12 Nuclear Medicine
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12848/10
COM(10) 423
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| Commission Communication on medical applications of ionizing radiation and security of supply of radioisotopes for nuclear medicine
Commission staff working document
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| Legal base | —
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| Document originated | 6 August 2010
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| Deposited in Parliament | 19 August 2010
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| Department | Health |
| Basis of consideration | EM of 3 September 2010
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| Previous Committee Report | None
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| To be discussed in Council | No date set
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| Committee's assessment | Politically important
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| Committee's decision | Cleared
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Background
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.
Funding
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.
Conclusion
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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