The Law Regulating Data Exclusive Right Will Be Enacted in the Year after Next. The Confrontation between the Local and Foreign Pharmaceutical Manufacturers Goes Intense.

Regarding the controversial issue of data exclusive right, the Director General of the Bureau of Pharmaceutical Affairs, Wang Huei-Po (王惠珀) confirmed that it would take 9 to 12 months to amend the law. Taiwan Pharmaceutical Manufacturer’s Association expressed that once the regulation of data exclusive right is enacted in accordance with foreign manufacturers’ propositions, local pharmaceutical industry will completely go backward, and such regression will cause a loss in the amount at least above NT$10,000,000,000. Foreign pharmaceutical manufacturers, however, considered that data exclusive right should be promulgated and enforced immediately by Department of Health through governmental order.

 
　Foreign manufacturers, in their statements made to Taiwanese government, stressed that the Euro, US, Japan, and China had agreed with data protection term for about 5-10 years according to Article

39.3 of TRIPS regarding data protection of intellectual property right in WTO negotiation. In this regard, Taiwanese government should also enact amendment bills and systems to grant 6-year data protection term, during which unless the original inventor agrees, pharmaceutical affairs divisions or any third party, within 6 years, shall not use the information submitted for the application for registration by the inventor.

In order to invite investment of the cross-national pharmaceutical manufacturers in Taiwan, Department of Health (DOH), Executive Yuan last week went to the US for consultation and then decided that the Pharmaceutical Affairs Law should be amended and the system of “data exclusive right” should be enacted to respond to foreign manufacturers’ request. DOH indicated that this system will be enacted in 2006 as soon as it can. According to health authorities’ estimate, the market value of the medicines in this country per year amounts to about NT$140,000,000,000. The enactment of data exclusive right may produce great impact on the market of generic drugs in this country, while such enactment will help people’s investment in the research and development of new medicines. (2004.02)

CYJ/CCS