European Union (Withdrawal) Bill

Lord Warner Excerpts

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

[Lord Kakkar (CB)]

My Lords, I support the noble Lord, Lord Patel, on his amendment. As we have heard, the proposed revision to the clinical trials directive, the agreed clinical trials regulation, is vital. Despite many positive aspects of the directive, which was applied in the United Kingdom in 2004, it is regrettable that our contribution to clinical trials globally in the period from 2000 to 2010 diminished from 6% of all patients who went into clinical trials in 2000 to just 1.4% in 2010. That was why clinical researchers from not only the United Kingdom but throughout the European Union came together to undertake a thorough revision which resulted in the 2014 clinical trials regulation.

The regulation is quite complicated. It has two attendant regulations: one, 2017/556, deals with the regimen that will be applied to inspection of clinical trials in the European Union after the regulation comes into force; the other, 2017/1569, deals with the manufacturing standards that need to be applied to interventional products that are being assessed in clinical trials. Those two regulations also need to be considered along with the 2014 regulation.

The real concern, from looking at information available about the regulation, is that for non-member states of the European Union, there is an obligation to continue to apply the 2004 clinical trials directive, also recognising elements of the new regulations once they come into force across the European Union. How do Her Majesty’s Government intend to deal with the broader issue? The amendment is designed to ensure that once the regulation is fully adopted across the European Union in late 2019, so it will be applied in the United Kingdom. There are other considerations about being a non-member of the European Union with regard to what is stated about the standards that need to be applied to clinical trials. What approach do Her Majesty’s Government propose to take there?

It seems counterintuitive that, as things stand, if no action is taken, our country will be left with a clinical trials directive that was considered throughout the European Union to be in need of revision. That revision has been undertaken in such a way that it will make the performance of clinical trials more effective, efficient and responsive to the different nature of trials being undertaken and provide an appropriate level of bureaucratic intervention for individual trials to ensure the protection of patients. It would seem completely wrong, having led the revision of the clinical trials regulation, for our country to be left behind with a directive on its statute book that continued to make clinical research more difficult.

These are vital matters, because often when designing a clinical trial there is a long lag period. One takes one or two years beforehand to develop a protocol, identify participating sites and determine what regulatory framework the trial is to be conducted under. Therefore, early reassurance in these matters is critical. A failure to provide that early reassurance may lead for some years to a diminution of the contribution that our country can make to clinical research. As we have heard, that would be detrimental to our entire life sciences industry.

[Lord Warner (CB)]

My Lords, as a former pharmaceutical and life sciences Minister, I rise to support the modest amendment moved by the noble Lord, Lord Patel. I have done my time in the salt mines of trying to streamline the processes for undertaking clinical trials in this country. Despite what the noble Viscount, Lord Ridley, said, it was not just the 2004 directive that caused problems for clinical trials in this country; it was sometimes the sheer bureaucracy of securing agreement to undertaking them, which has contributed to the departure of clinical trials and sometimes investment by big pharma in this country. It is all very convenient at present in some quarters to lay the blame at the door of the EU, but there are historical facts that support a more balanced view of the 2004 clinical trials directive.

From my experience, I know how critical it is for securing a flourishing pharmaceutical and life sciences industry in the UK, and the investment and jobs that that brings. For a decade or so, we have struggled to maintain the level of clinical trials undertaken in this country, and the pharmaceutical industry’s investment in the UK has been dropping. A number of people have made that point time and again in this House in debates with the Government on this issue. The new EU clinical trials regulation will have an incredible impact on the system for conducting clinical trials across Europe with its new single data portal. That point has been made very clearly by the noble Lords, Lord Patel and Lord Kakkar. We have to be a part of this future development if we are to protect our position on clinical trials and life sciences inward investment. That is why it is so important to have an amendment of this kind in the Bill.

