My Lords, I am moving Amendment 105 on behalf of my noble friend Lady Thornton; it leads the group of amendments following Clause 16, which provides the legal framework for the medical devices information system. I will also speak to our other amendments in this group—Amendments 128, 130 and 132—and on the remaining amendments, including government Amendment 126.
The number of amendments in this group shows the strength of feeling on this issue. Key issues raised last week and in debate on Clause 16 earlier today are also relevant here. As we have all stressed, First Do No Harm, the landmark report by the noble Baroness, Lady Cumberlege, very much places the importance of the MDIS system centre stage. The complete lack of safety data and record-keeping on pelvic mesh implants in thousands of women—including basic details about the patient’s name, medical history and health problems, and manufacture and supply information for these devices after implantation, which would have enabled patients to be traced and treated—reinforces the need for MDIS and its future role as both an information and tracing system.
Amendment 105 would add a new clause after Clause 16 to place a statutory requirement in the Bill that the devolved Administrations in Scotland, Wales and Northern Ireland must be consulted before regulations on the MDIS are laid and that the Secretary of State must have regard to the views of the devolved authority. Government Amendment 126 and Amendments 105, 127, 128, 129 and 132 all aim to strengthen consultation provisions, including public consultation before making regulations under any provision of Parts 1, 2 or 3 of the Bill or under Clause 16(1).
This focus on the importance of consultation and ensuring that NHS Digital—with its existing remit and expertise limited to England—fully engages in meaningful and active collaboration with the devolved authorities is absolutely crucial for the UK-wide development of MDIS. If the system is to be fit for purpose, the work to deliver it must be informed by and responsive to the local requirements and realities across the devolved Administrations. The devolved nations must be fully involved in the system’s design and modelling, have equal access to MDIS data analysis and sharing, have a governance structure for MDIS that includes representatives from all the devolved authorities’ institutions, and have parity of funding across the four nations.
I am very grateful for the helpful correspondence of 9 November from the Minister to the noble Baroness, Lady Finlay, regarding MDIS and working with the devolved Administrations. It was shared with Members, together with the 4 November letter from NHS Digital setting out its intended “collaborative approach”. These letters contain a number of assurances on both the current work being undertaken and how the future four-way relationship needs to be taken forward to develop the UK-wide system.
The remaining amendments in this group, including the government amendment, refer to the general duty under Clause 41 to consult before making regulations. Our Amendment 132 would insert a new clause on the duty to consult the devolved Administrations and “have regard” to their views. I hope the Minister will agree that that is not an unreasonable requirement.
Government Amendment 126 would amend Clause 41 to ensure consultation with the devolved authorities under Clause 16, headed “Information systems”. Although the inclusion of this statutory duty to consult as far as Clause 16 goes is a step forward, other key parts of the Bill have an impact on the devolved authorities. We want to see a general duty in Clause 41 to consult the devolved Administrations, as is common practice in a number of Bills—not just limited to consultation in relation to Clause 16. I hope that the Minister will undertake to review the Bill after Committee and consider this key point in relation to Clause 41.
In his 13 October letter to noble Lords, the Minister refers to the Government’s amendments as providing “certainty” that the Government will ensure that the devolved authorities’ views are heard throughout the development of the regulations and in their implementation. The certainty given, however, is in relation only to Clause 16 and not to the rest of the Bill, as we would like to see.
Amendment 130 is a probing amendment that would remove the permissive provision in Clause 41(3) that consultation carried out before the Act was passed could satisfy the duty to consult. This clause is very open-ended. Can the Minister provide details of the purpose and intended use of this provision? There is no explanation in the Explanatory Notes. Will there be a time limit on how up to date a consultation needs to be for it to be considered done and dusted?
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Clause 41 is very scant in detail, so our Amendment 128 specifies cohorts that must be consulted under the clause—healthcare, pharmaceuticals, veterinary, medical
research and patient representative organisations, and other such persons considered appropriate. Amendment 129 in the name of the noble Lord, Lord Sharkey, covers similar ground and gives welcome clarity on the consultation details, including the terms, start date and length of consultations.
Amendment 127, in the name of the noble Lord, Lord Patel, quite rightly brings the focus back to listening to the voices of patients directly affected by the regulations. Can the Minister tell the Committee what structure and formal processes will be in place to ensure that the knowledge and expertise from health organisations, patients and staff across health and social care impacted by MDIS is drawn on in the system’s development and operation?
I have a few questions for the Minister on the various letters to Peers and to the noble Baroness, Lady Finlay, and from NHS Digital, to which I referred earlier. If he does not have the answers to hand, I am happy for him to write to me. First, on NHS Digital’s reference in its letter of 4 November to the need for further detailed discussions with the devolved authorities to design and plan the MDIS solution and proposal to formally review where further input is needed with further workshops and consultation, can the Minister update the Committee on the programme of work that has occurred so far and what regular engagement is planned regarding both the content of the regulations on MDIS under Clause 16 and its future operation?
Secondly, NHS Digital refers to engagement with stakeholders, including clinicians, patients, devolved authorities, private providers, MHRA, the CQC and NICE, as the key to delivering “a full interoperable UK-wide system”. This is, of course, welcome. We are told that there are active discussions with the devolved authorities and how they can best be supported in their engagements with stakeholders within their own nations. Can the Minister tell the Committee what work is being undertaken and how that is progressing?
Thirdly, the letter of 9 November from the noble Lord, Lord Bethell, also reminds us of the involvement of the private provider sector in MDIS, which we have not really looked at yet. Can the Minister say what discussions have been held and what work has taken place with private providers and how it is envisaged that they will participate in MDIS?
Fourthly, in that same letter, the Minister refers to reassurances given by NHS Digital, NHSX—which has responsibility for setting national policy and developing best practice for NHS technology, data and digital—and the Department of Health and Social Care teams responsible for developing the regulations, that they will engage with the devolved Administrations “to ensure there is an effective system across the UK”. How will this three-way relationship be overseen and co-ordinated?
Finally, the Minister’s letter of 9 November updates on the ongoing process of consultation on Clause 16 with the devolved authorities. The Scottish Health and Sport Committee has agreed to recommend consent to the clause to the Scottish Parliament and Northern Ireland officials have laid a legislative consent memorandum at the Assembly business office for scrutiny. However, in Wales there are “residual concerns”. Can
the Minister tell us what these are and what has been done to address them? As a result of the overall consultation, does the Minister envisage changes to the Bill on Report and, if so, will he undertake to ensure that any such amendments are circulated to Peers in advance of their submission to the Marshalled List? I beg to move.