The DOJ said government prosecutors found probable cause to file charges against Garin and nine other unnamed officials of the Department of Health, the Food and Drug Administration (FDA) and the Research Institute for Tropical Medicine (RITM). The DOJ did not mention the names of those indicted – except Garin’s – due to privacy concerns.
Michael Varcas/ File
DOJ indicts Garin, others over Dengvaxia
Robertzon Ramirez (The Philippine Star) - February 22, 2020 - 12:00am

MANILA, Philippines — The Department of Justice (DOJ) has indicted former health chief and now Iloilo Rep. Janette Garin as well as other former health officials for reckless imprudence resulting in homicide in connection with alleged deaths caused by the anti-dengue vaccine Dengvaxia. Also indicted was the president of Sanofi Pasteur Inc., manufacturer of Dengvaxia.

The DOJ said government prosecutors found probable cause to file charges against Garin and nine other unnamed officials of the Department of Health, the Food and Drug Administration (FDA) and the Research Institute for Tropical Medicine (RITM). The DOJ did not mention the names of those indicted – except Garin’s – due to privacy concerns.

Sanofi officers and directors were also indicted for violation of the Consumer Act of the Philippines. The DOJ did not also name them.

The DOJ said Sanofi violated the Consumer Act of the Philippines for manufacturing Dengvaxia vaccine “which poses certain risks to seronegatives, or those who have not previously contracted the Dengue disease.”

“Likewise, the panel found that the circumstances surrounding the dispensation of the Dengvaxia vaccine made the same a mislabeled drug and held liable the President of Sanofi and four of its other officers or directors for violating the same act,” the DOJ said. The panel’s 78-page resolution was released on Feb. 19, according to the DOJ.

Just like in their March 2019 resolution, the prosecutors said that Garin and the others were found to have exercised “inexcusable lack of precaution” for the “fast-tracking of the procurement process” for the Devangxia despite its low efficacy results and potential risks with its use.

Under Executive Order No. 49, series 1993, the DOJ said that the Philippine National Drug Formulary (PNDF) requires listing before any drug purchase by the government, subject to certain exceptions.

It also said the vaccines were purchased even before the completion of clinical trials. The FDA approved the registration of the vaccine even as clinical trials were still ongoing.

The penalty for reckless imprudence resulting in homicide is imprisonment of up to six years for each count, based on the Revised Penal Code.

“The panel found that Sanofi submitted its application for the registration of Dengvaxia in January 2015 and its CPR (Certificate of Product Registration) was granted in December of that same year, before the completion of the two clinical trials and before the same was WHO certified,” it said.

During the immunization program, the prosecutors said Garin and the others committed negligence when they failed to inform the parents of the children about the nature and risks of the Dengvaxia “thus, they failed to obtain the informed consent of the its recipients.” 

DOJ RESEARCH INSTITUTE FOR TROPICAL MEDICINE
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