Hebrew daily “Yediot Ahronot” reports that ethical drugs registered in Israel will be soon have data exclusivity for five years. Until now, ethical drugs had no data exclusivity in Israel at all.
Minister of Industry Trade and Labor Ehud Olmert instructed ministry officials to prepare a bill on the matter, to be included in the 2005 economics arrangements bill. Olmert did not accede to demands by the US Trade Representative for eight years data exclusivity for ethical drugs.
For the past four years, the US Trade Representative and the Israeli government have been arguing over protection for ethical drugs registered in Israel. The dispute reached a peak last year.
Until now, when a foreign pharmaceutical company registered an ethical drug in Israel, a local pharmaceutical company could simultaneously register a generic version of the ethical drug. The Ministry of Health would approve the generic version on the basis of clinical data appended to the ethical drug's registration file, as guaranteeing its effectiveness.
Data exclusivity laws in most Western countries bans the use of data in ethical drugs' registration files, and forbid the registration of generic versions of ethical drugs for five years from date the ethical drugs are registered. By passing a similar law, Israel effectively gives ethical drugs five years exclusivity after being registered in Israel.
Israel is one of the few Western countries that has not passed a data exclusivity law, and it was clearly only a matter of time before it would have to toe the line with the world.
Passage of a bill has been delayed because the US Trade Representative, at the behest of the US pharmaceutical industry, demanded drug exclusivity for eight years, even though the accepted period in rest of the world, including the US, is five years.
The US threatened that if Israel did not accede to its demands, it would include Israel on the US Trade Representative priority watch list of countries violating intellectual property rights.
Olmert said yesterday, "There is no reason to capitulate to US pressure to grant ethical drugs protection that does not exist in the US."
Published by Globes [online], Israel business news - www.globes.co.il - on March 24, 2005