Health and Care Bill

Lord Kakkar Excerpts

Committee stage & Lords Hansard - Part 1
Tuesday 11th January 2022 Lords Chamber

[Baroness Walmsley (LD)]

My Lords, a duty to establish parity of esteem between physical and mental health was, of course, inserted into the Health and Social Care Act 2012 at the instigation of the noble Baroness, Lady Hollins—if I remember rightly, we on these Benches were right behind her. That is not reflected in this Bill, as she said, despite the fact that the importance of addressing mental health issues has been so amply demonstrated by the rise of these problems during the Covid pandemic. The shortage of services to address them is of great concern—services which were already under stress before the pandemic started because of underfunding over many years.

Although the insertion of parity of esteem into the 2012 Act was welcome and significant, no legislation is enough without the resources in cash and people to make it happen. They have not been forthcoming in the amounts needed to match the growing demand. Like the noble Baroness, Lady Hollins, and my noble friend Lady Tyler, I too have heard concerns in the sector that the share of resources that are currently available might be cut over the next three years under the Government’s plans.

The situation is not good. Waiting lists, particularly for children and young people, have been growing. I understand that the average waiting time for a young person for a first appointment is something like 13 weeks and 18 weeks to get to a referral for treatment. It is a bit of a postcode lottery, because some young people get there quite quickly and some wait a very long time. The noble Lord, Lord Warner, is absolutely right that it takes a great deal longer for those waiting for a diagnosis of autism.

According to research from the Resolution Foundation, in 2000, 24% of 18 to 24 year-olds had a common mental disorder. That was the lowest rate of any age group at that time. By 2018-19, that figure had grown to 30% and, astonishingly, by April 2020 it was up to 51%. So, as we set up the new integrated care system, it is essential that we restate the equivalence of mental and physical health. We know, as the noble Baroness, Lady Jones, so eloquently reminded us, that each affects the other, but it is not enough to assume that that is understood in this legislation. It must be clearly stated in both Clause 16 and Clause 20, where the noble Baroness, Lady Hollins, seeks to add it to the duty of the ICSs to secure improvement in the quality of services. We support her, of course.

Perhaps at this point I will mention my little amendments in this group. Amendments 48 and 49 are two of those little amendments that would insert the words “physical or mental” illness into Clause 16, which specifies a list of health provision that the ICB must make for its population. Other noble Lords would insert similar amendments into other places in the Bill. I support all of them.

Amendment 76 would also insert parity of esteem into new Section 14Z38 in Clause 20, which refers to the duty to obtain appropriate advice. We put it there to emphasise the fact that mental health is a very specialised area, and often very good advice can be obtained from small community or not-for-profit social enterprises that deliver mental health services in the community where people work and live, often to very marginalised groups. Large organisations such as an ICS might very easily overlook such good advice about what is needed and where to put it. I support the amendment spoken to by my noble friend Lady Tyler that the triple aim must become a quadruple aim. Mental health needs to go right at the core of what we are trying to achieve.

There is an enormous and growing number of people in the country with poor mental health. The NHS cannot just treat its way out of the problem. There needs to be more focus on public mental health, much of which is addressed by the small community groups I just mentioned, the role of which we will deal with later with Amendment 148 and others. But without the specific acceptance of the parity of esteem duty in the Bill, there is a danger that the diagnosis, prevention and treatment of mental ill-health will continue to take a back seat. It must be in the statute.

[Lord Kakkar (CB)]

My Lords, I support the objectives of this group of very important amendments. In so doing, I remind noble Lords of my interests as chairman of the King’s Fund and of King’s Health Partners. I have seen this work directly in King’s Health Partners through a programme defined as Mind & Body, which proposes to promote pathways of care across the entirety of our health economy that look in equal measure at physical and mental health for all patients, irrespective of their principal clinical presentation. Initiatives such as that important programme could be brought to fruition only because of the emphasis in the 2012 Act regarding parity for physical and mental health. It demonstrates very clearly that legislative intervention can have a profound impact. I very much join in congratulating my noble friend Lady Hollins on her relentless commitment to these issues in your Lordships’ House over the past 10 years, which have had and will continue to have a profound impact.

