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 assessment he has made of the quality of medical devices being delivered to the NHS; and if he will make a statement.
Answered by Jackie Doyle-Price
The Government is committed to the safe and effective regulation of medical devices in the United Kingdom; we continue to strengthen safety while ensuring patients and the public have fast access to new, innovative devices.
All medical devices placed on the UK market must comply with the European Union Medical Devices Directive 93/42/EEC (MDD). The CE mark for a device is placed on a product by a manufacturer to attest to its compliance with the safety, quality and performance requirements of the MDD, before it can be placed on the market, which includes supply to the National Health Service.
Once a device is placed on the market, the manufacturer is required to continually monitor the performance of their device, submit vigilance reports to the Medicines and Healthcare products Regulatory Agency (MHRA) when incidents occur involving their device and take appropriate safety action when required. Additionally, the MHRA monitors adverse incident reported though the Yellow Card reporting system. Adverse incident reports can be submitted to the MHRA by members of the public, healthcare professionals and the device manufacturer.
Furthermore, the new EU Medical Devices Regulation 2017/745 (MDR), which entered into force in May 2017, have introduced more stringent requirements from manufacturers to ensure a high level of patient safety. These include increased scrutiny by notified bodies, particularly for higher risk devices, new standards for clinical evidence and more rigorous vigilance reporting requirements.
Asked by: Kevan Jones (Labour - North Durham)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will reclassify dermal fillers as prescription-only medicines.
Answered by Jackie Doyle-Price
Currently, the Medicines and Healthcare products Regulatory Agency only regulates dermal fillers that are placed on the United Kingdom market as medical devices, as defined in the Medical Devices Regulations 2002. The majority of these products are intended to be used in reconstructive surgery, and thus they are considered to be medical devices, although some manufacturers also indicate their products for aesthetic use as well.
Cosmetic dermal fillers placed on the market without any medical purpose being attributed to them by the manufacturer fall outside the scope of the Medical Devices Regulations, although in practice the majority of the products on the UK market are CE marked as medical devices.
From May 2020 all dermal fillers, irrespective of their composition and intended use, will be regulated as medical devices under Annex XVI of the Medical Device Regulations (EU 2017/745). The Regulations will significantly strengthen the quality assurance and safety of dermal fillers and ensure a consistent legal status of these products on the UK market. This will lead to a stronger market surveillance of these products.
Medical devices cannot be designated as ‘prescription only’, as this term only applies to medicinal products. The Government currently has no plans to introduce such a category for medical devices.
The Government is committed to the safe and effective regulation of medical devices in the UK; we continue to strengthen safety while ensuring patients and the public have fast access to new, innovative devices.
Through the ‘no deal’ statutory instrument, which will amend the Medical Devices Regulations 2002, the UK will have a regulatory system in place, which will mirror all the key elements contained in Medical Device Regulations (EU 2017/745) and which will be brought into force in line with the transitional timetable being followed by the European Union for the full application of this Regulation.
Asked by: Laura Smith (Labour - Crewe and Nantwich)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what recent steps has he taken to ensure that medicines developed from public research are (a) accessible and (b) affordable.
Answered by Steve Brine
The National Institute for Health Research (NIHR) provides support for the development of new drugs, medical devices, diagnostics and treatments, primarily through its investment in research infrastructure in the National Health Service and through a range of research funding programmes. NIHR-supported research supports the early translational and clinical development of new medicines and generates high quality evidence which is made available to inform decisions about the NHS and patients on the effectiveness and cost-effectiveness of medicines, including through National Institute for Health and Care Excellence (NICE) guidance.
NICE technology appraisal guidance, and the associated funding requirement, play an important role in ensuring that patients have access to cost-effective new medicines, including medicines developed from public research. NICE assesses important new medicines through a robust evaluation process.
The Accelerated Access Review made recommendations to get transformative drugs and treatments to patients faster, while ensuring that the NHS gets value for money and remains at the forefront of innovation.
We have also formed the Accelerated Access Collaborative to accelerate patient access to high performing innovations that meet NHS needs.
The NHS is required by law to ensure that medicines recommended by NICE are routinely funded within three months, ensuring patient access to cost-effective medicines in England. There is no explicit link between the terms of NIHR research grants and the price the NHS pays for medicines.
The Department ensures that branded medicines remain affordable to the NHS through two pricing schemes. One is the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (2019 Voluntary Scheme) and the other is the statutory scheme set out in legislation.
