Revised Laws of Saint Lucia (2021)

2.   Interpretation

In this Act —

“adverse event” means any untoward medical occurrence in a subject to whom an investigational medicinal product or investigational medical device is administered including occurrences which are not necessarily caused by or related to that investigational medicinal product or investigational medical device;

“adverse reaction” means any untoward and unintended response in a subject to an investigational medicinal product or investigational medical device which is related to any dose administered to that subject;

“Appeals Board” means the Appeals Board established under section 30;

“applicant” means —

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   (a)     in relation to an application for an ethical opinion, the chief investigator;

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   (b)     in relation to an application for an authorization, the sponsor;

“application” means —

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   (a)     an application for an ethical opinion under section 11; or

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   (b)     an application for an authorization under section 13;

“authorization” means an authorization issued under section 15(2);

“chief investigator” means —

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   (a)     in relation to a clinical trial conducted at a single trial site, the person who takes primary responsibility for the conduct of the clinical trial for the trial site; or

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   (b)     in relation to a clinical trial conducted at more than one trial site, the authorized health practitioner, whether or not he or she is an investigator at any particular trial site, who takes primary responsibility for the conduct of the clinical trial;

“clinical data” means the safety or efficacy information that is generated from the use of a medicinal product or medical device sourced from —

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   (a)     a clinical trial of an investigational medicinal product or medical device;

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   (b)     a clinical trial or other study reported in the scientific literature, on a similar investigational medicinal product or investigational medical device for which equivalence to the investigational medicinal product or investigational medical device in question can be demonstrated; or

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   (c)     a published or an unpublished report on other clinical experiences of the medicinal product or medical device in question or a similar equivalent;

“clinical trial” means —

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   (a)     any investigation in human subjects, other than a non-interventional trial, intended —

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      (i)     to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products or medical devices,

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      (ii)     to identify any adverse reactions to one or more medicinal products or medical devices,

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      (iii)     to study absorption, distribution, metabolism and excretion of one or more medicinal products or medical devices,

with the object of ascertaining the safety or efficacy of the medicinal products or medical devices;

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   (b)     includes a post-market clinical follow-up;

“conditions and principles of good clinical practice” means the conditions and principles of good clinical practice under section 19(1);

“conducting a clinical trial” includes —

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   (a)     administering, or giving directions for the administration of, an investigational medicinal product or investigational medical device to a subject for the purposes of the clinical trial;

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   (b)     giving a prescription for an investigational medicinal product or investigational medical device for the purposes of the clinical trial;

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   (c)     carrying out any other medical or nursing procedure in relation to a clinical trial; and

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   (d)     carrying out any test or analysis —

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      (i)     to discover or verify the clinical, pharmacological or other pharmacodynamic effects of the investigational medicinal product or investigational medical device administered in the course of a clinical trial,

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      (ii)     to identify any adverse reactions to an investigational medicinal product or investigational medical device, or

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      (iii)     to study absorption, distribution, metabolism and excretion of the investigational medicinal products or investigational medical device,

but does not include any activity undertaken prior to the commencement of the clinical trial which consists of making such preparations for the clinical trial as are necessary or expedient;

“confidentiality” means prevention of disclosure, other than to authorized individuals, organizations or legal entities, of —

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   (a)     an applicant's proprietary information;

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   (b)     a trial subject's personal identity;

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   (c)     personal medical information and other personal data;

“day” means a calendar day;

“Ethics Committee” means the Ethics Committee appointed under section 6;

“informed consent” means a trial subject's free and voluntary expression of his or her willingness to participate in a particular clinical trial, after having been informed of its nature, significance, implications and risks and other aspects of the clinical trial that are relevant to the trial subject's decision to participate;

“investigational medical device” means the medical device being tested or used as a reference in a clinical trial;

“investigational medicinal product” means a pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be used, as a reference in a clinical trial, and includes a medicinal product or medical device which has a marketing approval but is, for the purposes of the clinical trial —

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   (a)     used or assembled, formulated or packaged in a way different from the form of the product or device authorized under the marketing approval;

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   (b)     used for an indication not included in the summary of product or device characteristics under the marketing approval for that product or device; or

