Senators question nat’l gov’t 'monopoly' on procurement of COVID-19 vaccine

Several senators on Monday questioned why the Food and Drug Administration (FDA) was "monopolizing" the process for COVID-19 vaccine procurement in the Philippines.

"It would appear na parang monopolized ng national government ang pagbili ng bakuna. Eh kaya naman ng pribado na bumili din para sa kanilang mga empleyado, katulad ng ibang LGU... So, bakit 'di natin payagan? Why leave it all to the national government?" Senate President Pro Tempore Ralph Recto said during the hearing.

"It's just a regulatory issue. We are imposing it upon ourselves... Why not just allow the private to [buy] at their own risk? Lahat ng taong babakunahan natin pipirma din naman eh," he added.

He further said the private sector should also be allowed to freely choose the vaccine they deemed to be with the highest effectivity rate.

“We are talking about a strategy, a plan. If you tell us there is a deficiency in the law, then we can amend the law quickly. That’s the purpose of our meeting, right? So tell us where are the bottlenecks,” he said.

FDA director general Eric Domingo reiterated that the emergency use authorization (EUA) that will be issued for the COVID-19 vaccines is not a market authorization.

"'Yung company mismo na magma-manufacture hindi pa po siya magpapa-register. Di pa sila ready na magpa-register ng kanilang produkto for commercial distribution and for use of the general public. Ang data nila is enough lang po para humingi ng emergency use authority," Domingo said.

Vaccine czar Secretary Carlito Galvez Jr. supported FDA's position and said no company will approach the private sector directly because dealing with the national government is the global practice when it comes to the vaccine for the novel disease.

Senate Minority Leader Franklin Drilon, meanwhile, agreed with Recto and said the country's internal regulatory regime must be fixed.

"Right now there appears to be a stumbling block... Even if the private sector would want to deal with the manufacturer and for some reason or another the manufacturer would want to deal with them, they cannot do so because of this regulatory stumbling block," Drilon said.

"Allow and authorize not only the private sector but also the LGUs to be able to deal directly with the supplier. If the supplier would not want to deal with us, that's another matter, we don't have control over that," he added.

National Task Force Against COVID-19 deputy implementer Vince Dizon said the FDA regulatory rules can be amended by lawmakers, if necessary.

"If we can find a way to amend via legislation then I think this is possible," Dizon said.

Senate Majority Leader Juan Miguel Zubiri pointed out that he already introduced a provision for such in Section 12 of the Bayanihan to Recover as One Act or Bayanihan 2.

"Nothing in this Act shall prohibit private entities from conducting research, developing, manufacturing, importing, distributing, or selling COVID-19 vaccine sourced from registered pharmaceutical companies, subject to the provisions of this Act and existing laws, rules and regulations," Zubiri said.

Senator Pia Cayetano, on the other hand, stressed  that this Section 12 specified that only the Phase 4 trial is waived.

"Pero right now, 'yung Phase 3 nga hindi natapos. That's the situation that I believe IATF and FDA find themselves in," she said. "We gave them exemption for Phase 4 pero ang Phase 3 di pa nga tapos all over the world."

"Absent any law, or any new amendment with this existing Bayanihan 2, gumawa ngayon ng emergency use regulation ang FDA... The point is wala siyang legal coverage to allow the product to be released in public," she added, noting that this can further be discussed by the FDA and lawmakers.

The Philippine government plans to inoculate 50 to 70 million individuals within the year and the earliest possible arrival of COVID-19 vaccines may happen by February 20, according to Galvez.—AOL, GMA News