Optimising the UK’s Post-Brexit Influence in Global Standards-Setting – Example II: Brexit and Medical Devices’ Regulation

Introduction

My previous post focused on some of the implications of Brexit (UK withdrawal from the EU) for pharmaceuticals’ regulation. Specifically, I examined some of the key implications of Brexit for UK influence in global standards-setting. In that post I also charted a path for optimising the UK’s post-Brexit influence in global bioethics standards-setting. Global standards-setting in respect of pharmaceutical’s regulation, through the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use or ICH, is only one piece of the puzzle that is the post-Brexit health policy domain at the global level. This puzzle is far from fully understood. In this post I intend to fill in another piece of the puzzle, and improve understanding further, by looking at medical devices’ regulation. I shall outline the apparent difficulties that exist for optimising the UK’s post-Brexit influence in one of the most important global standards-setters for medical devices, the IMDRF. The IMDRF stands for the International Medical Device Regulators Forum.

In respect of this body the UK is set to lose its voice, just as it is in respect of the ICH. This is because Brexit means the UK will no longer be a part of (or at least will not be capable of informing) the EU’s delegation to the IMDRF. The UK will thus step outside of this key site for global bioethics standards decision-making for medical devices. The IMDRF is a highly influential international organisation which aims to discuss future directions for the harmonisation of medical devices regulation around the globe. The IMDRF’s harmonisation work involves many of the essential safety requirements that medical devices must meet in order to be marketed within the EU, in other major markets (such as the US and Japan), and around the world.

So that the points in this post line-up with and can be easily compared with those I made in my previous post about the ICH, the order of discussion remains much the same as it was there. This post outlines why the IMDRF is so influential within the global medical devices market. The post then highlights the role played within the IMDRF by the UK, through its influence as part of the EU delegation to the IMDRF, and how the UK’s influence will be lost when the UK leaves the EU. Finally, this post discusses the apparent difficulties that exist for optimising the UK’s post-Brexit influence, and proposes a solution to this issue: the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) should lobby for a role within the IMDRF. This is because, unlike the ICH, participation in the IMDRF is, at least on paper (as per the Terms of Reference of this body), dependent on an invitation to join. Put differently, unlike the ICH, there is no application procedure to join the IMDRF.

However, if the MHRA/UK is invited to become a Member of the IMDRF, formally speaking it would seem to have the potential to exercise the same level of influence in decision-making as any other Member, including the EU. This is because decision-making in the IMDRF is carried out on the basis of consensus rather than a vote. MHRA membership of the IMDRF could enable the UK to have a voice in a key site for global standards-setting in respect of medical devices post-Brexit.

Why is the IMDRF so Important?

The IMDRF came into being in October 2011, when it replaced the Global Harmonisation Task Force (GHTF). The GHTF was established in 1992 as a partnership between the regulatory authorities and regulated industries of five founding Members: the EU, US, Canada, Australia and Japan. The GHTF sought – and the IMDRF continues to seek – increased harmonisation between the different systems that regulate medical devices. Harmonisation focuses on improving patient safety and increasing access to safe medical devices worldwide. The IMDRF’s membership comprises the regulatory bodies of Australia, Brazil, Canada, China, the EU, Japan, Russia, Singapore and the US. These are the sole decision-makers in relation to the IMDRF’s harmonisation work, through their inclusion in the Management Committee.

The Management Committee reaches its decisions, including on the adoption of guidance, on the basis of consensus only, since there is no voting.[1] In addition to its Members, the Management Committee:

 ‘[M]ay designate a limited number of Official Observers to the [Management Committee] from the World Health Organisation, other regulatory authorities, or Affiliate Organisations…on the basis of perceived contribution or value to IMDRF’.[2]

Currently the WHO and the Regulatory Harmonisation Steering Committee of the Asia-Pacific Economic Cooperation Life Sciences Innovation Forum are Official Observers. There are also currently two Affiliate Organisations: the Asian Harmonisation Working Party and the Pan-American Health Organisation.

The guidance produced by the IMDRF is not, in itself, legally-binding. However, the guidance usually informs the law in IMDRF Members; the guidance is essentially de facto binding in the law of its Members, including the EU. Within the EU’s regulatory system guidance documents known as MEDDEVs are used to assist stakeholders (manufacturers and those performing assessments of conformity (‘conformity assessments’)) in implementing legislation related to medical devices.[3] The MEDDEVs are in turn (often) derived from IMDRF technical standards:

To the extent possible, guidance developed for medical devices at international level, in particular the International Medical Devices Regulators Forum (IMDRF)…should be taken into account to promote the global convergence of regulations which contributes to a high level of safety protection worldwide, and to facilitate trade, in particular in the provisions on Unique Device Identification, general safety and performance requirements, technical documentation, classification rules, conformity assessment procedures and clinical investigations’.[4]

Moreover, compliance with the guidance is effectively required by those who export medical devices into the EU, or indeed other Members of the IMDRF. Put differently, compliance with IMDRF guidance is a de facto requirement for the development, registration and marketing of medical devices in any of the Members, including the EU.

