The nuclear industry lobby is desperate for the UK to remain in Euratom, as it would mean the massive subsidies they receive for research and development via Euratom would be lost. But they don't believe such concerns would really bother most politicians, but claiming Brexatom would result in loss of radioactive isotope supplies for medical diagnoses, which does concern the public and politicians. So they have made a huge song and dance - successfully- over this red herring claim, to keep the UK in Euratom. Below is the latest in this ongoing saga.
Nuclear research and medical isotopes
European Scrutiny Committee, 15 January 2018
Committee’s assessment
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Politically important
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Cleared from scrutiny; further information requested; drawn to the attention of the Business, Energy and Industrial Strategy and Health Committees
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Document details
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Proposal for a Council Decision on the adoption of the 2016–2019 High Flux Reactor supplementary research programme to be implemented by the Joint Research Centre for the European Atomic Energy Community.
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Legal base
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Article 7 of the Treaty establishing the European Atomic Energy Community (Euratom)
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Department
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Business, Energy and Industrial Strategy, and Health
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Document Number
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(38639), 7892/17, COM(17) 83
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Summary and Committee’s conclusions
4.1At EU-level, nuclear research is coordinated by the European Commission as part its responsibilities under Euratom. One of Euratom’s research projects is based at the High Flux Reactor (HFR), a nuclear research reactor located in Petten (the Netherlands). The HFR is one of the world’s better known multi-purpose research and test reactors. The reactor has also been increasingly involved with medicine around Europe, as a key producer of medical radio-isotopes, some of which it provides to the UK (see below). Medical isotopes, primarily technetium-99m or Tc-99m, are used to detect and treat certain types of cancer.
4.2On 31 March 2017, the European Commission presented a proposal for a new research programme for the reactor to cover the period 2016–2019. Its key objectives would be to allow efficient use of the HFR by research institutes in a broad range of disciplines, including improvement of the safety of nuclear reactors, nuclear medicine including the development of medical isotopes, nuclear fusion, and management of nuclear waste.
4.3The Explanatory Memorandum on the proposal for the reactor’s new research programme, submitted by then-Minister of State Jesse Norman in April 2017, noted that the UK will not contribute financially to the project, or be a participant in the research undertaken. The proposal was formally adopted by the Council on 29 May 2017, before it was cleared from scrutiny.16 On 28 July, the new Minister for Energy and Industry (Richard Harrington) informed us that the Government had overridden scrutiny to vote in favour of the proposal, because “failure to support this decision would have required a high profile intervention in Council by a UK minister in a manner likely to be perceived as antagonistic”.
4.4While the substance of the proposal was not controversial, its political context is—of course—Brexit. The Prime Minister’s formal notification of the UK’s withdrawal from the EU under Article 50 of the Treaty on European Union (TEU) also included Euratom.17 Nuclear industry stakeholders have expressed concerns that the two-year negotiating period under Article 50 is insufficient for the UK to replicate Euratom’s existing regulatory safeguards regime for nuclear facilities domestically and agree new cooperation agreements with the EU, the IAEA and third countries. In addition, the medical establishment has warned that withdrawal from Euratom could impact on the availability and cost of medical isotopes in the UK post-Brexit.18
4.5Given the HFR’s prominent role in the production of molybdenum-99, the decay product of which is the medical isotope Tc-99m, the previous Committee in its consideration of the Commission proposal in April 2017 focussed primarily on the implications of Brexit—specifically, withdrawal from Euratom—for the UK’s access to medical radio-isotopes for use in hospitals. The Committee also discussed the broader implications of the UK’s exit from the Atomic Energy Community.19
4.6On 28 July, the new Minister for Energy (Richard Harrington) replied to our predecessors’ letter of 25 April. He noted that the Government had not conducted a formal impact assessment on leaving Euratom, but emphatically confirmed that the UK’s ability to import medical isotopes from the EU or the rest of the world “will not be affected by withdrawal from Euratom”. He also acknowledged the nuclear industry’s broader concerns about the UK’s exit from Euratom, noting that an “unsatisfactory withdrawal risks significant impacts for the nuclear sector”.
4.7Representatives of the medical profession gave evidence to the House of Lords on the potential implications of Brexit for the supply of radio-isotopes on 22 November. Representatives of the British Medical Association, the British Nuclear Medicine Society and the Royal College of Radiologists urged the Government to provide more detail on the exact procedures that will apply to transports of such products after Brexit. They expressed particular concerns about the possibility of new customs controls on transports from the EU. The delays resulting from such controls could necessitate a new approach to importation given that any delays could render the isotopes useless.20
4.8The proposed supplementary research programme for the High Flux Reactor did not raise any issues of substance, and we are content to clear the document from scrutiny. We also accept the Minister’s reasoning for the override of scrutiny on this proposal, in view of its uncontroversial nature.
4.9With respect to the supply of medical isotopes post-Brexit, we have taken note of the Minister’s assurance that the UK’s ability to import medical isotopes from the EU or the rest of the world will not be affected by withdrawal from Euratom. However, medical isotopes are covered by the organisation’s common market for nuclear materials and the wider absence of customs controls within the Single Market, of which the UK will cease to be a Member in March 2019. We ask the Minister to clarify urgently:
- what arrangements will apply to the import of medical isotopes from the EU during any post-Brexit implementation period of around two years as proposed by the Prime Minister during her Florence speech; and
- what assessment has been made of additional customs controls on transports of radio-isotopes from the EU to the UK after Brexit, and how those would be mitigated in view of the short half-life of the product.
4.10We note that, largely through the European Observatory on the Supply of Medical Radioisotopes, the Euratom Supply Agency (ESA) has an important function in relation to the coordination of security of supply, particularly following the 2008–10 supply shortage, which had a serious clinical impact in the UK. The ESA is also at the forefront of efforts to consider future EU supply of enriched uranium, which is required for the production of medical radioisotopes. We ask that the Minister clarify:
- how, in the light of the serious 2008–10 supply shortage and the shutdown of supply reactors in Canada and the Netherlands, the Government plans to replace the security of supply function currently fulfilled by the Euratom Supply Agency; and
- in the absence of engagement in the Euratom Supply Agency, what steps the Government plans to take to assure the supply of enriched uranium.
4.11We expect to receive his response by 2 February 2018. We draw this chapter to the attention of the Business, Energy and Industrial Strategy and Health Committees.
Full details of the documents
Proposal for a Council Decision on the adoption of the 2016–2019 High Flux Reactor supplementary research programme to be implemented by the Joint Research Centre for the European Atomic Energy Community: (38639), 7892/17, COM(17) 83.
Background
4.12At EU-level, nuclear research is coordinated by the European Commission as part of its responsibilities under Euratom, formally the European Atomic Energy Community. Euratom, which was established alongside the European Economic Community in 1957, created a common market for the nuclear industry. It also sets safety standards for nuclear facilities and transport of materials; carries out safeguarding inspections of nuclear facilities in its Member States; and has responsibility for Member States’ international nuclear cooperation agreements with third countries, including Canada, Japan and the USA.
4.13Euratom is a separate legal entity from the EU, but shares its institutions. The Prime Minister’s formal notification of the UK’s withdrawal under Article 50 of the Treaty on European Union (TEU) also included Euratom,21 although there is some ambiguity as to whether this was necessary as a matter of law.22
High Flux Reactor
4.14One of Euratom’s research projects is based at the High Flux Reactor (HFR), a nuclear research reactor located in Petten (the Netherlands). Since the HFR is an asset belonging to the Commission, all EU Member States have an indirect interest in its operation as they all benefit from data from the programme of experimentation from the reactor.
4.15The HFR is one of the world’s better known multi-purpose research and test reactors. Since 1963, it has offered irradiation and post-irradiation examination services. In addition, it provides services such as processing materials with neutrons and gamma rays, and acts as a training facility hosting doctoral and post-doctoral researchers. The reactor has also been increasingly involved with medicine around Europe, as a key producer of medical radio-isotopes, some of which it provides to the UK (see below).
4.16In addition to the reactor’s day-to-day activities, supplementary research programmes are set on a multi-annual basis by the Council, voting unanimously, on a proposal from the Commission.23 The research objectives of the HFR for 2012–2015 were adopted by EU Finance Ministers in November 2012.24 On 31 March 2017 the European Commission presented a proposal for a new research programme for the reactor to cover the period 2016–2019.25 The costs of the proposed supplementary research programme are borne by Netherlands and France.
4.17The key scientific and technical objectives of the proposal are the following:
- To ensure safe and reliable operation of the HFR, in order to guarantee the availability of the neutron flux for experimental purposes; and
- To allow efficient use of the HFR by research institutes in a broad range of disciplines, including improvement of safety of nuclear reactors, nuclear medicine including the development of medical isotopes, nuclear fusion, and management of nuclear waste.
4.18The Explanatory Memorandum on the proposal for the reactor’s new research programme, submitted by then-Minister of State Jesse Norman on 19 April, noted that the UK will not contribute financially to the project, or be a participant in the research undertaken. The Minister added, however, that research from the HFR “contributes to the overall knowledge base for nuclear energy technology accessible to the UK and its partners”.26
4.19The proposal was formally adopted by the Council on 29 May 2017, before it was cleared from scrutiny.27 On 28 July, the new Minister for Energy and Industry (Richard Harrington) informed us that the Government had overridden scrutiny to vote in favour of the proposal, because “failure to support this decision would have required a high profile intervention in Council by a UK minister in a manner likely to be perceived as antagonistic”. He also argued that it would have resulted in delays “that could have caused significant financial hardship for the national research establishments of fellow Member States”.28
Nuclear research and medical isotopes
4.20When the Committee considered the HFR proposal at its meeting on 25 April 2017, it was primarily interested in the implications of Brexit—specifically, withdrawal from Euratom—for the UK’s access to medical radioisotopes for use in hospitals. The new 2016–2019 supplementary research programme explicitly identifies the production of such isotopes as one of its objectives. The Committee also discussed the broader implications of the UK’s exit from the Atomic Energy Community (see paragraphs 4.24 to 4.28 below).
