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Abstract

Drug lag, also known as drug innovation lag, can be categorized into marketing lag and reimbursement lag. This study investigates the trend and factors influencing drug innovation lag in Taiwan, and makes a comparison with major countries like USA, Canada, Japan, and Europe on marketing lag. The reimbursement lag in the National Health Insurance (NHI) of Taiwan is also explored. This is a retrospective study covering a total of 347 new drugs that were reimbursed by the Bureau of National Health Insurance (BNHI) from 1996 to 2002. Data collection includes time of regulatory approval, type of innovation, country of origin, and time and price of reimbursement by BNHI. The time of new drug approvals in study countries was obtained from relevant websites for comparison. The drug lag index between Taiwan and study countries was also analyzed. Data were analyzed by SPSS software for frequency distribution and multiple regressions. We found that new drugs are predominantly imported, and 30.5 months in Taiwan. Most of the new drugs were of me-too nature; only very few could be classified as breakthrough new drugs. In terms of marketing lag, USA was the shortest (5.6 months), followed by European countries (8.2 months), Canada (18.0 months), and Taiwan (30.5 months). The reimbursement lag was 11.7 months on average after product license granted by DOH, yet it was not affected by the NHI reimbursement price. The drug lag index from smallest to largest was: the USA (0.14), Europe (0.21), Canada (0.45), and Taiwan (0.76). Drug marketing lag is a serious issue in Taiwan. The average marketing lag of 30.5 months could be attributed to the fact that nearly all new drugs were of foreign origins. The average time after DOH's regulatory approval to NHI reimbursement was as long as 11.7 months. The government should re-examine the current function of the regulatory and reimbursement systems. More specifically, the health authorities should focus on faster regulatory process for breakthrough medicines instead of approving only "me-too new drugs".

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