United States of America
Sri Lanka
Undisclosed Information
21. Please describe in detail the manner in which protection is provided test data regarding pharmaceutical and agricultural chemical products submitted to the government in order to obtain marketing approval in Sri Lanka and cite to the relevant provisions of law.
Under the proposed law the required safeguards are offered under the law of unfair competition. The proposed Section 142(6)(d) provides as follows : Any act or practice, in the course of industrial or commercial activities, shall be considered an act of unfair competition if it consists or results in- (i) an unfair commercial use of secret test or other data, the origination of which involves considerable effort and which have been submitted to a competent authority for the purposes of obtaining approval, of the marketing of pharmaceutical or agricultural or chemical products which utilise new chemical entities; or (ii) the disclosure of such data, except where necessary to protect the public, or unless steps have been taken to ensure that the data is protected against unfair commercial use. Thus such tests and data will be protected against unfair commercial use and disclosure as required by Article 39.3 of the TRIPS Agreement. The law of unfair competition which includes the protection of undisclosed information does not establish time limits for the protection of such information.