MANILA, Philippines — Two senators on Friday called on the country’s health authorities to simplify the “impractical” and “circuitous” process for the entry and use of Covid-19 vaccine donations to the country.
During the Senate hearing into the government’s Covid-19 vaccination plan, Senator Francis Tolentino asked the Food and Drug Administration (FDA) regarding existing regulations on donated vaccines.
CRAFT REGULATIONS FOR VACCINE DONATIONS: Sen. Francis “Tol” Tolentino urges officials of the Department of Health (DOH) and the Food and Drug Administration (FDA) to craft, this early, the guidelines for Covid-19 vaccine donations to ensure donated vaccines will reach their intended recipients.
FDA director-general Eric Domingo told senators that once such donations reach the Bureau of Customs (BOC), the latter agency will be asking for necessary clearance from the FDA.
FDA HEAD ATTENDS COW HEARING: Food and Drug Administration Director-General Rolando Domingo answers queries from senators during the hybrid hearing of the Senate Committee of the Whole, Friday, January 22, 2021, on the national government’s COVID-19 vaccination program. (Alex Nueva España/Senate PRIB)
If the vaccine donated has yet to secure an emergency use authorization (EUA) from the FDA, the donated product will be referred to the Department of Health (DOH) Bureau of International Health Cooperation.
The said bureau would be the one to apply for the donated vaccines’ EUA.
“Ang alam ko po yung EUA isang beses lang i-issue. ‘Pag na-issue na ‘yan, like Pfizer, continuing na ‘yan. Hindi yung kada donation EUA ka nang EUA,” Tolentino said in response.
(From what I know, an EUA is only issued once. If an EUA is already issued, like for Pfizer’s case, it’s continuing. Donations for the same product should no longer have to secure for one.)
Domingo explained that clearance would still be needed from the FDA to ensure that the donated product was indeed manufactured by the company that received the EUA.
“That is why I am now alerting you to craft the regulations this early. Because I foresee an event involving returning residents coming for instance from the United States, bringing in with him or her a box of vaccines for his or her relatives here,” Tolentino said.
“What will the Customs do? Will it be confiscated and disposed of? At this early stage you should craft the regulations,” the senator asked.
Sen. Panfilo Lacson during the Senate Committee of the Whole’s third hearing into the government’s Covid-19 vaccination plan. (Alex Nueva España/Senate PRIB)
Expounding on the issue raised by Tolentino, Senator Panfilo Lacson proposed that procedures be streamlined and be made less bureaucratic, especially those with EUA from countries or territories with stringent regulatory agencies.
“Hindi ba mas impractical ‘yon? Bakit kailangan circuitous pa ‘yong daan? This is critical because there are many associations abroad that may donate vaccines to their sister cities in the Philippines,” Lacson said.
“Would it not be more practical to ensure the goods reach the intended recipients directly under strict supervision and guidance by health authorities, instead of coursing the goods through the Department of Health and having the DOH distribute them?” he added.
Many local government units, like Baguio City, already have their own cold storage facilities for the vaccines, as their local leaders had the foresight to act accordingly, Lacson noted.
“Allowing such donated vaccines to go directly to the LGUs instead of having to go through the logistical requirements of the DOH and Inter-Agency Task Force on COVID-19 would also avoid the prospect of double handling and additional costs,” he added.
Lacson stressed that the pandemic involves an emergency where authorities cannot afford to have vaccines go through the bureaucratic processes.
“Ang purpose ng tanong ko, baka may paraan tayong ayusin natin ang sa halip na iikot pa, idiretso na,” he said.
(The point of my question is that we should find ways to simplify instead of complicate things.)
Vaccine czar Sec. Carlito Galvez Jr. they are open to the idea raised by the senators.
“Tama kayo, sir. Yan din ang gagawin namin. Kaya magkakaroon ng time and motion rehearsal para in case capable ang LGU, pwede idiretso para wala nang double handling,” Galvez said.
(You are right, sir. That is what we will do. We will have a time and motion rehearsal so we can allow donated vaccines to go directly to the LGUs so we don’t have to have double handling.)