Amendment of the Procedure for Clinical Trials in Human Subjects
A new update to the Israeli Clinical Trial procedure determines that certain clinical trials must now be registered on the Israeli Ministry of Health’s website; and allows advertising information for purposes of recruiting participants in various media channels.
On May 29, 2017, the Department of Pharmacy at the Israeli Ministry of Health (the “MOH“) published amendment No. 14/03 to the Procedure for Clinical Trials in Human Subjects (the “Amendment“). The major changes introduced by the Amendment are as follows:
1. Registration of clinical trials on the MOH’s website
As of May 1, 2017, controlled and prospective clinical trials, which include one or more medical interventions and an examination of the respective impact on subject’s health, must be registered on the Digital Database of Clinical Trials on the MOH’s website (https://my.health.gov.il/CliniTrials/Pages/Home.aspx).
The Digital Database of Clinical Trials contains information regarding researches conducted at the different medical centers in Israel. The purpose of the database is to provide access to updated information regarding the clinical trials to patients who wish to participate in trials and their family members, as well as to researchers, health professionals and the general public.
The applicable ethics committee may exempt researchers and entrepreneurs, from this registration obligation, if such exemption is necessary in order to protect certain proprietary rights.
The Amendment further clarifies that there is no longer a requirement to register the trial the NIH , and that such registration is subject to the discretion of the relevant sponsors and investigators.
2. Advertising for Participants Recruitment Purposes
Pursuant to the Amendment , one may advertise information relating to a duly approved clinical trial, that is at the stage of recruitment, solely for the purpose of recruiting participants.
These advertisements must comply with the requirements published by the MOH on its website (form 10), and be ethical. Nevertheless, these advertisements may include the additional information that is already included in the Digital Database of Clinical Trials.
In special circumstances, the applicable ethics committee may require the approval of the MOH as a pre-condition for allowing advertisement.
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Update of permit terms for medical cannabis patients:
Possession and place of use of cannabis for medical purposes
• License to use medical cannabis expanded to out-door locations;
• Form of use of medical cannabis oil expanded; and
• Smoking of medical cannabis restricted to locations specified within the license.
On May 10, 2017, the Medical Cannabis Agency (Yakar) at the MOH published an update to the terms of permits previously granted to patients. The update relates to the use and possession of medical cannabis. The update includes the following provisions:
1. The possession by a patient of medical cannabis oil, in its original package, is now allowed in any location in a quantity that shall not exceed the lower of the monthly amount approved by the patient’s permit or one original package.
2. The possession by a patient of medical cannabis inflorescences, in their original package, is now allowed in any location in a quantity that shall not exceed the amount of cannabis equivalent to the amount required for five days of consumption by such patient.
3. The use of “medical cannabis oil” is allowed in a sub-lingual form or other configuration, other than the evaporation or smoking of the oil, in any location unless there is an explicit prohibition for such use in such a location.
4. The use of cannabis products for medical purposes, either as medical cannabis inflorescences or as cannabis oil is permitted in any location provided that the use of such products (a) will not be made in the presence of another person; (b) will be made in a separate room with reasonable ventilation; (c) has been done following the approval of the property holder; and (d) will not be made in a place where there is a specific prohibition on the use of such products. In addition, evaporation will be forbidden in places designated for minors (such as schools).
5. Using medical cannabis products in the form of smoking is permitted only in a location specified explicitly in the patient’s permit.
Notwithstanding all of the above, cannabis products for medical use should not be used in any configuration in work areas in which the use of cannabis is prohibited (e.g. operators of public vehicles, heavy machinery, etc.) and/or where a specific prohibition on use or possession exists. Additionally, cannabis products for medical use should not be used in any configuration in customs areas (including airports, ports, border crossings, etc.).
This recent update reflects the efforts made by the Israeli regulator in recent years in order to alleviate the terms of use and possession for medical cannabis patients; such efforts include the extensive reform adopted by the MOH for the standardizing of the medical cannabis market.
For additional information please contact your GKH attorney or one of the following Adv. Hili Cohen, partner and head of the Life Sciences department [Hili@gkh-law.com], Adv. Tami Fishman [Tamif@gkh-law.com], or Adv. Roie Kaner, an associate in the Life Sciences department [Roiek@gkh-law.com].
