European Union (Withdrawal) Bill

Baroness McIntosh of Pickering Excerpts

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

[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.

[Lord Ribeiro (Con)]

My Lords, I support the amendment because I think it is very important after all the points that have been made by previous speakers.

In my Second Reading speech, I referred to something slightly different: a loss of some £32 million to nuclear research, which would have gone to 25 university institutions, as a consequence of leaving Euratom and the Horizon 2020 project. The key benefits of the CTR are the improvement in collaboration, information sharing and decision-making between member states, as well as maintaining high safety standards for all participants in EU clinical trials. Withdrawing from these arrangements will have a negative effect on UK research and clinical trials.

The PM’s speech has been mentioned. It is worth reading because this is perhaps about holding her to account. She said:

“We will … explore … terms on which the UK could remain part of EU agencies such as those that are critical for the chemicals, medicines and aerospace industries”.


There is an opportunity here to hold her to account because it sounds as if the decision that was made early on to withdraw from Euratom was rather hasty and the consequences of it are only now beginning to dawn. The amendment is essential to re-establishing the research collaboration that we need with the EU, which has benefited us greatly in the past.

--- Later in debate ---

[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.

[Baroness McIntosh of Pickering]

We have established in this debate and in the earlier debates on Amendments 18 and 81 that precisely what the Government may wish to do, and what this amendment and Amendment 18 try to do, to which my noble and learned friend Lord Mackay has given a very elegant solution, are not permitted by the Bill. There is no legal basis. Will my noble friend come forward with a form of words to cover the 23 eventualities in the form of directives identified by the Library and other situations in the directive that apply to regulations, such as this, to give a legal basis to permit the Government to have the discretion where they choose to do so to implement the content of those directives and regulations at that time?

[Lord Judge (CB)]

If Clause 3(3) will not do the trick, will the Minister please take advice about whether we need to add EU regulation 536/2014 to the group of matters raised in Clause 2(2)?