Medical Innovation Bill [HL]

Lord Kakkar Excerpts

Friday 12th December 2014 Lords Chamber

[Lord Kakkar (CB)]

My Lords, I declare my interest as professor of surgery at University College London. I also support the amendment very strongly. It comes to the very heart of innovation and sharing the results of that innovation openly, whether they are negative or positive. Therefore, the register needs to be obligatory, in which all innovation and the outcome of that innovation is properly reported. It would do much to ensure the development of an enhanced culture of innovation, but also, fundamentally, to provide very important protections.

[Lord Winston]

My Lords, as far as patient safety is concerned, it is clear that there is a need to keep a record so that other patients do not receive a misguided innovative treatment following an unsuccessful one. That is very important.

Health and Social Care in England

Lord Kakkar Excerpts

Thursday 11th July 2013 Lords Chamber

[Lord Kakkar]

My Lords, I, too, thank the noble Lord, Lord Patel, for having secured this important debate. I declare my interests as professor of surgery at University College London and as a consultant surgeon for University College London Hospitals NHS Foundation Trust.

We have heard that the National Health Service is a vital part of society’s infrastructure in our nation. It provides a unique reassurance by ensuring free and universal access to healthcare. In addition, it provides a most remarkable structure for the provision of public health and preventive strategies, which are vital in ensuring the nation’s long-term health and in containing costs. It also provides a unique environment for biomedical research. Indeed, the research infrastructure that we have heard about has resulted in much innovation and a change in clinical practice for the benefit not only of our own citizens but of people throughout the world. Furthermore, it provides the basis for a vibrant and important life sciences industry which makes a huge economic contribution to the welfare of our country. Beyond that, it is the social solidarity, or glue, that the National Health Service has provided to bind our society together that forms a vital part of the debate about its future.

During this debate we have heard from many noble Lords about the increased financial demands of the National Health Service. Some 50 years ago, it consumed 3.2% of our gross domestic product; last year, some 8.2%; and in 50 years’ time it will be some 20% of GDP if the rate of growth—the 4% per year that we have seen over the past 50 years—is sustained over the next 50 years.

Figures relating to the increasing financial requirements of the NHS produced by the Office for Budget Responsibility show that in 2032 the OBR expects £132 billion to be spent on NHS provision, whereas if the 4% growth that we have traditionally seen in the past 50 years is sustained, the figure will be closer to £170 billion. However, what is striking is the number of people employed in the NHS—currently one in 18 of the working population. If we continue at the same rate of growth with 20% of GDP consumption by 2062, one in eight of the working population will be employed by the NHS. What modelling is done in the Department of Health and the Treasury around this increasing consumption of healthcare resources? Does the noble Earl recognise these figures, and does he, as well as others in government, consider this a sustainable trajectory?

In terms of a solution, one that has been suggested during this debate is to increase taxation. There is a great fondness among our fellow citizens for the National Health Service but even providing one extra percentage point in GDP to be diverted towards health spending would require an increase in taxation of £570 per household per year, and that is a huge increase in taxation. Of course, we know that the demand is going to be much greater. We could settle on giving a greater proportion of public expenditure to health, but 20% of departmental spending is currently already devoted to the National Health Service. Is it sustainable to take more and more from other public services and divert it to health if we do not increase the income available?

A third potential option is to improve the effectiveness and efficiency of the services that we provide, and in this regard Her Majesty’s Government have to be congratulated. The report entitled Innovation, Health and Wealth, published last year, clearly focuses on ensuring that the National Health Service can improve the outcomes that it achieves for fellow citizens in a way that adds to economic growth rather than continuously draining economic resources, although I think that many would agree that it is not a drain of resources to ensure that our nation is healthy.

In establishing the outputs of Innovation, Health and Wealth and, in particular, in establishing the academic health science networks—I declare a further interest as chair for clinical quality at the recently designated academic health science network at UCL Partners—what metrics will be applied to determine whether the networks are successful in terms of the economic rather than just the health question? We know that, as part of the designation process, each of these networks across England has been asked to define high-impact innovations that will be applied across the population and to adopt NICE guidance to improve clinical outcomes, but both those sets of interventions should also have an impact on resource utilisation. Are metrics defined that we will be able to assess over time to determine whether a focus on improving efficiency and effectiveness in the NHS can also result in better utilisation of resource?

