Since taking office in 2023, National Health Insurance Administration (NHIA) Director General Shih Chung-liang has proposed several reforms to policies on National Health Insurance-covered drugs to overcome challenges of drug shortages as well as encourage the development of domestic drug makers. After NHIA Deputy Director General Parng I-ming proposed the latest iteration of the reforms, it is rumored that the proposals will be announced by the Ministry of Health and Welfare soon with the aim of implementing the changes in the beginning of 2025.
Aiming to benefit domestic generic drug makers, the proposal covers the following:
- Preferential NHI reimbursement pricing for domestically manufactured generics whose originators have either received marketing approval abroad within the past two years; or those that contain novel ingredients not yet approved in Taiwan but have been approved in the A10 countries in the past five years.
- Preferential NHI reimbursement pricing at the same rate as imported originators, for the first two bioequivalence study applications for generic and biosimilar drug approval.
- An added 10 percent to the NHI reimbursement pricing, for generic drugs made with domestically sourced active pharmaceutical ingredients whose safety have been vetted with clinical trials and publications in international journals and listed on the drug label, have submitted a P4 declaration and application for a generic drug permit.
Taiwan Pharmaceutical Manufacture and Development Association Director Lee Chien-hung pointed out that domestically manufactured generic drugs accounted for only 54% of Taiwan's NT$85 billion market for generic drugs as of 2023. Taiwan Generic Pharmaceutical Association Chairperson Chen Yi-fen emphasized the importance of a stable domestic drug supply and voiced support for the series of drug pricing reforms being promoted by the NHIA since 2023.
[2024-7-30/Economic Daily News]
