COA flags Dengvaxia procuring entity

The Commission on Audit (COA) has flagged the Philippine Children's Medical Center (PCMC) for allegedly conducting pre-procurement activities ahead of the effectivity date of its memorandum of agreement (MOA) with the Department of Health (DOH) for the use of the anti-dengue vaccine Dengvaxia.

State auditors said the PCMC, the procuring entity of the vaccine, started holding pre-procurement activities for the P3-billion dengue vaccination program about a month before the MOA with DOH took effect on February 19, 2016.

"Pre-procurement activities were conducted before the effectivity of the date of the Memorandum of Agreement by and between the DOH and PCMC. The date of the MOA as earlier mentioned was February 19, 2016 signed on the same date," the 2017 audit report read.

The activities mentioned in the COA report include the pre-procurement conference held on January 22, posting of invitation to bid on January 23, pre-bid conference conducted on February 1, receipt of bids/bid opening and bid evaluation on February 15, and post-qualification held on February 16.

The COA further said the purchase of the vaccine was not in compliance with the Implementing Rules and Regulations (IRR) of Executive Order No. 49 and the Revised IRR of the Government Procurement Reform Act.

Under the IRR of EO 49, government entities are mandated to promote the rational use of drugs and medicines by using the Philippine National Drug Formulary (PNDF) Volume 1 as basis for procurement.

DOH Administrative Order No. 2012-0023 allows exemptions in this provision as long as the end user justifies its use and subject to the approval of the National Center for Pharmaceutical Access and Management (NCPAM) upon recommendation of the Formulary Executive Council (FEC).

The COA, however, said the recommendation for provisional exemption issued by the FEC was not submitted to the program director of NCPAM but to then-DOH Secretary Janette Garin instead.

"Based on the FEC recommendation, the DOH Secretary issued a certification for provisional exemption of 'dengue tetravalent vaccine (live, attenuated) powder for suspension for injection (SJ).' Thus, the issuance of the exemption from E.O. 49 was not obtained/issued pursuant to the regulation," COA said.

The COA also cited the contrasting shelf life of Dengvaxia in the approved Purchase Order (PO) and the provisions of the Terms of Reference (TOR) created by the PCMC Technical Working Group for the procurement of the vaccines.

The PO stated that all delivered vaccines should have at least a 12-month expiration, while the TOR said the dengue vaccine vials have a shelf life of 18-24 months upon delivery.

In its comment, the PCMC said the differing expiration period is a mere "inadvertence" on its part and it will adopt to the TOR shelf life.

Moot and academic

The COA, however, admitted that the findings in its audit report on Dengvaxia have become moot and academic.

The DOH has ordered the suspension of the vaccine program, while the Food and Drug Administration has ordered Sanofi to stop the sale, distribution and marketing of Dengvaxia.

The COA said it still released the audit observations to "ensure that implementation of future projects/programs/transactions of similar nature be dealt with proper caution and the due observance of laws/rules/regulations governing the transactions."

Nonetheless, the COA urged PCMC to "strictly comply with the requirements" of EO 49 and the RIIR of the government procurement law in securing exemptions from the mandatory use PNDF listed medicines and on the purchase of goods and services, respectively.

The PCMC management told COA that it submitted the FEC recommendation to Garin since she holds administrative supervision over NCPAM.

It also rebuked COA on the bidding of the program, saying the DOH Legal Service had reviewed the MOA as early as January 14 while the date stated in the MOA was only its date of notarization.

No undue haste

Garin had denied claims there was undue haste in the procurement of the Dengvaxia vaccine from Sanofi Pasteur, which cautioned the prescription of the vaccine to patients who have not had dengue in the past, and the implementation of the mass immunization program. 

Garin said that as early as 2010 there had been talks on the need of a dengue vaccine, after cases of infections in the country shot up to 150 percent.

Former President Benigno Aquino III also refuted insinuations that the multi-billion vaccination program was rushed. 

Garin and Aquino are facing at least two criminal complaints before the Office of the Ombudsman in connection with the allegedly anomalous health program. — MDM, GMA News