It therefore seems counterintuitive for Her Majesty’s Government, in bringing forward this important legislation, to move away from the opportunity to emphasise the importance of this parity. Is it sensible to move away from this position? Why not use the opportunity afforded by this important legislation to emphasise once again the importance of parity between mental and physical health in every respect—not only funding but the organisation and supervision of services and the construction of organisations within the NHS—so that, step by step, we can achieve what every Member of your Lordships’ Committee who has spoken in this debate has emphasised?

Will the Minister, in replying to the debate, reassure your Lordships that not proceeding with these amendments does not undermine what has been achieved so far and that what is proposed in the Bill can without the amendments achieve the continued momentum and concentration of focus on this vital issue, to ensure that we continue not only to develop mental health services but to ensure that they can be integrated more broadly into physical health, and that physical health services can be developed to ensure that the mental health consequences of physical conditions can also be appropriately addressed? In taking this holistic approach, we will achieve the objectives of better well-being and health for all our fellow citizens—one of the most important aspects of the triple aim.

[Baroness Finlay of Llandaff (CB)]

My Lords, I should declare my interests as having worked with liaison psychiatry extensively in the cancer centre in Cardiff, and as chair of the National Mental Capacity Forum for England and Wales.

One group that has not been mentioned yet—I appreciate the noble Lord, Lord Warner, mentioning some—is those with impaired capacity and learning difficulties. We should not underestimate the importance of access to psychiatry for those people who develop mental health problems as a result of their physical health problems. To view the two as separate is a fallacy because they are completely integrated in many people. Many people present initially with a physical illness but develop mental health problems which, if ignored, become really major. The opposite also occurs, of course. Those people with learning difficulties and impaired capacity at different levels often have a raft of quite serious physical medical conditions that might be particularly difficult to diagnose because their mental health problems get in the way of their ability to express themselves.

If we are really to drive up the health of the nation at all, we would be completely misguided to ignore the importance of this group of amendments. Like others, I urge the Government to grasp this nettle, put this in the Bill and make sure we finally address this severe imbalance, which has left so many people never accessing the care they need. That applies both to mental health care and to those with mental health difficulties who then fail to access the physical healthcare support they need because they just cannot express their needs properly.

Medical Schools: Training Places

Lord Kakkar Excerpts

Monday 13th December 2021 Lords Chamber

[Lord Kamall (Con)]

When training doctors from abroad, we follow international guidelines and World Health Organization ethical guidelines. For example, when I recently had a meeting with the Kenyan ministry to talk about the UK-Kenya health partnership, the point was made to me that they were training far more people than they had places for in their own country. They thought that their talent was a valuable export, while at the same time, remittances went back to their country.

[Lord Kakkar (CB)]

My Lords, I draw attention to my registered interests. Does the Minister accept that long-term workforce planning requires an effective apparatus that is able to understand the changing population demographic, changes in the nature of the delivery of healthcare and how technology and innovation might impact that? Do Her Majesty’s Government have a view about establishing such an apparatus as part of the current Health and Care Bill before your Lordships’ House?

[Lord Kamall (Con)]

There has rightly been much discussion of workforce planning for the NHS and adult social care, and the Bill will build on this. Clause 35 will bring greater clarity and accountability in this area, requiring the Secretary of State and the NHS to produce a workforce plan.

Covid-19 Update

Lord Kakkar Excerpts

Wednesday 8th December 2021 Lords Chamber

[Lord Kamall (Con)]

I thank my noble friend for making those two important points. As we know from what happened previously, as a consequence of lockdown, many people were unable to have operations or even diagnoses. In fact, much of the waiting list—80%—is for diagnosis. It is too early to tell what the impact will be, but I will find out and write to her. It is quite clear that there will be a negative economic impact. I do not think one has to be the former head of research for an economic think tank to say that, but it depends on how long this lasts and what economic activity continues in the meantime. I will look at that.

[Lord Kakkar (CB)]

My Lords, the Minister rightly made the point that two variants will shortly be circulating in high volume—the delta and omicron variants. Is he content that there is sufficient genomic sequencing capacity to distinguish between the two and, therefore, understand the epidemiology and the natural history of the two competing virus strains, at a basic level?

