Vietnam's Ministry of Health (MOH) has published for public consultation a draft amendment of the Law on Donation, Recovery, and Transplantation of Human Tissues and Organs and Donation and Retrieval of Cadavers, a law which has been in effect since 2007.
Among its changes, the draft amendment notably includes new provisions on stem cells, a hot-button topic with social, legal, and ethical ramifications extending beyond the medical field. There are currently no specific regulations on stem cells under Vietnamese law—only the MOH's technical guidance—leaving many controversial issues unsettled.
Key points related to stem cells that may impact the activities of researchers and institutions in Vietnam and abroad are highlighted below.
Requirements for Stem Cells
Under the draft amendment, stem cells are defined as cells naturally occurring in the body, having the ability to divide and differentiate into various types of cells.
The draft amendment outlines conditions for stem cell donation, establishes requirements for medical facilities authorized to receive stem cell donations, and specifies the rights of stem cell donors. Under the draft amendment, it is prohibited to receive, screen, or produce stem cells at facilities that do not satisfy conditions.
Establishment of Private Stem Cell Banks
In addition to state-owned stem cell banks, the draft amendment also addresses independent stem cell banks established by private investors. In general, the stem cell banks (whether public or private) must obtain an operation license by meeting various conditions on personnel, equipment, facilities, and management systems to be further guided by the government. Notably, stem cell banks will have the right to cooperate with foreign entities in exchanging stem cells for treatment, education, and research purposes.
Prohibition on Creating Embryos for Stem Cell Research or Therapy
Considering the ethical concerns over the use and destruction of embryos, the draft amendment expressly prohibits the creation of embryos for the purpose of generating stem cells for research or treatment, regardless of developmental stages. The draft amendment does not cover synthetic embryos (e.g., stem cell-based embryo models).
Next Steps
The MOH will close the public consultation for the draft amendment on May 19, 2025. While there is no set date for adoption of the draft amendment, researchers and institutions involved in stem cell research and activities in Vietnam should be aware of these policies, as they may affect how stem cell research is conducted in the near future.
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