4.21Medical isotopes can be used to detect serious diseases (including cancer of the bone, cardiac, lung and kidney) at an early stage, before other scanning methods are capable of doing so. They are also used for surgical procedures in patients with breast and other cancers such as melanoma. However, the UK currently does not produce any molybdenum-99 (99Mo), the decay product of which (technetium-99m or Tc-99m) is ultimately used for 90% of medical interventions involving radio isotopes.29 The UK is entirely reliant on import from other countries. The material cannot be stockpiled as it has a half-life of only 66 hours.
4.22The Petten High Flux Reactor is a crucial producer of radioisotopes, with the supply it generates covering more than 60% of all the 10 million medical diagnoses executed each year in Europe. Moreover, through its location, the output of the reactor can be rapidly transported to European medical centres. For these reasons, the European Commission has called it a “fundamental supplier for European radiopharmaceutical companies in this field”. In England, approximately half a million scans are performed annually using imported radioisotopes,30 while more than 10,000 patients across the UK have their cancers directly treated by these materials each year.31
4.23To make the supply of medical isotopes more secure, the European Commission in 2012 established a European Observatory on the Supply of Medical Radioisotopes.32 Its objectives are to support a secure 99Mo, supply across the EU, principally by coordinating reactor shutdowns so production in Europe is never entirely interrupted.33 The Commission has previously suggested more active EU intervention in the market for medical isotopes, for example via loans34 to support production, or through a Joint Undertaking which could actually take control of the production cycle.35 It will publish a strategy paper setting out its recommendation for further EU-level measures in this field in 2018.36
Impact of withdrawal from Euratom on the UK
4.24On 23 February 2017 the Financial Times reported that Fiona Rayment, Director of the National Nuclear Laboratory (which is owned by the Department for Business, Energy and Industrial Strategy) had said that imports of medical isotopes “would not be possible without new regulatory agreements after [UK] withdrawal from Euratom”. The Royal College of Radiologists has also said that it is “seriously concerned about continued access to [imported medical isotopes] if we leave the Euratom treaty”, as well as about potential “increased radioisotope pricing”.37 Similarly, the British Nuclear Medicine Society has argued that “leaving Euratom will impact on the supply and cost of medical radioisotopes”.38
4.25In response to these concerns, the previous Committee wrote to the Minister on 25 April 2017 asking him whether the UK would still be able to import medical isotopes from the EU following Brexit if no new nuclear cooperation agreement was in place with Euratom on “exit day”.39 Our predecessors also asked him to clarify what proportion of isotopes used in British hospitals originated in nuclear reactors located in other EU Member States.
4.26The UK’s withdrawal from Euratom has raised a broader set of issues for the UK’s nuclear industry beyond the supply of medical isotopes. In the previous Parliament, the Business, Energy and Industrial Strategy Committee identified risks to quality of the UK’s safeguarding regime for nuclear materials and facilities; potential disruption to trade in nuclear materials (including uranium); and fewer opportunities for UK participation in international nuclear research programmes.40
4.27In light of these risks, the Nuclear Industry Association (NIA) has called for a transitional arrangement during which the UK would keep its current arrangements under Euratom post-Brexit, while a new agreements for nuclear cooperation are concluded with the EU, the International Atomic Energy Agency (IAEA) and third countries.41 If the UK cannot put in place a domestic regulatory regime and replace existing agreements by “exit day”, both imports and exports of nuclear material and technology could be severely disrupted.42
4.28Given the potential consequences of a disruptive exit from Euratom, the previous Committee therefore also asked the Minister to supply Parliament with the Government’s overall assessment of the consequences of leaving the Atomic Energy Community, including for the supply of equipment for the nuclear industry and the transfer of responsibilities (such as safeguard inspections) currently performed by Euratom staff.
The Government’s view
4.29On 13 July 2017, the Government published a position paper on its approach to the UK’s withdrawal from Euratom,43 and on 28 July the Minister replied to our predecessors’ letter of 25 April with respect to the questions raised about the supply of medical isotopes.44
4.30He reiterates his position from the Westminster Hall debate of 12 July, in which he called for the UK to have a “constructive, collaborative relationship with Euratom”.45 With respect to the supply of medical isotopes, he states that the UK will still be able to import Tc-99m irrespective of its withdrawal from the EU and Euratom:
“It is correct that medical isotopes are currently governed and regulated under the Euratom framework, however Euratom places no restrictions on the export of these isotopes to countries outside of the EU. Moreover, these isotopes are not subject to Euratom Supply Agency contracts or to Euratom nuclear safeguards arrangements, meaning that there are no special arrangements that will need to be put in place ahead of the UK’s withdrawal from Euratom. Therefore, the UK’s ability to import medical isotopes from the EU or the rest of the world will not be affected by withdrawal from Euratom.”
4.31He also notes that there are three main companies in the UK that import molybdenum-99, sourcing supplies from reactors mainly in Europe, but also from South Africa. He was unable to supply us with data on the proportion of Mo-99 imported from the EU, saying that “this data will be held by the companies”.
4.32We note that, the Minister’s unequivocal statement about the availability of radioisotopes after Brexit has not assuaged the concerns of the medical profession. In November 2017 representatives of the British Medical Association, the British Nuclear Medicine Society and the Royal College of Radiologists urged the Government to provide more detail on the exact procedures that will apply to transports of such products from the EU into the UK after Brexit, in particular with regards to new customs controls and resulting delays, which could render the isotopes useless.46
4.33With respect to the nuclear industry’s broader concerns about the UK’s exit from Euratom, the Minister acknowledges that an “unsatisfactory withdrawal risks significant impacts for the nuclear sector”. He adds that, in order to ensure no interruption in the “quality and robustness of our civil nuclear regime”, a “new team in the Department has been established and tasked with, among other work, taking forward negotiations with the EU, nuclear cooperation agreements with key partner states and establishing a domestic safeguards regime”.
4.34The Minister signs off by saying that the Government did not conduct a formal impact assessment of leaving Euratom, but explains that “detailed assessment of the impact and implications of leaving were made through dialogue and engagement with the nuclear industry, the R&D community and the independent regulator”. We note in this respect that the Nuclear Industry Association has said that it “made the case to Government that it [was] not necessary to leave Euratom as part of the Brexit process”.47 It appears that the UK may effectively remain a member of Euratom (albeit without political representation) during the “implementation period” sought by the Government. We have considered the exact implications of this development elsewhere in this Report.
Previous Committee Reports
None.
16 Competitiveness Council conclusions, 29–30 May 2017.
17 Letter from Theresa May to Donald Tusk (29 March 2017), p. 1.
18 See for example the Royal College of Radiologists, “RCR statement on the potential impact of leaving the Euratom treaty“ (10 July 2017) or the BNMS, “British Nuclear Medicine Society statement on leaving Euratom“ (July 2017).
19 In the previous Parliament, the Business, Energy & Industrial Strategy Committee identified a number of risks flowing from the UK’s decision to quit Euratom. These related to the UK’s safeguarding regime for nuclear materials and facilities; potential disruption to trade in nuclear materials (including uranium); and fewer opportunities for UK participation in international nuclear research programmes.
20 House of Lords EU Committee, “Health implications of leaving Euratom explored by Committee in one-off session“ (22 November 2017).
21 Letter from Theresa May to Donald Tusk (29 March 2017), p. 1.
22 Nuclear Industry Association, “Exiting Euratom” (accessed 9 January 2018): “The NIA and its members believe it is not necessary to leave Euratom as part of the Brexit process”.
24 See Council Decision 2012/709/Euratom of 13 November 2012.
26 Explanatory Memorandum submitted by the Department for Business, Energy & Industrial Strategy (19 April 2017).
27 Competiveness Council, “Outcome of the Council meeting“ (29–30 May 2017).
29 There are also a number of other medical radioisotopes that the UK imports including I-131, which is used for the treatment of thyroid cancer, Ra-223 used in the treatment of bone tumours and Lu-177 that is used for the treatment of neuroendocrine tumours. However, the material used for PET/CT scanning is produced domestically in the UK.
30 For the figures for 2016–17, see “Diagnostic Imaging Dataset Statistical Release“ (18 May 2017), p. 7.
31 BSNM, “Future Supply of Medical Radioisotopes for the UK“ (2014).
32 See the European Commission website for more information.
34 See Article 172 of the Euratom Treaty.
35 See Commission Communication COM(2010) 423, “Medical applications of ionizing radiation and security of supply of radioisotopes for nuclear medicine“ (8 July 2010).
36 See “Outcome of the Council meeting“ (6 and 7 June 2016).
37 Royal College of Radiologists, “RCR statement on the potential impact of leaving the Euratom treaty“ (10 July 2017).
38 BNMS, “British Nuclear Medicine Society statement on leaving Euratom“ (July 2017).
39 Letter from Sir William Cash to Jesse Norman (25 April 2017).
40 Business, Energy and Industrial Strategy Committee, Leaving the EU: negotiation priorities for energy and climate change policy, 25 April 2017, HC 909.
41 The EU Treaties Office lists 107 agreements to which Euratom is party, and which by extension cover the UK until it leaves the EU. These include agreements with Australia, Canada and Kazakhstan on the transfer of uranium. Together, these three countries provide 65% of the global supply. The agreements were concluded (ratified) by Euratom under its exclusive competence, and as such the UK is not independently party to them.
42 NIA, “The UK’s withdrawal from Euratom“ (May 2017).
43 DExEU, “Position paper: nuclear materials and safeguards issues“ (13 July 2017).
44 Letter from Richard Harrington to the Chair of the European Scrutiny Committee (28 July 2017). This is a separate letter from the Minister’s other letter, also dated 28 July (see paragraph 4.19 above).
