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RP gov’t to sue Sanofi over dengue vaccine

The Philippines intends to sue Sanofi after authorities suspended the pharmaceutical giant’s anti-dengue vaccine in response to the company warning the drug could lead to severe infections in some cases, the health secretary said Thursday.

Regulators froze the Philippines’ world-first public dengue immunization program last week and suspended all sales of the vaccine on Monday after Sanofi said Dengvaxia could worsen symptoms for vaccinated people who contracted the disease for the first time.
“Eventually it’s the court of law that is going to decide in so far as the liability of Sanofi is concerned,” Health Secretary Francisco Duque said on ABS-CBN television
The previous administration of President Benigno Aquino launched the vaccination program last year, making the Philippines the first nation to use Dengvaxia on a mass scale.

About 830,000 schoolchildren had received at least one dose of the vaccine, Duque said on Thursday. Previously the government said more than 733,000 people had been vaccinated.
Sanofi’s announcement last week caused great concern in the Philippines — where the mosquito-born disease is extremely prevalent.
The French company on Monday sought to allay concerns, saying Dengvaxia would not cause anyone who was immunized to die and would not cause a dengue infection.
However, Duque said Thursday Sanofi’s recent statements on Dengvaxia were “confusing”.
Duque said he may ask Sanofi to refund P1.4 billion worth of unused Dengvaxia supplies.
He added the government might also demand Sanofi set up an “indemnity fund” to cover the hospitalization cost for children vaccinated under the public program who would fall ill.
Sanofi was not immediately available to comment on Duque’s remarks.
Asked if the government would sue Sanofi if allegations of a lack of transparency were proved, Duque said: “I’m sure it’s going to get there.”
He added: “If it’s found out that (Sanofi) withheld material information that would have changed the outcome of all of these problems and the decision makers of the Department of Health in the previous administration, then they are liable.”
Duque said congressional hearings into the issue would start next week.
Ex-gov’t officials in dengue vaccine program to face serious raps
Former government officials privy or involved in the now controversial P3.5- billion dengue vaccine program could be facing numerous serious charges given the apparent violations to the law committed, Sen. Richard Gordon said yesterday.
“This was not programmed in the budget. It was not in the GAA(General Appropriations Act). This was just inserted and that is going to be a major, major anti-graft case against them,” said Gordon, chair of the Senate blue ribbon committee that conducted an initial investigation on the issue early last year.
Sen. JV Ejercito, in a news forum at the Senate, said former President Aquino, who was the incumbent Chief Executive when the dengue vaccine was acquired from France-based Sanofi Pasteur in Dec. 2015, said the latter should speak about the issue on his alleged meetings with the pharmaceutical company.
“If possible former President Aquino can just speak about his meetings with the Sanofi Pasteur officials , this is better as he is not as yet being accused but because the issue is a hot topic. You really can’t blame people for thinking this to be so such as why prior to the procurement there had to be two meetings. It may be coincidence but it would be better if he (Aquino) explains what happened,” he said.
Ejercito, however, said it’s still premature to include Aquino in any investigation.
“We look at how it goes.But if needed, well I hope he would shed light. These are already two issues — before it was just public funds, now it’s an issue of public health and going to the figures, it’s serious at P3.5 billion and then 700,000 children injected,” he said.
Ejercito said it’s questionable why a sitting president would have such meetings involving a huge quantity of Dengvaxia vaccine and also shared the observation that it was all apparently done in haste.
Ejercito said he’s encouraging former and current Department of Health (DoH) officials to appear and air their side. So I hope they would shed light,” he stressed.
From all indications, Gordon said former administration personalities being implicated in the P3.5-billion dengue vaccine are likely to be facing numerous and serious charges with their apparent undue haste in the acquisition of Dengvaxia and violations to the law concerning alleged budget misuse in 2015.
Gordon noted the insinuations, based on the circumstances that led to the acquisition of the vaccine from France-based Sanofi Pasteur, that the program was used to advance the interests of the administration in the 2016 national elections.
The senator noted that transactions involving the said vaccine started only in Dec. 2015 following a series of meetings of Sanofi executives with no less than former President Aquino and former Department of Health (DoH) Secretary Janet Garin and the issuance of the Special Allotment Release Order (SARO) for the release of the funds weeks after.There was undue haste,” Gordon said.
Gordon also found questionable the role taken by Garin as acting FDA at the time when the vaccine was supposedly approved or endorsed by the agency.
Cases like negligence, reckless imprudence and even outright homicide, or multiple homicide if there will be numerous casualties, the senator said.
With AFP

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