Regulatory Updates:
Digital Informed Consent in Clinical Trials; and
Guidelines for Export of Medical Cannabis
Digital Informed Consent
The Israeli Ministry of Health (“MOH“), issued procedure no 169/01 “Use of Digital Means in the Process of Obtaining Informed Consent” (“Procedure 169/01“) on October 19, 2020. Procedure 169/01 was issued in order to promote the use of innovative technologies in the process of obtaining consent from subjects in clinical studies.
Pursuant to Procedure 169/01, the clinical study sponsor is responsible for determining the appropriate digital means for the informed consent process. The Institutional Ethics Committee is required to review the informed consent process, upon approval of the study. The Ethics Committee is responsible to ensure that the process is tailored to the entire study population, that the clinical study personnel will be qualified to obtain consent by digital means and that there is a full documentation of the consent process.
Procedure 169/01 stipulates that the use of digital means will be performed in line with the risk management questionnaire, attached to Procedure 169/01, while taking into consideration the clinical study’s circumstances, the clinical study’s population and the severity of the risks arising therefrom. The higher the risk, the higher level of certainty required for ensuring the identity of the study participant. Similarly, the higher the risk, the higher the requirement to use digital means that better satisfy the informed consent purpose. The digital informed consent process must meet all applicable security and privacy protection requirements.
Procedure 169/01 constitutes an additional step forward in the MOH’s changes in the field of clinical studies, initiated at the end of 2019, by issuing revised versions of the guidelines and regulations governing the performance of clinical studies in Israel, which will enter into effect on January 1, 2021.
Guidelines for Export of Medical Cannabis
The Israeli MOH has been implementing since 2016 a precedential and revolutionary reform regarding medical cannabis, which regulates all phases of the medical cannabis process, starting from cultivation and up the sale of medical cannabis products by licenses pharmacists (the “Reform“). See our previous legal update in the matter.
The MOH issued, on October 4, 2020, a pilot program allowing certain medical cannabis companies to export their products (“Pilot Program“). See our previous legal update in the matter.
Further to such Pilot Program, on October 2020, the Israeli Medical Cannabis Agency (“IMCA“) issued Procedure 110, which sets out guidelines for the export of medical cannabis for medical use and research (“Procedure 110“). According to Procedure 110, an export license will be issued only if suitable supply for the local Israeli market demand is ensured, and only to such persons or entities with a valid license from the IMCA to hold medical cannabis for research or for any part in the medical cannabis supply chain (e.g. growing, production, packaging). Pursuant to Procedure 110, an inter-ministerial steering committee will be established for monitoring cannabis export and the effects of such export on the availability and prices of cannabis products for patients in Israel. Procedure 110 does not indicate how, if at all, it relates to the Pilot Program.
The process of obtaining an export license consists of five steps:
- Obtaining a license from the IMCA to hold medical cannabis for research or for any part in the medical cannabis supply chain.
- Obtaining an import permit from a competent authority in the country that will receive the cannabis shipment.
- Obtaining an export permit from the IMCA. The application for such permit will be submitted to the IMCA through a district pharmacist. The IMCA will have discretion in examining the application and may refuse and/or impose further demands for granting the permit.
- Obtaining an export license from the IMCA’s export department. The application for such license will be submitted online.
- Exporting the cannabis cargo. Procedure 110 details the transportation, storge and security requirements for the transfer of medical cannabis from the exporter to the customs. Including, that the unloading of cannabis cargo at the customs will not be carried out without the presence of an IMCA representative, and that such cannabis cargo will be subject to certain inspections by both customs and the IMCA.
Furthermore, any person or entity which obtained an export license from the IMCA, will be required to notify the IMCA within 48 hours of any export of cannabis. Additionally, a report detailing all cannabis exported will be submitted to the IMCA at the end of each year by such person or entity.
For additional information please contact your GKH attorney or one of the following Adv. Hili Cohen, partner and head of life sciences department (Hili@gkh-law.com) Adv. Tami Fishman, partner (Tamif@gkh-law.com), or Adv. Ofir Goldstein (ofirg@gkh-law.com).
Gross, Kleinhendler, Hodak, Halevy, Greenberg, Shenhav & Co. (GKH), is one of the leading law firms in Israel, with some 170 attorneys. GKH specializes, both in Israel and abroad, in various fields of law including Mergers and Acquisitions, Capital Markets, Technology, Banking, Project Finance, Litigation, Antitrust and Competition, Energy and Infrastructure, Environmental Law, Intellectual Property, Labor Law and Tax.
This alert is prepared as an informational service to clients and colleagues of Gross, Kleinhendler, Hodak, Halevy, Greenberg, Shenhav & Co. (GKH) and the information presented is not intended to provide legal opinions or advice. Readers should seek professional legal advice regarding the matters about which they are particularly concerned.
