European Union (Withdrawal) Bill

Lord Deben Excerpts

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

[Lord Empey (UUP)]

My Lords, before I speak to the amendment in my name, the noble Lord, Lord Tope, tempts me down memory lane. I served on only the first two terms of the Committee of the Regions; he is a veteran with many stripes on his arm and much more experience. I recall that when it began we had a president, Jacques Blanc, who was the president of Languedoc-Roussillon. We invited him to Belfast and he came in a pillar of fire, having hired a private jet. By the time he came to Belfast, he was Jimmy White and not Jacques Blanc. He then proceeded to tour the European capitals in that jet, much to the chagrin of our paymasters in the European Parliament. I do not know whether the jet has yet landed—but, whatever it did, President Blanc ran up against the buffers of the accountants in the Parliament. Nevertheless, it was an interesting body, but it was a mixture of those of us who were from local authorities and the very powerful—the Bavarians were on it and others with enormous resources. So it was not a balanced body, but it was interesting and at least everybody could have their say.

This probing amendment would require the UK Government to seek agreement with the European Union during the withdrawal discussions—which would of course include the transition period—that the current legal framework underpinning the regulation of medical devices in the EU will be maintained after 29 March 2019. This would enable notified bodies hosted in the United Kingdom, such as the British Standards Institute, to continue to perform conformity assessments on medical devices both from within the UK and across the EU, and issue CE safety label marking after the UK’s withdrawal. The noble Baroness, Lady Kennedy of The Shaws, earlier introduced a number of amendments concerning the welfare of women and young girls and said that she was hoping to put this clearly on the agenda that was moving forward—and this is what I am trying to do this evening.

On 14 September 2017 the noble Lord, Lord O’Shaughnessy, our Health Minister, gave a speech at the Association of British Healthcare Industries on the future of medical technologies post Brexit. He set out the Government’s commitment to the medical tech sector and discussed the opportunities and challenges it faces as the UK leaves the EU and what support the Government were going to offer. There were some core principles in the speech about regulation and conformity assessments post Brexit, including that patients should not be put at a disadvantage and that the industry must get its products into the UK market as quickly and simply as it does now. He said:

“I want to give this promise; no matter what the outcome of the negotiations—on basic patient safety and public health issues—the UK will be, as it always has been, a willing and reliable partner for Europe”.


Furthermore, the European Commission recently warned manufacturers within the EU that CE safety labels provided by notified bodies based in the UK may no longer be valid after Brexit. The Commission document states:

“Subject to any transitional arrangements that may be contained in a possible withdrawal agreement, as of the withdrawal date, the EU rules in the field of non-food and non-agricultural products, whether for use by consumers or professionals no longer apply to the United Kingdom”.


That means that the UK will no longer operate as a host country for EU notified bodies as it currently stands.

Significantly, the European Commission has advised manufacturers to consider the legal repercussions of their current conformity assessment procedure, advising that in future they will need to gain their CE certification through an existing EU member state after the UK’s withdrawal, or to transfer existing files to an EU notified body. It should be noted that, while manufacturers can obtain a CE label from any notified body in the EU, the UK has built an expertise in this area, with approximately 40% of medical devices and 60% of high-risk medical devices on sale in the EU having been certified in the UK by a notified body. The British Standards Institute has led the way in such testing and has recently set up an office in the Netherlands so that it will continue to have an EU-country representation post Brexit.

The development with the European Commission regarding the publication of the notice to stakeholders mentioned earlier would impact on the five existing UK-based notified bodies working in the area of medical devices, including the BSI. BSI chief executive Howard Kerr has previously suggested in media interviews that he believes that a mutual recognition agreement on medical devices between the UK and EU will most likely be achieved during the course of the negotiations, allowing for retained aligned standards after Brexit. As for the possibility of the UK hosting notified bodies after the UK’s withdrawal from the EU, some so-called third countries are able to operate as host nations for a notified body, including Turkey, Switzerland and Norway—so it is possible that an agreement can be made between the UK and the EU.

I believe that mutual recognition agreements and related conformity assessments post Brexit will be vital for sustained patient access to medical devices post Brexit. Although not always at the forefront of the current debate on the EU withdrawal Bill, they are still important so that treatment is consistent for patients. I believe that this approach is also in the spirit of the broad principles and objectives of the Bill: to make sound provision for the transfer of EU law into UK law. Mutual recognition agreements will be the mechanism within the necessary new trade arrangements to transfer into UK law the rights with regard to conformity assessments that the UK currently has in the area of the regulation of medical devices.

