Is the vaccine roll-out legal even without public bidding and years of clinical trial?

By Atty. Eduardo T. Reyes III

With only a measly 3 million people fully vaccinated as of last week’s update from the NTF adviser when the target is 50 million, unmasking as well as the ditching of face shields are still a long way to go in so far as the Philippines is concerned.

With Covid-19 mutating into deadlier variants and waves of the pandemic rushing to South-East Asian countries’ shores, the inoculations must be hastened in order to avert a health crisis that India had just endured and is now Indonesia’s ordeal.

Indeed, desperate times call for desperate measures. However, it is no less true that “haste makes waste”. In the procurement of Covid-19 vaccines,  striking a balance between these two aphorisms is primordial.

Paranoia about the efficaciousness of the vaccines being administered through the LGUs is prevalent. The fear is not totally unfounded given that this columnist was able to talk to some seasoned medical professionals and they had confirmed that the usual vaccine undergoes several stages of clinical trials which usually span a decade or longer.  By contrast, the Covid-19 vaccines being currently rolled-out had been under clinical study for only less than 2 years. As a matter of fact, death or other serious adverse side effects have been reported in reference to people who had just received their jabs although it is unclear if these were caused by the vaccines.

With this factual backdrop in mind, can the President through the Department of Health (DOH) in particular, be compelled through court action, to conduct a competitive public bidding pursuant to Republic Act No. 9184 or the Government Procurement Law, and to conduct competent clinical trials first before the vaccines are rolled-out en masse?

The court action where a person is seeking an order to compel a government office or official to perform a mandatory duty is known as “Mandamus”. Case law holds that “Mandamus, lies to compel the performance, when refused, of a ministerial duty, but not to compel the performance of a discretionary duty. A purely ministerial act or duty is one which an officer or tribunal performs in a given state of facts, in a prescribed manner, in obedience to the mandate of a legal authority, without regard to or the exercise of his own judgment upon the propriety or impropriety of the act done. The duty is ministerial only when the discharge of the same requires neither the exercise of official discretion or judgment. When an official is required and authorized to do a prescribed act upon a prescribed contingency, his functions are ministerial only, and mandamus may be issued to control his action upon the happening of the contingency.  

For a writ of mandamus to be issued, it is essential that petitioner should have a clear legal right to the thing demanded and it must be the imperative duty of the respondent to perform the act required. The writ neither confers powers nor imposes duties. It is simply a command to exercise a power already possessed and to perform a duty already imposed. Mandamus applies as a remedy only where petitioner’s right is founded clearly in law and not when it is doubtful. The writ will not be granted where its issuance would be unavailing, nugatory; or useless. (Citations omitted) (Pedrito M. Nepomuceno, Former Mayor-Boac, Marinduque v. President Rodrigo R. Duterte, et al.,UDK No. 16838. May 11, 2021).

But mandamus is only available when the duty is ministerial or one which is not reliant on the public officer’s sound discretion. Because if it is, then mandamus cannot be availed to compel the public officer to perform an act. Still in the recent case of Pedrito M. Nepomuceno, it was held that “Discretion”, when applied to public functionaries, means a power or right conferred upon them by law or acting officially, under certain circumstances, uncontrolled by the judgment or conscience of others. A purely ministerial act or duty in contradiction to a discretionary act is one which an officer or tribunal performs in a given state of facts, in a prescribed manner, in obedience to the mandate of a legal authority, without regard to or the exercise of his own judgment upon the propriety or impropriety of the act done. If the law imposes a duty upon a public officer and gives him the right to decide how or when the duty shall be performed, such duty is discretionary and not ministerial. The duty is ministerial only when the discharge of the same requires neither the exercise of official discretion or judgment.”

The pandemic that Covid-19 had caused to the world in 2020 – which persists until today- can be deemed as unprecedented. This is because in terms of gravity, incurability and morbidity, not even the Spanish flu of the 1920’s can come close. To address this dire situation we are in, as held in Pedrito M. Nepomuceno, Congress passed Republic Act No. 11494  which delegated the authority to the President to exercise “discretion” on two (2) very important matters: (1) the emergency use of vaccines without public bidding; and, (2) the immediate use of the vaccines even without a full-blown clinical trial. Thus:

“The grant of discretion in favor of the President with respect to the manner of performing his duty to address the pandemic brought about by the spread of COVID-19 is fortified by the enactment of Republic Act No. 11494 (R.A. 11494). The law paved the way for President Duterte to exercise powers that are necessary and proper to undertake and implement COVID-19 response and recovery interventions. 10 Pertinent provisions of R.A. 11494 read as follows:

Sec. 4. COVID-19 Response and Recovery Interventions. -Pursuant to Article IV, Section 23(2) of the Constitution, the President is hereby authorized to exercise powers that are necessary and proper to undertake and implement the following COVID-19 response and recovery interventions:

 

(a) x x x 

Sec. 12. Procurement of COVID-19 Drugs and Vaccine. – Notwithstanding any law to the contrary, the requirement of Phase IV trials for COVID-19 medication and vaccine stipulated in the Universal Health Care Law is hereby waived to expedite the procurement of said medication and vaccine: Provided, That these are recommended and approved by the WHO and/or other internationally recognized health agencies; xxxx  

Section 1. Emergency Use Authorization for COVID-19 Drugs and Vaccines. The Director-General of the FDA is hereby authorized to issue an Emergency Use Authorization (EUA), subject to conditions provided in this Order.

Outside clinical trials and except in cases where a Compassionate Special Permit is issued, no unregistered COVID-19 drug and vaccine may be manufactured, sold, imported, exported, distributed or transferred without an EUA.”

            Subsequently, as a follow through to Republic Act No. 11494,  another law was passed (Republic Act No. 11525 (R.A. 11525), or the “COVID-19 Vaccination Program Act of 2021)  which was signed into law on February 26, 2021 which exempted altogether the use of Covid-19 vaccines from prior Phase IV clinical trials.

On this score, the Supreme Court had deferred to the wisdom of the law and exercised restraint by refusing to accrete unto itself the power which the law had clearly bestowed on the President. It held that “As the judicial branch of the government tasked to interpret laws, settle actual controversies, and keep every government office within the scope of their authority, it is not within the office of the Court to go beyond what the law requires, including those involving the procurement of COVID-19 vaccines. As the law has expressly excluded the conduct of clinical trials and exempted its procurement from the general rules of the bidding process, the Court cannot step in to add another layer of requirement before the procurement of COVID-19 vaccines, and their use, specifically those granted with EUA”.

(Pedrito M. Nepomuceno, Former Mayor-Boac, Marinduque v. President Rodrigo R. Duterte, et al.,UDK No. 16838. May 11, 2021).

Indeed, under the rule of law, the Stately powers are either exercised complementarily among the three branches (ie., the Executive, Legislative and Judicial departments), or by way of check and balance. But to be sure, in this most volatile or precarious time, the people are looking to their government to do what is best for them and save them from the deathly claws of a monstrous virus the world seems hard-pressed to vanquish.

 

(Atty. Reyes III is the senior partner of ET Reyes III & Associates– a law firm based in Iloilo City. He is a litigation attorney, a law professor and a book author. His website is etriiilaw.com).