The influence of EU law extends to clinical investigations for medical devices. So, for example, if a company wants to draw on evidence from clinical investigations conducted outside the EU, it must ensure that those investigations are performed in accordance with the legal standards required by EU legislation in medical devices and in turn IMDRF guidance. Thus, the influence of both IMDRG guidance and of relevant EU legislation conforming to that guidance extends beyond IMDRF Members. In addition, it seems likely that the IMDRF’s guidance, like the ICH’s guidelines, receives further legal backing through the World Trade Organisation’s rules for the resolution of trade disputes.

What Influence is the UK Set to Lose? What is the Way Forward?

The UK Government has said that it plans to forge a post-Brexit economy that trades globally and builds on its strengths. These include in the development of medical devices. Consequently, if the UK’s strength in medical devices is to be retained, UK law will need to be aligned to and mirror EU law and IMDRF guidance. As an important EU Member State, and one that wields particular influence due to the expertise and reputation of its MHRA, the UK has, to date, been particularly influential in the development of IMDRF, and thus EU, policy and practice. Further, as an EU Member State, the UK helps to make decisions on EU standards via its say on the form and content of EU law and policy. The UK contributes significant expertise and knowledge towards EU law and policy, particularly through the MHRA.

However, once the UK leaves the EU, the UK is set to forego its influence. In my discussion of steps towards maximised influence in the ICH post-Brexit, I explained how there is indeed a way forward, and that is through an application process. Making an application clearly relies on a positive decision by the relevant decision-makers in the ICH, as I have previously explained. The difficulty faced by the UK in respect of the IMDRF is that there is no formal membership application process. Instead, prospective participants in the IMDRF, on any of the bases noted above (Member of the Management Committee, Official Observer or Affiliate Organisation), are on the basis of an invitation from the Management Committee.

But this assessment is based upon a reading of the Terms of Reference of the IMDRF: the institutional or practical reality might be quite different. Indeed, the close working relationships that are (still) in place would seem to be conducive to ‘behind the scenes’ lobbying, prior to Brexit, and then more open lobbying post-Brexit. The need for the MHRA to tread more carefully and informally before the UK exits the EU is a consequence of EU law: this provides that it is the EU and not its Member States which are competent in the fields of medical devices covered by the IMDRF guidance. 

Should the MHRA/UK become a Member of the IMDRF in its own right, the reliance on consensus in decision-making might mean that the MHRA/UK has greater influence than at present i.e. since even the smallest Member could in theory hold-up or prevent a decision from being reached. Of course, the pressure exerted on a Member that prevents a consensus could be so intense, and the benefits of standing in the way of a decision so limited, that withholding consent from a decision might remain an option only in theory.

Conclusion

In terms of the growing global marketplace for medical devices, Brexit not only means UK withdrawal from the EU, it also effectively means withdrawal from the highly influential medical devices regulatory forum, the IMDRF. The central role of the IMDRF in the harmonisation of the global market for medical devices means that the UK cannot afford to lose its influence within this key organisation permanently.

By contrast with the ICH, for example (see my previous post), the MHRA/UK is, on paper at least, far more reliant on outreach by existing Members if it is to become a Member of this important forum. This is because there is no formal application process to join the IMDRF. The MHRA/UK should therefore take immediate action to lobby existing Members of the IMDRF to become a Member, or at least an Official Observer or Affiliate Organisation. As a Member of the IMDRF, the MHRA/UK will, in principle at least, be far less of a ‘taker’ and more of a ‘maker’ of IMDRF guidance. In this way the UK could have an opportunity to regain the influence it will lose due to Brexit: through the EU’s delegation to the IMDRF, and on EU law, as an EU Member State. Membership of the IMDRF might allow the MHRA/UK to voice its positions more clearly than it can possibly do at present. And should the MHRA/UK (re)gain a seat at the table, it might even have greater influence than at present, since decision-making within the Management Committee of the IMDRF is on the basis of consensus only.

This blogpost is an output from the Economic and Social Research Council funded project ‘Health Law Outside the EU: Immediate, Intermediate and Long Term Impacts for which I am a Co-Investigator. I am responsible for overseeing the research undertaken in Northern Ireland and Scotland. The other members of the research team are the Principal Investigator Professor Jean McHale (Birmingham) and the other Co-Investigator Professor Tamara Hervey (Sheffield).

 

[1] IMDRF, Terms of Reference, 7.

[2] IMDRF, Terms of Reference, 4.

[3] Three directives are currently in force and apply: Directive 90/385/EEC on Active Implantable Medical Devices; Directive 93/42/EEC on Medical Devices; Directive 98/79/EC on In Vitro Diagnostic Medical Device. The UK transposed this legislation into national law through the Medical Devices Regulations 2002. These directives are to be replaced by two new regulations. The regulations are in force, but do not currently apply (i.e. as of the date of this post). The new regulations are: Regulation (EU) 2017/745 on medical devices, which is to apply from spring 2020. There is also Regulation (EU) 2017/746 on in vitro diagnostic medical devices, which is to apply from spring 2022.

[4] Recital 5, Regulation (EU) 2017/745 on medical devices. Emphasis added.

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