The Department of Health (DOH) on Thursday vowed to exhaust all legal remedies against drug firm Sanofi Pasteur, amid DOH’s preparations for the filing of a civil suit to be lodged against the French pharmaceutical giant.
Health Secretary Francisco T. Duque III said that the DOH will bring Sanofi’s “misrepresentations to justice.”
The health chief added that they have received a letter on Monday dated February 15, 2018, from Mr. Thomas Triomphe, head of Asia-Pacific region, Sanofi Pasteur, declining the DOH’s demand to refund the used doses of Dengvaxia.
Sanofi had refused to return the amount of P1.6 billion and to set up an indemnification fund that will be used for the benefit of the Dengvaxia recipients.
“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,” Duque said.
He added Sanofi Pasteur’s labeling “did not qualify the recommended use or risk on the serostatus at baseline of the intended recipient of the vaccine.”
He said that prior to the November 29, 2017, announcement, Sanofi Pasteur never issued a warning or precaution regarding the vaccine’s use among individuals who have had no prior dengue infection.
“It was only on this announcement that Sanofi Pasteur revealed that Dengvaxia poses a heightened risk of contracting severe dengue to seronegative individuals,” Duque added.
“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 lamented.
Earlier Sanofi said that the refunding of 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 news statement.
Sanofi also had agreed to refund the unused Dengvaxia vials worth P1.4 billion, but not the whole amount of P3.4 billion.