ISRAEL Law and Practice Contributed by: Lior Glassman, Matan Kovacs, Alexandra Cohen and Tamar Morag Sela, Reinhold Cohn Group
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices In Israel, pharmaceuticals and medical devices are regulated by various legislative acts and reg- ulatory bodies. What follows is a summary of the main legislation and regulatory bodies. • The main legislations for pharmaceuticals are the Pharmacists Ordinance of 1981 and the Pharmacists Regulations (Preparations) of 1986. • The Minister of Health and the Ministry of Health (MoH) are the main regulatory bodies. The MoH is the government agency respon- sible for public health policy and regulation in Israel. It oversees and regulates pharmaceu- ticals and medical devices, as well as health- care (providing services through state, mental health and geriatric hospitals), and issues guidelines relating to the various matters for which it is responsible. • The Pharmacy Department of the MoH over- sees the regulation of pharmaceuticals. This includes registration and monitoring of phar- maceutical preparations or medicinal drugs, manufacturing plants, importation/exporta- tion, advertisements, and clinical trials. • The main pieces of legislation dealing with medical devices are the Medical Device Law of 2012 and the Medical Devices Regulations (Registration of Medical Equipment in the Register and its Renewal) of 2013. Although the Medical Device Law of 2012 has yet to formally enter into force, the relevant actors are conducting themselves in accordance with it. • The MoH’s Medical Device Division (AMAR) oversees the regulation of medical devices, including registration and monitoring.
• In addition, Israel’s National Health Insur- ance Law of 1994 and those regulations and orders issued in accordance therewith ensure funding for a standardised healthcare pack- age. This package encompasses a range of medical products and services and is regu- larly updated. • All Israeli residents are covered by one of four statutorily organised Health Maintenance Organisations (HMOs), based on personal choice, which serve both as insurers and providers of these healthcare services. Some HMOs also manage public hospitals. • Additional relevant legislation is the Public Health Ordinance of 1940, which relates to clinical trials, epidemics, and more. 1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation Decisions made by Israeli regulatory bodies are subject to various legal and administrative chal- lenges. Although there is no process similar to the United States Food and Drug Administration (FDA) citi- zen petition procedure in Israel, the applicable law provides procedures to challenge decisions (administrative procedures) in certain instances. By way of example, a registered pharmaceuti- cal preparation owner may object to the MoH’s decision not to renew the registration thereof before the MoH’s director (or others in the MoH who are authorised by the director to hear such claims). Another example is individuals seek- ing funding for treatments not covered by the standard healthcare package (eg, for off-label or compassionate use), who may apply to their HMO’s special committee. Decisions made by these committees can be appealed before the labour courts.
169 CHAMBERS.COM
Powered by FlippingBook