FDAnews Drug Daily Bulletin


April 6, 2006

PhRMA has asked the Office of the U.S. Trade Representative (USTR) to block Israel's bid to join the Organization of Economic Cooperation and Development (OECD) on grounds the country does not provide sufficient intellectual property protection for U.S. pharmaceutical companies operating in Israel.

The request, in the form of an official filing with USTR, is not about a specific country "but rather the need to have a robust worldwide respect for intellectual property to keep new innovations and discoveries coming," PhRMA said recently. "We cannot keep the process of discovery going if other nations continue to weaken their legal support for our innovation."

Israel currently is on the USTR's Priority Watch List, which is part of the USTR's "Special 301" list of countries with problems related to the protection of intellectual property rights. The USTR elevated Israel to its Priority Watch List in 2005 on grounds the country provides inadequate intellectual property protection for U.S. pharmaceutical companies.

A spokesman for the Israeli government sharply criticized PhRMA's position. "We are very concerned about PhRMA's recommendation to block Israel's inclusion into the OECD -- which is in direct opposition to the will of Congress -- and also that Israel be placed on the [USTR's] Priority Foreign Country List," a spokesman for the Israeli Embassy in Washington, D.C., told FDAnews.

Countries on the Priority Foreign Country List are considered the worst offenders regarding intellectual property violations.

"We are trying to work with the USTR, Congress and the White House to let them know that PhRMA is going too far, and that Israel abides by its obligations," the spokesman said.

The OECD is an international organization that works to improve economic growth in member countries. To join the OECD, countries must be committed to democracy and a free market economy, which includes meeting OECD standards of intellectual property protection.

Israel was added to the Priority Watch List "based on [its] implementation of an inadequate data protection regime, as well as its apparent intention to pass legislation to weaken patent term adjustments," according to the USTR Special 301 report issued in April 2005.

Israeli law does not provide OECD-level protection for proprietary test data submitted by U.S. biotechnology and innovator pharmaceutical companies, according to the report. (http://www.fdanews.com/did)