Amos Shapira

Hereditary protein C deficiency during pregnancy

Hereditary protein C, a primary hypercoagulable state, has not been previously associated with preeclamptic toxemia. A woman with previous preeclamptic toxemia and fetal deaths presented with recurrent deep vein thrombosis during her third pregnancy. Hereditary protein C was diagnosed but full heparinization followed by low-dose heparin failed to prevent preeclamptic toxemia.

Country Report Israel

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).

Israel Country Report

Until 1980, Israeli law did not prescribe a specific scheme for prior review of biomedical experimentation involving human beings. The licensing of drugs in Israel is generally regulated under the Pharmacists Regulations (revised in 1986). The Pharmacists Regulations prohibit the manufacture, marketing, importation, and authorization for use of a pharmaceutical, unless it is registered under the Regulations and according to the registered specifications. The Director-General of the Ministry of Health (hereafter: Director-General), who is in charge of keeping the Pharmaceuticals Registry, is duty bound under the Regulations not to register a drug unless, among several other pre-conditions, he is satisfied that the drug in question “is not harmful or likely to harm health and is effective for the purpose prescribed to it”. Both freedom from risk and functional effectiveness are thus made a sine qua non to the licensing of a drug in Israel. These requirements seem reasonable in view of the fact that registration authorizes the mass manufacture, marketing, importation, and use of a drug in the free market.

IL — Country Report Israel

The law presumes that an adult person of sound mind is competent to consent for himself to medical interventions. By contrast, a medical procedure sought to be performed on an incompetent (such as a minor or a mentally incapacitated person) requires the surrogate consent of a duly authorized guardian or representative. In performing their task, such guardian or representative are duty bound to take care of the incompetent’s needs and to act in his or her best interests.

Public Control over Biomedical Experiments Involving Human Beings: an Israeli Perspective

Current dramatic developments in biomedical research on humans have produced a conflict between two weighty social concerns: On the one hand, the interest in the advancement of biomedical science for the benefit of the present and future generations;1 and on the other hand, the principle calling for treating the individual as an end in itself, with his rights to privacy, autonomy, and self-determination adequately protected. These two all-important social concerns require proper consideration and mutual balancing.

The Process of Interest Analysis — Ascertainment of Relevant Interests

The preceding two chapters were devoted to an articulation of the concept of interest in conflicts contexts. It is proposed now to embark upon a structured elaboration of the process of interest analysis in choice-of-law cases. The present chapter focuses attention on the first step in such a process — the ascertainment of relevant interests.

The Traditional Approach to Choice of Law

The first question confronting any choice-of-law methodology is: why should a forum ever bother to consider applying foreign laws? Traditional thinking has identified several reasons allegedly explaining the desirability or expediency of occasionally resorting to foreign laws. Among the most familiar of these are the following: obedience to constitutional or statutory mandate and the compulsion of precedent; judicial justice; economic and social policies; the jurisprudential conception of law; political ideologies (e.g., the concept of nationality); considerations pertaining to international relations — comity, reciprocity, sense of universalism.1

The Concept of Public and Private Interests in the Choice-of-Law Process-Perspectives and Values

The concept of public and private interests is the keystone of the choice-of-law methodology elaborated in this book. The major perspectives and values of this concept will presently be discussed.

The Prospects of Standardization in the Process of Interest Analysis

Having outlined, in the preceding two chapters, the process of interest analysis, it is proposed finally to assess the prospects of standardization in such a process.

Public Interests Peculiar to Conflicts Contexts: Transnational Concerns

Having discussed, in the previous chapter, the general concept of public and private interests, it is proposed now to deal specifically with public interests peculiar to conflicts contexts, i.e., transnational concerns.