Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, chair of the Urology Trade Association, Fellow of the Royal Society of Medicine and Trustee of the Institute of Medical Ethics, updates on a series of senior appointments and policy changes happening despite the summer holidays.
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The United Kingdom might have a prime minister in name only, whilst the Conservative Party chooses Boris Johnson’s successor, to be announced on 5th September, and the health secretary, Steve Barclay, may only be an interim appointment until then, but the world of medtech policy has not ground to a halt as might be expected during the summer.
The recently created MedTech Directorate of the Department of Health and Social Care established to promote innovation in medical technology, encourage speedy uptake of new devices and reduce overall system costs for the NHS, has a new director, David Lawson, as the former director, Chris Stirling, moves on to challenges new.
Lawson is currently the chief procurement officer at Guys and St Thomas’ NHS Foundation Trust. Hopefully, he understands that medtech isn’t always about unit cost, but of whole cost to the system of keeping patients well, for longer, and in hospital for fewer treatments more effectively delivered.
We also have a new commissioner for Patient Safety. Following a pre-appointment hearing before the House of Commons Health and Social Care Committee, chaired by former health secretary, Jeremy Hunt, Dr Henrietta Hughes has been appointed for three years taking up her position in September. Dr Hughes is a practising GP with a background in women’s health who was the National Guardian for the NHS until 2021.
Hughes’s appointment to the role follows the inquiry and report, First do No Harm, led by Baroness Julia Cumberlege, into patient safety and launched by Jeremy Hunt whilst health secretary in February 2018. The report of that Independent Medicines and Medical Devices Safety Review considered the implications of three adverse medical incidents:
- hormone pregnancy tests – tests, such as Primodos, which were withdrawn from the market in the late 1970s and which are thought to be associated with birth defects and miscarriages;
- sodium valproate – an effective anti-epileptic drug which causes physical malformations, autism and developmental delay in many children when it is taken by their mothers during pregnancy; and
- pelvic mesh implants – used in the surgical repair of pelvic organ prolapse and to manage stress urinary incontinence. Its use has been linked to crippling, life- changing, complications.
The change in health secretary from Hunt to Sajid Javid saw DHSC officials try to ditch the key recommendation from Cumberlege that a Patient Safety Commissioner be appointed and empowered; a move against which the House of Lords then rallied most effectively during the debates on the Medicines and Medical Devices Act 2021, holding government ministers firmly to account, and insisting the appointment went ahead.
The Review also laid the foundations for a new system of adverse device reporting so that every device could be linked to the patient-identifiable database of implanted devices. This will in future facilitate the earlier identification of patterns of problems and better and faster identification of risk factors, so promoting overall patient safety.
The Medicines and Healthcare products Regulatory Agency is also picking up the government’s response to its consultation on the post-Brexit regulatory landscape, and the Agency has a whole heap of work on its hands relating to issues such as the Northern Ireland protocol, conformity, device certification, classification, and surveillance, all of which remain high priorities for attention. Its officials will be busy during August and September.
But one thing that has been delayed due to the current lack of political leadership within the Department of Health and Social Care, is the publication of the now long-awaited MedTech Strategy, first planned for publication in January of this year, but delayed time and again, as politics got in the way. We wait with bated breath the clear exposition of a strategy for achieving the objectives of the MedTech Directorate behind which the whole sector can unite with a determination to drive forward new innovation to the benefit of industry, clinicians and patients alike. Publication is now expected in October.
By the time my next article is published in early September, we might even know the identity of the new prime minister, the new health secretary and the parliamentary under secretary of state for technology, innovation and life sciences, the current holder of the latter office currently being Lord Kamall a former academic and research director at the Institute of Economic Affairs. He also previously served as a Conservative Member of the European Parliament. Will he survive in office or become an innocent victim of the coming cull of the Old Johnsonian Guard?
Questions about or comments upon this article can be addressed to the author at chris.whitehouse@whitehousecomms.com.
