Health and Care Bill

Debate between Lord Sharkey and Lord Lansley

Lords Hansard - Part 2 & Committee stage
Monday 24th January 2022 Lords Chamber

[Lord Lansley (Con)]

My Lords, I am pleased to follow the noble Lord and I endorse the points he makes about the diversity of provision, which is certainly something that we should aim for; I am not sure how we will make sure it is in the Bill, but we will get to that later on. I will not dwell on the other amendments; I will simply explain why I oppose Clause 70 standing part. I was pleased to see that the noble Baroness, Lady Thornton, shares that view, although she may do so for different reasons.

This gives me an opportunity to explain something that I have been saying to Ministers—not necessarily these Ministers but their predecessors—for the last two or three years: if the NHS took the view that the structure of the procurement regime that was applied to it was a constraint, cumbersome and the various other words that it used, Ministers could do something about it very quickly because, in the legislation, they have the power to change the regulations. So why do they not do so? I also want to explain that the existing regulations do not impose some of the constraints that it is argued they do. That begs the question behind my opposition to the clause standing part: why are we legislating in this way in this clause, when the effect is to remove a power to make regulations relating to the procurement regime in order to then put into the Bill a power to do just that? It really does nothing much more than that.

Of course, in truth, we do not know what these new regulations will look like because they have not been published, as the noble Lord, Lord Hunt of Kings Heath, rightly said. The issue lies in the regulations because, as I will demonstrate, what mattered to the service, as it turned out, was not what was in Section 75 of the 2012 Act but what was in the subsequent 2013 procurement, choice and competition regulations. I am sorry, but this is going to take a few minutes.

Clause 70 does nothing much more than refer to the fact that there should be transparent and fair processes, that “managing conflicts of interest” should take place and that compliance should be verified—I do not know quite what that means but it is probably a good thing. It also makes reference to general procurement objectives. You might ask what those are, since they are not specified in Clause 70 itself.

If one goes back to the previous legislation, one gets to the point in the NHS (Procurement, Patient Choice and Competition) (No. 2) Regulations 2013, which are also revoked later in Clause 70. In the regulations, there is a paragraph that says what the procurement objectives are:

“for the purposes of the NHS … a relevant body must act with a view to … securing the needs of the people who use the services … improving the quality of the services, and … improving efficiency in the provision of the services”.

I rather hope that we are not yet encountering anything to which people would object. It then goes on to say:

“including through the services being provided in an integrated way (including with other health care services, health-related services, or social care services).”

Frankly, we have had years now of people explaining that the legislation did not allow them to do things in an integrated way. But when one looks back to 2013 and the regulations brought in, they say that the objective is to do things in an integrated way. I slightly wonder why the NHS did not do that, rather than complain that it could not.

Let me go on. When looking at the general requirements of procurement subsequently in that regulation, it includes the provision to

“act in a transparent and proportionate way, and … treat providers equally and in a non-discriminatory way”,

and wants projects delivered with “best value”. So far, again, there is nothing to which people object.

In Regulation 3(4) we hit something that people might object to. In defining what quality and efficiency look like, the regulations go on to say that the services should be

“provided in a more integrated way”—

which we have already heard about, and it repeats exactly that point—

“enabling providers to compete to provide the services”.

This may be where the objection came from, in which case my argument to Ministers is this: if that is what you do not like in the regulations, omit it from them. Ministers could have done it literally in a matter of weeks.

What is the other objection to the existing structure of the legislation? Section 75 of the Health and Social Care Act 2012, about the power and what it should be used to do, talked about good practice in procurement and the right to patient choice. I mentioned in a previous group the importance of, in my view, putting the right to patient choice into the provider selection regime, but we will come on to that again at a later stage.

Here is a third point, and something to which I think some people objected to, and have objected to subsequently; that providers

“do not engage in anti-competitive behaviour which is against the interests of people who use such services.”

I might say that if the anti-competitive behaviour is in the interests of the people who use those services, it is not necessarily objectionable. However, when one looks further, Regulation 10 of the subsequent regulations describes the circumstances in which anti-competitive behaviour might be justified:

“unless to do so is in the interests of people who use health care services … which may include … the services being provided in an integrated way”.

We keep coming back to this.

The other point I would make—she is not here, but the noble Baroness, Lady Blackwood, said it at Second Reading—is that the NHS objected to the fact that it was required to engage in compulsory competitive tendering. Section 75 of the 2012 legislation says that the regulations may

“impose requirements relating to … competitive tendering”,

as well as to the management of conflicts of interest, but it does not require the regulations to be made at all, and it certainly does not require the regulations to include compulsory competitive tendering, and nor do the subsequent regulations published in 2013 require that.

