This Bill is an opportunity. It is necessary to ensure that we have the ability to continue to update our regulatory frameworks after the end of the transition period. We must ensure that we continue to be able to respond swiftly to pressing need. This is not a standstill Bill, however. It is designed to underpin the way in which the UK approaches the life sciences sector and innovation in health from 2020 onwards—an approach where we promote, to the best of our ability, patients’ access to cutting-edge treatments and encourage the cultivation of new, safe and patient-focused technology, balanced with the need to take swift and effective regulatory and system action, to ensure that patients do not experience adverse outcomes.
I put on record my gratitude to Members from all parts of the House. On Second Reading and in Committee, they have approached the Bill with a consensus that I hope will continue in the other place. We have all understood the principles behind the Bill, and any differences of opinion and scrutiny have been firmly in the best interests of patients and in the interest of ensuring that the Bill goes to the other place in good shape.
Our experience of the health system is a personal one. We have relationships with our GPs and clinicians, and some of us have long-term health conditions or short-term immediate needs that require surgical intervention. We all want to know that the health system is taking all possible steps to prevent harm to patients and that the regulator and the health system work in partnership to identify when something is going wrong and to take swift corrective action. We would hope that in the event that we experienced an adverse outcome or reported concerns to our doctor, GP or surgeon when something was not working properly, the patient, system and statistical significance of that outcome would be understood and properly addressed; and the clinician, the system and the regulator would engage with the patient on required action.
We also want to ensure that, where required, the regulator will continue proactively to engage with the manufacturer of a medical device and ensure that information is supplied alongside that device or improvements are made so that we learn from the patient experience. Finally, we want to ensure that data is available to drive regulatory or system action, to limit the use of that device or remove it from the system so that our experience as patients results in changes to prevent future harm and suffering, even if that risk cannot be removed completely.
I will first speak to the amendments tabled in the name of the Secretary of State for Health and Social care, before I move on to those tabled by hon Members present. I thank all those who have shown an interest in this area, particularly my hon. Friend the Member for Newton Abbot (Anne Marie Morris) and the hon. Member for Central Ayrshire (Dr Whitford), who put forward their own amendments. Both were extremely well intended and thoughtfully drafted and there have been further thoughtful contributions from all parties and both Houses in thinking about what an amendment to that effect might need to deliver.
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We all recognise that medical devices are not subject to the same comprehensive regulatory system of pre-market assessment that medicines are. The Government also recognise that the system could be made stronger in
respect of how devices are purchased, used and reviewed. The issue is incredibly important. Like me, Members across both Houses are anticipating the forthcoming report from the independent medicines and medical devices review, which looked into significant matters, with an expectation that it might make recommendations in this area. I put on the record that I am deeply sympathetic to patients and families affected by the issues covered in the review. That is why I am keen to take action now, when we know that there are gaps that we might close in the regulations made under the powers in this Bill, rather than wait.
New clause 1 introduces a power for the Secretary of State to create a medical device information system through regulations for the purposes of the safety and performance, including the clinical effectiveness, of devices; the safety of individuals who receive or are treated with a medical device; and the improvement of medical devices’ safety and performance through advances in technology.
The new clause has a number of detailed subsections because there are a number of considerations that Members will wish to know are being taken into account in the light of the productive discussions that have been had in this place and elsewhere about the important question of patient safety and the system’s capacity to protect us all.
To be clear, some of the matters covered by the clause can be dealt with already, under the Health and Social Care Act 2012. That Act established the Health and Social Care Information Centre, otherwise known as NHS Digital, and allows for the Secretary of State to issue a direction, asking NHS Digital to collect data in respect of the NHS in England. It is under that Act that the Secretary of State sought to act late last year, by issuing a direction to NHS Digital to begin to collect data with regard to implanted devices in England so that we could begin to build a picture.
However, this issue affects the whole UK and patients in all four nations. Devices are also implanted in private institutions by providers who are under no obligation to provide data to a central system if they are not working under contract to the national health service.
In their amendments in Committee, Members referred to device registries. We have a number of existing device registries in this country and a global exemplar in the National Joint Registry, which describes its own mission as
“Working for patients, driving forward quality”.
It collects information on operations to monitor the performance of certain implants and the effectiveness of different types of surgeries, improving clinical effectiveness and benefiting patients, clinicians and the sector as a whole. That works for patients, at a local level, who receive devices under the aegis of a registry. But not all higher-risk devices have a registry, and some registries will generate insights or patterns that are of use to other types of implants or devices—or, indeed, to improving regulation and the safety of devices as well as our system responses.
Data is fundamentally a driver of change. It is how we identify trends and draw links between individual issues to find patterns. It is by bringing data together that we see a bigger picture that can drive our response. The new clause seeks to create the legal backbone for
future data collection and construct an information system to support existing and new registries in the future.
Members will be concerned about how data is safeguarded, how it might be used and by whom, and I will come to that shortly. But it is worth reflecting and understanding that the benefits of this system will be broad. Such a system would monitor the performance of devices and ensure that patient outcomes can be tracked. The longer-term aim is to intervene earlier, through clinical analysis of the data in the information system, to prevent patient harm before it happens by enabling the healthcare system to flag concerns, drive clinical system and regulatory action where appropriate, and use alternative and better devices and procedures to mitigate risk to UK patients. It would support the registries, both present and future, to take action underpinned by the national data from all four corners of the United Kingdom.
