data associated with applications for marketing approval submitted by pharmaceutical companies, in apparent violation of Article 39.3 of the TRIPS Agreement. Specifically, Hungary does not provide protection against the unfair commercial use of test or other data submitted to its regulatory authorities in order to obtain marketing approval. As a result, generic pharmaceutical companies have been permitted to rely on data generated and submitted at great cost and effort by innovator companies -- without their consent -- almost immediately after the original applications for marketing approval have been filed. U.S. industry estimates that it loses between $50 million and $100 million annually due to the TRIPS Article 39.3 problem and other weaknesses in Hungary's data protection regime.
Other countries that do not appear to meet their TRIPS obligations include several countries in the Andean Community, as well as the Dominican Republic, India, Israel and Kuwait. The United States will consider all options, including but not limited to possible initiation of new WTO dispute settlement cases, in working with these countries toward full TRIPS implementation. The United States will continue to consult in the coming months with all of these countries in an effort to encourage them to resolve outstanding TRIPS compliance concerns as soon as possible.
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