THE Court of Appeals has junked a motion filed by French pharmaceutical giant Sanofi Pasteur seeking reconsideration of its order issued early this year which upheld government’s decision to revoke its certificate of product registration (CPR) for Dengvaxia, the controversial anti-dengue vaccine.
In a two-page resolution dated September 20, the appellate court’s Former Seventh Division through Associate Justice Eduardo Ramos Jr. said Sanofi’s motion for reconsideration dated February 28 has no merit and its arguments had been resolved in the assailed January 31 ruling.
In that ruling, the CA denied Sanofi’s petition for review of the decision of the Department of Health and the Food and Drug Administration to cancel the CPR for being moot and academic as the authorization already expired on Dec. 22, 2020.
“A careful perusal of Sanofi Pasteur Incorporated arguments in its motion reveals that it is anchored on a plea to revisit the evidence and facts already considered in the assailed decision. A motion for reconsideration grounded on arguments already submitted to this Court and found to be without merit may be denied summarily, as it would be a useless ritual for this Court to reiterate itself,” said the CA decision which was concurred in by Associate Justices Edwin Sorongon and Ruben Reynaldo Roxas.
In its motion for reconsideration, Sanofi said the CA should have resolved the issues raised in the original petition notwithstanding the expiration of the CPR and the absence of a new application. It said the appellate court should have taken into consideration delays brought about by the COVID-19 pandemic and ruled that the instant case is too short to be litigated.
But the DOH and FDA, through the Office of the Solicitor-General, argued that the motion is pro forma and that it is already moot.
Records of the case showed that on Dec. 29, 2017, the FDA suspended Sanofi’s CPR for a year and meted it a fine of P100,000 for the firm’s failure to submit post-approval commitment documents. A year later, the FDA revoked Sanofi’s CPR.
Sanofi’s motion for reconsideration, where it argued it was denied due process, was also denied by the FDA, prompting it to go directly to the DOH which also denied its appeal on Aug. 19, 2019.
Sanofi then elevated the appeal to the Office of the President, which also rejected its plea, prompting it to go to the CA.
To recall, in 2017, the Philippines suspended its dengue vaccination program using Dengvaxia following Sanofi’s announcement that it could cause severe dengue if given to those without prior exposure to the disease.
About 860,000 people, including 830,000 children, were inoculated with Dengvaxia before the DOH stopped the program.
Public Attorney’s Office chief Persida Rueda Acosta, who spearheaded the filing of cases against health officials and that of Sanofi, has said they documented close to 100 deaths of children attributable to Dengvaxia.
