Shibolet’s Medical Regulation Practice has more than twenty years of experience in medical regulation, healthcare-system regulation, and a wide range of other related matters in Israel and internationally.
The practice, headed by Firm Partner Amos Bentzur, specializes in providing legal and regulatory advice to all parties involved in the manufacture, import, and distribution of medical products, including pharmaceuticals, medical devices, medical cannabis, and more. This field requires the implementation of and compliance with Israeli legislation and regulations, as well as applicable international standards, such as Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Storage Practice (GSP), and similar standards. It also involves ongoing engagement with regulatory authorities, drafting quality agreements, developing internal audit plans, and preparing internal procedures, while ensuring their effective implementation.
The practice has extensive experience in establishing and operating healthcare systems, including facilities and logistics centers for several of Israel’s largest hospitals. The practice’s team advises on regulatory matters, financing, private and public joint ventures, public financing models, and insurance policies. In addition, the practice’s lawyers have in-depth knowledge of establishing clinical performance procedures, implementing risk-assessment models, drafting tenders, and leading tender committees in connection with new technologies and pharmaceutical products.
In addition to its expertise in these areas, the Medical Regulation Practice has established a strong reputation through its work in clinical trials, ethics matters, agreements with clinical research organizations, and other agreements, as well as healthcare crisis management, including international crises and litigation where necessary.
Shibolet’s clients in this area include leading organizations in Israel’s healthcare system and pharmaceutical industry, such as Clalit Health Services, currently one of the largest health maintenance organizations in the world, as well as individual entrepreneurs and various local and international public companies. Practice representatives are regularly called upon to advise the Ministry of Health and parliamentary committees on relevant legislative and public-policy matters.
