It’s Friday afternoon and I just received news that the Supreme Court has rejected the Motion for Reconsideration filed by the Department of Health (DOH) on the Temporary Restraining Order (TRO) that has affected implants and the registration of other contraceptives.
My initial reaction was of course one of dismay.
The full decision is not yet available online. Media friends said that the SC just sent them a briefer a few hours after RH advocates transmitted to the High Court more than 300,000 signatures calling for the lifting of the TRO, and the reversal of the harsh August 2016 decision. This latest decision was made in April while the Court was in Baguio. Again, the ruling originated from the Second Division of SC, and it was a unanimous decision penned by Associate Justice Jose Mendoza. It will be recalled that AJ Mendoza also penned the controversial decision last year.
Pending scrutiny of the whole decision, and based only on limited information from reports, the #LiftTRO advocacy may have gained some small victory here. The TRO on contraceptive implants Implanon and Implanon NXT still stands pending statement from the Food and Drug Administration that they are not abortifacient.
Let me say that implants are used in many parts of the world and have passed scrutiny of many FDAs in countries where they are available. Even the World Health Organization’s experts have found implants as safe and effective as contraceptives. Implants are listed as contraceptives in the WHO List of Essential Medicines. There is a separate category for abortive drugs; implants are not there.
The hormones in implants are the same hormones that are found in pills and injectables. The advantage of implants over pills is they are effective for three years (3) after insertion. Thus, women no longer have to take a pill on a daily basis or have an injection every three months. Its effectiveness and ease of use make the implant a popular option for women who want to space childbearing for three years. Since all these methods are made of the same hormones, I am puzzled at the controversy over implants.
The FDA has certified Implanon and Implanon NXT. This should mean that this body has examined them and they passed the FDA standards, that these are not abortifacient. The new SC ruling orders the FDA to install a process wherein oppositors to contraceptives are heard. At this point, the FDA should not have problems following this SC order and RH advocates will now expect the FDA to do so. If the FDA moves fast, then the implants that were procured by the DOH nearing expiration may still be used.
An important thing I noticed in the SC ruling as reported is its clarification that the Court did not mean to affect the certification of other contraceptives. This is crucial because the August decision seems to have voided all existing certifications and registrations when the Court said in the second paragraph of page 16 that:
“Due to the failure of the respondents to observe & comply with the basic requirements of due process, the Court is of the view that the certifications/re-certifications and the distribution of the questioned contraceptive drugs by the respondents should be struck down as violative of the constitutional right to due process. ” Emphasis mine.
It is important to note that the petitioner has questioned all registrations of all contraceptives. This recent clarification by the SC therefore, is a big relief to the women who need these contraceptives.
Another important part of the SC’s April 2017 decision is the change it made to its August ruling where it made FDA decisions appealable to the Court of Appeals. Instead, now the SC said that such appeal may be made with the Office of the President. FDA decisions being appealed to the CA was a major thing that RH advocates were protesting against for several reasons.
One, it transformed the FDA from being a regulatory body to one that is quasi-judicial. Some lawyers said that the SC cannot do this as this is tantamount to judicial legislation. Justices can only interpret the Constitution and the laws BUT cannot make new laws. Changing the mandate of the FDA is for Congress to do, not the SC.
Two, people are uneasy in putting medical questions before lawyers and judges. If the August decision on this matter was upheld, it would be the lawyers and judges who will decide on matters they are not experts on.
Third, and not the least important, this would have created a much longer and more complex process for registration of each contraceptive. We are all familiar with how protracted our court processes are. Surely, the anti-RH will appeal each and every approval by the FDA of applications for registration of contraceptives. We know how the anti-RH have filed petitions against the RH law one after the other to the point that the law could not be fully implemented because of legal impediments.
The SC solved this problem (it created in the first place) by amending its decision. FDA functions within the Executive Branch headed by the Office of the President. I am more hopeful that lodging the appeal with the OP will shorten the process of registration of contraceptives compared with putting the same in the hands of the courts.
Pending a thorough reading and study of the full decision, I say that the #LiftTRO advocacy has gained some ground. However, advocates should not let their guard down. This is not yet over.
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