Republic Act No. 9288
An Act Promulgating A Comprehensive Policy And A National System For Ensuring Newborn Screening

Article 1 General Provisions

Section 1. Short Title. This Act shall be known as the "Newborn Screening Act of 2004."

Sec. 2. Declaration of Policy. It is the policy of the State to protect and promote the right to health of the people, including the rights of children to survival and full and healthy development as normal individuals. In pursuit of such policy, the State shall institutionalize a national newborn screening system that is comprehensive, integrative and sustainable, and will facilitate collaboration among government and non-government agencies at the national and local levels, the private sector, families and communities, professional health organizations, academic institutions, and non-governmental organizations. The National Newborn Screening System shall ensure that every baby born in the Philippines is offered the opportunity to undergo newborn screening and thus be spared from heritable conditions that can lead to mental retardation and death if undetected and untreated.

Sec. 3. Objectives. The objectives of the National Newborn Screening System are:

Article 2 Definition Of Terms

Sec. 4. Definitions. Under this Act, the following terms shall have the meanings respectively given to them below:

 

Article 3 Newborn Screening

Sec. 5. Obligation to Inform. Any health practitioner who delivers, or assists in the delivery, of a newborn in the Philippines shall, prior to delivery, inform the parents or legal guardian of the newborn of the availability, nature and benefits of newborn screening. Appropriate notification and education regarding this obligation shall be the responsibility of the Department of Health (DOH).

Sec. 6. Performance of Newborn Screening. Newborn screening shall be performed after twenty-four (24) hours of life but not later than three (3) days from complete delivery of the newborn. A newborn that must be placed in intensive care in order to ensure survival may be exempted from the 3-day requirement but must be tested by seven (7) days of age. It shall be the joint responsibility of the parent(s) and the practitioner or other person delivering the newborn to ensure that newborn screening is performed. An appropriate informational brochure for parents to assist in fulfilling this responsibility shall be made available by the Department of Health and shall be distributed to all health institutions and made available to any health practitioner requesting it for appropriate distribution.

Sec. 7. Refusal to be Tested. a parent or legal guardian may refuse testing on the grounds of religious beliefs, but shall acknowledge in writing their understanding that refusal for testing places their newborn at risk for undiagnosed heritable conditions. A copy of this refusal documentation shall be made part of the newborn’s medical record and refusal shall be indicated in the national newborn screening database.

Sec. 8. Continuing Education, Re-education and Training Health Personnel. The DOH, with the assistance of the NIH and other government agencies, professional societies and non-government organizations, shall: (i) conduct continuing information, education, re-education and training programs for health personnel on the rationale, benefits, procedures of newborn screening; and (ii) disseminate information materials on newborn screening at least annually to all health personnel involved in material and pediatric care.

Sec. 9. Licensing and Accreditation. The DOH and the Philippine Health Insurance Corporation (PHIC) shall require health institutions to provide newborn screening services as a condition for licensure or accreditation.

Article 4 Implementation

Sec. 10. Lead Agency. The DOH shall be the lead agency in implementing this Act. For purposes of achieving the objectives of this Act, the DOH shall:

Sec. 11. Advisory Committee on Newborn Screening. To ensure sustained inter-agency collaboration, the Advisory Committee on Newborn Screening is hereby created and made an integral part of the Office of the Secretary of the DOH. The Committee shall review annually and recommend conditions to be included in the newborn screening panel of disorders; review and recommend the newborn screening fee to be charged by Newborn Screening Centers; review the report of the Newborn Screening Reference Center on the quality assurance of the National Screening Centers and recommend corrective measures as deemed necessary.

