EVEN as the Senate Blue Ribbon Committee chairman’s report recommending the prosecution of former President Benigno S. Aquino III and other officials in the previous administration over the Dengvaxia scandal awaits plenary verdict, senators are already eyeing remedial legislation arising from the inquiry.
High on the list of recommendations ensuing from the joint inquiry by the Blue Ribbon panel chaired by Sen. Richard J. Gordon and the Senate Committee on Health chaired by Sen. Joseph Victor G. Ejercito is a proposal to promptly pass an enabling law separating the Food and Drug Administration (FDA) from the Department of Health (DOH).
“The [Blue Ribbon-Health] hearings also revealed the need to provide for an FDA independent of, and autonomous from, the DOH. This is the purpose of Senate Bill [SB] 1631 that I filed,” Ejercito told the BusinessMirror.
The bill is titled “An Act instituting Food and Drug Administration as an independent agency and separate from the Department of Health, amending certain sections of Republic Act [RA] 3720, as amended by RA 9711, and for other purposes.”
It has been read on first reading and referred to the Committees on Civil Service, Government Reorganization and Professional Regulation; and Health and Demography.
The setup between the DOH and the FDA came to the fore in the course of the inquiry after it was learned that at a crucial point in the processing of the Dengvaxia vaccine program, then-Health Secretary Janette L. Garin assumed the helm at the FDA, thus, effectively short-circuiting the envisioned independence of the FDA as a regulatory body with a big say in clearing pharmaceutical products for public use. When Garin was meeting with Sanofi oficials, the FDA had not yet cleared Dengvaxia for use in the Philippines.
Garin’s assumption of the FDA post raised the Senate probers’ eyebrows during the hearings, as the timeline of Dengvaxia-related events had indicated her active role in pushing the vaccine program—visiting the Sanofi vaccine facility in France, meeting with Sanofi officials, briefing Aquino on the details of the impending program, working closely with then-Budget Secretary Florencio B. Abad and giving instructions to the head of the Philippine Children’s Medical Center (PCMC), which was used as the spending conduit for the P3.5-billion Dengvaxia procurement.
Also during the hearings, Garin’s successor, Dr. Paulyn Jean B. Ubial, had admitted she had come under pressure from politicians so she would sign the expanded phase of the Dengvaxia vaccination when she took office under the Duterte administration. She named Garin’s congressman-husband among those prodding her on Dengvaxia, but Garin has strongly denied her husband or family exerted such pressure for political or financial gain.
In the chairman’s report, Gordon listed Abad and Garin for a possible graft prosecution, together with Aquino. The former President is liable, according to the chairman’s report, for having provided the political push and the approvals for using savings—an unprecedentedly huge P3.5 billion—to fund the vaccination of 800,000 schoolchildren.
The Dengvaxia controversy began in late-November 2017, when Sanofi issued a bulletin acknowledging that further assessments showed injection with the vaccine in seronegative persons (those who never had dengue before) could put them at risk of severe dengue when they contract the dreaded mosquito-borne disease, even though it has so far been deemed effective for preventing further or repeat infections among those who previously contracted dengue (the seropositives). Unfortunately, as the Senate hearings showed, no effort was done, neither by the DOH nor Sanofi, to first distinguish the seropositives from seronegatives before rushing to vaccinate.
Charter prohibits double posts for Cabinet
With respect to the remedial legislation proposed in Ejercito’s SB 1631, the Blue Ribbon chairman’s report explicitly tagged Garin’s assumption of the FDA post concurrently with her wearing the DOH hat as a blatant violation of the Constitution. Aquino is equally liable for allowing Garin to violate this Charter prohibition, per Gordon: “Aquino allowed Garin to designate herself as FDA head, in violation of Section 13, Article VII of the 1987 Constitution, which prohibits ‘The president, vice president, the members of the Cabinet, and their deputies or assistants’ from holding any other office or employment during their tenure unless otherwise provided in the Constitution.”
According to Gordon’s report, Garin “completely disregarded the eight conditionalities recommended by the Formulary Executive Council [FEC] before an exemption from the Philippine National Drug Formulary [PNDF] is granted to Dengvaxia,” and one of these is the requirement that there must have been “[iii] an FDA-approved risk-management plan from Sanofi-Pasteur.” In the eyes of Senate probers, circumventing such requirement became possible because Garin herself assumed the FDA top post.
Worse, at the time of Aquino’s meeting with Sanofi executives in Paris in late-2015, the FDA had not licensed Dengvaxia for use in the country. Gordon’s report made this clear when it noted the supposed “additional 34-percent discount” that Garin claimed, in a TV interview, as having been wangled when the former president visited Paris and met Sanofi executives. “That could only be reached through a negotiation, through a tawaran. The president cannot negotiate a commercial transaction. Additionally, how can he negotiate for the supply of a drug that was not even a part of the National Drug Formulary, much less licensed by the FDA for use in the Philippines?” the chairman’s report asked.
