This is the fifth 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.
The ever present issue of balancing innovation with safety drove discussion on medical devices in the fifth House of Lords committee session on the Medicines and Medical Devices Bill last week. The pace of change and transformative nature of advances in software and algorithm use in healthcare were raised to demonstrate the issues at stake in future regulation. Other issues discussed were the extension of prescribing rights to other healthcare professionals and the regulation of veterinary medicines. The Government continued to be pressed on its commitment to appropriate scrutiny and consultation.
Extending Prescribing Rights
The session began with discussion on amendments aimed at committing the Government to act on its past assurances of extending prescribing rights (and responsibilities) to other health care professionals such as dieticians, physiotherapists, and others. There was agreement across the House, including from the Government Minister, that such extensions are welcome. As Lord Bradley indicated, they would represent a recognition of the broadening role of healthcare professionals already prevalent and, as argued by many Peers, would relieve some pressure on the healthcare system as a whole and allow for adaptation in the post-covid world. Perhaps predictably, Baroness Penn agreed in principle whilst dismissing the amendments as unnecessary in light of ongoing consultation on this matter and because the Bill already allows for powers to amend prescribing rights.
Reporting and Government Amendments
Before moving to deal with issues raised in relation to medical devices specifically, discussion turned to one of the Government’s amendments purporting to deal with the criticisms of the Delegated Powers and Regulatory Reform Committee (DPRRC). The Government’s amendment creates a duty to report to Parliament on the efficacy of any regulations created using the powers of the Bill two years after implementation. It also mandates that the relevant authority should consult who they think appropriate. Whilst alternative tabled amendments aimed at increasing the frequency of reports from biennial to annual and included consultation with devolved powers, Lord Patel highlighted the discretionary nature of the Government’s amendment in choosing who is consulted for the reports. Amendments requiring reporting on the progress of any information system for medical devices created by using clause 16 also featured as part of this line of questioning.
In response, Lord Bethell took pains to emphasise that reports were distinct from consultations conducted prior to drafting regulations which are subject to strict Cabinet Rules and which, he argues, should provide ample scrutiny of regulations. However, this does not necessarily address the motivation behind Lord Patel’s concerns. His point was that a report on the workings of new regulations is influenced by the views of those included. As such, it should perhaps not be left solely to the discretion of the Secretary of State to choose who or what groups/organisations ought to be consulted. This especially so in light of Lord Bethell’s later comment that these reports are intended to be forward and backward looking for the purposes of evaluating regulations and the potential need for consolidating legislation (something which was raised by Baroness Thornton and Lord Patel in earlier sessions). Lord Bethell’s response to amendments requiring reporting on any information system on medical devices was to deny the practicability of the proposed timeframe, arguing that a year would not be long enough for any system to be sufficiently implemented. None of Lord Bethell’s counterpoints seemed to address the underlying issue that the Government amendments do not fully address the concerns of the DPRRC, including the need for transparency.
Medical Devices: Definitions, Data, and Registries
Debate moved to consider the provisions relating to medical devices. Lord Freyburg’s amendments aimed at committing the Government to conduct a technical review of the definition of medical devices to address developments within software, AI, and algorithms. He highlighted the very technical nature of the issues. For example, the difficulty in regulating dynamic or ‘black box’ algorithms capable of shifting methodological parameters in processing data which are difficult to audit and assess in how they reach their outputs. The recent exam results scandal was used to illustrate how algorithms can discriminate, something which could be extremely damaging in health policy.
Baroness Penn replied that dynamic algorithms are covered by the existing definition of software as a medical device. Even so, it is not necessarily the case that the existing definition captures these appropriately. Nor is it clear that the regulation of software and algorithms in general is not in need of thorough evaluation and likely overhaul. Baroness Thornton indicated that she believed these issues were similar to those debated in the Human Tissue Act and Human Fertilisation and Embryology Act, as AI technology has ‘the potential for huge benefits and huge harms’ and the issues ‘go to the heart of our humanity’. Her concern is that the use of AI, algorithms, and software developments in healthcare, specifically in relation to medical devices, have the same transformative potential and raise similarly sensitive social and ethical issues. As such she suggests they should be subject to primary legislation. Baroness Penn responded that such issues were beyond the scope of the Bill, but referred to the Government’s intention to evaluate them across the board and offered assurances that medical device definitions would be in secondary legislation.
Lack of transparency and trust in current systems of regulation motivated debate on tabled amendments requiring the development of medical device registries, as well as that on requirements for appropriate consent procedures for gathering and storing data. Baroness Cumberlege expressed concern over the interpretation of her recommendations by Government, arguing that whilst a minimum of device data needs to be recorded, patient experiences and clinical information are also essential as part of registries. The gathering and inclusion of such information on a registry would therefore also require proper consent procedures. She expressed concern that sufficient information will not be included in the information system proposed by the Government and that patient consent is being overlooked.
Lord Bethell argued that the amendments for consent procedures were not necessary as personal data would not be collected. The proposed information system is for the purposes of market surveillance and would only gather information about the devices and the procedures they are used for, not personal data. This appears to miss the point of the Cumberlege Review’s findings that contextual data on patient experience is crucial to understanding safety issues. Baroness Thornton spoke to this, asking the Minister how the information system and his response to their questions was meant to improve safety. Lord Bethell replied that the system would allow patterns between adverse incidents to be caught sooner than otherwise would be the case. However, this still does not address the root concerns that failure to capture patient experience was a core issue in failure to identify problems under the current system. Additionally, the broader normative question of what counts as device and/or personal data is not being addressed.
The last amendment relating to medical devices in this session related to the creation of an innovative devices fund mirroring that which was debated for medicines in the previous session Baroness Finlay proposed this as a way to capture the potential of medical engineering in the UK and support the trialling of, and access to, devices in the NHS. Lord Lansley suggested that such a fund is premature and more information is required to ascertain whether the (lack of) uptake of devices in the NHS would warrant such a system. However, Lord Hunt argued that the bureaucracy of the UK system means other markets appear more attractive and that the centralised system of the NHS fosters a philosophy that new technology is costly and must be avoided. Lord Bethell made clear that the Government values device innovation and has high ambitions, highlighting other initiatives facilitating uptake of innovation, such as the Accelerated Access Collaborative.
The Committee reconvenes on 17 November 2020.
Written by: Laura Downey and Rachael Dickson
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.