Switzerland

Bahrain, Kingdom of

Undisclosed Information

6. Please explain in detail if your legislation ensures that undisclosed test or other data submitted by an applicant to the responsible State agency in the procedure for market authorisation of a pharmaceutical or of an agricultural chemical product is protected against disclosure and against unfair commercial use by a competitor, for example by prohibiting a second applicant from relying on, or from referring to the original data of the first applicant, when applying subsequently for market authorisation for his own product. Does your legislation provide for exceptions to this? If yes, under what conditions would such exceptions apply? Does your legislation set a specific term of protection for undisclosed test or other data of the first applicant ?

Article 2 of the draft Law on the Protection of Trade Secrets protects undisclosed tests or other data submitted by an applicant to the responsible State agency for market authorisation of a pharmaceutical or of an agricultural chemical product which utilises new chemical entities. The relevant provisions and limitations are contained in Article 2 which states: "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 us."