[Lord Kamall (Con)]

I attended a meeting this afternoon with leading epidemiologists, showing the data and separating the omicron variant, the delta variant and the original coronavirus. They have the data, and one of the reasons we have made this announcement is because we are able to distinguish between them. We are constantly reviewing the data for the original coronavirus and the variants but, if the noble Lord has any more scientific or medical questions, he should let me know or attend the briefing with Jenny Harries on Friday.

Health and Care Bill

Lord Kakkar Excerpts

2nd reading
Tuesday 7th December 2021 Lords Chamber

[Lord Kakkar (CB)]

My Lords, I thank the Minister for the thoughtful way in which he introduced this Bill and draw attention to my own register of interests, in particular the fact that I am chairman of the King’s Fund, King’s Health Partners and the Office for Strategic Coordination of Health Research.

I welcome much of what is proposed in this Bill, because it has a specific purpose— to drive integration. It has long been desired across the National Health Service that greater emphasis be placed on integrated care, including integration between primary and secondary care, between physical and mental healthcare, and between health and social care.

Clause 5 also sets some guiding principles for all NHS organisations, with the triple aim of ensuring better health and well-being, improved quality of services delivered and the most effective and efficient use of resources, applied by the state for the provision of health services. However, it fails in setting a guiding light and principle for the NHS to address the important issue of inequalities, which we have seen exacerbated during the Covid pandemic. Might Her Majesty’s Government consider amendments that address this issue in Committee and ensure that there is a fourth guiding principle for all NHS organisations with a duty to address health inequalities and inequalities in outcomes?

We have heard about other important provisions in this Bill, many of which will be addressed by noble Lords today. Although there is consensus that much has to be achieved, a number of the provisions and the failure to address other issues are somewhat controversial. I hope Her Majesty’s Government will give sufficient time in Committee to ensure that these issues can be properly addressed and that there can be absolute confidence, finally, once this Bill passes through your Lordships’ House.

I will emphasise just three additional areas in the time remaining to me. The first is research. We all recognise that a research environment and culture is critical to the sustainable delivery of health and care in our country—research not only in terms of development of new therapies or devices but into new models of care and how best we can deploy the workforce to achieve effective and efficient delivery of healthcare. Clause 20 makes provision for integrated care boards to have a duty to promote research, but that does not appear to go far enough to ensure that the commissioning environment secures a proper ecosystem for research, driving not only the provision of facilities but a culture in the development of a workforce able to engage in research, which is the lifeblood of the future of the NHS.

There is also considerable concern about Clauses 25 and 142 regarding the change in the regulatory environment. It seems counterintuitive to provide a new system-wide regulatory obligation for the CQC, as mentioned by the Minister in his opening remarks, yet retain the very specific provision for the CQC to regulate individual institutions. Regulation drives culture and behaviour in the NHS, and those two objectives might be in tension with each other, driving unintended consequences and undermining the capacity to achieve true integration.

Finally, there is the question of the workforce. This is critical. Your Lordships’ committee on the long-term sustainability of health and care, chaired by my noble friend Lord Patel, identified this as the key issue critical to the sustainability of the NHS and the care system in our country. The provisions proposed in the Bill are welcome, but they do not go far enough. Your Lordships’ committee suggested the creation of an office for the sustainability of health and care, which would have responsibility to look at demand over an extended period—some 20 years—and, from that, understand what workforce decisions and planning measures should be taken to ensure a sustainable workforce, in terms of not only numbers but its capacity to deliver over time. Those measures are addressed in Clause 35. I hope we will be to explore some of these issues in Committee.

NHS: Elective and Cancer Care Backlog

Lord Kakkar Excerpts

Tuesday 7th December 2021 Lords Chamber

[Lord Kamall (Con)]

Even before the pandemic there was a growing number of referrals across elective and cancer care. This had been driven by a number of different factors, including people’s awareness of cancer, the symptoms associated with it and media campaigns. In addition, one of successes of having an ageing population is that people face a number of different issues. For example, over half of cancers are diagnosed in patients over 65. We know that we have to tackle this issue. That is why we have published the long-term plan with a £33.9 billion budget.

