SC clarifies RH decision: No total TRO, only on 2 implants and only until FDA decides » Manila Bulletin News

Manila Bulletin Philippines

Breaking News from the Nation's leading newspaper

Tempo

Online Newspaper

Showbiz and Celebrity News

Sports News

World News
News Asia
  • Home Category
  • National
  • SC clarifies RH decision: No total TRO, only on 2 implants and only until FDA decides

SC clarifies RH decision: No total TRO, only on 2 implants and only until FDA decides

Published

by Rey Panaligan

The Supreme Court (SC) clarified on Thursday that there is no restraining order against the implementation of the Reproductive Health (RH) law or on all contraceptive products, only on two contraceptive implants Implanon and Implanon NXT.

“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,” the SC said in a statement issued by Chief Justice Maria Lourdes P. A. Sereno.

“What has been issued was a TRO against two specific contraceptives regulated under the Reproductive Health (RH) Law. This pertains to two implants – Implanon and Impanon NXT. This  was issued by the Second Division in the consolidated cases of Alliance for the Family Foundation Philippines Inc. et al. v. Hon. Janette Garin, et al. (G.R. No. 217872) and Maria Concepcion S. Noche, et al. v. Hon.  Janette Garin, et al., (G.R No. 221866).

“As clearly stated in the decision dated August 24, 2016, and again in its April 26, 2017, resolution denying the Motion for Reconsideration, the TRO is limited to those two implants.

“The TRO also has a sunset provision – as soon as the FDA (Food and Drug Administration) certifies as provided by law that they are not abortifacient, the TRO is lifted.

“By the express terms of the court’s decisions, there is no TRO against the implementation of the RH Law or all contraceptive products.”

Thus, Sereno said, the lifting of the TRO on the two contraceptive implants depends on the action of the FDA, not on the SC. The reason the TRO has not been lifted yet does not lie with the court but with the FDA.

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

The statement was issued in reaction to President Duterte’s personal message to Chief Justice Sereno, who was present during the State-of-the-Nation’s Address (SONA) last Monday, in connection with the SC’s TRO on contraceptive products.

Earlier, the President had signed Executive Order No. 12 that mandates aggressive government action in providing universal access to RH programs.

The dispositive portion of the April 26, 2017, resolution that denied the motion for reconsideration filed by FDA states:

“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. Ochoa, 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.

“After the final resolution by the Food and Drug Administration, any appeal should be to the Office of the President pursuant to Section 9 of EO No. 247. As ordered in the August 24, 2016, decision, the Food and Drug Administration is directed to amend the Implementing Rules and Regulations of RA No. 10354 so that it would be strictly compliant with the mandates of the court in Imbong v. Ochoa.”

EXCEPTS FROM DECISION

Excerpts from the Supreme Court decision follow:

“On the prayer to lift the TRO, the respondents lament that the assailed decision undermines the functions of the FDA as the specialized agency tasked to determine whether a contraceptive drug or device is safe, effective, and non-abortifacient. They also claim that the assailed decision requiring notice and hearing would unduly delay the issuance of CPR thereby affecting public access to state-funded contraceptives.

“Finally, in a veritable attempt to sow panic, the respondents claim that the TRO issued by the court would result in ‘a nationwide stockout of family planning supplies in accredited public  health facilities and the commercial market.

“On this score, it should be clarified that the decision simply enjoined the respondents from registering, recertifying, procuring, and administering only those contraceptive drugs and devices which were the subjects of the petitioners’ opposition, specifically Implanon and Implanon NXT. It never meant to enjoin the processing of the entire gamut of family planning supplies that have been declared as unquestionably non-abortifacient.

“Moreover, the injunction issued by the court was only subject to the condition that the respondents afford the petitioners a genuine opportunity to their right to due process. As the decision explained, the court cannot lift the TRO prior to the summary hearing to be conducted by the FDA. To do so would render the summary hearing an exercise in futility. Specifically, the respondents would want the court to consider their argument that Implanon and Implanon NXT have no abortifacient effects. According to them, ‘the FDA tested these devices for safety, efficacy, purity, quality, and non-abortiveness prior to the issuance of certificates of registration and recertification, and after the promulgation of Imbong.’

“The court, however, cannot make such determination or pronouncement at this time. To grant its prayer to lift the TRO would be premature and presumptuous. Any declaration by the court at this time would have no basis because the FDA, which has the mandate and expertise on the matter, has to first resolve the controversy pending before its office.

“This court also explained in the decision that the issuance of the TRO did not mean that the FDA should stop fulfilling its mandate to test, analyze, scrutinize, and inspect other drugs and devices. Thus, nothing in this resolution should be construed as restraining or stopping the FDA from carrying on its mandate and duty to test, analyze, scrutinize, and inspect drugs and devices. What are being enjoined are the grant of certifications/re-certifications of contraceptive drugs without affording the petitioners due process, and the distribution and administration of the questioned contraceptive drugs and devices, including Implanon and Implanon NXT until they are determined to be safe and non-abortifacient.

“On delay, the respondents claim that this judicial review of the administrative decision of the FDA in certifying and recertifying drugs has caused much delay in the distribution of the subject drugs with a dire impact on the effective implementation of the RH Law.

“In this regard, the respondents have only themselves to blame. Instead of complying with the orders of the Court as stated in the Decision (dated August 24, 2016) to conduct a summary hearing, the respondents have returned to this Court, asking the Court to reconsider the said decision claiming that it has wreaked havoc on the organizational structure of the FDA.

“Had the FDA immediately conducted a summary hearing, by this time it would have finished it and resolved the opposition of the petitioners. Note that there was already a finding by the FDA, which was its basis in registering, certifying and recertifying the questioned drugs and devices. The pharmaceutical companies or the MAHs need not present the same evidence it earlier adduced to convince the FDA unless they want to present additional evidence to fortify their positions. The only entities that would present evidence would be the petitioners to make their point by proving with relevant scientific evidence that the contraceptives have abortifacient effects.

“Thereafter, the FDA can resolve the controversy. Indeed, in addition to guaranteeing that no person shall be deprived of life, liberty and property without due process of law, the Constitution commands that ‘all persons shall have the right to a speedy disposition of their cases before all judicial, quasi-judicial, and administrative bodies.”

Tags: , , , , ,

Related Posts

  • Erwin RC

    The Philippines needs to implement this RH before the population doubles in just a few years. Japan is a developed country but population growth is dwindling. On the other hand, the Philippines is poor but population is significantly growing by leaps and bounds.

  • MAGNETIC LEVITATION

    Lol, on those millions wasted because FDA wasn’t doing it’s job and the Supreme Court is too supreme to give directions.

    It only takes a President to get things moving.. Such Bureaucracy.

  • general problem

    ganun naman pala 2 gamot lang ang na TRO, why the hell PANOT did not implement the LAW during his term. 2 reasons – 1. he don’t want to antagonize the CBCP sa madaling salita – syokot sya, 2. what do you expect for a NOYNOYING President.