The Food and Drug Administration is expected to issue a resolution shortly that clarifies whether contraceptives under its review are abortifacients or not. The resolution is in compliance with a Supreme Court directive and should pave the way for the full implementation of the Reproductive Health Law.
The agency is in the final stages of the compliance procedure and once completed, the 40-month old Temporary Restraining Order issued by the High Court in 2015 will be lifted.
Contraceptives found non-abortifacient shall be issued Certificates of Product Registration. Some 400,000 contraceptive implants have not been distributed and are set to expire soon due to concerns raised by anti-RH advocates that these cause abortion.
The FD was directed by the SC in a resolution dated April 26, 2017 to conduct 'summary hearings' and amend the Implementing Rules and Regulations (IRR) of the Reproductive Health Law or Republic Act 10354.
During the 60-day review period, the FDA looked into the normal physiology and mechanisms of action of the contraceptives using various internationally-recognized publications. Further, it engaged in the re-evaluation of evidences of non-abortifacients previously submitted and conducted a parallel review of the evidence from the FDA Technical Working Group and Expert Working Group (EWG).
The EWG is composed of five obstetrician-gynecologists working in Level 3 hospitals for at least 20 years, and are also part of the academe.
According to the FDA, they are already in the finalization stage and will soon release its resolution on the listed products.
11-month deadline for implant insertion
If the implants in question (Implanon and Progestin Subdermal Implants/PSIs) will be certified as non-abortifacients by the agency, the Health department, local governments and partners will need to expedite its distribution and use of the products as they only have 11 months to insert the implants. Beneficiaries are mothers and young women in communities who choose to avail of the service, according to POPCOM Director Juan Antonio Perez, who spoke at a briefing with reporters.
Presently, there are 200,000 PSIs in the DOH inventory. "These PSIs [will] become ineligibe for insertion by September 2018, Director Perez said.
As with implants, Combined Oral Contraceptives (COCs) or pills will likewise run out by next year, and there is currently no supply of Progestin Only Pills (POPs) at the Health agency. Twelve contraceptives are set to expire in 2018.
A direct consequence of the TRO imposed by the SC is the stream of near-expiring contraceptives.
Revised IRR on RH Law
Another directive of the High Tribunal is the revision of the IRR, which was signed by the Drafting Committee of the Responsible Parenthood and Reproductive Health Law.
Erstwhile Health chief Paulyn Ubial had affixed her signature on the revised IRR.
Some of the revisions include he deletion of the word 'primarily' in defining abortifacients and contraceptives, as well as requiring written parental consent for a minor to access contraceptives even if she is already a parent.
"Any health care service provider who fails or refuses to disseminate information regarding programs and services on reproductive health because of his or her religious beliefs will not be punished," said the statement, provided that the professional can present evidence of his or her belief.
The POPCOM director noted that the twin actions of the FDA and DOH have "put the RPRH law back on tract to full implementation."
Dr. Esperanza Cabral, former Health Secretary and head of the DOH's National Implementation Team for the RH law, who was likewise at the briefing, lamented, "The law will have been a law for five years by the end of December this year. But in those five years, the law was unencumbered by restraining orders from the Supreme Court for only one year."
She said legal impediments have profoundly affected their ability to fully implement the law.
The Responsible Parenthood and Reproductive Health Act of 2012 is a “landmark legislation that laid the foundation in the fulfillment of the reproductive health and rights of all Filipinos toward better health outcomes, and socioeconomic growth and development.”
But in June 2015, pro-life group Alliance for the Family Foundation Philippines Inc (ALFI) alleged that contraceptives can cause abortions. SC then issued a TRO on the distribution of implants, as well as prohibited the regulatory agency, FDA, from renewing certificates for contraceptive drugs and devices.
If the TRO is not lifted, only condoms will remain in the market as contraceptive. MIMS
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