6. We consider that the following raises questions of political importance,
but make no recommendation for its further consideration at this stage:--
Department of Health
(17536)
10365/96
COM(96)465 |
Draft Council Directive on health protection of individuals against the dangers of ionising
radiation in relation to medical exposures, replacing the Directive
84/466/EURATOM. |
| Legal base: |
Article 31 of the EURATOM Treaty; qualified majority voting. |
Background
6.1 The proposal would revise the current Directive[10] laying down basic measures for the radiation protection of person undergoing
medical examination or treatment.
The draft Directive
6.2 The main changes to the existing Directive are described by the Parliamentary
Under Secretary for Health (Mr Horam) in his Explanatory Memorandum (dated 5 November 1996) as:
"(a) a more prescriptive approach to the role of Member States in avoiding
unnecessary proliferation of installations;
"(b) a strengthening of the provisions concerning justification and
optimisation of medical exposures, including a requirement to consider always previous diagnostic
investigations;
"(c) an expansion of existing requirements on the quality control of
installations with requirements for quality assurance programmes including assessment of patient
dose and written guidelines for all equipment and procedures;
"(d) a more prescriptive approach to continuing education and training;
"(e) the introduction of additional requirements for special practices
including paediatric exposures, health screening programmes, practices involving high doses, the
exposure of pregnant and breast feeding women and the exposure of individuals caring for or
comforting patients who have had radiopharmaceuticals administered to them;
"(f) an extension of the inspections by competent authorities to make these
regular;
"(g) a requirement for the introduction of procedures for audit;
"(h) more clearly defined scope in relation to exposures for medico-legal
purposes, insurance or legal purposes. It has also been enlarged to include volunteers in research
and individuals helping in the support and comfort of patients;
"(i) an increased role for the persons requesting medical exposure and the
delegation of responsibilities for practical aspects of a medical exposure to individuals other than
the medical practitioner as authorised by the competent national authority."
The Commission notes in its explanatory memorandum that the proposal is consistent with the 1990
Recommendations of the International Commission for Radiological Protection (ICRP) and with the
International Basic Safety Standards for Protection Against Ionizing Radiation and for the Safety
of Radiation Sources issued in December 1994.
The financial implications
"As regards the cost of implementing the Directive, in some cases the introduction of
quality assurance and quality control measures may require some cost for the holders of the
radiological installations concerned. However, these costs will bring benefits in terms of reduced
exposures. Increased attention to the justification of each individual radiological examination
is likely to reduce their number and the associated cost for society. A direct cost benefit
analysis is impossible, without agreeing on a value of the mansievert[11] averted by the introduction of measures pursuant to the provisions of the
proposed Directive. Several figures for such values can be found in the literature, ranging from
5,000 to several million ECU/mansievert according to the circumstances. No international agreement
could be reached so far on these figures."
The Government's view
6.4 The Minister agrees that it is appropriate to update the Directive.
"The proposals for a revised Directive are generally welcome since they reflect the
internationally accepted recommendations of the International Commission for Radiological Protection
(ICRP), which have been the basis of previous Directives and national legislation. In particular
the concepts of justification and optimisation are relevant to medical exposures. The ICRP
recommendations have been endorsed by the UK's National Radiological Protection Board which has a
statutory duty to advise on the acceptability to the UK of international recommendations and
standards.
"The UK has several particular concerns about the Directive currently drafted. They
are:
"(a) inconsistencies in approach and specific wording compared with the
Basic Safety Standards Directive 96/29/Euratom;
"(b) lack of/removal of flexibility for individual Member States to act as
necessary eg the proposal that Member States shall take steps to avoid unnecessary proliferation
of installations;
"(c) the proposed, unnecessarily prescriptive, approach to training;
"(d) the proposed, unnecessarily comprehensive, approach to the surveillance
of radiological installations by competent authorities;
"(e) the unnecessary detailed requirements concerning exposures of pregnant
and breast feeding women;
"(f) the proposed, unnecessarily prescriptive, approach to the consideration
of previous diagnostic information;
"(g) unclear proposals for auditing processes."
6.5 On cost of implementation the Minister says that, provided the UK's concerns can
be satisfactorily resolved, these would be relatively small. A preliminary compliance cost
assessment (CCA), attached to his EM, reveals that, if the UK fails to achieve any of its
negotiating aims, costs could be high; maximum quantifiable initial costs and recurring costs over
a ten year period, at current prices, total £37.2 million and £8.6 million respectively.
Consultation
6.6 The Minister reports that a number of Departments, including the Health and
Safety Executive (HSE), the National Radiological Protection Board and the Scottish, Welsh and
Northern Ireland Offices have already been consulted by the Department of Health. He says that
meetings with professional bodies have started and will continue over the coming months.
Conclusion
6.7 The maximum costs set out in the CCA are clearly unacceptable if, as the
Minister claims, the proposals are over-prescriptive. We ask the Government to inform us of the
progress of negotiations and to provide us with a Supplementary Explanatory Memorandum in good time
before the draft Directive is put to the Council for adoption. In the meantime we shall not clear
the document.
10. (4632) 4188/81; see HC 21-xxiv (1981-82), paragraph 1 (23 June 1982), HC 78-i
(1983-84), paragraph 28 (27 July 1983), and HC 78-xxxiii (1983-84), paragraph 7 (18 July 1984).
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11. This is a measure, directly related to risk, of the exposure of an individual
to radiation. Whereas exposure of workers long-term are measured in millisieverts (one thousandths),
medical exposures are much higher, and in chemotherapy are near lethal.
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