Medicines and Medical Devices Bill

Debate between Lord Kakkar and Lord Hunt of Kings Heath

Committee stage & Committee: 1st sitting (Hansard) & Committee: 1st sitting (Hansard): House of Lords
Monday 19th October 2020 Grand Committee

[Lord Hunt of Kings Heath (Lab)]

My Lords, I have added my name to Amendments 1 and 140 tabled in the name of my noble friend Lady Thornton. As we are at the start of the Committee stage, perhaps I may remind the House of my membership of the board of the General Medical Council and my role as president of GS1 and the Health Care Supply Association.

I agree with my noble friend Lady Thornton about the clash between the first day of the Committee stage of this Bill and the Second Reading of the United Kingdom Internal Market Bill in the main Chamber. Today we are dealing with some of the most important debates in the whole Bill and when we come back on Report there will be a need to give more time to allow those people who could not be present today to make a full contribution to these debates. I hope that the usual channels will take that away. I am not quite sure about the procedure in these unusual circumstances, but in normal times I would have asked that the Committee stage procedure be used for these introductory debates on Report in order to allow for interventions. However, since interventions are now limited, that may not run well, although I think that noble Lords will understand what I am getting at.

This is an important Bill on patient safety and the health of our life sciences sector. It is striking in its brevity and in the extensive powers to be given to Ministers. The noble Lord, Lord Patel, has spelled out the wide range of delegated powers contained in the Bill, while a pungent analysis by my local university, the University of Birmingham, points out that, while delegated powers may be needed to ensure responsiveness in the EU exit transition period and to meet the challenges of technological change, they should not be used indefinitely or relied on to implement matters of policy. I am not going to repeat what the Delegated Powers Committee or the House of Lords Select Committee on the Constitution have said, but it is rare for two Select Committees to comment at the same time and in such a critical way about the skeletal nature of a Bill. It is to be hoped that the Government will listen carefully to what is being said.

At Second Reading, the Minister suggested that the sunset clause as proposed by my noble friend would emasculate legislation

“meant to give regulators the powers to be effective and to future-proof medical regulation in a fast-changing industry for many years to come. We must understand the impact on an industry that needs regulatory certainty or else, as many noble Lords have noted, will move elsewhere.”—[Official Report, 2/9/20; col. 433.]

I have to say to the Minister that most of the regulatory uncertainty has been caused by the Government’s failure to be clear about what regulatory regime they want for medicines and medical devices. They have now had four years to think about this and we are still nowhere near knowing what regulatory system they want to put in place. Are they going to go for alignment with the European Medicines Agency or do they want to strike out on their own? Do they want to ally with the US FDA? What on earth are the Government’s aims? The industry is at risk because of this huge uncertainty. The idea that we should allow the Government willy-nilly to get this Bill through and make whatever changes they want without the House treating it as primary legislation simply will not wash. I am absolutely convinced that the long-term regulatory system must be subject to detailed primary legislation. As far as I can see, the amendment to bring in a sunset clause is probably the most appropriate vehicle to ensure that that happens.

[Lord Kakkar (CB) [V]]

My Lords, in contributing to the first day in Committee on this Bill, I draw the attention of noble Lords to my registered interests, in particular to those as a professor of surgery at University College London and as the chairman of UCLPartners.

I support Amendments 50, 67 and 115 tabled in the name of my noble friend Lord Patel, to which I have added my name. The point has been well made by my noble friend that the ecosystem for the delivery of healthcare in our country and therefore the use of medicinal products, medical devices and veterinary medicines is a complex one that is attended by substantial legislation, much of which has been brought into force as a result of the European Communities Act 1972. It is therefore absolutely right, to echo a point made previously by the Minister, that there is a need for this Bill to ensure that such regulation can continue, so that we can continue to have a safe and effective healthcare system and take advantage of the essential requirement to avail ourselves of medicinal products and medical devices.

There is surely also an absolute obligation to ensure that regulation should avoid adding to the complexity that already exists. For those who have to labour under these regulations and ensure that they can present innovation and advances to benefit our fellow citizens within the context of the regulations, we should always be working to simplify them.

