My Lords, I support the amendments in the name of the noble Baroness, Lady Thornton. As she said, they should be read in conjunction with my Amendments 26, 39 and 63 on the need for consolidating legislation, which I will come to in a minute.
As has previously been debated, the Bill confers an extensive range of delegated powers relating to medicines, veterinary medicines and medical devices. Previously, the power to create relevant secondary legislation in the UK was derived from the European Communities Act 1972. Those delegated powers were simply to allow the implementation of laws in the UK that have already been consulted on, debated and scrutinised at EU level and by our own EU committees in the Lords.
The powers in the Bill are such that areas of policy that previously would have been subject to greater scrutiny at EU level may now be amended without similar levels of scrutiny in the United Kingdom. They do not, as such, represent an equivalent conferral of power to the legislature seen under the previous regulatory arrangements.
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As has been mentioned, the House of Lords Constitution Committee recommended that, although delegated powers are appropriate to make provision for minor and technical matters, it is essential that primary legislation is used to legislate for policy and other major objectives. The risk of delegated powers that provide significant flexibility is that substantial policies are amended, and not merely implemented, by secondary legislation. That was also emphasised in the report of the Delegated Powers and Regulatory Reform Committee, which concluded that the Bill represents an unjustified delegation of power. I admit that the Government state that the Bill is intended to be primary legislation and they have brought in amendments to improve it, but, although amendments in Committee increased the scrutiny that these powers will be subject to, they still cover wide areas of policy that should properly be the subject of primary legislation.
As the Bill stands, the delegated powers conferred would allow the Government to make substantial policy changes in these areas through secondary legislation
as a matter of course into the indefinite future. These powers conferred by the Bill go far beyond what is either necessary or prudent, and for that reason there should be a time limit on them. Therefore, I support this amendment.
Before speaking to my own amendments, I thank the noble and learned Lord, Lord Mackay of Clashfern, the noble Baronesses, Lady Thornton and Lady Jolly, and the noble Lord, Lord Kakkar, for putting their names to them. My amendments would require draft consolidated legislation for human medicines, veterinary medicines and medical devices. Together, the new clauses that I propose and the other, related amendments would require the Secretary of State to publish draft consolidated legislation within three years. I realise that that is a tall order, and there might be some discussion about the period required to streamline the existing regulatory framework.
As I said, these amendments are linked to the one moved by the noble Baroness, Lady Thornton, providing for the three-year sunset provision. They would create an obligation to draft primary consolidating legislation in respect of human medicines, veterinary medicines and medical devices and are intended to be read together. The need for clauses requiring consolidated legislation is inextricably tied to the time-limiting of powers conferred by the Bill, as primary legislation will still be needed to form the basis of the regulatory regimes in these areas.
Of equal concern is that the existing regulatory regimes for medicines and medical devices are complex and unwieldy, spanning multiple pieces of primary and secondary legislation that implement several EU directives. This existing complexity has only been added to by several more pieces of secondary legislation in these areas, implemented in preparation for Brexit.
In Committee, I tabulated at length—it ran to a couple of pages—the different regulations that have been brought in, since the early days, because of the directives and regulations. For example, currently the regulatory regime for medical devices consists of the Medical Devices Regulations 2002, which implemented three different EU directives, and the Medical Devices (Amendment etc.) (Exit) Regulations 2019. The 2019 regulations were intended to ensure that the existing Medical Devices Regulations continued to operate correctly once we left the EU, but then other regulations were added to it. Those are examples of how many different regulations there are and, therefore, of the need for consolidation.
In addition to those uncertainties, in the final months of 2020 several new statutory instruments were laid before Parliament setting out complex new systems of regulation for medicines and medical devices as between Northern Ireland and the rest of the UK. The situation with Northern Ireland greatly adds to the complexity of regulation and has implications that we are only just beginning to understand. This matter should be of prime consideration. Once the shape of relations with the EU becomes more apparent, clarifying this complex relationship will become a priority for stakeholders and patients alike.
As it stands, the Bill merely grants powers to create future regulations through statutory instruments, simply adding to the existing regulatory complexity.
Not consolidating or clarifying any of these issues could lead to further uncertainty among stakeholders about their obligations. This demonstrates the need both to time-limit these delegated powers and to ensure that consolidating primary legislation is introduced to Parliament after three years—although, as I said, I recognise that it might take longer—in order to subject any policy changes to adequate scrutiny.
The lack of detail in the Bill and the broad delegation of powers, with no indication of the substantial content of future regulations created by them, provide no clear or certain path ahead for regulations covering medicines and medical devices to be either scrutinised or relied on by stakeholders. For those reasons, these amendments and those linked to the amendment moved by the noble Baroness, Lady Thornton, will limit the extent of these broad delegated powers and require the Government to return with consolidated legislation in respect of human medicines.