Medicines and Medical Devices Bill

Debate between Lord Kakkar and Lord O'Shaughnessy

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

[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.

NHS: Specialist Services in Remote Areas

Debate between Lord Kakkar and Lord O'Shaughnessy

Tuesday 11th December 2018 Lords Chamber

[Lord O'Shaughnessy]

I shall look at the scheme the noble Lord mentions and would be delighted to follow up with him directly on that. We need more staff; we have more NHS staff than we did in 2010, but nevertheless we need more GPs and nurses. Of course, we also need to diversify the workforce in new ways. One of the most exciting innovations in the workforce sphere recently is the creation of several thousand nursing associate posts to support nurses and doctors in a range of settings.

[Lord Kakkar (CB)]

My Lords, I declare my interest as chairman of UCLPartners. The provision of centralised specialist services is predicated on the basis that there is an appropriate mechanism for integrated care across the tertiary, secondary and primary care institutions. Are Her Majesty’s Government satisfied that the regulatory framework to assess the quality of that care exists? If not, what mechanisms are being put in place to ensure regulation across integrated care pathways?

[Lord O'Shaughnessy]

The noble Lord makes an excellent point with great insight, as ever. We all want to move to an integrated care system which allows us to worry less about levels of care and think instead about patients and the care around them. We believe a lot can be done within the current regulatory framework but, when the Prime Minister asked the NHS to produce its long-term plan in return for the significant funding increase we are giving, she asked what legislation might be needed to complete that framework.

Government Vision on Prevention

Debate between Lord Kakkar and Lord O'Shaughnessy

Tuesday 6th November 2018 Lords Chamber

[Lord O'Shaughnessy]

I am grateful to the noble Baroness for the question. On learning disabilities and autism, I know that the Secretary of State has been very moved by some of the cases that he has become aware of since taking the job in the summer. He has instigated not only serious incident reviews into individual cases but a thematic review by the CQC, with contributions from NHS England, on how to improve the system and ensure that we move more services out of in-patient facilities and into the community. I am absolutely confident—I will confirm this to the noble Baroness—that the best providers, from wherever they are, will be able to contribute to that review.

[Lord Kakkar (CB)]

My Lords, I declare my interests as chairman of UCLPartners and business ambassador for healthcare and life sciences. In repeating the Statement, the Minister focused on the important opportunities provided by genomics and the application of artificial intelligence to transform the landscape for prevention. In answer to a previous question, he identified the importance of trust for the ability to marshal this vast amount of deeply personal data and ensure that it can be appropriately applied for individual benefit and, more broadly, population benefit. In that regard, I make two points to the Minister.

First, what progress has been made towards achieving that social licence which will ensure broad trust with regard to the mechanisms available and the security of the structures, not only for data collected in hospital but now in the community and the prevention setting, so that it may be shared and applied for individual as well as population benefit? Secondly, there will need to be a substantial investment in skills to ensure that not only professionals who work in healthcare for the delivery of health services but those who will have to engage more broadly in the prevention agenda are able to respond to this vast amount of data, and help individual citizens and patients apply it for maximum benefit.

[Lord O'Shaughnessy]

On the question of trust and social licence, which is a very good expression, KPMG published a report in September which found that the NHS was the most trusted organisation in the country when it came to looking after people’s data. That is a very precious thing and we must not lose it, so a number of steps are being taken to try to reinforce that degree of trust. We have introduced a national data opt-out and very recently had the national data guardian Bill, which puts the National Data Guardian on a statutory footing to provide that security and statutory guidance to government, so that we can ensure we build on that trust. On investment in skills, we have commissioned Eric Topol to carry out a review of the skills needed in the workforce to adopt new technology, which will report soon. We also have to recruit new professions: it turns out that bioinformatics is one of the most important things to have in taking advantage of that. We do not currently train enough people in that field but we need to ensure that we do, so that every patient and every clinician can take advantage.

General Practitioners: Indemnity Scheme

Debate between Lord Kakkar and Lord O'Shaughnessy

Monday 16th July 2018 Lords Chamber

[Lord O’Shaughnessy]

My understanding is that the scheme is for all providers of primary medical care services under GMS, PMS and APMS contracts.

[Lord Kakkar (CB)]

My Lords, I declare my interests as in the register. In reducing the problem of clinical negligence, it is vital to ensure that general practitioners are able to learn from the entirety of their clinical practice. As has been heard, many work in single-handed practices. How do Her Majesty’s Government propose to ensure that there is proper learning across the primary care system to reduce errors once mistakes have been made?

