Israeli Rx import safety fears: funds and hospitals must take responsibility, says MoH

Around 100 drugs prescribed to Israeli patients, costing up to NIS200 million ($44.6 million) a year, are imported without supervision by the Ministry of Health, say media reports, although other estimates put this figure at NIS60 million in 2000.

The medicines are brought into Israel under a MoH permit, special regulation 29c, issued when hospitals, sick funds and doctors believe that patients need them, even though they are not registered for use.

Israel is perhaps unique in that even drugs which are registered, but not for that specific indication, also require this special permit for off-label use. However, some of these drugs are part of the basic basket of health services. 25% of drugs in the basket are not registered for use in Israel, presumably because the license holder has not reviewed the registration. Media reports claim that, often, the drugs are imported without the package leaflet or instructions for use, or with the instructions in a foreign language.