European Union (Withdrawal) Bill

Lord Empey Excerpts

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

Moved by

[Lord Empey]

227B: After Clause 9, insert the following new Clause—
“Mutual Recognition Agreements relating to the safeguarding of public health
In respect of mutual recognition agreements relating to the safeguarding of public health, within one month of the passing of this Act, a Minister of the Crown must publish a strategy for ensuring that existing United Kingdom notified bodies, in accordance with provisions laid out in the EU Medical Devices Regulation, may continue to conduct conformity assessment certification for both United Kingdom and EU medical devices to ensure continuity within and beyond the EU.”

[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”.

--- Later in debate ---

These are some of the challenges that both sides will face. Moving forward on the basis of the Mansion House speech given by my right honourable friend the Prime Minister in the area of mutual recognition will bear much fruit. Again, I must stress that the outcome will rest with the negotiations, and those negotiations have not yet begun. On that basis, I hope that the noble Lord will feel able to withdraw his amendment.

[Lord Empey]

My Lords, little did I believe when I moved this amendment that I was going to open up the spectre of your bionic Lordships. Nevertheless, it did personalise the issue to a point. My noble friend Lady Finlay pointed out that science and very often SMEs emerge out of spin-offs from universities. That is true, but there are larger international companies involved in this as well, and that might have been overlooked. It is not all a matter for small business.

I thank all noble Lords who participated in this debate. I did not know when I tabled the amendment what would happen today. I am glad the Minister has confirmed that this matter is on the agenda for those discussions. I shall certainly follow that extremely closely and obviously reserve the right to come back to this matter later in the Bill’s proceedings. With the assurance that the Minister has given, however, I beg leave to withdraw the amendment.

Amendment 227B withdrawn.