European Union Committee: Multiannual Financial Framework

Lord Kakkar Excerpts

Tuesday 19th June 2012 Grand Committee

[Lord Kakkar]

My Lords, I join other noble Lords in congratulating the noble Lord, Lord Boswell of Aynho, on his thoughtful introduction of this report and I pass to your Lordships the regrets of the noble Baroness, Lady O’Cathain, who is chairman of Sub-Committee B on the internal market and would have liked to be here, but cannot. As the recent addition to that sub-committee, I have come in her place to draw your Lordships’ attention to some of the important issues with regard to scrutiny of the part of the multiannual financial framework relating to infrastructure and innovation. In so doing, I remind noble Lords of my entry in the register of interests as professor of surgery at University College, London, an institution that is in receipt of funds from the framework 7 programme for innovation in biomedical sciences research, and as an applicant to that funding scheme.

The Connecting Europe Facility is the proposal in this MFF to bring together the funding streams related to infrastructure spending on transport, telecommunications and energy. These are all important areas, and Sub-Committee B recognised in its scrutiny that appropriate investment in this type of infrastructure could have important benefits by driving growth, improving infrastructure and meeting the objectives of European added value. If properly focused on what independent nations are unable to do but what the European Union could do more effectively by working together, this type of activity could potentially be very important.

In addition, the focus on European added value through properly transparently described and funded programmes of infrastructure investment would allow the opportunity to develop criteria that properly assessed European added value at the outset and ensured that projects could be tracked to demonstrate that added value, which is vital to convince the people of our country that this type of investment through their contributions to the European Union is effective and cost-effective.

Equally, this area of investment could be used to leverage private sector investment in major infrastructure projects, if properly directed. The proposal that the Commission play some important and enhanced role in the supervision of these projects was also potentially welcome, with the caveat that national competences must not be overridden in areas where member nations could perform tasks more effectively.

There were some concerns. The proposal in the current MFF is that funding in this area be increased fourfold over previous infrastructure investments in the areas of transport, energy and telecommunications. This was considered somewhat unrealistic. The emphasis must be on investment and a budget commensurate with that investment that focus on areas of infrastructure development that are truly European added value. As the sub-committee scrutinised proposals in this area, there was some concern that that may not be the case. With this unrealistic proposal for a large increase in expenditure, it is very important for attention to be focused on those areas of added value where nations would be unable to make the appropriate infrastructure investments.

Equally, there was concern that previous budgets have focused more on transport infrastructure and that moving forward in this MFF there should be particular emphasis on energy and telecommunications. There were some concerns about the detail of the various instruments included in this proposal. With regard to the transport instrument, for instance, the Government have recognised that there are concerns about the proposed core corridors and the potentially unwarranted mandatory infrastructure investment that could cost our country and other European nations substantially and inappropriately. The sub-committee is aware of the important advances that the Government have made in negotiations on these matters to ensure that that will no longer be the case, but it remains concerned to hear more from the Government about instruments in the telecommunications and energy areas. What progress has been made to reduce the substantially increased budget to a more realistic level? Are there areas of concern over some features of the transport instrument and mandatory infrastructure investment?

The point was also made in the sub-committee that the proposal that the Commission has a more important role in the supervision of this type of infrastructure investment should not in any way infringe national competences in these areas. This is a vital issue that would need to be emphasised during the period of this budget.

The second area I turn to is Horizon 2020, which is the innovation instrument dealt with in the MFF. The sub-committee agreed that this was a vital area, and we have heard many noble Lords in this important debate emphasise the importance of investment innovation in research and technology to drive economic growth and ensure that Europe more broadly is competitive in the coming years as we see increasing global competition from countries such as the United States, China and others, where investment in research and development continues to play a vital role in public and private investment policy.

On Horizon 2020, we have heard that there is a proposed substantial increase in the budget on research spending, but the Government consider it unrealistic given the current overall financial constraints. The sub-committee was of the view that there should be an increased emphasis on investment in innovation expenditure but within a smaller budget. So there is a very clear view that innovation should rise up the spending priorities of the European Union, should overtake areas such as the common agricultural policy and become the heart of spending proposals from the EU. That would ensure that investment in innovation translates into innovation being applied to small and medium-sized enterprises so that they can promote economic growth and create jobs.

If the proposed budget increase for innovation will not be achieved in this MFF round, it is certainly suggested that the focus should again be on areas where there is European added value. This is to drive forward the European Research Council and research excellence in Europe to ensure that co-operation in research and fostering research networks is achieved as a primary focus of the investment of those valuable funds to drive research.

