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Biologics Compliance Guide for Philippines

This is a compliance guide for clinics that want to operate in the Philippines.

Key Pieces of Legislation:

1. Republic Act No. 7180 (The Human Organ Donation Act)

Regulates the ethical use of human tissues, including stem cells.


2. Republic Act No. 11223 (Universal Health Care Act)

Mandates quality health services and establishes regulatory frameworks for health technologies like stem cell therapies.


3. FDA Act of 2009 (Republic Act No. 9711)

Empowers the FDA to regulate health products, including stem cell therapies, and oversee clinical trial approvals.


4. Administrative Order No. 2013-0012

Provides guidelines for the ethical and scientific use of stem cells in research and clinical applications.


5. Philippine Medical Act (Republic Act No. 2382)

Ensures that only licensed medical professionals administer treatments, including stem cell therapies.


6. National Ethics Guidelines for Health Research (2017)

Sets ethical standards for health research involving stem cells, focusing on informed consent and monitoring.


7. DOH Circulars and Advisories

Regular updates from the Department of Health regarding regulations and warnings on unauthorized stem cell practices.


8. Compliance Checklist

Licensing and Accreditation:

  • Verify that the medical facility is accredited by the Department of Health (DOH).
  • Ensure that the physician is licensed and registered with the Professional Regulation Commission (PRC).
  • Confirm that the facility has the necessary permits for handling and administering stem cell treatments.

Regulatory Framework:

  • Familiarize yourself with the Republic Act No. 11223 (Universal Health Care Act) and related laws regarding stem cell therapies.
  • Understand the guidelines set by the DOH and the Food and Drug Administration (FDA) regarding stem cell use.
  • Ensure compliance with the Philippine FDA’s regulations on the use of investigational products.

Ethical Considerations:

  • Obtain Institutional Review Board (IRB) or Ethics Review Committee approval for any clinical trials involving stem cells.
  • Follow ethical guidelines as per the Declaration of Helsinki and the Council for International Organizations of Medical Sciences (CIOMS).
  • Ensure informed consent is obtained from patients, detailing risks, benefits, and alternatives to the treatment.

Patient Selection Criteria:

  • Assess patient eligibility for stem cell treatment based on established medical guidelines.
  • Document the rationale for selecting stem cell therapy as a treatment option.

Source of Stem Cells:

  • Ensure that stem cells used for treatment are sourced from legal and ethical providers.
  • Verify compliance with the National Transplant Act and regulations concerning the procurement of human tissues.

Documentation and Record-Keeping:

  • Maintain comprehensive medical records for all patients receiving stem cell treatments.
  • Document informed consent, treatment protocols, and any adverse events.

Post-Treatment Monitoring:

  • Establish a system for monitoring and documenting patient outcomes post-treatment.
  • Be prepared to report any adverse effects or complications to the appropriate regulatory bodies.

Public Awareness and Patient Education:

  • Provide patients with clear information regarding the experimental nature of stem cell treatments.
  • Educate patients about potential risks, benefits, and the current state of research.

Insurance and Financial Considerations:

  • Ensure transparency regarding the costs associated with stem cell treatments.
  • Verify coverage and reimbursement options for patients through health insurance providers.

Continuous Education and Training:

  • Stay updated on the latest research, regulations, and best practices in stem cell therapy.
  • Participate in training programs and conferences related to regenerative medicine.


9. Who can administer

Licensed Physicians:

Only licensed medical doctors who have undergone appropriate training and are accredited can administer stem cell therapies. They must also have a valid license from the Professional Regulation Commission (PRC). This ensures that the administration is done by qualified individuals who can manage any potential complications​

Accredited Medical Facilities:

Treatments must be provided in medical facilities that are accredited by the DOH and comply with FDA regulations. These facilities should have the necessary infrastructure and personnel trained in handling stem cell procedures


10. Adverse Effects Reports

There have been numerous reports of adverse reactions from patients undergoing unauthorized stem cell treatments, which have prompted investigations by health authorities. Patients have filed complaints about ineffective treatments and serious health complications, leading to a broader discussion on the need for stricter regulations and oversight in the field of regenerative medicine


11. Public Health Warnings

The Department of Health (DOH) has issued warnings against illegal stem cell treatments, emphasizing that only specific procedures, such as hematopoietic stem cell transplantation and corneal resurfacing, are approved. The DOH's stance aims to protect patients from clinics offering unverified treatments, which could result in legal action if patients experience harm