European Union (Withdrawal) Bill

Debate between Lord Warner and Lord Kakkar

Committee: 6th sitting (Hansard): House of Lords
Monday 12th March 2018 Lords Chamber

[Lord Kakkar (CB)]

My Lords, I support the noble Lord, Lord Patel, on his amendment. As we have heard, the proposed revision to the clinical trials directive, the agreed clinical trials regulation, is vital. Despite many positive aspects of the directive, which was applied in the United Kingdom in 2004, it is regrettable that our contribution to clinical trials globally in the period from 2000 to 2010 diminished from 6% of all patients who went into clinical trials in 2000 to just 1.4% in 2010. That was why clinical researchers from not only the United Kingdom but throughout the European Union came together to undertake a thorough revision which resulted in the 2014 clinical trials regulation.

The regulation is quite complicated. It has two attendant regulations: one, 2017/556, deals with the regimen that will be applied to inspection of clinical trials in the European Union after the regulation comes into force; the other, 2017/1569, deals with the manufacturing standards that need to be applied to interventional products that are being assessed in clinical trials. Those two regulations also need to be considered along with the 2014 regulation.

The real concern, from looking at information available about the regulation, is that for non-member states of the European Union, there is an obligation to continue to apply the 2004 clinical trials directive, also recognising elements of the new regulations once they come into force across the European Union. How do Her Majesty’s Government intend to deal with the broader issue? The amendment is designed to ensure that once the regulation is fully adopted across the European Union in late 2019, so it will be applied in the United Kingdom. There are other considerations about being a non-member of the European Union with regard to what is stated about the standards that need to be applied to clinical trials. What approach do Her Majesty’s Government propose to take there?

It seems counterintuitive that, as things stand, if no action is taken, our country will be left with a clinical trials directive that was considered throughout the European Union to be in need of revision. That revision has been undertaken in such a way that it will make the performance of clinical trials more effective, efficient and responsive to the different nature of trials being undertaken and provide an appropriate level of bureaucratic intervention for individual trials to ensure the protection of patients. It would seem completely wrong, having led the revision of the clinical trials regulation, for our country to be left behind with a directive on its statute book that continued to make clinical research more difficult.

These are vital matters, because often when designing a clinical trial there is a long lag period. One takes one or two years beforehand to develop a protocol, identify participating sites and determine what regulatory framework the trial is to be conducted under. Therefore, early reassurance in these matters is critical. A failure to provide that early reassurance may lead for some years to a diminution of the contribution that our country can make to clinical research. As we have heard, that would be detrimental to our entire life sciences industry.

[Lord Warner (CB)]

My Lords, as a former pharmaceutical and life sciences Minister, I rise to support the modest amendment moved by the noble Lord, Lord Patel. I have done my time in the salt mines of trying to streamline the processes for undertaking clinical trials in this country. Despite what the noble Viscount, Lord Ridley, said, it was not just the 2004 directive that caused problems for clinical trials in this country; it was sometimes the sheer bureaucracy of securing agreement to undertaking them, which has contributed to the departure of clinical trials and sometimes investment by big pharma in this country. It is all very convenient at present in some quarters to lay the blame at the door of the EU, but there are historical facts that support a more balanced view of the 2004 clinical trials directive.

From my experience, I know how critical it is for securing a flourishing pharmaceutical and life sciences industry in the UK, and the investment and jobs that that brings. For a decade or so, we have struggled to maintain the level of clinical trials undertaken in this country, and the pharmaceutical industry’s investment in the UK has been dropping. A number of people have made that point time and again in this House in debates with the Government on this issue. The new EU clinical trials regulation will have an incredible impact on the system for conducting clinical trials across Europe with its new single data portal. That point has been made very clearly by the noble Lords, Lord Patel and Lord Kakkar. We have to be a part of this future development if we are to protect our position on clinical trials and life sciences inward investment. That is why it is so important to have an amendment of this kind in the Bill.

I do not think it is fair to say that the Prime Minister’s speech of a fortnight ago is sufficient guarantee that everything will be all right on the night. We have had a number of those speeches on a number of subjects, which tend to show that it will not necessarily be all right on the night. The show may go on but UK participation in the show may be sadly absent in some areas that are critical to this country, as this particular sector of industry is. That is why we have to look a little more carefully at what sort of guarantees we want and that the spirit and meaning of the noble Lord’s amendment is guaranteed in the future.

I do not think we can just rest on ministerial assurances. It has been a convention in this House—I have been in it for nearly 20 years—that we accept ministerial assurances. However, on Brexit, ministerial assurances, while well-intentioned, are not always good enough to ensure that British interests will be guaranteed after we have left the European Union. That is why we need more than simply ministerial assurances. I would like to hear the Minister’s explanations of what the Government’s policies are and what they will do. I for one want to see an amendment of this kind to the Bill before it leaves this House. This issue is too important for a major sector of our economy. It is one of life’s great ironies that we, who have been a moving force in improving clinical trials with proposals for such trials in the EU could, by one of the strange fates of history, be unable to benefit from those improvements if we are not very careful. I hope the Minister will give us an explanation, but it will need just a bit more than warm words to give us guarantees on this issue before the Bill leaves this House.

