TRO on implants to stay, SC blames DOH for delay
MANILA, Philippines – The Supreme Court (SC) on Friday, May 26, said the Department of Health (DOH) is to blame for the "supposed" delay in the distribution of contraceptive implants covered by a 2015 temporary restraining order (TRO).
The SC also noted that the TRO would be deemed lifted if, after compliance with due process, the "questioned drugs and devices are found not abortifacient" by the Food and Drug Administration (FDA).
During its summer session in Baguio City on April 26, the High Court denied the DOH's motion seeking a partial reconsideration of an August 2016 decision that ordered the FDA to determine if certain contraceptive drugs and devices are abortifacients or non-abortifacients.
The SC said "respondents have only themselves to blame" for the supposed delay in the distribution of the "subject drugs" that are "due to the review of the FDA decision."
"Instead of complying with the orders of the Court as stated in the Decision to conduct a summary hearing, the respondents have returned to this Court, asking the Court to reconsider the said decision claiming that it has wreaked havoc on the organizational structure of the FDA," the Court said.
The SC said the FDA would have finished and resolved the opposition of the petitioners already by this time had it "immediately" conducted a summary hearing on the issue.
The High Court even noted that only the petitioners – the Alliance for the Family Foundation Philippines (AFFP), and a certain Maria Concepion Noche – would need to present evidence before the FDA "to make their point by proving with relevant scientific evidence that the contraceptives have abortifacient effects."
"Thereafter, the FDA can resolve the controversy," the SC added.
The SC in its recent decision also modified its August 2016 decision ordering the FDA to consider the petitioners' opposition and to decide on the case within 60 days "from the date it will be deemed submitted for resolution."
"After compliance with due process and upon promulgation of the decision of the Food and Drug Administration, the Temporary Restraining Order would be deemed lifted if the questioned drugs and devices are found not abortifacient," the SC said.
Any appeal to the FDA's final resolution should be made to the Office of the President.
Will PH run out of contraceptives?
In 2015, the SC issued a TRO prohibiting the DOH from "procuring, selling, distributing, dispensing or administering, advertising and promoting the hormonal contraceptive 'Implanon' and 'Implanon NXT.'"
This contraceptive implant can prevent pregnancies up to 3 years.
Since then, the health department has repeatedly asked the High Court to lift the TRO.
According to the Commission on Population (PopCom), only 23 contraceptives remain available for the public this year as a result of the TRO. It said 15 certificates of product registration (CPR) expired in 2016, while 10 expired as of this month.
"By 2020, no contraceptives can be procured from the market. As such, CPR expirations will effectively lead to a total phaseout of [family planning] commodities in the market before 2020. Without FP commodities, the Philippines' national Family Planning program will effectively be put to a halt," the PopCom said in a statement Friday.
But in its recent decision, the SC clarified that it simply enjoined the DOH from "registering, recertifying, procuring, and administering" Implanon and Implanon NXT.
"It never meant to enjoin the processing of the entire gamut of family planning supplies that have been declared as unquestionably non-abortifacient. Moreover, the injunction issued by the Court was only subject to the condition that the respondents afford the petitioners a genuine opportunity to their right to due process," the SC explained.
The High Court reiterated that it cannot lift the TRO prior to the summary hearing to be conducted by the FDA as "to do so would render the summary hearing an exercise in futility."
The recent decision also emphasized that the SC "cannot make such determination or pronouncement at this time" on the DOH's argument that Implanon and Implanon NXT have no abortifacient effects.
"To grant its prayer to lift the TRO would be premature and presumptuous. Any declaration by the Court at this time would have no basis because the FDA, which has the mandate and expertise on the matter, has to first resolve the controversy pending before its Office," the decision read. – Rappler.com