A4-0146/97

Proposal for a Council Directive on health protection of individuals against the dangers of ionizing radiation in relation to medical exposures, replacing the Directive 84/466/Euratom (COM(96)0465 - C4-0548/96 - 96/0230(CNS))

The proposal was approved with the following amendments:

(Amendment 1)

Article 1, second paragraph

>Original text>

The purpose of this Directive is to supplement Directive 80/836/Euratom on the basic safety standards as regards medical exposures.

>Text following EP vote>

The purpose of this Directive is to supplement Directive 96/29/Euratom on the basic safety standards as regards medical exposures.

(Amendment 2)

Article 2, indent 'potential exposures'

>Original text>

- potential exposures: exposure with a probability of occurrence that can be estimated in advance for accidents and incidents, such as a failure of equipment, a misadministration, a human error or a computer failure;

>Text following EP vote>

- potential exposures: exposure resulting from events such as equipment failure or faults, or a human error and with a probability of occurrence that can be estimated in advance;

(Amendment 3)

Article 2, indent 'medical physicist'

>Original text>

medical physicist: an expert in radiation physics applied to medical exposures whose training and competence to act is recognized by the competent authorities and who, as appropriate, gives advice on patient dosimetry, on the development and use of complex techniques and equipment and on optimization, on quality assurance, including quality control, and on matters relating to radiation protection as defined in Article 3, as appropriate. This expert might also give advice on radiation protection aspects as regards workers and the public;

>Text following EP vote>

medical physicist: an expert in radiation physics applied to medical exposures whose training and competence to act is recognized by the competent authorities and who, as appropriate, gives advice on patient dosimetry, on the development and use of complex techniques and equipment and on optimization, on quality assurance, including quality control, and on matters relating to radiation protection as defined in Article 3, as appropriate.

(Amendment 4)

Article 2, indent 'quality assurance'

>Original text>

quality assurance: all those planned and systematic actions necessary to provide adequate confidence that a structure, system or component will perform satisfactorily in service. Satisfactory performance in service implies the optimum quality of the entire procedure. In the case of radiodiagnostic procedure, the consistent production of adequate diagnostic information with minimum exposure of both patients and personnel. In the case of a radiotherapeutic procedure optimum exposure of patients and minimum exposure of personnel;

>Text following EP vote>

quality assurance: all those planned and systematic actions necessary to provide adequate confidence that a structure, system or component will perform satisfactorily in service. Satisfactory performance in service implies the optimum quality of the entire procedure. By optimum quality is meant:

(a) in the case of radiodiagnostic procedure, the consistent production of adequate diagnostic information with minimum exposure of patients and optimum exposure of workers;

(b) in the case of radiotherapeutic procedure, the optimum exposure of patients and workers;

(Amendment 5)

Article 4(1), second subparagraph

>Original text>

The prescriber and the practitioner will always check if previous diagnostic information or medical records relevant to the planned exposure are available and consult these data to avoid unnecessary examinations.

>Text following EP vote>

The prescriber and the examining doctor shall be involved in the process of justification, taking specific responsibility in accordance with the provisions laid down by the Member State.

(Amendment 6)

Article 4(1a) (new)

>Text following EP vote>

1a. Every radiological unit must have the possibility of consulting a medical physicist for the necessary advice on the exposure.

(Amendment 7)

Article 4(4)

>Original text>

4. Special attention shall be given for those exposures where there is no direct health benefit for the person undergoing the exposure and especially for exposures on medico- legal, insurance and legal grounds.

>Text following EP vote>

4. Exposures where there is no direct health benefit for the person undergoing the exposure, especially exposures on medico-legal, insurance and legal grounds, shall be avoided.

(Amendment 8)

Article 5(4a) (new)

>Text following EP vote>

4a. Member States shall adopt measures to ensure that equipment and installations which do not meet predetermined acceptability criteria are taken out of service or replaced.

(Amendment 9)

Article 5(5)

>Original text>

5. In radiotherapeutic practices, a medical physicist shall be closely involved. In diagnostic nuclear medicine practices, a medical physicist shall be involved as appropriate. For other radiodiagnostic practices, a medical physicist shall be available for consultation on optimization and quality assurance, including quality control, as appropriate, and also to give advice on matters relating to radiation protection concerning medical exposures, as required.

>Text following EP vote>

5. In radiotherapeutic practices, a medical physicist shall be closely involved. In diagnostic nuclear medicine practices, a medical physicist shall be involved as appropriate. The medical physicist must check any work done on the equipment used for radiotherapy. For other radiodiagnostic practices, a medical physicist shall be available for consultation on optimization and quality assurance, including quality control, as appropriate, and also to give advice on matters relating to radiation protection concerning medical exposures, as required. The medical physicist will also check the suitability of the equipment on the basis of the exposure/diagnostic benefit ratio, laying down maximum and minimum reference criteria to be respected.

(Amendment 10)

Article 10(1) third indent a (new)

>Text following EP vote>

- exposures for therapeutic purposes,

(Amendment 11)

Article 11(2)

>Original text>

2. If pregnancy cannot be excluded, depending on the type of medical exposures, special attention shall be given to the justification, particularly the urgency, and to the optimization of the medical exposure both for the mother and the unborn child.

>Text following EP vote>

2. If pregnancy cannot be excluded, and unless the health of the woman will be seriously affected, medical exposure involving in particular the pelvic and abdominal regions shall be avoided.

(Amendment 12)

Article 13(2)

>Original text>

2. In the case of a patient undergoing a treatment with radionuclides Member States shall ensure that the practitioner provides the patient or legal guardian, before leaving the hospital or clinic, with written instructions as appropriate on the reduction of doses to persons in contact with the patient and with information on the risks of ionizing radiation.

>Text following EP vote>

2. In the case of a patient undergoing a treatment with radionuclides Member States shall ensure that the examining doctor provides the patient or legal guardian, before leaving the hospital or clinic, with written instructions as appropriate on the reduction of doses to persons in contact with the patient and with information on the risks of ionizing radiation.

Legislative resolution embodying Parliament's opinion on the proposal for a Council Directive on health protection of individuals against the dangers of ionizing radiation in relation to medical exposures, replacing the Directive 84/466/Euratom (COM(96)0465 - C4-0548/96 - 96/0230(CNS))

(Consultation procedure)

The European Parliament,

- having regard to the Commission proposal to the Council, COM(96)0465 - 96/0230(CNS) ((OJ C 341, 13.11.1996, p. 17.)),

- having been consulted by the Council pursuant to Article 31 of the EAEC Treaty (C4-0548/96),

- having regard to Rule 58 of its Rules of Procedure,

- having regard to the report of the Committee on the Environment, Public Health and Consumer Protection (A4-0146/97),

1. Approves the Commission proposal, subject to Parliament's amendments;

2. Calls on the Commission to alter its proposal accordingly, pursuant to Article 119, second paragraph of the EAEC Treaty;

3. Calls on the Council to notify the Parliament should it intend to depart from the text approved by Parliament;

4. Asks to be consulted again should the Council intend to make substantial modifications to the Commission proposal;

5. Instructs its President to forward this opinion to the Council and Commission.