Asked by: Paul Farrelly (Labour - Newcastle-under-Lyme)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether the UK leaving the EU will affect the way in which medical technology is regulated in the UK; and what assessment he has made of the potential effect of the UK leaving the EU on the ability of UK citizens to travel abroad with dialysis machines.
Answered by Stephen Hammond
The Government is committed to the safe and effective regulation of medical devices in the United Kingdom. We continue to strengthen safety while ensuring patients and the public have fast access to new, innovative devices.
Subject to the ratification of the Withdrawal Agreement, there will be a two-year Implementation Period, during which the Medicines and Healthcare products Regulatory Agency (MHRA) would continue to be recognised as a European Union competent authority designated under the EU Directives for medical devices, and the regulatory framework would operate as it does now. Arrangements beyond the implementation period are subject to further negotiation.
In a ‘no deal’ scenario, the UK’s current participation in the European regulatory network for medical devices would end, and the MHRA would take on the responsibilities for the UK market that are currently undertaken through the EU system.
The UK is seeking bilateral agreements with individual Member States to secure the continuation of existing arrangements or the establishment of comparable ones.
In the meantime, the Government continues to advise people who require treatment for pre-existing conditions, including dialysis users, to seek the advice of their doctor or specialist unit before making travel arrangements. They should also contact the chosen specialist administrator in their destination to ensure treatment received after 29 March 2019 would not be affected by a ‘no deal’ scenario.
Asked by: Lord Taylor of Warwick (Non-affiliated - Life peer)
Question to the Department for Exiting the European Union :
To ask Her Majesty's Government whether they intend to prioritise imports of medicine in their post-Brexit trading arrangements, in the event of a no-deal scenario.
Answered by Lord Callanan - Parliamentary Under Secretary of State (Department for Energy Security and Net Zero)
DHSC are working closely with life sciences industry and the NHS to make detailed plans to ensure continued access to medicines and devices in all scenarios.
We are working with industry to reroute supplies that make use of freight capacity acquired by Government. Medicines and medical products will be prioritised within this additional capacity to ensure that the flow of all these products will continue unimpeded after 29 March 2019. In addition, we are working with pharmaceutical companies to ensure that there is a minimum of six weeks additional supply of medicines in the UK, over and above existing business-as-usual buffer stocks.
Asked by: James Frith (Labour - Bury North)
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 publish its consultation on the regulation of orphan drugs after the UK leaves the EU.
Answered by Jackie Doyle-Price
The Government is committed to the safe and effective regulation of medicines in the United Kingdom; ensuring patients and the public have fast access to new, innovative medicines, including medicines for rare diseases.
The Medicines and Healthcare products Regulatory Agency (MHRA) launched in October 2018 a consultation on the regulation of medicines in the event of a ‘no deal’ exit, which included the proposed UK approach to the regulation of orphan medicines post-exit, including on incentives to encourage such medicines onto the UK market. Following this consultation, the MHRA, on 3 January 2019, published guidance on the UK proposed arrangements for the regulation of orphan medicines, in the event of a ‘no deal’ exit. This can be accessed at the following link:
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 voluntary scheme for branded medicines pricing and access: heads of agreement, published on 23 November 2018, whether NHS England’s commissioning support programme will be discontinued.
Answered by Steve Brine
It is expected that the commissioning support programme, which provides support for service development relating to medicines, as well as medical devices or other sorts of intervention, will continue for 2019/20. The new voluntary scheme for branded medicines pricing and access includes new commitments to the National Institute for Health and Care Excellence (NICE) appraisals for medicines; any implications will be considered through implementation of the new scheme.
Asked by: Ben Bradshaw (Labour - Exeter)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what other aspects of medicines regulation including regulation related to patient safety is postponed due to contingency planning for the UK leaving the EU without a deal; and if he will make a statement.
Answered by Jackie Doyle-Price
The Government is committed to making sure that patients continue to access safe and innovative medicines and devices, and regulation related to medicines and patient safety have therefore not been postponed because of contingency planning.
For example, we have continued with the implementation of the Falsified Medicines Directive, which is designed to help identify and remove falsified medicines from the supply chain, ahead of coming into force in February 2019, and continued to make the necessary preparations to implement the new Clinical Trials Regulation and Medical Devices Regulation, both due to be implemented before the end of 2020.
