MANILA, Philippines—The Department of Health on Wednesday released the implementing rules and regulations that will cover stem cell and cell-based therapy to prevent abuses and dubious practices.
Health Secretary Enrique Ona said the regulations contained in DOH Administrative Order 2013-0012 aimed to ensure that human stem cell and cell-based therapies in the country would be safe and effective for their intended use.
“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,” Ona said.
He said the rules restrict 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.
They also prohibit 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 for human treatment and research, Ona said.
To stop the spread of communicable diseases, the rules would ensure a minimum quality of service and staff qualification in health facilities that offer stem cell therapy, he added.
Ona said the guidelines also classify which stem cell preparations and therapies would be registered and allowed with certain restrictions.
He added that preparations that would be allowed include those with adult human stem cells, human umbilical cord stem cells, and human organ-specific cells.
Ona also said that health facilities utilizing stem cell preparations and cell-based or cellular therapies would be mandated to comply with the guidelines set by the Bioethics Advisory Board.
The board will be composed by representatives from the DOH, the National Transplant Ethics Committee, the Philippine Food and Drug Administration, a government health facility, a private organization or health facility, academicians, researchers, local and international experts, Ona said.
“This board will ensure that ethical and professional standards are upheld and that contentious scientific, ethical and legal issues are addressed. Charges and complaints shall be addressed to the DOH Bureau of Health Facilities & Services and the Philippine FDA,” he added.
Ona said an Institutional Review Board would review and approve stem cell therapies, based on the guidelines set by the Bioethics Advisory Board.
“There are minimum standards for personnel qualifications, physical facilities, equipment and supplies and work environment which will be prescribed by the guidelines,” Ona said.
Proper record keeping in each facility that will provide readily available information on each donor, patient, procedures on stem cell and cell-based therapies will be mandated as well,” he added.