If the government is sincere about boosting the biotechnology sector, it needs to cut the red tape stifling development, industry insiders said yesterday.
"Taiwan's government requires new drugs, even locally developed ones, to obtain approval from at least one other country before applying for domestic permission," said Chen Kuang-chi (
"Such a requirement seems to indicate that the government lacks confidence in domestically developed pharmaceutical products," Chen said.
Maywufa Bio-Pharmaceutical is a Taipei-based company with businesses covering pharmaceutical research and development, drug distribution and drugstore chains. Its revenues reached NT$3.5 billion last year.
Chen said the industry hopes the regulatory authorities will abolish such unreasonable regulations for the sake of nurturing the nation's developing biotech industry.
The government said in 2002 that it would spare no efforts to promote the biotech industry, making it one of the key sectors of the government's "Two Trillion, Two Star" (兩兆雙星) investment plan for the next 10 years. Other sectors include semiconductors, flat-panel displays and digital content industries.
Annual revenues in the fledgling biotech industry rose 13 percent to NT$125.6 billion last year from NT$110.9 billion the previous year, according to figures provided by the Biotechnology & Pharmaceutical Industries Program Office (BPIPO) under the Ministry of Economic Affairs.
The government plans to pour NT$150 billion into the sector by 2006, hoping the investment can help boost annual revenues 25 percent a year to NT$250 billion by 2006, said William Chung (
Taiwan is one of several Asian countries where international biotech companies are considering possible business opportunities.
"Asia, with a population of 3.23 billion, is a market of huge potential for the industry," said Jonathan Watters, senior vice president of BioPro Pharmaceutical Inc, a Waikanae, New Zealand-based pharmaceutical R&D and marketing company.
Asia's market, excluding Japan, could be worth US$30 billion next year, with China making up 34 percent of the total, Watters said, and Taiwan 14 percent.
However, the variation in regulations between countries in the region make it more costly for companies to get drugs approved.
"One decision [for new drugs] can then become effective in 23 countries in the European Union, starting from this July," Watters said.
The industry, he added, was hoping Asian countries could harmonize regulatory requirements or recognize drugs approved elsewhere.
This is unlikely, even in the next few decades, as such a move would reduce countries' autonomy, said Chen Chei-hsiang (陳啟祥), director of BPIPO.
In the absence of regulatory harmonization, companies could encourage mutual recognition of their drugs by undertaking clinical trials for new drugs, a necessary process ahead of application, in several countries at the same time, Maywufa's Chen said.
"The result of scientific experiments would speak for us," Chen said. "And we expect cross-border efforts by the private sector to stimulate change in the official sector."
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