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 ensures national treatment for U.S. rightsholders in accordance with the 1950 exchange of letters between the United States and Israel; the issuance of regulations in 2007 and policy clarifications in 2008 by the Ministry of Health on the manufacturing of pharmaceutical products for export; and the announcement by the Government of Israel in its recent Special 301 submission that the Israeli Ministry of Justice has commenced preparatory work for a bill that will require the publication of patent applications following the expiration of a period of eighteen months from the determining date for patent applications filed in the Israeli Patent Office.

Despite this progress, the United States remains seriously concerned with two key matters: Israel's inadequate protection against unfair commercial use of undisclosed test and other data generated to obtain marketing approval for pharmaceutical products, and measures that adversely affect the length of patent term extension granted to compensate for delays in obtaining regulatory approval of a pharmaceutical product. These policies result in an unfair disadvantage to innovative pharmaceutical companies who receive comparatively weak protection for innovative pharmaceutical products under Israel's current laws.

The United States has encouraged Israel to amend its laws to provide an appropriate term of data protection to innovative pharmaceutical companies, commensurate with Israel's advanced level of development. For example, due to the significant amount of time it takes for the Ministry of Health to complete its regulatory approval process for pharmaceutical products, Israel only provides an effective period of approximately three and a half to four years of data protection under its current laws. The United States continues to request that Israel amend its laws to provide at least five years of effective data protection to innovative pharmaceutical companies, which is equivalent to the term of data protection provided by the United States.

We have also asked that Israel amend its laws to increase the effective patent term extension given to pharmaceutical products to compensate for delays in the regulatory approval process. Both U.S. innovative pharmaceutical companies and Israeli generic pharmaceutical companies have raised concerns about the significant amount of time it takes for the Israeli Ministry of Health to complete its regulatory approval process, which delays public access to both innovative and generic medicines in Israel. We appreciate that the Ministry of Health has established a goal of completing its marketing approval reviews within six months, and we encourage the Israeli Government to provide the necessary resources and funding to the Ministry to achieve this goal. We also note that U.S. pharmaceutical companies have raised concerns with procedures issued by Israel's Ministry of Health in late 2008, which are intended to clarify how the Ministry handles confidential information.

The United States hopes that Israel will accede to and implement the WIPO Internet Treaties in order to address the growing problem of Internet piracy in Israel. As noted in past reports, the United States continues to expect Israel to provide an appropriately high level of IP protection that reflects its status as a partner in the U.S.-Israel FTA and its objective of becoming a member of the OECD. The United States will continue to work closely together with Israel during the OCR to ensure the strengthening of Israel's IPR regime.