overseas Territories and Crown Dependencies during the COVID-19 pandemic; and whether this support will extend to the provision of vaccinations when trials are concluded.
Answered by Baroness Sugg
The UK Government has undertaken a major operation to support the Overseas Territories (OTs) in dealing with COVID-19. Support has been sent to all of the inhabited OTs with the exception of Pitcairn. UK support has enabled seven OTs to start testing for the virus and the others to continue testing when supply routes were cut. Supplies of PPE were sent to ensure no OT ran out. Medical equipment was sent to ensure hospitals could cope when each island was cut off from their usual medical evacuation routes by providing field hospital equipment, medicines, ventilators, CPAPS and other equipment. Expert support was provided in the form of advice from PHE, deployments of medical staff and a remote telemedicine service providing OT clinicians with remote access to clinical advice in the treatment of COVID-19 and other critical conditions. Military teams were deployed to the Cayman Islands and Turks and Caicos Islands to support with logistics and border security. Flights were arranged by the FCDO to repatriate British nationals to and from the OTs. Emergency budgetary support has been provided to Montserrat, St Helena and Anguilla to keep essential public services running and ensure these OTs can respond to the impacts of the pandemic.
The UK Government has worked closely with the governments of the Crown Dependencies throughout the COVID-19 pandemic. While the Crown Dependencies are responsible for their own emergency planning, response and recovery, the UK has engaged at working and political level with these jurisdictions to support their own efforts to combat COVID-19 and mitigate against its spread on the islands. This has included ensuring that the Crown Dependencies can access UK supply chains for key medicines and medical devices, including PPE and ventilators. The UK will maintain this engagement over the coming months to ensure that the UK can continue to offer support to Crown Dependency governments.
Through the Vaccine Task Force, the UK Government is procuring vaccines on behalf of the Crown Dependencies and OTs, and is working with them to ensure the smooth deployment of a COVID-19 vaccine once a safe and effective one is available.
Asked by: Anne Marie Morris (Conservative - Newton Abbot)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the report by the All-Party Parliamentary Group on Access to Medicines and Medical Devices on Special Medicinal Products, what assessment he has made of the potential merits of creating a national formulary of red-amber-green coded specials.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
The Government published a Consultation last year which asked stakeholders to give their feedback to proposals that included improving the system for reimbursement of special medicinal products. The Government will consider the report on Special Medicinal Products by the All-Party Parliamentary Group on Access to Medicines and Medical Devices as work post the consultation is taken forward. The Consultation is available at the following link:
https://www.gov.uk/government/consultations/community-pharmacy-drug-reimbursement-reform
Asked by: Baroness Masham of Ilton (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what steps they are taking to ensure that people living with urinary incontinence have access to high quality medical devices after Brexit.
Answered by Lord Bethell
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.
Asked by: Jackie Doyle-Price (Conservative - Thurrock)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, when his Department plans to update the House on its response to the Independent Medicines and Medical Devices Safety Review; what the Government's priorities are for women's health; and if he will make a statement.
Answered by Nadine Dorries
We do not consider it appropriate to commit to a specific timeframe for a response while these recommendations are being considered. While this report was published on 8 July, it took over two years to compile and we therefore consider it vitally important that it is given full consideration.
Supporting women’s health is critical for the health and care system. We know that there are significant differences and inequalities between different groups of women in terms of access to services, experience of services and health outcomes. We are reflecting on the detailed and thorough First Do No Harm Report published by Baroness Cumberlege and what this tells us about priorities for women’s health.
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 steps he is taking to support the Medicines and Healthcare products Regulatory Agency (MHRA) to uphold quality and safety standards following the UK’s withdrawal from the EU.
Answered by Nadine Dorries
The Medicines and Healthcare products Regulatory Agency (MHRA) has made preparations to amend medicines and medical devices regulations to make sure we have the strongest regulatory framework for medicines from day 1 after the end of the transition period, This will enable the MHRA to continue to have the appropriate oversight for medicines placed on the market, to maintain patient safety and be able to take action where necessary.
After the transition period, our aim is to make sure patients in the United Kingdom continue to be able to access the best and most innovative medicines and medical devices. We want patients to be reassured that their safety will be protected through the strongest regulatory framework.
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 steps he is taking to support the Medicines and Healthcare products Regulatory Agency to uphold quality and safety standards after the end of the transition period.
Answered by Nadine Dorries
The Medicines and Healthcare products Regulatory Agency (MHRA) has made preparations to amend medicines and medical devices regulations to make sure we have the strongest regulatory framework for medicines from day 1 after the end of the transition period, This will enable the MHRA to continue to have the appropriate oversight for medicines placed on the market, to maintain patient safety and be able to take action where necessary.
After the transition period, our aim is to make sure patients in the United Kingdom continue to be able to access the best and most innovative medicines and medical devices. We want patients to be reassured that their safety will be protected through the strongest regulatory framework.
Asked by: Lord Birt (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what steps they are taking to stockpile sufficient (1) personal protective equipment and (2) medical equipment and supplies, to cope with any second wave of the COVID-19 pandemic. [T]
Answered by Lord Bethell
We are working to expand the supply of personal protective equipment (PPE) from overseas and improve domestic manufacturing capability. We are expanding and improving the logistics network for delivering to the front line.
We are confident in the stocks and sources of supply of PPE to meet the needs of health and social care over the coming months.
As part of our concerted national efforts to respond to the COVID-19 outbreak, 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 and medical devices and equipment they need. Precautions are in place to reduce the likelihood of future shortages, including management of demand.
The Department shares regular information about impending supply issues and management plans with the NHS via networks in primary and secondary care and will liaise with relevant patient groups about issues affecting specific medicines, medical devices and equipment.
Asked by: Tulip Siddiq (Labour - Hampstead and Kilburn)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what recent assessment his Department has made of the adequacy of supply of (a) buprenorphine, (b) methadone and (c) naltrexone during the covid-19 outbreak.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
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 safe and effective medicines. Supplies of buprenorphine, methadone and naltrexone continue to remain available.
The Department has well-established procedures to deal with medicine shortages and is working closely with industry, the National Health Service and others in the supply chain to reduce the likelihood of future shortages.
The Department shares regular information about impending supply issues and management plans with the NHS via networks in primary and secondary care and will liaise with relevant patient groups about issues affecting specific medicines, medical devices and equipment.