Data Exclusive Right of New Drugs; Foreign Pharmaceutical Manufacturers keep on lobbying the government.

After European Economic and Trade Office (EETO) proposed to the Department of Health, Taiwan, R.O.C. (DOH) the amendment suggestion of “Six-year exclusive right of the clinical research data of new drugs”, foreign pharmaceutical factories kept on lobbying the government with the help of economic or trade associations. Facing the consecutive lobbying pressure from the foreign pharmaceutical factories, with the help of the attorneys, the Bureau of Pharmaceutical Affairs tried to confirm the law source of the data exclusive right under the structure of WTO and hoped to contribute to the coordination meeting between the foreign and domestic pharmaceutical factories for a reciprocal goal. The Pharmaceutical Manufacturer’s Association representing the pharmaceutical manufacturers in this country recently also plans to draft white paper stating that the their interests and rights are not allowed to be sacrificed.

 

The claims made by the foreign pharmaceutical manufacturers about the amendment of “data exclusive right” appeared to be more and more intense since the second half of the last year. Other organizations also lobbied the Department of Health or even the Executive Yuan for the necessity of “data exclusive right” in turn, including American Chamber of Commerce, Pharmaceutical Research and Manufacturers of America (PHRMA), the European Economic and Trade Office of the European Union, Japan representative in foreign countries and International Research-Based Pharmaceutical Manufacturers Association (IRPMA). Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provides two conditions and one proviso relating to “data exclusive right”. One condition is that the drugs are made of completely new chemical composition. The other condition is that the data is never divulged before. By fulfilling the said two conditions, the manufacturer could be granted the “data exclusive right”. The proviso states that each country can decide whether to reveal the “data exclusive right” according to its citizens’ rights and interests.

 

The drugs that the “data exclusive right” can apply to means the original drugs that are patented in the international market but not in this country. As to these drugs, the government in the past has given five-year “data exclusive right” to the first pharmaceutical manufacturer who did the clinical research in Taiwan as stipulated in the relevant regulations regarding “the new drugs during the period of surveillance”. If other manufacturers would like to obtain the license of the identical drugs, they have to the do the same clinical researches. (2004.01)

CYJ/WYL