Healthcare & Medical Regulatory

Shibolet’s Healthcare & Medical Regulatory Practice, led by partner Amos Bentzur, has more than two decades of experience on healthcare-related regulatory, activities, and other issues within Israel and internationally.

Specifically, we focus on providing legal and regulatory consulting for all parties at all levels participating in the manufacturing, importation, and distribution of medicinal products, including pharmaceuticals, medical devices, medical cannabis, and more. This necessitates implementing and assuring compliance with Israeli legislation and regulations, as well as applicable international standards (GMP, GDP, GSP, etc.), liaising with regulators on an ongoing basis, executing quality agreements, establishing internal audit programs, and drafting internal procedures, while also ensuring the successful implementation of such procedures and programs.

The practice has significant experience in establishing and operating healthcare systems, including facilities and logistics centers for some of Israel’s largest hospitals. This involves supplying counsel on regulations and regulatory issues, funding, private and public joint ventures, reimbursement models, and insurance policies. Furthermore, the practice’s attorneys have in-depth knowledge related to establishing clinical SOPs, applying risk assessment models, drafting tenders, and leading tender committees on the topics of new technologies and pharmaceutical products.

Beyond these areas, the Healthcare & Medical Regulatory Practice is also recognized for its work on clinical trials (compliance, ethical issues, and CRO and other agreements) and crisis management in the healthcare sector, including crises on a national scale and litigation when necessary.

Shibolet’s clients in this area include key leaders in the Israeli healthcare system and pharmaceutical industry (such as Clalit Health Services –currently the second largest HMO in the world), in addition to individual entrepreneurs and various public companies, both local and international. Practice representatives are also regularly called upon to contribute to Ministry of Health and parliamentary committees, advising on relevant legislation and public policy.