First, I thank all noble Lords for their contributions. I shall deal first with the last question of the noble Baroness, Lady Hayter, and commend her for her ingenuity in bringing the subject up in this Committee. As she knows, under the EU withdrawal Act there is a provision for the Government to amend exit day by use of secondary legislation powers. There has been no decision to do that yet. We await details of the various votes that will happen next week, but we remain confident that we will be able to deliver a withdrawal agreement that the House of Commons can vote for with enthusiasm and therefore we will not need to table any references or any further secondary legislation, but if it is required, the ability is there. That is set out in the EU withdrawal Act. That is as far as I want to go with that at the moment in this forum.
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As I set out, this SI makes amendments to legislation using the consequential and correcting powers in the European Union (Withdrawal) Act 2018 to prepare the UK for withdrawal from the EU. The purpose of the instrument is to ensure that the statute book
accommodates retained EU law. The instrument will make clear how certain cross-references to EU legislation are to be read after exit day and make amendments to the interpretation legislation for Scotland and Northern Ireland to ensure that it adequately references and incorporates retained EU law.
The instrument will also repeal and revoke pieces of primary and secondary legislation that were made domestically to enable the UK to fulfil its EU obligations, but that will become redundant as a consequence of the repeal of the European Communities Act and the UK’s withdrawal from the EU.
Let me deal with a number of the questions raised. The noble Baroness, Lady Hayter, asked about the Committee of the Regions and whether this will be the only statutory instrument-making legislative amendment relating to the UK’s participation in the committee. As I have already mentioned, these regulations repeal the provision which determines who is eligible to be sent to participate on the UK’s behalf at the committee. When the UK withdraws from the EU, it will no longer be entitled to send a delegation to represent the UK at the committee. My department laid the European Institutions and Consular Protection (Amendment etc.) (EU Exit) Regulations 2018, which made amendments and revocations to address deficiencies in respect of retained direct EU legislation that relates to the functioning of institutions and bodies of the EU and the application of its rules in EU legislation. Seven of the decisions that were revoked by those regulations relate in part to the Committee of the Regions. That is because the decisions are deficient because the UK will not form a part of the institutions to which the provisions relate after exit.
Was one of those institutions the Economic and Social Committee? The noble Baroness, Lady Neville-Rolfe, asked about the Committee of the Regions and I think I have responded to her point. She also asked about how we will ensure representation and consultation on issues going forward. That is a live discussion. We are also discussing with the devolved Administrations how they can feed in to EU and UK policy-making during the implementation period because during the implementation period we will not have direct representation in any of the institutions that we have been talking about, the European Parliament or the Council, and we will have no UK Commissioner. As she is aware, in the withdrawal Act there is provision for governance arrangements. It is a joint committee that will comprise a number of committees and sub-committees. We are talking further to the EU about how that will work in practice. There are live discussions with UKRep about how it can continue to influence the legislative process in Europe because it will have to switch from being a body that directly represents us in the various fora to being one which seeks to influence by other methods. There is a great deal of policy-making work going on about how we can do that and how Parliament will continue to be consulted and represented in decisions. As I said earlier, we are discussing this further with the devolved Administrations, which are very interested in these considerations, as you would imagine.
The legacy arrangements following the end of the UK’s participation in the Committee of the Regions are being considered further by the Ministry of Housing, Communities and Local Government. I have received representations from members of the Committee of the Regions, who want some sort of ongoing body. Personally, I am not convinced of the necessity for such a thing, because we already consult plenty of other local government fora and there is no need for a separate one, but I know that the Ministry of Housing, Communities and Local Government is taking these discussions forward with existing members of the Committee of the Regions. Discussions are constructive, both with them and the various local government associations, about how the consultative rights and responsibilities that local government currently has at European level through that committee might be replicated domestically in a non-statutory way when the UK has left the EU.
The noble Baroness, Lady Hayter, also asked about the clinical trials regulation. As I am sure she remembers, we debated this at great length during the passage of the EU withdrawal Act, and it is an important issue. These regulations will not affect whether the CTR would come into force in the UK if implemented by the EU during the implementation period. The clinical trials regulation is expected to be implemented in 2020 and would therefore apply to the UK under the terms of the implementation period. We think that the clinical trials regulation is good legislation and we fully support it, but the noble Baroness will remember that one issue we had with it is access to various EU databases. Of course, access to those databases is a subject of live discussion and negotiation with the EU, which we hope to take forward when we enter the implementation period and discuss the ongoing relationship. We gave assurances at the time that we are committed to taking part in the regulations as much as possible under the negotiations. So it is not just a question of implementing the legislation, which we may do anyway if it occurs during the implementation period; it is also about ongoing participation in the various databases.
The Government have confirmed that UK law will remain aligned with parts of the EU’s CTR legislation, but within the UK’s control in all circumstances, so that researchers conducting clinical trials can plan with greater certainty. As I said, commitments were made in this House in April during the passage of the EU withdrawal Act, and have since been restated in the Government’s no-deal technical guidance issued to stakeholders in August. Any legislative requirements to deliver this commitment will be announced in the usual way.
Regardless of the outcome of the negotiations, the UK is committed to offering a competitive service for clinical trial assessment. This covers regulatory approval from the Medicines and Healthcare products Regulatory Agency, as well as services from the Health Research Authority’s Research ethics service, the National Institute for Health Research and the NHS. If UK legislation makes references to the clinical trials regulation, normal rules will apply to those references, as set out in the EU withdrawal Act and these regulations.
I deal next with the question raised by the noble and learned Lord, Lord Hope. The restriction on using the correcting power in Section 8 to amend or repeal a
devolution Act does not apply to the Government of Wales Act 1998, as this is not a protected Act. It is under Section 8, but the amendments to the Scotland Act 1998 fall within both exceptions under Section 8(7)(g). It is consequential from the repeal of Section 6 of the European Communities (Amendment) Act and the provisions within which it is being repealed, which modify another enactment. I can tell the noble Lord that we have consulted with the Scottish and Welsh Governments; we have written to Ministers about this directly and they have raised no concerns about our proposed course of action. As I said, the SI was drafted in consultation with the devolved Administrations, with particular regard to these consultation amendments. The technical consequential amendments to the Scotland Act 1998 and the Government of Wales Act 1988 were explicitly agreed with the devolved Administrations. As I said, we wrote to them; no concerns have been raised by Ministers either.