Medical Technology Regulations and the NHS

Martyn Day Excerpts

Tuesday 28th March 2023 Westminster Hall

[Martyn Day (Linlithgow and East Falkirk) (SNP)]

I am grateful to the hon. Member for Gosport (Dame Caroline Dinenage) for securing today’s debate, and for the manner in which she summarised the case. I may disagree with her optimism on the Brexit side, but I think there is a lot here that we can agree on.

This issue is of great concern to all our nations. Medical devices are used in the diagnosis, treatment and management of a wide range of diseases and conditions. Across these islands, it is estimated that one in 25 people has an implanted medical device. The regulation of medical devices is reserved to the UK Parliament and regulator, and the Medicines and Healthcare products Regulatory Agency covers all medicines and medical devices used in the diagnosis and treatment of illnesses. Under the current UK regulations, manufacturers must report any adverse issues involving medical devices to the MHRA.

In the Scottish context, Health Facilities Scotland assists the MHRA in providing technical and operational support to the Scottish Government health and social care directorate, and to NHS Scotland. In February 2018, the independent medicines and medical devices safety review was launched to investigate how the health system responds to concerns about the safety of treatments. The review, chaired by Baroness Cumberlege, focused on vaginal mesh, sodium valproate and hormone pregnancy tests. The review’s report, published in July 2020, made nine recommendations. My colleagues in the Scottish Government have committed to implementing all the recommendations of Baroness Cumberlege’s review, including the appointment of a Scottish patient safety commissioner.

As we have heard, patients, families and campaigners brought to light those horrific medical disasters: the use of the hormone pregnancy test Primodos; the use of the antiepileptic drug sodium valproate in pregnancy; and the use of vaginal mesh. It is clear that the same underlying issues have driven all three disasters. There were four main features: a failure of licensing and regulation in the first place, particularly regarding implantable devices, such as vaginal mesh; a lack of accurate information to enable doctors to discuss the risks of those devices and allow patients to give informed consent; a weak system for doctors or patients to report the adverse events, which would have resulted in action; and, in some cases, a failure of doctors to listen to the affected women who raised concerns.

Health technology, medical devices and equipment are crucial in delivering services in NHS Scotland, and they must meet clinical and information governance requirements to minimize the risk of adverse events. To provide high-quality patient care, medical technology must be procured, managed and maintained appropriately. Although the regulation of medicines and medical devices is currently a reserved matter for the UK Government, the Scottish Government support ongoing reform of the assessment of medical device safety. However, there are concerns that the UK Government intend to compound the Brexit harms in the NHS by removing many European standards and regulations from the statute book with their Retained EU Law (Revocation and Reform) Bill.

The Scottish Government are concerned about the impact of the UK’s departure from the EU on the regulation of medicines and medical devices. The Scottish Government believe that regulatory reform must include the systematic incorporation of patients’ experiences in decision making. There have been shortages of medicines since the UK’s departure from the single market, and they have resulted in price increases and the use of serious shortage protocols. It will come as no surprise that the SNP opposes the Retained EU Law (Reform and Revocation) Bill, which could remove important protections, such as food labelling, animal welfare, and environmental controls. Scotland wants to maintain EU standards for medication safety and controls.