Law Articles
2017-09-11
Law Articles
Brief on Regulatory Structure of Cell Banking in Taiwan
【Zhongyin Law Firm Managing Partner Charlotte Wu Esq., and Associate Ann Luo, Esq. 】
charlotte.wu@zhongyinlawyer.com.tw
charlotte.wu@zhongyinlawyer.com.tw
A. Preamble
With the arrival of an aging society and late marriages coupled with rapid development of biotechnology and advances in medicine, in recent years, there has been a growth spurt in the human cell bank industry, such as sperm, oocyte and cell banks. However, no legislation has been enacted specifically targeting the cell bank service industry, resulting in a vague and ambiguous interpretation of applicable law. This brief will discuss the current regulatory structure of Taiwan’s cell bank service in the hope of shedding some light to interested parties.
B. Current Applicable Regulatory Structure for Cell Bank Services
Currently, there is no legislation enacted specifically targeting cell bank services. The applicable regulation or administrative order will vary depending on the category of cells to be stored. The determination of such applicable regulation is as follows:
1. Storage of reproductive cells is governed by the Artificial Reproduction Act.
Pursuant to the Regulations for Administration on Human Organ Bank[1], storage of reproductive cells, such as sperm and oocyte, should adhere to the provisions of the Artificial Reproduction Act[2]. Furthermore, artificial reproduction services should only be provided by artificial reproduction institutions, limited to medical care institutions and public interest judicial persons licensed by the competent authority.
2. Pursuant to the Ministry of Health and Welfare’s Administrative Orders (ShuSoShiTze), whether the Regulation for the Administration on Human Organ Bank or administrative orders of the Ministry of Health and Welfare would be applicable is determined by the future use of the stored human cells.
i. If the purpose of the stored cells is for transplantation use during the normal course of a physician’s medical practice, the applicable law would be the Regulation for Administration on Human Organ Bank.
If the purpose of the stored cell is for transplantation use during the normal course of a physician’s medical practice, then in accordance with the Ministry of Health and Welfare’s administrative order (ShuSoShiTze) No. 1010028235 issued on June 27th, 2012, those engaged in the organ bank storage service must adhere to the Regulations for Administration on Human Organ Bank and apply with the relevant health authority for a permit for the establishment of an organ bank.
ii. If the purpose is autologous cell storage, then the applicable law would be the Ministry of Health and Welfare’s administrative orders (WeiShuYiTze).
The Ministry of Health and Welfare issued an administrative order (WeiShuYiTze) No. 0990260843 on March 22, 2010 (WeiShuYiTze Order) providing guidelines for human organs, tissues, and cell banks that do not fall within the scope of the Regulations for Administration on Human Organ Bank. The three primary issues clarified by the guidelines are as follows:
1) The rights and responsibilities between the organ bank service provider and the donor should be based on the <standard form contract for stem cell storage>.
2) Where the stored cells may in the future be used for transplantation medical purposes, marketing materials must be based on scientific evidence without embellishments and such materials must be submitted to the local competent authority.
3) Quality assurance measures should be established based on proven scientific methods and testing for the stored cells should be conducted during the storage term and prior to medical use.
C. Analysis of Legislation Governing Human Cell Bank Services
Legislative efforts and relevant legislation are not in pace with the rapidly developing human cell bank service industry in Taiwan. In particular, the only available regulatory guidelines for autologous cell bank services exist only in administrative orders issued by the Ministry of Health and Welfare. Cell bank service providers are faced with the predicament that no competent authority exists due to lack of legislation.[3] Apart from this, with no guidance available from competent authorities and inadequate standards, cell banks not qualified as medical care institutions, are unclear as to the permissible scope of storage service provision and may inadvertently, during the course of storage, risk violating the law by performing medical services such as blood collection and cell therapy.
Currently, the determination of applicable regulation is based on the “purpose of future use” of the stored cells. However, at what point in time does “future” actually refer to? Furthermore, if the donor changes the purpose of the stored cells in the future, then should the applicable regulation be based on the purpose prior to the change or after the change? Available legislation and administrative orders do not address these issues creating difficulties for execution by law enforcers and unforeseeable risks for cell bank service providers.
Based on administrative orders from the Ministry of Health and Welfare, the rights and responsibilities between the donor and the cell bank for autologous cell storage services should adhere to the <standard form contract for stem cell storage>.[4] Contravention of obligations provided for in the standard form contract[5] by the cell bank service provider results in a breach of contractual obligations[6]. However, where the purpose of the stored cell is for transplantation, then an infraction of obligations would result in a violation of the Regulations for Administration on Human Organ Bank, an administrative law, of which administrative punishments, such as penalties and revocation of licenses will apply. This demonstrates that consequences for violation of legal obligations will vary greatly depending on the purpose of the future use of the stored cells. Therefore, if the purpose of the stored cell changes during storage, and such change breaches contractual obligations, interpretation of law would be problematic.
Cell bank services will become an important industry for the future development of Taiwan. As such, there is an urgency and necessity to ensure that comprehensive legislation is in place to provide people with opportunities to create a brighter future.
If you should have comments or further interest in the above article,
please kindly contact Charlotte Wu, Esq.
charlotte.wu@zhongyinlawyer.com.tw
TEL +886 2 2377 1858 EXT 8888
[1] Article 2, Paragraph 2 of the Regulations for Administration on Human Organ Bank
[2] Article 2, Paragraph 8 of the Artificial Reproduction Act.
[3] The authors have placed a phone query to the Ministry of Health and Welfare, inquiring which department is responsible for cell bank services and was informed that no such department exists.
[4] Please refer to the administrative order of the Ministry of Health and Welfare (ShuSoShiTze) No. 1011101273 issued on July 24, 2010 <Standard Form Contract for Stem Cell Storage>.
[5] Obligations of the cell bank service provider are provided for in the <Standard Form Contract for Stem Cell Storage>, for example Article 3 stipulates that Party B shall adhere to the regulations of the competent authority for the industry and the articles provided for in this Agreement when conducting collection of the cord blood, collection of maternal blood, transportation, analysis, processing and storage. Article 4 stipulates “Party B shall, pursuant to standards provided for by the competent central health ministry and relevant quality management systems, ensure that the cord blood stored by Party A is appropriately stored so as to avoid contamination.” Etc.
[6] Please refer to Article 12 of the <Standard Form Contract for Stem Cell Storage>, breach of this Agreement by the stem cell bank shall provide the expectant mother with the right to terminate this Agreement.