46 House of Lords EU Committee, “Health implications of leaving Euratom explored by Committee in one-off session“ (22 November 2017).
47 NIA, “The UK’s withdrawal from Euratom“ (May 2017), p. 1.
The Commons European scrutiny committee
said in a statement:
The committee’s concern comes in the light
of the serious shortage of radioisotopes [from 2008 to 2010] due to the
prolonged shutdown of supply reactors in Canada and the Netherlands. The
principal material, Molybdenum-99, is not produced in the UK and its decay
product (Technetium-99m) is ultimately used for 90% of medical interventions
involving radioisotopes. Molybdenum cannot be stockpiled as it has a half-life
of only 66 hours.
The security of supply of isotopes is
currently fulfilled by the Euratom Supply Agency. Euratom provides the basis
for the regulation of civilian nuclear activity, implements a system of
safeguards to control the use of nuclear materials and controls the supply of
fissile materials within EU member states. The UK’s future relationship with
Euratom has emerged as a significant issue in the negotiations between the UK
and the EU on EU withdrawal.
The European Commission warns that the
supply of medical radioisotopes is becoming more fragile and requires a more
coordinated approach. The European Scrutiny Committee seeks assurance from the
Government and an explanation of how the UK will develop its own policy.
Dr Philippa Whitford, an SNP member of the committee, said:
I was working as a breast cancer surgeon
during the Technetium shortage which lasted well over a year. During that time
we were faced with having to ration bone scans to only the most urgent or
worrying cases.
In addition it held back the roll out of
Sentinel Node Biopsy technique across the UK which has since allowed much less
destructive surgery to be used when staging the spread of breast cancer. With
all of these reactors nearing the end of their working lives, the Euratom
Supply Agency plays an important role in avoiding such a shortage in the
future.
Health implications of leaving Euratom explored by Committee in one-off session
22 November 2017
The EU Home Affairs Sub-Committee takes evidence from medical practitioners on the health implications of leaving Euratom. The evidence session covers the implications of leaving Euratom on the safe and timely transport and delivery of medical radioisotopes, and the options available for future relations with Euratom.
Witnesses
Wednesday 22 November, Committee Room 3, Palace of WestminsterAt 10.30am
- Professor Michael Rees, Co-Chair of the Medical Academic Staff Committee, BMA
- Dr John Buscombe, President-Elect, British Nuclear Medicine Society
- Dr Jeanette Dickson, Vice President, Faculty of Clinical Oncology, Royal College of Radiologists
Possible questions
- What medical products and procedures are likely to be impacted by the UK's departure from the Euratom treaty?
- What would you identify as the key safeguards in the Euratom Treaty for the safe and timely transport and delivery of medical radioisotopes? What safeguards will need to be maintained in the future?
- What are the implications for hospitals and other health providers and for patients of a disruption to the supply of radioisotopes?
- Do you foresee any opportunities arising from leaving Euratom for your members or for patients in the UK? Should the UK invest in alternative technologies to produce radioisotopes? What other steps could mitigate any negative consequences of leaving Euratom?
Professor Michael Rees, Co-Chair of the Medical Academic Staff Committee, BMA; Dr John Buscombe, President-Elect, British Nuclear Medicine Society; Dr Jeanette Dickson, Vice President, Faculty of Clinical Oncology, Royal College of Radiologists.
Select Committee on the European Union
Home Affairs Sub-Committee
Uncorrected oral evidence:
Brexatom: the health implications of leaving Euratom
Wednesday 22 November 2017
10.30 am
Members present: Lord Jay of Ewelme (The Chairman); Lord Crisp; Baroness Janke; Lord Kirkhope of Harrogate; Lord O'Neill of Clackmannan; Baroness Pinnock; Lord Ribeiro; Lord Soley; Lord Watts.
Evidence Session No. 1 Heard in Public Questions 1 - 11
Witnesses
I: Professor Michael Rees, Co-Chair of the Medical Academic Staff Committee, BMA; Dr John Buscombe, President-Elect, British Nuclear Medicine Society; Dr Jeanette Dickson, Vice President, Faculty of Clinical Oncology, Royal College of Radiologists.
USE OF THE TRANSCRIPT
- This is an uncorrected transcript of evidence taken in public and webcast on www.parliamentlive.tv.
- Any public use of, or reference to, the contents should make clear that neither Members nor witnesses have had the opportunity to correct the record. If in doubt as to the propriety of using the transcript, please contact the Clerk of the Committee.
- Members and witnesses are asked to send corrections to the Clerk of the Committee within 7 days of receipt.
Professor Michael Rees, Dr John Buscombe and Dr Jeanette Dickson.
Q1 The Chairman: Welcome. Thank you very much for coming and giving evidence to this Committee today. Many potential consequences of Brexit were not looked at in any detail at all either before or immediately after the referendum, one of which was the impact of leaving Euratom, which I am not sure how you pronounce but it will look the same in print. The EU Energy and Environment Committee is looking at the broader consequences of leaving Euratom, but in this Committee we wanted to look specifically at what the implications might be for our access to medical isotopes if we were to leave Euratom, and we are grateful to you all for coming to give evidence to us. We have interrupted our usual inquiry to have one session on what struck us all as a potentially extremely important subject. That is the background. I would be grateful if you would introduce yourselves. If you want to make any kind of initial statement, that is fine; otherwise, we will move on to the questions that we have, and maybe one or two others will be interlaced with them.
Dr Jeanette Dickson: I am a consultant clinical oncologist and the vice-president for clinical oncology at the Royal College of Radiologists.
Professor Michael Rees: I am a nuclear medicine physician and cardiac radiologist. I work with Bangor University and the Betsi Cadwaladr University Health Board.
Dr John Buscombe: I am a consultant nuclear medicine physician in Cambridge and the president-elect of the British Nuclear Medicine Society.
Q2 The Chairman: Thank you. As a technical point, the acoustics are not brilliant in this room, so if we can all speak up, the chances of our getting through both to people at the back and to us here will be that much greater.
I begin by asking you two things. First, what medical products and procedures do you think are likely to be impacted by the UK’s departure from the Euratom treaty? At the same time, can you give us a sense of the size and scope of the UK’s reliance on medical radioisotopes and the importance of those procedures and treatments for patients and for medical research? There is a general question and a slightly more specific one.
Dr John Buscombe: As a general nuclear medicine physician, I will start. We use medical radioactive isotopes for a range of diagnostic tests. I suppose the most commonly understood one is for cancer, but we also deal with a lot of significant non-cancer conditions such as heart disease, kidney disease and bone disease. From our survey in the British Nuclear Medicine Society, we think that it is used for around 700,000 patients a year. However, we know that we underreport the number of studies, so the number is probably closer to 1 million across the United Kingdom: that is, in all the nations in the United Kingdom.
We also have a significant therapeutic arm using unsealed sources, which includes iodine-131 for thyroid diseases and new treatments such as radium for bone metastasis in prostate cancer. There is also a new treatment called Lutathera, which is used to treat a rare condition called neuroendocrine tumour and is almost the only effective treatment for that condition.
Around 80% of these radioisotopes are imported from outside the UK. The majority are from the European Union but not exclusively; we have some imports from Australia, South Africa and the United States. Some products are made here in the UK, and we have a significant radiopharmaceutical company in the United Kingdom. It does not produce the base radioactive products, but it does a lot of the processing and then exporting of those products.
The Chairman: Exporting?
Dr John Buscombe: Yes, we also export. The company used to be the Radiochemical Centre, then it became Amersham plc, and it is now GE Healthcare. It is a major exporter of radioisotopic products. Across the world, different countries tend to produce different products, which are then sold worldwide. Setting up the production when you use things like reactors and cyclotrons is expensive, so there tends to be a dovetailing of work across the whole world. The world works as one sort of co-operative group and Europe works as a closer co-operative group.
The Chairman: Do the products that we export have the same problems of a very short half-life?
Dr John Buscombe: Absolutely. It is exactly the same. We have importation for our patients, but obviously export will affect patients in other parts of Europe and the world. Obviously, if countries are outside Euratom, I understand that it may be less complex, but there still need to be arrangements to enable that to happen.
The Chairman: We will come to that later.
Dr John Buscombe: So probably around 1 million patients are affected in the United Kingdom each year.
Professor Michael Rees: I will talk a bit about research. I am co-chair of the BMA’s Medical Academic Staff Committee, so we are concerned with research, which is important to the UK. Euratom is a major contributor to the Horizon 2020 programme, and the UK has benefited by about £32 million for nuclear research under that programme.
The wider aspects of research into the nuclear industry are also important. My own university, for instance, has just established a new nuclear research centre with a grant that is partly from the Welsh Government and partly from the EU, which is worth £6 million. Locally, we are very interested in the development of the new Wylfa nuclear power station.
On the question of research generally, co-operation with Euratom and with the various programmes is very important to universities and to medical research. My colleagues will probably talk a little more about that, but a developing area of medical research is neurochemistry and immuno-treatments involving isotopes for cancers. It is a very important area that we have to maintain.
The Chairman: Do you feel that the research—I am not talking about the medical isotopes but the actual research—is threatened by our leaving Euratom? Is that a worry to you and your colleagues?
Professor Michael Rees: It is a significant worry to us, because, if one takes it together with the EU research programmes, there is no other research funding organisation like it. Universities are a net beneficiary of money that we put into the EU for research, and a great deal of UK-based research is dependent on those types of programmes and on importing expertise. In our own university, if we are going to bring in nuclear scientists we have to make sure that there is a free exchange and the ability for those scientists to come to work here.
The Chairman: Thank you.
