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, whether he is taking steps to help ensure that the Medicines and Healthcare products Regulatory Agency process for registering medical devices facilitates an adequate level of supply of safe medical devices.
Answered by Will Quince
The Medicines and Healthcare products Regulatory Agency (MHRA) intends to strengthen the regulation of medical devices as set out in the Government’s response to the consultation on the future regulation of medical devices in the United Kingdom. Availability of medical devices remains a key consideration as we develop this future regime, including aspects on medical devices registration.
The MHRA continues to recognise the importance of availability of medical devices in the UK, and is taking a variety of steps to help ensure continuity in supply of medical devices. Firstly, the MHRA will consider applications for an exceptional use authorisation where there is a clear clinical need for a device, that does not otherwise have a valid Conformité Européene (CE) or UK Conformity Assessed (UKCA) mark, to remain on the market. We assess applications for European Union Allowance based on the needs of patients. The MHRA is also working to expand Approved Body capacity to enable more manufacturers to obtain UKCA marking. Four bodies have already been designated and a further six are progressing through the designation process, with more in the pipeline.
In addition to this, the MHRA is working to ensure adequate transitional arrangements for its future regime for medical devices, including continued acceptance of CE marked medical devices taking into account the revised transitional arrangements for European Union (EU) medical devices regulations being progressed in the EU, which will apply in Northern Ireland. Finally, MHRA is working to ensure industry have clear guidance on registration requirements as the above progress and recently published an update on EU timeline revisions to support this.
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: 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 assessment he has made of the impact of supply chain disruption on the supply of medical devices to the UK.
Answered by Will Quince
We continue to see the impact of global events on supply chains and are aware of increased pressures on global manufacturing capacity. In response, the Department works closely with the Devolved Administrations, NHS England, NHS Supply Chain and suppliers to maintain continuity of supply across a broad range of products to minimise the impact of any potential supply disruptions on patient care.
While supplies have been maintained, responding to some supply chain disruptions has required a switch to alternative products in some instances. The Department proactively monitors supply conditions and engages extensively with industry to identify threats to the supply of medical equipment.
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 assessment he has made of the effect of the covid-19 outbreak on the access of multiple sclerosis patients to critical healthcare professional support; and what long-term plan he has in place to ensure that MS patients are able to access treatment and support conveniently.
Answered by Edward Argar - Minister of State (Ministry of Justice)
While no specific assessment has been made, throughout the COVID-19 pandemic, the National Health Service in England has maintained access to urgent and emergency care, including for patients with multiple sclerosis (MS). For non-urgent care, providers have offered remote consultations using video, telephone, email and text message services as a priority where appropriate.
On 23 December 2020, NHS England and NHS Improvement outlined priorities for the remainder of 2020-2021 and into 2021-2022, including maximising the NHS’s capacity to treat non-COVID-19 patients. This capacity includes services for people with neurological diseases, including MS - for example, physiotherapy, occupational therapy and speech and language therapy. In the longer term, NHS systems should also continue to implement the guidance set out in the Progressive Neurological Conditions RightCare Toolkit, which was developed in collaboration with key stakeholders such as the MS Trust and the MS Society.
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 assessment he has made of the implications for his policies of the Scottish Medicine Consortium’s approval of ozanimod for Scottish patients with relapsing remitting multiple sclerosis; and whether it is his policy to provide for the same access to innovative medicines for MS patients in England.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
The National Institute for Health and Care Excellence (NICE) is the independent body responsible for providing evidence-based guidance for the National Health Service in England on whether medicines represent a clinical and cost-effective use of resources. NICE’s appraisal of ozanimod for treating relapsing remitting multiple sclerosis is ongoing and a consultation on NICE’s draft guidance closed on 12 February.
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 contingency plans he has with respect to the UK's future relationship with the EU in the event of an interruption in the supply of medicines after the transition period.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
The Department, in consultation with the devolved administrations and the Crown Dependencies, is working with trade bodies, product suppliers, and the health and care system to help ensure continued supply of medicines and medical products, to the whole of the United Kingdom at the end of the transition period.
As set out in a letter from the Department to industry of 17 November, we are implementing a multi-layered approach, that involves asking suppliers of medicines, vaccines and other medical products to the UK from or via the European Union to get trader ready, reroute their supply chains away from any potential disruption and stockpile on UK soil where this is possible. The letter is available at the following link:
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, with reference to his oral contribution of 7 July 2002, Official Report, column 839, what assessment he has made of the potential effect of testing asymptomatic people for covid-19 on returning (a) merchant mariners and (b) oil rig workers to the UK.
Answered by Helen Whately - Minister of State (Department of Health and Social Care)
Current clinical advice is that testing of individuals without symptoms should be used where clinically appropriate. We continue to use the latest science and clinical advice to inform our approach.
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, whether his Department plans to undertake or commission research into low dose and combinatory effects of pesticide exposure; and if he will make a statement.
Answered by Jackie Doyle-Price
The Department, through the National Institute for Health Research (NIHR) has commissioned the Health Protection Research Unit in Chemical and Radiation Threats and Hazards to deliver research on ‘Chemical Exposure and Neurological and Psychiatric Disorders’. One project within this research theme concerns organophosphate pesticide exposures in domestic and occupational settings. The project aims to assess exposure and also any effects on cognitive function.
The NIHR welcomes funding applications for research into any aspect of human health. It is not usual practice to ring-fence funds for particular topics or conditions. Applications are subject to peer review and judged in open competition, with awards being made on the basis of the importance of the topic to patients and health and care services, value for money and scientific quality. In all areas, the amount of NIHR funding depends on the volume and quality of scientific activity.
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, whether his Department plans to undertake or commission research into low dose and combinatory effects of pesticide exposure; and if he will make a statement.
Answered by Jackie Doyle-Price
The Department, through the National Institute for Health Research (NIHR) has commissioned the Health Protection Research Unit in Chemical and Radiation Threats and Hazards to deliver research on ‘Chemical Exposure and Neurological and Psychiatric Disorders’. One project within this research theme concerns organophosphate pesticide exposures in domestic and occupational settings. The project aims to assess exposure and also any effects on cognitive function.
The NIHR welcomes funding applications for research into any aspect of human health. It is not usual practice to ring-fence funds for particular topics or conditions. Applications are subject to peer review and judged in open competition, with awards being made on the basis of the importance of the topic to patients and health and care services, value for money and scientific quality. In all areas, the amount of NIHR funding depends on the volume and quality of scientific activity.
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, with reference to paragraph 61 of the Report of the Smith Commission, what plans he has for the devolution of abortion.
Answered by Jane Ellison
The Smith Commission Agreement recommended further serious consideration should be given to devolution of abortion and a process should be established immediately to consider the matter further. The issue is currently under consideration.