I do not think it is fair to say that the Prime Minister’s speech of a fortnight ago is sufficient guarantee that everything will be all right on the night. We have had a number of those speeches on a number of subjects, which tend to show that it will not necessarily be all right on the night. The show may go on but UK participation in the show may be sadly absent in some areas that are critical to this country, as this particular sector of industry is. That is why we have to look a little more carefully at what sort of guarantees we want and that the spirit and meaning of the noble Lord’s amendment is guaranteed in the future.

I do not think we can just rest on ministerial assurances. It has been a convention in this House—I have been in it for nearly 20 years—that we accept ministerial assurances. However, on Brexit, ministerial assurances, while well-intentioned, are not always good enough to ensure that British interests will be guaranteed after we have left the European Union. That is why we need more than simply ministerial assurances. I would like to hear the Minister’s explanations of what the Government’s policies are and what they will do. I for one want to see an amendment of this kind to the Bill before it leaves this House. This issue is too important for a major sector of our economy. It is one of life’s great ironies that we, who have been a moving force in improving clinical trials with proposals for such trials in the EU could, by one of the strange fates of history, be unable to benefit from those improvements if we are not very careful. I hope the Minister will give us an explanation, but it will need just a bit more than warm words to give us guarantees on this issue before the Bill leaves this House.

[Baroness McIntosh of Pickering (Con)]

My Lords, I am not an expert in clinical trials but there are remarkable similarities between the discussion on this Amendment 84, moved by the noble Lord, Lord Patel, and words expressed by the noble Lord, Lord Kakkar, at Second Reading on that group of directives and regulations that will have been adopted but not implemented at the time of Brexit. We had a full discussion, which I will not repeat at this time, but which was spoken to very eloquently by the noble Lords, Lord Wigley, Lord Judd, Lord Liddle, and, I think, the noble Baroness, Lady Young of Old Scone. The noble Lord, Lord Wigley, mentioned 23 directives identified by the House of Commons Library that fall potentially into this category. This is too important an area for us to risk being out of kilter, whether in clinical trials, the circular economy—as identified by the noble Baroness, Lady Young—or a number of environmental directives, to which I referred. This is too important an area—where Britain has been at the forefront of and party to all discussions at earlier stages—for us no longer to be aligned at the point of Brexit.

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[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.

[Lord Warner]

Can I ask for clarification on the subject which we discuss fairly frequently in this House: the jurisdiction of the European Court of Justice? Is it the Minister’s understanding that any disputes under this new regulation, when it is in operation, would be settled under that jurisdiction whether or not the UK was in the EU? Would she therefore accept that there is a risk that we might not always be able to benefit from the advantages in this set of regulations?

[Baroness Goldie]

I thank the noble Lord for his intervention. This is an area where a dispute resolution procedure will have to be agreed, and that is currently part of the negotiations.

I will continue with the point I was making; there were many frankly authoritative contributions to this debate. I cannot pre-empt the negotiations, nor can I disadvantage the UK’s position in these negotiations by giving premature guarantees at this time.

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[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—

[Lord Warner]

My Lords—

[Baroness Goldie]

With all respect to the noble Lord, Lord Warner, I will come back to him but I am trying to deal with a point that has been raised. I think that two issues are getting conflated. My noble and learned friend Lord Mackay raised an interesting point about alignment of our law post Brexit. As I have just been trying to explain, to that extent matters lie in our own hands, and obviously any Government would legislate in the best interests of the UK. However, my noble friend’s question also embraces matters which, under the new clinical trials regulation, will reach into the EU. They will concern EU agencies and regimes, and these will be capable of being embraced by the UK only if we can negotiate that.

[Lord Warner]

I think the noble Baroness might want to have a conversation with the noble Lord sitting on her left. As a former pharmaceuticals and life sciences Minister, I know only too well that the pharmaceutical industry, including the biotech industry, makes decisions on planning its clinical trials quite a long way ahead. It would be a pretty strange company that, knowing there were going to be a new set of rules for 27 countries in the EU, which it would be of much greater benefit to participate in, entered into clinical trials with the one country that was not in that set of arrangements and which was using the 2004 clinical trials directive. Can the Minister explain how she expects big pharma and biotech companies to make sensible investment decisions on the basis of the sorts of assurances she has given the House in this debate?