In this regard, we are all conscious of the fact that many different types of regulations touch on the healthcare system. There are those that pertain to ethics, and those that deal with the function and delivery of ethics committees and the evaluation of intervention at a local and national level. We have regulations that deal with the adoption and evaluation of innovation within the context of the MHRA, and with the evaluation of intervention and innovation pertaining to NICE. We have heard from the noble Lord, Lord Patel, about the medical device regulations enacted in 2002, which codify and implement various EU directives in this matter, and the substantial amendment attending medical device regulations in terms of the legislation passed as part of EU exit regulations in 2019.

Health and Social Care Bill

Debate between Lord Kakkar and Lord Hunt of Kings Heath

Wednesday 21st December 2011 Lords Chamber

[Lord Kakkar]

My Lords, I rise to move the amendment in my name and that of my noble friend Lord Patel, who sends his apologies to the Committee. He is strongly enthusiastic about the amendment but regrettably cannot be here. The amendment would introduce a new clause to provide for a review and scrutiny of the operation of the Act.

The noble Earl, in responding to the Second Reading debate, was kind enough to deal with the matter I had raised regarding post-legislative scrutiny. Your Lordships’ House has determined that careful post-legislative scrutiny should be considered because it is of value and importance for all complex Bills. The detailed Committee stage which has attended the passage of this Bill in your Lordships’ House has clearly shown that there has been considerable anxiety about the potential implications and operation of what will eventually be the Health and Social Care Act. It is only right that a Bill of this complexity should be subjected to post-legislative scrutiny. This can be undertaken only if appropriate information is made available to both Houses of Parliament.

The purpose of exploring the opportunity for the Government to consider the issue at this stage is to determine whether the noble Earl—in addition to confirming the Government’s commitment to scrutiny of the Act, if Parliament decides to pass it—would consider initiating post-legislative scrutiny earlier than the three years which he kindly indicated when answering the Second Reading debate. A range of between three to five years is the normal period in which scrutiny might be considered for an Act once Royal Assent had been received. However, in view of many of the issues that have been raised, it would seem appropriate to attend to the matter of scrutiny earlier.

It might be argued that having scrutiny one or two years after enactment would be a little too early, but many of the new mechanisms and arm’s-length bodies being established to deliver the purpose of the Bill are already available in shadow form. For example, the chief executive-designate of the NHS Commissioning Board has already been appointed. The chairman has been appointed and the board is starting to make other important appointments and to deal with its structure so that when the Act comes into operation the board will be in a position to start its work. It means that, after a year, we should all be able to perform reasonable scrutiny.

With regard to clinical commissioning groups, pathfinder commissioning groups have already been established. They are starting to develop the alliances and relationships in their areas and localities that will allow them to become fully operational at the time that the Bill proposes. Therefore, the period of finding their feet has already been established.

A commitment to both rigorous scrutiny after enactment and early, formal post-legislative scrutiny will allay a lot of anxieties and provide your Lordships and the other place with reassurance that if there were to be unintended consequences associated with the Bill, they may be identified earlier. If other elements of legislation were required to ensure that the Bill’s objectives could be fully achieved, given that the Government are considering a further Bill to deal with matters such as education, research and social care in the next Session, scrutiny of the Bill could inform what legislation might be added to that Bill. I beg to move.

[Lord Hunt of Kings Heath]

I rise to support the noble Lord. Earlier today, he made a very pertinent point on Lords reform, and this one seems equally pertinent. Before I do so, perhaps I may take this opportunity to say that my noble friend Lady Gould has just vacated the Deputy Speaker’s seat. That was her last session, and I wanted to say to her—I am sure on behalf of the whole House—what a wonderful job she has done. She has accompanied us through many pieces of legislation, often very late at night, always with tolerance and very efficiently, as befitting a former fearsome organiser of the Labour Party, if I may say so.

Health and Social Care Bill

Debate between Lord Kakkar and Lord Hunt of Kings Heath

Wednesday 9th November 2011 Lords Chamber

[Lord Kakkar]

My Lords, I support many of the amendments in the group. I do so as a biomedical research and clinical academic, therefore benefiting from many of the opportunities that the current systems for biomedical research in the National Health Service provide.

