European Union (Withdrawal) Bill

Lord Duncan of Springbank Excerpts

Committee: 8th sitting (Hansard - continued): House of Lords
Monday 19th March 2018 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, this has been an excellent debate. Here we have a successful and innovative industry with lots of SMEs involved, but their very future is at risk because of the approach that the Government are taking to Brexit. We need to be clear about this. The noble Lord, Lord Empey, talked about CE marking and the notified body. What is crucial is that the CE marking is a logo placed on medical devices to show that they conform to the requirements of the various EU directives. The notified body is an organisation that has been designated by an EU member state to assess whether manufacturers and their medical devices meet the requirements set out in legislation. As part of our being within the EU, the Medicines and Healthcare products Regulatory Agency is the designated competent authority in the UK. That sets out the legal position and why it is so important in terms of both patient safety and the ability of UK companies to do business in the rest of the EU and market some of the most extraordinary machines, devices and developments that have been seen in the world.

Here we come to the point where there is such a risky position for our companies. To take the point of the noble Lord, Lord Deben, we should look at Mrs May’s Mansion House speech, where she referred to the fact that the Government,

“want to explore with the EU, the terms on which the UK could remain part of EU agencies such as those that are critical for the chemicals, medicines and aerospace industries”—

and she mentioned the European Medicines Agency by name, although, extraordinarily, not Euratom, which we will come to debate later this evening and tomorrow. She went on to explain why we should be seeking associate membership of the European Medicines Agency and the other agencies named. She said:

“First, associate membership of these agencies is the only way to meet our objective of ensuring that these products only need to undergo one series of approvals, in one country. Second, these agencies have a critical role in setting and enforcing relevant rules … Third, associate membership could permit UK firms to resolve certain challenges related to the agencies through UK courts … Fourth it would bring other benefits too. For example, 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”.


If ever I have heard a convincing case for remaining a member of the EU, the Prime Minister set it out in her Mansion House speech. The point is the one that the noble Lord, Lord Deben, made. We are going to beg for associate membership. As the Prime Minister said, we will follow the rules and pay the cost, but we will have no say in the rules that are being set. At the moment, the MHRA is one of the most effective negotiators in the EU, so when it comes to medicines safety or devices, the UK has a huge influence. That means a big advantage for UK companies, because it has in mind the interests of the UK as a whole.

We are to throw all this away and be supplicants at the altar of those agencies, because the Government have woken up to the fact that they cannot let those industries go down, so they will have to negotiate associate membership. It will be on EU terms, because they are a lot bigger than we are. We will have to abide by their rules but no longer will we have any say in how those rules are developed. As the noble Lord, Lord Deben, said, we are trying to negotiate the least worst option, but it is a worst option.

It is a wholly depressing picture: this Government seeking to destroy so many of our innovative industries through their obdurate and ignorant approach to the way industry, the UK and the EU work. The noble Lord, Lord Empey, has done us a great service tonight by letting us debate this important issue. It would be nice, would it not, to hear a proper response from the Government to show that they recognise the problems that they are now causing for British industry?

[The Parliamentary Under-Secretary of State, Northern Ireland Office and Scotland Office (Lord Duncan of Springbank) (Con)]

My Lords, this medical device amendment has been deemed a probing amendment, and I can tell the noble Lord, Lord Empey, that I feel well and truly probed by the comments made across the Chamber this evening.

The noble Lord, Lord Deben, made a number of sweeping statements, which of course are accurate, about the response that I must give at this point. He will not be surprised to know that. We have agreed today the beginning of a journey with regard to the transition. I sought confirmation again that medical devices and the CE framework are included in that transition, and indeed they are, so I can give that assurance just now. The noble Lord, Lord Deben, will also be aware that the matters that we have discussed this evening must necessarily be a matter for negotiation. I am sure he will understand why that is so, also.

Were I to stop there, the Committee would rightly be disappointed. This has been a wide-ranging debate touching on a number of points. The noble Lord, Lord Hunt, in summation, raised the Mansion House speech delivered by my right honourable friend the Prime Minister. That speech is a recognition of the importance of mutual recognition, what it means and why it will be important after we leave the European Union.

