DOH asks SC to lift TRO limiting contraceptives

Ina Reformina, ABS-CBN News

Posted at Oct 10 2016 03:40 PM | Updated as of Oct 10 2016 03:52 PM

MANILA - The Department of Health (DOH), through the Office of the Solicitor General (OSG), urged the Supreme Court (SC) on Monday to lift its temporary restraining order (TRO) limiting the distribution of certain contraceptives. 

The TRO, issued more than a year ago, prohibits the DOH from: 

(1) granting all pending applications for registration and/or re-certification for reproductive products and supplies, including contraceptive drugs and devices; and, 

(2) procuring, selling, distributing, dispensing or administering, advertising and promoting the hormonal contraceptive “Implanon” and “Implanon NXT” which have been certified by the Food and Drug Administration (FDA) “to have abortifacient character.” 

In its 47-page motion, the DOH cited the following grounds:

- the SC failed to address the issue of why re-certification of contraceptives is quasi-judicial in character;

- registration and re-certification involve the exercise of the FDA's regulatory and administrative power;

- the FDA did not violate Section 1, Article III of the Constitution;

- Section 4 (k) of Republic Act (RA) No. 3720 (Food, Drug, and Cosmetic Act) is inapplicable to re-certification of contraceptives;and,

- the assailed decision would have dire consequences for the public.

"With all due respect, it is respondent's admission that courts have no technical expertise to overrule the FDA's appreciation of scientific evidence. The Court of Appeals (CA) and the [SC] have no jurisdiction to determine a scientific controversy whose competence is recognized by Congress to exclusively repose with the FDA," the DOH's motion read. 

The case is pending with the high court's Second Division, brought about by petitions filed by the Alliance for the Family Foundation Philippines, Inc. (ALFI) and Maria S. Noche. 

The Second Division issued the TRO on June 17, 2015. 

The DOH asked the high court to refer the case to the court en banc. 

The filing of the omnibus motion was led by Health Secretary Paulyn Ubial and Solicitor General Jose Calida. 

REMANDED TO FDA 

Last September, the SC remanded the case to the FDA, directing the latter "to observe the basic requirements of due process by conducting a hearing, and allowing the petitioners to be heard, on the re-certified, procured, and administered contraceptive drugs and devices, including 'Implanon' and 'Implanon NXT,' and to determine whether they are abortifacients or non-abortifacients.” 

The high court stressed the need to uphold due process, and directed that these rules of procedures must contain at least the following minimum requirements: 

(1) publication, notice and hearing; 

(2) interested parties shall be allowed to intervene or participate; 

(3) the standard provided in the Constitution, and also laid down in the RH Law, as to what constitutes allowable contraceptives, that is, “those which do not harm or destroy the life of the unborn from conception/fertilization,” shall be strictly followed; 

(4) in weighing the evidence, all reasonable doubts shall be resolved in favor of the protection and preservation of the right to life of the unborn from conception/fertilization; and, 

(5) other requirements of administrative due process already upheld by the SC (i.e., Ang Tibay vs Commission/Bureau of Internal Revenue) shall be complied with. 

The DOH, meantime, in coordination with other concerned agencies, was directed to formulate the rules and regulations or guidelines which will govern the purchase and distribution of reproductive products and supplies, covered by a certification from the FDA that these products and supplies are made available on the condition that these will not be used as an abortifacient, again subject at least to the following minimum due process requirements: 

(1) publication, notice and hearing; and, 
2) interested parties shall be allowed to intervene or participate.