European Union (Withdrawal Agreement) Bill

Lord Davies of Stamford Excerpts

Committee: 2nd sitting (Hansard continued) & Committee stage & Committee: 2nd sitting (Hansard continued): House of Lords
Wednesday 15th January 2020 Lords Chamber

[Baroness Hamwee (LD)]

My Lords, can I ask my noble friend a question? If he were negotiating any sort of agreement and learned that the other side had a self-imposed time constraint, would he not regard that as a huge advantage?

[Lord Davies of Stamford (Lab)]

My Lords, the noble Lord, Lord Newby, made an unanswerable case. Human beings have been conducting negotiations since the beginning of time, and over that period there have been certain common conclusions about the sort of approach to negotiations that leads to a favourable outcome and the sort that, on the whole, does not. That is part of the common wisdom of humanity. Part of that is that you are at a great disadvantage in any negotiation if you have time constraints greater than those of your counterparty. What we have here is a Government who want to impose on themselves a time constraint greater than that which applies to their counterparty, which is most extraordinary. Mr Johnson may feel that, after all these millennia, he can revolutionise human psychology, and that the conclusions that have been drawn from human experience up until now are no longer valid. I have had quite a lot of experience of negotiations in my life, both as part of a team and from conducting negotiations myself as a diplomat, as an investment banker, as a Minister and so forth. I know that most of those common wisdoms of humanity are valid and correct, and one veers away from them at one’s peril. If somebody behaves entirely irrationally, as appears to be the case in the Government at the moment, one has to ask whether there is perhaps some Machiavellian plot behind the behaviour that explains this irrationality. That is what worries me, because the obvious explanation of Mr Johnson’s behaviour is that he does not want a successful outcome at all. He wants a hard Brexit or a bare-bones solution. He does not want to say so; he does not want to take responsibility for saying so.

A bare-bones solution would leave out altogether these very important issues of our relationship on security matters with the rest of the European Union, the future of the common arrest warrant, the pooling system of information exchange, and so forth. It would leave out a number of very important matters that appear in other amendments on the Marshalled List today: such things as the Euratom relationship, the European Medicines Agency relationship, the future rights of British subjects living abroad to receive their full pensions in the country in which they have taken residence, and the availability of medical cover to British people finding themselves elsewhere in the European Union. All these are very important matters and of course they would be set aside at a stroke if there were a bare-bones solution. There would be no chance of regaining those benefits. It could be that Mr Johnson actually wants that outcome and does not want to be held responsible for the consequences—human, economic, et cetera—of that solution.

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[Lord Warner]

My Lords, I support this amendment, to which I have given my name, which has been moved so clearly by the noble Baroness, Lady Brinton. I do so as a former Life Sciences and Pharmaceuticals Minister who has stayed in touch with this sector since my time as a Minister.

The UK life sciences ecosystem has thrived, with an EU pharmaceuticals regulator based in this country and a strong medicines research base working closely with other European researchers. Over the years a strong pan-European research collaboration has grown up, which has benefited UK jobs and NHS patients. Every month, 45 million packs of medicines move from the UK to the EU and 37 million packs come the other way. The pharmaceuticals sector invests more in R&D than any other—20% of all UK business R&D. This is an industry with an annual turnover of £60 billion and exports of £30 billion. It employs 63,000 people, of whom 24,000 are working in high-paid jobs in R&D.

I say this because all of this is now at risk of lasting damage, particularly if there is not enough time to agree a well thought out deal during the transition period. There is now the prospect of a very clunky regulatory system, with companies having to deal with two regulators—the EMEA and the MHRA—if they want market authorisations in both the EU and the UK. The Government are saying that they want the UK market authorisations to be obtained first, but the EU is the bigger market and some companies think that they may end up with shorter IP protection in the larger market if they do what the Government ask. A dual regulatory system is likely to mean higher costs, driving up NHS prices and damaging patient access to new drugs. It will mean fewer joint research projects benefiting from EU funds, and UK-based companies are less likely to find the UK Government replacing the lost R&D funds from the EU. Over time, we may well see fewer clinical trials being done in the UK.

That is why this amendment is important. It offers the possibility of repairing some of the damage done by Brexit to UK life sciences and UK-based pharmaceuticals and biotech companies. We need to do our utmost to restore some basis for extensive collaboration and research work between us and the EU in the life sciences, and we need to do the best we can to make the regulatory processes as smooth as possible if we want people to continue to do pharmaceuticals research in this country. The Government have been slow to appreciate the damage they have been doing over the last three years to this British success story. Passing this amendment would start to repair some of the damage.

[Lord Davies of Stamford]

My Lords, my two colleagues have made a powerful case for the European Medicines Agency. They are perfectly right. The consequences of getting rid of it—of leaving the EU structure—are very serious. There are two parties involved in any introduction of a new ethical compound to the market. One is a pharmaceutical major—and by “major” I mean household names that the House will be familiar with: Pfizer, Merck, Eli Lilly, AstraZeneca, Glaxo, Boehringer, Bayer, Sanofi, Roche—I have left out two or three and a couple of Japanese ones, but you can count them on the fingers of three hands or so. The second is a regulatory agency that provides registration, which is of course the key to licensing, prescribing and selling freely a drug in the jurisdiction concerned.

