Philippine Newborn Screening Act

Policy, objectives, and declared intent

Section 2 declares it to be the policy of the State to protect and promote the right to health of the people, including children’s rights to survival and full and healthy development.
Section 2 directs the State to institutionalize a national newborn screening system that is comprehensive, integrative, and sustainable, and that facilitates collaboration among national and local government, the private sector, families and communities, professional health organizations, academic institutions, and non-governmental organizations.
Section 2 requires that the National Newborn Screening System ensures every baby born in the Philippines is offered the opportunity to undergo newborn screening to spare babies from heritable conditions that can lead to mental retardation and death if undetected and untreated.
Section 3 states the objectives of the National Newborn Screening System include ensuring access to newborn screening for certain heritable conditions; integrating the system within the public health delivery system; ensuring health practitioners understand newborn screening advantages and responsibilities; and ensuring parents recognize responsibility under responsible parenthood through newborn screening.

Key definitions governing the Act

Section 4 defines “Comprehensive Newborn Screening System” as a system that includes education of relevant stakeholders; collection and biochemical screening of newborn blood samples; tracking and confirmatory testing; clinical evaluation and biochemical/medical confirmation; drugs and medical/surgical management and dietary supplementation; and evaluation activities to assess long-term outcome, patient compliance, and quality assurance.
Section 4 defines “Follow-up” as monitoring a newborn with a heritable condition to ensure full compliance with medicine or dietary prescriptions.
Section 4 defines “Health institutions” as hospitals, health infirmaries, health centers, lying-in centers, or puericulture centers with obstetrical and pediatric services, whether public or private.
Section 4 defines “Healthcare practitioner” as physicians, nurses, midwives, nursing aides, and traditional birth attendants.
Section 4 defines “Heritable condition” as any condition that can result in mental retardation, physical deformity, or death if left undetected and untreated and which is usually inherited from the genes of either or both biological parents of the newborn.
Section 4 defines “NIH” as the National Institute of Health.
Section 4 defines “Newborn” as a child from the time of complete delivery to 30 days old.
Section 4 defines “Newborn Screening” as collecting a few drops of blood from the newborn onto an appropriate collection card and performing biochemical testing to determine if the newborn has a heritable condition.
Section 4 defines “Newborn Screening Center” as a facility with a newborn screening laboratory that complies with NIH standards and provides all required laboratory tests and recall/follow-up programs for newborns with heritable conditions.
Section 4 defines “Newborn Screening Reference Center” as the central NIH facility that defines testing and follow-up protocols, maintains an external laboratory proficiency testing program, oversees the national testing database and case registries, assists in training, oversees educational materials content, and acts as the Secretariat of the Advisory Committee on Newborn Screening.
Section 4 defines “Parent education” as information provided to parents or legal guardians about newborn screening.
Section 4 defines “Recall” as locating a newborn with a possible heritable condition for confirmation testing and, as appropriate, treatment.
Section 4 defines “Treatment” as prompt, appropriate, adequate medicine, medical and surgical management, or dietary prescription to treat or mitigate adverse health consequences of a heritable condition.

Coverage and who must act

Section 5 applies to any health practitioner who delivers or assists in the delivery of a newborn in the Philippines.
Section 6 applies to newborn screening performance for newborns in the Philippines, requiring the system to be done within specified life-age timelines.
Section 6 places responsibility on the parent(s) and the practitioner or other person delivering the newborn to ensure newborn screening is performed.
Section 7 grants a parent or legal guardian the option to refuse testing on religious-belief grounds, subject to written acknowledgment and documentation requirements.
Section 9 makes health institutions subject to DOH and Philippine Health Insurance Corporation (PHIC) requirements to provide newborn screening services as a condition for licensure or accreditation.
Section 12 requires the operation of any Newborn Screening Center to be contingent on DOH accreditation based on standards recommended by the Committee.

Newborn screening requirements and refusals

Section 5 requires every covered health practitioner to inform parents or legal guardians prior to delivery of the availability, nature, and benefits of newborn screening.
Section 5 places on the Department of Health (DOH) responsibility for appropriate notification and education regarding the obligation to inform.
Section 6 mandates that newborn screening be performed after twenty-four (24) hours of life but not later than three (3) days from complete delivery.
Section 6 allows exemption from the 3-day requirement only when a newborn must be placed in intensive care to ensure survival, but in that case requires testing by seven (7) days of age.
Section 6 makes the parent(s) and the delivering practitioner or person jointly responsible to ensure newborn screening is performed.
Section 6 requires DOH to make available an appropriate informational brochure for parents, to be distributed to all health institutions and available to any health practitioner requesting it for appropriate distribution.
Section 7 allows refusal to be tested only on the grounds of religious beliefs.
Section 7 requires the parent or legal guardian to acknowledge in writing understanding that refusal places the newborn at risk for undiagnosed heritable conditions.
Section 7 requires that a copy of the refusal documentation be made part of the newborn’s medical record.
Section 7 requires refusal to be indicated in the national newborn screening database.

