Country Report Israel

Abstract

In 1980, the Director-General of the Ministry of Health promulgated the Public Health Regulations (Human Experimentation). The Regulations provide that no medical experiment on humans may be conducted in violation of the Helsinki Declaration, which has thus been incorporated into Israeli law. The two principal criteria prescribed in the Helsinki Declaration are Risk-Benefit calculus and Informed Consent. In 2006, the Ministry of Health issued a detailed Directive on Medical Experiments on Humans. The Directive stipulates that medical human experiments must conform to, inter alia, the provisions of the Harmonized Tripartite Guideline for Good Clinical Practice (ICH-GCP E6) and to the provisions of the Standard for Clinical Investigation of Medical Devices for Human Subjects. “Good Clinical Practice” is defined as “standards of practice and methodology which are designed to safeguard the welfare and rights of the experiment’s subjects as well as to guarantee the experiment’s quality and efficacy”. While the 1980 Human Experimentation Regulations were a step in the right direction, such a complex and sensitive problem-area is worthy of treatment by the Legislature itself, speaking through primary legislation. Indeed, a draft bill titled “Medical Experiments on Human Beings Act” has been pending for some time now before the Israeli Knesset (Parliament).