European Union (Withdrawal) Bill

Baroness Ludford Excerpts

Committee: 6th sitting (Hansard): House of Lords
Monday 12th March 2018 Lords Chamber

[Baroness Thornton]

I absolutely agree with the noble Baroness. In fact, several noble Lords who are much more expert on this have already mentioned that aspect. The noble Baroness is absolutely right. I do not think I need to say anything more. I think this amendment is the remedy. I hope that the Government will respond positively to it. The case is unanswerable.

[Baroness Ludford (LD)]

My Lords, when she replies, will the Minister comment on the remarks of her noble and learned friend Lord Keen of Elie on 28 February, when we discussed this issue in the context of directives whose implementation date was beyond exit day? The noble and learned Lord addressed this issue, partly because the noble Baroness, Lady Hayter, mentioned regulations. In his reply, he said something rather interesting: namely:

“There are examples of regulations … where we accept that the regulation has come into domestic law but its actual operation is deferred, perhaps until 2020”.


I think that date was given just as an example. The noble and learned Lord continued:

“That regulation … will form part of our domestic law at the exit date, even though the operative provisions come into force only after the exit date”.—[Official Report, 28/2/18; col. 690.]


Will the Minister clarify whether she believes that the clinical trials regulation falls into the category envisaged by the noble and learned Lord, Lord Keen of Elie? If not, why not?

[Baroness Goldie (Con)]

My Lords, I am very grateful to the noble Lord, Lord Patel, for raising this extremely important issue, and to all your Lordships who have contributed so authoritatively to the discussion on this amendment. It provides me with the opportunity to set out the Government’s position on the regulation of clinical trials and the introduction of the new EU clinical trials regulation.

As I am sure the noble Lord is aware, the MHRA is working towards the implementation of the new clinical trials regulation. The new regulation, agreed in 2014, is a major step forward as it will enable a streamlined application process, harmonised assessment procedure, single portal for all EU clinical trials and simplified reporting procedures, including for multi-member state trials. This has been widely welcomed by the industry.

A key priority for the Government throughout the negotiations is to ensure that the UK remains one of the best places in the world for science and innovation. Noble Lords will be aware that the life sciences sector in the UK is world-leading, a point emphasised by my noble friend Lord Ridley. It generates turnover of over £63.5 billion per annum and the UK ranks top in major European economies for life sciences foreign direct investment. There are over 5,000 life sciences companies in the UK, with nearly 235,000 employees, and the Government are determined to build on this success as we leave the EU.

But it is not just UK industry that benefits from a thriving life sciences sector. More importantly, UK patients benefit from having access to the most innovative and cost-effective treatment available. That is why the Secretary of State for Health and Social Care committed to a post-exit regulatory system underpinned by three key principles: first, patients would not be disadvantaged; secondly, innovators should be able to get their products to market in the UK as quickly and simply as possible; and, thirdly, the UK should continue to play a leading role in promoting public health.

The UK has a strong history of collaborating with European partners through EU, pan-European and other multilateral and bilateral initiatives. I entirely agree with your Lordships that it is in the interest of patients and the life sciences industry across Europe for the UK and the EU to find a way to continue co-operation in the field of clinical trials, and for continued sharing of data and information, even if our precise relationship with the EU will by necessity change.

As the Prime Minister outlined in her Mansion House speech on 2 March, the UK is keen to explore with the EU the terms on which the UK could remain part of EU agencies such as the European Medicines Agency. Membership of the European Medicines Agency would mean investment in new, innovative medicines continuing in the UK, and it would mean these medicines getting to patients faster as firms prioritise larger markets when they start the lengthy process of seeking authorisations. But it would also be good for the EU, because the UK regulator assesses more new medicines than any other member state. These matters are all key components of the negotiations.

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[Baroness Goldie]

I thank my noble friend for his intervention. I was about to say that the existing UK legislation based on the current clinical trials directive will be corrected using the powers in this Bill so that that regime continues to function properly when the UK is no longer a member of the EU. This will mean that there is no interruption in UK clinical trials approval. Perhaps I may deal with the point raised by the noble Lord, Lord Kakkar.

[Baroness Ludford]

I thank the Minister for letting me ask her a question. First, how will that operate if we continue to apply the directive and the other member states apply the updated regulation? There is a rather peculiar situation in justice and home affairs where that is envisaged, although I have never been sure how it is supposed to operate. Perhaps she can tell us how it will operate for clinical trials and how we will avoid a bumpy playing field. Secondly, can she explain what the noble and learned Lord, Lord Keen of Elie, meant? What category of regulations was he talking about if he was not talking about the clinical trials regulation?

[Baroness Goldie]

Taking the last point first, I will need to check that out in Hansard because I do not recall in detail the point to which the noble Baroness is referring. I say to my noble friend Lord Forsyth that the practical difficulty we have is that we have something that we all agree is very good but is not yet functioning EU law. Of course, this Bill is concerned with a snapshot—making sure that we do not go down a large legislative hole with gaps in our body of law. The Bill means that we have to bring over what is there at the point that we leave. One consequence of being in charge of our own legislative functions after Brexit is that we are free to make such changes as we wish. Perhaps I may try to deal with the point—

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[Lord Wallace of Saltaire (LD)]

My Lords, perhaps I may make what I hope is a helpful suggestion. This is not a unique regulation. There is a class of regulations and directives, some of which have now been agreed but not implemented and others that, as the noble Lord, Lord Wigley, and others have observed, are currently moving through the policy-making process and may or may not have been agreed by March 2019. The Government must have a list of all of these and must have a clear idea of which ones they think we automatically ought to accept, others that we would prefer not to accept and those about which they are not entirely decided. Since we are all concerned about giving business as much certainty as far ahead as possible, will the Government commit to publishing that list so that we can see where we are and come back on a more informed basis to discuss which of these directives and regulations that have been passed but not yet implemented automatically ought to go into British law and which of those going through are or are not thought to be in the national interest?

[Baroness Ludford]

Perhaps I may draw the noble Baroness’s attention to Clause 3(3)(a):

“For the purposes of this Act, any direct EU legislation is operative immediately before exit day if—


(a) in the case of anything which comes into force at a particular time”.

The regulation came into force in June 2014, 20 days after its publication in the Official Journal and is stated to apply from a later date—that is, 2020 when the EMA certifies that the portal and the database are ready,

“it is in force and applies immediately before exit day”.

This regulation is not only in force, but it applies before exit day according to the Government’s own proposed legislation. Have I misread Clause 3(3)(a)?

[Baroness Goldie]

I am looking at the provision and my understanding is that technically, the character of the regulation that we are discussing is that it is not currently in force.

[Baroness Ludford]

Forgive me, but according to Article 90-something of the regulation, it came into force 20 days after it was published in the Official Journal. That was in May 2014. Therefore, it was in force some time in June. It applies from a date to be specified once the EMA has done its homework.

[Baroness Goldie]

I am certainly interested in the point that the noble Baroness raises. I suspect that we have probably exhausted all possible aspects of this discussion, but I undertake to look at that point. As I said, I do not have technical information available, but I will certainly have that point clarified.