Expert: David Scott - 8/17/2006

Question
I have a Regulatory question.  Where can I find the guidelines/regulations for getting a generic drug approved by the Ministry of Health in Israel?  I went to the Ministry of Health's webpage and I cannot turn the webpage from Hebrew to English. Is there a way I can view guidelines/regulations from that webpage or do I need to go to a different site? I basically want to be able to search like I do on the FDA website. Any advice?  

Answer
Thu Mar 24 06:40:32 2005
Ynetnews

Israel may adopt drug exclusivity policy

Israel may pass exclusivity law as demanded for years by the United States; Would ensure temporary monopoly for original medications

By Navit Zomer

Israel may pass an exclusivity law that would give medications patented in Israel a monopoly in the local market and eliminate the manufacturing of generic drugs, bowing to years of U.S. pressure for Israel to adopt Western pharmaceutical regulations, Yedioth Ahronoth reported on Thursday.

Until now, if Israeli registered an original drug by a foreign manufacturer, local pharmaceutical firms could register generic drugs at the same time.

Exclusivity laws in most Western countries forbid authorities to reveal the make up of patented drugs for five years, and prevent the marketing of generic brands during that time. U.S. trade representatives had been pressing Israel in the past four years to adopt such a policy, threatening to blacklist it as violating intellectual property if the demand was not met.

Minister of Industry, Trade, and Employment Ehud Olmert has instructed staff members to prepare a bill that would grant temporary exclusivity to companies registering their drugs in Israel. The United States had pushed for an eight-year monopoly but Olmet agreed to five. U.S. law provides the standard five-year protection.

"There is no reason for us to cave in to American pressure," Olmert told Yedioth Ahronoth. "We were more than prepared to be flexible. I only insisted on the same rules the Americans themselves use.

"I am certainly not looking for a fight with the United States, but at the end of the day I am the Israeli Minister for Industry and Trade," he said. "I have no intention of abandoning Israeli pharmaceutical companies to serve the interests of American firms that can't compete with Israeli companies on equal footing."

I checked YnetNews.com for more information, but found nothing.  I hope this pushes you in the right direction.