Chapter 6 Penalties
Article 28
If a non-medical care institution has any of the following circumstances, it shall be punished with a fine of not less than NT$2 million and not more than NT$20 million:
1. Violating the provisions of Article 11 and performing regenerative medicine.
2. Violating the provisions of Article 21, Paragraph 2, and advertising regenerative medicine.
If any of the following circumstances exist, a fine of not less than NT$200,000 and not more than NT$2 million shall be imposed:
1. Violating the provisions of Article 7 and not conducting or completing human trials before performing regenerative medicine.
2. Violating the provisions of Article 8, Paragraph 3, by performing the regenerative technique under Paragraph 1, Subparagraph 1 of the same article without approval from the central competent authority.
3. Violating the second portion of the provisions of Article 14, Paragraph 2, by performing cell manipulation without a permit.
4. Violating the provisions provided by the front portion of Article 18, Paragraph 1, by establishing a cell bank without a permit.
5. Broadcasting recruitment advertisements by medical care institutions not approved to perform regenerative medicine or cell banks that do not store tissues or cells in violation of Article 21, Paragraph 1, or those not entrusted by the central competent authority to handle recruitment and promotion for human tissue and cell provider according to Article 6, Paragraph 1, Subparagraph 4.
6. Violating the provisions of Article 21, Paragraph 2, for advertising regenerative medicine by medical care institutions that have not been approved to perform regenerative medicine.
7. Violating the provisions of Article 22, Paragraph 2, and broadcasting advertisements without approval or providing the approval documents to the broadcaster, or changing the original approved advertising content or broadcasting method without approval.
In addition to the penalties under each subparagraph of Paragraph 1 and the third subparagraph of the preceding paragraph, the violator’s name may also be published. In case of a violation under Subparagraph 1 of Paragraph 1, the equipment and regenerative products used for regenerative medicine may also be confiscated.
Article 29
If any of the following circumstances exist, a fine of not less than NT$200,000 and not more than NT$2 million shall be imposed, and a deadline shall be set for improvement. If the improvement is not made within the prescribed deadline, the penalty shall be repeated until the improvement is made:
1. Violating the provisions of the cell manipulation methods, control measures, distributions, or licensing matters as provided by Article 14, Paragraph 4.
2. Violating the provisions of Article 17 or Article 18, Paragraph 1, and failing to ensure the suitability of providers.
3. Violating the provisions of Article 18, Paragraph 2, regarding the items to be preserved, changes in licensing matters, the facilities, equipment, quality management, fee collection, refunds, or commercial use profit sharing.
4. Violating the provisions of Article 22, Paragraph 3, and broadcasting advertisements that have been disapproved, ordered to be immediately discontinued, or prohibited from continuing to be broadcast.
5. Violating the provisions of Article 22, Paragraph 4, regarding the places where advertisements may be broadcast.
6. Violating the provisions of Article 22, Paragraph 5, by advertising regenerative techniques under Article 8, Paragraph 1, Subparagraph 1.
7. Violating the provisions of Article 23, Paragraph 1, by broadcasting advertisements that have not been approved, do not conform to approved matters, have been disapproved, have been ordered to be immediately discontinued, or have been prohibited from continuing to be broadcast.
If an order is issued under Paragraph 1 to limit the deadline for improvement, and the progress is not made within the improvement period or the prescribed deadline, the cell manipulation and preservation may be ordered to be suspended in whole or in part. If the circumstances are serious and there is a fact of damage to the life, body, or health of patients, or there is a risk of harm, the whole or part of the permit may be revoked.
Article 30
If a medical care institution violates the provisions of Article 12, Paragraph 1, by performing regenerative techniques or using regenerative products designated by the central competent authority without approval and registration, said institution shall be punished with a fine of not less than NT$100,000 and not more than NT$1 million, and its name may be published.