[Lord Kakkar (CB)]

My Lords, I draw attention to my registered interests. Is the Minister content that the NHS has a workforce strategy sufficiently robust to ensure that the extra funds provided can be effectively deployed?

[Lord Kamall (Con)]

In June 2019 the NHS published a people plan that would improve the NHS workforce, including a dedication to recruit more nurses. We continue to work hard to deliver that commitment. Latest workforce figures show that there are 5,100 more doctors and more than 9,700 more nurses.

Ageing: Science, Technology and Healthy Living (Science and Technology Committee Report)

Lord Kakkar Excerpts

Wednesday 20th October 2021 Grand Committee

[Lord Kakkar (CB)]

My Lords, I join other noble Lords in congratulating my noble friend Lord Patel on the remarkable, thoughtful and insightful way in which he chaired your Lordships’ Science and Technology Committee on this inquiry, on the preparation of the attendant report, and, of course, on the way he introduced this debate. In so doing, I declare my own interests, in particular those as chairman of the King’s Fund, of UK Biobank and of the Office for Strategic Coordination of Health Research.

Your Lordships’ Science and Technology Committee identified the profound consequences of an ageing society and demographic in terms of the impacts economically and on the delivery of health services, but also of the broader societal impact. In considering the implications of ageing, we must be clear at the heart of all consideration and the development of any policy that it is the responsibility of society and government to ensure that we continue to deliver support and care for an ageing population compassionately.

We also have to ask ourselves the question, “What is going wrong at the moment?”, particularly in the delivery of health services. The committee was able to receive important evidence in this regard. We heard that the delivery of services is not joined up; we still provide healthcare services in a very disjointed fashion. In so doing, we have a focus on single diseases and single conditions, rather than providing a service for an ageing population where there is capacity to consider multiple comorbidities at the same time and provide interventions that ensure that each of those is addressed meaningfully and in an integrated fashion, so that individuals can maximise the opportunity for improved outcomes and avoid the many deleterious consequences of ill-co-ordinated multipharmacy and multiple ill-co-ordinated interventions.

Her Majesty’s Government will shortly bring to your Lordships’ House the Health and Care Bill. In that Bill there will be the opportunity to look at the way services are delivered. Is it Her Majesty’s Government’s intention that this Bill will provide the opportunity to deliver and address with a potential legislative change the important recommendations in this report that plead for the more co-ordinated and joined-up delivery of care services for an ageing population?

We also received evidence of the remarkable basic science research effort established over recent years in the creation of a new specialty of biogerontology—basic scientists studying the processes of ageing at a molecular and cellular level. That scientific output has identified hallmarks that can be associated clearly at a cellular level with the ageing process, such as telomere attrition, mitochondrial dysfunction and stem cell exhaustion. All this fundamental research provides the opportunity both for novel targets in the establishment of biomarkers that can be used to address, identify and diagnose the ageing process clinically at a much earlier level, and, most importantly, for novel therapeutic targets that will become future interventions and the opportunity for us to target the multifactorial manifestations of the ageing process.

We also heard that the next stages in the development pathway in clinical research in particular are dysfunctional. The current way we regulate clinical trials is to provide regulation to achieve a single treatment for a single disease, rather than undertaking clinical research for the ageing process, which, by definition, affects multiple end organs. We also heard that elderly populations and those with multiple comorbidities are frequently excluded from clinical trials, so much of the evidence generated for potential therapeutic intervention is generated in populations who are not elderly, and we extrapolate from those populations to a highly complicated ageing population. That is why the interventions we offer frequently fail to have the impact we might anticipate or to provide the advantages that so much technology and innovation in healthcare and research could provide. It is essential that the insights, innovations and interventions we will provide to deal with the ageing process and diseases associated with ageing are derived in and from those specific populations, rather than extrapolation.

