Moved by Lord Sharkey
3: Clause 1, page 1, line 8, at end insert—“( ) Regulations made under subsection (1) that introduce significant new policy or significant changes to existing policy 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.”
My Lords, the amendments in this group are in my name and the names of the noble Baroness, Lady Andrews, the noble Lord, Lord Forsyth of Drumlean, and the noble and learned Lord, Lord Judge. I am grateful for their support and regret that the noble Lord, Lord Forsyth, cannot be here today. He is currently chairing a meeting of the Economic Affairs Committee.
The purpose of the amendments is to replace the use of the affirmative SI procedure in Parts 1, 2 and 3 of the Bill with the super-affirmative procedure. This is to restore an element of meaningful parliamentary scrutiny to a Bill that so conspicuously lacks it. This is a skeleton Bill. Parts 1, 2 and 3 contain no policy detail and effectively give Ministers carte blanche to decide policy. They give the Minister almost unfettered power to remake our human medicines, our veterinary medicines and our medical devices regimes.
Our DPRR Committee and the Constitution Committee were extremely critical of this approach. On Second Reading, as the noble Baroness, Lady Thornton, has reminded us, 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:
“Parliament is effectively bypassed; that is a sick joke of good law.”—[Official Report, 2/9/20; cols. 415-16.]
Parliament is bypassed largely because the affirmative SI procedure does not allow for real scrutiny. We cannot amend SIs, and the House has voted down affirmative SIs on just four occasions in the last 70 years.
The Constitution Committee was clear in its 2018 report, The Legislative Process: The Delegation of Powers, when it said:
“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.”
The affirmative SI procedure does not constitute meaningful parliamentary scrutiny.
By contrast, the super-affirmative SI procedure is designed and used to deliver a measure of real scrutiny. Erskine May, in part 4, paragraph 31.14, characterises the 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 should be noted 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.)”
In Committee, I set out at some length the details of how our super-affirmative procedure could work. In her response, the Minister helpfully summarised 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.”—[
According to the Library, the last recorded insertion in a Bill from a super-affirmative procedure was by the Government themselves, in October 2017, in what became the Financial Guidance and Claims Act. In Committee, I noted that when they are not doing it themselves, the Government traditionally object to the use of the super-affirmative on all or any of three grounds. The first is that it is unnecessary, because the affirmative procedure provides sufficient parliamentary scrutiny; the second is that it takes too long; and the third is that it is cumbersome. The Government did not depart from tradition. In Committee, they used all three objections.
The first objection, that the affirmative procedure provides sufficient scrutiny, is plainly and simply wrong, unless of course the Government regard no effective scrutiny as sufficient. The second objection, that it takes too long, is to misread its purpose. It is the case that the super-affirmative procedure takes longer, but that is because it contains provisions for real scrutiny, which necessarily takes time. This is not a negative; it is the merit of a procedure and the point of it. I should point out here that any emergency or urgent need will not trigger the super-affirmative procedure. The Bill now allows for the “made affirmative” procedure to be used in such cases.
The third objection raised by the Minister was that the super-affirmative procedure could be cumbersome and involve a disproportionate use of parliamentary time. She gave the example of the minor change to the Human Medicines Regulations 2012 to illustrate the point. This was a very helpful observation, and we are grateful for it. It would obviously be wrong to take up parliamentary time on minor changes, but, accordingly, we have revised our amendments since Committee to take account of this. The amendments now before us apply the super-affirmative procedure only to regulations that introduce what the Secretary of State considers to be either significant new policies or significant changes to existing policies. All other SIs can be dealt with as currently specified in the Bill.
This is a skeleton Bill. The noble Lord, Lord Hodgson of Astley Abbotts, chair of our Secondary Legislation Scrutiny Committee, had something to say about this type of Bill in a
“First and foremost, parliament should continue to be vigilant about the balance of power that is at the heart of our constitution. The right of the legislature (parliament) to resist any encroachment on its powers by the executive (government) is central to our democratic system. … parliament should continue to object to the use of ‘skeleton bills.’”
He proposes that the Government:
“Put the appropriate level of detail into primary legislation and avoid skeleton bills.”
It is obviously too late to do that with this Bill, which allows Ministers to take powers and make policy before they have decided what that policy is. Secondary legislation was never intended as a means of making policy. Using secondary legislation to do that, as the noble Lord, Lord Blencathra, so clearly put it, bypasses Parliament.
