The Health Technologies and Life Sciences Regulation Department offers comprehensive regulatory legal services to companies and entities acting in the health and life sciences field. The department specializes in the legal aspects of regulatory classification of health products, registration, licensing, manufacturing, importation, distribution, marketing, labeling, sales promotion, advertisement, pricing and reimbursement of pharmaceutical products, medical devices and consumer products.
In addition, the team has significant expertise in all fields of healthcare legislation, including the National Health Insurance Act, the Patients' Rights Act, the People's Health Ordinance, clinical trial regulation, medical institute regulation and the legislation regulation the medical practice and the para-medical practices. We also have specific expertise in general fields of law which impact the healthcare field, such as the Freedom of Information Act, The Liability for Defective Products Act, privacy protection law, consumers' rights law, broadcasting law, internet law, etc.
The department offers HFN's clients full legal services in said fields, including ongoing legal counselling on regulatory matters, preparation of written legal opinions in Hebrew or English, representation before governmental authorities and parliamentary committees and drafting legislation bills and guidelines proposals in the healthcare field. The team has extensive experience representing multinational companies and is uniquely acquainted with their needs. The Department also provides assistance on regulatory aspects of the commercial activity of HFN's clients, in matters such as drafting distribution, agency, quality, pharmacovigilance and all relevant clinical trial agreements.
The Department's in-depth familiarity with applicable legal provisions and the common practice, its close relationship with decision makers as well as its reputation among the healthcare authorities, often enables it to reach amicable solutions for disagreements with the authorities, while avoiding the need for lengthy and risky legal procedures. The lawyers in the department have reached considerable achievements in discussions with the health authorities, which, in many cases, have led to changes in the Authorities' decisions, the publication of new guidelines and/or the modification of existing ones.
The department is focused on reaching amicable solutions for disputes between HFN's clients and the regulatory authorities. However, when such solutions may not be found, the department offers comprehensive legal representation before administrative courts, including the High Court of Justice and the District Courts of Administrative Affairs. The team is also experienced in arguing at all levels of substantial law, from constitutional law to internal guidelines and common practice, as well as has a thorough familiarity with the special procedures before the administrative institutions. Throughout the years, the department's lawyers have been involved in the most significant cases of healthcare regulatory affairs that have been heard by the Supreme Court.