This is our eighth post looking at the passage of the Medicines and Medical Devices Bill 2019-21.
[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]
The Medicines and Medical Devices Bill was back in Parliament for the House of Lords Report Stage on the 12th and 14th January with significant issues from Committee revisited. A number of new Government amendments – including powers to create an independent Patient Safety Commissioner (PSC) in line with the Independent Medicines and Medical Devices Safety Review (IMMD) recommendations – were a welcome addition.
However, despite some Government concessions, the Lords remained largely unmoved in their position that the Bill confers unreasonable and undemocratic powers. This led to the passing of Peers’ amendments time limiting the powers in the Bill, requiring consolidated primary legislation, use of the super affirmative Parliamentary procedure, and inserting a public interest requirement to the information sharing provisions. The Third Reading of the Bill took place on the 21st January and passed with no further challenges or amendments.
This post explores these successful amendments and looks closely at the Government’s own changes to the Bill.
“Safeguarding Public Health” and the Patient Safety Commissioner
In previous debates Peers subjected the Government to pressure over a lack of response to the IMMD and a failure to prioritise patient safety. Baroness Cumberlege spearheaded amendments introducing a PSC to the Bill in Committee, although the Government argued against it. Therefore, the fact that the Government had tabled their own amendments on the appointment of a PSC was widely welcomed. Although it should be noted that issues remain over the true independence of the position, the timeframe for appointment, and proper resourcing. This addition implements one of the recommendations of the IMMD Review. Other amendments, such as the formation of a Redress Agency and specific redress schemes to compensate victims of the sodium valproate, Hormone pregnancy test, and vaginal mesh scandals were not successful.
Broader issues raised in Committee concerned safety and the framing of the powers in the Bill. In particular, the requirement to consider the “attractiveness” of the UK as a place to develop, supply, and research medicines and medical devices when exercising the delegated powers proved controversial. Following debate at Committee the word “attractive” was dropped at Report, although it remains in the form of “favourable” – arguably only slightly improved in meaning. However, the Government tabled a further new sub-clause requiring that where regulations might impact on safety, the appropriate authority may only make them where it “considers that benefits of doing so outweigh the risks”(referred to as a “lock on patient safety”). The balancing of risk and benefit still prompts concerns as highlighted by Baroness Cumberlege.
Time Limiting the Bill and Consolidating Legislation
The breadth of delegated powers and the concomitant lack of scrutiny to be afforded to any potential policy change has been the primary objection across debates. Whilst it was acknowledged that the Government had moved some way to address these issues, including through expansion of requiring the affirmative procedure, they had not gone far enough for most Peers. Baroness Thornton, noting the affirmative procedure rarely results in the voting down of regulation, concluded that it is “ neither democratic nor safe to run medicines, devices and veterinary medicines through regulation alone in the long run.” Lord Patel remarked that the powers “go far beyond what is necessary and prudent”.
As such Baroness Thornton, Lord Patel, and Baroness Jolly, introduced a suite of amendments time-limiting the delegated powers to three years and requiring the Secretary of State to lay draft consolidating prim
ary legislation for medicines and medical devices. The issue of consolidation being further justified by the complexity of existing regulation – added to by the rushed passage of Statutory Instruments dealing with the
Northern Ireland Protocol at the end of 2020 – and need to provide clarity and certainty to stakeholders. Unsurprisingly Lord Bethell argued strongly against them. He cited practical difficulties of timetabling new legislation at the same time as implementing
regulations under the Bill, and argued that introducing a “cliff edge” in legislation creates uncertainty for stakeholders. His argument confusingly lent support to Peers’ objections by stating “that potentially substantive, bold new regulation to protect patients from harm and ensure the highest standards of safety for medical devices” could be immediately rewritten within three years. Notwithstanding the argument that such policy should not be made using delegated powers, such changes could surely be transferred verbatim into any subsequent consolidating legislation.
The majority of the House voted for this sunset clause and the clause requiring consolidating legislation into the Bill. This is a very welcome development and something which, along with other colleagues here at Birmingham, we have been arguing for since the inception of this Bill. This was followed by approval of Lord Sharkey’s amendment requiring the super affirmative procedure to be used where regulation under the Bill would result in significant policy changes.
Information Sharing and the Public Interest
The Government suffered further defeats concerning clauses granting power to share information “in connection with” medicines and medical devices with persons outside the UK where for the “purpose of giving effect to an international agreement or arrangement concerning the regulation of human medicines.” Amendments to these at Report mean that patient information cannot be shared without consent – but this does not apply to anonymised data. Baroness Thornton highlighted data has huge commercial value and Lord Patel indicated that the clauses potentially allow it to be bartered in trade agreements. Use of such data constitutes a major policy decision that the clauses grant broad discretion to the Government to decide. This goes to the heart of the principal objections to this Bill, which concern the extent of executive overreach and lack of scrutiny inherent in these powers. As such, Baroness Thornton tabled an amendment requiring that information should only be shared where necessary for pharmocovigilance, the monitoring of safety of medical devices, and where it would be in the public interest to do so.
Lord Bethell argued that the amendment was unnecessary as the MHRA does not share information for commercial purposes. Confusingly, he also claimed the inclusion of new principles might have unintended negative consequences on the safety and innovation of new medicines and medical devices and on the running of the healthcare system in general, whilst also stating that information shared would be shared in the public interest by default. However, if decisions are to be made in the public interest anyway, it is unclear why it should not be included in the Bill. Unconvinced by the Minister’s arguments, Peers voted in favour of its addition.
Whilst these new amendments have successfully made it into the Bill, and may have provided much needed safeguards on Executive power in this area, the Government’s continued antipathy to them remains. It will be interesting to see how these amendments fare as the Bill makes its way back to the Commons.
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.