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[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)]

My Lords, I welcome the opportunity to discuss this important issue, and I thank all noble Lords for their, as always, thoughtful and expert contributions. During the Government’s preparations for EU exit, this House has discussed on a number of occasions the great value of the UK’s life sciences industry and the importance of ensuring that it remains—as the noble Lord, Lord Warner, rightly said—one of the most productive health and life sciences sectors in the world. As noble Lords will know, this sector alone contributes over £74 billion a year to the UK economy and employs close to 250,000 people. I contest the argument that it has recently been damaged. A report just today shows our leading position in cell and gene therapies, in which ongoing UK trials represent 12% of global trials and have increased by over 45% in the last year alone. That is in the context of Brexit.

The Committee is right that this is a crucial sector to the delivery of healthcare treatments to patients across the UK and will continue to be so in future. We must get this right. I assure noble Lords that the quality and safety of patient care is paramount in the department’s and our partners’ EU exit plans. This has been visible in our extensive efforts and preparations to ensure that the supply of medicines and medical products into the UK remains uninterrupted following the UK’s departure from the EU. This led to the department’s multilayered approach to put in place in the case of a no-deal exit from the EU. It was a substantial approach, which included work to procure additional freight capacity and to ensure buffer stocks and stockpiling; working closely with industry to improve trader readiness; and collectively helping to ensure visibility in the supply chain and, therefore, much more robustly ensuring continuity of supply processes.

While no-deal planning has been stood down, there is no question but that this work will stand us in good stead going forward, given the strategic importance of the supply of medicines and medical products in all scenarios—as the noble Lord, Lord Warner, pointed out. In fact, we are finding that the learning from this work is already helping us to better manage routine shortages, which are becoming increasingly common globally.

During our preparations for EU exit, we have at all times worked closely with our delivery partners. We are committed to doing so in future. Their support, expertise and hard work have been invaluable and will remain so as we enter the next stage of negotiations.

Turning to the amendment moved by the noble Baroness, I hope noble Lords will understand that we cannot accept this proposed new clause. The amendment was originally proposed in the other place and was not accepted there. I do not want to impute motive, but following debate, the sponsor in the other place chose not to move his version of the amendment to a vote there.

I wish to reassure the Committee on some of the questions raised, because it remains our objective to work closely with our EU friends, as we do at present, to ensure that patients continue to have access to safe and effective medicines and reap the rewards of our new relationship with the EU. Our overarching aim for medicines and medical devices regulations at the end of the implementation period is underpinned by the following commitments, which I have given before: patients should not be disadvantaged, which speaks to questions raised around rare diseases in particular; innovators should be able to get products to the UK market as quickly as possible; and the UK should continue to play a leading role in promoting the health of the public. We are in a better position than some of the countries—

[Lord Davies of Stamford]

All this is fine PR speak. All these principles sound splendid, but what are the Government actually going to do? The answer cannot be simply, “We will stay close to the European Medicines Agency.” Does that mean that we will leave that agency, not leave it or have some new, structured relationship with it?

[Baroness Blackwood of North Oxford]

As always, the noble Lord gets to the point. As my noble friend Lord Callanan said, the exact relationship with agencies will be subject to negotiation. I have set out the core principles which will be part of our negotiation, and I would also point out the key assets which we bring to the table. The MHRA has real expertise in many areas —licensing of medicines, pharmacovigilance, clinical trials regulation—and already provides benefits to patients across the UK and the EU.

Regarding the points on clinical trials, raised by the noble Baroness, Lady Brinton, as part of EU exit negotiations, we are working to ensure that we will continue to have the best possible environment to support clinical trials. Our overall aim is to ensure not only that patients in the UK have access to the best and most innovative medicines but that we improve UK trials applications—so that they continue to be authorised by the MHRA and ethics committees, as they are now—and that the UK’s ability to participate in multinational trials will not change. We will also have a simpler way of allowing a single application to a single national decision in the UK, which we have been working on very hard.

The Government have set out the key principles of the UK’s negotiations with the EU in their manifesto, and as part of the political declaration. However, as has been said this evening in response to similar amendments, a statutory negotiating objective in primary legislation, as proposed in this amendment, is neither necessary nor the constitutional norm. We cannot accept a statutory reporting requirement either, but the Government will support this House in fulfilling its crucial role of scrutinising the actions of the UK Government during negotiations. The Prime Minister committed at Second Reading in the other place that Parliament will be kept fully informed of the progress of these negotiations. We will have many challenging and robust debates in this place as well, where your Lordships will hold us fully to account on the progress of those negotiations with the EU.

It is important to note that our approach to negotiations with the EU in this area is set out in the political declaration and the Government’s mandate, but this is only one part of our overall support for the life sciences sector. This commitment is also clearly demonstrated through the medicines and medical devices Bill, which was published in the Queen’s Speech and which we will have a lot of debate about in this place. The Bill is to ensure that the UK remains competitive and at the cutting edge of innovation, to the benefit of patients. I look forward to discussing those provisions with the House later this year. I hope that I have reassured the noble Baroness on the Government’s intentions, and on how we intend to take this forward, and on that basis I urge her to withdraw her amendment.