All of that leads me to the conclusion that Section 75 of the 2012 Act simply creates a power; it does not need to be changed for new regulations to have been made. Section 75 says that subsequent 2013 regulations may be objectionable to people in so far as they refer to qualified providers and to competitive tendering. If that was the problem, you should revise the regulations, publish them, take out the bits you object to and give the NHS a provider selection regime that fits their anticipated needs. The objectives are all there: quality, efficiency, best value, fairness, proportionality and an integrated service—and an integration, if that is what this Bill is all about, was already there in the 2012 legislation.

My question to my noble friend for before Report, and the question asked by the stand part debate, is: why are we doing what we are doing in Clause 70? Cannot we do it perhaps more simply and effectively by amending the existing legislation, rather than by trying to do wholesale repeals, introducing something that we will not know what it looks like until after this Bill has passed through this House?

[Lord Sharkey (LD)]

My Lords, Amendment 213 is in my name and that of the noble Baroness, Lady Thornton, and I am very grateful for her support. I can be briefer than I was expecting to be, given what the noble Lords, Lord Lansley and Lord Hunt, have said in the last few minutes.

My amendment addresses another instance of an attempt by the Government to bypass parliamentary scrutiny, and it proposes in response an enhanced form of parliamentary scrutiny. As the noble Lord, Lord Hunt, remarked, the DPRRC report on the Bill notes that the delegated powers memorandum says that, although initial consultation has been carried out by NHS England on the content of the procurement regime, full analysis has not been completed and there has not been time to produce a more developed proposal. Clause 70 gives the Minister the power to impose a new procurement regime, without giving any details of what it might be. This is the clearest possible example of the Government taking powers to make policy without specifying at all what that policy may be.

The DPRRC rejects the inclusion of regulation-making powers as a cover for inadequately developed, or undeveloped, policy. What is worse, the delegated powers memorandum says that a Cabinet Office procurement Bill will most likely follow this Bill, and it may require some amendments to the regulation-making powers that we are discussing in this Bill. The regulatory powers in question are to be subject to the negative procedure. I think we all, except for the Government Front Bench, would recognise that the negative procedure is emphatically not effective parliamentary scrutiny.

What we have here is a skeleton clause, with regulation-making powers of very broad scope. There is nothing in this clause, or in the Bill more generally, which would in practice constrain how broadly these powers could be used in constructing a procurement regime. It would probably be better, from the point of view of parliamentary scrutiny, to leave out Clause 70 entirely, as the noble Lord, Lord Lansley, my noble friend Lady Walmsley and the noble Baroness, Lady Thornton, propose, and wait for the full policy to be set out in the Bill, as promised to follow soon from the Cabinet Office.

If the Minister can advance compelling reasons why this Bill should be the vehicle for setting up the procurement regime by regulations, there is one route we could take, as set out in my amendment. This amendment imposes the super-affirmative procedure on the delegated powers proposal. The super-affirmative procedure is designed and used to deliver a measure of real scrutiny in circumstances that require it. In proceedings on the recent Medicines and Medical Devices Bill, the Minister very helpfully summarised the super-affirmative procedure as follows, saying that the

“procedure would require an initial draft of the regulations to be laid before Parliament alongside an explanatory statement and that a committee must be convened to report on those draft regulations within 30 days of publication. Only after a minimum of 30 days following the publication of the initial draft regulations may the Secretary of State lay regulations, accompanied by a further published statement on any changes to the regulations. They must then be debated as normal in both Houses and approved by resolution.”—[Official Report, 19/10/20; col. GC 376.]

According to the Library, the last recorded insertion in a Bill of a super-affirmative procedure was by the Government themselves, in October 2017, in what became the Financial Guidance and Claims Act.

I repeat that, if the Minister really can convince us that he has a compelling reason to have this new procurement regime set up by regulations in the Bill, my amendment would provide the opportunity for detailed parliamentary scrutiny. If he cannot accept that, then we would be wise to take out Clause 70 in its entirety.

Medicines and Medical Devices Bill

Debate between Lord Sharkey and Lord Lansley

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

[Lord Sharkey (LD) [V]]

Can you hear me now? Yes? Good. Noble Lords will be relieved to hear that I will not start again. I will speak to Amendments 34, 36 and 37.

Clause 4 deals with clinical trials, which delivered £1.5 billion in GVA and £335 million to the NHS in 2018-19. They are an absolutely critical part of UK life sciences and part of what makes the UK a global leader in medical research. Anything that reduces the number or share of clinical trials in the UK weakens that leadership and could delay access to new drugs or treatments.

