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Home News National

TRO on implants beyond SC –Sereno

Rey E. RequejobyRey E. Requejo
July 28, 2017, 12:01 am
in National
Reading Time: 3 mins read
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President Rodrigo Duterte may have not been properly abreast of the legal status of the temporary restraining order issued by Supreme Court against the distribution of two contraceptive implants by the Department of Health when he criticized the 15-member bench on the matter during his State of the Nation Address. 

Chief Justice Ma. Lourdes Sereno on Thursday said that the lifting of the TRO on Implanon and Implanon NXT is now beyond the control of the SC as it now actually depends on the action of the Food and Drug Administration, an agency under the Office of the President.            

“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 DFA,” Sereno said.

In a ruling last April, the high court has turned down the DoH’s appeal on the TRO issued in June 2015 but also made clarifications on its coverage.            

The SC 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.           

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This means that the determination of the safety of Implanon and Implanon NXT is now with the FDA, 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 reiterated the Court’s pronouncements in its ruling that the TRO does not cover the implementation of the Reproductive Health 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 second State Of The Nation last Monday, President Duterte asked the high court to lift theTRO and allow the implementation of the RH law.

“I’m not for abortion and birth control but I’m for giving of freedom to Filipino families to decide on size of children,” he said, saying that the medicines bought by the DOH for RH implementation are set to expire next month and have not been distributed supposedly due to the TRO issued in June 2015.

Duterte even personally addressed Chief Justice Sereno, who was in the VIP gallery during his two-hour speech.

The President earlier signed Executive Order No. 12 that mandates aggressive government action in providing universal access to RH programs.

In issuing the TRO, the SC has 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 SC 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 to formulate rules for purchase and distribution of the said products and also to generate the complete list of government’s programs and services under the RH law for distribution to all health care service providers.         

Tags: Chief Justice Ma. Lourdes Serenocontraceptive implantsDepartment of HealthSupreme CourtTRO
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Rey E. Requejo

Rey E. Requejo

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