U.S.-Australia Free Trade Agreement

Article 17.10: MEASURES RELATED TO CERTAIN REGULATED PRODUCTS...

1. (a) If a Party requires, as a condition of approving the marketing of a new pharmaceutical product, the submission of undisclosed test or other data concerning safety or efficacy of the product, the Party shall not permit third persons, without the consent of the person who provided such information, to market a same or similar product on the basis of (1) such information or (2) the approval granted to the person who submitted such information for at least five years from the date of marketing approval in the Party.

(b) If a Party requires, as a condition of approving the marketing of a new agricultural chemical product, including certain new uses of the same product, the submission of undisclosed test or other data concerning safety or efficacy of that product, the Party shall not permit third persons, without the consent of the person who provided such information, to market a same or similar product on the basis of (1) such information or (2) the approval granted to the person who submitted such information for ten years from the date of the marketing approval of the new agricultural chemical product in the Party.

(c) If a Party permits, as a condition of approving the marketing of a new pharmaceutical or agricultural chemical product, third persons to submit evidence concerning the safety or efficacy of a product that was previously approved in another territory, such as evidence of prior marketing approval, the Party shall not permit third persons, without the consent of the person who previously submitted information concerning safety or efficacy, to market a same or similar product on the basis of (1) evidence of prior marketing approval in another country or (2) information concerning safety or efficacy that was previously submitted to obtain marketing approval in another territory for at least five years for pharmaceutical products and ten years for agricultural chemical products from the date of marketing approval in the Party, or in the territory, whichever is later.^17-18

(d) For purposes of this Article, a new product is one that does not contain a chemical entity that has been previously approved in the Party.

(e) If any undisclosed information concerning the safety or efficacy of a product submitted for purposes of obtaining marketing approval to a government entity, or entity acting on behalf of a government, is disclosed by a government entity, or entity acting on behalf of a government, each Party is required to protect such information from unfair commercial use in the manner set forth in this Article.

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FOOTNOTE:

17-18 It is noted, that at the time of entry into force of this Agreement, neither Party permits third persons, not having the consent of the person that previously submitted information concerning the safety or efficacy of a product in order to obtain marketing approval in another territory, to market a same or similar product in the territory of the Party on the basis of such information or evidence of prior marketing approval in another territory.