g Se EP eervouicor me nauioned ¢ Kars ‘SUPREME COURT ye MANILA 6 famed SECOND DIVISION PS ALLIANCE FOR THE FAMILY FOUNDATION PHILIPPINES, INC. (ALFI), et al., Petitioners, ~versus- GR. No. 217872 DR. JANETTE L, GARIN, Secretary-Designate of the Department of Health, et a/., Respondents, MARIA S. NOCHE, in her own behalf and as ‘counsel of petitioners, et al., Petitioners, ~versus- .R. No, 221866 JANETTE —L. —sGARIN, Secretary-Designate of the Department of Health, et al., Respondents, TO RESOLVE OMNIBUS MOTE D 10 OCTOBER 2016 Respondents, through the Office of the Solicitor General (OSG), respectfully move for an urgent resolution of the Omnibus Motion for (1) Partial Reconsideration; (2) To Lift the Temporary Restraining Order dated 17 June 2015; and (3) To Refer the Case to the Honorable Court En Banc (Omnibus Motion), on the following discussion: 1. On 24 August 2016, the Honorable Court issued its Decision in G.R. Nos. 217872 and 221866, which, among others, remanded the case to the Food and DrugsAdministration (FDA) and denied respondents’ Motion to Lift the Temporary Restraining Order dated 17 June 2015. 2. Despite concerns over the possible stock-out of contraceptive products in the country that may be occasioned by the protraction of the present case, imately decided to file the above-mentioned Omnibus Motion in view of the perception that the Decision, if not reconsidered, would have dire impacts on the effective implementation of Republic Act (R.A.) No. 10354, or “The Responsible Parenthood and Reproductive Health Act of 2012” (RH Law) and, in general, the duty of the government to provide “universal access to medically-safe, non abortifacient, effective, legal, affordable, and quality reproductive health care services, methods, devices, supplies.”* 3. Thus, on 10 October 2016, respondents filed an Omnibus Motion, arguing, among others, that the FDA's registration and re-certification of contraceptive drugs and devices is not a quasi-judicial proceeding, but is an exercise of regulatory and administrative power. 4. Respondents respectfully submit thatthe Immediate resolution of the above-mentioned Omnibus Motion is warranted for the following reasons: 5. First. According to the data from the Department of Health (DOH) and the FDA, the Certificates of Product Registration (CPRs) of fifteen (15) of the forty-eight (48) contraceptive drugs and devices that were issued by the FOA in compliance with the RH Law expired In 2016. The CPRs of fourteen (14) more contraceptive drugs and devices will expire by end of 2017. 6. As a result of the successive expiration of the CPRs without the issuance of new ones, only nineteen (19) contraceptive drugs and devices will be available in the market by the period 2018-2020.? By 2020, all CPRs of family planning products will have expired, resulting in a nationwide stock-out of contraceptive drugs and devices. 7. It bears stressing that these contraceptive drugs and devices had been available in the market even prior tothe enactment of the RH Law. Furthermore, it is onl ine government. that certif is non-abortifacient, primarily and secondari ensuring that once the FDA issues a CPR, the drug or device Is indeed safe and non-abortifacient. 8. The Irony, however, is that after the enactment of the RH Law championing the reproductive health of women, contraceptive drugs and devices will not be readily available to the public, which defeats the very purpose of the RH Law of promoting access to all methods of family planning.? 9. With all due respect to the Honorable Court, the Imited access to contraceptive drugs and devices as a result of the Issuance of the TRO and the pendency of the present case have had adverse effects on the country’s family planning program as well as the individual’s freedom to Choose the familly planning program that they desire, as shown by demographics collated by the DOH, the FDA, and the Commission on Population (POPCOM) 10. Using the 2010 and the 2015 Population Census, the 2008 and the 2013 National Demographic Health Surveys, Projected Life Expectancy Based on the 2000 Census, and the Philippine Clinical Standards Manual on Family Planning, the POPCOM conducted a study on the impact of the withdrawal of subdermal progestin implants Implanon and Implanon NXT alone from the family planning program of the Philippines for the period 2016-2022." The study concluded that the withdrawal of Implanon and Implanon NXT from the family planning program would be quantitatively significant and would cause the country missing the demographic dividend,* effectively postponing It for another ten years to 2032. The key demographics collated by POPCOM are shown and summarized below: (a) Contraceptive Prevalence Rate. The 2013 National Demographic and Health Survey showed that 55.1% of married women of reproductive age were using either a "Malis Piipine Demographic Sonatetraditional or modern family planning method. Based on reports of new acceptors of subdermal implants, which account for 2.6% of the total number of married women of reproductive age, the contraceptive prevalence rate was projected to have Increased to 57.7% by 2015. POPCOM's demographic scenario predicts that the share of married women of reproductive age wha use subdermal implants would have risen to 9% in the period 2016- 2022, and the increase of the total contraceptive prevalence rate to 64.1%, if not for the issuance of the TRO and the pendency of the present case. This projection reflected in the illustration below under the heading “CPR with Implant.” In a scenario where subdermal implants would remain unavailable, the contraceptive prevalence rate would decrease to 55.1% starting in 2018, the same