[Baroness Goldie]

I think these businesses understand the very real and practical challenges that confront the Government in the unprecedented complexity of a process to leave the EU: that is, when we leave, we will not be part of the body of EU member states nor its regimes, agencies and institutions. However, there is no reason to imagine that in the UK post Brexit we will not continue to be at the forefront of the life sciences or that we will not have the most excellent regime of clinical trials regulatory structures. These will fall within our control.

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[Lord Warner]

My Lords, I have added my name to the amendments and agree entirely with what the noble Lord, Lord Stevenson, said. I do not intend to traverse the same ground as him and may not be quite as helpful to the Prime Minister as he has been.

I want to add a dimension on data protection from the perspective of someone who has been a Minister and a senior civil servant. It is very easy for even the most well-intentioned Minister to overlook the importance of data protection and privacy to some of our fellow citizens when we are trying to push through what is seen as a measure of great collective benefit. We have seen how easy it is for free-speech arguments to trump individual privacy considerations. In the rush to secure medical advances through research, it is easy to see people who are nervous of giving their medical history to a researcher they do not know as Luddites to be overruled. That is why the Data Protection Act 1998 was a landmark Act. It calls on bureaucracies to stop and think and to become more thoughtful about citizens’ rights to privacy and individual data protection. Since that Act, case law has extended those protections in many cases. We do not want any backsliding, and there are plenty of powerful interests who would backslide if these legal protections were diminished. It is for similar reasons that the successor to the 1998 Act needs to be fully protected following our departure from the EU, and that protection needs to be set out clearly in this Bill. This is even more the case given that the Government have set their face against protecting the transfer into UK law of the Charter of Fundamental Rights, which contains privacy provisions.

As I said on an earlier amendment on clinical trials, we need overtly to protect existing rights and provisions important to our fellow citizens from casual vandalism later. That means being sceptical about assurances from Ministers, even the Prime Minister, in relation to this Bill and relying on future actions to preserve safeguards. We have to put more guarantees in the Bill before it leaves this House, as I said on Amendment 84. I want before I sit down to draw the attention of those who were not present for the debate on that earlier amendment to two important points made respectively by the noble and learned Lords, Lord Judge and Lord Mackay. My noble and learned friend Lord Judge, as I understood him, ventured the view that the new EU regulations of concern under Amendment 84 could be added to Clause 7(7). That seems to give support to this amendment. If we went down that route, we would be doing exactly the same for data protection issues as for clinical trials. That suggests that there is scope in the Bill for specific EU regulations to be given particular protection where it is considered of such importance to the rights and safeguards of citizens.

Similarly, on the same amendment—I would need to read Hansard to check that I understood it correctly—the noble and learned Lord, Lord Mackay of Clashfern, made a contribution that was extremely helpful to the Minister, who, if I may put it delicately, was in a little trouble over that amendment. He suggested that, where there were new provisions and some ambiguity about whether the full protections would be safeguarded, it would be open to this House and the Government to consider putting a list of regulations requiring special protection in some form in this Bill.

If that course of action commended itself to the Government before Report, I would respectfully suggest that data protection should be on that list as something that will be given particular protection. I think there is a very strong case, as the noble Lord, Lord Stevenson, has argued very convincingly, to give some special protections in the Bill to data protection. Regardless of whether this amendment is precisely the right wording, or whether there is another way of doing it, I think that the noble Lord has made the case, just as I think that we made the case earlier this afternoon on clinical trials regulations. I think the Government need to think, in the way that the noble and learned Lord, Lord Mackay of Clashfern, was saying, about the kinds of issues that merit that kind of protection if we are to safeguard well-earned citizens’ rights and protections that have built up over time.