Our proposal restores a measure of parliamentary scrutiny where there are proposed significant new policies or significant changes to existing policies. It is activated only by significant policy changes. It amounts to meaningful scrutiny without removing the final decision from Ministers. It does not get in the way of emergencies or urgent need, but it does prevent Parliament being bypassed. This is an important test of the balance between the Executive and the legislature and an opportunity for Parliament to assert its right, and its duty, to scrutinise. Subject to the Minister’s response, I intend to test the opinion of the House. I beg to move.
My Lords, I apologise to the House; this is the first time I have spoken on this Bill and I have not been able to speak earlier in the proceedings, so I will try to be brief. I also assume that, notwithstanding the recent vote on sunset clauses, the Minister’s response during the debate indicates that the Government will not be very interested in leaving it in the legislation.
This Bill’s importance is obvious. It is hardly regulation light; to the contrary, in the modern way, it has a banquet of regulation-making powers which would, as the debate has shown, enable the Minister to extend policy and create policy by statutory instrument. For that purpose, I need simply refer to the observations of the noble Lord, Lord Patel, in the previous debate.
Time and again, the cross-party committees of the House have complained about, for example, skeleton Bills, Henry VIII powers and inappropriate delegated powers. Time and again, in Bill after Bill, the pleas—convincing, constitutional and persuasive—have been totally ignored. A cascade of regulation-making powers continues its unabated flood in every Bill that comes before the House, and this Bill is such an example.
That is not the end of it. The consequences are vividly described in the report of the Secondary Legislation Scrutiny Committee, dated
The wider use of the super-affirmative process would ensure better parliamentary scrutiny and control of the Executive, which for too long have simply ignored the constant urgings of the parliamentary committees in this House, in particular, as this Bill shows, the recently expressed concerns of the Constitution Committee and the Delegated Powers Committee. One day they will ask why they bother. They do so only in the hope that, one day, the Executive of the day will take notice.
As these pleas have been ignored and have failed, and, as is perfectly plain, as I indicated at the outset, the Minister’s reservations and distaste for consolidation and sunset clauses were absolutely manifest, this amendment will secure that, for this Bill and for this department, with these wide-ranging and important powers, the super-affirmative level of control should be exercised. The time to exercise it is now. It is time that the power is exercised more frequently.
My Lords, it is a pleasure to follow the noble and learned Lord, Lord Judge, and his magisterial assertion of parliamentary sovereignty, which I entirely agree with. I am pleased to support the amendments in the name of the noble Lord, Lord Sharkey; at the same time, I apologise to your Lordships’ House for not having been able to do so in Committee.
In his opening statement on this amendment, the noble Lord made an irresistible case in principle, as well as explaining with great clarity the process by which a super-affirmative order enables effective parliamentary scrutiny in a way that the simple affirmative procedure—however the Government argue it—cannot. In using it, the implementation of this extremely important Bill becomes a less risky and unpredictable affair.
On Second Reading, I said that the Bill was good in many ways but that, as a skeleton Bill, it created unnecessary risks. Despite the Government’s amendments and their very recent and welcome response to the DPRRC’s scathing report—I am very pleased to say I am a member of that committee—they have still not strengthened the process of parliamentary scrutiny in such a way that should satisfy either the DPRRC or this House.
It is worth reflecting that our wrath as a committee was directed as much at the casual flimsiness of the reasons offered and the false dichotomies between primary and delegated legislation that were set up as at the sheer and extraordinary sweep of the powers across the whole fields of medicine and veterinary science. “Free rein” was one of the milder terms the committee used. Failing at least to take the option of a super-affirmative procedure on these delegated powers still in effect gives the Government free rein. We would be able to challenge the statutory instruments but not change them, however strong the grounds, weighty the evidence or serious the anxieties and risks.
It is significant that, in their response to the committee published this week and in their amendments, the Government recognise that there are risks in the breadth of the powers, but to remove those risks they have merely tightened focus, improved transparency in some cases and assured us that those who use the powers will do so with great care. While any movement was welcome, the Government have refused to acknowledge what is right and proper here—as both the noble Lord, Lord Sharkey, and the noble and learned Lord, Lord Judge, have said, and as the committee made clear—which is a way to engage with and not bypass Parliament.