Asked by: Lord Warner (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what arrangements they will put in place to ensure the provision of medicines and medical supplies to acute hospitals after 29 March 2019 if no Brexit withdrawal deal is agreed.
Answered by Lord O'Shaughnessy
As the Government has now agreed, in principle, the Withdrawal Agreement with the European Commission, the Department has assessed that market access to medicines and medical equipment under the terms of that agreement will remain unchanged for industry and
the National Health Service during the implementation period, which will run from March 2019 until December 2020.
As a responsible Government, however, we continue to prepare proportionately for all scenarios, including the unlikely outcome that we leave the European Union without any deal in March 2019.
The Department has held confidential discussions with logistics companies and trade associations representing the vast majority of the medical suppliers in developing its plans.
On 23 August 2018, the Department wrote to pharmaceutical companies that supply the United Kingdom with selected pharmacy or prescription-only medicines, including non-national programme vaccines, from, or via, the EU/European Economic Area, asking them to ensure they have a minimum of six weeks’ additional supply in the UK, over and above their business as usual operational buffer stocks, by 29 March 2019 in the event of a no deal EU exit. On the same date, the Government published two technical notices on the batch testing and regulation of human medicines in the event of a no deal, together with a further technical notice on the submission of regulatory information on medical products.
Officials in Public Health England are leading a programme to ensure the continuity of supply for all centrally procured vaccines which are distributed to the NHS for the UK National Immunisation Programme.
On 23 August, the Department also announced contingency measures to increase stock holding at a national level for medical devices and clinical consumables. To this end, we are working with suppliers that routinely import products from EU countries to determine what measures they need to take so that they can continue to provide products in the unlikely event of a no deal EU exit.
Since these initiatives were announced, the Department has received very good engagement from industry who share our aims of ensuring continuity of medical supplies for patients is maintained and able to cope with any potential delays at the border that may arise in the short term in the event of a no-deal EU exit.
On 23 August, the Department also wrote to all NHS trusts, pharmacies, healthcare providers and general practices to inform them of our contingency plans for ensuring continuity of supply of medical supplies. The NHS was asked not to stockpile medicines and clinicians were advised to tell patients that the Government has plans in place to ensure a continued supply and they will not need to and should not seek to store extra supply at home.
Asked by: Lord Warner (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what guidance will be given to doctors and patients about obtaining and storing supplies of medicines if no Brexit withdrawal deal is agreed.
Answered by Lord O'Shaughnessy
As the Government has now agreed, in principle, the Withdrawal Agreement with the European Commission, the Department has assessed that market access to medicines and medical equipment under the terms of that agreement will remain unchanged for industry and
the National Health Service during the implementation period, which will run from March 2019 until December 2020.
As a responsible Government, however, we continue to prepare proportionately for all scenarios, including the unlikely outcome that we leave the European Union without any deal in March 2019.
The Department has held confidential discussions with logistics companies and trade associations representing the vast majority of the medical suppliers in developing its plans.
On 23 August 2018, the Department wrote to pharmaceutical companies that supply the United Kingdom with selected pharmacy or prescription-only medicines, including non-national programme vaccines, from, or via, the EU/European Economic Area, asking them to ensure they have a minimum of six weeks’ additional supply in the UK, over and above their business as usual operational buffer stocks, by 29 March 2019 in the event of a no deal EU exit. On the same date, the Government published two technical notices on the batch testing and regulation of human medicines in the event of a no deal, together with a further technical notice on the submission of regulatory information on medical products.
Officials in Public Health England are leading a programme to ensure the continuity of supply for all centrally procured vaccines which are distributed to the NHS for the UK National Immunisation Programme.
On 23 August, the Department also announced contingency measures to increase stock holding at a national level for medical devices and clinical consumables. To this end, we are working with suppliers that routinely import products from EU countries to determine what measures they need to take so that they can continue to provide products in the unlikely event of a no deal EU exit.
Since these initiatives were announced, the Department has received very good engagement from industry who share our aims of ensuring continuity of medical supplies for patients is maintained and able to cope with any potential delays at the border that may arise in the short term in the event of a no-deal EU exit.
On 23 August, the Department also wrote to all NHS trusts, pharmacies, healthcare providers and general practices to inform them of our contingency plans for ensuring continuity of supply of medical supplies. The NHS was asked not to stockpile medicines and clinicians were advised to tell patients that the Government has plans in place to ensure a continued supply and they will not need to and should not seek to store extra supply at home.