Her Majesty’s Government have suggested that they will use the opportunity availed by leaving the European Union to look at the clinical trials regulation. Do they intend to look at the regulation to ensure that we can address this major fault in conducting clinical research to address the ageing process, so that we can not only achieve important benefits for those individuals and citizens who will benefit from the research output but have the opportunity to provide for our country to lead in the clinical development of interventions and innovations to address the ageing process?

Finally, we were also able to look at the question more broadly of how the health service can help us to address this important societal and national challenge. One of the important questions is how we are able to mobilise and use data collected within the National Health Service and in many large cohort studies that Her Majesty’s Government and research charities have supported over many years and decades, in terms of generating data to identify novel biomarkers, to establish approaches to appropriate imaging, and to apply emerging techniques of data science to these large cohorts and datasets to help us identify novel biomarkers and accelerate and improve the clinical trials process.

This is a very real challenge and once again Her Majesty’s Government have identified the opportunity to look at the general data protection regulation. Will that opportunity be used to provide for a review that allows us to access and address health data in a responsible and meaningful fashion, of course with appropriate social licence, to ensure that we can drive forward innovation in this important area? It is with data and it will be with innovation that we are able to make a major contribution to the issues identified in your Lordships’ Science and Technology Committee report.

Women’s Health Strategy

Lord Kakkar Excerpts

Tuesday 9th March 2021 Lords Chamber

[Lord Bethell (Con)]

I pay tribute to my noble friend for his campaigning on this important cause. It is not the specific focus of the health strategy but it will play a part in it, and I encourage my noble friend to submit the characteristically detailed evidence, for which he is so well known, to this important evidence-gathering process.

[Lord Kakkar (CB) [V]]

My Lords, I draw attention to my declared interests. In taking forward an initiative for clinical research as part of their G7 health agenda, how do Her Majesty’s Government propose to ensure alignment of the clinical research regulatory framework so that the approval of innovative devices and therapies is predicated on clinical trial and registry methodologies with appropriate representation of women, including those from ethnic minorities?

[Lord Bethell (Con)]

The noble Lord makes a really good point. I am not sure whether we have considered the gender aspect of the clinical trials work programme in our G7 agenda. It has been very much about pandemic-preparedness and ensuring that next time we are able to share clinical trial information. Of course, we pat ourselves on the back for our own vaccine clinical trials in the UK, which, I think, have met a new standard for gender representation. He makes a good point, however, about making that case in our G7 work programme, and I will take it back to the department for further consideration.

Future of Health and Care

Lord Kakkar Excerpts

Tuesday 23rd February 2021 Lords Chamber

[Lord Bethell (Con)]

The noble Baroness is right that there are distinctive qualities to social care and medical care, but the lived experience of most patients and residents is that those living in social care are very often heavy consumers of the NHS. As far as most of them are concerned, the support and treatment they are given needs to be much more closely linked. For instance, it is a strange anomaly that many living in residential social care have a completely different budget and sometimes completely different staff providing their medical treatment and their care treatment. This is not a functional distinction that we are seeking to overturn; what we are seeking is to get those teams of people and the decisions made about the care of individuals working much more closely together. We are not seeking to introduce a revolution in the funding of social care, and the financing of social care by local authorities and private individuals will continue, but we would like to see the distinction between social care and NHS medical care become more seamless, more joined up and, therefore, more effective.

[Lord Kakkar (CB) [V]]

My Lords, I draw attention to my registered interests. The justification for any reorganisation of the health and care system must be to improve patient and population outcomes. The current system, which has been unable to deliver the benefits of integrated care, is heavily regulated on the basis of distinct institutional boundaries and care settings. How do Her Majesty’s Government propose to address the regulatory impediment to the successful delivery of integrated care as part of the proposed reorganisation?

[Lord Bethell (Con)]

My Lords, the noble Lord is entirely right that the regulation of both clinical care and social care is critical and key not only to good performance by both sectors but to the way in which they work together. That is why we will look at the CQC and its role in social care regulation. We will seek to enhance the way in which the CQC can look deeply into social care to set higher standards and to ensure that, when it comes to integrated care, social care is stepping up to the challenge as best it can.

