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 notice. The following are the main matters addressed therein:
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- New submissions for clinical studies may be performed online.
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- Under certain circumstances, it is permitted to deliver the investigative drug directly to the study subject’s residence, and to allow study subjects to receive the investigational treatment in a different medical institution, than the original medical institution where the study was initiated.
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- If the study subjects are in quarantine, informed consent form (ICF) may be sent to them digitally. Furthermore, any change related to the performance of the study per these Guidelines does not require a full ICF, and an information sheet listing the changes would be sufficient.
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- Any deviation from the MOH’s regulations and guidelines for clinical studies, arising from the coronavirus pandemic, will not be considered as a violation. Sponsors are required to prepare procedures relating to the effects of the coronavirus and to related deviations from the study protocol, and properly record any such deviations. Moreover, amendments to the study protocol, which are related to the coronavirus pandemic, will be sent to the institutional Helsinki Committee as a notification only, without the need to receive the committee’s approval.
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- The MOH will consider, and in the future, may ease its labelling requirement (with respect to drugs used in clinical studies outside of Israel, where labeling cannot be adjusted to Israeli requirements) in order to maintain continuance of the treatment.
The above does not constitute a legal opinion and is provided as a general update only. 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).
