CHIEF Justice Ma. Lourdes A. Sereno on Thursday said the lifting of the temporary restraining order (TRO) on the distribution of two contraceptive implants by the Department of Health (DOH) would depend on the findings of the Food and Drug Administration (FDA) whether they are abortifacient or not.
Sereno issued the statement in response to President Duterte’s State of the Nation Address (Sona) on Monday, where he asked the Supreme Court (SC) to lift the two-year-old TRO and allow the implementation of the reproductive-health (RH) law.
The chief magistrate suggested that Duterte is barking at the wrong tree when he mentioned the issue during his Sona since the lifting of the TRO on Implanon and Implanon NXT is now beyond the control of the SC.
“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 the TRO has not been lifted yet is not within the Court, but with the FDA,” the SC chief said.
The FDA is an agency under the executive branch.
It can be recalled that the SC, in a decision issued in April, rejected the DOH’s appeal on the TRO issued in June 2015, but also made clarifications on its coverage.
The SC said 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 the determination of the safety of Implanon and Implanon NXT is now with the FDA, which is an agency under the DOH.
Implanon and Implanon NXT are thin rods inserted under the skin, which release hormones that prevent pregnancy for up to three years.
Sereno also noted that the TRO does not cover the implementation of the RH law or any other contraceptive products.
“As clearly stated in the decision denying the motion for reconsideration, the TRO is limited only to those two implants…. By the express terms of the Court’s decisions, there is no TRO against the implementation of the RH law or all contraceptive products,” Sereno said.
In his Sona, Duterte lamented that the medicines bought by the DOH for the implementation of RH law are set to expire next month and have not been distributed due to the TRO. The President earlier signed Executive Order 12, which mandates aggressive government action in providing universal access to RH programs.
In issuing the TRO, the SC nullified the certification and recertification earlier issued by the agency covering 77 contraceptive drugs and implants due to the failure of the DOH to observe and comply with the basic requirements of due process.
The Court held that the FDA certified, procured and administered contraceptive drugs and devices, without the observance of the basic tenets of due process, without notice and without public hearing, despite the constant opposition from petitioners Alliance for the Family Foundation Philippines (AFFP) and a certain Maria Concepcion Noche.
However, the Court remanded to the FDA the two consolidated petitions seeking to stop the government from “procuring, selling, distributing, dispensing and administering, advertising and promoting” contraceptive drugs and implants, such as Implanon and Implanon NXT, with alleged “abortifacient” side effects.
The Court agreed with the petitioners that the FDA should “observe the basic requirements of due process by conducting a hearing, and allowing petitioners to be heard” on the matter.
In light of this, the SC directed the FDA to formulate rules of procedure in the screening, evaluation and approval of all contraceptive drugs and devices that will be used under Republic Act (RA) 10354, other wise known as the Responsible Parenthood and Reproductive Health Act of 2012.
It should contain, according to the court, the minimum requirements of due process, such as publication, notice and hearing; allowing interested parties to intervene; strictly following the standard laid down in the Constitution and RA 10354, as to what constitute allowable contraceptives should be followed, that is, those which do not harm or destroy life of the unborn from conception/fertilization; and in weighing evidence, all reasonable doubts should be resolved in favor of the protection and preservation of the right to life of the unborn from conception/fertilization.
The Court also tasked the DOH, in coordination with other concerned agencies, to formulate the rules and regulations that will govern the purchase and distribution of contraceptives covered by the certification from the FDA that said product and supply will not be used as an abortifacient.
The health department was also directed to come up with the complete and correct list of government RH programs and services under RA 10354, which will serve as the template for the complete and correct information standard and to distribute the same to all health-care service providers covered by the said law.