Medicines and Medical Devices Bill

Lord Kakkar Excerpts

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

[Lord Mackay of Clashfern (Con) [V]]

My Lords, I strongly support the amendments dealing with consolidation. I regard it as very important that the legislation that controls medicines, medical devices and veterinary medicines is consolidated in a way that makes it possible for an interested person easily to achieve knowledge of the regulations. After all, when you think of how important medicine is—we have just had a considerable debate about its safety—it is important to make sure that those who administer and operate the system know the rules. If you do not know what the rules are, the chances are that you will be misled into thinking that you know when you do not know at all. Therefore, it is important to make sure that we do everything we can to lay before those who practise these arts the true rule that has been set down, and it should be possible for them to reach it without too much research into a number of statutory instruments.

We just need to think for a moment about the current virus regulations. I have had occasion to look at them from time to time, and it is quite difficult to follow what is required at a particular moment in England, Scotland or other parts of the United Kingdom. If that is the position in relation to the virus, it is obvious that the general position in relation to these sciences as a whole will be even more difficult. Therefore, I regard it as vital—indeed, as a fundamental duty of government—to ensure that the regulations on these important matters are clear and the rules accessible.

I am not very keen on the sunset clause because, if it operated without consolidation, we would be in a pretty difficult position. Therefore, I regard it as vital to require consolidation.

I am aware of the difficulty of consolidation. For a short time, I was the chairman of the committee on consolidation and, when it sat, it was extremely difficult to get a quorum because people did not find the exercise interesting. But unfortunately, although it might not be very interesting or novel, in the sense that you are not doing anything very new, it is absolutely vital to allow the system to work properly. So I regard it as important that that is put into the statute as an obligation. If we are allowing the Government to legislate in these important areas by statutory instrument —the criticism has been levelled that they are doing so too much—that should be replaced in a reasonable time. Three years is probably quite reasonable, but I am very willing to hear whatever is said about that. I regard it as very important that this is an obligation on the Government as a condition of getting away with this method of legislating quickly in this area.

[Lord Kakkar (CB) [V]]

My Lords, it is a pleasure to speak in support of Amendments 29, 36 and 63 in the name of my noble friend Lord Patel, to which I have added my name, and broadly for the principles of the other amendments in this group. This is a critical area of public policy, as we have heard in this debate and in the excellent debates on these questions in Grand Committee. We have also heard that the regulations—the legislation attending medicines, medical devices and veterinary medicines, and their regulation in our country —have appeared on the statute book as a result of facilitations through the European Communities Act 1972. These represent in many ways a haphazard patchwork of regulation, created over time, with good intention, but obviously with the need to be consolidated and brought to a clear and precise place, as we heard from the noble and learned Lord, Lord Mackay of Clashfern, in such a way that any party interested in this vital area, which impacts on the lives of every citizen, can do so with simplicity, understanding obligations, understanding their rights and protections and being able to act confidently with regard to the rule of law.

The current regulations represent a challenge, and as a result of our departure from the European Union, there remains much contemporary regulation, agreed at the European level, with specific reference to clinical trials and medical devices, that has yet to be incorporated into domestic legislation, once again representing an important challenge with regard to the framework within which we are to proceed.

The Government rightly have stated that patient safety is at the forefront of their thinking when it comes to regulations regarding medicines and medical devices. To bring clarity will improve safety and will also achieve the Government’s other stated objective of ensuring that our country can continue to lead globally in the life sciences. We have seen the benefits of that leadership during the Covid pandemic, in terms of innovation, the application at scale and pace of that innovation for the benefit of our citizens, and the sharing of that knowledge globally.

Therefore, it is difficult to understand why Her Majesty’s Government would reject the opportunity to commit to consolidating legislation so that simplified, clear, effective and intuitive regulatory regimes exist in our country and can deliver the objectives that we all agree upon. In Grand Committee, we heard from the noble Lord, Lord Lansley, an interesting proposition that the Law Commission might be approached to support the task of consolidating legislation in this area of public policy. We have heard from the noble and learned Lord, Lord Mackay of Clashfern, that when he chaired a committee of consolidation there was little interest in dealing with some of the more demanding and exacting elements with the fastidious nature that is required to create effective consolidated primary legislation. Has the Minister had an opportunity to explore whether the Law Commission might be approached on the basis of the Law Commissions Act 1965, to determine whether it would be in a position to propose and engage with the consolidation of legislation regarding medicines, medical devices and veterinary medicines, as part of its forthcoming 14th programme under the obligations and opportunities afforded by the Law Commissions Act?