Health and Social Care Bill

Debate between Lord Warner and Lord Kakkar

Monday 27th February 2012 Lords Chamber

[Lord Warner]

My Lords, I had not intended to speak for very long on this set of amendments but some issues have cropped up which are worth reflecting on, particularly by those of us who have sat in Richmond House and have had to deal with them. It is easy to assume from listening to the debate that we have a wonderful set of arrangements in place to deal with conflicts of interest. That is very far from the case. The noble Lord, Lord Walton, made the point very well that many doctors already do a range of activities—rightly, appropriately and well within their competence—that potentially involve conflicts of interest. One of the great dangers in this area is that we tie ourselves up in a labyrinth of controls that actually work against innovation in an area where science is driving change rapidly. We want people to use their creativity and to change the way they work. We want them to take on new roles. We should not always assume that in doing that they are just seeking to line their pockets. There is a danger that we might do a very British thing and create a large number of rules that will prevent innovation. We had that debate over research and we are in danger of going down the same track in this area.

The other point raised by the noble Lord, Lord Walton, which is very important, is in relation to the role of professional bodies. We had a case—I will not mention the name—of an eminent businessman doctor who was the chief executive of a large chain of nursing homes. He was taken to the GMC because of something that went wrong in one of the nursing homes for which he had no direct responsibility whatever. Although the governing bodies of the professions have an important role, their role was constructed in relation to the actions of a doctor towards individual patients, not in relation to a doctor who was performing other business and organisational functions. It is very important that we do not rely on professional bodies to deal with what is organisational malfeasance rather than lack of professional integrity in dealing with individual patients.

My noble friend Lord Hunt made a very important point. It is very strange that at this stage we are still arguing the toss around corporate governance of some of the bodies in the Bill, particularly the clinical commissioning groups. That is a bit of an indictment of the Government for not getting some of this material thought through at an earlier stage rather than well into Report stage in the House of Lords after having gone through the Commons. However, we are where we are and I think we should not tie ourselves up in knots and prevent incumbents.

Lastly, a very important point that has come out in a number of speeches today is that two issues are critical. First, it should be clear legally to all people participating in these new sets of arrangements that declarations of interest are essential. Secondly, it should also be clear in the Bill exactly what the consequences are of not declaring those interests and pursuing deliberately a conflict of interest for your own advancement, financially and otherwise. Those are the two issues about which we need to be clear in the Bill and I rather agree with the noble Baroness, Lady Barker, that much of the rest of it should be for regulation, provided that the Bill has sufficiently powerful regulation-making powers.

[Lord Kakkar]

My Lords, I too have my name to one of the amendments in this group and would like to reiterate much of what has been said in this very helpful discussion. There is no doubt that there remains considerable anxiety about potential conflict of interest. If, early after enactment of the Bill, the new structures that come into place with regard specifically to clinical commissioning groups were to be attended by serious conflict of interest failings, very rapidly confidence in these new structures would be eroded. That is of very considerable concern.

In Committee, I proposed an amendment suggesting that the Nolan principles be included in this Bill. The Nolan principles are well accepted in public life and play an important role in the conduct of acute and foundation trusts. They have served those organisations well in providing a framework and drawing the attention of those involved in the discharge and governance of those organisations to their obligations with regard to potential conflicts of interest and their conduct more broadly with regard to execution of public responsibility.

In Committee, the Minister felt that adoption specifically of the Nolan principles was not an appropriate course of action and may have a rather unhelpful limiting effect on more broadly ensuring that conflict was dealt with appropriately. Having listened to debate in your Lordships’ House today, it is very clear that considerable anxiety continues. It is important that something is done to ensure that in having taken this Bill forward the Government well recognise the potential for conflict of interest and provide the specific obligations for those who for the first time are going to be directly involved in commissioning and therefore the spending of large amounts of taxpayers’ money. Those obligations are in many ways different from acting as a private individual and it will help those discharging these new responsibilities to understand the high standards to which they will inevitably be held and ensure that they discharge those responsibilities for the benefit of the general public and patients.

Health and Social Care Bill

Debate between Lord Warner and Lord Kakkar

Tuesday 25th October 2011 Lords Chamber

[Lord Kakkar]

My Lords, I strongly support the amendment in the names of the noble Lords, Lord Walton of Detchant and Lord Patel. I remind your Lordships of own interest as professor of surgery at University College, London. I point out that of all the Members of your Lordships' House who have a background in medicine, I completed my training most recently, some 12 years ago, and am acutely sensitive to the fact that training is vital if we are going to deliver high-quality care. I still remember vividly, and benefit from, the instruction that I was given in my training as a general surgeon.

The purpose of the Bill is to ensure that we provide the highest quality healthcare, achieving the very best outcomes and always putting the interests of the patients of our country at the centre of everything that we do. For this purpose, we need to achieve two fundamental objectives. We need high-quality education of undergraduates to prepare them properly for a life in any of the healthcare professions and to inspire them to be excellent doctors and other healthcare professionals. We must also ensure in postgraduate training that we train future doctors and other healthcare professionals to develop the skills that they require to deliver the best for our patients, and the judgment to apply their skills in an appropriate fashion.