Dr Jeanette Dickson: The diagnostic use of radioisotopes has been touched on, so I will talk a bit about their therapeutic use, especially for malignant diseases. Certainly for cancer of the cervix, iridium is a radioactive isotope that we use for delivering brachytherapy, which is a type of radiation that is delivered internally to the patient. Cancer of the cervix is pretty much dependent on that for a cure, in combination with other types of radiotherapy. Cancer of the cervix is a relatively rare cancer affecting 3,500 patients a year. About half of those require brachytherapy, and they require the whole treatment to be delivered in no more than 42 days, so there is that time pressure or the cure rates reduce.
In terms of other radioisotopes, for brachytherapy for prostate cancer we use an iodine-125 isotope, which is inserted into the patient on a permanent basis. About 500 procedures are done in the UK, although it is difficult to be absolutely precise about the reporting of that.
The Chairman: Five hundred a year?
Dr Jeanette Dickson: Yes, and they are patients who would otherwise go for surgery with a different set of side effects or who are unsuitable for surgery and would have to have other treatment with different side effects. It is the same with advanced prostate cancer; the iridium isotope that I spoke about is often used as a boost to external beam treatment. If used on its own, rather than giving external treatment it is used internally but in a temporary fashion. Again, its use is increasing significantly, but at present there are about 500 patients per year in the UK.
There are a lot of uses of medical radioisotopes in oncology, and often in a curative setting. We have touched on palliative treatment and the improvement in symptoms and survival from injected radioisotopes; radium-223 is one of the classic ones.
The Chairman: Thank you very much. You have raised a number of points which I am sure we will come to in our hearing.
Q3 Lord O'Neill of Clackmannan: We know that the Euratom treaty covers a variety of areas, but could you identify the key safeguards for safe and timely transport? It seems that the shelf-life is very limited and it is essential that things go through without interruption.
Beyond Euratom and our membership of it, what would we need to maintain to ensure that the supply was as consistent and safe as it is at the moment? Indeed, could it be better?
Dr John Buscombe: My understanding is that the advantage of being in the Euratom group is that we can transport radioisotopes without prior warning and consent. Obviously, I cannot write you a prescription for radioiodine for you to go down to Boots to collect it. There are very significant rules and regulations about transportation, importation and exportation. For very obvious security reasons you want to know where every isotope is, from the moment it leaves the factory to the moment it goes into a patient. Every single batch has to be tracked.
At the moment across Europe, that is much easier because we are operating as a single market, so there is no equivalent stop at a customs point to check it. Obviously it is not so much what we need to keep but what we need to create. We would need to create a system that is similar to the one we use for radioisotopes that come from outside the EU, which is around 20% of what we import. Again, all things are possible and achievable; it is a question of how it is done and the timescale. The same arrangements that we have for isotopes from outside the EU would now need to occur for all the radioisotopes that come from inside the EU.
Let us get down to a practical point: most of the radioisotopes in the EU come on a van through the Channel Tunnel at night. That seems to be the quickest and easiest way. If, however, that is all clogged up with lorries trying to get through customs, how does my little van with my radioisotope get through if it is a priority product? It often comes down to very practical things and how we build a system around them. The problem is that we have a very limited time in which to build that system and make sure that everything is in place.
That is our concern: this really needs to come to the fore of the great minds who are thinking about how we are going to arrange how we deal with being outside Euratom—if we go outside Euratom—and get all these things in place ready to go from day one to make that things are not delayed. Unlike normal pills and potions, radioisotopes have a half-life, which means that the thing decays away. If there is a delay, less is delivered. If less is delivered, you need to buy more, which will cost more, let alone the tariffs that could be added to the cost. These costs will be borne by the British taxpayer through the NHS.
I also understand that unless we have an agreement on medicines, which are also pharmaceuticals—an added complication—we need a mutual recognition agreement between countries to enable us to transfer a pharmaceutical. It potentially means that if they come to the EU they cannot be distributed without being quality-checked again by a qualified pharmacist, which would again add delay and cost. There would be a whole series of different bands, and one of the problems is that it is so complex; it involves security, transport, medicines, pharmaceuticals, and the Environment Agency—we do not want any of these going missing in the environment—so one problem is that we have no single voice in government. We have multiple voices who are just looking at the facet that they are interested in. That might not tie up with facets from other groups. One of our pleas is to have a unified approach to the whole problem, from all the government ministries and agencies involved.
Professor Michael Rees: Europe has the most secure and largest producers and processors of medical radioisotopes. Alternative countries that could supply us are South Africa, Australia and Russia. I think Russia has ambitions to become a net exporter. If we import isotopes from South Africa, we know that we lose 20% of the activity by the time it reaches us.
Our radiopharmacists in north Wales—we have three hospitals there—are always on the phone asking, “Are we going to get our next consignment?” Currently we are reasonably secure. We have had two episodes in the past where European and Canadian reactors have gone down and we have had to cancel patients’ appointments. We have to carefully adjust the patient appointments to the supply of radioisotope. We cannot simply say that they can go and have a CT scan; we have to plan everything very carefully.
Q4 Lord Kirkhope of Harrogate: I think we started to touch on this, but I wanted to probe further the assumption that if we come out of the Euratom treaty on leaving the EU we become a third country. The Government have suggested that we might have a so-called association agreement and agreements with other countries. Is there a default position on continuing to import the radioisotopes if we have no other agreement when we leave? In your experience, to what extent are alternative arrangements possible? How much time do they take to organise? Is it an easy marketplace for us to be able to find alternatives?
Professor Michael Rees: Perhaps I can help with that. I have already touched on the alternative supply from South Africa and the reduction. The commonest isotope is technetium, which has a half-life of six hours. It is produced in a generator from molybdenum-99, which has a half-life of 66 hours and is the isotope that is produced in the nuclear reactors and then processed. Anything that takes more time will start to count down from that 66 hours, so the further afield we source isotopes from and the longer it takes, the less activity we have and the greater the cost, which Dr Buscombe talked about.
The best arrangement is to have a source as close to the hospitals as possible, which at the moment is Europe. The alternatives are longer-term solutions to try to find some way of generating our own isotopes. Research is going on into that, but we have a short-term problem that we need to try to address as effectively as we can to make sure that we are not putting additional barriers in the way of sourcing isotopes so we can diagnose and treat our patients.
Lord Kirkhope of Harrogate: This is a question from ignorance: can we have these things transported by air?
Professor Michael Rees: Yes.
Dr John Buscombe: Most of our non-EU product comes to Coventry, which has a very good facility for looking after these radioisotopes. They have customs officers who are very well trained. They know what paperwork to look for. You need to have pre-consent and pre-agreement. Paperwork comes through first, then the radioactive product. They are matched up and dispatched. They are very good, but will they cope with four times the amount of work? I do not know. That is the problem.
Some EU countries, such as the Netherlands, will not allow radioisotopes to leave their country by air. If we want product made in the Netherlands, it will need to be transported by road to an airport outside the Netherlands and then be sent. All this adds time and expense. The system has been designed to be as smooth, time-efficient and cost-efficient as possible. Everything is possible and achievable, but the question is whether it will just add cost and time to what is currently a working system.
The Chairman: Is the design of the system that you describe Euratom’s responsibility in some way at the moment? Does our membership of Euratom give us a say in the design of the system that we would not have outside?
Professor Michael Rees: Yes. The Euratom treaty and the atomic supply agency have a European observatory that tends to oversee this and is working towards a seamless supply. The observatory monitors the supply of isotopes and tries to make sure that the seamless supply of isotopes is written into its purpose. If we come out and are not associated with that observatory or with the European supply agency, we will be a third country and a third party, and the future of that type of safeguard will be somewhat unknown.
Dr John Buscombe: Of course, it will affect the exports of our industry that makes this product. We employ very well-paid and well-qualified scientists and producing agents in GE Healthcare in Buckinghamshire. They will be affected by this, because it will be more difficult for them to compete and export into Europe. If they feel that they cannot do that and that they would rather do that within Europe, our last home production would also go. It would mean that most of the isotopes that we use, except for some of the ones that we can make locally, will have to be imported. As I said, there are wheels within wheels across different departments. It makes it very difficult to have a unified idea of what will happen.
Q5 Lord Ribeiro: On the basis of a unified idea of what will happen, do we currently have a unified system for allowing the transportation of radioisotopes across Europe?
Professor Michael Rees: Yes. European Council Regulation 1493/93 covers transport. It is the regulation which all the European countries that are part of Euratom follow. I am told that it makes the paperwork and the transport much easier. Again, if we come out of that process we will have to negotiate our own administrative arrangements, as Dr Buscombe indicated.
Lord Ribeiro: Presumably if we come out of the European Union, we will then have custom arrangements. Do you envisage that these will have a significant impact—you have already talked about the delay, et cetera—on getting hold of materials? I say that, because Jo Johnson is quoted as saying that this is not a fissile nuclear material and that medical isotopes are not covered by the arrangement.
Professor Michael Rees: They are covered by all the arrangements that safeguard patients and the public from unnecessary radiation exposure, which is another part of Euratom. We adhere to all the European directives on the safe use and safe transport of radiation material.
Lord Ribeiro: But it does not inhibit transportation.
Professor Michael Rees: It does not, but the materials have to be transported according to that regulation, which facilitates transport. At the same time, we have followed the European directives on radiation safety and exposure. That also comes down to how we practise nuclear medicine in our hospitals, how we dispose of nuclear materials and all that aspect of those safeguards.
Lord Ribeiro: Do either of you want to add to that?
Dr John Buscombe: No. That has been put very well.
Q6 Lord Ribeiro: Overall, then, what are the implications for hospitals and our patients if we experience a disruption of radioisotopes? We have already seen evidence of this from 2008-09. We were able to deal with that even though it affected patient care.