Medicines and Medical Devices Bill

Lord Kakkar Excerpts

Committee stage & Committee: 3rd sitting (Hansard) & Committee: 3rd sitting (Hansard): House of Lords
Wednesday 28th October 2020 Grand Committee

Finally, I am also concerned about equivalence. We heard much during our review about medical devices. These devices were able to claim equivalence to an existing product and thus gain, in effect, automatic authorisation without any approval process. The equivalence arrangement is rather like a chain reaction. If a second product successfully claims equivalence to the original product, it may well be slightly different in composition or intended for a somewhat different use, yet it gains the ability to be marketed for the same purposes as the first product. A third product then comes along and is somewhat similar to the second, so it gains equivalence status, yet its composition or intended use is further removed from that of the original authorised product. So it can go on, and the products claiming equivalence can bear little relation to the original product. This can give rise to serious safety concerns. With that in mind, I ask my noble friend the Minister: how do the Government intend to approach the matter of equivalence in the field of medical devices once the Bill is enacted? I have given him notice of my question.

[Lord Kakkar (CB) [V]]

My Lords, I shall speak to Amendment 97 in my name and that of my noble friend Lord Patel. In so doing, I of course recognise the important points the noble Baroness, Lady Cumberlege, made. I will answer some of her questions in a moment.

The particular purpose of Amendment 97 is to extend the reach of Clause 16, which already gives powers to establish information systems for assessing

“the safety and performance … of medical devices that are placed on the market”,

to include provision for the establishment of an information system for the safety and performance of medical devices before they are placed on the market via a form of provisional licence. It would provide for the Secretary of State to require, under certain circumstances, that new devices would in the first instance be given a limited approval based on clinical evidence and clinical trials. However, it recognises that further information would be required and that a provisional licence, or formal marketing authorisation, would therefore be given only for information gathering purposes. This would ensure that the level of evidence provided prior to broad unfettered use of a device would be much greater than is currently available.

This approach is both important and practical. It is important, as we have seen in the report from the noble Baroness, Lady Cumberlege, because implanted devices can have serious, harmful effects for patients. Not all devices have the capacity to be harmful, but where there is concern, where there are limited data or where the argument is based on equivalence using the kinds of arguments that the noble Baroness has made, the introduction of a device into routine clinical practice would be limited by a provisional licence, with the need for careful, pre-specified monitoring and evaluation, both for efficacy and for safety. This will protect the patient. It will protect innovation and it will ensure that we continue to facilitate innovation but in a responsible way.

Arguments are made about the practicality of such an approach. During this debate, we have heard that there are differences between the standards required for the authorisation for marketing a medicinal product compared with a medical device. The reality is that medical devices have profound implications for the management of patients. Implantable devices, in particular, also have profound implications for patient safety. The approach is practical because successive Governments have emphasised and prioritised the ability of the National Health Service to collect data and to develop its digital capacity.

We have seen the benefit of these investments and this emphasis during the Covid-19 national research effort. The regulator working, for example, with NHS Digital could devise integrated data-acquisition platforms and clinical research methodologies, potentially applied in specialist clinical centres. Data might then be collected prospectively to a high level and a high quality on the devices selected for such a provisional licensing process. These devices would also be used under appropriate and informed clinical supervision by experts before widespread adoption across the entire health system was allowed.

Rather than stifling innovation, which is a concern, I believe such an approach would ensure that our country could secure a position of leadership in the increasingly important field of medical devices development. These are going to play an increasingly important role in the delivery of healthcare. We would provide a fully facilitated environment for the appropriate clinical evaluation of medical devices, both their efficacy and their safety. In much the same way that the establishment of NICE and the Scottish Medicines Consortium, of which my noble friend Lord Patel was a founding leader, helped establish our country at the forefront of the evaluation of medicine and the responsible adoption of innovative medicines, the proposals included in this group of amendments and the proposal for provisional licensing outlined in Amendment 97 would allow us to develop unique leadership in the development, evaluation and responsible advocacy for the use of medical devices in a way that is clearly not available currently.

