萬國法律事務所

In November 2012, Taiwan’s Legislative Yuan passed new amendments to the Medical Care Act. One important change was made to Article 79, in which the approved researchers using humans as subjects may be exempted from criminal liability.

The amended Article 79 stipulates that if unforeseen circumstances cause harm or death to human subjects during any approved research on human subjects, where the researchers have complied with the requirements for specific disclosure to the human subjects and have obtained prior approval from the authority as listed at Article 79, the conduct of the researchers will not fall within the scope of Articles 13 or 14 of the Criminal Act, which define “intentional” and “negligent” crimes. In other words, the approved researchers will not be deemed to have committed any intentional or negligent crime, and thus will not be subject to criminal liability under the Criminal Act.

Regarding the specific policy consideration behind this amendment, Legislator Mr. Ching-Chuan Su of the KMT Party explained that in the past, human subject research often resulted in disputes between the subject and the researchers, such that the doctors conducting the experiments frequently faced litigation. The aim of the amendment is to encourage lawful human subject research in order to stimulate the development of Taiwan’s biotechnology industry.

However, it was noted that the new amendment also raised the fine for conducting research on human subjects without first obtaining approval from the authority from the original NT$ 100,000-NT$ 500,000, to NT$ 200,000-NT$ 1,000,000. If the violation is serious, the researcher’s medical license may be suspended for month to a maximum of one year. The amendment also adds fines of NT$ 50,000 to NT$ 250,000 for unlicensed medical personnel hired by hospitals, such as pharmacists or nurses, who do not have the required professional license to practice.