Nov 14, 2013
The Ministry of Health and Welfare (MOHW) has announced an amendment to the National Health Insurance Pharmaceutical Benefits and Reimbursement Schedule in a move designed to encourage domestic and foreign pharmaceutical companies to engage in research on diseases that are specific to Taiwan and give the country’s residents early access to treatment with appropriate new drugs.
The MOHW points out that in the past, most international drug companies directed their development of new drugs primarily at Europeans and Americans, and rarely took Chinese diseases as their main subjects. The data shows that drugs currently used by the people of Taiwan were developed mainly in Europe and America, and are not necessarily suited to the Chinese physiology.
Certain diseases that have a high prevalence rate in Taiwan, such as hepatitis B, liver cancer, pulmonary tuberculosis, and gout have generally not been subjects of research by drug companies and it is relatively difficult for sufferers of these diseases to obtain treatment with appropriate new drugs.
It is in view of this deficiency that the MOHW has amended the National Health Insurance Pharmaceutical Benefits and Reimbursement Schedule to add a new provision, Article 17-1. In the case of a new drug which is first introduced in Taiwan with new molecular entity showing significant improvement in clinical outcome or with new molecular entity to treat specific disease, the reimbursement price of the drug may be set in reference to market price or cost plus method, or the prices of drug with similar therapeutic effect in 10 major pharmaceutically advanced countries. These flexible rules are much favorable than the current new drug pricing rules set forth in Article 17.
The MOHW will also give additional payments to encourage large multinational drug firms to include Taiwan in multinational and multi-center clinical trials, so that Taiwan’s pharmaceutical sector will gain an understanding of the therapeutic effect and safety of new drugs during the clinical trial stage. Following the amendment of Article 21 of the Pharmaceutical Benefit and Reimbursement Schedule, vendors of drugs for which registration application has been submitted to the U.S. Food and Drug Administration or the European Medicines Agency, and for which Phase III clinical trials have been carried out in Taiwan on a sufficient scale, can receive an additional payment of 10%.