Lords take Government to task over future of medicines and medical devices regulation: Part 2

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This is the second of our posts looking at the main points of contention so far at Committee Stage in the House of Lords for the Medicines and Medical Devices Bill 2019-20.

[Part 1 available here]

In this post, which reports on the first session of the Lords Committee Stage for the Medicines and Medical Devices Bill, we turn to issues of safety. Specifically, we are looking at the competing views on how protecting public safety is to be framed as a means to provide a purpose and test for any legislation created using powers in the Bill. This discussion, whilst ostensibly distinct from issues of scrutiny, process, and the extent of the delegated powers, is still animated by these concerns. The lack of substantive policy in the Bill, means that the framing of safety, and the disputed inclusion of the “attractiveness” clause (discussed below), mean that the framing of safety in the Bill could serve as check on the scope of future regulation.

Conflicting understandings of patient safety

A common rebuttal from the Government in relation to tabled amendments on sunset clauses and the need for consolidated legislation was that they could have a negative impact on patient safety. Arguing that the legislative framework needs to be flexible, the findings of the Cumberlege Review were cited frequently to stress that patient safety cannot wait for primary legislation to respond to new threats. This is somewhat ironic given that earlier criticisms of the Bill expressed concern that it would weaken safety protections. This was, in particular, due to the requirement that in exercising powers in the Bill, the appropriate authority must have regard not only to the availability of medicines, veterinary medicines, and medical devices, but also the “attractiveness” of the UK as a place in which to conduct clinical trials/develop and market medicines, veterinary medicines, and medical devices.

The lack of definition of “attractiveness” leaves much (arguably too much) to interpretation. There is a concern that the economic reality of a Britain as a smaller, and thus less attractive market, outside the EU might lead to a lowering of standards in order to boost investment. In short there is a worry that safety and attractiveness might in some cases conflict. It is also notable, that whilst the Government cites the Cumberlege Review in defence of the delegated powers, some MPs in the Commons expressly questioned whether the abrupt reappearance of the Bill was an attempt to rush it through before the publication of the Review’s findings.

Fears over safety are inseparably intertwined with critique over the Bill’s skeleton nature, and Peers were keen to translate the Government’s verbal commitments to safety into the text of the Bill. Lords Lansley and Woolf put forward an amendment designed to give the Bill purpose and move it from a skeleton to what they described as a framework Bill, with the purpose providing a test by which any regulations created using the powers in the Bill would be subject. They were critical of the Government’s own amendments on this issue which would only provide a subjective test, requiring that the appropriate authority be ‘satisfied’ that regulations ‘promote’ public safety. Their amendment would make this more objective by requiring that the appropriate authority ‘have the objective’ of ‘safeguarding’ public safety. This wording reflects the objective of the original EU legislation on safeguarding public safety (in all EU legal instruments) conferred by Article 168 of the Treaty of the Functioning of the European Union (TFEU). Peers queried why the Government’s own test and wording did not reflect this framing.

The Government’s rejoinder to this was that recent legislation from the EU on these topics and relying on Article 168 also relied upon Article 114 TFEU that seeks to promote the functioning of the internal market, so public safety is not the only objective for EU legislation in this area. For this reason, Lord Bethell stated that there is a “challenge in this area”. It is not clear what Lord Bethell means by this or what the ‘challenge’ is a reference to. The response seems to be a fudge at best since adopting the framework of Article 168 does not necessitate that Article 114 also be referred to going forward. What this exchange does reveal is the disconnectedness of the different stages of the Brexit process, and underscores the fact that there seems to be no overarching policy aims.

Lord Patel raised the fact that the Government’s new subjective test also potentially elides the distinction between safety and attractiveness further. The insertion of the new test is complemented by new wording in each of Clauses 1, 8, and 12 that in “considering whether” regulations being made would ‘promote public safety’ they must have regard to the three factors outlined above; safety, availability, and attractiveness. This could be interpreted as subsuming ‘attractiveness’ into understandings of safety (as the overall aim) making it more difficult to argue in the future that considerations of attractiveness may in some scenarios undermine safety.

What is next?

A key takeaway from the discussions is the extent to which details on the Government’s preferred system of regulation are lacking. This permeates all discussion, especially anxiety over ‘attractiveness’ and patient safety, since there is no substantial policy proffered for scrutiny. Lord Hunt emphasised this, stating that four years after the referendum vote we are no further along in understanding what the Government wants for the future. He emphasised that in order to compete for business, away from the established EU system and much larger market base, the UK will have to offer lucrative incentives. Yet details beyond Government assertions of quicker approval processes have not been provided. The Government’s repeated emphasis of the UK being a leader rings hollow without the detail as to how this will be maintained.

In terms of where things stand, this first Committee session did not get through all of the amendments. This was not surprising given, as mentioned in Part I, that these run to 46 pages. Further Government amendments are still to be discussed, including an intriguing and potentially controversial new clause empowering the disclosure of information held by the appropriate authority ‘in connection’ with medicines, veterinary medicines, and medical devices to ‘any person’ outside the UK in fulfilment of international agreements.

Of the issues covered many were slated for further discussion at Report Stage. Lord Bethell appeared to constructively engage with suggestions and signalled that more detail would be provided. It will be interesting to see whether this materialises. Debate will continue today in the second Committee Stage session.

Written by: Rachael Dickson and Laura Downey

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 an ESRC Impact Acceleration Award.