THE Court of Appeals has rejected the plea of French pharmaceutical giant Sanofi Pasteur Inc. questioning the government’s decision to revoke its certificate of product registration (CPR) for the controversial anti-dengue vaccine Dengvaxia.
In a decision promulgated on January 31, the appellate court’s Seventh Division held that Sanofi’s petition for review is “moot and academic” considering that its CPR expired in December 2020.
“All told, it is our view that the expiration of the marketing authorization on December 22, 2020 has rendered this case moot and academic. It is thus futile to insist on the reinstatement of the CPR whose validity period had long expired,” the CA ruling penned by Associate Justice Eduardo Ramos Jr. held.
To recall, the Food and Drug Administration issued an order in December 2017 suspending Sanofi’s certificate for product registration for one year and imposed a fine of P100,000 because of its failure to submit post-approval commitment documents.
The following year, the FDA permanently revoked of Dengvaxia’s certificate of product registration.
Sanofi then asked for a reconsideration of the FDA order, arguing it violated its right to due process for lack of notice or warning that there was an administrative proceeding against it.
The FDA rejected the motion for reconsideration, prompting Sanofi to appeal before the Office of the Secretary of the Department of Health. But the DOH in an order in August 2019 upheld the FDA’s order. The Office of the President also rejected Sanofi’s appeal as it upheld the DOH ruling. Sanofi then elevated the case to the CA, which also rejected its plea.
In denying Sanofi’s petition, the appellate court agreed with the position of the Office of the Solicitor General which represents the respondents DOH and FDA, arguing that the reinstatement of the petitioner’s certificate of product registration would no longer possible as it has expired in December 2020.
“To be clear, however, this Court finds that the issue at hand is not the efficacy of Dengvaxia. Rather, the crux of this controversy centers on the compliance or non-compliance of the post-marketing authorization requirements by Sanofi,” the CA said.
The appellate court also did not give weight to Sanofi’s assertion that the reinstatement of the certificate of product registration for Dengvaxia is in the interest of health and safety of the Filipino people, as this would help mitigate the dengue epidemic.
In 2017, the Philippines suspended its dengue vaccination program using Dengvaxia shots following the announcement of Sanofi that it could cause severe dengue if given to those without prior exposure to dengue.
Some 860,000 persons — about 830,000 of them children, were inoculated with Dengvaxia before the DOH stopped the program.
