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

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This is the first of a series of 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 2 available here]

The second session of the Lords Committee Stage on the Medicines and Medical Devices Bill starts today (26th October 2020). The first session took place last week and raised a number of issues that are sure to be revisited as proceedings get underway. In advance of today’s session, this is the first of two posts looking at the main points of contention so far. Each post focuses on one of two intertwined and overarching themes: concerns over the breadth of delegated powers and potential for inadequate scrutiny, and understandings of and safeguarding of safety of medicines, veterinary medicines and medical devices.

Monday 19th October 2020 was the first day of the Lords Committee stage on the Medicines and Medical Devices Bill (MMDB). The Bill is intended by the Government to form the primary legislation for medicines, veterinary medicines, and medical devices. If the Bill passed in its current form, it would confer broad delegated powers on Government to create new and amend existing legislation (which is mainly EU-derived) in each of these areas. In the Commons the Government was roundly criticised for the rushed timetabling of the Bill, initially introduced with little warning in February 2020 and resumed, after a pause due to the Covid-19 outbreak, in June 2020 similarly suddenly and with expedited progression. This approach to timetabling could be construed as reducing Parliament’s capacity to subject the Bill to proper scrutiny. If the Government was under any illusions that the Lords would be sympathetic, the lively and engaged Second Reading and first Committee Stage sessions surely proved them wrong.

The list of amendments submitted for Committee Stage was extensive, running to 46 pages. However, the scheduling of the controversial Internal Market Bill in the main chamber at the same time as the first Committee session of the MMDB meant some Members could not speak to their tabled amendments. The Government was reprimanded over the choice to double book these two significant Bills and multiple members of the Lords called for the opportunity to be afforded to those unable to attend, to speak at a later stage in proceedings. Regardless, the MMDB session was a packed afternoon of Parliamentary debate.

(In)sufficient Scrutiny and Executive Overreach

Cutting across the entire debate, and drawn upon frequently throughout the session, was the concern that the Bill is being rushed through Parliament and that effective scrutiny is being undermined. Aside from the clash with the Internal Market Bill, new government amendments to the MMDB were submitted only just before the deadline – less than a week before the session date – and with the Minister urging Peers to give approval due to the need to initiate the Northern Ireland Consent Procedure that same day. Lord Sharkey in particular took issue with this last action of the Government, and even after having requested an unscheduled adjournment early in the proceedings to seek further clarity from the Minister on the reasons for this haste, was still unclear and unconvinced of its necessity.

A major issue for those present was the skeleton nature of the Bill and the sweeping delegated powers it grants the Secretary of State. As noted in an earlier Briefing from ourselves, the existing separate medicines and medical devices regulations are already voluminous and complex. Whilst the Government has argued that the powers to amend them in this Bill are “specific” and “targeted”, the sheer number of issues they touch on belie this. In effect the Bill grants sweeping powers with no indication of the substance of the Government’s plans regarding policy in these areas. This effectively removes (or would at least severely reduce the depth and quality of) Parliamentary oversight of any measures introduced. Both the Delegated Powers and Regulatory Reform Committee and the Constitution Committee have been outspoken on the Government’s persistent approach to legislating in this manner. The Government Minister, Lord Bethell, attempted to argue the new Government amendments tabled addressed their concerns. However, there was a strong feeling from Members present that these amendments did not do enough, with Baroness Thornton remarking that they merely serve to “placate and circumvent”.

A number of amendments introduced by the Lords sought to introduce limits and checks on the powers contained in the Bill. First, Baroness Thornton suggested the insertion of a sunset clause which would require the Secretary of State to introduce new primary legislation within 2 years of the Bill’s passing. Lord Bethell countered that this was not enough time, although arguably it provides significantly more time than has been afforded to the drafting and passing of this Bill. He also cautioned that the inclusion of sunset clauses would be “setting an unhelpful precedent” that could impact all legislation going forward. It is not clear why this would be the case unless all future legislation is also intended to be of a skeleton nature. Lord Patel’s amendment suggested a more limited sunset, affecting only clauses 1, 8, and 12 (the key clauses which grant the broad powers), leaving in place provisions, such as those introducing new enforcement measures for medical devices. The response was that this could still undermine emergency provisions provided by clauses 6 and 15 and the new clause 16 power to create an Information System for medical devices.

Lord Patel’s complementary amendments requiring the Government to introduce consolidating legislation gained support across the party benches, and arguably would address concerns that sun-setting the delegated powers would undermine the provisions listed above. However, the Minister remained firm that this would be better informed subject to consultation, rather than written into statute. This ignores the already complex array of regulation for, in particular, medical devices which could benefit from clarity.

Lord Sharkey’s suggestion to use the super affirmative procedure to improve scrutiny opportunities was also received with interest. This process provides both the Lords and the Commons with opportunity to comment and suggest amendments to draft proposals for secondary legislation before it is brought forward for a vote on approval. It is still at the discretion of the Government to actually implement any amendments, but it does provide greater opportunity for scrutiny. However, Baroness Penn, speaking on behalf of the Government, argued that the right balance has already been struck between regulatory flexibility and scrutiny. New Government tabled amendments would require that the draft affirmative procedure – requiring approval of both the House of Commons and House of Lords but with no opportunity to suggest amendments – be used for most of the regulations created from the Bill’s powers. Again, however, this does not address the key concern that large areas of policy will be left to secondary legislation, with no real power for Parliament to challenge it. Left unamended this effectively permits ‘rubber stamping’ executive power.

What seems clear from these early skirmishes is that the Lords are committed to the full rigour of Parliamentary scrutiny and these issues will be picked up again when the Bill reaches report stage. Questions of adequate scrutiny and the lack of checks on Government powers to create new regulations permeate and punctuate the debate around safety. In the second post, we turn to these and look at the differing interpretations of how safety is to be framed in the Bill. We also consider what is still to come in future sessions of the Committee Stage.

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.