UDK No. 16838 - Nepomuceno vs. Duterte

Pedrito M. Nepomuceno, former mayor of Boac, Marinduque, filed a petition for a writ of mandamus.
The petition seeks to compel respondents to strictly follow the Food and Drug Administration (FDA) rules on the acquisition, procurement, and use of drugs, with a specific focus on COVID-19 vaccines.
Petitioner challenges the procurement, trial, and use of the Sinovac vaccine in light of reported doubts about its efficacy and the absence of conclusive clinical trial data in the Philippines.

President Rodrigo R. Duterte (dropped from the suit due to constitutional immunity as an incumbent).
Secretary Francisco Duque of the Department of Health (DOH).
Gen. Carlito Galvez Jr. [Retired], Chief Implementer of the National Task Force against COVID-19.

The petition alleges that despite prevailing doubts regarding the efficacy of the Sinovac vaccine, and insufficient studies on its performance against COVID-19, the national government planned to procure and use it to control the virus spread.
Petitioner further requested that the DOH-FDA issue a Cease-and-Desist Order for the procurement and use of the Sinovac vaccine, insisting that all COVID-19 vaccines undergo requisite clinical trials in the Philippines prior to their emergency or regular use.
The underlying concern stems from the alleged neglect of statutory and regulatory mandates particularly involving the conduct of clinical trials and observance of the public bidding requirement in line with procurement law.

Based on settled jurisprudence, the President is immune from suit during his tenure.
The petition was noted to be improperly invoking President Duterte as a respondent, since judicial precedents prevent lawsuits against an incumbent President to avoid distracting him from discharging his official duties.
The Court cited prior decisions, such as De Lima v. President Duterte and Rubrico v. Macapagal-Arroyo, to reaffirm the principle of presidential immunity.

Various legislative measures and executive orders provided the government with wide discretion in addressing the pandemic:

Republic Act No. 11494 (Bayanihan to Recover as One Act) empowered the President to undertake necessary COVID-19 response interventions while suspending some regulatory requirements (e.g., Phase IV clinical trials).
Executive Order No. 121 granted the Food and Drug Administration the authority to issue an Emergency Use Authorization (EUA) for drugs and vaccines without the complete set of typical clinical trial data.
Republic Act No. 11525 (COVID-19 Vaccination Program Act of 2021) exempted the procurement of COVID-19 vaccines from the usual public bidding process, allowing negotiated procurement in emergency cases.

Petitioner asserted that respondents had a ministerial duty, mandated by law, to adhere strictly to standard FDA protocols on vaccine trial and procurement.
However, the petitioner’s argument was undermined by the existence of legal provisions and suspensions that granted the executive considerable discretion in the procurement process amidst the pandemic crisis.

Whether the inclusion of President Duterte as a respondent is proper given the doctrine of presidential immunity.
Whether the petitioner has identified a ministerial duty on the part of the respondents that was allegedly neglected.

Whether there is a clear statutory or regulatory mandate compelling the respondents to conduct clinical trials and procure vaccines strictly through public bidding.
Whether the government’s exercise of discretion under emergencies (as provided in RA No. 11494, RA No. 11525, and EO No. 121) precludes the performance of what petitioner alleges as a ministerial duty.

Whether the petitioner’s direct resort to the Supreme Court is proper, considering the established doctrine of hierarchy of courts.
Whether the petition falls within the proper jurisdiction for mandamus, or should have been filed with a lower court (e.g., Regional Trial Court) given its factual nature.

Whether the Court is authorized to review matters involving vaccine efficacy, procurement protocols, and emergency measures that involve technical and policy decisions.
Whether the issues raised are matters of law, as opposed to questions of fact that are beyond the Court’s review.