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Legality of Invasive Biomaterial Sampling from a Comatose Patient

Task

Substantiating the legality of taking biomaterials from a comatose patient in a Russian hospital for use in Swedish drug manufacturer’s studies

Client
Hungarian medical management company
Industry
Outsourcing of clinical studies

Background

Human liver cells were supposed to be delivered to a Swedish laboratory to study a drug designed to treat patients with Wilson’s disease. Before the sample was taken, the patient lapsed into a coma and had not signed an informed consent to the invasion.

Taking a biological sample from him by decision of a medical officer on duty would violate the principles of European medical ethics and prevent the studies from being carried out. The client asked us to conduct a review, prepare a legal opinion on the principles of biopsy in Russia and substantiate the legality of sampling without the patient’s express consent.

Outcome

Our legal opinion made it possible to export the biomaterial. As a result of the studies, the patient was found to suffer liver cirrhosis not related to Wilson’s disease.

Swedish researchers found the diagnosis made to be wrong, so the patient was withdrawn from the studies and prevented from taking a potentially useless drug.