My Lords, I will begin by speaking to government Amendment 133 on behalf of my noble friend Lord Bethell. It provides significant changes that I know many will welcome. We have listened to the concerns raised about parliamentary scrutiny on emergency powers. I assure noble Lords that we have carefully considered their views and the different amendments that have been put forward on this topic.
As a result, government Amendment 133 would change applicable parliamentary procedure for reactive emergency regulations to the “made affirmative” procedure. It also provides that regulations about prescribing, advertising, packaging and labelling in relation to human and veterinary medicines will no longer be subject to the negative resolution procedure, but instead to the draft affirmative procedure. Using the “made affirmative” procedure when making regulations reactively in emergency situations affords the Government the required speed and flexibility to react to emergencies while providing that Parliament can scrutinise what has been done and why. When we make the regulations proactively, we must demonstrate the need to protect the public from the risk of serious harm; these regulations will be subject to the draft affirmative procedure.
It is important to acknowledge that the emergency powers are not intended to be used. However, as the noble Baroness, Lady Thornton, said, we are in a situation where we are currently using emergency powers, so she is correct that the “made affirmative” procedure has been put to good effect during the current pandemic. None the less, these powers are a measure of last resort to protect the public from the risk of serious harm to health.
We want to avoid using the powers reactively where possible. It is already a condition in the regulations that the situation must be accompanied by a declaration of the urgent need to protect against the imminent risk of serious harm to health. I note the questions asked by the noble Lord, Lord Patel, about the definition of that statement. I will write to him further on that matter.
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Coupled with the amendment that these regulations are now to be subject to the “made affirmative” procedure, I believe that we have achieved the correct balance. Other provisions in Parts 1, 2 and 3 that are not already subject to the draft affirmative procedure will now be. This means that going forward, provisions around prescribing, advertising, labelling and packaging human and veterinary medicines will be subject to the draft affirmative procedure. There are exceptions to this in relation to fees and supplementary regulations in the new devices civil sanctions regime.
Amendment 133 provides a significant lift in parliamentary scrutiny of the regulations made in relation to human and veterinary medicines in particular. Taken in conjunction with the other government amendments, the Government’s accountability to Parliament and the public in making regulatory change is very strong. Coupled with Amendment 131, Amendment 133 means that Parliament will have early sight of the Government’s thinking on future regulation, we will have public consultations to inform regulation, and will have the opportunity to scrutinise regulation under the draft or “made affirmative” procedures. This is a large package of reassurances. I therefore hope that government Amendment 133, which is tabled in the name of my noble friend Lord Bethell, satisfies the Committee that we have carefully considered the DPRRC report and taken onboard its views in considering which procedure should apply to the different regulation-making powers in the Bill.
Against that background, let me explain why I do not feel it appropriate to accept Amendments 6, 53, 71 and 98, tabled by the noble Lord, Lord Sharkey. When taken with Amendments 143 and 144, they would provide that regulations made under these powers are subject to the super-affirmative procedure, which is a novel procedure for even some members of this Committee. As the noble Lord said, that 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.
I recognise the importance of parliamentary debate; it is already provided for in government Amendments 131 and 133. Alongside any draft regulatory changes laid before Parliament we would expect to publish an impact assessment, an Explanatory Memorandum and a statement on why there are good reasons for amending secondary legislation made under Section 2(2) of the European Communities Act 1972. This would, of course, follow a period of consultation. Not only that, we would be obliged to lay a report before Parliament on regulations within a specified period and on the consultation that took place. As drafted, the amendments in the name of the noble Lord, Lord Sharkey, would apply to the regulations needed reactively in emergencies. This would evidently impose a dangerous delay in our ability to act rapidly to keep people safe.
Of course we must be cognisant of the demands that the super-affirmative procedure would place on parliamentary time. There will undoubtedly be circumstances where the 30-day minimum period and the requirement for a committee report would place a disproportionate demand on parliamentary time. For instance, a small change to the Human Medicines Regulation 2012, such as updating the list of medicines which can be administered by these professionals by removing medicines which have become obsolete, would not warrant the quantity of parliamentary time which the super-affirmative procedure would require.
Amendment 134 deals with further changes to the negative procedure and provides for reactive regulations under Clauses 6 and 15 to be subject to the “made affirmative” procedure. Amendments 135, 136 and 142 in the name of the noble Lord, Lord Sharkey, would include Clauses 6 and 15 within the change to the “made affirmative” procedure. Amendments 137 and 138 in the name of the noble Lords, Lord Pannick, Lord Patel, and the noble and learned Lord, Lord Mackay, would apply the draft affirmative procedure instead to those clauses.
We have made clear our commitment to ensuring that the regulations made under the Bill are subject to the appropriate levels of parliamentary scrutiny. I am pleased to see that we are at least partially aligned in our thinking with regard to the made affirmative procedure. It is right that in an emergency regulations can be made quickly, but, as I have explained, I believe there are still matters where it is not necessary for changes in regulations to be subject to the draft affirmative procedure.
The noble Lord, Lord Patel, has sought to make changes to Clauses 6 and 15 to apply the draft affirmative procedure to reactive emergencies as well as proactive emergency regulations. I believe that he explained that they were probing amendments. In respect of emergencies, the global risk landscape is perpetually changing, and having flexible response arrangements provides some degree of preparedness against unforeseen risk. We therefore need to be able to make changes to the regulatory regime in an emergency, both proactively and reactively.
An illustration of how our existing emergency powers can be used proactively is seen in the changes we made last week to the Human Medicines Regulations. That change, using Section 2(2) of the European Communities Act, allowed for preparations we can foresee being needed for the distribution of a Covid vaccine. It would enable a wider range of healthcare providers to deliver a vaccine. That is a change we can foresee, and it has been subject to the negative procedure as a consequence of the current primary legislative basis. In the new year, we may need to make further changes to respond to unforeseen and newly identified requirements. They may need to happen quickly, and that is also when reactive changes might be required, but the parliamentary scrutiny would be greater than that currently applied.
Unfortunately, the Government cannot plan for every possibility and lay this out in pre-emptive regulations. However, if reactive emergency regulations are needed, they must be accompanied by a declaration of why they are required. Any decision to relax a requirement would not be taken lightly and, although that may need to be implemented at pace, consideration would be given to the promotion of the health and safety of the public.
We have moved very close together in the changes the Government have made and those proposed here. I hope that that, in conjunction with the amendments about laying reports before Parliament, will enable the noble Lord to see his path open to withdraw Amendment 6, and that others will not wish to move their amendments.