Documents considered by the Committee on 10 January 2018 Contents

4Nuclear research and medical isotopes

Committee’s assessment

Politically important

Committee’s decision

Cleared from scrutiny; further information requested; drawn to the attention of the Business, Energy and Industrial Strategy and Health Committees

Document details

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.

Legal base

Article 7 of the Treaty establishing the European Atomic Energy Community (Euratom)

Department

Business, Energy and Industrial Strategy, and Health

Document Number

(38639), 7892/17, COM(17) 83

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:

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:

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:

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.

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).

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”.

23 See Article 7 of the Treaty establishing the European Atomic Energy Community (Euratom).

24 See Council Decision 2012/709/Euratom of 13 November 2012.

25 The full proposal is available here.

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).

28 Letter from Richard Harrington to the Chair of the European Scrutiny Committee (28 July 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.

32 See the European Commission website for more information.

33 See this note from the Dutch Presidency of the Council on the security of supply of medical radioisotopes (May 2016).

34 See Article 172 of the Euratom Treaty.

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).

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).

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).

45 The transcript of the Westminster Hall debate of 12 July 2017 is available here.

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.




12 January 2018