Health and Care Bill

Debate between Lord Kakkar and Lord Sharkey

Lords Hansard - Part 1 & Report stage
Tuesday 1st March 2022 Lords Chamber

[Lord Sharkey (LD)]

My Lords, like the noble Lords, Lord Patel and Lord Kakkar, I have added my name to the government amendments in this group. These amendments directly address the criticisms which we made in Committee that, as things stood, a duty to promote research lacked any real force. Since we made these criticisms, we have met with the Minister and his officials to try to strengthen this research duty and make it more meaningful and concrete. These amendments, and the others in the next group, are the result of our discussions.

The Minister has explained, and given some examples, how they would help. The importance lies on what new things the amendments put in place. They require the NHS to explain, in its business plans and annual report, how it proposes to discharge, or has discharged, its research obligations. They also require a performance assessment of ICBs, which includes how well they have discharged their research duty and their duty to facilitate and promote the use of evidence in research. I thank the Minister and his team for their extensive engagement on the question of research in the NHS. I am pleased that we have strengthened the research duties of the Secretary of State and the ICBs. I am particularly pleased that progress will now be formally reported and assessed.

I should also mention that, in his letter of yesterday, the Minister listed a number of non-legislative measures either being taken or developed for facilitating or fostering a culture of research within the NHS, and for holding to account the people responsible for delivering this.

Finally, the noble Lord, Lord Patel, has asked me to say how sorry he is that he cannot be here today. He wanted the House to know that he supports the Government’s research amendments and is grateful for their co-operation in generating more research in the NHS. As the noble Lord, Lord Kakkar, has said, he is at home recovering from Covid, and I am sure that the House wishes him a speedy recovery.

[Lord Kakkar (CB)]

My Lords, I remind noble Lords of my own declarations of interests made in Committee: I am chairman of the Office for Strategic Coordination of Health Research, chairman of the King’s Fund and chairman of King’s Health Partners. In so doing, I make particular reference to the King’s Fund, since the Minister, in closing the last group of amendments, indicated the contribution to discussion which the fund has made with regard to the questions of inequalities.

I strongly support the amendments on the question of research that have been put by Her Majesty’s Government, and so ably and thoughtfully presented and introduced to your Lordships’ House by the Minister. The noble Lord, Lord Sharkey, has summarised why this is so very important. Ultimately, a research culture needs to be promoted at the heart of the NHS, and these amendments go a long way to achieving that clear objective.

There is so much by way of other initiatives that Her Majesty’s Government promote on the funding of research and support to bring together different parties to drive the broader life sciences agenda. However, ultimately, this all depends upon an NHS which is strongly supportive of, and facilitated to deliver, that research. Without this commitment, there was a very real risk that, with the other priorities that the NHS is inevitably required to pay attention to, the need to promote and facilitate research would be lost.

In facilitating research, NHS organisations, the Secretary of State, the NHS board and integrated care boards will have to pay attention to not only the facilities provided but the attendant workforce questions, ensuring that a workforce is properly prepared and able to engage in the research agenda, that progress in that regard is properly reported and that the full benefits of a research culture and the output of research are available to patients throughout our country.

Medicines and Medical Devices Bill

Debate between Lord Kakkar and Lord Sharkey

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

[Lord Kakkar (CB) [V]]

My Lords, I support Amendments 5 and 70 in the names of the noble Lord, Lord Lansley, and the noble and learned Lord, Lord Woolf. I seek further clarification on the Government’s purpose regarding the amendments proposed by the Minister.

First, what is the rationale for moving away from the current basis on which regulations in this regard exist, which states the purpose of safeguarding public health? Why do the Government not think that appropriate as the basis for legislation for medicines and medical devices? It has been the basis on which regulations have previously existed in domestic legislation and it seems counterintuitive to move away from that purpose, as so clearly explained by the noble Lord, Lord Lansley.

Secondly, there is this question of whether there should be an objective or a subjective test attending the purpose of legislation, all parties having agreed that it is of benefit to move away from simply having a power to clearly defining a purpose. There has been considerable debate and discussion about what is considered the frequent use of judicial review now and how in some way it undermines the position of Parliament and is less than helpful more generally in our country. It seems therefore intuitive for a Government who have concerns about what is sometimes considered excessive use of judicial review to try to provide legislation that would make it less necessary and less frequently turned to.

