Nuclear Safeguards Bill — House of Lords, 2018-02-07
Topic: Health
Alexander Carlile (Crossbench, Unknown): 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.