Dr John Buscombe: One reason why we could deal with it is because we knew it was time limited, so we could prioritise patients who needed scans done now and delay patients who could be delayed, although it was obviously inconvenient. We had to make a clinical choice, because we knew there was an end to the problem. This will not have an end, so we would need to look at it.
The problem is security of supply. We have certainly had problems with products coming in from places such as Canada in particular where they have just not turned up, they have been delayed or there has been a problem with paperwork. They just do not turn up to the hospital. You end up with a patient who is ready for treatment and who may be occupying a bed—as you all know, beds in the NHS are precious object to have—and you cannot treat them or scan them. They then need to be rebooked. Because the stuff has decayed while you have waited for it to be delivered you cannot use it again. You have to order a whole new order, which can take two weeks to produce.
Patients’ treatments can be significantly delayed. I am sure it will not happen with everybody, but the possibility of that happening increases if we have to have things go through borders and customs checks. It adds to the complication. We are often pretty good at being pragmatic, but it would just mean that more patients’ scans and treatments will be delayed than at present. Obviously that also adds to the cost. We are also acutely aware that we need to be cost efficient in everything we do in the NHS. Doing something that will add cost for no additional outcome is something we would like to avoid if we can.
Dr Jeanette Dickson: When we talk about patients being delayed and things like that, most of the time you can deliver another investigation, but not always as effectively. Most of those tests are done by radiologists. The workforce in radiology is in severe crisis. There are lots of vacancies. There is a lot of backlog. Releasing the capacity for those tests is not immediate. You cannot have a workforce doing nothing because something has not been delivered—apologies; they are not doing nothing, but they are switched to doing something else. The two parts of the workforce are very different. There is not the nimbleness to be able to substitute immediately.
Radiotherapy patients and especially prostate cancer patients can be treated in a different way, but that has a knock-on effect on capacity. Even if you are using only the internal brachytherapy treatment, that is a one-day treatment. External beam treatment takes somewhere between 20 and 40 days on a radiotherapy machine. There is no nimbleness of capacity to switch immediately, or it stretches capacity to do so. For things like cervical cancer, if you have an interrupted supply of iridium you are significantly diminishing patients’ chances of a cure.
Professor Michael Rees: The nuclear medicine workforce in this country is particularly dependent on EU doctors. About 30% of our workforce in nuclear medicine is from the EU. The BMA conducted a survey last week of the intentions of doctors who were EU nationals. Some 18% of them are intending to leave and 45% are thinking about it. If things went badly, we would lose a lot more. There is the important aspect of looking at our workforce, reassuring them and making sure that we do not inadvertently lose a particularly vulnerable group of doctors who take a long time to train and are in short supply.
Lord Ribeiro: You have all been very eloquent about the short-term problems that we face with this. Are there any long-term solutions, or is there a silver lining? In one of the briefings, you mentioned that we could be looking at proto-cyclotron treatment for producing our own technique for treatment. Are we being a bit pessimistic? How long would it take to do this?
Dr John Buscombe: I think that the record for the nuclear industry is 10 years longer than they say, sadly. The problem is cost. The advantage of the system that we have with these generators is that the cost of the technetium we use is very low; per patient it is just a few pounds.
The problem with anything to do with the cyclotron is that it tends to be quite expensive. For example, the most common product that we produce with the cyclotron is fluorine-18 for PET scanning. We can push the price down to about £120 per patient but not much below that. So, yes, it would be possible, but there would be a significant price hike. We are talking about 700,000 patients a year and multiplying that by the price hike, which again would have to be borne by the taxpayer through the NHS.
While we are very interested in this technology and think that it could be useful for a whole range of things—it certainly may be a solution 10 or 15 years down the line—it is not a medium-term solution. My suspicion is that any new technology tends to be more expensive than the old technologies; I think that is true in most of the world. Very seldom does something new cost less than what it replaces.
Professor Michael Rees: It is interesting to note that most of the nuclear reactors that produce medical isotopes are termed research reactors, so they are not commercial electricity-generating reactors. They have often arisen in conjunction with universities or out of research projects and do a number of things. We had a research reactor but we no longer have one.
It is theoretically possible to produce medical radioisotopes from commercial reactors. I think that Hinkley C will come on in 2025, so we might be able to produce some there in 2025. It is also theoretically possible to produce isotopes with the boiling water reactor, such as the one that it proposed for north Wales. These are, as I said, very long-term solutions. Shorter-term solutions might be to use alternative techniques, but the NHS does not have the capacity at the moment for us to suddenly switch 700,000 patient investigations to other techniques.
That leaves us with investing in cyclotron technology, which again is a research issue worldwide. It could be an area for the UK to invest in; we produce small amounts of diagnostic isotopes from cyclotrons and we could expand that, but all this will take time, effort and investment, particularly investment in research.
Lord Ribeiro: But it is not impossible?
Professor Michael Rees: No.
The Chairman: Can I follow up on that question? If you look ahead to March 2019 or perhaps, with a bit of a transition period beyond that, do you genuinely fear disruption of supplies and an effect on patients? Are there shorter-term contingency plans that you could make or that you think ought to be being made, or is it just so complex and the transportation so complex that there is nothing one can do?
Professor Michael Rees: The easiest way to ensure continuation of supply is not to put additional barriers in place, such as at customs points, and to maintain some sort of relationship with Europe and Euratom that is productive. Longer term, there are a number of alternatives that we could put in place, but in the short term the majority of supply is from Europe, so we have to find some way of working with Europe to secure that supply.
Dr John Buscombe: I will give a practical example. We had another crisis in 2012, when for about four weeks we had no technetium generators and we had a lot of patients on whom we needed to do bone scintigraphy to assess whether or not they had bone metastasis. There is an alternative, the PET tracer, which uses F-18, which we could make locally in the cyclotron. We used that with the patients who really needed treatment. The difficulty for the NHS was that instead of spending £150 on the bone scintigraphy, I was spending £1,400 of its money on the F-18 bone scans. Again, all things are possible, but we would need to prioritise, particularly where we were working within limited fiscal arrangements. We will do what we can for the patients we can do it for, but there will probably be some less urgent patients who drop out of the end of the system, if you see what I mean. The problem is that a less urgent patient today might be a more urgent patient in two months’ time. We just have to make that value judgment if and when we need to. That is our job as clinicians.
Q7 Baroness Janke: Following on from that, are there specific clarifications needed to give you assurance on supply and affordability, particularly in the short term after Brexit? You have mentioned some, but I wondered if there were any additional specific ones that you would like to raise.
Professor Michael Rees: Only what I mentioned. In the short term, it makes most sense to continue to secure the isotopes from neighbouring countries in Europe and to make sure that we do not put barriers in the way. We can source a limited amount of isotope from other producers, but they are a longer way away and it will cost more. We can do our best to ensure that patients have alternative techniques available, but it is difficult in some parts of the country. In north Wales where I work, we have three district general hospitals. We have just introduced a PET scanning facility, but it is just over the border in Wrexham because it is close to the cyclotrons that produce the isotopes.
We do not have enough mini-cyclotrons to produce isotopes; it would require significant investment in the NHS and in alternative technologies, such as more MRI scanners and CT scanners, or more PET scans. I come back to the point that the most sensible thing to do in the short term is to secure our isotopes supply so that we can have a seamless continuation of the service that we provide.
Baroness Janke: You mentioned capacity and workforce. Are there specific assurances in these particular areas that you feel would be helpful to highlight?
Professor Michael Rees: In the workforce we have to make sure that we do not lose doctors who are currently critical. Thirty per cent of our workforce in nuclear medicine is from the EU.
Baroness Janke: You mentioned radiologists in particular.
Professor Michael Rees: I defer to my colleague from the college.
Dr Jeanette Dickson: Approximately 15% of the radiology workforce are currently from the EU, so it is not an insubstantial proportion. We are also currently significantly short of radiologists, and we have a high number of vacancies throughout the country. Attracting people in from the EU has been profitable in the past, but it is not working as well at the present time.
Dr John Buscombe: I can mirror that. Our nuclear medicine workforce is about 30% EU nationals. We have many posts that have been advertised multiple times at consultant level that are unfilled. Also, it is a daily struggle to keep our posts for technical scientific staff and pharmacy staff filled. We literally search the world to find people to come to serve our patients.
At the moment we are very fortunate, because Portugal is producing more nuclear medicine technologists, who do the actual imaging, than it needs, so we have been importing some extremely good technologists from Portugal. Whether that will be possible after 2019 we do not know, but they have really helped us to provide a service for our patients. It just adds complications to what is already a complicated process. We already know that the poor old NHS is struggling a bit. I am not talking about straws and camels’ backs, but it makes life more difficult for anybody who is trying to do their best to deliver services to patients.
Professor Michael Rees: I work part time as a medical director of the workforce, so it is part of my day job to make sure that we have enough doctors. Radiology is a designated shortage specialty. We are aware, with the college, of the need to train more, so we are training more radiologists in Wales, where I have a responsibility. That should, I hope, come on stream next year, but it will take five years for a qualified doctor to train in radiology. On top of that, if they qualify in nuclear medicine they will have additional training in nuclear medicine, which takes up to two years. That means that we will be bringing no new doctors on stream for seven years, so we have to retain our existing workforce. If we were going to switch any of our investigations from nuclear medicine to other radiological techniques, we would still have that shortage of doctors and equipment.
Lord O'Neill of Clackmannan: Am I right in thinking that the treatments that you make available are between Monday and Friday in the main, or is it seven days a week? In the longer term, would seven days a week be an objective that would get that much further away, even if we were operating under the present constraints?
Dr John Buscombe: To be honest, the real problem with seven-day working is workforce numbers. It is not just the medical but all the technical and scientific stuff that we need. We have explored this in our hospital and we do some Saturdays, but we just do not have enough people.
Lord O'Neill of Clackmannan: You have expensive equipment that is lying idle.