The noble and learned Lord, Lord Woolf, made the point that clarity is essential. Surely an element of clarity would be to have in place an objective test—to safeguard public health—rather than, as currently, merely being “satisfied”. The need that the Secretary of State can make regulations if he is satisfied, as we have heard in this debate, is much more subjective and therefore must be open to much more frequent challenge.

[Lord Sharkey (LD) [V]]

My Lords, I have only just learned that if we do not pass the government amendments in this group, we put at risk the required legislative consent order for Northern Ireland. I had intended to oppose Amendments 2, 7 and 14; I did not understand why Amendment 2 was necessary or had any real force or meaning—in any case, I much preferred Amendment 5 —and Amendment 7 seemed downright confusing, since its net effect is to impose an obligation on the Minister to have regard to certain things when considering making regulations but no obligation to consider the specified things when actually making these regulations.

I have spoken to the Minister and will now not oppose the government amendments. However, I feel that we have been bounced. I first realised the Government’s intention to move when I read today’s Chair’s guidance and I understood that there was a Northern Ireland problem when I was given, about 40 minutes ago, a copy of the note from the noble Lord, Lord Bethell, to the noble Lord, Lord Lansley, from yesterday. We were not copied in on that note. I strongly feel that this is all very unsatisfactory.

The Minister has not really answered the question that I asked him in our impromptu interval of why we need to rush. Could he explain why delaying the start of the legislative consent order process until Report would be a problem? It is still not clear to me. I trust the Minister’s assessment but I do not understand how he arrived at it. In his note to the noble Lord, Lord Lansley, he says, for example, that the delay would mean that we could not meet some unspecified timing objective but he prays in aid the notion that the minimum interval between Committee and Report is a contributing factor. We can change that interval; we could choose. Could the Minister explain again why it is necessary to do this today?

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[Lord Sharkey (LD) [V]]

My Lords, we strongly support Amendments 4, 42, 52 and 92 in this group.

The proposal in the Bill to create new criminal offences by statutory instrument is completely unacceptable. It is a matter of basic principle that the creation of new criminal offences requires proper parliamentary scrutiny. The delegated powers affirmative procedure does not provide this or anything like it. This ought not to be controversial. The Government’s own list of the areas in which it is appropriate to use delegated legislation does not include the creation of criminal offences.

Our Constitution Committee has made its position very clear. It considers the use of delegated legislation to formulate policy or create new criminal offences or public bodies constitutionally unacceptable. The Government propose to do the first two of those things in this Bill; it is dismaying that they should so directly and bluntly ignore the conclusion of the Constitution Committee.

The Government appear, however, to have felt the need to modify their initial position somewhat. Their amendments in this group preserve the power to create new criminal offences by statutory instrument, but now cap any sentence for breach at two years. That is a category error. Our objection is to the creation of criminal offences by delegated powers. The length of the sentence attached is completely irrelevant and I am amazed that the Government think that capping the sentence might make the creation of criminal offences proposal more acceptable.

There is an obvious and fundamental principle at stake here. Criminal offences, no matter what penalties are attached, should not be created without full parliamentary scrutiny. They should not be created by the use of delegated powers. I urge the Minister to think again and to remove the offending provisions from the Bill. If he is disinclined to do that, I hope that the House will insist on Report.

[Lord Kakkar (CB) [V]]

My Lords, I very much support what the noble Lord, Lord Sharkey, has just said. In so doing, I support Amendments 4, 42, 52, 63, 69 and 92 in this group.

It seems counterintuitive at the very least for a Government to come forward with proposals to give a Minister powers using a delegated provision to create new criminal offences and, when challenged, to justify the position by saying, “Well, we will limit the sanction to two years’ imprisonment.” This completely misses the point, as we heard from the noble Lord, Lord Sharkey. There is a clear principle at stake here, which has been well described by the Constitution Committee in its report on this legislation. Very simply, it offends liberty and the functioning of our democracy that a Government can propose to create criminal offences that would deny a citizen their liberty for one day, let alone a maximum of two years, and feel that there should not be proper parliamentary scrutiny in the accepted fashion for the creation of criminal offences. Her Majesty’s Government should think very carefully about what they propose to do here and bring their own amendments beyond the government amendments suggested in this group.

