(US) Regarding Article 2(3) “Regulation on Data Security of Drug Registration Records” (“Regulation on Data Security”), please explain what is meant by “circulated pharmaceutical substances.” Regarding the term “business secret” as it is used throughout the Regulation on Data Security, please explain the criteria by which it is determined that information received from financial investment or intellectual activities becomes qualified to be a “business secret”, and what laws, regulations, decrees, etc., provide for any such criteria.Regarding Article 4 (2), please explain what constitues “significant effort”.According to Article 4(1), data to be secured must qualify as a “business secret”. Please explain the resoning behind the requirement that date to be secured under Article 10(2) must qualify as a “business secret”.
The above regulations stipulated in the Regulation on data security of drug registration records (issued by the Decision No. 30/2006/QD-BYT of 30 September 2006”) should be interpreted as follows:
- “Circulated pharmaceutical subtances” can be interpreted that subtances of the final drugs are allowed to be circulated in Vietnam according to regulations on registration of drug circulation.
- A business secret, stipulated in Article 4.23 of the IP Law, means information obtained from activities of financial and/or intellectual investment, which has not yet been disclosed and can be used in business
- “Significant effort” is one of protection conditions for secret data, stipulated by the IP Law (Article 128.1) corresponding to the requirements in Article 39.3 of the TRIPS Agreement. This term has not been specifically interpreted in the IP Law and the existing guidelines.
- The requirement that date to be protected must qualify as a “business secret” is provided for in Article 128.1 of the IP Law. The Law stipulating mechanism for protection of secret data under the protection of “business secret” comes from the requirement for protection of undisclosed data under the protection of “undisclosed information” in the Article 39 of the TRIPS Agreement. Secret data is a kind of undisclosed information (business secret), and only different in a way that such data should be submitted to a competent State agency in compliance with procedures for registration of product circulation. Therefore, undisclosed data is protected according to general principles on protection of “business secret” and particular regulations on responsibility of a state agency for data security in order that after being submitted, the data is still protected as if it was under the right holder’s control.