If any of the following circumstances exist, a fine of not less than NT$100,000 and not more than NT$1 million shall be imposed, and a deadline shall be set for improvement. If the improvement is not made within the prescribed deadline, the penalty shall be repeated until the improvement is made:
1. Violating the provisions under Article 12, Paragraph 3, regarding changes in licensing matters, fee collection, or refunds.
2. Violating the provisions of Article 27, Paragraph 1; having no relief measures; or the measures do not conform to the provisions announced by the central competent authority.
In addition to the penalties under the first subparagraph of the preceding paragraph, the person’s name may also be published if there is a violation under the first subparagraph of the preceding paragraph.
If an order is issued under Paragraph 2 to limit the time for improvement, and the progress is not made within the improvement period or the prescribed deadline, the regenerative medicine implementation work may be ordered to be suspended in whole or in part. If the circumstances are serious and there is a fact of damage to the life, body, or health of patients, or there is a risk of harm, the whole or part of the approved matters may be revoked.
Article 31
If any of the following circumstances exist, a fine of not less than NT$50,000 and not more than NT$500,000 shall be imposed:
1. Conducting regenerative medicine research involving embryos or embryonic stem cells in the manner prescribed in Article 9.
2. The physician performing regenerative medicine does not meet the qualifications announced by the central competent authority according to the latter portion of Article 13.
3. Violating the provisions of Article 14, Paragraph 4, regarding the qualifications of cell manipulation personnel.
4. Violating the provisions of the methods under Article 18, Paragraph 2, regarding the qualifications of cell bank personnel.
5. Violating the provisions of Article 19, Paragraph 1, as the provider is an adult without the capacity to make decisions.
6. Violating the provisions of Article 23, Paragraph 2, by failing to preserve data within the prescribed deadline or preserving incomplete data.
Article 32
If any of the following circumstances exist, a fine of not less than NT$50,000 and not more than NT$500,000 shall be imposed, and a deadline shall be set for improvement. If the improvement is not made within the prescribed deadline, the penalty shall be repeated until the improvement is made:
1. Violating the provisions of the methods under Article 14, Paragraph 4, regarding the requirement for cell manipulation personnel to complete relevant training.
2. Violating the provisions of Article 15, Paragraph 1, and failing to provide relevant explanations before performing regenerative medicine.
3. Violating the provisions of Article 15, Paragraph 2, and failing to obtain a consent form before performing regenerative medicine.
4. Failing to make records or preserve or register information systems according to the provisions of Article 16, Paragraph 1.
5. The record content did not include the matters stipulated in Article 16, Paragraph 2.
6. Violating the provisions of Article 19, Paragraph 2, by failing to obtain the provider’s written consent before obtaining tissues and cells or failing to handle the exercise of the right to consent per the provisions of Paragraphs 3 to 6 of the same Article.
7. Failing to inform the matters listed in Article 20, Paragraph 1, before obtaining consent.
8. Violating the provisions under Article 20, Paragraph 2, regarding the inform methods and procedures.
9. Violating the provisions of Article 23, Paragraph 3, by evading, obstructing, or refusing to provide documents and data of advertisements entrusted for broadcasting.
10. Failing to submit a result report within the deadline prescribed in Article 24, Paragraph 1.
11. The content of the result report does not include the matters stipulated in Article 24, Paragraph 2.
12. Violating the provisions of the front portion of Article 25 for failing to report serious adverse reactions or failing to report according to the methods stipulated in the latter portion of the same Article.
13. Failing to comply with the orders of the central competent authority to suspend or terminate all or part of the execution of regenerative medicine according to the provisions of Article 26, Paragraph 1.
14. Violating the provisions of Article 26, Paragraph 2, by suspending or terminating the approved regenerative medicine without prior application for consent.
15. Violating the provisions of Article 26, Paragraph 3, by failing to submit a follow-up treatment plan to the central competent authority for approval or failing to implement the approved follow-up treatment plan.
Article 33
For the fines stipulated in this Act, the responsible physicians for private medical care institutions shall be punished. For medical care institutions established by juridical persons in medical care, the juridical persons in medical care shall be punished.