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[Lord Sharkey (LD) [V]]

My Lords, Amendment 6 deals with human medicines. Amendments 53, 71 and 98 in the group make the same provisions as Amendment 6 but for veterinary medicines, medical devices and information systems. I will also speak to Amendments 143 and 144, which deal with the mechanisms that make Amendments 6, 53, 71 and 98 work. Our Amendments 135, 136 and 142 would replace the negative procedure in cases of urgency with the “made affirmative” procedure. I shall not speak to these because the Minister has more or less conceded the point in his new amendments.

Amendment 6 is in my name and those of the noble Lord, Lord Forsyth of Drumlean, the noble and learned Lord, Lord Judge, and the noble Baroness, Lady Andrews. I am immensely grateful for their support and regret that they cannot be present today because they are all speaking at the internal market Bill Second Reading in the Chamber. It is extremely unhelpful that the Government have scheduled two significant Bills for the same time slots. They should be decoupled to prevent future clashes.

Amendment 6 and its equivalents deal with the non-urgent scrutiny procedures currently set out in the Bill. They replace, in Parts 1, 2 and 3, the affirmative procedure for delegated powers with the super-affirmative procedure set out in Amendments 143 and 144 later in the Bill. The purpose of these amendments, taken as a whole, is to restore an element of parliamentary scrutiny to a Bill which so conspicuously lacks it.

This is a skeleton Bill. Parts 1, 2 and 3 contain no policy detail but give the Minister effective carte blanche. The Minister is given almost unfettered power to remake our human medicines, our veterinary medicines and our medical devices regimes. The reports of the DPRR Committee and the Constitution Committee were highly critical of this approach. At Second Reading, the noble Lord, Lord Blencathra, chair of the DPRRC and speaking for it, said that

“the structure of the Bill is absolutely atrocious and an affront to parliamentary democracy.”

He went on to say that his committee was

“deeply concerned not only by the Government’s failure to provide sufficient justification for the adoption of a ‘skeleton bill’ approach—which would give Ministers sweeping powers to almost completely re-write the existing regulatory regimes … but also by their failure to acknowledge the breadth of the powers that the Bill would confer.”

He concluded:

“Parliament is effectively bypassed; that is a sick joke of good law.”—[Official Report, 2/9/20; cols. 415-16.]


Despite all this, it is likely that the Minister will choose to represent the proposed use of the affirmative procedure in this Bill as meaningful parliamentary scrutiny, but it is emphatically not that. Parliament cannot amend SIs and this House has voted down affirmative SIs just four times in the past 70 years. The Constitution Committee in its 2018 report The Legislative Process: the Delegation of Powers noted:

“Without a genuine risk of defeat, and no amendment possible, Parliament is doing little more than rubber-stamping the Government’s secondary legislation. This is constitutionally unacceptable.”


Affirmative SIs do not constitute meaningful parliamentary scrutiny, and the Government’s promise of wide, but unspecified, consultation on the powers in the Bill does not somehow magically restore parliamentary scrutiny. Parliament is still bypassed.

There is a delegated legislation procedure that allows for significant parliamentary scrutiny. This procedure, which comes in several flavours, is known to the Government as “exceptional procedures” and to Erskine May, in Part 4 Chapter 31.14, as the “super-affirmative procedure”. This is what our amendments propose should replace the existing affirmative procedures written into Parts 1, 2 and 3. Erskine May characterises the super-affirmative procedure as follows:

“The super affirmative procedure provides both Houses with opportunities to comment on proposals for secondary legislation and to recommend amendments before orders for affirmative approval are brought forward in their final form.”


It notes that

“the power to amend the proposed instrument remains with the Minister: the two Houses and their committees can only recommend changes, not make them.”

