MANILA — A Department of Health (DOH) official said Monday they have no recourse but to file a civil suit against Sanofi Pasteur following its refusal to refund the estimated PHP2 billion spent by the department to procure the controversial Dengvaxia vaccine for its dengue immunization program.
Sanofi Pasteur on Monday declined the DOH’s second request for a refund, saying this “would imply that the vaccine is ineffective, which is not the case”.
“Initially, it will be a civil case on the basis that what they really sold us is a defective product. It is not the product that they promised it to be,” Undersecretary Enrique Domingo said in an interview.
Domingo said their legal office and the Office of the Solicitor General are going to work together to strengthen and file the case against Sanofi.
“We believe they are really at fault here. And of course, if we find any further evidence, it might lead to a criminal case because we believe there have been some misrepresentation on the side of Sanofi,” Domingo said.
In a statement issued Monday, Sanofi said they declined the second request “as we did in our previous reply to the DOH on 5 February 2018”.
“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 Pasteur said.
The DOH had requested a refund, aiming to establish an indemnification fund for those who received the vaccine.
During a congressional hearing, the pharmaceutical company declined to refund the used doses of Dengvaxia. The multinational firm also refused to establish an indemnification fund for recipients who may be hospitalized as a result of the vaccine.
“Our concern and empathy remains with any and all individuals and families that have been affected by these difficult circumstances,” its statement read.
It further cited that since dengue remains a major public health challenge in the country, the vaccine should be perceived as a tool to reduce incidence of the disease.
“Dengue remains a major public health challenge. Dengvaxia vaccination in the Philippines will provide a net reduction in dengue disease, including severe dengue and, thereby, reduce the overall public health burden with this disease,” Sanofi said.
Noting that no vaccine is 100 percent protective, it said Dengvaxia, like all other vaccines, has never claimed 100 percent efficacy in its approved label.
Sanofi however offered to hold a meeting with DOH on how they could work together to help the vaccinated children through other means.
“We also again made very clear our willingness to sit down with the Department of Health to find other ways we can assist their efforts to combat dengue in the Philippines and restoring public trust in vaccines,” the company said.
More than 830,000 children received Dengvaxia under the DOH’s school- and community-based dengue vaccination program, which began in 2016. The program was also extended to other children and cities in the National Capital Region and Cebu.
Earlier, the DOH was able to get Sanofi’s nod to refund the “unused vaccine”, worth PHP1.4 billion, after the department suspended the program when Sanofi disclosed certain adverse effects on recipients who did not have a previous infection.
With monitoring the recipients’ health expected to take years, worried parents have sought the department’s help in protecting the children against the possible ill effects of Dengvaxia.
In response, the DOH has assured that the recipients’ check-up, treatment and hospitalization would be covered by PhilHealth. It has also promised to reimburse the patients any additional expense not covered by PhilHealth. (Leilani Junio/PNA)
