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What You Need to Know Before You go to Trial Over a Clinical Trial

06 March 2013

Routledge Modise

The Department of Health (2006) Guidelines for Good Practice in the Conduct of Clinical Trials in South Africa (the Guidelines) focus on the management and regulation of drug trials on human participants. The Guidelines state that "regulations established in terms of section 90(s) of the National Health Act No 61 of 2003 enforce these guidelines and that compliance with these guidelines is compulsory under the direction of the Director General of Health. In the event that both a legal requirement and the guidelines apply to a particular issue of activity of the clinical trial, the legal requirement will always apply". The Guidelines outline the roles and responsibilities of the parties involved in conducting a clinical trial.

In terms of the Guidelines, all participants (principal investigator and sponsor) are required to take out comprehensive insurance for damages that may arise from injuries sustained by patient-volunteers in clinical trials.

When claiming for damages a patient will have to prove that, on a balance of probabilities, he sustained an injury that was as a result of the medicinal product under a trial and that the injury would not have occurred but for his inclusion in the trial. The Guidelines, however, provide that the patient does not need to prove negligence and the sponsor would therefore be strictly liable. Thus, the guidelines provide for similar terms as the Consumer Protection Act.

The Guidelines require the injury sustained by the patient to be "serious". There is no definition of the term serious, but it is indicated that the injury must be of an enduring or disabling character and include the exacerbation of an existing condition. An injury is not considered serious if the pain or discomfort is temporary or if the injuries are curable. Pain and suffering are subjective and therefore there may be some difficulty involved in classifying a patient's injury as serious or non-serious. There may also be difficulty involved when assessing the psychological effect on the patient and whether this should be considered serious or non-serious. This difficulty has been seen in the assessment of serious injuries in a number of the Road Accident Fund Amendment Act cases.

The Guidelines also list circumstances where there is no obligation to pay compensation. This includes the following:

Failure of a medicinal product to have its intended effect or to provide any other benefit to the participant.
Injury caused by other licensed medicinal products administered to the participant for the purpose of comparison with the product under trial.
Participants receiving placebos that fail to provide a therapeutic benefit.

Depending on the circumstances, compensation may be reduced or excluded:

  • To the extent that the injury has arisen through a significant departure from the agreed protocol.
  • To the extent that the injury has arisen through the act or default of a third party, including a doctor's failure to deal adequately with an adverse event.
  • To the extent that the injury has arisen through the contributory negligence of the patient.
  • Taking into account the seriousness of the disease being treated, the degree of probability that adverse reactions would occur and any warning given.
  • Taking into account the risks and benefits of the established treatments relative to those known or suspected of the trial medicines.

The Guidelines are clear that clinical trials' liability cover will not replace a medical practitioner's malpractice insurance and that the patient can still pursue other legal remedies in respect of any alleged injuries sustained.

Before a volunteer-patient can participate in a clinical trial the principal investigator must obtain informed consent from the volunteer-patient. The Guidelines set out in detail the nature of such informed consent, which includes explaining the purpose of the trial, the compensation and/or treatment available to the volunteer-patient in the event of trial related injury, and the foreseeable risks of harm or inconveniences to the volunteer-patient.

The Guidelines therefore seem to incorporate two key elements of the Consumer Protection Act, namely strict liability and informed consent. The Guidelines are also clear that "in the event that both a legal requirement and the guidelines apply to a particular issue of activity of the clinical trial, the legal requirement will always apply". The issue of strict liability should not pose much difficulty. What may be of relevance is that the volunteer-patient can sue anyone in the supply chain, as all parties are jointly and severally liable. With regards to informed consent, the Guidelines seems to comply with the Consumer Protection Act in that they have a list of requirements that must be complied with before a volunteer-patient can consent to participate in a clinical trial. The difficulty, however, is to what extent can the consent be considered valid if one were to consider the psyche of the potential volunteer-patient participating, for instance, in a trial for an incurable disease. It could be argued that such a potential volunteer-patient was in no state of mind to consent to such a trial, especially since the same list of requirements is used for participants in a less serious clinical trial.

It is yet to be seen to what extent the Consumer Protection Act will be utilised in the clinical trial setting and therefore caution should be exercised by both the principal investigator and the sponsor when dealing with claims and when obtaining informed consent.

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