[Lord Clement-Jones (LD)]

My Lords, it is a pleasure to follow the noble Lord, Lord Warner, and speak to Amendment 88 and the other amendments in this group. I very much support the words and the very comprehensive introduction that was given by the noble Lord, Lord Stevenson. It is vital to many key sectors—manufacturing, retail, health, information technology and financial services in particular—that the free flow of data between ourselves and the EU continues post Brexit with minimum disruption. With an increasingly digital economy, this is critical for international trade. TechUK, TheCityUK, the ABI, our own European Affairs Sub-Committee and the UK Information Commissioner herself have all persuasively argued that we need to ensure that our data protection legislation is treated as adequate for the purpose of permitting cross-border data flow into and out of the EU, post Brexit.

Fears were expressed in Committee and eventually the Data Protection Bill was amended on Report and at Third Reading to show that some principles, at least, were incorporated in the Bill, despite the fact that the European Charter of Fundamental Rights will not become part of UK law as part of the replication process in this Bill. The noble Lord, Lord Stevenson, quoted the Prime Minister’s recent Mansion House speech, a speech that I am sure will be quoted many times, when she said that,

“we will need an arrangement for data protection. I made this point in Munich in relation to our security relationship. But the free flow of data is also critical for both sides in any modern trading relationship too. The UK has exceptionally high standards of data protection. And we want to secure an agreement with the EU that provides the stability and confidence for EU and UK business and individuals to achieve our aims in maintaining and developing the UK’s strong trading and economic links with the EU. That is why”—

this is exactly what the noble Lord, Lord Stevenson, said—

“we will be seeking more than just an adequacy arrangement and want to see an appropriate ongoing role for the UK’s Information Commissioner’s Office”.

Whether or not something more than adequacy will be available—the noble Lord, Lord Stevenson, also dealt with this—depends on the EU, which states quite clearly, in paragraph 11 of its recent draft negotiating guidelines:

“In the light of the importance of data flows in several components of the future relationships, personal data protection should be governed by Union rules on adequacy with a view to ensuring a level of protection essentially equivalent to that of the Union”.


I have slightly more extensively quoted paragraph 11 of the recent guidelines, but the difference between those two statements is notable. Both the statements recognise the fact, as many of us emphasised in this House during the passage of the Data Protection Bill, that the alignment of our data protection with the EU is an intensely important issue. There will be a spotlight on the question of whether we meet an adequacy assessment by the European Commission, which I think we all agree is necessary and essential.

As I said on Report and at Third Reading of the Data Protection Bill, the Government added a new clause designed to meet the adequacy test in future, yet this Bill also gives Ministers power to make secondary legislation to amend any retained EU law, which would include laws governing data protection rights. So the Government could give with one hand and take away with the other. This amendment, as the noble Lord, Lord Stevenson, emphasised, is exactly designed to avoid a situation where our data protection law does not meet the adequacy test, to the great disadvantage of our digital economy and other sectors. Set against this danger, it cannot be necessary or desirable to exercise any of the powers in Clauses 7, 8 and 9 to repeal any part of our data protection legislation, which we have so carefully crafted and adopted. These are probing amendments but I certainly hope the Minister can give us the necessary assurance to make sure that such amendments do not reappear on Report.

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[Baroness Goldie]

I say to the noble Lord that a phrase I used last week was that we need the powers to be broad enough to be useful and to let us cope with what will arise, but not so narrow as to restrict us in doing what we have to do. The difficulty is trying to quantify exactly what may require adjustment and tweaking once we leave; that is a genuinely challenging logistical problem.

[Lord Warner]

Could the Minister say something about the points I made in drawing on the debate we had earlier today on Amendment 84? Will the Government consider the rather thoughtful interventions of the noble and learned Lords, Lord Judge and Lord Mackay of Clashfern, about issues similar to the issue of data protection which might be given special protection in the Bill?

[Baroness Goldie]

I say to the noble Lord that I am still recovering from the debate on Amendment 84. I listened very carefully to it, as I know my colleagues did—my noble friends Lord O’Shaughnessy and Lord Callanan, the Minister on the Bill—and as did the officials. We will certainly look at the suggestion that my noble and learned friend Lord Mackay made.