As a Member of the European Parliament, I sat on the Environment, Public Health and Food Safety Committee when the medical devices and in vitro question was being debated, and I was aware how important that forum was for determining particular standards. I am also aware of the importance of the United Kingdom’s innovation in medical devices. It is global in its reach and import and is extraordinary in what it can achieve. I am aware that, as we exit the European Union, we must secure mutual benefit to both sides. I do not accept the assertion that this is a moment when big means right. We are seeking an outcome that is right for those who would seek the comfort and necessity of what those medical devices must be and can achieve for them.

[Lord Hunt of Kings Heath]

Will the Minister explain to noble Lords what effect mutual recognition would have? Can he explain how the UK will have as much influence on those rules in the future, outside the EU, as it does now, as a key member of it? Or does it mean that, in effect, we will simply have to follow the rules set by the EU?

[Lord Duncan of Springbank]

I thank the noble Lord for his question. I am again reminded of the importance of the United Kingdom’s academic sector and the academic excellence which it creates, not just in the wider area of science but specifically in medical science. I am aware of how important that innovation is and believe that, right now, it should be able to speak for itself in the negotiations and discussions in terms of the wider recognition and import of what they represent.

I am conscious that, as we embrace the challenges which lie ahead—

[Lord Bassam of Brighton (Lab)]

Will the Minister answer the point made by my noble friend Lord Hunt? It sounds to me that he is unable to do so. If that is the case, he should tell the House so. It is clear to me that he has not answered the question, which is highly pertinent and relevant to the direction of the debate.

[Lord Duncan of Springbank]

I am sorry if I have misled noble Lords. I am unable to answer the question. That will be a matter for the negotiations and I cannot comment upon them. This is the point made earlier by the noble Lord, Lord Deben. I wish I could, but I cannot. I am sorry if my response misled the noble Lord as well. Determining exactly how that mutual recognition will work in practice will be a matter for the ongoing negotiations. I hope that it will work on both sides in a common-sense way which recognises that, at the heart, we are talking about the health and well-being of individuals. We are not talking about constitutional matters or anything other than ensuring the best health for the people of the continent of Europe that we can achieve.

[Lord Wallace of Saltaire]

My Lords, the Government have talked about completing the negotiations by October 2018. Is this one element that they hope to have completed negotiations on by then, or will it have to be put off into the transitional period?

[Lord Duncan of Springbank]

It is the Government’s intention to complete all negotiations by that point.

I think that all noble Lords agree that UK notified bodies have a strong reputation in the EU. We have heard it more than once this evening. The notified bodies assess a disproportionate number of medical devices. According to a recent independent assessment of the market, UK notified bodies make up the first, third and fourth largest share of assessors. Furthermore, we estimate that UK notified bodies oversee between 50% and 60% of all the highest-risk devices on the EU market.

As I stated earlier, the UK has played a leading role in the negotiations of new regulations for medical devices in general and, specifically, for in vitro diagnostic medical devices. I believe that these innovations will make a significant difference. As the Government have made clear, whatever the outcome of negotiations, the principles which underpin our approach remain: that patients should not be disadvantaged; innovators should be able to access the UK market as quickly and simply as possible; and the UK will continue to play a leading role in both Europe and the world in promoting public health.

At the heart of much of this is the notion stressed by the noble Baroness, Lady Finlay. Inside the EU, there are a number of means by which research is supported, not least of which is the Horizon 2020 fund. We have been blessed by punching above our weight in securing funds from this resource. I believe that in future it will be an asset for the entire EU and this will be negotiated in the next few years. It has yet to be made clear exactly how it will be determined. I remind noble Lords that the last time this was negotiated the EU top-sliced a substantial amount of money away from the fund, to the detriment of the overall Horizon 2020 reach.

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[Lord Tunnicliffe (Lab)]

My Lords, I declare my interest as a recreational boater and I thank the noble Lord, Lord Fox, for proposing the amendment of my noble friend Lord Berkeley. Everything that he said seemed entirely reasonable and I am sure that the whole House awaits the Minister’s concession on this point.