While under many circumstances the affirmative order is accepted as an appropriate level of scrutiny, it is most certainly not in this case, particularly when the Government choose not to accept that the powers were designated as inappropriate in the first place by the scrutiny committee. A super-affirmative order at least gives Parliament the opportunity to press for further thought, advice and amendment as initiated by the Government. As the noble Lord, Lord Sharkey, said, the amendment has been trimmed so that it deals only with significant changes. This is hardly revolutionary; it is in fact the least that one could insist on, but it is significant. It acknowledges that risks persist but can be reduced and that changes are made to prevent perverse consequences. Surely, in a Bill of this significance, that cannot be too much to ask.
The arguments that the process is too long, slow and cumbersome were dealt with by the noble Lord, Lord Sharkey, in Committee and today. They are but the most recent reiteration of the arguments we hear all the time when we put the case for primary legislation in the face of inappropriate delegation, where speed and technical detail are usually deployed frivolously. They are hardly powerful or relevant when considering the scope of these regulations.
I regret to say that, in their short career, this Government have shown in different ways that they do not welcome interrogation and fear scrutiny. A confident Government would welcome both as a way of avoiding mistakes and creating precedents which in Opposition they could not change. This is a modest opportunity to strengthen this Bill and I hope the amendments will secure the support of the House today.
My Lords, I disagree with this amendment. I had the privilege of being the Chairman of Ways and Means and Senior Deputy Speaker in the other House from 1992 to 1997—possibly, legislatively, one of the most challenging periods. I certainly found that MPs were highly creative in their interpretation of the rules of debate and in holding the Government to account.
Noble Lords have only to read Erskine May to see that we have two procedures for SIs that are normal and have been with us for decades: the negative procedure, where no amendments can be taken in your Lordships’ House; and the affirmative resolution. The affirmative resolution is not just a weak tool that puts us on the side; it is a very powerful tool if used properly by Members of Parliament and those of your Lordships’ House who take an interest in these matters. They can ensure that the Government of the day have to listen.
Frankly, I find that the super-affirmative procedure does no more, really, than involve an additional stage of scrutiny where Parliament has considered a proposal for a statutory instrument before the statutory instrument is formally presented. Today this procedure is used for statutory instruments that are considered to need a particularly high level of scrutiny. Quite frankly, we have Select Committees, in the other House in particular, dedicated to particular departments, and there is a very active Select Committee on health matters.
In addition, yes, there are some specialised categories of statutory instruments that are used for those particular purposes, and they can be considered under the super-affirmative procedure. But these statutory instruments usually amend or repeal Acts of Parliament. Examples would include legislative reform orders, localism orders, public bodies orders, regulatory reform orders and remedial orders. It is not usual to have them as part of the primary legislative process.
It is time that we as politicians understood that this country will be successful only if we get on and understand the needs of British industry. It has to have some certainty that things are going to proceed at pace, not be delayed even further because some noble Lords feel that they want to have another bite of the cherry. We already had quite enough bites, in my judgment, on this Bill as we worked through it, and it is being done very thoroughly. It has been done in Committee and is being done on Report. But we have to understand that this all adds to delay and, even worse, possible confusion in the commercial world.
I think adequate procedures are already available. All this does is stretch the thing out for very little marginal benefit. I personally will vote against this proposal with enthusiasm.
My Lords, I must say that I very much disagree with the noble Lord’s remarks. If we want certainty, we need legislation that is well grounded and which has had thorough scrutiny in Parliament. The problem with this Bill is that it essentially gives a blank cheque to Ministers to change the regulatory regime for medicines and medical devices. If this was just to deal with the aftermath of Brexit, that, of course, would be understandable. But it was made clear in Committee and at Second Reading that the Government are wedded to this way of doing legislation. As the Minister said in Committee,
“this is a modern and fast-changing industry … we may still need to preserve our ability to amend and update regulations.”—[
“This is a skeleton bill containing extensive delegated powers, covering a range of significant policy matters, with few constraints on the extent of the regulatory changes that could be made … The Government has not provided the exceptional justification required for this skeleton approach.”
As the noble and learned Lord, Lord Judge, has said, the Government have form. We are increasingly seeing the use of skeleton Bills and Henry VIII clauses. We really must come to a point where we say to the Government that we will not put up with this any longer.
I listened to the Minister in the last debate: what did he offer the House in respect of further scrutiny? It seemed to me he offered a debate or two, and that was it. The Government do not have an answer; they are refusing to budge on a principle which I believe is fundamentally wrong.
