Senators yesterday protested the national government's monopoly on the coronavirus vaccine and the regulatory policy of the Food and Drug Administration (FDA) in not allowing some local government units and the private sector to procure COVID-19 jabs from drug firms of their own choice.
During the Senate Committee of the Whole (COW) session, Senate President Vicente Sotto and Senators Ralph Recto, Franklin Drilon, Migz Zubiri, Cynthia Villar, Francis Tolentino, Francis Pangilinan and Pia Cayetano demanded the FDA issue Certificates of Registration instead of just Emergency Use Authority (EUA) to drug manufacturers of the coronavirus vaccines chosen by some LGUs and the private sectors for their own constituents.
However, the Department of Interior and Local Government said all LGUs are included in the national government’s COVID-19 vaccination program, whether or not they have allocated funds for the procurement of their own supply of vaccines.
“We wish to assure our countrymen that whether or not your LGU is buying vaccines, you are included in the national vaccination program. We are going to get from as many suppliers as we can. The only condition, of course, is that the Food and Drug Administration has issued it an emergency use authorization,” DILG Undersecretary Jonathan Malaya said to GMA News.
At least 61 cities in the country are aiming to buy COVID-19 vaccines for their constituents, said League of Cities of the Philippines president Mayor Evelio Leonardia of Bacolod City.
The league is talking to eight vaccine makers about the procurement, Leonardia said at a briefing, adding that the LCP is set to meet with government vaccine czar Carlito Galvez today (Tuesday).
“We already had the commitments of about 61 cities. And all together, that amounts to something like more than P10 billion. We feel that this is our chance to be contributory to the national effort to vaccinate all our people,” Leonardia said.
“That’s why we feel that this is a matter of teamwork, and we are doing our part,” the LCP chief added.
Cities in Metro Manila — Makati, Quezon City, Taguig, Caloocan, Muntinlupa, Navotas and Mandaluyong among them — are allocating as much as P1.1 billion per city to purchase vaccines under a tripartite agreement with the National Task Force on COVID-19 and their chosen drugmaker, primarily AstraZeneca.
With commercial authorization, the senators said there will be no more obstacles for drug firms to directly deal or sell the vaccines to LGUs and the private companies.
But Health Secretary Francisco Duque III and FDA Director General Eric Domingo asserted that the agency cannot issue complete authorization or commercial marketing authority because the efficacy and safety of the vaccines are not yet fully guaranteed.
They pointed out that a drug should finish Phase 3 of the clinical trials to be to be fully registered with the FDA, an attached agency of the Department of Health.
Because of this regulation, contained in an FDA circular dated December 14, 2020 which emanated from President Duterte's Executive Order on December 1, 2020, LGUs and the private sector are mandated to go through the national government before they can buy vaccines from drug firms.
Domingo also cited the need for the FDA to properly monitor Filipinos who got the coronavirus vaccines.
Recto and Drilon questioned Duque and Domingo about the downsize in not giving full authority to LGUs and the private sectors in the procurement of the vaccines.
Because the country needs 140 million doses, the Senate leaders insisted that the vaccine is considered an emergency use as it will be used by everybody.
Stressing the LGUs' choice of the vaccines, Recto attributed Filipinos' fears of getting inoculated to low quality vaccines.
"So give the best possible vaccines based on clinical trials," said Recto, as he renewed his call to let private sectors and LGUs choose their own jabs.
"I'm sure the (drug) suppliers are globally selling to the private sectors and LGUs, they're signing with LGUs and the private sectors…Why not allow them?"
He also asked the Senate's resource persons why it appears that the government is monopolizing the purchase of vaccines when the private sector and some LGUs are capable of buying their own vaccines.
To hasten the vaccination program, Recto said the government should allow private hospitals, for example, to import vaccines by themselves and freely choose the brand 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 the bottlenecks are,” he said.
Drilon also objected to the FDA policy, and rallied behind Recto's proposition to immediately fix their own internal regulatory law.
"There appears to be a stumbling block in that one cannot deal directly with the supplier – whether you are in the private sector or in the LGU. Because only the national government can deal with the manufacturer," he said.
"The point being raised is — let us fix our own internal regulatory regime. Right now, even 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. Why can we not resolve the regulatory roadblock to allow the LGUs and the private sector to be able to directly deal with the suppliers?" Drilon said.
"We should at least authorize them to be able to negotiate. Their hands are tied by this regulatory roadblock."
"The 140 million doses are not for emergency use. What is the downside? Why cannot we grant full authority? Half of our problems will be solved," Drilon added.
Sotto echoed the sentiments of Recto and Drilon and repeatedly questioned the FDA on what would happen if a drug firm entered into a deal with LGUs and the private sector without getting approval from the national government.
Villar said allowing the LGUs and the private sectors to buy their own vaccines would ease the burden of the national government.
She said the government should let those financially capable LGUs make their own procurement so that it can focus and help poor LGUs in vaccinating their constituents.
Villar said LGUs and private companies are already signing agreements with vaccine providers like AstraZeneca, Pfizer and Moderna, and that they are only waiting for the FDA approval before they could start getting their supply of vaccines.
"We should approve the use of vaccines and let LGUs and the private sector buy so that we will not be all dependent on the national government. It is really hard for the government to pay for all of that. And then the economy can go on and the adverse effects on our economy and on employment will be less; because if we wait for the third quarter, we will not be able to recover for 2021,” Villar said.
Insisting that every sector to have access to it, Zubiri said the government should not stand in the way of the private sector and LGUs to purchase vaccines for their own use which is allowed under the EUA.
"Allow everybody whatever vaccines that it already gave the EUA. Absolutely, no sense evidence safe and effective by virtue of this authorization," he added.
He also emphasized that private entities, and not only the national government, are authorized to procure COVID-19 vaccines from pharmaceutical companies under the Bayanihan Law.
Zubiri said it was included in his amendment under the Bayanihan Law.
“Nothing in this act shall prohibit private entities from conducting research, developing, manufacturing, importing, distributing or selling COVID-19 vaccines sourced from registered pharmaceutical companies, subject to the provisions of this act," he added.
Meanwhile, Sen. Imee Marcos noted the LGUs' confusion in purchasing the COVID-19 vaccines.
"Our governors and city mayors are confused because aside from the FDA requirement, there is a tripartite agreement of the Department of Health, the pharmaceutical and the LGU which they can’t figure out because there hasn’t been a template," she said.
"In addition, there is a requirement that the price has to be pegged with that of the National Task Force (NTF), which is not stated,” Marcos said.
She said the government should come out with a systematic arrangement and most importantly, determine the price to pave the way for the acquisition of the COVID-19 vaccines.
Sen. Panfilo Lacson asked vaccine czar Galvez Jr. to share with the committee the date as to when he expects the first COVID-19 vaccine would be injected.
Galvez said the vaccine is estimated to arrive in the country by February 20, 2021 and the first vaccine dose is likely to be injected between the third and fourth week of the same month.
Lacson also asked government officials involved in the country’s vaccination program why there seems to be a delay in the procurement of vaccines.
“Why can’t we respond, react, or act on the initiatives of the other parties as quickly as we sense it as an emergency?” Lacson asked.