Our system of training is so good and respected throughout the world because it is clinically based. Throughout, those who are fortunate enough to be taken on for training in positions in the National Health Service are exposed to, and have the great privilege to be involved in, the care of the patients of our country. However, the delivery of education and training is a hugely complex issue. Not only must we have the matter in the Bill; it must be dealt with in detail. Notwithstanding the fact that Her Majesty's Government propose to introduce a further Bill to deal with education and training in healthcare, which will be hugely welcome, in the intervening period we must recognise that the delivery of healthcare is integral to the delivery of education and training.

I give an example from training in surgery. Consultants who wish to take on training responsibility have to be trained to do so. They must make time available to have the training to become a trainer. They need to organise the delivery of their clinical practice in the care environment in which they work in a thoughtful fashion, to provide training opportunities for their trainees. Frequently that will mean that the utilisation of NHS resources is less efficient than if the facilities and sessions were delivered purely by a consultant. Training takes time; trainees work at a slower rate; they interrupt what they are doing to seek guidance; and they must be provided with the confidence to become good practitioners.

Beyond that, we need to release those working in our healthcare systems to support medical royal colleges and other professional bodies to set and then supervise the standards of training that must be applied across the National Health Service. That takes them away from clinical practice and again makes the utilisation of the resource potentially less efficient. For trainees, we have to provide an environment that supports training. This is complex, because it requires not only release from service commitments—again, this has an impact on resource utilisation in healthcare systems—but time within the delivery of clinical practice to learn to develop judgment in a fashion that is less efficient than it would be if the clinicians had been fully trained as medical or other healthcare practitioners.

For this reason, I strongly support the amendment that education and training must appear in the Bill as a commitment, an obligation on the Secretary of State for Health. We must also spend more time dealing with the issues that might present problems between the enactment of the Bill and the subsequent appearance of a future health Bill that deals specifically with education and training.

[Lord Warner]

My Lords, I support Amendments 2, 6 and 44 in particular in this group. However, I am sympathetic to and support the other amendments. The debate is going downhill. Following the eminent doctors, noble Lords will now get the perspective of a jobbing ex-Minister who was responsible for workforce matters in his time. What is particularly attractive about this set of amendments is not just that they put education and training of staff in the Bill, but that they bring a proper national perspective to this set of issues. I want to talk more about that national perspective because it is often lost sight of as people get very concerned about the responsibilities of employers at the local level. Of course, employers at the local level have a lot of responsibilities. They have the responsibility to ensure that the people they appoint to particular jobs have the skills, expertise and character, and can actually do those jobs. However, the sphere of operation of many of these local trusts, or even GP practices, is quite small geographically and they simply do not have the perspective to do the kind of planning that is required.

My noble friend Lord Davies said that planning is a dirty word. I am a child of the 1960s and was brought up to think that planning was rather a good idea, and I still think it is rather a good idea. Trying to work out what you want to do in the future seems quite a sensible way to run a National Health Service. We need to accept that there is a national role for the Secretary of State and the Department of Health in workforce planning and development. If you do not believe me, it would be worth going back to some of the Health Select Committee reports on this issue under the previous Government, which are very condemnatory of historical approaches by the Department of Health to doing good workforce planning across the NHS.

The issues that arise in this area for a Minister sitting in Richmond House are not ones that you can leave to employers at the local level to deal with. These issues are of long-standing provenance, such as the relationship between doctors from other parts of the world coming to work in the NHS, immigration law and the European working time directive, which has had a massive influence on the way doctors work. We cannot expect local employers to sort these issues out. We also have other big issues to consider; for example, revalidation of health professionals to ensure that they can and do keep up to date.

Another area where the previous Government have a lot to be proud of is the development of a range of sub-medical professionals who could take on jobs to relieve doctors to do more significant work. A good example of this was emergency care practitioners in the ambulance service, where totally new groups of people were brought in, who turned the ambulance service, if I may put it this way, from being just a taxi service to a hospital into a service that had people who could keep patients alive until they got to the hospital. We have a good tradition of developing those areas but in many cases, after a lot of good pilot schemes were introduced by particular local employers, the NHS was reluctant to go to scale. Nurse prescribing is a very good example where we trained lots of nurses but local employers did not always use them to do the job they had been employed for. You need some national perspective to tackle some of these areas.

I now want to say a few words about the much-maligned strategic health authorities. It has become fashionable to say that they were just bureaucratic empires that did not do anything terribly worthwhile. I am still proud that I set up 10 SHAs. They did a good job. The Government will find that they will need an intermediate tier between Richmond House and clinical commissioning groups and local trusts. No one has run the NHS since 1948 without an intermediate tier. The strategic health authorities were the hosts; they worked with the deans and helped to do some of the workforce planning and development in this area. They were the people you could rely on if you needed to ensure that there were enough training places at the local level for the next generation of doctors to secure their specialist training. If you do not have some capacity at that level, you will end up with the really rather difficult problem of how to find the training posts for the next generation of doctors to undertake their specialist training.