This is the sixth 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.
[Part I available here, Part II available here, Part III available here, Part IV available here, Part V available here]
The final two sessions of the Lords Committee stage on the Medicines and Medical Devices Bill (taking place on the 17th and 19th of November) straddled many familiar issues raised in the previous five, but also visited the thorny issue of potential regulatory divergence with Northern Ireland. Patient safety once again dominated through debate on amendments aimed at inserting some of the Cumberlege Review Recommendations into the Bill and in discussion on the need to inform the public of known risks to health. Trust, transparency, and the concern around the breadth of powers conferred in the Bill were again addressed through discussion of consultation requirements and the removal of provisions relating to confidentiality.
This is the first of two posts looking at these final sessions. This post focuses on those points across the sessions that related to the Cumberlege Review recommendations. The second will look at regulatory divergence with Northern Ireland and issues surrounding consultation in the Bill.
Registries and Cumberlege Review Recommendations
Debate began with discussion on the clause 16 powers to create medical device information systems. Baroness Finlay’s amendment sought to make the creation of information systems a duty, not a discretionary power. She and others spoke to the need, as recommended by the Cumberlege Review, for device registries that collect greater detail and clinical information in order to ensure proper auditing and reporting of patient experiences. Lord Ribeiro highlighted the advantages of the National Joint Registry in flagging up problems with particular devices over others and in aiding clinical decision making. Again the amendments were opposed by Lord Bethell who said that the purpose of clause 16 information systems was to function as databases providing uniform information on devices, as opposed to gathering clinical information as a decision tool. He reiterated the Government’s commitment to the creation of information systems so changing the discretionary power to a duty was unnecessary. He also opposed Lord Lansley’s plea for a commitment to the Caldicott Principles in the Bill as a means of protecting data, arguing that this was unnecessary as this was expected in everyday practice.
Across both sessions Peers were at pains to introduce amendments to probe the Government for more information on their response to the Cumberlege Review and to push implementation of some of its key recommendations. These included amendments to create an Independent Patient Safety Commissioner (IPSC), a Taskforce to implement the Review recommendations, the introduction of a redress agency, and a specific scheme to address costs associated with injuries by patients who were the subject of the Review.
The IPSC was a key recommendation in the Review, with Baroness Cumberlege arguing that it should be independent, have a statutory basis, and be responsible for listening to patients. Despite support across the House, Lord Bethell dismissed all amendments aimed at implementing the Review recommendations citing the need for time to respond more fully to the Review, stating that the Government did not see the IPSC as a “silver bullet”. He stressed that patients already had means of reporting adverse events through the Yellow Card System, seeming to worry that the creation of an IPSC would misdirect such reports away from this vital monitoring system. He also outlined in detail existing Government undertakings to improve patient safety and, in response to amendments to create a taskforce, stated that meetings with officials across healthcare and a programme with the MHRA to develop a culture of transparency and learning were also taking place. This received short shrift from Baroness Cumberlege who pointed to a lack of transparency on the outcomes of such meetings and a lack of direct Government response. Lord Hunt added, in his speech addressing the creation of a redress agency, that the examples of measures the Government said it has taken amounted to isolated incidents of best practice rather than a proper strategy for patient safety.
In dismissing Lord Hunt’s probing amendment on the creation of a redress agency and Baroness Cumberlege’s more modest redress scheme for victims of Hormonal Pregnancy Tests (HPT), sodium valproate and vaginal mesh failures, Lord Bethell again cited the need for time to consult with stakeholders and decried the folly of creating policy through primary legislation. This seems a strange defence given that primary legislation is exactly the place where such policies are meant to be enacted as pointed out by the Delegated Powers and Regulatory Reform Committee in their criticisms of the lack of policy on the face of this Bill. It was clear from reactions from Peers that these issues will be returned to again at Report stage.
Duty to Inform of Safety Threat
Issues of safety and transparency framed debate on clause 35 of the Bill which provides that the Secretary of State “may” inform the public of a serious threat to health. An amendment tabled by Lord Patel sought to make information disclosure a requirement in such circumstances rather than a discretion. Again the Minister’s response was to suggest that the amendment was not necessary and would potentially cause more harm.
Baroness Penn argued that in some circumstances where a device shows a risk to health, healthcare practitioners are the ones qualified to take action. In such scenarios, she continued, the divulgence of such information to the public at large could lead to undue anxiety where patients are unable to take action themselves. Thus a duty to share information inappropriately removes a vital discretion. Lord Patel was unconvinced, countering that such discretion already exists for lesser threats and that a duty should be imposed where there is a clear risk of serious harm. He noted that it does not follow from the Minister’s explanation that the public should remain uninformed when many medical devices and medicines will require expert healthcare practitioners to take action. In the absence of registries and tracking of implanted medical devices, informing the public may be the only way of identifying those affected and taking action to remove or mitigate the effects of devices and medicines that pose such a threat.
Confidentiality
Considered in the same group of amendments as the duty to inform above, was clause 37 which, amongst other things, removes Reg 3B from the Medical Devices Regulations 2002. This in itself is interesting given that Reg 3B was only introduced in 2019 as part of the Medical Devices (Amendment etc)(EU Exit) Regulations 2019. It requires that all parties to the 2002 Regulations respect the confidentiality of information obtained in carrying out tasks in relation to the Regulations. The purpose is to protect personal data as per the Data Protection Act, as well as to protect commercially sensitive information. Lord Patel inquired why it was being removed so soon after its introduction and without there being equivalent provisions in the current Bill.
Baroness Penn in response seemed to believe that Lord Patel’s concerns for Reg 3B related to the discretion to warn of a risk to health outlined in clause 35 and discussed above. It is not clear that this was the case, and is relevant because Baroness Penn’s defence of the Governments position was firmly tied to the scenario where information is divulged where there is a threat to safety. She assured Lord Patel that subclauses in clause 35 already provided protection when there is a risk to health and that the information of concern in the operation of these regulations was that of manufacturers, not patients.
Whilst it is not clear that equivalent protections as found in Reg 3B are provided for by clause 35, it is of note that Reg 3B and the protections it provides do not simply relate to the occasion where information is shared under clause 35, but concerns the operation of the Medical Devices Regulations in general. Further, the controversial Government amendment relating to information sharing with persons outside the UK as debated in sessions 3 and 4 of Committee Stage (and discussed in posts Part III and Part IV) are also now included in what was clause 35 (now clause 37 in the latest version of the Bill following Committee Stage amendments). It will be interesting to see how this affects debate at Report stage.
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.