HTAC never intended to have same function as FDA

MANILA – The Universal Health Care (UHC) law never intended to give the Health Technology Assessment Council (HTAC) advisory board the same function as the Food and Drug Administration (FDA) of the Philippines, Malacañang said Monday.

Presidential Spokesperson Harry Roque made this remark after Vice President Leni Robredo backed a group of doctors from the University of the Philippines-Philippine General Hospital (UP-PGH) in calling for a further review of Covid-19 vaccines developed by China-based Sinovac.

Citing doctors, Robredo said while Pfizer (US) and AstraZeneca have secured emergency use authorization (EUA) and received a positive recommendation from the HTAC, the same should be done for Sinovac.

Sinovac-made “CoronaVac” vaccines have been approved by FDA for emergency use. However, they have yet to be assessed by the HTAC.

On Sunday, the Philippines received the initial 600,000 doses of Sinovac-made CoronaVac vaccines donated by China to the Philippines in a simple turnover ceremony led by President Rodrigo Duterte.

Roque, primary author of the UHC law or Republic Act 11223, maintained that the CoronaVac vaccines have already been assessed by the FDA, the main agency to establish safety or efficacy standards and quality measures for drugs and other products.

“HTAC was never intended to have the same function as the Food and Drug Administration. Pagdating po sa issue ng ligtas at epektibo, yung desisyon po ng FDA remains (When it comes to the issue on safety and efficacy the decision of the FDA remains),” he said in a press conference in Manila.

Roque said the UHC law included a provision to create the HTAC to facilitate the financing and coverage recommendations on health technologies to be financed by the Department of Health (DOH) and the Philippine Health Insurance Corp (PhilHealth).

“Bakit ba ho kami nag-provide ng provision niyan doon sa panukalang batas? Kasi importante po na masala natin kung ano yung essential services na ibibigay natin sa taongbayan ng libre, ano yung non-essential na mga services at gamot (Why did we provide a provision in that law? Because it’s important that we filter out the essential services we give to the public for free, what are the non-essential services and medicines),” he said.

He explained that since the CoronaVac vaccines were donated, they do not need to undergo HTAC assessment.

“So tama po, nakasaad po dun meron silang rekomendsayon kung bibilhin gamit ang pondo ng taongbayan (So that’s correct, stated in the law is they can make a recommendation if they purchase medicines using public funds) but the decision is still the decision of the Secretary of Health,” he added.

Sinovac’s CoronaVac is the third Covid-19 vaccine brand after Pfizer-BioNTech and AstraZeneca, approved by the FDA for emergency use.