Article by listed attorney: Fawzia Khan
The threat of the Ebola virus continues to take centre stage in the media, making world news headlines and instilling fear and panic amongst ordinary civilians and governments alike. We have all read and saw horror stories of the hapless victims who succumbed to this devastating illness. I’m sure many multinational pharmaceutical companies who are engaged in research and development are busy working frantically to be the first to lay claim to having found a cure for this dreaded disease. Apart from receiving world recognition of having developed a vaccine or other drug to combat Ebola, it will no doubt also be an extremely lucrative market to target.
As part of research, once a drug has been formulated, pharmaceutical companies conduct clinical or medical trials in order to provide an evaluation of the efficacy and safety of those drugs. Volunteers, usually patients who are already suffering with that particular illness or disease are invited to participate in the clinical trials. The upside for the patient who is prepared to act as a “guinea pig”, is that there would be no cost to him to receive that particular drug or treatment.
Once all the medical trials are completed and results established, the pharmaceutical company would be in a position to highlight all the adverse side effects (or “contra indications”) that would be associated with using that particular drug. In South Africa, the Medicines Control Council of South Africa strictly regulates theses medical trials. The MCC would provide the pharmaceutical companies with the necessary authorization allowing them to conduct the trial, which is to be done in accordance with the “protocol” supplied by the company.
What happens if a patient sustains an injury or is harmed in any way whilst participating in the clinical trial? Can he sue the pharmaceutical company for any damages he sustained? The answer is no as generally when a volunteer agrees to participate in these medical or clinical trial, he would sign a consent form in which he accepts the risk and provides his informed consent to such risk.
However a cancer patient, Venter, who participated as a volunteer in a clinical trial involving medication for cancer sufferers, which caused him to suffer a perforation of his bowel after he took the medication, took his case against the pharmaceutical company, Roche to the Supreme Court of Appeal, when he lost his case in the High Court. The consent form which Venter signed enabled him to be compensated only if he sustained an injury which was directly as a result of the medication he used or procedures arising from the protocol.
However Venter also claimed compensation for pain and suffering, loss of income and general damages. Venter, who signed the consent form at his oncologist’s consulting room, sued Roche, the company he said conducted the medical trial, as well as the oncologist’s practice as well. Venter claimed there was a tacit contract between him and the oncologist’s practice. The identity of the pharmaceutical entity Venter sued was also in dispute. The Supreme Court of Appeal dismissed his appeal and held that there were no grounds to justify a tacit contract with the oncologist and that Venter indeed sued the wrong pharmaceutical entity, even though he ought to have been aware of the correct entity.
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