Abstract

A 78-year-old Chinese woman joined a clinical trial sponsored by a Pharmaceutical companies. Unfortunately a serious Serious Adverse Event occurred. The sponsor paid for the cost of the medical care arising from the SAE, but refused the family’s request for compensation. The family then sued the company and the hospital in Beijing. Although the SAE was related to a complication of lower extremity angiography and not the drug itself, it was a direct consequence of participating in the trial. According Good Clinical Practice, a set of regulations promulgated under Chinese law, “the sponsor should provide Insurance to those human subjects who participate in clinical trials, cover the cost of Treatment and the corresponding economic compensation for the occurrence of the harm or death associated with the trial”. The court ordered the trial sponsor to provide a translation of the company’s insurance policy, so that the court could understand the amount of compensation available to the Patient under the policy, but the sponsor never surrendered either the documentation or a translation. Consensus was never reached about the amount of compensation due to the patient through negotiation with the hospital, the company and the family. The Litigation ended after nine hearings and five long years. This chapter provides an ethical analysis of the case relative to at least three areas of Risks of Exploitation when a major, international Pharmaceutical companies sponsors clinical research in a country with an immature legal system and where Research participants have limited resources.