No. 17/1990:

CONTROL OF CLINICAL TRIALS AND DRUGS ACT, 1990

ARRANGEMENT OF SECTIONS

Section

1. Definition.

2. Amendment of section 6 of Act of 1987.

3. Obligations to have security.

4. Amendment of section 13 of Act of 1987.

5. Immunities.

6. Short title, construction and collective citation.

ACT REFERRED TO

Number 17 of 1990

CONTROL OF CLINICAL TRIALS AND DRUGS ACT, 1990

AN ACT TO AMEND AND EXTEND THE CONTROL OF CLINICAL TRIALS ACT, 1987 , TO PROVIDE CERTAIN LEGAL IMMUNITIES FOR THE NATIONAL DRUGS ADVISORY BOARD IN THE EXERCISE OF ITS FUNCTIONS AND TO PROVIDE FOR MATTERS CONNECTEDTHEREWITH.

[11th July, 1990]

BE IT ENACTED BY THE OIREACHTAS AS FOLLOWS:

1.—In this Act "the Act of 1987" means the Control of Clinical Trials Act, 1987 .

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:

"(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,",

and the said definition, as so amended, is set out in the Table to this section.

TABLE

"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—

( a ) where

(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

(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,

or

( 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

( 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;

3.—The Act of 1987 is hereby amended by the substitution for section 10 of the following:

"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.

(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.

(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).

(4) It shall be a good defence for a person prosecuted for contravening either subsection (1) or (2) to show that he reason ably believed that the provisions of the subsection had been complied with.

(5) In this section 'security' includes a contract of insurance, a contract of indemnity, a guarantee, a surety, a warrant and a bond.".

4.—Subsection (2) of section 13 of the Act of 1987 is hereby amended by the substitution for paragraph (a)of the following:

"( a ) subject to paragraph (b), where an offence under subsection (1) is committed by a body corporate or by a person purporting to act on behalf of a body corporate or on Act, 1990 behalf of an unincorporated body of persons, every other person who at the time of the commission of the offence was a director, manager, secretary or other officer (including a member of any committee of management or other controlling authority) of such body, as well as the body corporate or the person so purporting to act, shall be guilty of an offence and shall be liable to be proceeded against and punished as if he were guilty of the first mentioned offence.".

5.—(1) No action or other proceeding shall lie or be maintainable 1 (except in the case of wilful neglect or default) against—

( a ) the Minister,

( b ) the National Drugs Advisory Board or any person acting as a member, officer or servant thereof,

( c ) an ethics committee or any member thereof,

for the recovery of damages in respect of any injury to persons or property alleged to have been caused or contributed to by reason of or arising from the discharge of any of their functions imposed by or under the Control of Clinical Trials Acts, 1987 and 1990.

(2) No action or other proceeding shall lie or be maintainable (except in the case of wilful neglect or default) against—

( a ) the National Drugs Advisory Board or any person acting as a member, officer or servant thereof, or

( b ) a committee established under Article 18 of the National Drugs Advisory Board (Establishment) Order, 1966 ( S.I. No. 163 of 1966 ), or any member thereof,

for the recovery of damages in respect of any injury to persons or property alleged to have been caused or contributed to by reason of or arising from the discharge of any of the Board's functions under Article 4 of the National Drugs Advisory Board (Establishment) Order, 1966.

6.—(1) This Act may be cited as the Control of Clinical Trials and Drugs Act, 1990 , and, other than section 5 (2), shall be construed together as one with the Act of 1987.

(2) This Act, other than section 5 (2), and the Act of 1987 may be cited together as the Control of Clinical Trials Acts, 1987 and 1990.