Rules ease doctors’ criminal liability in clinical trials

By Shih Hsiu-chuan  /  Staff reporter

Wed, Nov 28, 2012 - Page 3

The legislature yesterday approved an amendment to the Medical Care Act (醫療法) exempting doctors from criminal liability in cases where a patient’s death results from unpredictable risks during clinical trials.

Doctors shall not bear criminal liability for the death of a patient in a clinical trial when the trial is performed in accordance with the guidelines and physicians have paid proper attention to medical care during the procedure, the amendment states.

The revision was made because unpredictable risks can occur in the trials, it said.

Along with the revision, the amendment made explicit the legal obligation that medical institutions seek the permission of the Department of Health before conducting research with human subjects or making changes to a trial.

Violations of the obligations are punishable by a fine of between NT$50,000 (US$1,717) and NT$250,000, or suspension of the clinical trial, according to the amendment.

The amendment also raised the fine imposed on a teaching hospital found initiating clinical trials on human subjects without permission from the health authority, from between NT$100,000 and NT$500,000, to between NT$200,000 and NT$1million.

Chinese Nationalist Party (KMT) Legislator Su Cheng-ching (蘇震清) hailed the passage of the revisions, saying the changes would benefit the biotech and pharmaceutical industries.

The amendment also stipulates that if medical institutions suspend their medical practice for more than a year, they face the risk of a closure order.

Prior to the amendment, the lack of regulation on the length of suspensions meant a medical institution could suspend its operations indefinitely, making it difficult for the health department to manage and reallocate medical resources.