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Obligations to have security.
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3.—The Act of 1987 is hereby amended by the substitution for section 10 of the following:
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“10.—(1) A person shall not arrange for the conducting of a clinical trial unless such person establishes to the satisfaction of the Minister that there is available to that person security to provide for payments which, as a result of injury, loss or damage caused to any participant in the clinical trial by reason of negligence in the arrangement for the conducting of the clinical trial, he shall become liable to pay to such participant by way of damages or costs.
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(2) A person shall not conduct a clinical trial unless such person establishes to the satisfaction of the Minister that there is available to that person security to provide for payments which, as a result of injury, loss or damage caused to any participant in the clinical trial by reason of negligence in the conducting of the clinical trial, he shall become liable to pay to such participant by way of damages or costs.
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(3) Nothing in this section shall be construed as requiring, by virtue of section 8, an ethics committee to have regard to any security for the purposes of subsection (1) or (2).
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(4) It shall be a good defence for a person prosecuted for contravening either subsection (1) or (2) to show that he reasonably believed that the provisions of the subsection had been complied with.
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(5) In this section ‘security’ includes a contract of insurance, a contract of indemnity, a guarantee, a surety, a warrant and a bond.”.
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