This piece was originally posted as a University of Birmingham Research Perspective
“The final legislation, much like the Bill as originally introduced, does little to address the current unwieldy nature of the existing system of medicines and medical devices regulation.”
The Act has the potential to significantly impact the regulation of medicines, veterinary medicines, and medical devices in the United Kingdom, or, more specifically (and as will be explained below), on mainland Britain. Here we outline some critical issues which may prove problematic as the Government begins to exercise the powers enabled by the Act.
Prior to becoming an Act, concerns regarding patient safety were a recurring theme throughout debate on its draft form (‘the Bill’) in both Houses of Parliament. In the Bill as introduced, the Secretary of State was required to consider three factors when making regulations: patient safety; the availability of medicines and medical devices; and the ‘attractiveness’ of the UK as a place to conduct clinical trials or develop and supply medicines and medical devices. There was concern that placing the attractiveness of the UK in equal consideration to safety might lead to the latter being undermined.
As the Commons commenced debate on the Bill, the Independent Medicines and Medical Devices Safety Review (IMMDR) was preparing to report its findings on the sodium valproate, hormonal pregnancy tests (HPT), and vaginal mesh scandals. The Report subsequently set out a litany of systemic failures which had led to safety issues and patient harm. These included the influence of market interests on decision-making and opaque commercial-regulator relations. In light of such failures and with clear recommendations from the IMMDR, the Lords piled pressure on the Government to commit to safety through amendments to the Bill.
This pressure paid off in a number of ways. First, a requirement that regulations must safeguard public health was inserted into the Bill. Second, by the end of the Lords’ Committee Stage, the Bill required that the UK be seen as ‘favourable’ in terms of medicines and medical devices development and supply rather than ‘attractive’ (although arguably this is simply splitting hairs). Third, a ‘lock’ on safety was inserted which requires that the benefits must outweigh the risks where new regulations might have an impact on safety. Finally, and most significantly, under continued pressure from Peers, the Government tabled an amendment requiring the appointment of a Patient Safety Commissioner. This was a key recommendation of the IMMDR and it is intended that the Commissioner act as an independent advocate for patient safety.
In the latter stages of its Parliamentary journey, the Act was somewhat rebranded by the Government as being all about patient safety (which was certainly not how it started life). Whether it lives up to this billing remains to be seen. Worryingly, in the Act safety is placed on a par with the favourability requirement as a factor to be taken account of in making new regulations, albeit not as the primary criterion. This, along with the lack of specification of exactly which benefits and risks (health, economic, something else) need to be weighed and balanced, could potentially undermine patient safety in the future. The new Patient Safety Commissioner’s remit is also notably limited to medicine and medical devices (as opposed to also encompassing, for instance, social care). This could contribute to the prospect of a continued fragmented approach to patient safety going forward.
Complexity, Transparency, and Regulatory Divergence
The final legislation, much like the Bill as originally introduced, does little to address the current unwieldly nature of the existing system of medicines and medical devices regulation. In fact, it is likely to make things worse since the Act allows for (overly) broad delegated powers to make regulations. The probable consequence is that any secondary legislation made under the Act will simply add to already voluminous and complex areas of law.
This has the potential to impact significantly on the comprehensibility and transparency of the law in this area for multiple stakeholders, including industry, clinical and pharmaceutical practitioners, and patients. Ultimately, it may affect the ability of both Parliament and the public to scrutinise changes and hold the Government to account. This is worryingly illustrated by the fact that during the passage of the Bill the Government introduced multiple Statutory Instruments relating to medicines and medical devices. Arguably this active regulation-making, whilst future law was still being debated, hindered the ability of Parliament (but specifically the House of Lords) to properly assess the (potential impact of the) provisions of the Bill.
In particular, the Medical Devices (Amendment etc.) (EU Exit) Regulations 2020, which were drafted and implemented concurrently as the Bill entered its final stages, revoked key provisions of the 2019 Regulations (of the same name). These earlier Regulations had essentially ensured, at least initially, continuing alignment post-Brexit with EU law on medicines and medical devices. This alignment was taken as a given by MPs and Peers during debate on the Act (a mistake that went uncorrected by Government Ministers). Yet their revocation now means that the Act has the potential to move mainland Britain out of regulatory alignment with the EU, something which could have ramifications for both industry and patients.
Significantly, in combination with the Northern Ireland Protocol, it also means that Northern Ireland will be more closely aligned to the EU than the rest of the UK. And, as we are already beginning to see in other areas, barriers to trade and the movement of goods between Northern Ireland and mainland Britain are amongst the likely consequences when it comes to medicines and medical devices.
The full consequences of all of this are as yet unknown, but it would be a mistake to underestimate their potential significance on matters such as access to medicines and medical devices for patients in the years to come.
Dr Laura Downey, Research Fellow, University of Birmingham
Dr Rachael Dickson, Research Fellow, University of Birmingham
Ms Victoria Moore, PhD Candidate, University of Manchester
Professor Muireann Quigley, Professor of Law, Medicine, and Technology, University of Birmingham
Professor Jean V. McHale, Professor of Healthcare Law, University of Birmingham
Funding: Work on this was generously supported by a Wellcome Trust Investigator Award in Humanities and Social Sciences 2019-2024 (Grant No: 212507/Z/18/Z) and a Quality-related Research Grant from Research England.