The noble Baroness, Lady Cumberlege, made an important point about devices that are designed for implantation in a patient and whose removal is dangerous or practically impossible. What must be demanded here is a much higher level of evaluation in development and research—she made the clear point that equivalence is not an appropriate approach in those or any circumstances. Moreover, offering the opportunity after appropriate clinical evaluation for such devices to be introduced in a limited fashion—still in routine clinical practice but with careful, pre-specified evaluation and monitoring—ensures, as she said, that if there are early reports of adverse events, those might be identified quickly prior to any opportunity for such devices to be provided across the entire healthcare system, where reporting on their implantation and follow-up may be less rigorous. In a provisional system, data acquisition and reporting would be pre-specified, using platforms provided by the regulator and the NHS. With the remarkable capacity we now have for data acquisition and analysis in the NHS, such methodologies, applied in a routine fashion in appropriate circumstances, would provide the greatest opportunity to protect patient safety while driving forward innovation and making use of all the opportunities that the NHS provides in this regard.

[Lord O'Shaughnessy (Con) [V]]

My Lords, it is a pleasure to follow that excellent exposition of his and other amendments by the noble Lord, Lord Kakkar. I want particularly to speak in support of amendments aimed at putting post-marketing reporting requirements for medical devices on a par with those for medicines.

My noble friend Lady Cumberlege has again given a powerful and moving testimony of the reports that she uncovered in her review of the dangers for some patients of pelvic mesh, but severe problems have emerged in other medical devices, be that metal-on-metal hip replacements, PIP breast implants or elsewhere. They have shown how potentially dangerous medical devices, particularly, as other noble Lords have pointed out, those implanted into body tissue, are simply not regulated enough.

The regulatory regime for licensing medical devices distinguishes between different categories of risk. Higher-risk devices of course have to clear a higher bar, and the UK’s notified bodies are renowned for taking on such work—prior to Brexit, they carried out more higher-risk assessments than any other notified body in the EMA family. We therefore have potential strength in this area. However, these tragedies demonstrate that even this strong regulatory regime does not go far enough. We need a broader definition of risk which takes account of the nature of the device, the therapeutic ways in which it can be used and the places in a patient in which it can be put, as well as much better post-market surveillance and wider use of registries, including coverage of the independent sector, which is where some of the most acute problems arose.

It goes without saying that these are recommendations from my noble friend Lady Cumberlege’s report. Like other noble Lords, I strongly urge my noble friend the Minister and the Government more broadly to adopt them and reduce the unacceptable gap between the safety regimes for medicines and medical devices.

Having expressed my concerns the other day about access to experimental medicines, I applaud the intention behind the idea of provisional two-year licences, but we obviously have a job of work to do to reconcile these two sometimes competing imperatives—the noble Lord, Lord Kakkar, explained how he thinks that can be achieved. It may be stealing the thunder of a future group of amendments that we hope to deal with tonight, but I wonder whether a better answer would be the expansion promised in the Conservative manifesto of the Cancer Drugs Fund into an innovative medicines fund more broadly, as well as continuing and early access to compassionate-use schemes for medicines post Brexit.

Both the noble Lords, Lord Hunt and Lord Kakkar, raised the idea of these conditional licences being applied to devices, and my noble friend Lady Cumberlege mentioned safety concerns which might apply. I wonder whether the right approach would be to open the innovative medicines fund up to devices, digital and diagnostics. It would mean a name change, but that presumably would not be a problem. They could then qualify as well as medicines, so the kind of early access possible under these two-year conditional licences could take place in that specific, heavily monitored and controlled environment that has already demonstrated huge value when looking at transformative cancer drugs before they have achieved their full licence. Within these ideas is the right approach to balancing these two risks, and in fact merging them and getting something stronger as a result. I look forward to hearing from the Minister how the Government intend to move forward on these issues.