The Food and Drug Administration has at last approved the application for recertification of 51 contraceptives put on hold because of the Temporary Restraining Order (TRO) on contraceptives issued by the Supreme Court in 2015. The decision is contained in FDA advisory No. 2017 302 dated November 10, 2017. This issuance means that the 51 contraceptives in question, including the controversial subdermal implants Implanon and Implanon NXT, after thorough evaluation, have been determined to be safe, effective, and most importantly, non-abortifacient. This means further, that the TRO that has adversely affected government’s family planning (FP) program, is finally LIFTED.
What does the lifting of the TRO mean? One, this means that the more than 210,000 units of implants stored in Department of Health warehouses may now be used in the provision of FP services to women of reproductive age who want to use them. These implants were purchased by DoH before the TRO and have been kept in storage because of the restriction. Most of the stocks will expire in 2018, some in June, and others in September.
Two, now that the TRO is lifted and contraceptives recertified, Market Authorization Holders (MAHs) of these commodities may now bring them into the Philippine market again. It will be recalled that women have been complaining because their chosen brand of pills could no longer be found. This happened because the certification of these pills have expired, and until they get recertified, it is illegal to sell them here.
Three, the lifting of the TRO also means that government can now purchase supplies that have gone out of stock. At the moment, Progestin Only Pills (POP) are no longer available. This is the type of oral contraceptive given to breastfeeding mothers. If the TRO has not been lifted, even the Combined Oral Contraceptive (COC), the type of pills ordinarily used by women, will also be out of stock in a few months.
The lifting of the TRO can pave the way towards the full implementation of the Reproductive Health (RH) Law, at last! The law turns five years old in December but it has never been fully implemented because of the legal hurdles it has faced. The law’s family planning component has been weak primarily because of the TRO.
DoH is now in the process of downloading the subdermal implants to local health centers and non-government organizations helping government in implementing the RH law. In a matter of days, these will already be available to women. Since there are more than 210,000 units of implants that will expire by September of next year, this means the service providers must move fast in educating women and finding those who want to use implants as their FP method.
We have to note here that the expiration of implants refer to the date that it needs to be inserted and not the length of effectiveness of the contraceptive. For as long as it is inserted before the expiry date, it remains effective for three years. The ease of use and length of effect are the reasons why the implant is quite popular among women.
The DoH announcement that it will immediately release funds for purchase of needed contraceptives, especially those that are no longer available is a welcome development. Government procurement process is complex and time-consuming. It will take months, maybe even up to half a year before the supplies can be made available to end users. The process should start as soon as possible.
Budgetary allocations for FP is important. In fairness to the DoH, family planning is one program that has budget projections that are thoroughly studied and analyzed. They developed the Costed Implementation Plan (CIP) based on targets set by the RH law and President Duterte’s Executive Order No. 12 on Zero Unmet Need for FP. To meet these objectives, the CIP contains projections on how much will be needed for FP on a per method basis yearly.
Based on the CIP, the DOH needs a total budget of P1,630,391,453.00 for 2018 for FP in 2018. However, the DOH only requested an FP budget of P342,482,000.00. More importantly, perhaps because of the TRO and the existing supplies, the Health Department DID NOT REQUEST for any budget for implants and condoms for 2018. The CIP says that for the said year, P258,201,379.00 will be needed for implants and P148,723,994.00 for condoms. Now this can be a problem for the implementation of the RH law.
As already explained, the present supply of implants will expire in September of next year. This means that if government will not purchase this contraceptive early next year, we might again run out of needed stocks for the last quarter of 2018 and up to the first half of 2019. Without the needed budget, how will the DoH procure implants? Without the supplies, again the FP program will suffer.
The national budget has already been approved by the House of Representatives. It is in the final stages in the Senate. The next step is the Bicameral Conference Committee to reconcile the differing allocations. As what Rep. Edcel Lagman said, now that the TRO is lifted, the budget for family planning must be provided. Included here are the budgets for condoms and subdermal implants, especially the latter because of the expiring commodities.
It is still possible to put in the needed budget for FP. Pro-RH members of the Bicam should see to it that this is done so the RH law’s full implementation is not hindered again. Let us not allow the law to again be hijacked, this time, due to lack of funds.
bethangsioco@gmail.com @bethangsioco on Twitter Elizabeth Angsioco on Facebook