The Committee shall be composed of eight (8) members, including the Secretary of Health who shall act as Chairman. The other members of the Committee shall be as follows: (i) the Executive Director of the NIH, who shall act as Vice Chairperson; (ii) an Undersecretary of the DILG; (iii) the Executive Director of the Council for the Welfare of Children (iv) the Director of the Newborn Screening Reference Center; and (v) three (3) representatives appointed by the Secretary of Health who shall be a pediatrician, obstetrician, endocrinologist, family physician, nurse or midwife, from either the public or private sector. The three (3) representatives shall be appointed for a term of three (3) years, subject to their being reappointed for additional three (3) years period for each extension.

The Committee shall meet at least twice a year. The NIH shall serve as the Secretariat of the Committee.

Sec. 12. Establishment and Accreditation of Newborn Screening Centers. The DOH shall ensure that Newborn Screening Centers are strategically located in order to be accessible to the relevant public and provide services that comply with the standards approved by the Committee upon the recommendation of the NIH. No Newborn Screening Center shall be allowed to operate unless it has been duly accredited by the DOH based on the standards set forth by the Committee. At a minimum, every Newborn Screening Center shall: (i) have a certified laboratory performing all tests included in the newborn screening program, (ii) have a recall/follow up programs for infants found positive for any and all of the heritable conditions; (iii) be supervised and staffed by trained personnel who have been duly qualified by the NIH; and (iv) submit to periodic announced or unannounced inspections by the Reference Center in order to evaluate and ensure quality Newborn Screening Center performance.

Sec. 13. Establishment of a Newborn Screening Reference Center. The NIH shall establish a Newborn Screening Reference Center, which shall be responsible for the national testing database and case registries, training, technical assistance and continuing education for laboratory staff in all Newborn Screening Centers.

Sec. 14. Quality Assurance. The NIH Newborn Screening Reference Center shall be responsible for drafting and ensuring good laboratory practice standards for newborn screening centers, including establishing an external laboratory proficiency testing and certification program. It shall also act as the principal repository of technical information relating to newborn screening standards and practices, and shall provide technical assistance to newborn screening centers needing such assistance.

Sec. 15. Database. All Newborn Screening Centers shall coordinate with the NIH Newborn Screening Reference Center for consolidation of patient databases. The NIH Newborn Screening Reference Center shall maintain a national database of patients tested and a registry for each condition. It shall submit reports annually to the Committee and to the DOH on the status of and relevant health information derived from the database. A plan for long-term outcome evaluation of newborn screening utilizing the cases registries shall be developed within one (1) year of passage of this Act by the NIH Newborn Screening Reference Center in consultation with the Advisory Committee on Newborn Screening. Implementation of this plan shall become a responsibility of the Advisory Committee on Newborn Screening.

Sec. 16. Newborn Screening Fees The PHIC shall include cost of newborn screening in its benefits package. The newborn screening fee shall be applied to, among others, testing costs, education, sample transport, follow-up and reasonable overhead expenses.

To ensure sustainability of the National System for Newborn Screening, the newborn screening fee shall be divided and set aside for the following purposes; at least four percent (4%) to the DOH’s Centers for Health Development or its future equivalent to be spent solely for follow-up services, education and other activities directly related to the provision of newborn screening services; at least four percent (4%) to the Newborn Screening Centers for human resource development and equipment maintenance and upgrading; at least four percent (4%) to the NIH Newborn Screening Reference Center for overall supervision, training and continuing education, maintenance of national database, quality assurance program and monitoring of the national program; and the balance for the operational and other expenses of the Newborn Screening Center.

Article 5 Final Provisions

Sec. 17. Repealing Clause. All general and special laws, decrees, executive orders, proclamations and administrative regulations, or any parts thereof, which are inconsistent with this Act are hereby repealed or modified accordingly.

Sec. 18. Separability. If, for any reason or reasons, any party of provisions of this Act shall be declared or held to be unconstitutional or invalid, other provision or provisions hereof which are not affected thereby shall continue to be in full force and effect.

Sec. 19. Effectivity. This Act shall take effect fifteen (15) days after its publication in at least two (2) newspapers of general circulation.

Approved: April 07, 2004