[Lord Duncan of Springbank]

My Lords, in moving this amendment, the noble Lord, Lord Fox, said that it may not be at the front of everyone’s minds. But as often happens in these circumstances, this particular issue is almost the nexus of all the key issues affecting withdrawal from the EU, whether it be our mutual recognition of certain types of goods for the purposes of customs duty, the precise arrangements and procedures for ensuring cross-border security or the mutual recognition of professional qualifications. So in truth, one might argue that this is a key amendment in many respects. The noble Lord, Lord Fox, is right to remind us of the significance of this sector. It is a substantial contributor to the Exchequer and a major employer. It is also, as a number of noble Lords have noted, a source of much pleasure, and we should not lose sight of that.

In responding to this debate it is important that I am very clear, so perhaps I may turn directly to the specific question raised by my noble friend Lady McIntosh. She asked whether we will continue to align with future legislation within the EU. I am afraid that that is a commitment I cannot give at this moment because it will be determined by the ongoing negotiations and our future relationship at that point. However, it is important to stress that we are in very regular contact with the British marine sector and are attentive to the issues that it is raising. I hope that in saying that, my noble friend will recognise that it is our intention to be very careful as we take this matter forward.

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[Lord Tunnicliffe]

The noble Lord started by saying that this is the nexus of the issues virtually across the piece. He is painting a very dull picture of the future if he cannot assure us that in this area we are able to achieve the objectives of the amendment.

[Lord Duncan of Springbank]

I thank the noble Lord for his probe in this regard. This is, if you like, the epitome of the challenges we are facing, but unfortunately it is larger than the individual amendment can recognise and what it seeks to do, which is to have Ministers place before us a single report setting out both the current arrangements and thereafter the arrangements that we secure through negotiation. The arrangements we secure through negotiation will be detailed for this House and will be iterated so that we understand what they are, and they will emerge from that negotiation. It is not our intention to downplay the significance of these issues, but we must recognise that they play a part in a wider question, in particular when it comes to the customs issues. On that basis, I still hope that the noble Lord will be able to withdraw his amendment.

[Lord Fox]

My Lords, I thank the Minister for demonstrating his sensitivity to this issue, which will be reassuring to some extent for boat owners and boating businesses around the UK, so there may be some solace in that. The amendment is not seeking a running commentary on the negotiations. The Minister is correct to say that this goes to the nub of the customs and free movement issues as they unfold, but providing a promise of some kind to keep the industry informed about what is going on is very important. Obviously we will look at the Minister’s response in detail in Hansard, and with that, I beg leave to withdraw the amendment.

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[Lord Hunt of Kings Heath]

My Lords, this has been an interesting debate, and we have identified some of the challenges that we face in public health: air quality, environmental standards, food standards, accidents, infectious diseases and, indeed, huge health inequalities. I listened with interest to the noble Baroness, Lady Oppenheim-Barnes. Overall, I disagreed with her. Of course, you can pick out some regulations from the EU with which one might disagree or think that they do not go far enough, and she identified an issue around labelling. Overall, however, the EU has been generally helpful and a force for improvement in public health. I mention in particular air quality, because that is one clear example where it has pressed this country hard on our very poor performance. Governments have started to do something about it only because of the fines we face. There are other examples as well.

The fear expressed so well by noble Lords—I too pay tribute to the Faculty of Public Health for its briefings on this—is that without EU law, and in the context of already significant reductions in public health budgets, we will see a gradual erosion over time of our important public health legislation. The noble Baroness, Lady Finlay, and others mentioned food safety as an example. The Minister will no doubt tell us that he cannot say anything substantive because of the process of negotiations; he has said that a few times before. However, one of the fears clearly is that in the Government’s haste to negotiate a deal with the US—they are desperate to do so, for obvious reasons—when it comes to it, things like some of the food standards we have at the moment will go by the board. We know that that will happen because they have to produce a US trade deal; they have no option but to do it. They are so weak compared to the US in terms of the negotiation that it is quite likely that some of those standards will have to be thrown away.

That is why this amendment has been brought forward tonight. Ministers have helpfully discussed this amendment in meetings with some stakeholders. I know Ministers may say that the Secretary of State already has the powers set out in the amendment. However, as the noble Lord, Lord Warner, said, the amendment would place a duty on the whole of the Government to do no harm. That is a very important distinction. Importantly, it would also place a duty on other public authorities, including the devolved nations, so I believe that it goes further than current legislation. It is relevant to the European Union (Withdrawal) Bill, not just to a theoretical health and social care Bill which may be introduced at some point.

