In response to pressure from the U.S. government, Taiwan recently decided to take measures to regulate and protect the data of pharmaceutical companies. On September 22, 2004, Taiwan’s government approved draft amendments to their Pharmaceutical Affairs Law. Under these new amendments, foreign pharmaceutical companies will be given a five year period for the protection of pharmaceutical tests and studies on new products, as well as a three-year protection period for improvements on existing products. The US government hoped to see the protection set for a period of six to seven years, as the WTO has a standard data exclusivity protection period of six years.
The new amendments will ensure that any data provided by pharmaceutical companies for the purpose of registering a product will not be used by any other person or company for three or five years, depending on whether the product is new or improved. But as a result, it is estimated that Taiwan’s domestic pharmaceutical industry will lose approximately NT$4 billion (US$120 million) annually in drug production. In addition, the country’s national health insurance program may face increased expenses exceeding NT$3 billion (US$88 million).