Case Summary (G.R. No. 235891)
Background of the Dengvaxia Program
Sanofi’s tetravalent dengue vaccine, Dengvaxia, was approved by the FDA shortly after DOH Secretary Garin endorsed procurement of 3 million doses. The DOH secured a ₱3.5 billion Special Allotment Release Order and coordinated with the DILG for a school-based vaccination campaign in NCR, Regions III and IV-A. After initial rollout in early 2016, safety concerns prompted a suspension in July and subsequent expansion to Cebu. In November 2017, Sanofi issued new guidance restricting use only to those with prior dengue infection. The DOH and FDA suspended the program and distribution on December 1, 2017.
Petition and Procedural History
Petitioners filed a direct petition for continuing mandamus before the Supreme Court in December 2017, alleging violation of the constitutional right to health and accusing the DOH of using children as experimental “guinea pigs.” Respondents filed comments and the parties exchanged memoranda following the Court’s February 18, 2020 resolution. Petitioners sought orders compelling regular public reporting, further safety studies, central registry creation, and provision of free medical services and monitoring for all vaccinees.
Legal Standing and Doctrine of Hierarchy
The Court affirmed that the inoculated children have direct injury-in-fact thus sufficient standing. Private-citizen and legislator petitioners must still demonstrate specific injury beyond general public interest. The Court held that direct invocation of the Supreme Court’s original jurisdiction over mandamus is disfavored under the hierarchy of courts and requires exceptional, purely legal questions. Petitioners’ pleadings involved contested facts and administrative discretion, fitting lower courts’ competency and precluding direct Supreme Court relief.
Separation of Powers and Mandamus Limits
The Executive exercises health policy and program implementation under the Administrative Code, DepEd law and Local Government Code. The Judiciary cannot invade the Executive’s discretionary domain except upon clear grave abuse of discretion or lack of jurisdiction. Mandamus compels only ministerial duties clearly enjoined by law; it cannot direct agencies how to exercise expert judgment or supervise ongoing program administration.
Continuing Mandamus Requirements
Under Rule 8 of the Environmental Cases Rules, continuing mandamus lies only for enforcement of environmental laws or rights, requiring:
(a) unlawful neglect of a legally-enjoined duty;
(b) nexus to environmental law, rule or right;
(c) no other plain, speedy, adequate remedy; and
(d) factual showing of irreparable harm and specific, measurable, time-bound objec
Case Syllabus (G.R. No. 235891)
Facts
- In December 2015, President Benigno C. Aquino III and DOH Secretary Janette P. Garin met Sanofi Pasteur officials in Paris to discuss Dengvaxia, then anticipated as the first dengue vaccine.
- Garin proposed the procurement of 3 million doses; the FDA approved Dengvaxia shortly thereafter and the Department of Budget and Management released a ₱3.5 billion allotment for its purchase.
- The DOH Family Health Office secured an exemption from the Philippine National Formulary requirement for government procurement; the Philippine Children’s Medical Center procured 600,000 vials through Zuellig Pharma.
- Through DOH and DILG memoranda, a school-based dengue vaccination program commenced in NCR, Region III, and Region IV-A, targeting all elementary students nine years and older.
- In July 2016, DOH Secretary Paulyn S. Ubial suspended the program over safety concerns but soon lifted the suspension and expanded coverage to Cebu due to high dengue incidence.
- Emerging studies on adverse effects prompted Congressional inquiries into the vaccine’s safety, efficacy, and procurement.
- In November 2017, Sanofi Pasteur issued an advisory that Dengvaxia is beneficial only for those with prior dengue infection and may cause severe disease in dengue-naïve recipients.
- On December 1, 2017, Secretary Duque suspended the vaccination program; the FDA followed by suspending sale, marketing, and distribution of Dengvaxia.
- In December 2017, 74 children inoculated with Dengvaxia (represented by their parents), together with other citizens, taxpayers, and legislators, filed a petition for continuing mandamus directly with the Supreme Court, alleging respondents neglected to protect their constitutional right to health and were treated as “guinea pigs.”
Procedural History
- Petitioners invoked the Supreme Court’s original jurisdiction under Rule 65 seeking a writ of continuing mandamus against DOH, FDA, DepEd, and DILG officials.
- Respondents filed their Comment;