Estados Unidos de América
Bahrein, Reino de
Información no divulgada
22. Please describe in detail the manner in which protection is provided to test data regarding pharmaceutical and agricultural chemical products submitted to the government in order to obtain marketing approval in Bahrain and cite to the relevant provisions of law.
Article 2 of the draft Law on the Protection of Trade Secrets provides the following with respects to protection for test data: "The prohibition on disclosure of trade secrets referred to in the preceding Article shall extend to undisclosed tests or data the origination of which involves a considerable effort, and which have been submitted to the competent authorities for the purpose of obtaining approval for marketing of pharmaceutical or agricultural chemical products which utilise new chemicals entities. The competent authorities which receive such tests or data shall protect them against disclosure as from the date they are received until they are no longer secret, and shall prohibit their unfair commercial use by preventing any third party not having the consent of the person who submitted them from relying on such data or tests in the marketing of similar drugs or products for 5 years following the date of marketing approval of the drugs or products in Bahrain. Disclosure of the tests or data by the competent authorities shall only be made where necessary to protect the public or unless the necessary steps are taken to ensure that the data are protected against unfair commercial use."