European Scrutiny Committee Contents

12 Nuclear Medicine



COM(10) 423

+ ADD 1

Commission Communication on medical applications of ionizing radiation and security of supply of radioisotopes for nuclear medicine

Commission staff working document

Legal base
Document originated6 August 2010
Deposited in Parliament19 August 2010
Basis of considerationEM of 3 September 2010
Previous Committee ReportNone
To be discussed in CouncilNo date set
Committee's assessmentPolitically important
Committee's decisionCleared


12.1 Nuclear medicine is the branch of medicine that uses ionizing radiation (radioisotopes) in the diagnosis and treatment of disease. Diagnostic uses include X-ray imaging and CT scans. The most common therapeutic use is radiotherapy for the treatment of cancer. The growth in new medical techniques using ionizing radiation has led to a rapid increase in the demand for radioisotopes for use in nuclear medicine as well as higher levels of exposure of patients and medical staff to radiation.

The Commission Communication

12.2 The Communication identifies two main challenges arising from the growth in medical uses of ionizing radiation and suggests ways to address them. It also touches on regulatory controls and recent research on the risks of radiation exposure.

Limiting the exposure of patients and medical staff to ionizing radiation

12.3 The Commission says that, in many cases, the medical benefits of procedures using ionizing radiation outweigh the risk associated with radiation exposure but points to "a significant deficiency" in the medical justification for X-ray imaging, particularly with regard to children and pregnant women, and the possibility of serious injury resulting from inappropriate exposure to high levels of radiation.[45] The Commission suggests that the pace of innovation and demand for new radiotherapy or imaging techniques mean that they may be placed on the market without adequate regulatory supervision or medical justification. Moreover, "many medical specialties have access to, and use, radiological imaging without having enough knowledge of the radiation exposure involved in the procedures and of the possible detriment of the exposure on their patients and on themselves".[46]

12.4 Medical exposure to radiation is regulated by the Medical Exposure Directive[47] and the Basic Safety Standards Directive[48] but the Commission suggests that "the practical implementation of the requirements for radiation protection of patients, and in some cases of medical staff, is often weak".[49]

The supply of radioisotopes

12.5 According to the Commission, nuclear medicine is used primarily to diagnose serious diseases, such as cancer, cardiovascular and brain diseases. Europe is the second largest consumer of Technetium-99m (Tc-99m) — the most widely used diagnostic isotope — accounting for more than 20% of the global market. Demand for Tc-99m is rising but its production is complex and, as it decays rapidly, it cannot be stockpiled. Securing a regular and reliable supply of Tc-99m is therefore essential to enable hospitals to provide crucial diagnostic imaging tests. The global supply of Tc-99m is in decline because there are only seven government-owned production reactors (five in Europe, but none in the UK) and all are approaching the end of their lifespan. In the last three years, the supply of Tc-99m has been interrupted five times. The UK was one of 14 European countries seriously affected by the shutdown of one of Europe's main research reactors in autumn 2008. In order to ensure reliable and sustainable supplies of radioisotopes, the Commission is participating in a study[50] on the economics of the Tc-99m supply chain with a view to stimulating market-based private and/or public investment in medical radioisotope production and associated infrastructure.

12.6 The Commission proposes a number of actions at EU level to address the challenges identified in the Communication.

Strengthen the existing regulatory framework

12.7 The Medical Exposure and Basic Safety Standards Directives will be "recast"[51] and the provisions on regulatory supervision of the medical use of ionizing radiation strengthened.

Raise awareness and encourage a culture of safety

12.8 Medical training should include regular updates on good practice to ensure an appropriate balance between medical care and radiation protection. All exposure to radiation resulting from new technologies should be subject to medical justification and patients should be made aware of the risks associated with radiological examinations, especially if children are involved.

Promote research to improve radiation protection and a sustainable supply of radioisotopes

12.9 Research undertaken under existing Euratom and EU Framework Research Programmes can contribute to a better understanding of individual sensitivity to ionizing radiation, thereby improving health protection, and help identify suitable infrastructures for the future production of radioisotopes.

Better integration of policies

12.10 The medical use of ionizing radiation requires an integrated approach covering various policy areas, such as public health, research, trade, nuclear safety, waste management, transport and radiation protection. The Commission indicates that it will propose measures to simplify the cross-border transportation of radioactive materials which should help to speed up the delivery of radioisotopes to hospitals.

International co-operation

12.11 The Commission supports co-operation and engagement with international actors such as the World Health Organisation, the International Atomic Energy Agency, the Organisation for Economic Co-operation and Development and the Nuclear Energy Agency.


12.12 The Commission highlights the need to secure funding to ensure a sustainable supply of radioisotopes. Possible sources of funding include Euratom or European Investment Bank loans and guarantees to encourage investment in research reactors and radioisotope production facilities, or the establishment of Joint Undertakings covering the whole supply chain and including public and private sector partners.

The Government's view

12.13 The Parliamentary Secretary for Public Health (Anne Milton) says in her Explanatory Memorandum of 3 September that the Government "broadly agrees" with the Communication. She adds:

"The UK does not produce the raw material for medical radioisotopes, so we have limited options available to resolve this ourselves. From a UK point of view, we welcome the Communication on exploring options for securing the supply of radioisotopes in the long-term.

"There are no medicines policy implications on the proposed actions on improving the supply chain for medical radioisotopes. Should the underlying supply chain fragility not be resolved then policies will need to be introduced as to how the limited supplies and the number of scans that can be performed during shortages should be best targeted." [52]

12.14 The Minister notes also that the UK is "fully engaged" in the process of recasting the Directives on Medical Exposure and Basic Safety Standards which should be complete by 2012.


12.15 We draw this Communication to the attention of the House because it usefully highlights the rapid growth in the medical uses of ionizing radiation, the potential risks resulting from increased radiation exposure, and the vulnerabilities in the supply chain of radioisotopes which, if not addressed, may have a significant impact on the availability and use of ionizing radiation to diagnose and treat serious diseases in the UK. Like the Government, we believe that the Communication contains some constructive ideas, especially on the need to secure a sustainable supply of radioisotopes for the future in the face of growing global demand.

12.16 We would have welcomed further comment from the Government on the Commission's assertion that there is evidence of a significant deficiency in the medical justification for some X-ray imaging and insufficient awareness of the risks associated with this type of radiation exposure. While we are content to clear the Communication from scrutiny, we invite the Minister to address these issues in her Explanatory Memorandum on the Commission's proposal to recast the existing EU regulatory framework on medical exposure to radiation.

45   The Commission cites a number of studies which suggest that at least one fifth of X-ray examinations lack sufficient medical justification, rising to three quarters in some specific cases. Back

46   See paragraph 2.2 of the Communication.  Back

47   Directive 97/43/Euratom, OJ No. L 180, 9.7.97, pp. 22-27. Back

48   Directive 96/29/Euratom, OJ No. L159, 29.6.96, p. 1. Back

49   See paragraph 2.3.1 of the Communication. Back

50   The study is part of work being undertaken by a High level Group on the Security of Supply of Medical Radioisotopes established by the Nuclear Energy Agency and the Organisation for Economic Co-operation and Development (OECD).  Back

51   The recasting of legislation means adopting a new legal act which incorporates in a single text both the substantive amendments which it makes to an earlier act and the unchanged provisions of that act. The new legal act replaces and repeals the earlier act.  Back

52   See pages 5 and 6 of the Minister's Explanatory Memorandum. Back

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