• Israeli healthcare and life sciences legal update | April 2020

    The COVID-19 effects on Clinical Studies – Update The Israeli Ministry of Health issued additional guidelines for the conduct of clinical studies during the COVID-19 pandemic The Israeli Ministry of Health (the “MOH“) issued, on April 12, 2020, additional guidelines for sponsors, investigators, Helsinki Committees (the equivalent of IRB, or ethics committees) and medical institutions, with respect to the performance of clinical studies during the COVID-19 pandemic (See also our previous update). The matters below are the main issues addressed therein: New submissions for clinical studies may be performed by digital means and may be signed electronically. In non-interventional, prospective … Continue reading "Evan Schendler"
  • Israeli healthcare and life sciences legal update | April 2020

    The Coronavirus – Export Restrictions   Following the Coronavirus outbreak, Israeli Minister of Economy issued orders which impose restrictions on export of certain medical products from Israel   The coronavirus pandemic, which started at Wuhan, Hubei province of China, on December 2019, and ever since has been spread internationally, is having major effects on the healthcare systems all around the world. The Free Export Order-2006, states that certain goods are permitted for export only to the extent that an export license has been issued with respect thereto by a competent authority (the “Export License“). The Minister of Economy issued an … Continue reading "Evan Schendler"
  • Israeli healthcare and life sciences legal update | March 2020

    The Coronavirus effects on Clinical Studies   The coronavirus pandemic, which started at Wuhan, Hubei province of China, on December 2019, and ever since has been spread internationally, is having major effects on the healthcare systems all around the world. The Israeli Ministry of Health (the “MOH“) published, on March 16, 2020, guidelines for sponsors, investigators, Helsinki Committees (the equivalent of IRB, or ethics committees) and medical institutions, regarding the performance of clinical studies during the coronavirus pandemic (the “Guidelines“). These Guidelines, which are anticipated to allow the continuance of clinical research in Israel, shall be in effect until further … Continue reading "Evan Schendler"
  • Healthcare and Life Sciences Legal Update | January 2019

    Medical Cannabis export approved by the Israeli Government The Israeli Ministry of Health (“MOH“) has since 2016 been implementing a precedential and revolutionary reform regarding medical cannabis, which regulates all phases of the medical cannabis process, starting from cultivation and up to the sale of medical cannabis products by licensed pharmacists (the “Reform“). See our previous legal update on the matter. Earlier this week, on January 27, 2019, following the approval of the Israeli parliament last month, the Israeli government approved the export of medical cannabis from Israel. The Israeli government noted that this approval was granted due to the … Continue reading "Evan Schendler"
  • Healthcare and Life Sciences Legal Update | December 2018

    Israeli Parliament Approves Law re Medical Cannabis The Israeli Parliament approved on December 25, 2018, an amendment to the Dangerous Drugs Ordinance – 1973, which, amongst others, regulates medical cannabis (the “Amendment“). The Amendment: • Sets the division of authorities between the Israeli Ministry of Health (“MOH“) and Israeli Police; • Provides the Israeli Police with control and enforcement authorities, relating to the handling of medical cannabis; • Sets the sanctions for breach of the permits granted by the MOH allowing the engagement in medical cannabis activities. It should be noted that the Amendment resolves some authority questions with respect … Continue reading "Evan Schendler"
  • Healthcare and Life Sciences Legal Update - July 2018

    Ministry of Health Regulations –  Reporting and Monitoring Safety Information during Clinical Trials Procedure On June 14, 2018, the Department for Clinical Trials within the Israeli Ministry of Health (“MOH“) issued Procedure 164/01 (the “Procedure“). The Procedure will enter into effect on January 1, 2019 and will replace Chapter 13 in the Clinical Trials Procedure of the Pharmaceutical and Enforcement Department within the MOH. The Procedure specifies guidelines for documentation, monitoring and reporting of Serious Adverse Events (“SAE“) occurring during the trials, and relates to other safety matters. The requirements specified in the Procedure are supplementary to all existing requirements … Continue reading "Evan Schendler"
  • Healthcare & Life Sciences Update | June 2018

    Ministry of Health regulations – Commercial Engagements by Healthcare Institutions Health Institutions Commercial Engagements On June 18, 2018, the Israeli Ministry of Health (“MOH“) issued Directive 11/2018 (the “Directive”). The Directive applies to all public and private healthcare institutions operating under an MOH license with respect to their engagements with commercial activities regarding activities in Israel or outside of Israel. The Directive will enter into effect on November 1, 2018. The following are the major matters covered by the Directive: Establishment of Institutional and Supreme Committees: The Directive provides that each healthcare institution will establish an internal committee the authority … Continue reading "Evan Schendler"
  • Healthcare & Life Sciences Update | March 2018

    Ministry of Health Guidelines Regarding Secondary Use of Healthcare Information & Delay in Approval for Export of Medical Cannabis   Ministry of Health Guidelines Regarding Secondary Use of Healthcare Information On January 2018, the Israeli Ministry of Health (“MOH“) published two new guidelines regarding the Secondary Use of Healthcare Information. The MOH acknowledged the value of accumulated health related information and is interested in promoting research and commercial collaborations in order to exploit the potential of such information, while ensuring patients rights and the compliance with privacy regulations. The guidelines require that certain provisions and limitations be included in any … Continue reading "Evan Schendler"
  • Healthcare & Life Sciences Update | November 2017

    Nursing Care Reform in Israel On November 20, 2017 the Israeli Minister of Health together with the Minister of Finance announced a reform in the Nursing Care Reimbursement and Insurance in Israel. No legislation has been enacted to date, however, it is expected that the Reform will be approved by the Israeli parliament during January 2018, and implemented gradually thereafter. The reform deals with three major aspects – Reimbursement, Allowances for elderly people, and Group Nursing Care Insurance as follows: Reimbursement/ Health Maintenance Organizations, known as “Kupot Holim” (“HMOs”): • Increased budgets to HMOs will be for the purpose of providing … Continue reading "Evan Schendler"
  • Legal Update | August 2017

    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 … Continue reading "Evan Schendler"
  • Legal Update | February 2017

    Medical Cannabis Reform in Israel •  More than 50 Israeli Start Ups engaged in the field of cannabis. •  Israel is one of a few countries that proactively support the research and development of cannabis based products. •  The Israeli Ministry of Health recently issued regulations which standardized the medical cannabis market, which include:     – Unlimited number of the licensed growers and suppliers     – More physicians will be allowed to prescribe medical cannabis     – Pharmacies throughout the country will be authorized to distribute medical cannabis •   The new regulations are aimed to balance between … Continue reading "Evan Schendler"