level as in 2013 lity Rate. The table below radual decrease in the total 2015. In a scenario where implants would be available, the reaches almost 2.3 children inapproximate replacement level fertility and thus usher the onset of the demographic dividend for the country, which is necessary to reduce poverty levels to about 14% by 2022. On the other hand, a scenario where subdermal implants would remain unavailable shows a gradual return to 2013 levels, as shown in the table below under the heading “TFR w/o Implant.” (c) Total births, Annual crude birth rates, as shown below, have been and will continue to be affected ‘by the removal of subdermal implants from the family planning program of rate of 31306,112 In.2013. On the other hand, under the heading “Births w/o Implant," there would be a gradual increase in births annually from 2013 to 2022. ings of he Supe(d)Total population. The national population is projected to be at 110,145,592 by 2022 wi subdermal implants in the family plannir program, and 113,798,224 without. Su coms sia Seen) Furthermore, the POPCOM’s detailed analysis of rate by age group under the “without subdermal implant” scenario reveals that the 15-19 and 45-49 age groups have been seeing increased fert them the sectors most affected by government to provide, among others, subderm 12. Apart from the foregoing, the POPCOM estimates that there have been additional unintended pregnancies the issuance of the TRO in June 2015. Based on 15 from 221. By 10 8,398 if said implants would remain unaval ith all due respect to the Honorable Court, it is mentioning that the Commission on Human Rights (CHR) has taken the position that the TRO had weakened the implementation of the RH Law. In its reportfon the first national inquiry on reproductive health and Fights conducted between March and May 2016, the CHR noted that the TRO “deprivied] women acceptors of [Implanon] while supplies..amounting to millions are in danger of being wasted. 14. Third. There had been an increase in the out-of- pocket expenses of women of reproductive age who cannot be provided subdermal implants by public health providers and facilities." In certain areas of the country, women have had to buy supplies from private sources because of the lack of available stock in government health facilities. The table below shows a stockout in family planning commodities in Rural Health Units: oo eat eee (tegen a ey Regions soe | pops a ey | zs] 3 1 nr I 2 oft Regonlo 93 NANA Na {Region 11 49 2 o 1 Hepion 250 SAPNA Ne Regions | 73 1 [2 wo “ANIM. us NA’ NAT NA | “car 7 NA UNA. NA Nex i Cia Oia | Overt Tots | 1638 aw 15. The foregoing illustrates decreased access to safe ‘and free contraceptive and the unmet needs for family planning services by the government. Families have to pot Rp pt 0 ae he POCOMresort to buying family planning commodities, greater out-of-pocket expenses. 16. This finding Is supported by the CHR National Inquiry on the RH Law: ‘The TRO remains in place depriving women acceptors of the method while supplies of Tmplanon amounting. to Imillons are In danger of being wasted. This is despite the fact that many health service providers and women from the community prefer Implanon as an FP commodity."* In NCR for exam prefer Implanon wi women who are informal setters its effectivity lasting for three (3) Yyesrs, Nowever, the TRO prevents them from obtaining free Implanon shots. With the TRO in place, government facilities are prohibited trom dispensing Implanon and private clnies and CSOs can continue dispensing and administering Implanon, they do so for a fee ~ an amount ‘that women nthe Informal sector and from the urban poor cannot afford. 5 ‘The TRO on Implanon and. the occasions both in Manila and Marikina bar heal ly Implementing the RH Law.!® sufficient workers, from ‘Women from the urban poor also experience inconsistent provision of RH goods and services such in the case of a lwoman in Calaanan Relocation Site who had to pay for her second Implanon when it had been free during her first it, Another woman in the same site had to pay for iraceptive through “donations” but during pregnancy ivered her babies without paying through PhilHeaith. A woman in Macabalan always had to pay for contraceptives ‘and check-ups." 17. Fourth. The pendency of the present case wi result in the squandering of 459,294 units of the Implanon and Implanon NXT which are currently stored in DOH warehouses and will expire in 2018. These amount to Php261,444,000.00 if said products will not be distributed and used before their expiry.18. Fifth, Another important yet often overlooked, f the pendency of the present case is the ty of reproductive health commodities which ished by the United men and Children considers contraceptive implants as commodities because they avert maternal deaths 19. Respondents wish to. emphasize that contraceptives (including implants) are part of the 2015 World Health Organization's (WHO's) List of Essential Medicines, which the Republic of the Philippines is obliged to make available and accessible to the public. Etonogestrel releasing implants and other contraceptive drugs re-certified by the CPR are part of the core list, As explained by the WHO, “the core list presents a list of minimum medicine needs for a basic health-care system, listing the most efficacious, safe and cost-effective medicines for priority conditions. Priority conditions are selected on the basis of current and estimated future public health relevance, and potential for safe and cost-effective treatment.”