The second dimension to this is that there are a number of manufacturers of such devices in the United Kingdom, not only in my own region but elsewhere. They tend to have concentrated in the higher-value and higher-quality areas of the sector. So I believe that this item, although it may not attract the full House that we had earlier on other aspects of the debate, is nevertheless a significant matter. I believe that it should be drawn to the attention of the Government so that it is included in the agreement. It can be done—we know that—and I believe that it is something we should pursue vigorously. I beg to move.

[Lord Deben (Con)]

My Lords, I support the comments of the noble Lord, Lord Empey. It seems to me, though, that one should put them into a wider picture, because this is yet another example of how the best outcome of the negotiations is worse than where we are. I do not think that this Committee has to remind the country as a whole that this is what we are negotiating. We are negotiating a situation that we already have but in which we will of course have no say. Even if we get the very best deal we can, and protect our industry and the excellence of our regulatory structures—which, as the noble Lord, Lord Empey, rightly pointed out, has meant that in one case 40% and in another case 60% of these devices are brought here, whether or not they are manufactured here, because of the excellence of our regulatory control—we will no longer have a say in the central issue of how the regulatory structure is changed in future. This is crucial in this case because, as we all know, medical devices are constantly changing and improving. If we accept that, then we recognise that the way they are regulated—the way in which we set the standards—will also change, and that we will play no part in such decisions.

I am a patriotic person. I object strongly to the intention of sidelining my country from these things and us being the beggar, because that is what we are going to have to be. To compare us with Turkey, to put it delicately, does not fill me with enthusiasm. I suggest that this is another example of the intended consequences of Brexit because the people who are enthused by Brexit—and I see few of them around just at the moment—want to believe in a world in which we can operate on our own without any drawbacks. The noble Lord, Lord Empey, has rightly pointed out that that is not possible, and that the world we live in is a world of co-operation and joint concern in getting the right answers.

I wanted to intervene because I was unhappy with one part of what the noble Lord, Lord Empey, said. He talked of the need to protect ourselves and the importance of this to his own Province as part of the United Kingdom. I want to turn it round and refer to the importance of our contribution to these decisions, the important place that Britain should have in these discussions, not only with regard to medical devices—and the curious expression in the amendment that I particularly like, which refers to the “safeguarding of public health”—but of course to any medical aspect. We have had several debates in the Moses Room on precisely these issues. What this means, of course, is that Britain is saying, “We no longer want the opportunity to play a proper part in seeing that we do this right”.

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[Lord Wallace of Saltaire]

My Lords, I would say to the noble Lord, Lord Deben, that we are really shooting ourselves in the knee. It is a matter of active interest to a significant minority of Members in the House, because replacement knees and hips are among the medical devices which are most common among us.

[Lord Deben]

I was going to suggest that there is probably not a Member of the House who should not declare an interest in this debate, because there are few of us who have not had some device or other implanted. Are we not lucky that they were made and regulated in this country?

[Lord Wallace of Saltaire]

Shortly after the referendum, I was sitting in the orthopaedic surgeon’s office with my wife, who was about to have a new hip, and he explained to us how leaving the European Union would cost the NHS more and would make it more difficult for him to procure what, in his opinion, was the best artificial hip available for the occasion. It was made by a multinational company in southern Ireland with bits—as noble Lords will know, these are complicated devices—coming from across the border and various other places. This undoubtedly would be more expensive, take longer and cost the NHS more. It is yet another example of where, despite the false promises of how much money would flow into the NHS, it will actually be completely the other way round. We will be creating artificial obstacles of one sort or another for these artificial devices, which will affect us all extremely closely. Those of your Lordships who have not yet got one will probably get one within the next 10 years. As the noble Lord says, we are absolutely shooting ourselves in various different embarrassing places by accepting that, in leaving the European Union, we are making these possibilities more difficult and more expensive.

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[Lord Deben]

I bring the Committee back to the fact that this is a Bill about withdrawal, so we might ask why this amendment has been tabled. I say to the noble Lord, Lord Warner, how important the amendment is because of the Government’s commitment. The Government said that they were taking into British law all that was in European law. This amendment draws attention to the fact that the Government are not doing what they said they would: they are not taking into British law the protocols and those things that surround European law to which one can refer in a court case. We have been precise in what we have taken in and the Government have been precise in what they have excluded.

