DOH focusing on airtight case vs. Sanofi

MANILA — The Department of Health (DOH) on Wednesday said it is not in a hurry to file a case against Sanofi Pasteur, manufacturer of the Dengvaxia dengue vaccine, saying it is focusing on making an airtight case against the pharmaceutical firm.

“We cannot be too in a hurry in so far the as case build up is concerned. We need quality evidence. we cannot be just talking and showing pieces of evidence that might not hold water in the court of law,” DOH Secretary Francisco Duque III in an interview with the media.

Duque said that putting together all the pieces of evidence would make the case winnable.

“Yung (With regard to) case build-up, kailangan (it should be) very thorough, and very extensive kasi kung hindi naman baka naman (because if not), we might be unwittingly setting up ourselves for an embarassing legal defeat,” Duque said.

Duque said in previous interviews that precision and care in the gathering of evidence that would prove violations of Sanofi Pasteur should be done since the pharmaceutical giant has the resources to get the best lawyers to defend itself and its product.

Sanofi’s Dengvaxia triggered a Senate inquiry in November last year on the questionable effects on children immunized with the vaccine.

The product since then became controversial after making a disclosure that severe dengue can manifest among sero-negative Dengvaxia vaccinees that may be afflicted with dengue infection while it provide protection for those who have been sero-positive or those who already been infected with dengue.

As a result, DOH stopped the vaccination program as parallel investigations were conducted in the Senate and in the House of Representatives.

Initially, Duque said that they are mulling to file civil damage against Sanofi on the account of defective product since it did not comply with what had been expected of it, as indicated when the firm applied for label change to the Food and Drug Administration.

To date, DOH is still finalizing details of the case with the Office of the Solicitor General.

Meanwhile, Duque said that while they managed to convince the company to refund the fees for the unused Dengvaxia vaccine, they are not yet giving up on the possibility that Sanofi would agree on refunding for the used dengue vaccines.

Sanofi recently refunded around PHP1.161 billion for the unused Dengvaxia.

DOH is requesting that the refunded amount, now with the National Treasury Office, be used for the procurement of dengue kits which the parents of vacciness are asking from the DOH as a way to help them in monitoring of their children’s health at home.

He said that they hope that Sanofi would soon decide on the refund for the used Dengvaxia, amounting to at least PHP2 billion.

“If they decide to reimburse the cost of used Dengvaxia vaccines, that would be a very good development. We’re not giving up on that. We’re still asking them if they can do a full refund,” said Duque. (PNA)

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