The Constitution, stressed the Blue Ribbon Chairman’s Report, expressly prohibits members of the Cabinet from holding “any other office or employment during their tenure” (Section 13, Article VII, 1987 Constitution).
It cited further the case of Civil Liberties Union v. Executive Secretary (G.R. 83896, 22 February 1991), where the Supreme Court (SC) clarified that, “[…] while all other appointive officials in the civil service are allowed to hold other office or employment in the government during their tenure when such is allowed by law or by the primary functions of their positions, members of the Cabinet, their deputies and assistants, may do so only when expressly authorized by the Constitution itself.”
This meant, Gordon added—a veteran litigation lawyer before turning to politics—the SC mandated a “literal interpretation” of the exemption “to refer only to those particular instances cited in the Constitution itself, to wit: the vice president being appointed as a member of the Cabinet under Section 3, paragraph [2], Article VII; or acting as president in those instances provided under Section 7, paragraphs [2] and [3], Article VII; and, the secretary of Justice being ex-officio member of the Judicial and Bar Council by virtue of Section 8 [1], Article VIII.”
To be sure, Gordon said, “no provision in the Constitution provides and allows the secretary of health to concurrently be director general of the FDA. Garin appointing herself as FDA director general is clearly in blatant violation of the constitutional prohibition provided for in Section 13 of Article VII.”
Garin, per the report, following the timeline established in the Senate hearings, “would later relinquish her position as FDA head only when she was sure that her successor, Ma. Lourdes Santiago, would thereafter grant a license to Sanofi-Pasteur for Dengvaxia, through Melody Zamudio.”
Ejercito hopes that with his SB 1631, the recurrence of a similar ano-maly will be clearly rendered impossible, for the sake of public health.
Fund for Dengvaxia victims
Meanwhile, another legislation senators are pushing pertains to ensuring there are sustainable funds to take care of seronegatives who may subsequently fall ill as a result of being stricken with severe dengue after being injected with Dengvaxia.
“We need to do more to provide assistance to the victims. That is why I filed the Dengvaxia assistance program bill so we can monitor and address the needs of those victimized by this scandal,” Ejercito said in a statement last week. “I am calling on our government to help our people to initiate a class suit against Sanofi. Legal action should also be taken by the Philippine government against Sanofi toward the establishment of an indemnity fund for children who were vaccinated to provide them with financial assistance for medical care throughout their lifetimes.”
Ejercito agreed with Gordon’s report in prosecuting Abad and Garin, but disagreed that Aquino should be prosecuted for graft. “PNoy [Aquino] should have exercised more prudence and oversight instead of allowing Garin and Abad to proceed with the purchase of the controversial vaccine. That is a failure of leadership that should hound his conscience and legacy.
“Nonetheless, Ejercito stressed that the Senate hearings clearly showed Garin and Abad “are the principal conspirators in the anomalous procurement and questionable implementation of the vaccine.
Secretary Garin was the one who recommended the purchase of the P3.5-billion untested vaccine. The purchase was pushed, despite the fact that the clinical trials were not yet finished and ignored the warnings by some experts as to its dangers.”
Abad, on the other hand, “facilitated, recommended and approved the release of the money without congressional approval in amazing record time, and during a holiday period at that,” Ejercito noted.
Dengvaxia report a cover-up: LP legislators
Liberal Party (LP) stalwarts, while posing no objections to the proposed legislation for ensuring the FDA’s independence and providing some fund to take care of victims, have described Gordon’s chairman’s report as one meant to divert public attention from crucial issues hounding the Duterte administration.
“This is simply a smoke screen of the administration to hide the issues hounding its officials,” said former Rep. Erin R.Tañada III, now LP vice president for external affairs.
“Why was the committee report released to the public before it has been filed or sponsored? Are not the signatures of majority of the committee members required before the report can be filed?” Tañada wondered aloud.
“What happens to the report if the majority disagrees? There are no signatures yet,” he added. Over the weekend, Gordon said he was sure of getting at least 10 signatures, more than the majority required of 17 Blue Ribbon members.
Tañada said the release coincided with the impending closure of Boracay Island, the President’s order to the House to hasten the impeachment process against Chief Justice Maria Lourdes A. Sereno, and the rising prices of goods and services. Rep. Teddy B. Baguilat Jr. of Ifugao doubted the fairness of Gordon’s report, saying it focused mainly on the past administration, but did not dwell on the current government, even though the vaccination was continued under the Duterte administration, during Ubial’s tenure.