This is the third post 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.
In another busy week of Brexit-related Parliamentary business, two further Committee sessions took place in the House of Lords on the Medicines and Medical Devices Bill. As our posts (Part I, Part II) on the first session indicated, there is a lot in this Bill that the Lords are giving their full attention. The second and third sittings of the Committee (26/10/20 and 29/10/20) continued to focus on the Government’s attempts to provide more detail and assurances. In addition, Peers raised a number of significant and wider issues relating to the future regulation of medicines, medical devices, and healthcare in the UK.
Government approach to the Bill questioned
The second sitting commenced with a Government apology for their haste in tabling new amendments and the failure of communications to reach some Members ahead of the debate. Earl Howe also had to clarify the legal advice the Government had received, that their new amendments must be accepted at Committee stage in order to avoid delaying the Northern Ireland consent process by 3 months. This legal advice has subsequently been questioned and is now under review.
Objections to the Government’s handling of the Bill and last minute tabling of amendments became a fraught undercurrent to challenges to its new amendment on information disclosure. Lord Patel raised serious concerns with the Government granting power for the appropriate authority to share information ‘in connection with’ with medicines and medical devices with ‘any person’ outside the UK if necessary to satisfy conditions of ‘any international agreement or arrangement concerning regulation of …’ medicines and medical devices. He raised questions over the breadth of the provision, querying whether this could relate to any and all information contained in patient records relating to medicines and medical devices. He warned that the term ‘persons’ placed no limit on those with whom information might be shared. Baroness Thornton, took up his concerns and asserted the Government’s amendments on this part of the Bill were ‘dangerous, sloppy and possibly sinister’. The Government’s response to these will be heard in the next session.
These fraught exchanges go to the heart of Peers’ concerns regarding the tabling of late amendments by the Government. By requiring these amendments to be accepted at Committee Stage, the capacity for scrutiny is limited. However, it was confirmed that acceptance of the new Government amendments would not preclude a return to them at Report Stage and that further amendments and changes could be tabled then. As such, the likelihood of revisions being proposed looks high.
Meaning of ‘attractiveness’
Substantive debate on the Bill’s clauses moved to the consideration of the definition of ‘attractiveness’. No statutory definition of ‘attractiveness’ is provided in the Bill, yet the Secretary of State would need to ‘have regard’ to the ‘attractiveness of the UK as a place to conduct clinical trials and supply medicines/develop and supply veterinary medicines/develop and supply medical devices’ when making new regulations. Lord Hunt of King’s Heath argued that the concept of attractiveness is ‘vague and open to misunderstanding’ and Government needs to demonstrate commitment to safety, perhaps through the appointment of an Independent Patient Safety Commissioner as recommended in the Cumberlege Review. Concerns regarding this definition centred on the equivalence with safety given to it within the Bill. The fear is that the ‘attractiveness’ requirement could undermine safety unless the former is given a statutory definition and the latter is explicitly prioritised.
Countering these arguments, Lord O’Shaughnessy expressed concern that prioritising safety could preclude access to ‘riskier’ medicines that some patients may need. Lord Bethell in answering for the Government, underscored the need for regulatory flexibility. However, there is already a measure of flexibility under current regulations. As such, the Government argument for affording even more through this Bill, at the expense of proper accountability, remains to be convincingly made. Lord Bethell also argued that safety was ‘not the only aspect of the Bill’, and so Government must ‘get the right balance between the different aspects’. He did not elaborate on what these different aspects were, except to say that the Government amendment (ensuring the appropriate authority must be satisfied that any regulations ‘promote public safety’) strikes the ‘right balance’. Arguably, the multiple ‘balances’ in this Bill are part of the recurring set of problems that the Lords have raised with it: its potential purposes are varied, but none of them appear on the face of it to afford proper scrutiny of Government policy.
Highlighting wider regulatory issues
The lack of policy content, and the related concerns on broad delegated powers, may explain the tabling of many other issues that were raised at debate as a means to probe the Government further on its future policy plans. Such issues included: the ability of the NHS to adopt innovative treatments quickly; the future of medicine dispensing and pharmacy models; the UK’s role in facilitating equitable access to medicines in the developing world; human rights issues in the importation of organs and human tissue; and the cross-cutting issue of Parliament’s say on trade agreements. Members were also keen to implement changes reflecting the Cumberlege Review recommendations. Lord Hunt and Baroness Cumberlege in particular advocated for enhanced post-market monitoring of medical devices so problems can be identified earlier.
The Government would not be drawn, saying that a response to the Review would take time and stressing that the purpose of the Bill was to provide a framework in which future regulations would be created, not ‘lay down policy’ itself. However, as we mentioned in one of our previous posts, this is precisely the main point of contention with regards to the Bill. Without substantial amendment, the Bill would grant the Secretary of State a staggering breadth of powers. This combined with the lack of detail on the direction of future policy risks undermining Parliamentary scrutiny and essentially granting the Government carte blanche to make regulations across three major policy areas.
The Bill in its current form is so vague that Peers want to ensure everything related has been raised now in case it becomes an issue in the future. In addition, the new Government amendments, including and perhaps especially those in relation to information sharing, broaden the existing delegated powers even further. The final remarks in session three hint at the potential fireworks to come in the next sitting. As Baroness Thornton remarked, these new amendments ‘fundamentally change the purpose of the Bill’. There are perhaps underlying anxieties that there may be more to the Government’s rushed approach than the provisions of the Bill suggest in and of themselves.
Debate continues this week on Wednesday 4th November 2020.
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.