A clinical trial is the only activity in the pharmaceutical sector where a product not yet authorised for circulation is administered directly to human volunteers. When an incident occurs — a serious adverse reaction, harm to a participant’s health — the question “who is liable” is already answered in Articles 91 to 94 of the Law on Pharmacy 105/2016/QH13 (as amended by Law 44/2024/QH15) through a three-party allocation: the participant has a right to compensation; the organisation or individual owning the investigational drug (the sponsor) bears compensation liability for risks arising from the trial; and the trial site is responsible for participant safety and compensates for the portion of risk caused by its own fault. This article analyses that allocation; the hospital operations and sponsor contract angle is covered in the dedicated article on clinical trials at Vietnamese hospitals.
The gateway: ethics assessment and Ministry of Health approval
Article 94 of the Pharmacy Law sets the starting gate: a clinical trial may only be conducted after the trial dossier has been assessed for science and ethics by the national ethics committee in biomedical research and approved in writing by the Minister of Health. Participants must be volunteers who, under Article 91, are provided complete and truthful information and the possible risks before the trial, and who may unilaterally withdraw without liability. A trial missing any of these gates is not merely administratively sanctioned — it collapses the entire liability shield of sponsor and site, because every consent form and trial agreement is built on the assumption of a validly approved trial.
Allocating compensation when an incident occurs: sponsor — site
Article 91(1)(b) of the Pharmacy Law gives participants the right to “be compensated by the organisation or individual owning the investigational drug if damage is caused by the drug trial”. Article 92(2) places the corresponding duty on the sponsor: to compensate participants if a risk materialises from the trial; to sign a trial agreement with the trial site; and to be legally responsible for the quality and safety of the drug it supplies. Article 93(2) places a parallel duty on the site: responsibility for research results, for participant safety, and compensation where the risk arises from the site’s fault. Read together, the three articles yield the practical allocation: harm attached to the investigational product itself and the trial’s inherent risks belongs to the sponsor; harm attached to the site’s operational faults (protocol deviations, dosing contrary to the protocol, slow adverse-event handling) belongs to the site; the disputed zone is incidents carrying both elements — resolvable only through a tightly drafted trial agreement (indemnity clauses, clinical trial insurance, adverse-event reporting procedures) and complete incident files. Criminal or administrative liability of individual investigators arises independently according to their own fault and cannot be contractually assumed away.
Clinical pharmacy in hospitals: liability does not end with the trial
The clinical pharmacy part of this topic sits in the post-trial stage: clinical pharmacists in healthcare facilities join consultations, monitor medication use and detect adverse drug reactions (ADRs). When an authorised drug harms a patient, the liability mechanism shifts to the ordinary frame — product quality responsibility of the manufacturer and registrant, professional fault in prescribing and dispensing, and the healthcare facility’s ADR reporting duty into the pharmacovigilance system. The common confusion is applying the compensation mechanism of Articles 91–92 (which exists only for trial participants) to ordinary patients using marketed drugs; the two groups are protected by different mechanisms with different evidence files.
Frequently Asked Questions
Testing drugs on humans: who is liable when an incident occurs?
Under the Law on Pharmacy 105/2016/QH13: the participant has the right to compensation if damage is caused by the drug trial (Article 91(1)(b)). The sponsor — the organisation or individual owning the investigational drug — must compensate where a risk materialises from the trial and is responsible for the quality and safety of the drug it supplies (Article 92(2)). The trial site must ensure participant safety and compensate for damage caused by the site’s fault (Article 93(2)). Mixed-cause incidents are allocated under the trial agreement and the incident file; individual investigators’ liability is assessed independently by their fault.
What if a trial proceeds without ethics assessment and Ministry approval?
A clinical trial may only be conducted after assessment for science and ethics by the national ethics committee in biomedical research and written approval by the Minister of Health (Article 94 of the Pharmacy Law). Running a trial without these two gates breaches the preconditions of trial activity: it is handled under law, the trial data cannot be used for drug registration, and sponsor and site lose the contractual framework for allocating liability if a participant is harmed.
May a trial participant withdraw midway?
Yes. Article 91 of the Pharmacy Law gives participants the right to complete and truthful information and possible risks before the trial; confidentiality of personal information; and no liability when unilaterally ending participation in the trial. Their only duty is to follow the investigator’s instructions under the approved trial dossier while they remain in the trial.
How does this differ from the article on clinical trials at hospitals?
The hospital article (EXP-4660) covers the hospital’s operational role and responsibilities and the contract with the sponsor from the implementing organisation’s angle. This article focuses on a different slice: the compensation allocation mechanism when an incident occurs under Articles 91–94 of the Pharmacy Law among participant, sponsor and site, and the boundary between that mechanism and clinical pharmacy liability once a drug is marketed. The two articles cross-refer and do not replace each other.
This article has been quality-reviewed by the FLAW AI Legal Council