Other noble Lords have talked about the Lisbon treaty and the impact upon it. The amendment essentially seeks to ensure that there is a legal precedent and interpretive guidance on which to draw when determining the meaning of the proposed new clause, but, as I understand it, it does not seek to preserve EU law and regulation. Therefore, it would be for the British courts, on the basis of our doctrines of parliamentary sovereignty, to decide the future interpretation of the law.

This has been a very important debate. The Minister has to recognise that there is real concern that the Government’s desire to negotiate agreements with other countries will lead to them having to agree to reduce some of our essential public health standards. This amendment seeks to provide a guarantee and assurance that this will not happen. We should very much welcome it.

[Lord Duncan of Springbank]

I thank the noble Lord for his comments. I will start where he finished: no, we are not going to do that. I am afraid that is not the Government’s purpose. There will be no rollback of these standards because they are at the heart of what we believe to be right and proper. A number of noble Lords have implied that what has been proposed will be the case. I assure them that is not the case.

My noble friend Lady Chalker is right to stress the leadership role that the United Kingdom has long had in the area of public health. Indeed, that leadership role has been a beacon to not only the EU but its member states. As someone who currently lives in Edinburgh, I recognise the role that Scotland has had in pushing forward boundaries which are only now being adopted in certain parts of the world. It is important to stress that we are not in any way diminishing our regard for public health. Indeed, in bringing across the corpus of European law, those matters will rest in our statute book and will therefore be removable only by the other place and by this place.

Before I address some of the more substantive points, it is important once again to look at the EU itself, mostly in the area of public health. The noble Lord should be aware that public health has not been a core competence of the EU. Indeed, many of the aspects of public health have rested elsewhere within the statute books. Noble Lords will be aware that we have known about the pernicious and deadly impact of tobacco for many years, yet it is only in the last five years that the EU has phased out subsidies for tobacco growers.

I was a member of the European Parliament and sat on the environment committee. I also sat on the committee that investigated a scandal that came to be known as “dieselgate”. Noble Lords will be aware of exactly what that represented. At the heart of the EU, a major organisation installed cheap devices in vehicles that were specifically intended to undermine the core air quality standards. We should again remember that that was uncovered by an American public body, not by the EU’s body, which is in itself a borderline scandal. Further, we must also recognise that Volkswagen has compensated car owners in the US but has not in any way compensated car owners in the EU.

I am reminded also of the traceability of food and the horsemeat scandal, which riddled the EU. High standards are important only if they are met, and they must be met in each and every instance. Far too often we have found across the EU some of the most rigorous standards on paper that there could ever be, yet their enforcement is dreadful and woeful. Indeed, I am nearly certain that when we leave the EU the mean standard of public health will fall in the remaining states, so important is the contribution that we make to the wider question of public health.

When we look at the role of global standards and something like the recent Ebola outbreak, it was not the EU that pushed at that standard but France and the UK. They recognised an obligation to deliver against that pernicious pandemic. I believe we also need to recognise that the UK has been at the cutting edge of driving forward public health.

The noble Lord, Lord Warner, said that I might suggest that his amendment was vague. It is not vague; it simply duplicates exactly what the Government—indeed, not just this Government but every Government—have long said and long held to be dear. At the heart of good government must be the preservation of public health. It must be a cornerstone not just in the UK Government but in the Governments of the devolved Administrations, which in some respects have been brought into the ambit of the report. We need to recognise that.

Perhaps I may touch upon some of the other issues that have been brought into this wide-ranging debate. I reiterate that many of the aspects that we are touching on here will necessarily be part of ongoing negotiations, but I assure noble Lords that it is this Government’s intention to secure the highest possible engagement on matters of wider public health. I thank the noble Lord, Lord Patel, for bringing up a number of the areas that I believe the Government need to look at carefully—how we continue our collaboration, how we ensure that we can co-operate and how we can maintain that high standard. We can do so by sharing practice on both sides, because we both have a great deal to contribute and each will be the poorer for the absence of that collaboration.

