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.