European Union (Withdrawal) Bill

Lord Kakkar Excerpts

Committee: 2nd sitting (Hansard): House of Lords
Monday 26th February 2018 Lords Chamber

[Lord Patten of Barnes]

Can I clarify for my noble friend the position of countries from outside the European Union sharing in the European Research Area? I am sure he is aware that while some of them participate—I mentioned Switzerland and Israel– they play no part whatever in managing the programmes. They do not determine the priorities or what the money will go on. We could negotiate membership of the research council, I guess, although it would be with the financial consequences that the noble Lord, Lord Hannay, mentioned and the additional consequence that we would have no say in managing the programmes.

[Lord Kakkar (CB)]

My Lords, it is a great pleasure to follow the noble Lord, Lord Patten of Barnes, and in so doing I remind noble Lords of my declared interests at Second Reading.

This has been an important debate because it has highlighted the vital contribution that European Research Council funding, in the Horizon 2020 programme and others, has made to our national research effort—both the research effort delivered by our universities and, more broadly, the research undertaken through industrial and SME participation in such research programmes. It has also identified the invaluable contribution we have made as a nation to the delivery of those programmes by the European Union. The leadership provided by UK institutions has ensured strong delivery by those programmes and the global impact of that research effort.

In that regard, it is vital that Her Majesty’s Government are able to identify a way forward for our continued contribution to the development of the programmes that follow Horizon 2020. That is a matter of negotiation currently and the discussion takes place at a sensitive time, with Horizon 2020 coming to the end of its life and a new framework programme 9 being established. It would be useful for Her Majesty’s Government to identify how they are currently participating in that negotiation. How are they trying to influence that agenda while they define their final position on our future participation as a nation?

For instance, coming together at this moment is UK Research and Innovation, which will bring together our research councils and our national innovation structure. What role will UKRI potentially play in focusing our national research contribution with regard to those ongoing negotiations? Can Her Majesty’s Government confirm that they will not only secure funding for our research base beyond departure from the European Union but ensure that that funding can be directed towards continuing collaboration in European networks? It is the network participation, as much as the quantum of funding available, that has provided the strong base for our research effort and the high-quality outputs that we now enjoy.

There is very deep anxiety about this question because if we are unable to make an appropriate contribution to framing future programmes and ensuring the priorities that those programmes will address, then whether or not we participate in future the value of our own national contribution and the ability of our nation to benefit from that participation will be diminished. That is a question beyond the final disposition of our participation in those programmes, which is of course a matter of broader withdrawal negotiations.

European Union (Withdrawal) Bill

Lord Kakkar 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.

--- Later in debate ---

[Baroness Goldie]

The problem is that the Bill is intended to transfer a body of law from A to B. At the moment, this regulation is incomplete: it has not been enacted and it is not currently in the body of EU law. That is why there is a risk that it will not be covered under this Bill.

[Lord Kakkar]

I wonder whether the noble Baroness will take this slightly different point. If, as is argued, the clinical trials regulation will not form part of the applied European law at the time of exit, clinical trials will still have to be conducted under some form of law in our country, and that will be the 2004 directive that currently applies. If that goes forward, what ultimately will happen is that everything we know that is wrong with that directive, and which has been corrected by the new regulations, will apply in our own country. Even if we continue to be active participants in clinical research, we will be so under the less satisfactory situation of the current 2004 directive unless the Government decide to modify that directive. As there must be a legal basis for undertaking clinical research, does it not seem logical simply to apply what we have already agreed is a sensible approach rather than having to reinvent a new basis for legal provision to undertake clinical trials in our country?

[Baroness Goldie]

I partly agree with what the noble Lord is saying because if this regulation has not become law before we leave, we can use Clause 7 of the Bill to attend to deficiencies, amend or correct, and that is what we will do to keep our own regime of law up to date. However, at this point it is impossible for the Government to go further than that and embrace matters which are potentially directly enactable under this new regulation and involve the EU, which implies that you have to be a member of the EU and a part of the agency. We have a strong desire to see that kind of partnership continue, but it can only continue if it is successfully negotiated.

[Lord Kakkar]

Does not the Minister consider there to be a substantial risk? As I understand it, non-member states of the European Union are obliged to be fully compliant with the 2004 clinical trials directive. If we become non-members of the European Union and do not have an agreement in this area prior to leaving, will we not be forced to continue under the 2004 directive if we wish to participate in the data and information generated from clinical research being applicable more broadly for those who wish to take their arguments for adoption of those findings, and authorisation of new medicinal products as a result of those findings, in the European Union?

[Baroness Goldie]

My noble friend Lord O’Shaughnessy, who is advising me, says that once there is a new regime in Europe, all non-member states will have to make a decision about whether or not to be compliant with that. We hope that in our Brexit negotiations we have made clear—the Prime Minister has emphasised this—the huge importance we attach to these issues. They are massively important and we want to get a positive outcome in the negotiations, but it would be premature at this stage to incorporate into this Bill the anticipated enactment of the new regulation because it might be inert law.

European Union (Withdrawal) Bill

Lord Kakkar Excerpts

Report: 1st sitting: House of Lords
Wednesday 18th April 2018 Lords Chamber

[Lord Mackay of Clashfern (Con)]

My Lords, I have had the privilege of being involved in this sort of question for some time. Clinical trials need to be in a system which makes it relatively easy to set them up. The new regulation to which this amendment relates has very much simplified the system. Unfortunately, for fairly technical reasons to do with the portal, it has not come into force yet but the assurance that the Government have given in relation to this seems the best that they could give. It is entirely in accordance with the agreement that we came to yesterday; namely, that the Government will do all they can to bring the regulation into effect. Of course, if it happens during the implementation period then nothing more is required but if, unfortunately, it does not come into force during that period the Government will do everything possible to avoid delay and give certainty to those who plan clinical trials. As your Lordships know, planning clinical trials is not something that happens the day before they start; there has to be a good deal of planning so that such trials may be effective. I think the Government have done all that can be done in this situation to give effect to the intention of the noble Lord, Lord Patel.

[Lord Kakkar (CB)]

My Lords, I thank the Minister for her very full response to the amendment moved by my noble friend Lord Patel. She has given a powerful reassurance that the important elements of the European clinical trials regulation that can be applied independently of the European Union to improve the situation for the conduct of clinical research in our country will be brought into force. That is vital, as the Minister said, for ensuring that those who plan clinical research can do so with absolute certainty over a period of time prior to implementation. I, for one, am most grateful to her for this reassurance.

[Baroness Thornton (Lab)]

My Lords, I join everyone in thanking the Minister—the noble Baroness, Lady Goldie—and indeed the other Ministers who have been involved in the discussions. I thank them for the meetings we have had. I am sorry that I was not at the meeting the other day, but I thank her for sharing with me what she was going to say today. I am very happy that the Government have recognised the importance of this matter. Who would not be honoured to be on an amendment with the noble Lord, Lord Patel, and the noble and learned Lords, Lord Judge and Lord Mackay of Clashfern, and if they say that they are content, who am I to say that I am not? What will be necessary from now on is for the Government and all of us to reassure the medical professions and the researchers that this is exactly what will happen, so that they can plan with confidence clinical trials for the future.