SC denies DOH’s motion to lift TRO vs contraceptive implants

SC denies DOH’s motion to lift TRO vs contraceptive implants

Posted by on Sep 15, 2016 in Breaking News

Tuesday, September 13, 2016

THE Supreme Court (SC) has remanded to the Food and Drugs Administration (FDA) the case filed against the Department of Health (DOH) in connection with its decision to dispense contraceptive drugs and devices that were allegedly known to have an abortifacient character.
In a ruling on Tuesday, the SC second division has directed the FDA to conduct a hearing to determine whether its administered contraceptive drugs and devices including

Implanon and Implanon NXT have abortifacient side effects.
“Wherefore, the case is hereby remanded to the FDA which is herby ordered to observe the basic requirements of due process by conducting a hearing, and allowing 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,” the SC second division ruled.

Hormonal contraceptive Implanon, an implant inserted under the skin reportedly releases hormones that prevent pregnancy for up to three years.
The SC found that the FDA certified the said contraceptives without notice and public hearings, despite constant oppositions of the petitioners in the case and its failure to do so violates the due process in drug certification.

“Due to the failure of the respondents to observe and comply with the basic requirements of due process, the Court is of the view that the certifications and recertifications and the distribution of the questioned contraceptive drugs should be struck down as violative of the constitutional right to due process,” the resolution states.
With its findings, the second division has directed the FDA to formulate the rules of procedure in the screening and approval of all contraceptive drugs and devices that will be used under Republic Act 10354.

RA 10354, signed by President Aquino in December 2012, allows the state to use public funds to educate the youth on reproductive health and provide couples with contraceptives.

“The rules of procedure shall contain the standard laid down in the constitution as adopted under RA 10354 as to what constitutes allowable contraceptives shall be strictly followed, that is those which do no harm or destroy the life of the unborn,” the SC said.

The department was also ordered to make a complete list of the government’s reproductive health programs and services which will serve as a template to be distributed to the health care providers.

The resolution also ordered the DOH to amend the Implementing Rules and Regulations (IRR) of the reproductive health law to conform with the earlier ruling of the Court in Imbong et al vs Ochoa et al on April 2014.

In the ruling, the SC declared unconstitutional eight provisions in the RH law’s implementing rules and regulations.

Pending the resolution of the controversy, the Court also denied the motion to lift the Temporary Restraining Order (TRO) it issued by the Court on June 17, 2015.
It clarified however that the TRO only halts the power of the DOH and the FDA to approve pending applications for registration and recertification of reproductive health products and supplies and the distribution of Implanon and Implanon NXT and “does not mean that the FDA should stop fulfilling its mandate to test, analyze and inspect drugs and devices.”

The petitioners in the case who questioned the DOH’s decision to allow the distribution of the said contraceptives are Alliance for the Family Foundation Philippines Inc. and Maria Concepcion Noche. Named respondent in the case is former DOH Secretary Janette Garin. (Sunnex)