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   (c)     used to gain further information about the form of that product or device as authorized under the marketing approval;

“investigator” means a person responsible for the conduct of the clinical trial at a trial site;

“investigator's brochure” means a document containing a summary of the clinical data and non-clinical data on the investigational medicinal product or investigational medical device, which are relevant to the clinical trial;

“in vitro diagnostic medical device” means any medical device which is intended to be used, alone or in combination with others, as a reagent, reagent device, calibrator, control material, kit, instrument, apparatus, equipment or system, according to the intended purpose specified by the manufacturer, for the in vitro examination of specimens derived from the human body, including blood and tissue donations;

“manufacturer” means a person with responsibility for the design, manufacture, packaging and labelling of an investigational medical device with a view to placing it on the market for the first time under his or her own name, regardless of whether those operations are carried out by the person himself or herself or on his or her behalf by a third party;

“marketing approval” means the authorization to market a medicinal product or medical device in the United States of America, the European Union and any other jurisdiction recognized by the National Competent Authority;

“medical device” means any instrument, apparatus, implement, implant, machine, appliance, software, material or other similar or related article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for one or more of the following purposes —

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   (a)     diagnosis, prevention, monitoring, treatment or alleviation of disease;

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   (b)     diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;

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   (c)     investigation, replacement, modification or support of the anatomy or of a physiological process;

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   (d)     supporting or sustaining life; or

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   (e)     control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

“medicinal product” —

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   (a)     means —

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      (i)     any substance or combination of substances presented as having properties for treating or preventing disease in human beings, and

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      (ii)     any substance or combination of substances which may be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;

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   (b)     does not include a medical device;

“Minister” means the Minister responsible for health;

“minor” means a person under the age of 16 years;

“monitoring” means the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, good clinical practice and the laws of Saint Lucia;

“National Competent Authority” means the National Competent Authority designated under section 7;

“non-interventional trial” means a study of one or more medicinal products or medical device which have a marketing approval, where the following conditions are met —

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   (a)     the products are prescribed in the usual manner in accordance with the terms of the marketing approval;

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   (b)     the assignment of any patient involved in the study to a particular therapeutic strategy is not decided in advance by a protocol but falls within current practice;

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   (c)     the decision to prescribe a particular medicinal product or medical device is clearly separated from the decision to include the patient in the study;

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   (d)     no diagnostic or monitoring procedures are applied to the patients included in the study, other than those which are ordinarily applied in the course of the particular therapeutic strategy in question; and

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   (e)     epidemiological methods are to be used for the analysis of the data arising from the study;

“post-market clinical follow-up” means a clinical trial carried out following the marketing approval of a medicinal product or medical device and intended to answer specific questions relating to clinical safety or performance of a medicinal product or medical device when used in accordance with the marketing approved labelling for the medicinal product or medical device;

“protocol” means a document that describes the objective, design, methodology, statistical considerations and organisation of a clinical trial and includes successive versions of the protocol and modifications to the protocol;

“Regulations” means Regulations made under section 35;

“serious adverse event” means an adverse event that requires inpatient hospitalization or prolongation of existing hospitalization that —

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   (a)     results in persistent or significant disability or incapacity;

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   (b)     consists of a congenital anomaly or birth defect;

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   (c)     is life-threatening; or

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   (d)     results in death;

“sponsor” means the person who takes responsibility for the start, management or financing of a clinical trial;

“subject” means an individual, whether a patient or not, who participates in a clinical trial —

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   (a)     as a recipient of an investigational medicinal product or investigational medical device or of some other treatment or product; or

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   (b)     without receiving any treatment or product, as a control;

“trial site” means a hospital, health centre, surgery or other institution, site or facility at or from which a clinical trial or any part of a clinical trial is conducted;

“unexpected adverse reaction” means an adverse reaction the nature and severity of which is not consistent with the information about the medicinal product or medical device set out —

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   (a)     in the case of a product or device with a marketing approval, in the summary of product or device characteristics for that product or device;

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   (b)     in the case of any other investigational medicinal product or investigational medical device, in the investigator's brochure relating to the clinical trial.