The noble Lord, Lord Naseby, talked with joy about the effectiveness of affirmative statutory instruments. This is nonsense. I think eight SIs have been defeated in your Lordships’ House in history; the last one led the Government to threaten to abolish the House of Lords. Unfortunately, the affirmative procedure is hardly any better than the negative procedure, and they do not allow this House to really exert any change on the orders going through.
We have to stand up on this matter. It is much more important and much wider than the issue of medicines regulation. I very much support the amendment moved so effectively by the noble Lord, Lord Sharkey.
My Lords, these amendments, led by my noble friend Lord Sharkey with eminent cross-party support, replace the affirmative procedure for delegated powers in the Bill with the super-affirmative procedure.
Because of the skeleton nature of the Bill, outlined in the previous group, it is key to ensure that Parliament is able to properly scrutinise regulations made under the Bill. The super-affirmative procedure, which affords a committee of either House the opportunity to comment on a draft of the regulations and make representations, is in our view the best way to do it.
The past year has made clearer than ever the need for outward-facing health policy with public health and safety at its heart. The regulations brought forward under this Bill are central to doing this, and the highest level of scrutiny is needed to ensure their success.
One of the first things I had to learn when joining the House was the sovereignty of the House. My 10 years in your Lordships’ House have taught me to spot Henry VIII powers and call them out. As the noble Baroness, Lady Andrews, said, these amendments are hardly revolutionary, so I urge the Minister to accept them.
We need well-grounded legislation, and this Bill gives the department carte blanche to do what it likes. The amendments tabled by my noble friend give Members of the House the opportunity to scrutinise in a proper way and that, after all, is what the public expect of us.
The noble Baroness, Lady Jolly, and I are not in a competition about who can speak most briefly, but we have promised the Minister that we will—I overshot my promised three minutes by a minute in an earlier speech.
I say from these Benches that we will support this amendment and we are very pleased to be doing so. I reread the debate and discussion in Grand Committee, and I was actually so impressed with my remarks that I am nearly tempted to read them out again, but I will not do so. I also have to say that the whole debate was very good and important.
As my noble friend Lord Hunt says, this is not just about this Bill; this is about how the Government intend to move forward in terms of legislation and policy and subject themselves to appropriate scrutiny. That is what this amendment is about, in our view, and that is why we will support it.
My Lords, I am afraid I will breach the convention on short speeches, but only because this has been an incredibly powerful debate. The points were made very thoughtfully, and I am grateful for the fact that they were made briefly. I want to tackle them head on and perhaps, I hope, persuade the noble Lord, Lord Sharkey, to back off from these amendments.
The noble Lord, Lord Sharkey, suggested in Committee and again during discussions in December that we would return to this issue of procedure, which he has now done through the amendments in this group. I am extremely grateful to him for the advance warning, although I have to say that our positions are at some distance.
Amendments 3, 28, 41 and 49 would apply the super-affirmative procedure to the regulation-making powers in Clauses 1, 9, 14 and 18. The noble Lord has reflected the debate in Committee, where we spoke at length about the challenges of the universal application of the super-affirmative procedure without further refinement. I am pleased that we agree that there is an issue of proportionality as regards when these powers should apply. I commend his endeavour to make his drafting meet the intended purpose and thank him very much. He has drawn a distinction between what is defined in his amendment as “significant new” policy or significant change to policy, and the rest.
However, the noble Lord has combined Amendments 3, 28, 41 and 49 with Amendments 88 to 90. These remove all use of the draft affirmative procedure from the Bill where alternative procedural arrangements are not otherwise specified in Clause 45(3).
If these amendments were applied together, this would mean that there would be no alternative other than the super-affirmative procedure for the vast majority of the exercises of the powers under the Bill. In effect, all uses of the regulation-making powers, other than in relation to the setting of fees, or civil sanctions, or when in an emergency, would be subject to the super-affirmative because no procedure is specified in the noble Lord’s amendment for regulations that do not make significant policy changes. The distinction between the “significant policy” changes as he has suggested in Amendments 3, 28, 41 and 49 is therefore lost when they are combined with the other amendments in his name.
Before I address what this would mean in relation to emergencies, I will bring us back to the practical realities of what use of the super-affirmative procedure would involve. Significant amounts of legislation have yet to be made, where we know it has to be made, right across government. Indeed, it is likely that we have a very full year ahead of us. The former business managers among us know what that means in terms of process.
