Regulatory Process for Licensing of Biological Agents

Abstract

This qualitative research aimed to 1) study the important principles of issuing the biological agents license according to the Thai law to compare with those of the foreign law and 2) analyze and propose solution to the problems of the process of applying for the license according to the law on biological agents use. This research was done from December 2015 to September 2016. The research consisted of two parts as follows: 1) The researcher conducted the documentary research by collecting and analyzing data. 2) The researcher interviewed the sample groups consisting of five technical officers on medical sciences with the work experience in the law on pathogens and animal toxins and two technical officers on law. After that, the researcher analyzed data by using content analysis principles.

The research results found that the regulations on the application for the biological agents’ license were similar to those of The United States of America, Canada, and Singapore. Some regulations were less strict than those of The United States of America, Canada, and Singapore. However, the quantity of production of biological agents was not determined in the Thai law. Solution to the problems of the process of applying for the biological agents license are as follows: The steps of applying for the license should be reduced. The one stop service center should be established. And Ministry of Science and Technology should mainly coordinate work and distribute power to local state agencies to issue the license.

As for the research recommendations, related agencies should revise and consider the important regulations which are not provided in the Thai law. As for the license issuing process, the efficient one stop service center should be established. Related agencies should be integrated to participate in consideration of the license and instill values on anti-corruption into people in the society.