Republic Act No. 7170 otherwise known as the Organ Donation Act of 1991 which addresses the issue of brain dead cadaver donors does not include provisions for the acceptance and management of living organ donors. Living donor transplantation is offered as the preferred option for most patients with End Stage Renal Disease (ESRD) given the high cost of dialysis treatment. A 2-3 session per week of dialysis treatment costs P32,000-P54,000 per month (NKTI RedCop Registry, 2001). As a modality of treatment on a long-term basis, this amount is unaffordable for an average income earning Filipino.

Ninety percent of kidney transplants in the Philippines are from living donors while only ten percent come from cadaver donors. Of the total living donors, twelve percent are from Living Non Related Donors (LNRDs). The latter are currently increasing yearly because of rising need for transplantation and unavailability of preferred donors coming from Living Related Donors (LRDs) and brain dead cadavers. It is reported by the National Kidney and Transplant Institute that there are an estimated 11,250 Filipinos nationwide developing ESRD annually (NKTI RedCop 2001 Report). It is estimated that half of these ESRD patients are suitable kidney transplant candidates but only five percent are actually transplanted to date because of insufficient organ supply and the unaffordability of the operative procedure to most patients. Transplantation requires a huge financial investment but it is considered as the preferred therapy in terms of the effect on the quality of life of the patient and its long-term cost.

Advances in technology during the past decade have made transplantation from LNRDs comparable if not better than those coming from cadavers. Culturally, LNRDs are also becoming to be acceptable in the country as evidenced from a survey conducted by the Philippine Information Agency. Forty four percent of respondents agreed that LNRDs are acceptable sources of organs (Nationwide Survey on the People's Knowledge and Opinions About Organ Donation, January 2001).

Recent media reports on transplantation using LNRDs have highlighted the potential for abuse and manipulation. Both the organ vendor and potential recipient are easy and vulnerable targets in organ sale and brokering. Thus, there is a need for a guiding policy governing LNRDs to curb the reported cases of "backdoor" operations that defy acceptable ethical and medical standards in transplantation.

This Order therefore sets the general guidelines and ethical principles whereby the act of donation and conduct of transplantation from LNRDS shall be managed and regulated.

This Order supports a rational, equitable, ethical and accessible renal health care program in the country.

II. Coverage 

The following shall be governed by this Order:

1. Kidney donors and recipients
2. All health and health-related professionals and private individuals engaged or have any participation in the conduct of transplantation and donation.
3. All Offices/Bureaus, including attached agencies and field offices of the Department of Health.
4. All health and health-related facilities such as hospitals, clinics, laboratories, etc.
5. Other government and non-government agencies and organizations, such as foundations organized to promote and support transplantation and donation programs; and, associations such as medical and specialty societies. 

III. Definition of Terms 

1. Living Related Donors (LRDs) 

Following legal definition, this includes first-degree consanguinity - i.e. parents and children. However, considering the cultural and close kinship relationship in the country, this Order extends the definition of LRDs to include: siblings, cousins, nephews, nieces, and other blood relatives.

2. Living Non Related Donors (LNRDs) 

They are not related to the recipient by blood but have the willingness and intention to donate a kidney based on certain reasons. These donors are classified into two types:

1. Voluntary Donors - They are benefactors who donate out of the kindness of their hearts. They are of two kinds: (a) The first kind are those who are not related by blood to the recipient but bear close emotional ties with him/her. Examples are: spouses, relatives by affinity, friends, employees or employers, colleagues, fianc /fianc e and adoptive parents or children, (b) The second are those who are strangers who have no consanguine and direct emotional ties with the recipient but who donate out of benevolence or purely altruistic motivation. In both instances, gifts or tokens of appreciation are not a precondition or requirement for donation.
    
2. Kidney Vendors - also known as commercial donors for the reason that they offer their kidneys for a valuable consideration. They may engage the services of a broker or agent. Payment or a promise of payment is a precondition and pre-requisite to the organ donation.

