MANILA, Philippines – Several officials were grilled in a Senate hearing on why they allegedly gave free rein to a private company to oversee the clinical trials of African swine fever (ASF) vaccines in the country.

A total of 300,000 doses were imported by the Philippines from Vietnam through private company KPP Powers Commodities Incorporated. This was done after the Food and Drug Administration (FDA) released a special import permit following an endorsement by the Bureau of Animal Industry (BAI).

During a Senate hearing on Wednesday, October 25, senators grilled FDA, BAI, and importer KPP Powers Commodities for letting private farms use the vaccines even without a certificate of product registration from the FDA.

A certificate of product registration is an authorization issued by the FDA prior to the marketing, importation, exportation, sale, offer for sale, distribution, transfer, promotion, advertisement, and sponsorship of a health product.

And because there was only a special import permit, the vaccines shouldn’t have been sold to farms in the first place, said an agricultural stakeholder on Wednesday.

“Our worry is why 300,000 doses entered the market and were sold,” Arnulfo Frontuna of the Swine Industry Federation, said in Filipino. “It shouldn’t have been sold because they only have a special permit. But they sold it.”

Senator Cynthia Villar chided the government agencies involved for letting the supplier control the distribution of vaccines.

“‘Yung supplier yung nasusunod eh. Mali ‘yun. There’s conflict of interest doon,” said Villar. “Kasi kung supplier ang nag-trial eh di siyempre sasabihin nila okay ‘yung trial nila. Dapat BAI ‘yun, bakit ‘nyo pinayagan na supplier ang mag-trial?”

(The supplier was the one taking control. That’s wrong. There’s a conflict of interest. If the supplier conducted the trial, of course they would say their trial went fine. BAI should be in charge, why did you let the supplier run the trials?)

Here are the farms included in the distribution of vaccines under the special import permit. The list obtained by Rappler was submitted to senators during the hearing.

1. Faith Farms
2. V4 Farms
3. Sunjin Genetics
4. Central Farms
5. Wilco Farm
6. Mama Lyds Agricultural Farm
7. Pilmico Farm
8. Palangan Integrated Farm
9. RZ Naranjo Veterinary Clinic
10. Bibiana Farms
11. Gensan Valley Stockfarm Corp.
12. Porky’s Choice
13. BC Valles Farm Corp.
14. Jollipig Farms Corp.
15. Vetserve
16. San Miguel Foods Inc.
17. Phil Hog

According to the list submitted by KPP Powers Commodities, 19,300 doses were distributed to the farms listed above out of the 300,000 available; 280,700 doses remain unused.

Of the total 19,300 doses delivered, San Miguel Foods got 9,650 doses or half of the total delivered. Two farms on Negros Island accounted for 21% of doses delivered: Faith Farms received 2,550 (13.2%) and V4 Farms got 1,550 (8%) doses, based on the list.

Reynaldo Robles, legal counsel and spokesman for KPP Powers Commodities, vehemently denied the sale of vaccine doses.

“For the record, hindi po kami nagbenta. Kung sinasabi ‘nyo hong may binebenta, subukan ‘nyo pong bumili kung may mabibili sa amin,” Robles said.

(For the record, we were not selling. If you’re saying that the selling of vaccines took place, try buying from us if you will get anything.)

Robles said they entered into a cost-reimbursement contract with the farms.

“Cost-reimbursement po kasi,” Robles said. “Hindi po makakapag-trial test ‘yun ng 300,000 doses nang sasagutin lang ng isang kompanya. Hindi naman po charity ‘yun.”

(This is cost-reimbursement. We cannot conduct a trial test of 300,000 with only one company involved. This is not charity.)

BAI Director Paul Limson said during the hearing that they are well aware of the trials happening and are monitoring the activities. He said they expect the farms to submit blood samples by October. According to a Reuters report, Vietnam was poised to export around 2 million ASF vaccines to the country in the same month.

The vaccine in question was produced by AVAC Vietnam JSC, approved by the Vietnam government for commercial use last June. KPP Powers, in response to an article “Red flags cloud AVAC’s registartion bid and use in Philippines,” published by Rappler last August, has claimed that the vaccine is “safe and effective.”

Overlapping jurisdiction

Four years after the first outbreak of the highly contagious ASF in the Philippines, the FDA and the BAI have yet to settle regulatory jurisdiction on veterinary products.

Last October 16, Department of Agriculture (DA) Undersecretary for Livestock Deogracias Savellano told reporters that they had written the Office of the Executive Secretary to settle the issue.

Under the law, even veterinary vaccines are now under the jurisdiction of the FDA, said Savellano, when it used to be one of BAI’s functions.

“For the longest time, ang BAI lang ang gumagawa niyan eh. Then ngayon, because of that, ina-assume na ng FDA ‘yung role.”

(For the longest time, it was BAI who was doing that. Now because of the law, the FDA has assumed the role.)

The Department of Health and the FDA had also sought the opinion of the Department of Justice on who is responsible for inspecting and monitoring veterinary drug products.

In an opinion released May 5, 2023, the DOJ reaffirmed that the regulatory authority over veterinary drugs products and establishments fall under the purview of the FDA.

“How long will the clinical trials last? When will the clinical trials be done? Under whose auspices or supervision?” Senator Francis Tolentino asked on Wednesday.

“If there are no clear answers, we would have been testing while violating our own FDA laws right under our noses,” Tolentino said.

ASF is a viral disease of farm-raised and wild pigs with 100% fatality rate. It has become a global concern after outbreaks detected in many countries including China, Vietnam, and Korea. The Philippines had its first outbreak of the highly contagious disease in 2019. – Rappler.com