Rules for Organ and Corneal Donation Act

Definitions clarify terms such as Act, Department, Secretary of Health, Cornea/Corneal Tissue, Whole Eyes, Enucleation, Corneal Excision, Eye Bank (with four categories), Medico-legal Officers, and Death.
Death is medically and legally defined as irreversible cessation of circulatory and respiratory functions or all brain functions, diagnosed by two qualified physicians.
Brain death criteria include irreversible coma, absence of brainstem reflexes, and exclusion of confounding conditions like intoxication or hypothermia.

Decedent donors may donate organs/tissues through a valid donor card or will legacy, binding all heirs.
In absence of donor's prior consent, donation authorization follows a priority order: spouse, adult children, parents, siblings, or guardian, with objections resolved by priority.
For brain dead donors without family authorization, hospital officials may authorize organ removal after reasonable efforts to locate next of kin within 48 hours.
For cardiorespiratory death with no family authorization, medico-legal officers may approve corneal tissue retrieval within 12 hours without legal liability.
Autopsy consent implies consent for corneal retrieval unless family expressly objects.
Death certificate and authorization must be issued by two qualified physicians not involved in transplantation or authorization.

Removal of whole eyeballs can be performed by any trained licensed medical practitioner or certified eye bank technician.
Corneal tissue removal is restricted to ophthalmic surgeons or certified eye bank technicians certified by the National Association of Ophthalmologists.
Authorization for retrieval from medico-legal or violent death cases is limited to certified personnel from licensed public active eye banks.
Only licensed, qualified medical practitioners trained in transplantation are authorized to perform transplants.

The Department of Health (DOH) may collaborate with civic and non-governmental organizations to conduct public education campaigns.
Health workers are required to routinely inquire about organ donor status and encourage donation.
Specific directives will be issued to hospital staff to aid in tissue retrieval from unaccompanied decedents.
Educational efforts include lectures and workshops for health care workers.

Tissue and eye bank facilities must operate on a non-profit basis.
Service fees are permitted but limited to necessary expenses, including professional fees.
Donors with medical contraindications specified by the DOH manual are excluded from tissue collection.

DOH exercises regulatory authority via the Bureau of Research and Laboratories (BRL) or designated body.
Strict licensing and standardization protocols prevent proliferation of substandard facilities.
Eye/tissue banks are classified into four categories based on capability and scope (Public Active, Private Active, Public Passive, Private Passive).

Minimum requirements include qualified medical directors, medical supervisors, and trained technicians with continuous medical education.
Facility and equipment standards vary by category.
Safety and biosafety protocols must be strictly followed.
Record-keeping, reporting, and quality assurance procedures are mandatory.
Licenses are valid for one year and are non-transferable.
Application procedures require documentary submissions and inspections prior to approval.
Fees for licensing and renewal are fixed.

Service fees cover operational costs only and are capped by the DOH.
Monetary compensation for donations is prohibited.
Surplus tissues not used locally before expiration may be shared internationally under reciprocal agreements.
Importation of related equipment and materials is tax-exempt subject to approval.

Renewal requires compliance with updated staff qualifications, continuing education, reports, inspections, and fee compliance.
Non-compliance results in fines, suspension, or revocation of license.

Violations and appeals are addressed to the Secretary of Health.
A Quality Assurance Officer must be designated at each facility to ensure standards and investigate errors.

Yearly certification of operating eye/tissue banks is submitted for tax-exempt import privileges.
The BRL maintains and updates a list of allowable equipment and materials.
Importation requires submission of intent and certification by DOH officials.

Sanctions include license suspension, revocation, imprisonment (up to 5 years) for serious violations (e.g., distributing tissue from donors with contraindications).
Fines are imposed for failure to renew licenses and operating without authorization.
Professional licenses may be suspended or revoked upon recommendation due to violations or misrepresentations.

These rules supersede all prior Department Orders and Circulars inconsistent herewith.
The Rules take effect 15 days after publication in official gazette or newspapers.