IV. General Policy Statements 

As the mandated agency to promote and protect the health of the Filipino people, the Department of Health adopts the following policies and principles in the practice of kidney transplantation through the LNRDs:

1. Living non-related donations are permitted only under Section III, 2-a of this Order. Sale and purchase of kidney organs by kidney vendors is prohibited.
    
   All health and health-related facilities and professionals shall not allow the trade of kidney vendors. Violators shall be penalized through cancellation of licenses and other sanctions. (Refer to Section VII)
    
2. Kidney organ donation programs shall be guided by these principles: Equity, Justice, Benevolence, Nonmalifecence, Solidarity, Altruism and Volunteerism.
    
3. All health and health-related facilities shall implement and adopt quality standards and practices in the medical and organizational management of kidney transplantation.
    
4. The Department of Health (DOH) and the Philippine Health Insurance Corporation (Philhealth) shall enforce and monitor these health facilities through their licensing and accreditation rules and regulations.
    
5. An Organ Donation Program (ODP) shall be created under the Department of Health to develop policy guidelines for a rational and equitable program of kidney organ sharing and exchange. A National Ethics Committee shall also be put in place to serve as a body that shall exercise objectivity and fairness to both donor and recipient in the resolution of ethical issues. 

V. Operational Mechanism: Roles and Functions 

A. Department of Health (DOH)  

The Organ Donation Program (ODP) shall be organized directly under the Center for Degenerative Diseases, Health Operations Cluster of the Department of Health. It shall be headed by a Program Manager duly designated by the Secretary of Health. It shall formulate policies in support of a rational, ethical, accessible and equitable renal health care program in the country through coordination with the National Kidney and Transplant Institute (NKTI) and other organizations, associations and professionals engaged in transplantation and donation programs and activities.

The ODP shall serve as an advisory and recommendatory body to the Undersecretary or Assistant Secretary concerned in the area of policy development, program/project development and in matters involving kidney donation. ODP may also deal with issues pertaining to the donation of other solid organs except tissues (i.e. blood and cornea) as developments warrant.

  Specifically, the ODP shall be responsible for the:

1. setting of guidelines or criteria for the prioritization of recipients of kidney organs from donors.
    
2. development of systems and procedures that will allow for transparency, exchange, networking and collaboration with different health facilities, organizations, associations and professionals.
    
3. facilitate and promote technical assistance among professionals and health and health-related facilities involved in kidney and other organ transplantation. 

The ODP shall have an Advisory Board which shall be composed of five to seven members: a transplant physician/surgeon, a nephrologist, a bio-ethicist, a representative from the donor/recipient group and one to three other members coming from both public and private agencies, sectors, societies, associations and interested groups and individuals. The Secretary of Health shall appoint the members of this Advisory Board for a term of at most 3 years on a staggered basis, renewable for another term.

A National Transplant Ethics Committee (NTEC) shall also be formed. It shall formulate the ethical standards as an input to the operations of the Organ Donation Program. The NTEC shall be composed of three to five members to be appointed by the Secretary of Health.

A Kidney Donor Monitoring Unit (KDMU) shall be put in place under the ODP. This unit shall maintain a national kidney transplant registry to include.

1. Registry of all kidney transplants performed in the country
2. Registry of all LNRDs
3. Registry of all patients seeking kidney transplantation using LNRDs 

The Office of the Secretary of Health shall allocate funds on an annual basis for the operation of the ODP, the NTEC and the Monitoring Unit. Donations/grants/ or endowments can also be additional sources of funds to sustain operations of the program.

B. Bureau of Health Facilities and Services (BHFS), DOH 

Health and health-related facilities engaged in the conduct of kidney transplantation shall be regulated by the Bureau of Health Facilities and Services (BHFS). BHFS shall be primarily responsible for the issuance or revocation of the license of health facilities engaged in kidney transplantation.

