President announces regenerative medicine dual legislation, opening a new chapter in the quality of regenerative medicine and patient rights

07/08/2024

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President announces regenerative medicine dual legislation, opening a new chapter in the quality of regenerative medicine and patient rights

Katherine Juang 

Regenerative medicine is divided into medical treatment and medicinal products. In the past, "regenerative medical treatment" fell under the Regulations Governing the Application or Use of Specific Medical Techniques or Examination, or Medical Devices ("Special Regulations") authorized by Paragraph 2, Article 62 of the Medical Care Act, which focused on cell therapy. On the other hand, the Pharmaceutical Affairs Act and other regulations and standards for human cell therapy products governed "regenerative medicinal products," creating a dual-track system for medical treatment and medicinal products.

To ensure the safety and quality of regenerative medicine in healthcare institutions, protect patients' right to receive treatment, promote the development of regenerative medicine, and accelerate the application of research and development results in clinical medicine, the Ministry of Health and Welfare ("MOHW") began drafting special laws several years ago. The legislative consensus matured in 2023, and the draft Regenerative Medicine Act and Regenerative Medicine Product Act were proposed.

The draft bills continue with the dual-track system and respectively regulate "regenerative medical technology" and "regenerative medical products." After review and approval by the Executive Yuan (cabinet), the drafts were sent to the Legislative Yuan (congress) for deliberation. However, the drafts were further modified due to certain controversial articles and eventually passed as laws on June 4, 2024, after consultation between the ruling and opposition parties. The President announced the two laws on June 19, 2024, effectively elevating the regulations to statutory status.

 Given that the Executive Yuan has yet to determine the implementation dates for the dual laws on regenerative medicine, all sectors are closely monitoring the implementation schedule. As the MOHW is still working on the relevant draft regulations and orders, these two statutes will likely be implemented after the relevant subsidiary regulations are completed.

    The key points of the regenerative medicine dual legislation are outlined as follows:

1.     Regenerative Medicine Act (treatment): 

(1)     In the future, a Regenerative Medicine Review Council (the "Council") will be responsible for consulting on all regenerative medicine related matters, approving the funding of relevant research and development, and providing conditional approvals for regenerative products.

(2)     Before administering regenerative treatment, healthcare institutions should conduct human trials and obtain approval from the competent authority in accordance with the regulations. However, human trials may be exempted in cases where the treatment is for life-threatening or severely disabling diseases without appropriate drugs, medical devices, or technologies available domestically (known as "compassionate use therapy"), or if the regenerative medical treatments offered by medical institutions have been approved by the central competent authority before the implementation of this Act (i.e., those approved according to the Special Regulations). In the case of compassionate use therapy, approval must still be obtained from the MOHW on a case-by-case basis.

(3)     The definitions of "regenerative medicine," "regenerative medicine products," and "regenerative medicine treatment" do not explicitly exclude the use of heterologous cells and tissues. However, previous Special Regulations did not allow for medical technologies using heterologous cells and tissues, and this Act explicitly states that compassionate use therapy should also exclude the use of heterologous cells and tissues. Therefore, whether the use of heterologous cells and tissues will be permitted in the future will depend on the competent authority's review during human trial approval on a case-by-case basis.

(4)     Research of highly controversial ethical issues, such as the production of chimeras, is still strictly prohibited, and the Act provides no exceptions.

(5)     To protect patients' rights, healthcare institutions should obtain written consent from the patients or their legal representative, spouse, relatives, or related persons before administering regenerative treatment in accordance with the principles of the Medical Care Act and Special Regulations. The MOHW will further announce relevant relief measures for adverse reactions resulting in serious harm or death, and may require relevant liability insurance to be taken out.

(6)     Regarding the establishment of cell manipulation and cell storage facilities, the MOHW will further stipulate detailed requirements through regulations. Furthermore, the acquisition of tissues and cells from fetuses is prohibited.

(7)     To maintain public awareness and supervision, the MOHW should publicly disclose the treatment effects of medical institutions and statistics on medical quality on an annual basis.

(8)     Due to high controversy, healthcare institutions cannot establish regenerative medicine biopharmaceutical companies.

(9)     Violations of the provisions of this Act may result in fines ranging from NT$50,000 to NT$20 million, depending on the circumstances. Non-medical institutions implementing regenerative medicine may also have their regenerative medical equipment and preparations confiscated. 

2.     Regenerative Medicine Product Act (products): 

(1)    In order to promote industry development, this Act has been established as an addition to the basic provisions of the Pharmaceutical Affairs Act. Apart from the standard process of applying and registering for a drug permit, the MOHW can grant additional approval for using regenerative medicine products in specific circumstances. These circumstances include the treatment of life-threatening or severely disabling diseases, completion of phase II clinical trials, and assessment of risk-benefit, safety, and preliminary efficacy. However, the permit granted should not exceed five years and will not be extended upon expiration. This ensures that the public's right to early access to regenerative medicine products is balanced with proper regulation.

(2)   If the holder of a drug approval fails to fulfill the conditions of the approval or if there are significant safety concerns, the MOHW may revoke the drug approval to protect patients' rights.

(3)   Written consent from the provider should be obtained before human tissues and cells are acquired for the manufacture of regenerative medicine drugs in Taiwan.

(4)   Violations of the provisions of this Act may result in fines ranging from NT$30,000 to NT$2 million, depending on the circumstances. 

Our "Life Sciences & Healthcare" practice group has a team of experts specializing in regenerative medicine laws. Please feel free to contact us for further analysis or consultation.