Uimhir 17 de 1990

AN tACHT UM RIALÚ TRIALACHA AGUS DRUGAÍ CLINICIÚLA, 1990

RIAR NA nALT

Uimhir 17 de 1990

AN tACHT UM RIALÚ TRIALACHA AGUS DRUGAÍ CLINICIÚLA, 1990

[An tiontú oifigiúil]

ACHT DO LEASÚ AGUS DO LEATHNÚ AN ACHTA UM RIALÚ TRIALACHA CLINICIÚLA, 1987, DO SHOL-ÁTHAR DÍOLÚINTÍ DLÍTHIÚLA ÁIRITHE DON BHORD COMHAIRLEACH NÁISIÚNTA DRUGANNA I bhFEIDHMIÚ A FHEIDHMEANNA AGUS DO DHÉAN-AMH SOCRÚ I dTAOBH NITHE A BHAINEANN LEIS AN MÉID SIN. [11 Iúil, 1990]

ACHTAÍTEAR AG AN OIREACHTAS MAR A LEANAS:

Míniú.

1.—San Acht seo ciallaíonn “Acht 1987” an tAcht um Rialú Trialacha Cliniciúla, 1987.

Leasú ar alt 6 d'Acht 1987.

2.—I bhfo-alt (2) d'alt 6 d'Acht 1987, déantar leis seo an míniú ar “triail chliniciúil a sheoladh” a leasú tríd an méid seo a leanas a chur in ionad fhomhír (ii) de mhír (a):

“(ii) gurb é an príomhchuspóir atá leis an tabhairt sin galar ar an othar a sheachaint nó an t-othar a shábháil ón mbás, a shláinte a thabhairt ar ais dó, a bhreoiteacht a mhaolú nó faoiseamh óna phian a thabhairt dó,”,

agus tá an míniú sin, arna leasú amhlaidh, leagtha amach sa Tábla a ghabhann leis an alt seo.

Oibleagáidí urrús a sholáthar.

3.—Leasaítear leis seo Acht 1987 tríd an méid seo a leanas a chur in ionad alt 10:

“10.—(1) Ní dhéanfaidh duine socrú chun triail chliniciúil a sheoladh mura suífidh an duine sin chun sástacht an Aire go bhfuil urrús ar fáil ag an duine sin faoi choinne íocaíochtaí a dtiocfaidh sé chun bheith faoi dhliteanas iad a íoc le haon rannpháirtí sa triail chliniciúil, ar mhodh damáistí nó costas, de dheasca díobhála, caillteanais nó damáiste a thrúigtear don rannpháirtí sin de bhíthin faillí sa socrú chun an triail chliniciúil a sheoladh.

(2) Ní sheolfaidh duine triail chliniciúil mura suífidh an duine sin chun sástacht an Aire go bhfuil urrús ar fáil ag an duine sin faoi choinne íocaíochtaí a dtiocfaidh sé chun bheith faoi dhliteanas iad a íoc le haon rannpháirtí sa triail chliniciúil, ar mhodh damáistí nó costas, de dheasca díobhála, caillteanais nó damáiste a thrúigtear don rannpháirtí sin de bhíthin faillí i seoladh na trialach cliniciúla.

(3) Ní fhorléireofar aon ní san alt seo mar ní a cheanglaíonn ar choiste eitice, de bhua alt 8, aird a thabhairt ar aon urrús chun críocha fho-alt (1) nó (2).

(4) Is cosaint mhaith do dhuine a ionchúiseofar mar gheall ar shárú ar fho-alt (1) nó (2) a shuíomh gur chreid sé le réasún go raibh forálacha an fho-ailt comhlíonta.

(5) San alt seo folaíonn ‘urrús’ conradh árachais, conradh slánaíochta, ráthaíocht, urra, barántas agus banna.”.

Leasú ar alt 13 d'Acht 1987.

