Human Biobank Management Act Article 25

When engaging in any of the following violations, a Operator shall be subject to a fine of no less than two hundred thousand New Taiwan Dollars (NT$ 200,000) and no more than two million and one million New Taiwan Dollars (NT$ 1,000,000); and may be ordered to undertake timely corrective actions. An Operator who fails to timely undertake such corrective actions shall be subject to an additional fine imposed for each failure:1.violating Article 8, Paragraph 1 for refusing a Participant ’ s requests; or violating Article 8, Paragraph 2 by failing to destroy or notify the concerned third party to destroy biological specimens and related data and information provided by a withdrawing Participant.2.violating Article 16, Paragraph 2 by failing to use or provide to any third party the biological specimens and related data and information pursuant to the scope, duration, and method as agreed to by the Participant.3.violating the regulations stipulated pursuant to Article 21, Paragraph 2.4.violating Article 22 by failing to regularly publish biomedical studies and results.Violations of Article 29 by collecting or using biological specimens in biomedical research being not based on the population groups or specific population groups shall be subject to fines a fine of no less than two hundred thousand New Taiwan Dollars (NT$ 200,000) and no more than two million and one million New Taiwan Dollars (NT$ 1,000,000). The violators may be ordered to undertake timely corrective actions. An Operator who fails to timely undertake such corrective actions shall be subject to an additional fine imposed for each failure.