This announcement is the government’s attempt to secure the TPP negotiation.
This new regulation will encourage local biopharmaceutical manufacturers to engage in the researches of new indications, and attract foreign manufacturers to conduct clinical trials in Taiwan. It will have a profound impact on the development of the biopharmaceutical industry in Taiwan.
The Executive Yuan held a meeting to discuss TPP related issues yesterday. According to the MOHW’s report, the MOHW has already communicated with the pharmaceutical industry about granting new indications with data protection through legislation. The government will propose an amendment to the Pharmaceutical Affairs Law by next March to give new indications legitimate data exclusivity for at least 3 years.
According to government officials, this proposal follows the regulations implemented in many advanced countries and meets the TPP’s basic requirement.
In South Korea, new indications can have 4-year data exclusivity. However, the MOHW decides to implement a 3-year protection plus 2-year extension if clinical trials are conducted in Taiwan. The MOHW intends to attract more manufacturers to conduct clinical trials in Taiwan. This amendment is part of the government’s commitments given to the US in the TIFA talk in October.
Hsu Ming-Nung, the Deputy Minister of the MOHW, explained that developers can enjoy market exclusivity during the protection period. It will encourage new drug R&D.
(Translated by TRPMA)
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