[Lord O’Shaughnessy]

The noble Lord is quite right. I point him in the direction of the learning from deaths programme, which is attempting to do exactly that.

Long-term Plan for the NHS

Debate between Lord Kakkar and Lord O'Shaughnessy

Tuesday 19th June 2018 Lords Chamber

[Lord O'Shaughnessy]

The noble Lord speaks with great insight and makes a very important point. There is broad agreement on the need to simplify the structure of the health system but there has not to date been broad agreement on how we should do so. We are expecting in the next few months to explore the potential for the kind of streamlining that he is talking about. I hope that that can be done as a collaborative effort and, if it comes to primary legislation, that we can deliver it as a collaborative effort too.

[Lord Kakkar (CB)]

My Lords, I declare my interest as chair of University College London Partners Ltd. Although this substantial increase in funding has quite rightly been welcomed, important questions remain. It is essential that real progress is made in integrated care—integrated care between the community and secondary and tertiary sectors, and integrated care between hospitals and social care. It is vital that progress is made in the rapid adoption of innovation at scale and pace across entire health economies. It is also vital that a programme is put in place to ensure that there is a transformation of the healthcare workforce so that those who have committed themselves to being healthcare professionals can continue to be developed and serve their fellow citizens across an entire professional career. How do Her Majesty’s Government propose to achieve this? There has been much good intention and great commitment in this area over the past two decades, but we are now at a critical moment where a failure to deliver the transformation required will result in failure to achieve the long-term sustainability to which we are all committed.

[Lord O’Shaughnessy]

The noble Lord makes excellent points. It is right at this moment to applaud the wisdom and far-sightedness of the Lords Select Committee on the long-term sustainability of the health and social care system. It called for, among other things, funding of growth in line with GDP, delivering integration, a 10-year workforce strategy, a commitment to reduce variation and a joined-up Department of Health and Social Care, all of which, if we were not able to deliver it in time for our response to the report, we are delivering in short order afterwards.

One of the first ways in which we shall do it is to draw on the wisdom that resides in the NHS, in Parliament and elsewhere in the profession. In the Statement given by my right honourable friend, I point again to the commitment to take on integrated care, that being one of the tests of success. Equally, there is the commitment to transformation of the workforce, to make sure not just that we have enough people but that we have enough flexibility and digital skills, for example.

The final point, on innovation, is very close to my heart—and indeed the Secretary of State’s. We know that doing things in the same way will not deliver the standards we need. We really need a transformation in how we deliver healthcare, much greater digitalisation of the entire sector and the ability to take the amazing innovations that we develop in our laboratories and universities, such as the noble Lord’s own, and get them into use across the NHS. That is one reason why I was so delighted that we were able to announce today that the noble Lord, Lord Darzi, will be chairing our Accelerated Access Collaborative. It is hard to think of anybody more committed to this agenda than him.

NHS: Artificial Intelligence

Debate between Lord Kakkar and Lord O'Shaughnessy

Tuesday 24th April 2018 Lords Chamber

[Lord O’Shaughnessy]

Yes, I absolutely agree with that. As the report highlights, we have a unique opportunity because of the nature of the way that the NHS was set up and its potential for realising a comprehensive data set of 65 million people. It is not just about those procurement rules; we have talked about having the right framework. It is about providing reassurance within the system—at a time when the public are beginning to understand just what data can do for good and for bad—that the NHS will use their data safely, securely and legally so that they can trust that it is being used for proper purposes from which they will benefit.

[Lord Kakkar (CB)]

My Lords, I declare my interest as chairman of University College London Partners. Does the Minister believe that there is a sufficiently robust mechanism for the diffusion of the innovation associated with digitalisation and artificial intelligence across the NHS? In particular, what role does the Minister think the academic health science networks should play in that process?

[Lord O’Shaughnessy]

Of all the innovations, diffusion is probably one of the greatest challenges that the NHS faces, as the noble Lord knows very well. We are doing a couple of things. First, we are supporting the global digital exemplars, which are providing that digitalisation at trust level, to make sure that they have the infrastructure there. Secondly, he talks about academic health and science networks. They have just been relicensed and are now to have a national remit to promote innovation. AI is absolutely part of the work that we are expecting them to do.

