Choice of cheaper vaccine legal–Ona

MANILA, Philippines–Health Secretary Enrique Ona said his choice to go for a cheaper antipneumonia vaccine, which allowed the government to save more than P231 million, was in accordance with law and the findings of a World Health Organization (WHO) study on two competing vaccines.

In his explanation to President Aquino on his controversial choice, Ona said he requested the WHO to evaluate the costs and results associated with pneumococcal conjugate vaccine 10 (PCV 10) and PCV 13 amid a debate among Department of Health (DOH) officials and medical experts on what vaccine to procure.

A copy of the results of the WHO study on the cost-effectiveness of PCV 10 and its supposedly better-performing counterpart, PCV 13, was received by the DOH on July 17, 2013, six months after he issued the certificate of provisional exemption for PCV 10, Ona said.

The WHO study concluded that “introducing either PCV 10 or PCV 13 as part of a national program would be a cost-effective decision for the Philippines,” noting that the benefits of each vaccine would be different.

It said PCV 13 would prevent more cases of invasive pneumococcal disease (IPD) while the other vaccine would prevent more cases of acute otitis media (inflammation of the middle ear).

But the WHO report further stated that “it appears to be cost-effective to purchase a more costly but also more beneficial option (PCV 13) if the number of doses given is the limiting factor, and PCV 10 if the net healthcare budget is the limiting factor.”

‘Best judgment’

“The choice between preventing thousands of potentially fatal IPD episodes compared to millions of milder but far more prevalent otitis media episodes is inherently a subjective value judgment,” the study said.

Ona said that in light of the medical debate on the choice between the two vaccines, he exercised the “best judgment” to issue a certificate of provisional exemption for PCV 10 to allow the government to purchase the cheaper vaccine at $1 per dose “to optimize limited government resources.”

The antipneumonia vaccination initially targeted 700,000 children below a year old and identified in the government’s National Household Targeting System for Poverty Reduction.

It was ultimately decided that a nationwide vaccination program be rolled out for all children in the country, about 1 million.

“This exercise of value judgment is affirmed by the WHO study. The certificate of provisional exemption was issued in accordance with existing rules and regulations on the matter,” Ona said.

He emphasized that his decision allowed the government to realize savings of P231,720,401.

Aquino asked Ona to go on leave in late October to allow him to put together an explanation for his decision to purchase P800 million worth of PCV 10 instead of the supposedly more cost-efficient PCV 13 as allegedly recommended by global health authorities.

The National Bureau of Investigation is looking into the alleged irregularities in the procurement of the vaccines following a complaint filed directly in the Office of the President by the National Center for Pharmaceutical Access and Management (NCPAM) and the WHO.

But the WHO has denied filing any complaint regarding the controversial purchase of PCV 10, saying that it merely provided assessments based on the DOH request.

In his explanation, Ona said that pending the results of the WHO study, the DOH tapped the United Nations Children’s Fund (Unicef) as an agent to facilitate the procurement of vaccines under the Expanded Immunization Program in 2012.

The Unicef offered a price of $15.40 (P601.95) per dose of PCV 10 and $16.34 (P833.67) per dose of PCV 13, noting that both vaccines were not included in the Philippine National Formulary System (PNFS).

The health secretary explained that since both vaccines were not included in the PNFS, the head of the NCPAM approved the certificate of exemption for PCV 13 on Nov. 6, 2012. He approved the certificate of exemption for PCV 10 for the procurement of 1 million doses two months later.

Complied with law

Ona maintained that his action was in accordance with Administrative Order No. 2012-0023 (Revised Implementing Guidelines for the Philippine National Formulary System), Republic Act No. 6675 (Generics Act of 1988) and Executive Order No. 49, which directs the mandatory use of the PNDF (Philippine National Drug Formulary) Volume 1 as the basis for government procurement of drugs.

“The final approving authority on the inclusion or noninclusion in the PNDF, including the grant of exemption thereof, is expressly granted to the secretary of health,” Ona said.

“The decision of the NCPAM and the Formulary Executive Council is merely recommendatory. As head of the DOH, the secretary of health is not bound by [their] recommendations,” he added.

He assured the President that the issuance of the certificate of provisional exemption for PCV 10 was “solely impelled by my desire to advance the interests of the Filipino people and to ensure that the limited resources of the government are wisely spent.”

Originally posted: 9:28 PM | Sunday, November 30th, 2014