This post looks at the final changes to the Medicines and Medical Devices Bill 2019-21 as it concludes its passage through Parliament.
[Part I available here, Part II available here, Part III available here, Part IV available here, Part V available here, Part VI available here, Part VII available here, Part VIII available here]
The Medicines and Medical Devices Bill completed its final stages of Parliamentary scrutiny in the Commons on the 27th January and in the Lords on the 2nd February with a substantial roll-back on amendments introduced during the Lords’ Report Stage. The Lords had successfully tabled and passed into the Bill new clauses time-limiting the delegated powers to three years and requiring draft consolidated primary legislation within that same timeframe. These were aimed at keeping the broad powers in the Bill to make changes to policy through secondary legislation in check. In removing these, the Government tabled amendments in lieu as a compromise position, requiring the publication of a review of the legislation within 5 years of the passing of the Bill that would look specifically at factors such as the need for consolidating legislation.
This post looks at this new amendment, the brief discussion it attracted in the both the Commons and Lords, and the flawed compromise it represents.
Removal of the Lords Amendments and Discussion of the New Duty to Report
Throughout debate on this Bill the root concern has been the breadth of the delegated powers it confers. In the Commons Committee Stages Alex Norris challenged the Government to include a sunset clause in the Bill to settle concerns on how such powers would be used. Whilst he did not press his amendment to the vote in the Commons, peers successfully argued the case for and won divisions inserting a time-limit on the delegated powers, a requirement to introduce primary consolidating legislation, and a requirement to use the super-affirmative procedure for “significant” changes to policy.
It was clear that these successes would be challenged by the Government in the Bill’s next stages. Arguing in the Lords, the Government had contended that introducing a “cliff-edge” in legislation was impractical both in terms of allowing time for new legislation to “bed-in” and for consultation on replacement primary legislation, and that it would negatively impact safety. This argument was reiterated by Jo Churchill (Under-Secretary of State for Health and Social Care), who by invoking Alex Norris’ initial challenge, put to him that the Bill had returned to the Commons “materially changed” in how delegated powers could be used as a result of Government amendments during the Lords Committee stages. She continued that the arguments for time-limits and consolidating legislation were primarily concerned with the lack of detail on the likely changes to regulations and desire for “greater visibility” to Parliament of what happens next. She argued that the new amendment in lieu went further than amendments already made to the consultation requirements in the Bill in addressing this concern.
The new Government amendment requires a report on the operation of the legislation within 5 years of Royal Assent. This report is to consider, amongst other things, the need for consolidating legislation, whether provisions should be in primary or secondary legislation, the need for amendment or restructuring, with an obligation to take into account the reports of any Parliamentary Committees. Jo Churchill concluded that the 5 year timeframe allowed for consideration of the legislation in practice and that all the issues of concern voiced in relation to the delegated powers could be explored in such a report.
It seemed that this compromise was acceptable, not just to Alex Norris and other speakers in the Commons, but also to the Lords with Baroness Thornton, Baroness Jolly and Lord Patel welcoming it. Peers had sight of this amendment prior to its introduction in the Commons, as mentioned by Baroness Jolly, and along with the finished Bill in its entirety, it was hailed as a testament to cross-party collaboration. The amendment passed with no challenge.
A compromise too far?
It was perhaps inevitable that the amendments won in the Lords would not survive the Commons given the Government’s vehement opposition and decisive majority. In such light the compromise position could be seen as the best that could be hoped for. This is certainly the sentiment of Alex Norris who remarked that the amendment was a “fair deal” and more than he thought they would get. Even Baroness Thornton, who sought assurances that stakeholders would be consulted in the required report, commented that the compromise “reflects the need for scrutiny at the heart of the Bill”. However, this extra reporting requirement, regardless of the terms of its remit, will not necessarily be as effective as it has been purported to be. It does not address the underlying concern that the delegated powers enabled by this Bill go too far. There is still much discretion for Government to make significant changes to policy, with limited means to check that power.
The new reporting requirements do cover issues of concern expressed by the Lords and highlighted in our earlier briefing on this Bill. In particular, the consideration of the need for consolidating legislation and primary legislation addresses the complexity of the existing regimes. This is something which continues to be added to, even as recently as December 2020 (whilst this Bill was still under consideration), when new regulations relating to medicines and medical devices were passed to implement changes in line with the Northern Ireland Protocol. The issue with the new reporting requirement, however, is that there is no requirement for the Government to act on the findings of any such report.
The new consultation and reporting requirements and the removal of reliance on the negative procedure were not enough to convince Peers that the powers in the Bill were adequately constrained at the Report stage. As such it is difficult to account for the enthusiasm shown to a new reporting requirement that places no obligation on the Government to actually act upon its findings, which provides no guarantee that patients or other stakeholders will be consulted. It may be, as Baroness Thornton suggests, that the resulting report will “open the door for the restructuring and consolidation of the post-Brexit medicines and medical devices regulatory regime”. Yet without a concrete commitment to act on any report this may be wishful thinking.
Written by: Laura Downey and Victoria Moore
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.