SC makes TRO on contraceptives permanent

MANILA, Philippines -  The Supreme Court (SC) has made permanent its order restraining the distribution of contraceptive implants which President Duterte wants lifted.

In a resolution released last week, 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 and included a temporary restraining order (TRO) on their distribution.

SC spokesman Theodore Te explained that with the issuance of the entry of judgment in the case, the ruling on the TRO has become final and executory.

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

This means the government cannot distribute the contraceptives while the SC waits for the FDA certification, expected this month, on the two drugs.

The SC ruling last April, which denied the appeal of the Department of Health seeking to proceed with the distribution of the contraceptives, gave the FDA 60 days to decide on whether the 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.

The high court issued the ruling after Duterte again publicly criticized Chief Justice Ma. Lourdes Sereno for “sitting” on the case that supposedly hampered implementation of the Reproductive Health law.

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

In its 2015 ruling, the SC struck down the certifications and re-certifications issued by the FDA on 77 contraceptive drugs and devices – including Implanon and Implanon NXT – for violation of constitutional requirement of due process.

The Court has found that the agency certified and administered 77 contraceptive drugs and devices “without the observance of the basic tenets of due process, without notice and without public hearing, despite the constant opposition of petitioners.”

While the SC voided the certifications, it remanded the case to the FDA for processing of new certifications.

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.”

It directed the agency to start hearings of the applications within 30 days from receipt of notice.

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.

The SC has likewise ordered the DOH, for its part, to formulate rules for purchase and distribution of the products and also to generate the complete list of government programs and services under the RH law for distribution to all health care service providers. 

In a ruling last April, the SC rejected DOH’s appeal on the TRO issued and made clarifications on its coverage.

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