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Amendment of section 6 of Act of 1987.
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2.—In subsection (2) of section 6 of the Act of 1987, the definition of “conduct a clinical trial” is hereby amended by the substitution for subparagraph (ii) of paragraph (a) of the following:
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“(ii) the principal purpose of that administration is to prevent disease in or to save the life, restore the health, alleviate the condition or relieve the suffering of, the patient,”,
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and the said definition, as so amended, is set out in the Table to this section.
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TABLE
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“conduct a clinical trial” means the conducting of a systematic investigation or series of investigations for the purpose of ascertaining the effects (including kinetic effects) of the administration of one or more substances or preparations on persons where such administration may have a pharmacological or harmful effect, but does not include the conducting of such a systematic investigation or series of investigations as aforesaid—
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(a) where
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(i) the administration of one or more substances or preparations, as the case may be, is on a patient in the ordinary course of medical practice (in the case of a registered medical practitioner) or of dental practice (in the case of a registered dentist) and
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(ii) the principal purpose of that administration is to prevent disease in, or to save the life, restore the health, alleviate the condition or relieve the suffering of, the patient,
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or
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(b) where the substance or preparation concerned is to be administered to persons undergoing a course of training leading to a qualification which will entitle such a person to be registered as a registered medical practitioner or as a registered dentist or as a registered pharmaceutical chemist and where it is to be administered as part of such a course of training, or
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(c) for the purpose of examining the nutritional effect of the substance or preparation concerned where that substance or preparation is a normal dietary constituent;
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