I start by congratulating Her Majesty's Government on having included for the Secretary of State for the first time in a health Bill responsibilities to promoting research. That is hugely important, because it allows us to secure what has been achieved to date in structures and funding going forward in the National Health Service.

There are, of course, anxieties, which we have heard in this important debate, which need to be addressed. Can the noble Earl provide clarification in three areas, notwithstanding the fact that the Bill already emphasises the responsibilities of the Secretary of State for Health? First, how is it is envisaged that the funding for biomedical research will be protected when that fund moves to the NHS Commissioning Board? Secondly, how will the clinical commissioning groups be responsible for promoting research in future, how will that be supervised by the NHS Commissioning Board, and will any form of instruction or performance measure be included in the supervision that the Commissioning Board provides for clinical commissioning groups?

Finally, how, within the proposed structure of the Commissioning Board, will there be encouragement and support for academic health science centres, as they currently exist, and in the future, potentially, academic health partnerships? They provide the opportunity both to drive forward opportunities for biomedical research to improve healthcare and the health gain for our population, and to drive forward the economic opportunities that attend the biomedical sciences industry in our country. However, they also drive forward opportunities for a broader population health gain through a focus on the tripartite mission of improved clinical care, education, training and research.

[Lord Hunt of Kings Heath]

My Lords, this has been a very interesting debate, and I am very grateful to the noble Lord, Lord Willis, and other noble Lords who have spoken in it very persuasively about the importance of research.

At heart, there are three particular questions that we put to the noble Earl, Lord Howe. First, how is funding for research to be protected? Secondly, how are we to ensure that strong leadership will be given from the centre? The third is the question of levers. What levers are there in this system to ensure that research is given a prominent place?

First, there can be no doubt whatsoever, as the noble Lord, Lord Willis, said, of the direct link between research and the quality of patient care. That must be at the forefront of our consideration. Secondly, he is also right about public health. Research into public health, evidence and epidemiology is vital if we are to improve the overall health of people living in this country. Thirdly, we have the contribution that research makes to UK plc, and specifically the contribution of the pharmaceutical industry.

When I chaired the competitive taskforce with the industry some years ago, we found that out of the 100 most important branded medicines at the time, 30 had been developed in the UK. Although the UK share of global spend on pharmaceuticals was about 2 per cent, our R&D contribution, including that of the industry, was about 10 per cent. I suspect that those figures have slipped a little since that report, but there is no question that the pharmaceutical industry in particular makes a huge contribution to our economy. We cannot be complacent about that in the future.

On the question of leadership, I was fortunate to be present at the recent annual conference of the NHS Confederation. I take the point made by the noble Lord, Lord Mawhinney, that, “They would say that, wouldn’t they”, when it comes to this rather foolish idea that somehow if you just leave it to them everything will be all right, but I recall a speech made by Dame Sally Davies in which she talked about the importance of research. She argued that the NHS itself has to make a greater contribution to research. This was not about funding; this was about NHS organisations recognising that research was important. It was a brilliant speech. It is essential that we continue to have that kind of national leadership in research funding.

There is a big question about what exactly the duty of the Secretary of State will be with regard to research if we end up with a highly devolved structure in which the levers left to the Secretary of State will clearly be limited. It is clear that the day-to-day concerns of most people in the NHS are going to be diverted into a market-orientated culture, where, frankly, the kind of collaboration that research requires across NHS organisations may well be regarded as collusive behaviour by economic regulators and the competition authorities.

I speak with some experience of economic regulation. Ofgem was the last economic regulator with which I had regular dealings as Minister for Energy. What struck me was that regulators’ concerns are much more about day-to-day issues than they are about the long-term viability of a particular industry. We found, with Ofgem, that we had to change the law to make sure that it had some regard to future customers rather than simply being concerned about the actual price of energy to the customers of today. If we have regulators whose main concern is about driving day-to-day competition, I wonder where issues of research come into play.