Medicines and Medical Devices Bill

Lord Sharkey Excerpts

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

[Lord O'Shaughnessy (Con)]

My Lords, I point out to noble Lords my interests as set out in the register. On Second Reading, when taking a somewhat unfashionable stance in defence of the delegated powers, I said that I was not going to die on that hill again—but, to mix my metaphors, I have been drawn, like a moth to a flame, back into this argument.

I want to make two brief points. The first has been perfectly well made already by my noble friend Lord Lansley, and is about the sheer impracticality of sunsetting legislation. Committing to an arbitrary deadline of that kind is not something that any Government could responsibly do, particularly at this time, and given the uncertainty that has already been discussed.

The second point is that many of the criticisms raised by the Delegated Powers and Regulatory Reform Committee and by the Constitution Committee have been dealt with, to some extent, by changes that the Minister, my noble friend Lord Bethell, has proposed to the affirmative procedure, which we are not discussing today. It is therefore worth recognising the progress that the Government have already made to try to meet those concerns, which were set out so well by the noble Baroness, Lady Thornton, and others, about the powers being given to the Government.

Again echoing my noble friend Lord Lansley, I would say that if we were to go down that route, the amendments tabled by the noble Lord, Lord Patel, represent the right approach, which is to commit not to a sunset clause, with all the cliff edges that that would involve, but to providing draft consolidated legislation. There is a good case in its own right for doing that, particularly in the circumstances. Like my noble friend Lord Lansley, I encourage my noble friend the Minister to look seriously at that idea.

[Lord Sharkey (LD) [V]]

My Lords, we have Amendment 139 in this group. It would require all the delegated powers in the Bill to expire on the third anniversary of its passing. We chose the three-year time limit because that had been discussed in the Commons. But, having heard what other noble Lords have said on the issue of expiry, I am persuaded that two years may be more appropriate, as the noble Baroness, Lady Thornton, has argued, given the wide-ranging and carte-blanche nature of the delegated powers. I am also persuaded that a sunset provision is absolutely necessary.

As many noble Lords noted on Second Reading, this is a skeleton Bill. It contains no, or very little, policy, and allows policy to be made by secondary legislation. This clearly avoids meaningful parliamentary scrutiny, and is a direct and flagrant abuse of the delegated powers system.

In its 16th report of the 2017-19 Session, The Legislative Process: The Delegation of Powers, our Constitution Committee noted that the Government had designated

“functions for which delegated powers may be appropriate”.

These included

“providing for the technical implementation of a policy; filling in detail that may need to be updated frequently or is otherwise subject to change; and accommodating cases where the detailed policy has to work differently in different circumstances. Such purposes constitute reasonable uses of delegated powers.”

The Constitution Committee’s view of all this was clear. It considered the use of delegated legislation to formulate policy, or to create new criminal offences or public bodies, to be “constitutionally unacceptable.”

The Delegated Powers and Regulatory Reform Committee, in its recent report on the Bill, points out that the Government say nothing about why it would not be appropriate to have aspects of the regulatory regimes which are not detailed or technical on the face of the Bill, combined with more focused delegated powers to fill in the detail. This is still the case.

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[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?

[Baroness Jolly (LD) [V]]

My Lords, this has been a useful debate on health and safety when making regs. The Government have tried to strengthen this with their amendments in this group. My noble friend Lord Sharkey just spoke about that; I too will look at them in the light of Committee and determine what to come back with on Report.

On government Amendments 2, 7 and 68, we should have these regulations only if we are absolutely satisfied that they would promote health and safety. Government amendments 51, 54 and 56 are all about the promotion of one or more of health and welfare of animals, health and safety of the public, and the environment. There is a clear connection with animals and the environment; has the Minister spoken to Defra and BEIS about these amendments?

I also wonder that we are not discussing those medical devices that are joint veterinary and medical devices. As I said at Second Reading, veterinary medicine is becoming much more sophisticated and slightly less agricultural—that is not the right way to describe it, but it is now very high-tech in certain areas. Could the Minister outline the legal situation here, as, when we are discussing medical devices, veterinary devices are not included? Clearly this should fall within the scope of the Bill but, as I see it, there are no amendments covering that.

Moving to the amendments from the noble Lord, Lord Lansley, and the noble and learned Lord, Lord Woolf, I supported Amendment 5. We have left the EU, but I see no reason why we cannot use its regulation if we think it cannot be improved on. I was happy to put my name to this amendment and agree that subjective measures are nowhere near as effective as objective ones. This is an area where objectivity is much more important than subjectivity.

The amendment elegantly reflects the objective of safeguarding the public health element in EU regulations. A Secretary of State has a duty to maximise the public health of our English population. I am sure it is not written down anywhere, but that is absolutely what he or she is responsible for doing. As such, I firmly believe that this amendment belongs in the Bill. My noble friend Lady Walmsley spoke powerfully about Amendment 5; we should really consider her arguments when we determine what we will do on Report.

My final point is on the objective of Amendment 70 to

“safeguard public health through the supply of medical devices.”

This amendment elegantly reflects the objective of safeguarding public health in EU regulations. There is much to look at in this group. I am sure that we will determine what comes back on Report later in the day.

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[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)]

I call the noble Lord, Lord Sharkey.

[Lord Sharkey (LD) [V]]

[Inaudible.]

[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)]

Could the noble Lord please unmute his microphone?

[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.

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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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Moved by

[Lord Sharkey]

6: Page 1, line 6, at end insert—
“( ) Regulations made under subsection (1) are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Member’s explanatory statement
This amendment, and the amendments to page 5 line 12, page 7 line 22 and page 9 line 27 in the name of Lord Sharkey, replace the existing affirmative procedure with a super-affirmative procedure in order to increase parliamentary scrutiny.

[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.

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[The Deputy Chairman of Committees (Lord Bates) (Con)]

Finally, I call the noble Lord, Lord Sharkey, to respond to the debate on his amendment.

[Lord Sharkey (LD) [V]]

I am grateful for the support of the noble Lord, Lord Kakkar, and the noble Baronesses, Lady Jolly and Lady Thornton, but I am disappointed that the Minister still seems to regard the affirmative procedure as constituting effective scrutiny. Let me briefly quote again the Constitution Committee, which says:

“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.”


Neither the DPRRC nor the Constitution Committee agrees with the Government’s position on this, I think largely because it is obviously wrong. I am also disappointed that the Government seem to continue to believe that extensive consultation is equivalent to or a substitute for parliamentary scrutiny—another obviously wrong position, as the DPRRC makes clear.

As to the objection that the super-affirmative procedure is too cumbersome or lengthy, neither of these objections could have any weight unless there were some urgency. As I have explained, there is not; even if there were to be, the “made affirmative” procedure would kick in and take care of it.

As I remarked in the opening group this afternoon, at the root of all this is a desire by the Government to take powers to make policy before they have decided what that policy is. This is not only perverse but evades parliamentary scrutiny and bypasses Parliament. We will return to this issue on Report. In the meantime, I beg leave to withdraw my amendment.

Amendment 6 withdrawn.