Alliance for the Family Foundation Philippines, Inc. (ALFI), et al. v. Hon. Janette L. Garin, Secretary-Designate of the Department of Health, et al.
Facts:
The case involves a dispute on the certification process of contraceptive products in the Philippines. Petitioners, an organization and individuals advocating for the protection of the life of the unborn and aligned with the intentions of the Responsible Parenthood and Reproductive Health Act (R.A. No. 10354 or the RH Law), asserted that certain contraceptive products, specifically Implanon and Implanon NXT, possess abortifacient characteristics—properties that induce abortion or prevent a fertilized ovum from implanting in the womb. They filed oppositions to the recertification of these products, which were seemingly unaddressed by the respondents, who are officials of the Department of Health (DOH) and the Food and Drug Administration (FDA). The respondents argued that the FDA, through its regulatory powers, is not required to comply with due process requirements of notice and hearing in its certification procedures. The case proceeded to the Supreme Court after various motions and pleas made by the petitioners and respondents.
Issues:
1. Whether the FDA’s certification of contraceptive drugs/devices, including Implanon and Implanon NXT, requires compliance with due process in its proceedings.
2. Whether the FDA’s regulatory/administrative function exempts it from judicial review.
3. Whether the FDA is required to afford interested parties the opportunity to be heard and consider evidence submitted by such parties.
Court’s Decision:
1. The Supreme Court held that the petitioners were indeed deprived of their right to due process. The FDA is required to give interested parties the opportunity to be heard and to consider their opposition against the re-certification of contraceptive products.
2. The Court asserted its authority to review the FDA’s acts, stating that no act of a government agency exercising its regulatory power is beyond judicial review, especially when there is a possible violation of due process.
3. The Supreme Court directed the FDA to conduct hearings, observe due process requirements, formulate rules of procedure for the certification of contraceptives, and amend the implementing rules per guidelines in the decision and in Imbong v. Ochoa.
Doctrine:
The doctrine of due process applies to the FDA’s recertification procedure for contraceptive drugs and devices. The FDA must ensure that the process includes notice, publication, hearing, and allows interested parties to intervene.
Class Notes:
– A party’s right to due process in administrative proceedings includes the right to a hearing to present their case, the right for their evidence to be considered, and a decision based upon the record of the hearing.
– In administrative proceedings, findings must be supported by substantial evidence that a reasonable mind might accept as adequate to justify a conclusion.
– Judicial review of administrative actions can take place when there is a possible violation of due process.
Historical Background:
The context of the case comes after the enactment of the RH Law, which promotes responsible parenthood and universal access to reproductive health services. The law defines abortifacients and mandates that no contraceptive shall be declared as non-abortifacient without proper certification from the FDA. As a result of the legislative framework, the FDA came into controversy over its certification process, leading to allegations of infringement of due process and concerns about the protection of the life of the unborn.
Leave a Reply