Education, training, and facility licensing

Section 8 requires DOH, with assistance of NIH and other government agencies, professional societies, and non-government organizations, to conduct continuing information, education, re-education, and training programs for health personnel on the rationale, benefits, and procedures of newborn screening.
Section 8 requires dissemination of newborn screening information materials at least annually to all health personnel involved in maternal and pediatric care.
Section 9 requires DOH and PHIC to require health institutions to provide newborn screening services as a condition for licensure or accreditation.

Lead agency and institutional implementation

Section 10 designates DOH as the lead agency in implementing the Act.
Section 10 requires DOH to establish an Advisory Committee on Newborn Screening.
Section 10 requires DOH to develop the implementing rules and regulations for immediate implementation of a nationwide newborn screening program within one hundred eighty (180) days from enactment.
Section 10 requires DOH to coordinate with the Department of the Interior and Local Government (DILG) for implementation.
Section 10 requires DOH to coordinate with the NIH Newborn Screening Reference Center for accreditation of Newborn Screening Centers and preparation of defined testing protocols and quality assurance programs.
Section 11 creates the Advisory Committee as an integral part of the Office of the Secretary of DOH.

Advisory Committee powers and composition

Section 11 requires the Advisory Committee to review annually and recommend conditions for inclusion in the newborn screening panel of disorders.
Section 11 requires the Advisory Committee to review and recommend the newborn screening fee to be charged by Newborn Screening Centers.
Section 11 requires the Advisory Committee to review the Newborn Screening Reference Center’s report on quality assurance of centers and recommend corrective measures deemed necessary.
Section 11 establishes the Committee membership as eight (8) members, with the Secretary of Health as Chairperson.
Section 11 requires the Vice Chairperson to be the Executive Director of the NIH.
Section 11 requires membership to include an Undersecretary of DILG; the Executive Director of the Council for the Welfare of Children; the Director of the Newborn Screening Reference Center; and three (3) representatives appointed by the Secretary of Health chosen from qualified professions (pediatrician, obstetrician, endocrinologist, family physician, nurse, or midwife) from the public or private sector.
Section 11 sets the term of the three (3) appointed representatives at three (3) years, subject to reappointment for additional three (3)-year periods for each extension.
Section 11 requires the Committee to meet at least twice a year, and requires NIH to serve as Secretariat.

Newborn Screening Centers and reference services

Section 12 requires DOH to ensure Newborn Screening Centers are strategically located for accessibility to relevant public.
Section 12 requires centers to provide services that comply with standards approved by the Committee upon the recommendation of NIH.
Section 12 prohibits any Newborn Screening Center from operating unless duly accredited by DOH based on standards set forth by the Committee.
Section 12 requires, at minimum, that each Newborn Screening Center have a certified laboratory performing all tests included in the newborn screening program.
Section 12 requires at minimum recall/follow-up programs for infants found positive of any and all heritable conditions.
Section 12 requires centers to be supervised and staffed by trained personnel duly qualified by NIH.
Section 12 requires centers to submit to periodic announced or unannounced inspections by the Reference Center to evaluate and ensure quality performance.
Section 13 requires NIH to establish a Newborn Screening Reference Center responsible for national testing database and case registries, training, technical assistance, and continuing education for laboratory staff in all Newborn Screening Centers.
Section 14 requires the Reference Center to draft and ensure good laboratory practice standards for newborn screening centers, including an external laboratory proficiency testing and certification program.
Section 14 requires the Reference Center to act as principal repository of technical information relating to newborn screening standards and practices and to provide technical assistance to centers needing it.
Section 15 requires all Newborn Screening Centers to coordinate with the Reference Center for consolidation of patient databases.
Section 15 requires the Reference Center to maintain a national database of patients tested and a registry for each condition.
Section 15 requires the Reference Center to submit reports annually to the Committee and DOH on status and relevant health information derived from the database.
Section 15 requires NIH, in consultation with the Advisory Committee, to develop within one (1) year of passage a plan for long-term outcome evaluation using the case registries.
Section 15 requires implementation of the long-term outcome plan to become the responsibility of the Advisory Committee on Newborn Screening.

Fees, PHIC coverage, and fee allocation

Section 16 requires PHIC to include cost of newborn screening in its benefits package.
Section 16 applies the newborn screening fee to testing costs, education, sample transport, follow-up, and reasonable overhead expenses.
Section 16 requires the newborn screening fee to be divided and set aside to ensure sustainability of the National System for Newborn Screening.
Section 16 allocates at least four percent (4%) to the DOH’s Centers for Health Development (or its future equivalent) for follow-up services, education, and other activities directly related to provision of newborn screening services.
Section 16 allocates at least four percent (4%) to Newborn Screening Centers for human resource development and equipment maintenance and upgrading.
Section 16 allocates at least four percent (4%) to the NIH Newborn Screening Reference Center for overall supervision, training and continuing education, maintenance of the national database, quality assurance program, and monitoring of the national program.
Section 16 allocates the balance for operational and other expenses of the Newborn Screening Center.

Final provisions: repeal and separability

Section 17 provides that all general and special laws, decrees, executive orders, proclamations, and administrative regulations, or parts thereof, inconsistent with the Act are repealed or modified accordingly.
Section 18 provides separability: unconstitutional or invalid parts do not affect other provisions, which continue in full force and effect.