The “confusion” over which agency should regulate veterinary products, such as African swine fever (ASF) vaccines, must be ironed out to prevent undue harm to the livestock sector caused by the sale of unregulated items.
Sen. Cynthia A. Villar made this remark during a Senate Committee on Agriculture and Food hearing on Wednesday that looked into the alleged sale of ASF vaccines in the local black market.
In her opening remarks, Villar said the regulatory “confusion” between the Bureau of Animal Industry (BAI) and the Food and Drug Administration (FDA) on which agency would regulate veterinary products should be blamed for the supposed entry and sale of the ASF vaccines.
Citing the Department of Justice, Villar said the BAI does not have any regulatory jurisdiction over veterinary products and establishments. Villar added that this mandate falls under the purview of the FDA.
However, she noted that in the case of the ASF vaccines, it was the BAI that facilitated the trials and even the endorsement for the importation of doses for emergency use.
“Due to the confusion of who is in charge, over the BAI and the FDA over veterinary products, many incoming shipments which are not necessarily ASF or Avian Influenza related drugs ended up seized by the Bureau of Customs, unable to be released until now,” she said.
“This bureaucratic issue has disrupted the flow and supply of basic veterinary drugs to the swine, poultry and livestock industry putting it to unnecessary risk,” she added.
Villar said the BAI endorsed to the FDA the authorized importation for emergency use of the ASF vaccines from AVAC Vietnam Joint Stock Co. through KPP Powers Commodities Inc.
She said the ASF vaccines, at the time of their entry in the country, were not yet registered with the FDA, making them “illegal.”
“Before a company’s products are allowed entry into the Philippine market, each of these products must undergo an individual product registration process by the FDA, to secure a Certificate of Product Registration,” she said.
“What happens if I have no Certificate of Product Registration for my products? According to Philippine laws, failure to secure CPR for your products is illegal,” Villar said.
Villar claimed that a “small number” of the imported vaccines went to the hands of backyard hog raisers contrary to the rules of the trial that they should be used by commercial farms.
“Buyers of the vaccine were asked to sign a waiver of secrecy on the monitored effect of the vaccine on their animals,” she said.
The Philippines continues to experience outbreaks of ASF. Early this month, two Oriental Mindoro towns were placed under state of calamity following the confirmation of an ASF outbreak.
Villar noted that except for the National Capital Region, no region is left unaffected by the ASF. “Since 2019 when it was first discovered in a pig farm in Rizal, the lack of vaccine or effective treatment has made the control of the disease very challenging.”