I speak in favour of the amendment because there is no reason why the Government cannot accept it. It is not possible to say that this is all a matter of negotiation—we are not going to negotiate this. Before my noble friend Lord Duncan spoke on the amendment before last, he gently upbraided me for suggesting that I knew how he was going to reply, and of course he did reply that it was not possible to commit the Government to the protection of medical devices because that was going to be part of the negotiation. However, there will not be a negotiation as to whether we will uphold the highest standards of public health; that will not be part of the negotiation at all. What is true is that the protection that, as a member of the European Union, we now have under European law would no longer be afforded to us were we to leave the European Union. Therefore, this amendment is merely to ensure that the withdrawal Bill does what the Government said that they wanted to do, which is to take into British law all those things that at the moment are in European law. This is an important amendment, because it helps to complete what, unfortunately, the Government left out from what they said that they would achieve.

There is a second reason why the amendment is so important. I am fortunate to be the chairman of the Committee on Climate Change. One of the things that is important to us is that we have a statutory position. When the carbon budgets, which we prepare, are passed into law by both Houses of Parliament, they cannot be changed thereafter without the Committee on Climate Change saying that that is right and proper. That is how we in Britain have made sure that we do not go back on our climate change commitments.

For most of our laws, we do not have that kind of protection, but we did and do have it because of our membership of the European Union. That is the kind of change that we will have to make if we leave the European Union to make sure that the public are as well protected after so sad an occasion as they were before. It is not me saying that but my right honourable friend the Secretary of State for Defra, who is not known for his enthusiasm for the European Union. He has made it clear that we need to protect the people of Britain post Brexit by having very clear rules which give independent enforcement of environment law. He said we cannot have a system whereby environment law is affected by the whims—or sensible policies—of Ministers. He said we have to have something independent and has promised that he will present it to the Houses of Parliament. If that is true about environmental law, is it not also true about public health law? Do we not need precisely the same protection for public health that we clearly need to replace the protection we have in the European Union on the environment?

I shall listen extremely carefully to my noble friend’s answer, but I do not think that we can now say that the reason this is not acceptable is because of negotiation, nor do I think the Government can really say that they do not believe that this is what their policy is. This is, after all, only a statement of what the Government have said they believe—so why can we not put it on the face of the Bill, continue the protection which the British people have in the European Union, so that if we leave we at least make sure that public health is as protected afterwards as it was before?

[Baroness Finlay of Llandaff]

My Lords, as the noble Lord, Lord Deben, has pointed out, this is about moving into our law the regulations that currently protect us. That is why it seems appropriate in this Bill. I remind the Committee that the implications of Brexit for our health were published in the Lancet in a review in November last year, which detailed the areas that are in jeopardy. A fortnight ago, the Guardian reported a leaked document highlighting an unprecedented, co-ordinated effort by transatlantic right-wing think tanks to secure what they described as the “ideal” trade arrangement between Britain and the USA, which would involve the UK diluting its existing standards on food safety. I remind the House that the excessive use of antibiotics has resulted in superbugs, which is precisely why we have been worried about diluting any food safety standards. Working conditions in the farming areas that want to export to us are troubling. This would tear up the precautionary principle, whereby companies have to prove their product is safe before it can be sold, rather than waiting for it to be proven unsafe before it is recalled. That precautionary principle and the principle of safety run right through everything. As my noble friend Lord Patel outlined, and as previously discussed in Amendment 30, this relates to all of the infective areas, but it also covers toxic substances and the way that we handle those.

I strongly support this amendment because it would build up the health protections that we have built up slowly since we entered the European Union. It would simply guarantee the continuity of the present conditions and ensure that Articles 9, 11 and 168(1) of the Lisbon treaty are actually respected. It would require European institutions to maintain high levels of human health in all their policies and activities and would mean that these are then mirrored in the UK. It would of course affect areas of shared competence, such as environmental law, health and safety law, and public health law, as well as trade law. By mainstreaming this, it would build on precedents in UK law such as in Section 75 of the Northern Ireland Act, Section 149 of the Equality Act and Section 3 of the Human Rights Act. It covers acts of all public authorities, as I understand it. Judicial acts taken in interpreting retained EU law would then be subject to the same standards that we are used to and have become accustomed to. It covers the whole of the UK, irrespective of whether legislation is made or adopted in Westminster, Belfast, Cardiff or Edinburgh. I cannot see a reason not to accept it. It would maintain the standard to which we have become used. We are all aware of the dangers of dropping that standard.

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[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.