The super-affirmative procedure requires an additional layer of scrutiny to the draft affirmative. Parliament is given 30 days to consider a draft statutory instrument and present recommendations and representations. A final draft of the statutory instrument can then be formally laid to start its normal draft affirmative process only after that 30-day period has ended. All that could take significantly more than 30 days, since any period when Parliament is adjourned for more than four days is not taken into account in those 30 days. I also ask your Lordships: please remember that this super-affirmative process would be in addition to the existing assurances we have already built into the Bill.
Public consultation will apply to all regulatory changes other than in emergencies. Those consultations are those in which parliamentarians can themselves make comment—or indeed, parliamentary committees, if they feel so obliged. Parliament will be provided with a report every two years. That will allow it the opportunity to express itself, however it wishes to and on matters it wishes to, in relation to how the powers have been and may in future be exercised.
Since the Bill’s introduction, the majority of the exercises of the powers in the Bill were already subject to the draft affirmative procedure. We have since made changes to make that process near-universal, with the negative procedure now applying only to regulations about fees and regulations supplementing the enforcement regime for medical devices. We have also heard the recommendations of the Delegated Powers and Regulatory Reform Committee and the Constitution Committee, and have changed the use of the negative procedure to the “made affirmative” procedure when making emergency regulatory changes urgently where there is an imminent risk of serious harm to health.
We have listened. However, the noble Lord’s changes go considerably beyond the changes I made in Committee to meet him in the middle between the need for scrutiny and the need for practical legislation-drafting.
I understand that the noble Lord wishes to draw a line between what he might call a “minor” change to regulations and a “significant” change, which he thinks would be better dealt with through a higher level of parliamentary scrutiny such as the introduction of a new stand-alone medical devices regime. However, in attempting to make changes to the legislation to cater for the instances of significant policy, he draws everything else into the same unwieldy process, and does so when we have already sought to provide for the scrutiny and opportunity to influence that he seeks, in a more flexible way. If Parliament wants to take a view on legislative changes before they are made, it can, based on the amendments on public consultation already provided for in Committee. But it is not obliged to. That is our difference of opinion: that we should not be subject to an unduly restrictive process when the critical feature that the noble Lord wishes to see built into the Bill is not the timeframe, nor the specifics of the process, but a way of ensuring that there is an opportunity for Parliament to express a view at a point in time when the policy behind any changes is in development. That is already provided for.
The noble Lord has form in asking us to define terminology. He has presented us with a specificity without definition. It is unclear who would make the determination of what a “significant” policy change would be. Nor is it clear what “significant” would mean, and to whom. Indeed, how could we or anyone arrive at an objective test? Without such clarity, uncertainty would compel the application of the super-affirmative process, and we return to the difficulty of applying bulky procedure to matters where being deft and quick is essential. There is a real risk that the most urgent of changes would be ensnared by the super-affirmative procedure without a clear and unambiguous distinction on when the higher threshold must apply.
However, setting aside definitions of “significant”, removing the draft affirmative procedure from the Bill entirely would apply the super-affirmative without distinction. Let me give one example of what that would mean. It was necessary in December to make an urgent regulation to accommodate the coronavirus and influenza vaccination rollout, as we identified issues with the regulation. I do not think noble Lords would disagree that proactive regulation of that kind is helpful to all of us when it comes to an emergency situation. But even this would be subject to the super-affirmative procedure if the noble Lord’s amendment were to be carried.
It simply does not make sense to apply such a procedure when all the other safeguards in the Bill are in place to guarantee consultation, to ensure that views are heard and to ensure that Parliament can exercise its rights to be heard as freely as any other party.
I understand the arguments about parliamentary scrutiny. However, I strongly maintain that the Bill as amended in Committee strikes the right balance between effective challenge and scrutiny of our regulations, and is workable legislation. I hope the noble Lord has now received sufficient assurances, as well as understanding the challenges inherent in his proposed approach, and I hope that he will feel able to withdraw his amendment.
I am very grateful to all those who have spoken in support of these amendments. Skeleton Bills always limit parliamentary scrutiny, and this Bill is no exception. The Minister in his more than three-minute speech has exaggerated enormously the difficulties with the reach of our proposal. I disagree, for example, with the notion that our proposal blocks the use of the “made affirmative” procedure. It is clear that the Government are wedded to the idea of taking powers to make policy before they have decided what that policy is, and that is at the heart of the matter. This inevitably means bypassing Parliament and we should resist. I would like to test the opinion of the House.
Ayes 320, Noes 236.
We now come to the group beginning with Amendment 4. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press this or anything else in this group to a Division must make that clear in the debate.