DOH to file a case vs Sanofi over Dengvaxia mess

Published February 19, 2018, 6:56 PM

by Francine Ciasico

By Charina Clarisse Echaluce

Pharmaceutical company Sanofi Pasteur’s refusal to grant the Dengvaxia-related requests of the Department of Health (DOH) has left the agency no choice but to file a case, a top official from the department said.

“This morning natanggap ng Office of the Secretary ang letter from Sanofi saying that they are declining our request for a refund of used vaccines and the setting up of indemnification fund. So while the Secretary (Francisco Duque III) is very unhappy with the results because s’yempre gusto naming madaan ito sa mas magandang usapan at mabilis na usapan, this will leave us with no recourse but to file a case,” Health Undersecretary Enrique Domingo said in an interview.

Health Secretary Francisco Duque III following the the DFA's suspension of the sale of Dengvaxia for 1 year, and imposing a P100,000-administrative fine on Sanofi for failing to comply with post-marketing authorization requirements for the vaccine.(photo by ali vicoy)
Health Secretary Francisco Duque III (photo by Ali Vicoy/Manila Bulletin)

This morning, Sanofi has denied once again the requests of the DOH for the refund of all the Dengvaxia doses used during the government’s dengue immunization campaign and the putting up of an indemnification fund for the vaccinated children.

Domingo said the DOH’s legal office and the Office of the Solicitor General (SolGen) are now set to work together to file the proper legal complaint against Sanofi.

“Our legal office and the office of SolGen are going to work together so that we can strengthen our case and file a case against Sanofi,” he said.

“Initially it will be a civil case on the basis that what they really sold us is a defective product. It’s not the product that they promised it to be. Parang kung nagbenta ka ng sasakyan siguro pagkatapos sinabi nila maganda ‘yon. Tapos in the end nakita ang defekto. Kailangan isoli ‘yon. Hindi naman pwede nong una hindi mo nakita ang depekto wala ka ng kasalanan. 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,” he added.

At present, the legal team of the DOH is already looking at the Dengvaxia contract.

“Our legal team is now looking on the contract, specifically, all of the lines and of course what they promised the product to be. And we feel that we have a good case against them,” Domingo noted.

“Kasi talagang defective ang product na ito. They sold it to us saying it’s going to be good to everybody that they can use it for all children. And after two years they tell us that it’s not. So there’s an inherent problem in the product that they sold us,” he further stated.

Vaccine controversy

On November 29, 2017, the Sanofi Pasteur announced a “new finding” on its vaccine Dengvaxia, which was used in the government’s mass immunization program involving around 830,000 children.

“The analysis confirmed that Dengvaxia provides persistent protective benefit against dengue fever in those who had prior infection…. For those not previously infected by dengue virus, however, the analysis found that in the longer term, more cases of severe disease could occur following vaccination upon a subsequent dengue infection,” Sanofi said in a previous statement.

On December 1, 2017, Duque put on hold the government vaccination drive.

So far, the DOH has recorded 29 deaths of children who were given the dengue vaccine.

DOH requests

On January 12, the health department disclosed that it has asked Sanofi Pasteur to refund the unused Dengvaxia and shoulder the testing of the vaccinated children.

In a letter sent to Thomas Triomphe, head of Sanofi Pasteur Asia Pacific, the DOH laid down its demand for Sanofi to refund in the amount of P1.4 billion which corresponds to the remaining unused vials of Dengvaxia.

In a separate letter, the health department requested the company to conduct serotesting of the vaccinees using a newly developed test to determine their prevaccination status at no cost to the government.

Reimbursed doses

Sanofi has already reimbursed the unused Dengvaxia but clarified that agreeing to the DOH’s demand does not mean that their vaccine has a quality or safety issue.

“Our decision to reimburse for unused doses is not related to any safety or quality issue with Dengvaxia. Rather Sanofi Pasteur hopes that this decision will allow us to be able to work more openly and constructively with the DOH to address the negative tone towards the dengue vaccine in the Philippines today,” it explained.

“Sanofi Pasteur strongly believes that this tone is due to a misunderstanding of the benefits and risks associated with the dengue vaccine and a lack of awareness amongst the general public, particularly parents of vaccinated children, that the overall benefit of dengue vaccination remains positive in high endemic countries like the Philippines,” it added.

Sanofi, however, was urged later on to reimburse the used doses.