Revised Laws of Saint Lucia (2021)

18.   Withdrawal, revocation and suspension

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   (1)   The Ethics Committee or National Competent Authority may —

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      (a)     withdraw an opinion or authorization if the Ethics Committee or National Competent Authority subsequently becomes aware that grounds for refusal existed at the time of issuance of the opinion or authorization, if the conditions surrounding the clinical trials do not correspond with the information contained in the application or if facts give reason to doubt the safety or the scientific basis of the clinical trial;

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      (b)     revoke an opinion or authorization if the Ethics Committee or National Competent Authority becomes aware that subsequent to the opinion or authorization, the requirements for clinical trials under this Act are no longer fulfilled; or

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      (c)     suspend an opinion or authorization for a limited time in cases where the Ethics Committee or National Competent Authority believes that —

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         (i)     any condition, restriction or limitation which applies to the conduct of the clinical trial and is set out in the application for an opinion or authorization or the particulars or documents accompanying the application, or

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         (ii)     any condition imposed by the National Competent Authority under section 15, is no longer satisfied, generally or at a particular trial site; or

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         (iii)     there is sufficient information to raise doubts about the safety or scientific validity of the clinical trial, or the conduct of the clinical trial at a particular trial site.

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   (2)   Before withdrawing, revoking or suspending an opinion or authorization, the Ethics Committee or National Competent Authority shall by notice in writing —

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      (a)     inform the sponsor or investigator that the Ethics Committee or National Competent Authority proposes to issue a notice —

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         (i)     withdrawing, revoking or suspending the opinion or authorization, and

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         (ii)     suspending or terminating the clinical trial, or the conduct of a clinical trial at a particular site, and of the reasons for the suspension or termination; and

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      (b)     advise the sponsor or investigator that he or she may, within one week of the date of the notice, furnish the Ethics Committee or National Competent Authority with written representations as to whether opinion or authorization should not be withdrawn, revoked or suspended or the clinical trial, or the conduct of the clinical trial at a particular site, should not be suspended or terminated.

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   (3)   Subsection (2) does not apply where it appears to the Ethics Committee or National Competent Authority that there is an imminent risk to the health or safety of any of the subjects of the clinical trial.

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   (4)   Where a statement is not provided within one week or the statement does not adequately address the grounds for the withdrawal, revocation or suspension, the Ethics Committee or National Competent Authority may by notice —

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      (a)     withdraw, revoke or suspend the opinion or authorization; and

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      (b)     require that the clinical trial, or the conduct of the clinical trial at a particular trial site, be suspended or terminated.

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   (5)   A notice under subsection (4)(b) shall be served —

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      (a)     in a case where the suspension or termination applies to the clinical trial generally, on —

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         (i)     the sponsor, or

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         (ii)     the investigator at each trial site;

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      (b)     in a case where the suspension or termination applies to the conduct of a trial at a particular trial site, on —

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         (i)     the sponsor, or

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         (ii)     the investigator at that trial site.

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   (6)   A notice under subsection (4)(b) must specify —

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      (a)     whether the notice applies to the clinical trial generally or to one or more of the trial sites;

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      (b)     whether the notice requires suspension or termination of the clinical trial;

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      (c)     if the notice requires suspension of the clinical trial —

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         (i)     whether the suspension applies until further notice from the Ethics Committee or National Competent Authority or for such period as may be specified in the notice, and

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         (ii)     any conditions which are to be satisfied before the clinical trial or the conduct of the clinical trial at a particular site, may be recommenced; and

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      (d)     whether suspension or termination is to take effect immediately on receipt of the notice or on such date as may be specified in the notice.

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   (7)   Where the Ethics Committee or National Competent Authority issues a notice under subsection (4)(b), the Ethics Committee or National Competent Authority shall immediately inform, where the notice has not been served on the sponsor, the sponsor.

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   (8)   Any person who fails to comply with a withdrawal, revocation or suspension of an opinion or authorization or notice of suspension or termination served on him or her under this section, unless that notice has been withdrawn or revoked by the Ethics Committee or National Competent Authority, commits an offence and is liable on summary conviction to fine not exceeding $5,000 or to a term of imprisonment not exceeding 6 months or to both fine and imprisonment.

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   (9)   Where an opinion or authorization is withdrawn, revoked or suspended under this section, an applicant may, within 30 days from receipt of the withdrawal, revocation or suspension, appeal in writing to the Appeals Board, setting out the grounds on which the appeal is made.