Dr John Buscombe: Absolutely. We are keen to do more, but you cannot have just one radiographer coming in to use the CT scan. We need to have people to make the stuff and to dispense it safely, and there are laws and regulations that need to be followed. We are very keen to do this, and all my staff are signed up to seven-day contracts, but I just do not have enough to fill the gaps. If I had enough to fill the gaps, we would be there.
Lord O'Neill of Clackmannan: I appreciate that, but leaving Euratom will make this even more difficult.
Dr John Buscombe: Yes. Because of increased costs I will have little money for trained staff. Some hospitals in major conurbations can run six to seven-day services, so to some degree it depends on where you are.
The Chairman: It is a staffing problem, not any other kind of problem. It is just not being able to get the right staff to the right place.
Dr John Buscombe: We are not unique. As you know, it is a problem across the NHS. To get good, trained, quality staff is always an issue, as is retaining them. We need not only to recruit but to retain.
Professor Michael Rees: There is a problem with isotope supply, which is not a seven-day-a-week issue. The isotope is dependent on it being produced, processed and shipped, so we have to adjust our patient flows carefully to the activity that we get. Unlike other types of investigation, we have to plan our patient investigations carefully according to the supply.
Q8 Lord Crisp: What should our relationship with Euratom look like after the UK leaves? I know that there are countries, such as Norway and Switzerland, that use supplies from Europe; I think that Norway does not have a relationship but Switzerland does. Do you think that either of those are where we should be?
Dr John Buscombe: Of course, we have an opportunity to have a different relationship from both those countries. It would be ideal to have as close a relationship as possible. Nuclear medicine is just a small part of that; there is also the whole of the nuclear industry. Ideally, we would have the closest possible relationship that allows us to operate without barriers either to people or to radioactive substances travelling between countries. If we can manage that within a framework using the Swiss model or a model that we invent ourselves, that will be ideal.
Again, however, we have limited time for getting this into place. Norway was never a member of the EU, so it has never had to reinvent the rules that it already had. The problem is that we were outside the EU, then we joined and became part of Euratom and part of the directives, so we need to reinvent what we had 40 years ago. Sadly, of course, all the people who did it then are either retired or dead. We do not have the knowledge of those people to reinvent it. That is one of our problems. There is an opportunity to do something different, but it would be ideal to have the closest possible working relationship with Euratom that we can achieve.
Lord Crisp: So neither Norway nor Switzerland as a model. It would be more bespoke.
Dr John Buscombe: Yes. We will have to do something new anyway, so if we have the time and people make a co-ordinated effort, we should aim for the closest possible relationship.
Lord Crisp: From your facial expressions, I assume that others agree. You have talked about the practical difficulties of transport and the cost. We have not talked about quality and safety and whether there are significant risks here to both quality and safety as a result of change.
Dr John Buscombe: One issue, of course, is that these are pharmaceuticals. I am sure that the pharmaceutical industry has come here to talk about the problems that it has with pharmaceuticals. As we fall out of the EMA we become a third country, so there could be additional pharmaceutical barriers, because these are in effect drugs that may require additional local quality assurance before they can be delivered to ensure safety and to follow our own rules and regulations. Of course, that could add delay and cost, and so on.
Likewise, we will need to be safe in what we do. The International Atomic Energy Agency, which is the world’s nuclear policeman, will insist that we are safe. If we are not safe, we will not be allowed to import or export any radioactivity. That is the case with Jamaica, which I visited for the IAEA. The IAEA is desperately trying to give it a nuclear medicine service, but it cannot have it because the Jamaican Parliament will not pass an Act to enable the safe importation and exportation of radioisotopes. So the worst-case scenario is that we are told that nobody is allowed to import to us or export from us. We do not want to go down that path, which is why we need the closest possible relationship.
Lord Crisp: Euratom has a responsibility for quality and safety down the whole supply chain. Does that mean that we have to set something up ourselves?
Professor Michael Rees: Yes. As with other aspects of the EU, we will have to reproduce all the safety checks that we have in place at the moment. We will have to make sure that they continue and that we keep up to date with those and with the quality checks. We will also have to ensure, if we go outside Europe, that our suppliers maintain the quality so that we are not inadvertently injecting patients with something that is of a lesser quality. I think we have reassurances from our outside suppliers in South Africa. If we are to work with other countries that are new suppliers, we will need all the safety and quality checks to be put in place for those.
Lord Crisp: Professor Rees, you talked earlier about the difficulty in the UK of having to deal with a whole range of different government departments. Is the implication of what you are saying about having to set up some new arrangements here that you will need a new focal point in government to handle that?
Professor Michael Rees: In an ideal world you would have a coherent method of dealing with the legislation, the safety practices and the transport practices that we have with Euratom.
Lord Crisp: And that just does not exist at the moment, such as in the Department of Health.
Professor Michael Rees: Our nuclear inspection and safety regimes all come under the Euratom treaty. We are having to reinvent those with the nuclear industry, and we will have to do it for the pharmaceutical industry and for radioisotopes.
Lord Soley: My apologies if you have covered this point already, but I had an overlapping meeting.
On this issue, there must be other products that have to be brought in urgently, such as organ transplants, which must be brought in in controlled circumstances and by individuals. Is there a similar problem here, or is it totally different from radioisotopes?
Professor Michael Rees: We have talked a lot about molybdenum, which has a half-life of 66 hours, but with some products, such as those used in the investigation of Parkinson’s disease, the half-life of the iodine product is much shorter, at 13 hours. There are therefore some isotopes that we import that have very short half-lives. Again, we need to focus on those to make sure that the supply continues or that we find an alternative way of investigation or of generating those isotopes. Those solutions are much longer term than continuing urgent supplies.
Lord Soley: Is it different from the situation with Euratom?
Professor Michael Rees: The supply of iodine-123 comes from Germany and comes under the Euratom process. I am not an expert in the supply for radiotherapy, but I imagine that there are similar issues with urgent supplies being required.
Lord Soley: What about with kidney transplants and kidneys being brought in?
Dr Jeanette Dickson: I assumed that all kidneys were supplied internally.
Dr John Buscombe: There is Eurotransplant. I know only a little about that because I work in a hospital that does transplants. I know what you mean about Eurotransplant. The rules and regulations are different because it is a biohazard, not a radiation hazard. There will be different layers of rules and regulations. I suspect you will need to talk to an expert in that field. They may also have concerns. Obviously we know more about the legislation that covers radioactivity. People are obviously concerned about radioactivity. Clearly it is not something we want to go missing, especially in an unsettled and dangerous world where people might want to get hold of it and do mischief with it. Clearly it is very important to ensure that we know what we are doing.
The Chairman: If it all goes well and we have set up some arrangement of our own that, to begin with, mirrors Euratom, will it have to keep in step with it? What scope is there for any divergence as we go along our different paths?
Professor Michael Rees: As I understand it, there is no barrier to us working under the treaty and with other countries. We have that at the moment. With anything that we are going to source from Europe we will have to keep in step with the regulations to make sure that additional barriers are not put in place. We deal with other countries now. In the nuclear industry, we are working with Hitachi in Japan and the United States on our nuclear reactors. We have to make sure that all that legislation is kept in place. There will be a continuing need to update all our regulations and safety procedures to keep in step with whichever country we are dealing with.
Dr John Buscombe: The other thing, of course, is that if we do not maintain our legislation at a similar level, if we have a producer in the UK, as we do at the moment, it might have problems exporting to Europe unless the legislation is closely aligned. So we also have to remember that: that there is an export factor as well as an import factor in all this. I think that people in the nuclear industry would wish for there to be some agreement so that the two match fairly closely.
That should not be a problem, because most of the legislation is pretty good common sense. It is in no way trying to do something difficult or controversial; it is just trying to keep patients and the public safe. As long as we see that the prime role is not control but safety, there should be no problem with aligning legislation.
The Chairman: That has touched on Lord Watts’s question a little.
Q9 Lord Watts: You have set out the problems that you will face once we leave if there is no agreement in place and some idea of how that agreement might be put in place. Have the Government given any indication of a timeline for coming forward with something to replace what exists now before the time runs out on the treaty?
Professor Michael Rees: I attended a briefing with DExEU on the general issue of Euratom. It outlined the legislation in the Nuclear Safeguards Bill. The things that I thought could have further focus were the issues that we are dealing with, the supply and safety of medical isotopes and the research element, which is very important. DExEU talked about the nuclear fusion project, which it will continue to fund, but there was not much in the information that has come out about wider aspects of research, participation in Horizon 2020, and all the things that we are currently doing to take the treatment of patients forward. A huge amount of research is going into immunoradiopharmacy targeting cancer treatment. Again, my colleagues will probably know more about it than we do. We know that a very large number of researchers are engaged in this type of research. We are very successful at it. I would like to see more focus on many of the research aspects and widening it beyond the nuclear fusion project.
Lord Watts: You have talked about having an agreement with the Union after we have left. Are the third-party countries that we deal with already bound by European regulation? Does the European Union negotiate the existing system or do we do that individually?
Professor Michael Rees: I am not an expert on the law and I am not sure whether my colleagues are, but there are existing agreements between Euratom and the United States, for instance, that I gather will have to be revisited. There are certainly agreements between other countries, but I cannot say which ones they are.
Lord Watts: Do make them?
Professor Michael Rees: Euratom does.
Lord Watts: So we would have to negotiate separately with all those other states. That leads to my second question. You talked about bringing products in by air for speed if there are border controls. Then you said that there may be a capacity problem. Do you have any idea how long it would take to bring up a system that would give you the capacity to bring everything in by air? If you are exporting your products you will need that third country to have its own system in place and the capacity to take the product. It is a two-way process: you need to build capacity in the UK, but you need that same capacity in the importing countries.
