Medicines and Medical Devices Bill

Debate between Lord Judge and Lord Sharkey

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

[Lord Sharkey (LD) [V]]

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.”—[Official Report, 19/10/20; col. GC 376.]

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 4 January article in Prospect magazine:

“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.

[Lord Judge (CB) [V]]

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.

In the 30 December debate on the Bill on the trade agreement with the EU, I suggested that, now that all that was done finally, we in this House at any rate needed to focus on the sovereignty not of the Prime Minister or the Executive but of Parliament over the Executive, and proper parliamentary control over the legislative process. We are, as has been discussed, no longer bound to implement EU directives—hence, in part, this Bill. We should decide now—and if not now, when?—to brake, or at any rate better to control, the damaging, wide-ranging, regulation-making powers which now regularly come our way.

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 17 December 2020, just a few days before Christmas. It contains devastating criticisms of risks to proper scrutiny currently observed by that committee. I commend its reading to the whole House. In the first year of this Session, we had 901 statutory instruments. Of those relevant to this Bill, the number from the Department of Health alone was 126. No one in the report has suggested that the department’s work is exempt from its wide-ranging, broad criticism.

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.

Civil Liability Bill [HL]

Debate between Lord Judge and Lord Sharkey

Committee: 2nd sitting (Hansard): House of Lords
Tuesday 15th May 2018 Lords Chamber

[Lord Sharkey]

My Lords, we have Amendments 60, 64, 67, 68 and 71 in this group. They all have the same purpose. All are aimed at bringing forward the date of the first review of the PIDR and I want to thank the MDDUS for its help in drafting.

Amendments 60, 64, 67 and 68 each bring forward, in the appropriate place in the Bill, the start date for the first review of the PIDR to 30 days from commencement, which now seems rather timid in light of the proposals put forward by the noble Earl, Lord Kinnoull, and the noble Lord, Lord Faulks. However, as things stand, the Bill specifies a 90-day period from commencement within which the first review must start. The likely timing for the new rate determination to take effect is set out on page 3 of the Minister’s letter to us of 30 April. He said:

“Assuming the Bill receives Royal assent this year and that the provisions are brought into force within two months, the statutory timetable means the first review would be completed before the end of 2019”.


That is to take too long. Specifically, the 90-day period from commencement to the start of the first review is too long, so is the 180 days from the review start to its conclusion, and so is the unsatisfactory commencement provision in Clause 11(1), which allows the Secretary of State to choose any commencement date that he likes.

Our Amendment 71, which I will come to an a moment, deals with the 180-day period and the noble Earl’s later amendment in this group, Amendment 94, to which he has already spoken, deals with the commencement date issue. For the moment, I will speak only to the amendments that deal with the period within which the rate review must begin after commencement. The Bill specifies 90 days. We see no reason why it should be as long as that and our amendments reduce that period to 30 days.

The protracted timetable imposed by the Bill is unnecessary and inflicts real damage. Most noble Lords would agree that the current PIDR is causing real commercial harm. It is also causing real and irreversible financial damage to the NHS. For each month that the current rate operates, the NHS must accrue an additional £300 million against future clinical negligence claims. Those are enormous sums that would be much better spent on front-line activity in the NHS.

Amendment 71 also aims to bring forward the date of the first review. It addresses the length of the consultation period, who must be consulted and the length of the whole review period. Amendment 71 replaces paragraph 2 in new Schedule A1, inserted into the Damages Act 1996 by Clause 8(2) of the Bill. Paragraph 2 as it stands sets out the various elements of the timetable for conducting reviews of the PIDR and the timetable applies to the first and subsequent reviews. New paragraph 2 also sets out who must be consulted in the course of the reviews. It stipulates that the determination of whether to change the rate must be within the 180-day review period. That period must start no later than 90 days following commencement, which is left entirely to the discretion of the Secretary of State.

Amendment 71 replicates new paragraph 2, except that it addresses itself only to the first review and makes the following changes: it shortens the review period from 180 days to 90 days; it shortens the 90-day consultation period to 60 days; and it restricts the consultation for the first review to the Government Actuary—or his deputy if the office is vacant—and the Treasury. In other words, there is no consultation with the expert panel defined in paragraph 5 of new Schedule A1. Actually, it follows the original proposal made in the September 2017 Command Paper. Amendment 71 then goes on to restore all the existing provisions of paragraph 2 so that they no longer apply to the first review but to every subsequent review.

Our amendments in this group, together with Amendment 94 of the noble Earl, Lord Kinnoull, would significantly bring forward the review. By the Minister’s estimate, the Bill would produce the first review by the end of 2019 if all goes well. Our amendments, taken together, would produce the first rate review by mid-2019, at least six months earlier. This is what we should do and I commend these amendments to the Committee.

[Lord Judge]

My Lords, if we are to establish an expert panel for the review, and the Lord Chancellor has not yet done so, might it be a good idea for him to decide whom he wishes to invite to join it? Unless something is done about that, just finding the panel will itself add to the time taken.