Public Health: Strength and Balance Programme

Debate between Lord Kakkar and Lord O'Shaughnessy

Thursday 18th January 2018 Lords Chamber

[Lord O'Shaughnessy]

Indeed it is, as are other things such as yoga, tai chi and—believe it or not—carrying shopping bags.

[Lord Kakkar (CB)]

I declare my interest as chairman of University College London Partners. What assessment have the Government made of the provision of accountable care organisations to drive the integration across primary care, secondary care and social care to achieve the kinds of objectives that are the subject of this question?

[Lord O'Shaughnessy]

The noble Lord makes an incredibly important point. We know that we want an integrated health service, particularly as we have older people with comorbidities using a range of services. The five-year forward view—NHS England’s own strategy for the future—talks about how that integration will take place through what the noble Lord calls accountable care organisations or systems. We are moving ahead with these: indeed, the most recent Budget is providing significant capital to support that integration. This is the future of the NHS, and we all need to get behind it.

National Health Service

Debate between Lord Kakkar and Lord O'Shaughnessy

Tuesday 10th October 2017 Lords Chamber

[Lord O'Shaughnessy]

The noble Baroness asked a few questions that I will try to deal with. First, on new models of care and STPs: STPs are now being ranked in order to see their fitness for moving forward. The Chancellor announced in the Budget that we will invest £325 million initially, with more funding in the future to support the transformation that we all want to see. The noble Baroness is right to point out that our care model is still based around hospitals and curing infectious diseases, rather than dealing with chronic illnesses and comorbidities. That needs to change.

I echo, as the noble Baroness would, the Care Quality Commission’s report, which talked about staff dedication—nowhere is that more true than in mental health, where staff often deal with very difficult circumstances. It is important to talk about that on World Mental Health Day. She may be interested to know that the Cabinet was briefed today by mental health experts about training programmes going into schools, and so on. There is a lot of work going on, but these are the NHS’s own plans for change, which this Government are backing.

[Lord Kakkar (CB)]

I speak as Professor of Surgery at UCL and chairman of UCL Partners. It is widely accepted that innovation is essential to ensure NHS sustainability. Are Her Majesty’s Government satisfied that there is sufficient emphasis on and support for NHS England in driving types of innovation, such as therapeutic innovation—both in models of care and working practices—that will achieve long-term sustainability?

[Lord O'Shaughnessy]

The noble Lord makes an excellent point. It is true to say that in this country we are very good at creativity and innovation but not always very good at spreading it round. In a way, that is one of the biggest challenges the NHS faces. I would merely highlight a couple of areas where the NHS is working well. The first is the test beds programme, which is working with industry, taking new innovations and spreading them round. Secondly, we have committed to publishing our response to the accelerated access review by the end of the month on how to make sure the most transformative drugs, devices and therapies are taken up throughout the system.

Mental Health and NHS Performance Update

Debate between Lord Kakkar and Lord O'Shaughnessy

Monday 9th January 2017 Lords Chamber

[Lord O'Shaughnessy]

I am grateful to my noble friend for his kind words of welcome. On the specific issue raised on the “Today” programme, which I believe is the subject of a documentary, and how it relates to the Statement made by my right honourable friend, there is an important distinction, which is that it is at the discretion of local clinical leaders. It is not a blanket mandate to delay treatment where the ethical and clinical responsibilities of those treating a given patient require it to be done speedily.

On the issue of the workforce changing, I take my noble friend’s point about what in the education world we called FTEs—full-time equivalents—and will make sure that the workforce figures I use are always expressed in those terms.

[Lord Kakkar (CB)]

My Lords, I declare my interest as chairman of University College London Partners, and join others in welcoming the Minister to his new responsibilities. With regard to the current performance in accident and emergency departments, part of the explanation in the past has been the lack of access to and availability of primary care services. What thought have Her Majesty’s Government given to the potential for the provision of GP primary care services within accident and emergency departments? How is that work going forward and how might it be integrated with the broader provision of primary care services in the community?

[Lord O'Shaughnessy]

I thank the noble Lord for that question; he speaks with a great deal of knowledge and wisdom on the subject. Clearly, to ensure that we have the best possible services, the system needs to be as flexible as possible to local requirements. As is already happening in some areas, having GPs in A&Es as part of the triage, the streaming service, will provide that kind of efficiency and effectiveness, so that everyone is treated properly. I do not have the detail on where NHS England is on that process, but I will be happy to write to the noble Lord with more detail.