Stem Cell Therapy Philippines: DOH Releases Implementing Rules And Regulations

The Department of Health has released the implementing rules and regulations regarding stem cell and cell-based therapy in the Philippines.

Stem Cell Therapy (Image Credit: NIH.gov)

"Our efforts at regulating the practice of stem cell therapy in this country are aimed at safeguarding the welfare of our patients and the general public by making safe, effective and ethical stem cell modalities and practices are within emerging international and global standards considering the very complex nature of this therapy," DOH Secretary Enrique Ona said Wednesday.

The said rules and regulations are stipulated in DOH Administrative Order 2013-0012 (AO 2013-0012), also known as "Rules and Regulations Governing the Accreditation of Health Facilities Engaging in Human Stem Cell and Cell-based or Cellular Therapies in the Philippines."

The AO aims to ensure that human stem cell and cell-based therapies in the country are safe and effective for their intended use. It also intends to prevent the introduction, transmission, and spread of communicable diseases by ensuring a minimum quality of service and staff qualification rendered by hospitals and other health facilities capable of utilizing human stem cell preparations and cell-based therapies.

"These guidelines will classify which stem cell preparations and therapies will be registered and allowed with certain restrictions. Preparations that will be allowed include those with adult human stem cells, human umbilical cord stem cells, and human organ-specific cells," DOH wrote in a press release. "The AO restricts the use of genetically altered stem cells and tissues of human adults and the umbilical cord, fat-derived human stem cells, and live animal stem cells; the AO also prohibits for human treatment and research the creation of human embryos and their derivatives, the use of aborted human fetal stem cells and their derivatives, and plant parts labeled as stem cells."

The new IRR will take effect fifteen (15) days after March 20, its publication date, and shall be reviewed three years after its implementation.