European Union Membership (Economic Implications) Bill [HL]

Lord Kakkar Excerpts

Friday 25th November 2011 Lords Chamber

[Lord Kakkar]

My Lords, I join other noble Lords in congratulating the noble Lord, Lord Pearson of Rannoch, on securing this important debate on the Second Reading of his Bill. I will confine my comments to the area of healthcare and the impact that the European Union is having on the delivery of healthcare and biomedical research in our country. I remind noble Lords of my interests as a practising surgeon, professor of surgery and active biomedical researcher.

I will concentrate on two areas: the European working time regulation and its impact on the training of young doctors and other healthcare professionals in our country; and the impact of the clinical trials and data protection directives on our ability to conduct high-quality clinical research. On the European working time regulation, there has been extensive review and discussion about its potential implications. Its purpose is well recognised, but the unintended consequences with regard to the practice of medicine are not always so well recognised.

If the working time regulation had provided demonstrable evidence of an improvement in clinical quality, the safety of patients and the training of our young doctors and other healthcare professionals, it would be a very reasonable regulation to adopt and apply to the practice of medicine in our country. However, there is little evidence that the regulation restricting hours of work to 48 per week and applying to medical practitioners in training has achieved those objectives.

Clearly there are differences between different disciplines in medicine. The craft disciplines of surgical practice such as my own require a high level of exposure to large numbers of cases in order to develop technical skills, and also a broad ongoing continuity of management of patients to develop the judgment necessary for ultimate independent consultant practice.

The Royal College of Surgeons has taken a keen interest in the potential impacts of the working time regulation on surgical training in our country. In 2010 it produced a report that looked at the potential cost implications of the application of the working time regulation with regard to surgical training. In the two years prior to the introduction of the working time regulation, it collected data using freedom of information requests that were responded to by 96 acute NHS trusts, and extrapolated the findings to the 160 acute trusts where surgical training takes place. It concluded that in the year of introduction of the working time regulation, expenditure on locum costs to cover rotas as a result of the regulation increased from some £540 million a year to £750 million—an increase of more than £200 million.

That was across the board. When the royal college looked at surgical locums, it concluded that costs increased from £170 million a year to £230 million—an extra £60 million spent on locums as a result of the application of the working time regulation restricting surgical trainees to working 48 hours a week. It also tried to determine the number of surgical hours lost per month as a result of the restriction to a 48-hour working week and concluded that some 400,000 surgical hours a month were lost as a result of the restriction. If we were paying this price for achieving an improvement in clinical care or in training, it might be completely justifiable. However, the Royal College of Surgeons and the Association of Surgeons in Training concluded that that was not the case.

The second area is the impact of European directives and regulations on the conduct of clinical research in our country. Twelve per cent of the global citations in clinical and healthcare research are of publications from United Kingdom institutions and nearly one-quarter of the 100 leading medicines in the world have been developed in our country. Biomedical research is therefore hugely important to our economy and in terms of what we can do for our own people as well as for others around the world. In January a working group at the Academy of Medical Sciences chaired by Sir Michael Rawlins published a report, entitled A new Pathway for the Regulation and Governance of Health Research, which looked at ways of ensuring that we remain competitive. It concluded that the European clinical research directive has had a detrimental impact on the conduct of clinical research in our country. The directive was introduced for good reasons—to improve ethical standards and to ensure consistency of data and, ultimately, to ensure that patients are strongly protected in all clinical research—but there have been unintended consequences which have made the approval of clinical trials much slower and the conduct of clinical trials less effective. It has also increased the cost of doing clinical trials, so much so that, in 2000, 6 per cent of all patients going into clinical trials globally came from our country while, by 2006, the number had fallen to only 2 per cent of patients going into clinical trials. That has a very serious impact on our ability to function in that area.

These conclusions were also confirmed by your Lordships’ Science and Technology Committee in its second report for Session 2008-09, on genomic medicine, chaired by my noble friend Lord Patel. It also concluded that it would be important for Her Majesty's Government to review the working of the clinical trial directive and the data protection directive, which were having a detrimental impact on the conduct of clinical research in our country. I know that the Government are keenly aware of these important issues and that they are trying to address them. If a committee were established to look at the benefits and costs of our membership of European Union, consideration of the impact of European regulation on the conduct of research and the training of our doctors are important topics that should be considered.