Question & AnswerQ&A (PRESIDENTIAL DECREE NO. 1414)
The purpose is to protect the public and ensure the safety of patients and personnel by regulating health facilities engaging in human stem cell and cell-based or cellular therapies, preventing the spread of communicable diseases, and ensuring therapies are safe and effective.
They apply to all government and private health facilities involved in the use of human stem cell and cell-based or cellular therapies in the Philippines.
The BAB formulates ethical standards, addresses contentious ethical, scientific, and legal issues in stem cell research and therapies, and guides Institutional Review Committees (IRC) in health facilities.
Prohibited stem cell preparations include creation of human embryos for research, human embryonic stem cells and derivatives, aborted human fetal stem cells and derivatives, and plant parts labeled as stem cells.
Violating facilities may have their Certificate of Accreditation (COA) suspended or revoked, face penalties under related administrative orders, and may be subject to criminal action.
'Allogeneic' refers to cells obtained from a donor and infused into a genetically distinct recipient, while 'Autologous' refers to cells obtained from and infused back into the same patient.
They must have linkage with at least one Level three (3) hospital licensed by DOH through a contractual agreement.
The IRC reviews ethical aspects, scientific rationale, safety and efficacy data, certifies that prohibited stem cells are not used, and documents/report adverse events related to stem cell therapies.