HEALTH Secretary Francisco Duque 3rd on Thursday announced that the government would be filing a civil case against French pharmaceutical giant Sanofi Pasteur after rejecting for the second time its request to refund used Dengvaxia vials worth P1.6 billion and indemnify recipients of the anti-dengue vaccine.
In a statement, Duque said the Department of Health (DoH) has forwarded the reply of the drug manufacturer to its Legal Department.
“I have forwarded the letter to the Legal Department and ordered that a civil suit be instituted against Sanofi Pasteur,” he said in a statement.
“The DoH maintains that as per the Terms of Reference on the procurement of the dengue vaccines, the DoH made it categorically clear that it intends to use the dengue vaccine in a school-based immunization program for students regardless of whether they have been infected by the dengue virus or not,” he said.
He also said Sanofi’s labeling of the vaccine did not qualify the recommended use or risk of the drug on recipients who would be infected with dengue for the first time.
Duque said that prior to the advisory of Sanofi, the manufacturer never issued a warning and it was only after it was used in the government’s anti-immunization program did the pharmaceutical firm reveal its side effects on first-time dengue patients.
“It is regrettable that this crucial information was only made public by Sanofi Pasteur after the DOH has implemented the vaccine program to about 837,000 children,” he said.
The DoH will exhaust all legal remedies against Sanofi and to bring their misrepresentations to justice, Duque said.
In a news briefing last week, Duque said that if Sanofi would refuse, the DoH would invoke provisions of the Civil Code.
“So I have a new letter telling them I am invoking the provisions of the Civil Code of the Philippines. There is a provision there that says the government wouldn’t have agreed to the price they set if they only admitted the supposed effects of the product were untrue. Or the government would buy fewer doses or would not buy the vaccine at all if there were a full disclosure on the vaccine,” Duque told reporters.
Earlier this week, Sanofi refused to honor the demand saying a refund would mean the vaccine was ineffective.
“We stand firmly behind our product. Refunding the used doses of Dengvaxia would imply that the vaccine is ineffective, which is not the case. And at this time, there is also no known circumstance requiring indemnification,” Sanofi said in a statement. KENNETH HERNANDEZ