Professor Michael Rees: Dr Buscombe referred to the complexity of the process that we have now, which is facilitated and made easy by being part of the Euratom treaty. Again, I do not have particular expertise in this, but I imagine that your assumption is correct: we will have to negotiate separately all the current agreements held between Euratom and third-party countries. The United States agreement is particularly important. Then we would have to ensure that we have all the necessary legislation, safeguards and protocols in place to enable us to important and export radionuclide materials so that they are compliant with the countries that we deal with.
Lord Watts: What about the capacity for flying it into—where was it, Birmingham?
Dr John Buscombe: The majority is into Coventry, which is a freight-only airport. I do not know what additional capacity it has. We would need to multiply it by four. The easiest answer is to have a system whereby we do not have to do that. I do not know how long it takes to recruit and train the relevant people.
On having our own equivalent of Euratom and an inspectorate to make sure it works, I would have thought that at 16 months away we would need to have that set up and start recruiting in the next few weeks to be effective and to have people trained. We are not unique. Everybody has the same kind of thing, even custom officers: how do we recruit and train them in time? The problem is that nobody knows whether we need them. When we do know that we need them, how quickly can we recruit and train them? These are the great unknowns. That is the problem: we do not know what the situation will be. We all hoped that we would have an answer by now and we do not. That is our concern.
Professor Michael Rees: The only thing I have seen written and heard presented in briefings is the inspectorate that we have to train to be compliant with the International Atomic Energy Agency. I am not aware of much discussion that has gone on with the Department of Health or other departments in answering your questions.
Lord Ribeiro: Assuming, after all this happens, that we end up being a third country and having to find some kind of relationship with the EU, the great benefit that we have had is through research, which you identified, with Horizon 2020 and €32 million-worth of benefit to the UK. How can we ensure that we maintain a research collaboration with our partners?
Professor Michael Rees: The ideal solution would be to make sure that we have a very strong presence in Europe with research collaborations, but on a longer-term basis build up our research collaborations with the rest of the world. We are a net beneficiary of Horizon 2020 and we have always been because we are a research-orientated country. We could do more to develop a greater research and development culture in the NHS, because that is a huge asset to us in this country. If we can become the world’s leader in clinical research and development, the NHS is an ideal place to do that. But in the short term we will either have to pay into these funds to use our expertise to get more out of them, which is the current situation, or have to put money in ourselves if we do not contribute to those funds while looking to other partners. There is no equivalent in the world that I am aware of outside the United States of this type of research funding and opportunity. It is of great concern to our universities—it is certainly of great concern to my university regarding recruiting and retaining expert staff and funding the research that needs to go forward. This area of research is something that we are good at, so we should do everything we can to keep being very good at it.
Dr John Buscombe: Research is not an abstract; it is about people. It is done by researchers, and you want the brightest and the best researchers. Whatever comes out, we need to be a country that is attractive to the brightest and the best, where they feel that they have a future. The UK has done well at bringing in the brightest and the best, not just from Europe but from other places, and then convincing them that they would like to spend the rest of their lives here in the UK. Sitting on the research side, that has been a great asset. We need to demonstrate that we are still an outward-looking, friendly, research-orientated, welcoming country and not become xenophobic and inward-looking. The problem is that the perception—I agree that it may be only a perception—is that we have become more introverted. That does not serve the people of this country well.
The Chairman: Thank you. I think we would all agree with that.
Q10 Baroness Pinnock: In the course of your answers, you responded to the question I was going to ask, which is about government assurances if we leave Euratom. Jo Johnson in particular said that “availability should not be impacted by the UK’s exit”, and others have made similar points. However, it seems from what you have said that that is just half the tale. The other half is about time-critical transportation and not putting barriers in place; that research will be impacted, as you just said, because of loss of EU funding and not being able to attract expertise; that UK production of these radio isotopes is not possible in what we might call the immediate to long term, which is 10 years-plus from what we have said; that we will end up mirroring existing regulations; and, what struck me most, that some patients are likely to have less effective care. Indeed, Dr Dickson said—I think I have this quote right; put me right if I have not—that it could end up “significantly harming cervical cancer care”. Do I have the right perception? Should I be worried about anything else? That seems to be a fairly long list. Is there any mediation of those perceptions?
Dr John Buscombe: When Jo Johnson says that there will be no interruption in supply, we would like to see how that will be done. We want to see—
Baroness Pinnock: Practical answers.
Dr John Buscombe: Yes. I am not saying that Ministers sometimes say that things will not be a problem and then they tend to be, but because we are getting closer to the deadline I would like some idea of how the government agencies and ministries involved will put a structure together that will ensure that that happens. We are now in a situation where we need to get more detail than just being told that it will not be a problem.
Baroness Pinnock: That it will be okay on the night.
Dr John Buscombe: Yes. It is a bit like when they opened Terminal 5. That was going to be okay, was it not? We do not want a Terminal 5 with this where everything “will be okay” and the next day it is chaos. Like the old Boy Scouts, be prepared: get everything ready first and do not wait for disaster to happen.
The Chairman: Are you putting pressure on the Government yourselves, saying, “Come on, we have to get together to sort this out. Time is getting short”? Do you feel that the Government are responsive to your concerns?
Professor Michael Rees: We in the BMA have produced a number of briefing papers, particularly on research, which we can share with you. We have tried to take a relatively neutral stance; we do not have a formal position on Brexit, but we are looking at the issues arising from it. We will be happy to share those briefings with you.
The Chairman: That would be very helpful.
Professor Michael Rees: As Dr Buscombe said, we would like practical steps to be put in place to ensure that the worst does not happen and so that we are fully aware of the issues. We are very grateful to you for this opportunity to explain some of the issues. If this results in more practical steps being taken, that is very much to the good.
Dr John Buscombe: We all represent organisations that are willing to help in that process to get it right. We understand that some of these things are very technical. It is not just a matter of expecting the Government to do everything on their own; we are willing to be part of that process, because we understand that they may need technical help. It is a matter of us working together. However, the first step is being asked to do it. It is difficult to do something until you are asked to do it. We need to pass that first barrier, and then we will try to help as much as we can to find solutions.
The Chairman: Do you have any views on the transition period? The presumption now is that we leave on 31 March 2019 and then there will be a transition/implementation period during which it seems that things will be more or less as they are now.
Professor Michael Rees: If what we hear about the transition period is correct, for what we have tried to present as a short-term issue such a transition period would be helpful in enabling us to adjust to the future and have further conversations. I gather that the problem is that many of these conversations might be happening with our colleagues in Europe but are held up in the overall negotiation process. A transition period might therefore be helpful for ironing out some of these issues, working out bilaterally where we want to stand, how much we want to be part of an associate membership or whatever our status might be. It will give us time, and certainly our patients time, and cause much less anxiety along the lines of, “Do we have to suddenly switch from what we’re doing now to doing something else and cancel patients? Will there be transport issues?” So, yes, a transition period in that respect would be helpful from a clinical perspective.
Dr John Buscombe: It will depend a bit on the nature of that transition, which could mean anything. If our transition is that we effectively remain within Euratom, obviously we have time to sort the problems out. If the transition means that we are effectively out of Euratom, we would have the same issues as with what is described as a hard Brexit. It depends on the details of what any transition would be and the UK’s relationship with Euratom. Obviously, if we manage to get some form of associated relationship during transition, that might even work beyond transition. I do not know. But we do not really know what the word “transition” means. That is the problem.
Q11 Lord Soley: Can you think, both short term and long term, of any opportunities that might arise either for patients or for your members from leaving Euratom?
Professor Michael Rees: The interesting thing about the Euratom treaty is that, as I understand it, it allows us to deal with third countries. It is not restrictive in the same way that other aspects of being in the EU are perceived to be. We have a number of arrangements already. We have talked about some of the issues that might need to be revisited where Euratom has treaties with other countries that we deal with through that process, which I imagine is the same process for trade.
Any change will bring about both threats and opportunities. We have talked a lot about the threats. There may be opportunities, but I would have thought that they would be long term rather than short term. For us they would be to significantly consider how we take forward our research, our supply of isotopes and our use of the NHS as a research organisation, and how we adjust, if we have to, the balance of our treatments to make sure that patients are not subject to detriment.
There are always opportunities. During our presentations we have talked about the long-term opportunities related to research, with spin-offs from our investment in nuclear energy and in research into cyclotron production. All those things are possible and might involve us dealing with other countries as well as with Europe, but they tend to be longer-term investments. In the same way that it takes a long time to train a radiologist, we have to look longer into the future as well as looking at the short term.
Dr John Buscombe: One area in which there might be an advantage is that many of the new areas of research use positron emission tomography, which uses very short-lived isotopes of a few minutes to maybe an hour or two that are given only once. They may not require all the same legislation as a drug taken every day for a year or so. It might be possible in a less bureaucratic system outside the EMA to find arrangements where these can be used in research and practice without having a full equivalent of the same kind of legislation required for a drug that you will take for 50 years when it will be in your body for only 45 seconds.
There are possibilities. Strangely enough, the European Union is looking at that already anyway, but we might be able to do some things that Europe is not doing, or do it faster than Europe can. I am not trying to say that the news is all negative. It could be, but that is one area where being outside the EMA more than Euratom might be an advantage for some research and practice.
Lord Soley: Are there any indications that you are aware of that the leaving date is encouraging investment in alternative technologies? Are organisations or companies thinking about that?
Professor Michael Rees: From my discussions with companies, their current mode is concern. In the same way as I imagine there are other discussions with business, if we can be reassuring, we will retain some of our export industry in nuclear medicine. If we can then go beyond it and talk about investment and development, the future looks more optimistic than it might from a company perspective at the moment. We really do not want companies to disinvest in this, because it will be too difficult. We want exactly the opposite—investment.
Lord Soley: Presumably they are all waiting for answers to these questions very soon rather than later?
Professor Michael Rees: Having had very recent discussions with companies, that seems to be the case, yes.
