SC lifting of TRO hinges on FDA decision

The Supreme Court’s 2nd Division has made an official decision related to the lifting of the Temporary Restraining Order the High Tribunal issued two years ago prohibiting the distribution of Implanon and Implanon NXT and restraining the Food and Drug Administration from granting pending applications for registration and or recertification of reproductive contraceptive drugs and products.

On April 26, 2017, the SC broke its silence on the TRO with the announcement that it had promulgated the 2nd Division’s decision which was attested by its chair, Associate Justice Antonio Carpio and certified by Chief Justice Lourdes Sereno. The ponente was Associate Justice Jose Mendoza. Other members of the division are Associate Justices Arturo Brion, Mariano del Castillo and Marvic Leonen. Leonen made a separate and concurring decision.

The decision does not yet lift the TRO.

It gives the Food and Drug Administration (FDA) 60 days to explain whether contraceptive drugs Implanon and Implanon NXT are abortifacients or not. 

The TRO had been issued in response to pro-life advocates’ charge that the FDA had failed to consider their opposition to the contraceptive products.

The SC denied the motion for reconsideration filed by the Department of Health (DOH) asking for the lifting of the TRO on subdermal implants.

The decision said, “WHEREFORE, the August 24, 2016 Decision is MODIFIED. Accordingly, the Food and Drug Administration is ordered to consider the oppositions filed by the petitioners with respect to the listed drugs, including Implanon and Implanon NXT, based on the standards of the Reproductive Health Law, as construed in Imbong v. Ochon, and to decide the case within sixty (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 abortifacients.”

The Parenthood and Reproductive Health Act was passed in 2012 – after 14 years of deliberation and heated discussions in the two houses of Congress. But opponents of the bill asked the Supreme Court to stop the implementation of the law, claiming that contraceptives are abortifacients. Hence the SC issued  the TRO.

Hopes rose with President Duterte’s issuance of Executive Order on Jan. 9, 2017, ordering the full implementation of the RPRH law. The EO provides funds and support for modern family planning, in a bid to make modern family planning available to the poor by 2018.

“This Order aims to intensify and accelerate the implementation of critical actions necessary to attain and sustain ‘zero unmet need for modern family planning’ for all poor households by 2018,” reads Executive Order No. 12.

Among the strategies outlined in the four-page document is to do a comprehensive review of couples and individuals in need of family planning services. The government hopes to reduce poverty to 13 percent by the end of Duterte’s six-year term in 2022, Socio-economic Planning Secretary Ernesto Pernia said. 

The Philippines has six million women, of which two million are poor, that “have unmet need for any modern method of contraception, and remain unable to fully exercise their reproductive rights,” the Executive Order said, citing Philippine Statistics Authority findings from 2013.

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“The procurement of contraceptives is critically important in order to reduce the risk of unintended pregnancy. If a woman is sexually active, effective family planning methods help her correctly and consistently plans birthing. Among reversible methods of birth control, intrauterine contraception and the contraceptive implant remain highly effective for years,” POPCOM Executive Director Dr. Juan Antonio Perez III said.

According to the World Health Organization (WHO) Department of Reproductive Health and Research, contraceptives such as the pill and patch yields 6-12 pregnancies per 100 women in a year while implant and intrauterine device (IUD) produces less than one pregnancy per 100 women in a year. Meanwhile, condom is comparable to the least effectiveness of calendar method with 18 or more pregnancies per 100 women in a year.

“Aside from delaying birth, contraception reduces the need for abortion, especially unsafe abortion, as well as teenage pregnancy,” Dr. Perez said. Based from the WHO data, an estimated 225 million women in developing countries would like to delay or stop childbearing but are not using any method of contraception because of limited choice of methods, limited access to contraception, cultural or religious opposition, and poor quality of available services. 

Ben de Leon, president of The FORUM for Family Planning and Development says, “The onus is on the FDA to do its primary responsibility as defined in its charter R.A. No. 3720, as amended by R.A. No. 9711 to observe due process. The FDA then should immediately decide and issue certification/recertification of contraceptives and implants.’

There is good reason to hope that the FDA will show that the questioned contraceptives are not abortifacients. As the SC decision goes, once the FDA has complied with the order, the SC will submit the case for resolution. 

Says De Leon: “If the petitioners fail to prove their claim that their questioned FP products are not abortifacients, the High Court also decided that FDA decisions are only appealable to the Office of the President, not in the Court of Appeals as earlier promulgated.” This, adds De Leon, “is advantageous to the RH community.”

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Now, a few words about Implanon and Implanon NXT. These are similar contraceptive polymer rods about the size of a match stick that is implanted just below the skin of the inner, upper arm, and it slowly releases a contraceptive hormone, etonogesterel, preventing pregnancy of a woman for three years. It is not an abortifacient, as it only prevents pregnancy. 

This system has a failure rate of about 0.05% each year. And the fact that it prevents conception for three years makes it a popular choice for planning the number of children women desire.

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Let’s give our all-out support to the FDA, whose decision will be scrutinized as though through a prism by the High Tribunal.

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