AN ACT PROMULGATING A COMPREHENSIVE POLICY AND A NATIONAL SYSTEM FOR ENSURING NEWBORN SCREENING

Case Overview and Summary

Summary of the Newborn Screening Act of 2004 (Republic Act No. 9288)

General Provisions
- Declares the policy of the State to protect and promote the right to health, including the rights of children to survival and full development. (Section 2)
- Aims to institutionalize a national newborn screening system that is comprehensive, integrative, and sustainable. (Section 2)
- Objectives include ensuring access to newborn screening, establishing a sustainable system, educating health practitioners, and ensuring parental responsibility. (Section 3)

Definition of Terms
- Defines key terms such as "comprehensive newborn screening system", "follow-up", "health institutions", "healthcare practitioner", "heritable condition", "newborn", "newborn screening", "newborn screening center", "newborn screening reference center", "parent education", "recall", and "treatment". (Section 4)

Newborn Screening
- Health practitioners must inform parents about the availability, nature, and benefits of newborn screening before delivery. (Section 5)
- Newborn screening must be performed within 24-72 hours after delivery, or within 7 days for newborns in intensive care. (Section 6)
- Parents may refuse testing on religious grounds but must acknowledge the risk in writing. (Section 7)
- The Department of Health (DOH) must conduct continuing education and training programs for health personnel on newborn screening. (Section 8)
- Health institutions must provide newborn screening services as a condition for licensure or accreditation. (Section 9)

Implementation
- The DOH is the lead agency for implementing the Act. (Section 10)
- An Advisory Committee on Newborn Screening is established within the DOH to review conditions, fees, and quality assurance. (Section 11)
- The DOH must ensure the establishment and accreditation of Newborn Screening Centers that meet standards. (Section 12)
- The National Institute of Health (NIH) must establish a Newborn Screening Reference Center for training, technical assistance, and maintaining a national database. (Section 13)
- The NIH Reference Center is responsible for quality assurance, including laboratory proficiency testing and certification. (Section 14)
- Newborn Screening Centers must coordinate with the NIH Reference Center for consolidating patient databases. (Section 15)
- The Philippine Health Insurance Corporation (PHIC) must include the cost of newborn screening in its benefits package. The newborn screening fee is divided for various purposes, including follow-up services, education, human resource development, equipment maintenance, and operational expenses. (Section 16)

Final Provisions
- Repeals inconsistent laws and regulations. (Section 17)
- Separability clause. (Section 18)
- Effectivity clause. (Section 19)