My Lords, as I had four minutes to speak on Second Reading, it is inevitable that it will take me longer to speak to my amendments in Committee. I refer to Amendments 50, 67 and 115 in my name, and am grateful to the noble Lord, Lord Kakkar, for his support.
Amendment 50 requires consolidated legislation for medicines, veterinary medicines and medical devices. Together with Amendments 67 and 115, it creates the same obligation in respect of veterinary medicine and medical devices and intends to complement a later amendment calling for the powers of this Bill to be time-limited to three years. The Bill confers an extensive range of delegated powers in relation to medicines, veterinary medicines and medical devices. The Government state that they intend the Bill to be the primary legislation in this area while providing no substantive content to the law.
The powers granted in this Bill go far beyond what is necessary or prudent. The existing regulatory regime for medicines is complex and unwieldy, running to more than four pieces of primary and secondary legislation implementing several EU directives in preparing for Brexit. This complexity is mirrored in respect of medical devices as the Bill merely grants powers to create future regulation through such statutory instruments. It does not provide a clear picture of the future shape of regulations that can be scrutinised. This adds to the existing regulatory complexity.
The lack of detail in the Bill in its current form could lead to uncertainty among stakeholders as to their obligations. There is a need for clarity, for regulatory bodies, manufacturers, patients and other end-users, which makes the case for more streamlined primary legislation. The lack of detail in the current Bill, the broad delegation of powers with no indication of the substantive content of future regulation created by them provides no clear or certain path ahead for medicines and medical devices that can be scrutinised or relied on by stakeholders. For this reason, this amendment, together with similar amendments for veterinary medicines and medical devices, requires that the Government return with consolidated legislation in due course.
I refer briefly to Amendment 115, which relates to medical devices. As with medicines, the regulation relating to medical devices is complex and unwieldy. Currently, it consists of the Medical Devices Regulations 2002, which implement three different EU directives and the Medical Devices (Amendment etc) (EU Exit) Regulations) 2019, which came into force at the end of the EU exit implementation period and runs to over 200 pages of detailed amendments. The 2019 regulations were intended to ensure that the existing medical devices regulations continue to operate correctly, once we had left the EU, but they also mirror and implement key aspects of EU regulation on medical devices, Regulation (EU) 2017/745 MDR.
The regulations were due to be implemented this year, but following the European Union withdrawal agreement, they will come into effect at the end of the transition period. The MDR was also due to be implemented during the transition period. Had it done so, it would have automatically become part of UK law. However, due to the disruptions of Covid-19, the implementation date of MDR was postponed by a year. The situation is complicated further by the ambiguous operation of the 2019 regulations in light of the postponement until the end of the transition period, much like the MDR. The 2019 regulations contain clauses which set specific dates and periods of transition between the implementation of different provisions and considerations.
I hope I have made the point that there is a need to have consolidated legislation. The current Bill will simply add to the existing body of regulations without consolidating or clarifying any of these issues. This demonstrates the need to time-limit these delegated powers and ensure that consolidation primary legislation is introduced to Parliament after three years, in order to subject any policy changes to adequate scrutiny.
2.45 pm
I turn to my Amendment 141, also in this group, which I am obliged to speak to now, as I am allowed to speak only once. It is supported by the noble Lord, Lord Pannick, and the noble and learned Lord, Lord Mackay of Clashfern. I am sorry that they are unable to speak today, as they may have made more important legal points.
As touched on in previous statements, these delegated powers conferred on the Secretary of State make provisions amending or supplementing the existing law on medicines and medical devices, in effect to grant powers to amend substantive areas of public policy and law without the scrutiny afforded by primary legislation. Delegated powers may be needed to enable responsiveness through the uncertainty caused by Brexit and potentially rapid technological changes, but they should not be used indefinitely or relied on to implement matters of policy.
Previously, the power to create relevant secondary legislation in the UK derived from the European Communities Act 1972. Those delegated powers were simply to allow the implementation of law in the UK that had already been consulted on, debated and scrutinised at both EU level and by our committees. The powers in the current Bill are such that areas of policy that would previously be subject to greater scrutiny at EU level may now be amended without similar layers of scrutiny by the United Kingdom Parliament. They do not represent, as the Government have argued, an equivalent conferring of power to the legislature, seen under the previous regulatory arrangement, as I have just pointed out.
This point was highlighted by the House of Lords Select Committee on the Constitution in the delegated powers report. It recommended that while 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.
This amendment does not set out to sunset the entire Bill. While this might make some sense, a number of provisions, including those relating to consolidation
and the amendment of enforcement powers, can appropriately be scrutinised in the present. These provisions set out substantive law and do not grant further delegated powers in and of themselves and as such are the proper subject of parliamentary scrutiny now.
If, as was agreed earlier, the Government return with streamlined and consolidated legislation for medicines and medical devices, those provisions might be subsumed within such legislation anyway. This amendment instead sets out a sunset clause on Clauses 1, 8 and 12, which grant the broad delegated powers and essentially serve to circumvent proper parliamentary scrutiny.
The noble Lord, Lord Pannick, wants me to say that, had he been here, he would go back to the report of the Constitution Committee of 29 July. At paragraph 9 the report concluded:
“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 using these powers. Government has not provided any justification required for this skeleton approach”.
Concerns about the Government’s use of skeleton Bills, including this Bill, were expressed in a long letter to the Cabinet Secretary from the chairs of the House of Lords Secondary Legislation Scrutiny Committee, the Constitution Committee and the Delegated Powers and Regulatory Reform Committee. They have found the Government’s use of skeleton Bills containing broad delegated powers to be inappropriate.
The Government’s amendments, referred to in a letter dated 13 October from the Minister, do not in my view address the substance of the concerns. It is all very well to alter the safeguards that apply to the making of delegated legislation, moving away from the negative resolution procedure, defining the purpose of regulations, requiring consultations and imposing a reporting requirement, as the Minister set out in his letter, but none of this addresses a fundamental concern, which is that Ministers should not have the discretion to decide on primary policy choices. That should be a matter for full parliamentary debate. Regulations that might be debated for 90 minutes, where there is no power to amend, are a totally inadequate substitute. The powers granted in this Bill will be a gross act of legislative and executive overreach, hence the need for a time limit on certain parts of the Bill through a sunset clause.