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Sunday, August 26, 2012

Data Exclusivity in Indonesia


Discussions about whether to put in place a data exclusivity regime in Thailand have been reported here. Indonesia's system is the typical position on this. A Trade Secrets law protects undisclosed trade secrets. But that does not apply to regulatory data. When granting approval for a generic drug, the National Drug and Food Agency (BPOM) may rely on data previously used to grant approval for an innovator's drug or an earlier approved drug. This applies so long as the generic has an active substance with the same composition, power, preparation form, administering route, indication etc as the prior approved drugs.

The BPOM has the Regulation Relating to Criteria and Procedure Implementing Drug Registration of 2011 which suggests that BPOM can rely on information that it already possess. Another rule indicates that it is not required to submit clinical test data for generics.
 
Meanwhile the US Special 301 review states that "The United States encourages Indonesia to provide an effective system for protecting against the unfair commercial use, as well as unauthorized disclosure, of test or other data generated to obtain marketing approval for pharmaceutical and agricultural chemical products."  For now Indonesia seems to comply with the unclear procedures in TRIPS, but it like many other countries is under pressure to change to a regulatory data exclusivity regime. This may not matter until some level of bilateral deal is needed.  
 
  

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