Such a system, subject to safeguards, could allow for the sharing of certain types of information with clinicians, the regulators, the NHS and other healthcare partners in the longer term. That would improve the data available on medical devices, as part of post-market surveillance. As a result, the UK’s regulator, the Medicines and Healthcare products Regulatory Agency, will be better able to take action early and more effectively as part of its regulation of devices on the UK market.
New clause 1(2) sets out some of the matters that regulations that establish this system might make provision for. It enables provision to be made so that the information is provided to NHS Digital in order that it can carry out its functions under the regulations. It enables provision to be made about using or disclosing the information, and for NHS Digital to have regard to certain matters, such as the need to reduce burdens on healthcare institutions when exercising its functions.
Subsection (3) clarifies subsection (2) by asking a private provider of, for example, breast implants to supply data to the information centre and to do so in a manner and in such a time that is provided for in the regulations. Along with the UK-wide nature of the power, it would ensure that we have a national picture that would support the aim we are all here to drive forward.
Subsection (4) makes it clear that anyone whose services, powers or duties relate to medical devices can be specified in the regulations and thus required to provide that information to NHS Digital for the purposes of the information system. That is important, as we would not wish to inadvertently have a gap as technology and procedures move on.
Subsection (5) sets out that the kind of information we might expect to require is retained and entered in the information system. The first and most immediate use of the information system must be to ensure that if there is an issue with a device it is possible to find and then notify a patient. To support that, the unique device identifier must be retained, along with the details of the patient into whom the device has been implanted, through, for example, their patient record, and the information about any procedure that has taken place, including the name of the clinician who has implanted it. This was raised in discussions and the provision is, if you like, an indication at the outset of what we would expect to capture, but subsection (5) does not limit us to that if consultation takes us further.
Subsection (6) deals with the disclosure and analysis of information. There was considerable discussion on Second Reading, led by the hon. Member for Twickenham (Munira Wilson), on the need to trust how data is used and analysed in order for such a system to be supported by patients. Subsection (6) is therefore critically important in being transparent at the outset that it would be necessary not only to capture the information, but to ensure that it can be used to identify patterns or trends to determine whether a patient’s experience of a device is personal and highly specific to their particular circumstances, or whether there is something clinicians or regulators need to do to improve the way in which that device can be used.
Patients are absolutely critical. They want to know that their data is protected, and subject to data protection legislation and other safeguards. They wish to know that they can be traced in the event of a problem with a device, and that the healthcare system professionals they interact with may know their surgical history as part of any future or ongoing procedures. They also wish to know that system change will be informed by their experiences—that their voices will be heard and change will occur as a result.
I recognise there is a lot of concern in this place and in the other place as to how we ensure sensitive information is kept securely and processed for legitimate reasons only, and that there are strict safeguards on who has access to it. I wish to assure Members now that this legislation is here to provide the backbone for future regulation. The benefit of secondary legislation is that we do not have to have all the elements in place immediately, but we can put building blocks together of data to access it slowly over time, with the proper process of consultation with patients, clinicians and devolved Administrations and consensus behind the most appropriate course of action to build the longer-term vision that I have set out. We have specified the kind of things the regulation under this amendment might enable us to do, but we will need to return to Parliament with the detail. I can commit now that it is our intention that the consultation on regulations will indeed involve considering voices of patients at its heart.
Enabling provision to be made in secondary legislation means that any information system can be updated to reflect collaboration with existing and future clinical registries, so that the processes for data collection remain streamlined, avoid duplication and reduce the burden on organisations providing the data. Future amendments to the secondary legislation governing the operation of any information system will ensure that the system remains as effective as possible at monitoring the safety of medical devices, but while that is the future, we do intend to ensure through regulations that, in the short term, data are subject to appropriate safeguards such as anonymisation by NHS Digital, and able to be shared within the NHS system and with the regulator so that patients get the benefit immediately of improved product safety and the comfort of knowing they can be traced if there is information that they need about their specific advice. That can and should be in place before we are in a position to put in place the vision of a system of clinical registries.
We have spoken to Ministers from the devolved Administrations, and there is broad agreement about the need for improved tracking of medical devices.
The benefits for product and patient safety that an information system could bring is beyond party politics. It is the right thing to do for patients. IT projects are notoriously difficult and I think it would be difficult, if not impossible, to put one in legislation in detail. We have sought to strike the right balance between detail on what might be in the regulations in the interests of transparency, and enough flexibility to respond properly to the consultation on what the future should look like with those most affected by this. It is absolutely critical that this works, not least for clinicians who will need to record the information. We have published a detailed document setting out the long-term aspiration and some of how we would like to get there to accompany the amendments and to support Members’ scrutiny. I hope the amendment has support from all sides of the House.
Let me turn to the minor and technical amendments in the name of the Secretary of State. These are very small matters. Amendments 2, 3, 4, 5, 6 and 7 and 18 all make minor changes in order to enable new clause 1. Amendments 8 to 17 make minor and consequential amendments to enable regulations made under the powers in the Bill subject to the negative procedure to be combined in a single statutory instrument with regulations under powers which are subject to the affirmative procedure, or with regulations under powers in other legislation which are subject to the negative procedure. Allowing for different provisions to be combined in a single statutory instrument makes for greater efficiency within the parliamentary timetable.
I move now to amendments tabled by the hon. Members for Nottingham North (Alex Norris) and for St Helens South and Whiston (Ms Rimmer). I thank them for tabling them and hope that I can engage as much as possible with the points raised. Amendments 21, 22 and 23 are similar to those put down—