This issue of the Supreme Court temporary restraining order that has badly affected the implementation of government’s family planning program is not over yet.
Said TRO was issued in June 2015 and was only finally resolved by the SC through its ruling dated April 26, 2017. The TRO has prohibited the Department of Health from using, distributing, and promoting Implanon and Implanon NXT, the only available contraceptive subdermal implants in the country.
When the implant was introduced in the country, it became an instant favorite of women because of ease of use and long effectiveness. This type of contraceptive is inserted by trained health professionals and the entire process takes only around 10 minutes. It is effective for three years unlike the other short-acting methods.
With the TRO, implants purchased by the DOH have been unused since. At least 200,000 units of Implanon and Implanon NXT costing hundreds of millions of people’s money will expire in 2018, some in September, and some in June. Only non-government organizations, private health practitioners, and local government units can provide these to women provided that the implants they use are not from the DoH. It needs noting that this family planning method costs as high as P14,000.00 when accessed through private doctors. Thus, the TRO has prevented access of poor women to this effective and safe contraceptive.
The TRO has also directed the Food and Drugs Administration to put on hold applications for Certificates of Product Registration of contraceptives. This meant that no new contraceptive can be registered. Registration is important since no unregistered product can be made available in the market and government will not be able to purchase anything that has not been approved by the FDA.
In effect, contraceptives whose registrations have expired are no longer available affecting women using these brands. This is the reason why we hear women complaining that they can no longer find the pills of choice in the market. On the other hand, the DoH has run out of supply of progestin-only-pills which are most popular among breastfeeding women.
Moreover, if the TRO will not be lifted soon, even the combined oral contraceptive, the type of pills used by millions of women, will go out of stock in 2018.
The urgency of lifting the TRO cannot be overemphasized. However, this is no longer in the hands of the SC. The FDA is the office that needs to make the important decisions on contraceptives.
In its 26 April 2017 decision, the SC ordered the DoH and FDA to do certain things and when these are done, the TRO will be DEEMED LIFTED. The Justices ordered the DoH to revise the Implementing Rules and Regulations of the Reproductive Health Law based on the High Court’s rulings. Said revised IRR is already completed and was signed on Oct. 6, 2017.
The SC also ordered the FDA to revise its guidelines and process for registration of contraceptives so oppositors are given the chance to be heard. The FDA was also ordered to already go through this process and decide on whether contraceptives with applications for registration are abortifacient or not. This FDA decision is the only thing needed before the TRO is finally lifted.
It has been more than six months since the SC’s promulgation but up to now, the FDA has yet to decide on 51 pending applications despite the fact that ALL of these contraceptives have been previously registered prior to the TRO. After the April decision of the SC, the first target of FDA to release its decisions was August. RH advocates have been wondering why the FDA has been slow in carrying out the high court’s orders when ALL of the contraceptives in question only need recertification as these were already made available in the market.
We know that the FDA has already revised its guidelines and registration process according to the SC orders but it took them several months to do this. FDA only issued an advisory on Aug. 21 for interested parties to submit position papers and evidence pertaining to the applications for registration of contraceptives it is processing. Thus, the August deadline was moved to October.
It is now November and the only thing needed is for the FDA to promulgate its decision. There are those who say that the FDA has already approved the registration of 37 contraceptives. However, FDA director general Nela Charade Puno said that her office is still finishing all the processes before making their decisions public.
If it is true that the FDA has already approved 37 of the 51 applications, there is no reason why this must be kept secret. It need not decide on the 51 all at the same time. However, there is also the question of why the FDA is dragging its feet on the other 14 applications when these have already been available in the market before?
The RH law cannot be fully implemented if the whole array of modern family planning methods will not be made available. Contraceptives are crucial for this. The RH law will turn five years old this year with very little to show in terms of family planning implementation.
The FDA is headed by a woman and as one, she should understand the urgency of this issue. Her office must move faster because women’s rights, health, and lives are at stake here. FDA must decide in favor of addressing women’s needs for quality and safe contraceptives, NOW not later.
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