Review on compensation for damages of clinical trial subjects due to commercially available drugs in clinical trials

Clinical trials in which commercially available drugs are used include phase 4 clinical trials, phase 3 clinical trials using active-controlled groups, combination therapy studies of commercially available drugs and test drugs, bioequivalence tests, etc. Damage to subjects caused by commercially available drugs usually has a dual nature: damage caused by participation in clinical trials and side effects of commercially available drugs. If the damage occurred regardless of the intention or negligence of those involved in the clinical trial, it is subject to compensation, and if the damage caused by a commercially available drug occurred due to the intention or negligence of those involved in the clinical trial, it is subject to indemnification. Meanwhile, the Pharmaceutical Affairs Act stipulates that damages caused by clinical investigational drugs are excluded from payment of side effect relief benefits. However, if the clinical trial drug is a commercially available drug, considering the purpose and essence of the damage relief benefit system, regulatory system of related laws, and that there is no essential difference between taking a current drug as a control drug in a clinical trial and taking it by a patient who did not participate in the clinical trial, it is reasonable to interpret that it is eligible for damage relief benefits for side effects of the drug. In addition, subjects who suffer health damage during clinical trials can receive indemnification or compensation from the sponsor or trial director. In particular, in cases where compensation is eligible, it should be viewed as being applied in an selecting manner with the above drug side effect damage relief benefit system. However, due to controversies in the interpretation of related laws, there is a need to clearly overhaul the regulations to dispel concerns about insufficient protection of subjects.