Implementation of Data Exclusivity Protection Is Added to the Amended Pharmaceutical Affairs Law. Loss to Local Pharmaceutical Manufacturing Industry’s Production Value Is Estimated to be NT$4 Billion during the Transitional Period of 3 to 5 Years.

The Executive Yuan passed the draft amendment of the Pharmaceutical Affairs Law on September 22, 2004; this amendment added the policy of drug data exclusivity protection and gave 5-year protection on data exclusivity to all new drug substances. The protection on new drugs of new efficacy, new compound, or new administration routes is 3 years. Data exclusivity should be implemented on the basis on reciprocity, upon which application for protection on new drugs from China shall not be turned down after such amendment has been passed.

 

The period of data exclusivity, regarded as a trading issue about which the US is intensely concerned, is shortened from 7 years that the US originally expects to 5 years after several rounds of negotiation. During such period, upon the issuance of permit license of new drugs with new active substances, other pharmaceutical companies cannot cite the data of such new drugs for registration without the license holder’s consent, so as to encourage new drugs research and reinforce intellectual property protection.

 

In order to ensure nationals’ right of drug taking and development of domestic pharmaceutical manufacturing industry simultaneously, this draft amendment also regulates that, 3 years after issuance of permit license of new drugs with new active substances, other pharmaceutical companies shall apply for inspection on the drugs with same ingredient, same dosage form, same dosage, and same unit, and then obtain drug permit license in 5 years upon expiration of the new drug permit license.

 

It is expected that such a measure will impact on domestic manufacturers of generic drugs, and the loss therefrom possibly will reach NT$4 billions each year. In addition to exclusivity protection, 20-year period of patent protection is also provided. In this regard, a maximum 25-year period of protection is given to new drugs.

CYJ/CCS