4.—Leasaítear leis seo fo-alt (2) d'alt 13 d'Acht 1987 tríd an méid seo a leanas a chur in ionad mhír (a):

“(a) faoi réir mhír (b), i gcás cion faoi fho-alt (1) a bheith déanta ag comhlacht corpraithe nó ag duine a airbheartaíonn a bheith ag gníomhú thar ceann comhlachta chorpraithe nó thar ceann comhlachta neamhchorpraithe daoine, beidh gach duine eile a bhí, an tráth a ndearnadh an cion, ina stiúrthóir, ina bhainisteoir, ina rúnaí ar an gcomhlacht sin nó ina oifigeach eile don chomhlacht sin (lena n-áirítear comhalta d'aon choiste bainisteoireachta nó d'aon údarás rialaithe eile), chomh maith leis an gcomhlacht corpraithe nó leis an duine a airbheartaíonn a bheith ag gníomhú amhlaidh, ciontach i gcion agus dlífear imeachtaí a thionscnamh ina choinne agus é a phionósú amhail is dá mbeadh sé ciontach sa chion céadluaite.”.

Díolúintí.

5.—(1) Ní bheidh aon ábhar caingne ná imeachta eile ann, ná ní bheidh an céanna inchoimeádta ar aghaidh (ach amháin i gcás faillí nó mainneachtana de chineál toiliúil)—

(a) in aghaidh an Aire,

(b) in aghaidh an Bhord Comhairleach Náisiúnta Druganna nó aon duine a bheidh ag gníomhú mar chomhalta, mar oifigeach nó mar sheirbhíseach don Bhord sin,

(c) in aghaidh coiste eitice nó aon chomhalta de,

chun damáistí a ghnóthú i leith aon díobhála do dhaoine nó do mhaoin a líomhnaítear gurb é ba chúis nó ba chionchúis leis an díobháil gur de bhíthin nó de dhroim urscaoileadh aon fheidhme dá gcuid feidhmeanna a fhorchuirtear leis na hAchtanna um Rialú Trialacha Cliniciúla, 1987 agus 1990, nó faoi na hAchtanna sin, a tharla sí.

(2) Ní bheidh aon ábhar caingne ná imeachta eile ann, ná ní bheidh an céanna inchoimeádta ar aghaidh (ach amháin i gcás faillí nó mainneachtana de chineál toiliúil)—

(a) in aghaidh an Bhord Comhairleach Náisiúnta Druganna nó aon duine a bheidh ag gníomhú mar chomhalta, mar oifigeach nó mar sheirbhíseach don Bhord sin, ná

(b) in aghaidh coiste a bheidh bunaithe faoi Airteagal 18 den Ordú um an mBord Comhairleach Náisiúnta Druganna (Bunú), 1966 (I.R. Uimh. 163 de 1966), ná in aghaidh aon chomhalta den choiste sin,

chun damáistí a ghnóthú i leith aon díobhála do dhaoine nó do mhaoin a líomhnaítear gurb é ba chúis nó ba chionchúis leis an díobháil gur de bhíthin nó de dhroim urscaoileadh aon fheidhme d'fheidhmeanna an Bhoird faoi Airteagal 4 den Ordú um an mBord Comhairleach Náisiúnta Druganna (Bunú), 1966, a tharla sí.

Gearrtheideal, forléiriú agus comhlua.

6.—(1) Féadfar an tAcht um Rialú Trialacha agus Drugaí Cliniciúla, 1990, a ghairm den Acht seo, agus, seachas alt 5 (2), forléireofar le chéile é mar aon ní amháin le hAcht 1987.

(2) Féadfar na hAchtanna um Rialú Trialacha Cliniciúla, 1987 agus 1990, a ghairm den Acht seo, seachas alt 5 (2), agus d'Acht 1987, le chéile.

Number 17 of 1990

CONTROL OF CLINICAL TRIALS AND DRUGS ACT, 1990

ARRANGEMENT OF SECTIONS

Number 17 of 1990

CONTROL OF CLINICAL TRIALS AND DRUGS ACT, 1990

Definition.

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

Amendment of section 6 of Act of 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;

Obligations to have security.

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 reasonably 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.”.

Amendment of section 13 of Act of 1987.

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 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.”.

Immunities.

5.—(1) No action or other proceeding shall lie or be maintainable (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.

Short title, construction and collective citation.

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.