Nuclear Safeguards Bill

Lord Carlile of Berriew Excerpts
Lord Henley Portrait Lord Henley
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My Lords, Euratom consists of the 28 members of the EU and no others. There are two countries which have some sort of associate membership, but that would not be appropriate for us. Being members of EFTA would not do that. The noble Lord will have to accept that we are leaving Euratom. That is the case and we therefore need to make provisions. If the noble Lord will bear with me, I will now tell him about the Bill.

Clause 1 will amend the Energy Act 2013 to replace the Office for Nuclear Regulation’s existing nuclear safeguards purposes with new nuclear safeguards purposes which reflect the nature of the new regime. The ONR will reflect the new nuclear safeguards regime primarily using its existing relevant functions and powers. Clause 1 will also amend the Act by inserting new powers so we can set out in regulations the detail of the domestic safeguards regime, such as accounting, reporting, control and inspection arrangements.

Clause 2 will create a limited power—I stress limited power—enabling consequential amendments to be made to the Nuclear Safeguards and Electricity (Finance) Act 1978, the Nuclear Safeguards Act 2000, and the Nuclear Safeguards (Notification) Regulations 2004. It is a very narrow power that will mean that references in that legislation to existing agreements with the IAEA can be updated once international agreements have been reached.

In addition, in January we published two sets of pre-consultation draft regulations to support consideration of the powers in the Bill, on which we have been working closely with the ONR. The Government are committed to an open and transparent approach as they continue to develop these regulations, which set out the detail of the domestic civil nuclear safeguards regime. We expect these draft regulations to continue to evolve in response to comments from and consideration by noble Lords and other stakeholders. To that end, the department is planning a series of stakeholder events and workshops in addition to the public consultation on the regulations, which we intend to take place later in the year. The drafts we eventually consult on will, of course, in certain respects differ from the working drafts that we have provided for the benefit of Parliament.

I now turn to one final issue that is not strictly relevant to the subject of the Bill but has been raised in another place and in meetings that I and others have had with noble Lords. It is the question of medical radioisotopes. I appreciate that the noble Lord, Lord Hunt of Kings Heath, has tabled an amendment to the EU withdrawal Bill on this very issue. It might be that that would be a better place to discuss these matters in due course rather than here. I could not possibly comment on what might be the appropriate Bill, other than to say that I do not think that it is, strictly speaking, relevant to this Bill, but because of the concerns that been expressed on this issue, it would be right for me to make a few points and give assurances to the House that the supply of medical radioisotopes is, and will continue to be, a very high priority for the Government. We share that concern about the well-being of patients receiving such treatment that results from being able to import such materials in good time, bearing in mind the relatively short lives that medical radioisotopes have.

We have made it clear that Euratom currently does not place any restrictions on the export of medical radioisotopes to countries outside the European Union. As they are not classified as special fissile material they are not subject to the international safeguards regime or to the approval of the Euratom Supply Agency, which governs the supply of special fissile materials. Although its role does not extend to ensuring the supply of medical radioisotopes, the Euratom Supply Agency established in response to the last shortage crisis in 2012 the European Observatory on the Supply of Medical Radioisotopes. The observatory aims to consolidate and share information between the EU, European Union member states, international partners, the medical community and industry stakeholders on supply, but crucially it does not have a decision-making or executive role in responding to shortages.

However, the Government recognise the concerns that changes to our customs arrangements after our withdrawal from the European Union could potentially affect the timely supply of medical radioisotopes. Therefore I offer an assurance to the noble Lord, Lord Hunt, and other noble Lords who have raised this point that the Government are committed to minimising any impact such changes might have. I have had meetings with counterparts in the Department of Health and Social Care and Her Majesty’s Treasury to step up our work in this area. We are working across government to prepare domestically and to negotiate a future customs arrangement with the European Union that ensures cross-border trade in this area is as frictionless as possible.

Lord Carlile of Berriew Portrait Lord Carlile of Berriew (CB)
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I am grateful to the noble Lord for what he has just said, but are we to take it that the sentence in the factsheet on the Bill that was given to your Lordships’ House at some very useful meetings still applies in relation to radioisotopes:

“This will be part of the broader negotiations of the UK’s future with the EU”?


If so, will he tell us what that means?

Lord Henley Portrait Lord Henley
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My Lords, it is exactly the same as what I have said—as part of our broader negotiations we will obviously want to ensure that, in the words I think I used, a future customs arrangement with the European Union is as frictionless as possible. We understand the importance of these matters. It is as frictionless as it can be at the moment; we want to make sure that that continues. I do not believe that it is strictly relevant to the Bill but it was important to bring the matter up. I am very grateful to the noble Lord, Lord Hunt, for tabling an amendment, which will be discussed, to another Bill, but I want to give assurances that the Government are doing everything we can to make sure that such imports are frictionless, just as their export from Europe will be frictionless and just as they are frictionless in their export from Europe to non-EU countries at the moment. It is a matter of giving assurances as to what the Government can do and I hope that that will help to reassure noble Lords.