It important for me to stress that the Secretary of State for Health and Social Care has a statutory duty under the National Health Service Act 2012 to protect the health of the public. A number of noble Lords have raised that, as indeed has the briefing from a number of sources, not least the Royal College of Physicians of the United Kingdom. Of course we are going to argue that the Secretary of State for Health and Social Care already has these powers, and it is his intention to hold them to the highest possible standard. I stress that, although there is an equivalent duty under the NHS—

[Lord Warner]

Can I make it clear that the Minister is saying that the powers and duties of the Secretary of State are as wide as the powers and duties in this amendment?

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[Lord Duncan of Springbank]

I am stressing once again that the powers and duties that rest upon a Secretary of State for Health and the health department are high enough and wide enough to capture the intent of this amendment, and that is why the Government will not support the amendment on this occasion.

[Lord Warner]

That was not my question. Can the Minister say whether the current powers extend to the devolved Administrations, the other public bodies and the whole of government, as covered by the amendment?

[Lord Duncan of Springbank]

No, for one very simple reason. As the noble Lord knows, we cannot impose on the devolved Administrations by this mechanism. I am afraid that that is a simple statement of where the law and the devolution settlement rest.

[Lord Hope of Craighead (CB)]

My Lords, there is another way of approaching this, and that is to ask whether the provision in the treaty on which my noble friend Lord Warner has based his amendment is part of retained EU law. If it is, then it has a place in the statute and will be applied by the courts if necessary. Is the noble Lord able to answer that? Is it part of retained EU law?

[Lord Duncan of Springbank]

In this instance, it is not part of EU retained law, but that is not the point. We are saying that the powers that already rest in the Secretary of State’s hands are equal to the powers that would come through this amendment.

[Lord Deben]

If it is not part of this Bill, why not? The Government said that they were going to take this into the legislation. Why is it excluded? That is why people are frightened—because the Government have not put it in the Bill.

[Lord Duncan of Springbank]

Because it is superseded by the power that rests in the hands of all good Governments to deliver at that particular level. That is the purpose, and that is the point that I raised just now. If I may, I will make some progress.

It is important that I stress that we are committed to continuing co-operation not just within the EU but more broadly. That is why we are an active participant in the World Health Organization and in various other elements of global public health. My noble friend Lord O’Shaughnessy, the Parliamentary Under-Secretary of State for Health and Social Care, who is sitting beside me this evening, has committed to continuing the UK’s leading role in promoting and ensuring public health, in Europe and beyond. This commitment builds upon the principles set out by my right honourable friend the Secretary of State for Health and Social Care last July on a post-Brexit regulatory system where patients are not disadvantaged and patient safety remains at the heart of our endeavours. It is the Government’s intention, as stated in the future partnership papers, to continue collaboration with the EU to safeguard resilience. This of course will be determined as we move through the engagement on this matter.

I stress that the values and principles which have underpinned our National Health Service for the past 70 years—and which are not to be traded away with the US or any other trade partner we might have—will continue to guide us, just as they have contributed to the development of health and social care services across the EU. That is why, in this instance, I ask the noble Lord to withdraw his amendment.

[Lord Warner]

My Lords, I am grateful to everybody for their contributions in this debate. My score-card shows 14 in favour of the amendment and two against, including the Minister, and that was across the Benches. I am glad that he has moved on from saying that the amendment is vague—that is a bit of progress from what Ministers said before to the Faculty of Public Health.

The Minister seems to be setting up the EU as a straw-man villain to criticise. I never claimed in the past that everything that the EU did in this area was perfect and for all time. What I was trying to do in this amendment was take a principle in the Lisbon treaty, which this country has signed, and apply it to the jurisprudence of the future. If I may, I remind him of the quotation from the High Court judgment, which he needs to read carefully. It makes it very clear that the courts found it useful to apply this principle and put it at the “epicentre”—the word of the judgment, not mine—of public health. It was used in coming to a judgment that actually helped the Government’s position on tobacco policy.

I have heard nothing from the Minister which suggests that the Government have got the same breadth and width of coverage as this amendment provides in this legislation. As the noble Lord, Lord Deben, said, I cannot see why on this issue the Government cannot put in the Bill what they claim to be their policy. It would reassure a very large number of people and help with the exit from the EU. I can guarantee the Minister that I shall return to this issue on Report.

I would be very happy to have a meeting with him, if he feels some flexibility coming upon him, as would many of my colleagues. However, if he does not, I think he can expect a rerun of this on Report. In the meantime, I beg leave to withdraw my amendment.