The Chairman: Thank you very much indeed. We are extremely grateful to you. It has been a fascinating, if rather disquieting, session. Next week we have Lord O’Shaughnessy, one of the Ministers in the Department of Health, on other subjects, but he said he would be very happy to answer one or two questions arising from this session. That will give us a chance to reflect on what you have said and put some of our thoughts to the Minister. Thank you very much indeed all three of you. We are very grateful to you. It has been an extremely helpful session.
http://www.parliament.uk/documents/lords-committees/eu-home-affairs-subcommittee/euratom-letter-beis.pdf
The Rt Hon Greg Clark MP 8 December 2017
Secretary of State
Department for Business, Energy and Industrial Strategy
1 Victoria St
London, SW1H 0ET
Dear Greg,
Health implications of leaving Euratom
I am writing this letter to raise concerns about the health implications of leaving Euratom. On 22 November the Home Affairs Sub-Committee of the House of Lords EU Select Committee held a meeting to look at the implications of leaving Euratom for the safe and timely import and export of medical radioisotopes. During that meeting the Committee heard from Professor Michael Rees of the British Medical Association (BMA), Dr John Buscombe, President-Elect of the British Nuclear Medicine Society (BNMS), and Dr Jeanette Dickson from the Royal College of Radiologists (RCR). The Sub-Committee also discussed this topic with Lord O’Shaughnessy during the Sub-Committee’s meeting the following week.
After hearing from our expert witnesses and Lord O’Shaughnessy, we are very concerned that the health implications of leaving Euratom have not been given the priority that they require within Government. Medical radioisotopes are essential tools for both diagnostic tests and treatments for cancers, heart disease, kidney disease and bone disease. It is estimated that medical radioisotopes are used in the care of 700,000 patients a year. Dr Buscombe of the BNMS suggested that the figure is probably closer to 1 million patients. The UK imports around 80% of its medical radioisotopes, mostly from the EU. Patients depend on the timely delivery of medical radioisotopes, and anything that threatens that supply chain will put patients’ health and wellbeing at risk. Medical radioisotopes have a very short half-life, and our concern is that leaving Euratom risks disrupting this time-sensitive supply chain.
I would draw your attention to the key issues that were raised by our witnesses, and ask you to answer some questions resulting from their evidence:
Government co-ordination
1. We are concerned that not enough has been done to engage stakeholders or develop a plan for ensuring a secure supply of medical radioisotopes for the UK post-Brexit. Although BEIS is taking the lead on the Euratom exit negotiations, our witnesses noted that they had no clear Government point of contact on the issue of medical radioisotopes. Dr Buscombe called for "a unified approach" across Government and reported that organisations like the BNMS, BMA and RCR are "willing to help" to get the process right. We note the need to set up urgently a cross-departmental group to
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coordinate the Government’s plans for ensuring that the supply of medical radioisotopes is not interrupted.
- What is being done at Government level to coordinate the work that needs to happen to ensure a smooth transition and facilitate stakeholder engagement?
Planning and contingencies
2. Security of supply of medical radioisotopes needs to be prioritised. Delay and disruption to the supply of medical radioisotopes can have serious consequences for people’s lives. We heard from Dr Dickson that patients who receive brachytherapy to treat cancer of the cervix need to receive the whole treatment within no more than 42 days "or the cure rates reduce". We are concerned that time is running out to set up a system to replace the current structure and ensure uninterrupted access to medical radioisotopes.
3. On leaving Euratom, the UK might need to expand the system currently in place for importing isotopes from non-EU countries. However, doing so will require significant planning and will take time to develop and implement, including the recruitment and training of staff to carry out necessary customs checks. Another consideration raised by Dr Buscombe was about the means of ensuring that delivery vehicles entering the UK carrying medical radioisotopes could be identified and prioritised in the event of any hold-ups at borders.
4. It is worth noting that one advantage of being a member of Euratom is that the UK is able to import and export radioisotopes to another EU country without prior warning or consent. Isotopes sourced from non-EU countries take longer to arrive, cost more and carry a greater risk of delay. The variable but usually short half-life of these products means that delays can result in some or all of the product being unusable.
5. We are also concerned about how changes to nuclear safety standards will impact the import of medical radioisotopes. Our experts told us that the Euratom Treaty is the basis for the UK’s nuclear safety regime and that it covers not just the nuclear industry but also the pharmaceutical industry and radioisotopes. Professor Rees noted that leaving Euratom would require the UK to reproduce the system of safety checks that is currently underpinned by the UK’s membership of Euratom. In addition to the safeguards outlined in the Euratom treaty, EU legislation such as European Council Regulation 1493/93 on shipments of radioactive substances between Member States and EU radiation protection legislation provides the framework for the safe and timely delivery of medical radioisotopes.
6. Government assurances that leaving Euratom will not have any impact on the safe and timely import of medical radioisotopes from the EU are not enough.
- What is being done to plan for a post-Euratom system for importing and exporting isotopes?
- What options are being considered for how the UK will import isotopes from the EU, post-Brexit and ‘Brexatom’? How will the new system ensure that the import of isotopes from the EU does not take longer, cost more or carry a higher risk of encountering delays?
- How do you see this system working during any transition/implementation period?
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Research
7. The UK has a world-leading nuclear medicine research community that underpins the development of new cancer diagnostic procedures and treatments. To cite one example, we heard from Professor Rees about the importance of developing areas of research in neurochemistry and immuno-treatments involving medical radioisotopes. The UK attracts high-quality researchers; it is a net beneficiary of research funding from the EU Horizon 2020 and the Euratom research programme; and it enjoys valuable research collaborations with European partners. There is no other equivalent research fund, and the Committee heard from its expert witnesses that the potential loss of this funding is cause for concern. Research depends on people, and our reputation in this field will depend on our ability to continue to attract the best and the brightest.
- How will the Government ensure that the UK stays at the cutting-edge of research in nuclear medicine and radiology and attract the best people to the UK after Brexit?
- What funding opportunities for nuclear medicine and radiology research will replace those that the UK will lose when we leave the EU?
Alternatives
8. Careful consideration needs to be given to the connection between the treatments provided to patients and the workforce that delivers that treatment. Dr Dickson gave the example of radiotherapy for prostate cancer patients. An internal brachytherapy treatment which uses imported medical radioisotopes is a one-day treatment. An alternative is an external beam treatment, but this can take between 20 and 40 days to deliver. There are obvious implications, not just for the patient but for how the workforce is able to adapt to delivering different treatments.
9. Dr Buscombe noted that most alternative procedures are very much more expensive and some are less effective, diminishing a patient’s chances of being cured. Potential long-term solutions, such as investment in national cyclotron facilities to produce isotopes domestically, do not obviate the need for short- and medium-term planning and are likely, at least initially, to be significantly more expensive than existing mechanisms for the supply of these products.
- Is the Government considering the implications of leaving Euratom on the existing workforce, and what impact would alternative treatments have on the workforce and the health system more broadly?
- What is the Government doing to plan for the long-term implications of leaving Euratom?
Future relations with Euratom
10. We understand that the UK’s future relationship with Euratom will be a matter for negotiation. The best chance of securing a reliable and timely supply of medical radioisotopes and for maintaining our world-leading position in nuclear medicine research would be, as our witnesses said, to have as close a relationship as possible with Euratom post-Brexit.
- What options is the Government looking at in terms of future cooperation with Euratom on the import and export of medical radioisotopes?
11. The Committee heard from Lord O’Shaughnessy that a risk assessment on the UK’s departure from Euratom has been commissioned. We would be interested to hear what role BEIS is playing in that assessment, and more about its scope and timing. We have also heard that a stakeholder meeting was held on 8 December and would appreciate
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hearing your feedback from that meeting, including a list of the stakeholders who attended.
12. We have outlined the concerns and questions that we have on this issue. For convenience they are:
i. What is being done at Government level to coordinate the work that needs to happen to ensure a smooth transition and facilitate stakeholder engagement?
ii. What is being done to plan for a post-Euratom system for importing and exporting isotopes?
iii. What options are being considered for how the UK will import isotopes from the EU, post-Brexit and ‘Brexatom’? How will the new system ensure that the import of isotopes from the EU does not take longer, cost more or carry a higher risk of encountering delays?
iv. How do you see this system working during any transition/implementation period?
v. How will the Government ensure that the UK stays at the cutting-edge of research in nuclear medicine and radiology and attract the best people to the UK after Brexit?
vi. What funding opportunities for nuclear medicine and radiology research will replace those that the UK will lose when we leave the EU?
vii. Is the Government considering the implications of leaving Euratom on the existing workforce, and what impact would alternative treatments have on the workforce and the health system more broadly?
viii. What is the Government doing to plan for the long-term implications of leaving Euratom?
ix. What options is the Government looking at in terms of future cooperation with Euratom on the import and export of medical radioisotopes?
x. What role is BEIS playing in the development of the risk assessment, and what is the scope and timing of that report?
xi. What was discussed at the stakeholder meeting held on 8 December, which stakeholders attended?
We look forward to hearing from you soon on this very important and time-sensitive issue. 5 of 5
I am copying this letter to Lord O’Shaughnessy, Parliamentary Under-Secretary of State for Health; Richard Harrington MP, Parliamentary Under-Secretary of State, Minister for Energy and Industry; Lord Teverson, Chair of the House of Lords EU Energy and Environment Sub-Committee; Sir William Cash MP, Chair of the House of Commons European Scrutiny Committee; Lynn Gardner, Clerk to the Commons EU Scrutiny Committee; Arnold Ridout, Legal Adviser to the Commons EU Scrutiny Committee; Les Saunders, Department for Exiting the EU; and Briony Thompson, BEIS Departmental Scrutiny Co-ordinator.
Lord Jay of Ewelme
Chairman of the EU Home Affairs Sub-Committee
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