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Lord Carlile of Berriew Portrait Lord Carlile of Berriew
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My Lords, given that I intend to address my remarks to the issue of medical isotopes, I am grateful to the Minister for talking about it so fully in his introduction to the debate. Like all your Lordships, I trust implicitly his integrity and intentions; that goes without saying. However, I have some misgivings about the lexicon that he has been given, which led to his using particular words in his opening remarks. Having said that, I express my thanks to him, to his colleague in the other place and to the Bill team, which has worked hard to inform noble Lords about the Bill.

I have heard more often than I can remember—it is merely a mantra—that this Bill is about nuclear safeguards, not nuclear safety. If you say it often enough you may well come to believe it, but I suspect that we would all believe something quite different when we did so. I understand the reason for that distinction: it is entirely political, of course, because it gives the Government the excuse for leaving a significant section of the industry out of the Bill. I am afraid that it is no more than a semantic explanation, and I am sure that the distinction would be totally lost on the broader public. For example, if significant detriment were caused to staff and patients because of a problem with radio- pharmaceuticals brought into a hospital from a European Union country, I doubt that the distinction that we have been given would be regarded as mitigation in the public inquiry that would ensue following such an accident. Concern, which I share, has been expressed strongly among professionals, including the Society for Radiological Protection—the SRP—of which I have the honour to be patron. It says that the supply of imported radiopharmaceuticals is implicitly part of the Euratom arrangements that have been reached over years, as I shall explain.

I am advised that the isotopes used for the treatment of cancer are not produced in the UK at present. That means that we rely on imports from the European Union and elsewhere. I think that the Minister mentioned South Africa. My understanding is that the supply from South Africa is currently not available because of safety issues there, although supplies are being brought in from Australia and America, as well as from the EU. However, the important point is that those products have a half-life of around three days. As your Lordships will know, that means that the effective radioactivity in the product falls by a half in about three days. As a consequence, the intended effectiveness of the medication is reduced and indeed in many cases destroyed.

The industry believes—and I support it—that the continued availability of such medical isotopes in the best condition should be encompassed in this Bill. It is just not good enough to say that this will be part of the broader negotiations about the UK’s future relationship with the European Union. That is uncertainty on toast and it is not acceptable. Although the Minister has said—I have heard this in meetings—that this issue has nothing to do with the Bill before us, I am told, and accept, that it does. For example, a shipment of isotopes falls within Council Regulation (Euratom) No. 1493/93 as amended—it is still in force as amended. This regulation is designed to safeguard health workers and the general public against ionising radiation, and that is stated as its purpose in the recital of the regulation.

Although that regulation recognises the removal of border controls within the EU, in order to protect the public, including those who receive medical isotopes, it provides a notification system. Not only has it become a safeguarding system but it is a system that has been used to ensure the regular and steady supply of fresh medical isotopes. It provides for the safe and speedy transfer of the products concerned. It involves so-called “competent authorities” in each country—in the UK the main authority is the Office for Nuclear Regulation—which devolve responsibilities to others, such as the Environment Agency, and, importantly, its counterparts in Scotland and Wales. There is a devolution issue here too, although that seems to have been overlooked.

The Government say that this part of Euratom’s statutory activity can be consigned to those later and general negotiations about the transfer of goods and services between the UK and the EU—the same category as applies to, for example, the importation of processed croques-monsieur into the United Kingdom. I do not accept that; it is much too important. That promise—if it be a promise—provides no assurance whatever for continuity. Indeed, it raises the prospect of UK patients, if they can afford it, having to travel for this kind of treatment to France and Germany, where such isotopes are manufactured. I suppose that it also provides the insurance industry with a potential bonanza, cashing in on a new form of insurance that enables those who take private medical insurance to buy treatment in countries abroad as part of their policy.

Major suppliers of radiopharmaceuticals in the European Union have confirmed that the current arrangements, which are made, so they tell us via Euratom, ensure the timely supply of material from the point of manufacture to patients in the UK. That includes such urgency that the product can be delivered and then reporting arrangements can be used retrospectively in cases of urgency. It is a very important part of medical treatment.

There is also the issue of resilience of supply of medical isotopes. The UK, due to the work of the European observatory, is in a better position to be able to rely on a fair share of radiopharmaceuticals from Europe without fear of loss of supply. But the continuation of these advantageous arrangements—they benefit hospitals such as the Royal Free, University College Hospital, London and other places where important cancer treatments are carried out or clinical trials are being performed—is critical for such places, given that we manufacture none in the UK and suppliers in South Africa, as I said earlier, and also in Canada have major production issues.

There are issues that worry the industry around three other matters. First, the potential uncertainty of UK participation in future Euratom research projects that engage British academics and others will either reduce UK-based expertise or, worse, drive most nuclear physicists to go and work in other countries. Secondly, there is the designation of professionals as medical physicists. The recognised standards entitling scientists to be designated as medical physicists are arranged under the umbrella of Euratom, with a requirement for all relevant clinics to employ such a person. Thirdly, standard designations apply to medical isotopes just as they apply to any other goods. Those are currently agreed on an EU basis, which is based on conversations within Euratom.

There is an overwhelming case for provision in the Bill for the medical isotope matters to be the subject of assurance for the future. They should be included, and I look forward to debates in Committee on that subject.