TRO vs contraceptive implants stays: SC

In a resolution released Aug. 31, SC spokesperson Theodore Te said the second division of the high court issued an entry of judgement on its revised ruling last April that voided the certifications issued by the Food and Drug Administration (FDA) in Implanon and Implanon NXT. (Photo: Supreme Court of the Philippines/Facebook)

MANILA — The Supreme Court (SC) has affirmed the temporary restraining order (TRO) imposed against the distribution of contraceptive implants.

In a resolution released Aug.31, SC spokesperson Theodore Te said the second division of the high court issued an entry of judgment on its revised ruling last April that voided the certifications issued by the Food and Drug Administration (FDA) on Implanon and Implanon NXT.

“The Decision and Resolution of the Court in the referenced matter, which involves a TRO over two implants only and not all contraceptives and not over the entire RH (Reproductive Health) Law, became final and executory after an Entry of Judgement was made for the Decision dated August 24, 2016 and the Resolution dated April 27, 2017 on June 15, 2017,” Te explained.

“There’s nothing left to be done other than to comply,” he stressed in a statement.

In April, the SC denied the appeal of the Department of Health (DOH) seeking to proceed with the distribution of the contraceptives and gave the FDA 60 days to decide on whether the said implants are abortifacient or can cause abortion and re-issue the certification.

“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,” read the order.

Te reiterated that the SC ruling “involves a TRO over two implants only and not all contraceptives and not over the entire RH Law.”

Last July, Chief Justice Ma. Lourdes Sereno clarified there was TRO issued against the government’s full implementation of the law. Sereno made the clarification in response to President Rodrigo Duterte’s statement during his second State of the Nation Address (SONA) on SC’s issuance of a TRO against the implementation of the RH Law and all contraceptive products.

”After its decision on the partial constitutionality of the RH Law, the Supreme Court has never issued a Temporary Restraining Order (TRO) against the implementation of the Reproductive Health (RH) Law,” Sereno said in a statement.

Sereno said a TRO was issued against two specific contraceptives regulated under the RH law.
“This pertains to two implants—Implanon and Impanon NXT… As clearly stated in the decision dated August 24, 2016 and again in its April 26, 2017 Decision denying the Motion for Reconsideration, the TRO is limited to only those two implants,” she said.

In his SONA, President Duterte cited the Supreme Court’s restraining order hindering the government’s full implementation of the Reproductive Health Law.

He pointed out that the RH is already a law that has to be implemented.

“I am not for abortion, I am not for birth control, but certainly I am for giving of freedom to Filipino families to decide,” the President said, adding that subdermal implants purchased by the government are already nearing expiration.

The high court held that it cannot lift the TRO prior to the summary hearing to be conducted by the FDA on the safety, efficacy, purity, quality, and non-abortiveness of the two contraceptive products.

This means that determining the safety of the two contraceptive products is now with the FDA, an agency under the DOH.

Sereno also reiterated the high court’s pronouncements in its ruling that the TRO does not cover the implementation of the RH law or any other contraceptive products, adding that the lifting of the TRO on Implanon and Implanon NXT is now beyond the control of the high court.

“The TRO has a sunset provision – as soon as the FDA certifies as provided by law that they are not abortifacient, the TRO is lifted. The reason why the TRO has not been lifted yet is not within the Court but with the FDA,” the SC chief noted.

The SC specifically ordered the FDA “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.”

In the same ruling, the high court also directed the FDA to formulate rules for screening, evaluation and approval of all contraceptive drugs and devices to be used under the RH law.

Implanon and Implanon NXT are thin rods inserted under the skin, which release hormones that prevent pregnancy for up to three years.