To this effect, the BHFS shall upgrade its existing licensing system for licensing kidney transplant health facilities. Initially, it shall ensure that these health facilities meet the following requirements:

1. Capability in immunosuppressive drug level monitoring studies
2. Laboratory diagnostic capability in virology and other post immuno-suppression infection
3. Surgical and medical expertise of medical practitioners and support staff earned through training, specialization, and recognition by medical specialty societies
4. Existence or creation of these committees: Ethics Committee on Organ Donation/Transplantation, Organ Donors and Recipients Registry, and Organ Transplant Programs.
5. All other minimum requirements for licensing. 

The BHFS shall regularly update these essential requirements as advances in transplantation technology prosper.

The BHFS in effectively performing its functions shall regularly coordinate with the ODP in terms of policies, ethical standards and information updates.

  C. Philippine Health Insurance Corporation (Philhealth)  

In support of regulation, Philhealth shall be responsible for:

1. Accrediting health facilities and providers that meet the accreditation requirements subject to the conditions stipulated in Article VIII of the National Health Insurance Act of 1995 and other related Philhealth reimbursement guidelines and directives.
    
2. Conducting utilization reviews and performance monitoring in relation not only to cost efficiency measures and programs but also in support of accreditation standards with the end-view of institutionalizing best quality clinical and medical practices in kidney transplantation. 

To effectively undertake their functions, BHFS and Philhealth shall regularly coordinate and synchronize their efforts to regulate health and other health-related facilities involved in organ transplantation.

D. Health and Health-Related Facilities 

All health and health-related facilities engaged in kidney transplantation shall develop and organize programs and services in support of its development and improvement as required by existing DOH standards and regulations. These health and health-related facilities must put in place the following:

1. An Ethics Committee that shall be primarily responsible for resolving ethical issues and concerns relating to the act or process of donation. They shall be guided by the minimum ethical standards and requirements set by the NETC.
    
2. A Donors/Recipients Registry Unit shall actively coordinate and network with the Kidney Donor Monitoring Unit (KDMU) under the ODP. This unit shall be responsible for providing reports to the KDMU on a quarterly basis. The report shall include the number of kidney transplants performed in the hospital, lists of all LNRDs and lists of all patients seeking kidney transplantation using LNRDs. Failure to submit report for a specified period of time shall become a basis for the non-issuance of license to perform transplantation.
    
   The Donors/Recipients Registry Unit shall be responsible for developing a mechanism for a comprehensive psycho-social and economic profiling of the prospective donors. It shall likewise facilitate transplantation, organ exchange, as well as information/technical exchange.
    
3. The Organ Transplant Unit that shall take charge of advocacy activities in renal health care and promotion of voluntary organ donation; conduct family education, pre-transplant sessions and screening; issuance of clearances; and, undertake pre and post clinical transplant follow-ups. 

E. Organizational Structure and Linkages 

This organizational diagram represents the linkages and coordination of the different offices/structures involved in LNRDs:

(Diagram available at ONAR, U.P. Law Center)  

VI. Monitoring and Evaluation  

The Undersecretary of the Health Operations Cluster shall take the lead in the conduct of monitoring relative to compliance to rules and regulations of all those covered in this Order. The Undersecretary shall call on the support of independent bodies and organizations involved in kidney transplantation such as medical and specialty societies, non-government organizations, the private sector, other professionals and the civil society in its monitoring activities and programs. It shall continually develop and support programs and projects towards achieving a world-class status for the country in renal care and transplantation.

VII. Sanctions and Penalties 

Violations done in relation to this Order shall be dealt with according to existing licensing and accreditation rules and regulations of the DOH and the Philhealth. Erring health professionals shall also be dealt with according to the rules and regulations of the Professional Regulations Commission and other sanctions as may be agreed among medical and specialty societies and organizations in nephrology and organ transplantation.

VIII. Repealing Clause 

Any existing provision or issuance found inconsistent with this Order shall be repealed.

IX. Effectivity  

Specific operational guidelines shall be formulated to allow for a smooth implementation of this Order as these relate to the management, regulation and conduct of transplantation from LNRDs and all other types of donors as conditions warrant.

This Order takes effect immediately.

Adopted: 3 June 2002

(SGD.) MANUEL M. DAYRIT, MD, MSC
Secretary of Health