Illegal to administer unauthorized COVID-19 vaccines, says Drilon

Senate Minority Leader Franklin Drilon, Screen grab / Senate PRIB file photo

MANILA, Philippines — Senate Minority Leader Franklin Drilon on Tuesday said it was illegal to administer unauthorized vaccines following the disclosure that some members of the Cabinet and President Rodrigo Duterte’s security personnel were inoculated against COVID-19.

In a statement, Drilon said this has “set a bad example” and “undermined the very purpose” of the creation of the Food and Drug Administration (FDA).

He pointed out that the FDA has repeatedly said that “it is illegal to import an unregistered drug, to distribute it, and for a doctor or a medical practitioner or any health personnel to administer unlicensed drugs in the country.”

“What was done completely dismissed the well-entrenched public safety and health protocols. It further undermined the regulatory authority of the FDA with regard to the inspection, licensing and monitoring of establishments, and the registration and monitoring of health products,” Drilon said.

“As government officials, our priority is the safety of our people. That is the very purpose of FDA authorization- to make sure that the vaccines that we administer to our people are safe, effective and of certain quality,” he further stressed.

The senator said that the administration of the unauthorized drug to some Cabinet members and the military “clearly violates” FDA Circular No. 2020-036 or the Guidelines on the Issuance of Emergency Use Authorization for Drugs and Vaccines for COVID-19.

The circular, he said, applies both to “pharmaceutical industry and government entities such as national procurer or health program implementors” and requires that an application for the issuance of an Emergency Use Authorization (EUA) be filed and obtained from the FDA.

The FDA has yet to grant a EUA to a candidate COVID-19 vaccine. American drugmaker Pfizer is so far the only firm to have applied for a EUA in the Philippines.

Drilon also cited Republic Act No. 3720 or the FDA law, which prohibits the “manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is adulterated, unregistered or misbranded or any health product which, although requiring registration, is not registered with the FDA pursuant to this Act.”

Under Section 21 of the law, Drilon noted that “no person shall manufacture, sell, offer for the sale or transfer any new drug, unless an application filed containing full reports of investigations to show that such drug is safe, efficacious and of good quality for use based on clinical studies, prior to manufacture, sale, importation, exportation, distribution or transfer thereof.”

He warned that any person found violating this can face a penalty of imprisonment ranging from one to 10 years or a fine of not less than P50,000 but not more than P500,000, or both.

The manufacturer, importer, or distributor face stiffer penalties of 5 to 10 years imprisonment and a fine of P500 thousand to P5 million, Drilon further said.

“I hope this does not give us a glimpse of how they intend to implement the biggest vaccine drive in Philippine history. Otherwise, we are doomed,” he said, referring to the early vaccination of Cabinet officials and security personnel.

“I hope that when the government’s COVID-19 vaccination program starts – with FDA-authorized vaccines — frontline healthcare workers and the poor should be given priority. Let the frontline doctors and nurses get the first and limited shots. No one should cut in line,” he added.

Drilon issued his statement after the President said that many Filipinos have already received the COVID-19 vaccine of China’s Sinopharm, even as regulators have yet to approve any vaccine for local use.

The senator questioned how an unregistered COVID-19 vaccine was able to get past the Bureau of Customs (BOC).

“How did it get past the BOC? Were the vaccines smuggled at the ports?” Drilon asked.

On Monday, Interior Secretary Eduardo Año and the military confirmed the inoculation among members of the Cabinet and the Presidential Security Group (PSG).

It was not clear which vaccine was used but Año claimed that the drug was administered under an emergency use authorization (EUA).

However, the FDA said it has yet to authorize a COVID-19 vaccine.

Malacañang, meanwhile, had previously insisted that it is not against the law to receive an unregistered vaccine.

“Unang una po, hindi po ipinagbabawal ng batas natin ang magpaturok nang hindi rehistrado. Ang bawal po ‘yung distribution at pagbebenta. So ito naman po ay tinurok sa mga sundalo na pumayag,” Presidential spokesperson Harry Roque said in an online briefing Monday.

(First of all, it is not against the law to be inoculated with a vaccine that is yet to be registered. What’s illegal is the distribution and the sale. This was inoculated to soldiers who gave their consent.)

JPV