Our amendments follow this pattern and are more generally based on the variant of the procedure used in the Public Bodies Act 2011. Amendments 143 and 144 set out the details and the stages. First, the Secretary of State must lay before Parliament a draft of the proposed regulations and a document explaining them; secondly, he or she must request a committee of either House whose remit includes health, science or technology to report on the draft regulations within 30 days; and thirdly, in proposing a draft statutory instrument containing the regulations, the Secretary of State must take account of any representations, any resolution of either House and any recommendations of the committee to which the draft was referred. After the expiry of the 30-day period, the Secretary of State may lay before Parliament regulations in terms of the original or a revised draft. The Secretary of State must also state what representations, recommendations or resolutions were made in the 30-day period and give details of any such. He or she must also explain any changes made in a revised draft. After that, the normal affirmative procedure continues.

The Library records that the last insertion in a Bill of the super-affirmative procedure was by the Government themselves in October 2017 in the Financial Claims and Guidance Bill. When they are not doing it themselves, the Government traditionally put forward any of or all three routine objections to the use of super-affirmatives. The first is that it is unnecessary because the use of the affirmative procedure provides sufficient parliamentary scrutiny. Sometimes, this objection is elaborated by praying in aid extensive consultation. I remind the Minister of the DPRRC’s remarks in paragraph 45 of its report on the Bill where it says that

“we are concerned at consultation being presented as a substitute for Parliamentary scrutiny.”

It is quite obviously untrue that the affirmative procedure allows any kind of effective scrutiny.

The second routine objection is that the super-affirmative procedure is cumbersome. I take this to mean only that this procedure is more elaborate than the affirmative procedure, which is, of course, the whole point. It is necessarily more elaborate because it provides for actual scrutiny where the affirmative procedure does not. The third routine objection is that it all takes too long. This has force only if there is some imminent deadline. The Minister may argue that there is such a deadline at midnight on 31 December. At this point, the Government lose the powers conferred by Section 2(2) of the European Communities Act to modify the regimes, but does this really present a deadline? I leave aside here the issue of whether this Bill will have been passed by then, given its very slow progress and the sparse future scheduling.

The impact assessment helpfully sets out, in Annexe B, the number of times the Section 2(2) powers have been used. Between 2013 and 2019 they generated a total of 11 SIs. In each of the last four years they have generated just one SI. This is not an avalanche. Nothing in these figures shows urgency. Nothing suggests we need to rush regime changes by excluding scrutiny provisions from the Bill. Nothing suggests that using the super-affirmative procedure would cause significant delay or disadvantage.

The impact assessment notes explicitly, on page 5:

“policy development is at an early stage”.

This was in June. If policy development has made progress since then, perhaps the Minister can now tell the Committee what policy changes he intends to propose, using the delegated powers in Parts 1, 2 and 3.

If policy development has not made progress, it is vital that when it does, and sees daylight in SIs, those SIs are scrutinised as fully as possible, as the super-affirmative procedure permits. In the event that a policy or technical change is required urgently, the provisions of this Bill, with the latest Government amendment, should allow the use of the “made affirmative” procedure.

This is a skeleton Bill. It is an attempt to bypass Parliamentary scrutiny. It contains no policy details and has no special claim to urgency as a reason for limiting scrutiny. The affirmative procedure is not meaningful scrutiny, as our Constitution Committee has pointed out—but the super-affirmative procedure is. That is what these amendments propose. Parliament should not be bypassed. I beg to move.

[Lord Kakkar (CB) [V]]

My Lords, I support the noble Lord, Lord Sharkey, and everything he has said in moving Amendment 6. These are clear matters of principle, and although one must accept that government Amendment 133 is an attempt to provide concessions on them, the noble Lord has set out clearly why adoption of even the affirmative procedure will not provide sufficient scope for appropriate scrutiny of what may turn out to be exceedingly important regulations.

The argument for adoption of the super-affirmative procedure has been well made, and I shall not repeat all the noble Lord’s arguments, save to say that in moving his amendment he also dealt with all the potential arguments that could be put against what is proposed in the amendments. In those circumstances, bearing in mind the importance of the issues that the legislation will cover, and the deep anxieties already expressed in Committee about the nature of the Bill, both in practical terms and in terms of its constitutional implications, Her Majesty’s Government should seriously consider accepting these important amendments.