ISRAEL Law and Practice Contributed by: Lior Glassman, Matan Kovacs, Alexandra Cohen and Tamar Morag Sela, Reinhold Cohn Group
of non-commercial quantities for personal use, preparations made in Israel or imported for reg- istration purposes, preparations intended for treating epidemics, and registered preparations for off-label use by medical institutions for their patients. The MoH’s guidelines provide more details on such cases (see also 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations ). Registered Medical Devices Medical devices should be registered in AMAR’s Medical Device Registry. Non-Registered Medical Devices The Medical Device Law of 2012 allows the Min- ister of Health to issue regulations that exclude certain types of medical devices from the regis- tration requirement for purposes such as R&D, export, emergency, and more. A draft of such regulations was published in August 2023 for public comments but has not yet been enacted. The Public Health Ordinance of 1940 and the Public Health Regulations (Medical Experiments on Humans) of 1980, which apply the Declara- tion of Helsinki, are the main legal acts over- seeing clinical trials in Israel. In addition, several MoH guidelines and circulars apply. For actors interested in conducting trials in Israel, the main guideline is Guideline 14 on Medical Experi- ments on Humans (2020), which governs the submission and approval of clinical trials. The guidelines include the requirement that the principal investigator adhere to international Good Clinical Practice (GCP) guidelines and ISO 2. Clinical Trials 2.1 Regulation of Clinical Trials
14155 (Clinical Investigation of Medical Devices for Human Subjects). In addition, legislation relevant to the realm of the specific research may apply, such as the Physicians Ordinance of 1976, the Patients’ Rights Law of 1996, the Genetic Information Law of 2000, privacy laws, the Medical Device Law of 2012 and standards, the Prohibition of Genetic Intervention Law (Human Cloning and Genetic Modification of Reproductive Cells) of 1999, and the Dangerous Drugs Ordinance of 1973. 2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial The procedure for securing authorisation to conduct clinical trials in Israel is outlined in the Public Health Regulations (Medical Experiments on Humans) of 1980 and MoH Guideline 14 on Medical Experiments on Humans (2020), as described in 2.1 Regulation of Clinical Trials . The approval process entails a dual scrutiny mechanism involving assessment by both the medical institution’s Helsinki Committee and the MoH. In many kinds of “specialised medical tri- als” , as defined in the Public Health Regulations (Medical Experiments on Humans) of 1980 (eg, trials on registered preparations and medical devices), approval by the institution’s director is sufficient. Trials relating to human genetics, non-natural female fertilisation, and others determined by the MoH require the opinion of the Higher Helsin- ki Committee. This committee may also approve urgent medical cases where the informed con- sent of a trial participant cannot be given. Trials on existing data or questionnaires also require approvals and have specific instructions in the guidelines.
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