In its briefing, the APBI points out that our share of clinical trial applications and patient recruits has fallen since 2016. As the noble Lord, Lord Hunt, said, we now rank behind the US, Germany and Spain for phase 3 trials—and Covid has had a dramatic effect. The University of Southampton has published research showing that 1,500 clinical trials of new drugs and treatments for cancers, heart disease and other serious illnesses have been permanently closed down in Britain, with a further 9,000 suspended.

The Government know all this and acknowledge the importance of clinical trials. Given that, Clause 4 is a surprisingly weak response. It does not require the Government to do anything at all. It simply says that they may regulate—it does not say how they may regulate—and lists the areas in which they may regulate. This is another example of the abuse of secondary legislation. It gives unspecified policy-changing powers to Ministers without saying what these policies might be, except that they should do no harm—not a very demanding qualification.

When questioned about this and asked which bits of the CTR they will carry across, the Government’s response is, “The elements that are in the UK’s best interests.” These best interests are to be identified after consultation with interested parties. This all seems unnecessarily feeble. Researchers, commercial and academic, need certainty and stability as soon as possible. Ideally, they would like the provisions of the new UK regime to incorporate all possible provisions of the CTR as they come into force. We know what these provisions are. We know all the thinking behind them. The UK played a central part in their construction in the first place. Our amendments try to give some clarity and certainty to the situation.

Amendment 34 would replace “may” with “must”. It would oblige the Government to do something and does not just give them the power to do something if they feel like it. Substituting “must” for “may” would mean that the Government must make provision corresponding or similar to provision in the CTR.

Amendment 36 would modify this requirement slightly to acknowledge that we cannot adopt certain provisions of the CTR. These are the provisions that relate to the EU clinical trials information system and the assessment model involving co-ordinated decision-making on multi-state trials. Amendment 36 would add “where possible” to the requirement to make provision corresponding to or similar to provision in the CTR to allow for this.

Amendment 37 specifies two features of the CTR that the Government must incorporate. These are specified because they are new and very important, and for the avoidance of doubt about the meaning of “corresponding to” or “similar”. The two new features are the new definition of clinical trials and the allowing of co-sponsorship. In its briefing, CRUK notes that the MHRA has had considerable input in the new definition of clinical trials. It notes in particular that the new definition expands the scope of low-risk trials and excludes altogether some studies, such as pure pharmacology studies that are focused on how medicines work rather than on the extent to which they do. The CTR also defines and allows co-sponsorship, where two or more sponsors across multiple countries may share responsibilities. CRUK regards this as a very positive move, allowing for more flexibility in trial set-up and helping to foster collaboration. We helped to design both these new features. We should ensure that they are incorporated into our new regulatory regime.

[Lord Lansley (Con)]

My Lords, I am glad to follow the noble Lord, Lord Sharkey, because he made some important points and it saves me having to make the same points less well.

The purpose of Amendment 35—in my name and that of the noble Lord, Lord Kakkar—is precisely to explore the issues that the noble Lords, Lord Sharkey and Lord Hunt, raised. I am concerned that, as it stands, the provision may mean that we do not align sufficiently with the clinical trials regulations as they exist in the European Union. That is a great pity because we have gone to an enormous amount of trouble to try to improve the clinical trials regulations in the European Union; indeed, we arrived at a point where they were significantly better than the previous regulations. To depart from them now seems a retrograde step.

We cannot be sure that we will stay aligned with those regulations for ever but having the objective of seeking to have our clinical trials regulations correspond to those in the European Union opens the option for us to be in the clinical trials information system. If we start to diverge from the EU clinical trials regulations, I am not sure how we can then be incorporated into that system. That automatically means significant difficulties in trying to manage multi-state clinical trials in Europe with a view to an authorisation process through the European Medicines Agency because the information system will, I think, be an essential pre-condition for marketing authorisation applications to the EMA. The purpose of Amendment 35 is precisely to explore this issue. What do the Government mean by “or similar”? Do they intend to diverge or not? If they intend not to diverge and to retain corresponding regulations, that is excellent. If they intend to do otherwise, that is not so good.

I do not intend to enter into the argument about aligning with the European Medicines Agency for the simple reason that we have been here before. We legislated in the Trade Bill in the last Session to align ourselves with the agency and to participate in its processes. Unfortunately, I do not think that that is going to be available to us, so legislating for it in the United Kingdom will be, I am afraid, without effect. I will focus on the Clinical Trials Information System because there is likely to be a willingness and interest on the part of our European partners to retain the United Kingdom in this process. I hope that is so, that we might be able to attain that, and that that will be the Government’s objective.