Senators question vaccine ‘monopoly’: ‘Do you want to play God?‘

MANILA, Philippines — “Do you want to play God?”

That question by Senate Minority Leader Franklin Drilon hit officials in charge of the coronavirus vaccination program hard on Monday as senators pressed them to explain vaccine procurement bottlenecks, including why the government appeared to be bent on cornering the acquisition of COVID-19 shots.

The senators, in a show of unity, wondered what was stopping the cash-strapped national government from allowing private companies and local governments to take up the slack so the Philippines could catch up with its Southeast Asian neighbors in the race to get their shares of the fast-diminishing global supply of vaccines.

The discussion turned heated at certain points, but the senators were near unanimous in questioning what they described as a virtual government monopoly in vaccine procurement.

Red tape

“Why does the national government want to monopolize the purchase [of the vaccines]? Why not just let [local governments] and the private sector do their own purchases?” Senate President Pro Tempore Ralph Recto said during the inquiry of the Senate committee of the whole.

“If this is truly a whole-of-nation approach, why not let the private sector, if they are willing to pay … to do their own importation, or the [local governments] for that matter?” he said.

Recto was following up on a point raised by Sen. Panfilo Lacson, who cited various cases of bureaucratic red tape in the Philippines, including a botched deal between unidentified local governments and the UK pharmaceutical company AstraZeneca that he said should have been coursed through the Go Negosyo entrepreneurial group.

“My question is, why is [the] government making it difficult for the private sector to just do it themselves?” Lacson asked. At present, only the national government is authorized to negotiate with pharmaceutical companies, including Pfizer of the United States, AstraZeneca and China’s Sinovac and Sinopharm, for COVID-19 vaccines.

Wealthier local governments that wish to buy vaccines on their own are compelled to sign a tripartite agreement with the national government and the supplier, which is required to secure an emergency use authorization from the Food and Drug Administration (FDA).

The same mechanism has been approved for private companies that may want to have their employees vaccinated. But the need for government intervention in such deals, Recto said, is just “a regulatory issue.”

“We are imposing it upon ourselves. Why not let the private sector, at their own risk—everyone will sign waivers anyway—why not let private hospitals, for example, be able to import for themselves, the brand of vaccine they want, say, the one with the highest efficacy?” he said.

Not good for public policy

Drilon said the main issue was “why the national government would want to impose this rule that will give birth to a monopoly, which is not good for public policy.”

FDA Director General Eric Domingo, however, argued that none of the pharmaceutical companies is ready to have its vaccine registered for commercial distribution, and the authorization it has obtained is only for emergency use. He said the standard set by the government for “safe and effective” vaccine was “in the context of the emergency” and, thus, commercial release of the vaccine was not possible at this time.

“If we roll it out, that goes hand in hand with the fact that we will be observing it very closely,” Domingo said. “Mr. Undersecretary, do you want to play God?” Drilon asked. Domingo replied: “No, we just have to watch closely the people we’ll be vaccinating.”

“No company anywhere in the world will go to the [local government] or to the private sector,” said the vaccine program’s chief, Carlito Galvez Jr., who is also chief implementer of the National Task Force Against COVID-19.

Local governments are allowed to import but only with the imprimatur of the national government as pharmaceutical companies have limitations in direct procurement, Interior Undersecretary Epimaco Densing III added. “What law says that?” Recto asked.

“That’s why we’re here today. We’re talking of a strategy. So if you tell us … should we allow [the] private sector to import vaccines themselves? What is the downside to allowing the private sector to procure by themselves?” he said.

Densing replied: “Since the vaccine is under emergency use, its safety and efficacy is not established.” To which an exasperated Recto answered: “The only difference is you only want to be the one to buy.” He said there was no actual difference between the government, which intended to buy 148 million doses of COVID-19 vaccines in the next few months, and local governments or private companies buying the vaccine, since all would be incurring the same risk.

Vince Dizon, deputy chief implementer of the government’s COVID-19 response, said he agreed that the government should have a partnership with local governments and the private sector to effectively roll out the vaccines.

“[O]nly the Philippines … has a mechanism to deal with the private sector and [local governments],” he said. “In countries around the world, it’s all government-to-government transactions.”

Dizon echoed the other officials’ argument that no vaccine maker would agree to direct procurement deals with a private company or a local government.

But Drilon said that was not the government’s concern. “We have to fix our own internal regulatory regime … If the supplier does not want to deal with us, then that’s on them,” he said. Senate President Vicente Sotto III chimed in with a hypothetical: “What if they (pharmaceuticals) agree?”

Dizon then reverted to the argument that the FDA “cannot give commercial authority to sell because it has yet to successfully complete Phase 3 trials.”

Phase 3 trials completed

But Rabindra Abeyasinghe, the World Health Organization representative to the Philippines, said a number of pharmaceuticals had in fact already completed Phase 3 clinical trials, among them Pfizer, Moderna and AstraZeneca.

Galvez told the senators that the government was trying to negotiate with the pharmaceutical companies for a “fair share” of the remaining 20 percent of the global supply of COVID-19 vaccines, 80 percent of which had already been secured by wealthy countries.

The government, he said, aims to inoculate 50 million to 70 million Filipinos using the 148 million doses of vaccines it expects to obtain from seven pharmaceutical companies.

Galvez said front-line health workers, soldiers and policemen, and essential workers would be given priority in the vaccinations, but all Filipinos would have access to vaccines “without exception.” “To sum it up,” he said, the vaccine program “aims to save more lives, [heal] our economy and restore [normality] to the lives of the Filipino people by 2023.”

More than 80 percent of the government’s P85.2 billion funding for its massive vaccination program this year, or about P70 billion, will be sourced from foreign and domestic loans, Galvez said.

Logistics and other supplies will be funded with P2.5 billion lodged in the 2021 budget of the Department of Health and P10 billion in unspent funds in the second Bayanihan law, he said. The initial rollout of vaccines and clinical trials of vaccines from the COVAX program of the World Health Organization (WHO) are expected in February, he added.

COVAX is a global collaboration that aims to “accelerate the development and production of COVID-19 tests, treatments, and vaccines” and “guarantee fair and equitable access for every country in the world,” according to the WHO website.

“This (COVAX) clinical trial involving 15,000 doses of vaccine will serve as a mini rollout and dress rehearsal for our immunization program,” Galvez said. Vaccine sources

He said the Philippines was negotiating to acquire vaccines from AstraZeneca of the United Kingdom, Gamaleya Research Institute of Russia, Johnson & Johnson, Moderna and Pfizer of the United States, Novavax Serum Institute of India and Sinovac of China.

AstraZeneca, he said, has committed to supply the Philippines with 20 million to 30 million doses of its vaccine, while Novavax has pledged 30 million doses by July this year. The Indian company has also allotted an additional 30 million doses for the Philippines that can be requested for local governments and the private sector, Galvez said. —WITH A REPORT FROM MELVIN GASCON INQ