COA: Dengvaxia procurement skirted regulations

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Pharmaceutical company Sanofi Pasteur in November 2017 announced the anti-dengue vaccine Dengvaxia posed potentially severe dengue risks among those with no dengue history.

Metro Manila (CNN Philippines, May 9) — The Commission on Audit (COA) flagged the government-run children's hospital responsible for procuring the dengue vaccine Dengvaxia for violating regulations.

In a 45-page report, auditors said the Philippine Children's Medical Center (PCMC) conducted pre-procurement activities for the P3 billion worth of  vaccines around a month before its memorandum of agreement (MOA) with the Department of Health (DOH). PCMC procured the vaccines under the term of former Health Secretary Janette Garin.

"The MOA provides that it shall take effect upon signing by the parties and shall be effective for a period of one year and five months renewable thereafter.  The date of the MOA as earlier mentioned was February 19, 2016 signed on the same date," the report read.

However, the report stated PCMC conducted a pre-procurement conference, posting of invitation to bid, pre-bid conference, bid opening, bid evaluation and post-qualification, all before February 19, 2016.

The report added the procurement process did not follow implementing rules and regulations (IRR) on making an exemption to procure the vaccine.

"The procurement of Dengue Tetravalent Vaccine amounting to P3.0 billion were not in accordance with the Implementing Rules and Regulations (IRR) of Executive Order No.49, the Revised Implementing Rules and Regulations of Republic Act 9184 and the Memorandum of Agreement by and between the DOH and PCMC," the report read.

Under the IRR of EO 49, only medicines in the National Formulary may be procured by government bodies. Exemptions may be granted if the request is approved by the National Center for Pharmaceutical Access and Management (NCPAM) Program Director, upon the recommendation of the Formulary Executive Council.

However, COA's review of the documents said the request was not submitted to the NCPAM but forwarded to Garin instead.

The audit body also said the shelf life of Dengvaxia in the approved purchase order of Dengvaxia differed from those in the provisions in the terms of reference (TOR) for the procurement, as created by the PCMC's technical working group.

While the purchase order said all vaccine vaccines should have at least one year before expiring, the TOR said the vials should have a shelf life of 18 to 24 months.

COA recognized the recommendations have been "moot and academic" since DOH has suspended the vaccination program. The Senate has also investigated the Dengvaxia mess, with Blue Ribbon Committee Chair Richard Gordon recommending graft charges against Garin, former President Benigno Aquino III, and other officials.

"The inclusion in this Annual Audit Report of the said audit observations is 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," the commission said

Pharmaceutical company Sanofi Pasteur in November 2017 announced the vaccine posed potentially severe dengue risks among those with no dengue history.