*” 20. The pendency of the present case exacerbates the reproductive health risks and harms faced by women and girls in the country. Since the issuance of the TRO in June 2015, there has been a decrease in the number of registered le modern contraceptives available in the market. spect, the Honorable Court's directive proscribing the FDA from “granting any and all pending applications for registration and/or re-certification for reproductive products , including contraceptive drugs and devices” uurther orders would eventually lead to the yy of registered contraceptive drugs and devices in the market. This would not only impact vulnerable subgroups of women who rely on government facilities and supplies of family planning products but also women, who out of their pockets, would like to choose and avail of contraceptives as their family planning method.21. Contrary to petitioners’ allegation _ that respondents did not specifically refute the allegations of fact in the Petition,2! the FDA, by issuing the CPRs, has made a categorical finding that the subject contraceptive drugs and devices are not abortifacient. The non-abortifacience of a contraceptive drug or device Is an inquiry subject to scientific evaluation, and not to judicial determination. In Imbong v. Ochoa,* the Honorable Court expressly recognized that it is the FDA that has the expertise to determine this inquiry: In this ragard, the observations of Justice Brion and Justice Del Castillo are well taken. As they pointed out, with the Insertion of the word "primarily," Section 3.01(2) and G) of the RH-IRR must be struck dovin for being ultra vires. Evidently, with the adgition of the word “primarily,” in Section 3.0l(2) and G) of the RH-IRR is indeed ultra vires. It contravenes Section 4(a) of the RH Law and should, therefore, be declared invalid. There is danger that the Insertion of the qualifier “primarily” will pave the way for the approval of contraceptives which may harm or destroy the life of the unborn from conception/fert Viclation of Article I, Section 12 of the Constitution. Such qualification la'the RH-IRR, it appears to insinuate that a contraceptive will only be considered as an “abortifacient” if its sole known effect is abortion or, as pertinent here, the prevention of the Implantation of the the approval of contraceptives which are abortifacients because of their fail-safe ‘mechanism, Also, as discussed earlier, Section 9 calls for the certification by the FDA that these contraceptives cannot act as abortive. With this, together with the definition of an abe Law and Its a tundeniable conclusion is that contraceptives to be Included In the PNDFS and the EDL will not only be those contraceptives that do not have the primary action of causing abortion or the destruction of a fetus Inside themother’s wom® or the prevention of the fertilized ovum to each and be implanted in the mother's womb, but also ‘those that do not have the secondary action of acting the ssame way. [At any rate, it bears pointing out that not a single ‘contraceptive has yet been submitted to the FOA pursuant to the RH Law. Tt behooves the Court to await its determination which drugs or devices are declared ¢ Congress ‘and intra- jent. The fist nee of Section 9 that ordains thel jon by the National Drug Formulary in the Ei using the mandetory "shall" Is to be construed as operative only after they have been tested, evaluated, and approved by the FDA, The FDA, not Congress, has the expertise to determine whether a particular hormonal, contraceptive or intrauterine device is safe and non- iclent. The provision of the third sentence Stated dliferently, the provision in Section 9 covering the Inclusion of hormanat cont uterine devices, and effective family planning products and supplies by the National Drug Formulary in the EDL is not mandatory. ‘There must first be a determination by the FDA that they are in fact safe, legal effective family planning - There can be no predetermination by Congress that then-abortifacient 22. Recently, President Rodrigo Roa Duterte Issued Executive Order (E.0.) No. 12,2 emphasizing the need to fast-track the implementation of the RH Law as it is one of the sustainable development goals of the administration to ensure universal access to sexual and reproductive health care. It is also one of the socio-economic agendas of the government in order to enable poor couples to make informed choices on financial and family planning. Section 2 of £.0. No, 12 provides: SECTION 2. Purpose. This Order aims to intensify and n of ertical actions necessary 23. Pres. Duterte, through this issuance, _ has mobilized various agencies—the DOH, POPCOM, DILG,® and ‘ther relevant national government agencies—to accelerate the implementation of the RH Law.2 At the core of the successful implementation of this law, however, is the immediate availability and accessibility of contraceptive drugs and devices to the public, which can only be made possible if the FDA is allowed’ to make an independent scientific evaluation on the drug or device's safety, efficacy, purity, quality, and non-abortifacience and issue a CPR, without “subjecting the Issuance thereof to prolonged trative and judicial appeals process. The immediate y of contraceptive drugs and devices is also essential for POPCOM to effectively perform its mandate under the law, as it Is tasked to “formulate and adopt integrated and comprehensive long-term plans, program and recommendations on population.””” 24 Respondents plead the Honorable Court that its ruling in this case would have a tremendous impact on the effective implementation of the RH Law. To relterate,contraceptive drugs and devices, which prior to. the enactment of the RH Law were not subject to re- certification, are now subject to further scrutiny for non abortifacience. This added layer of scientific evaluation ensures that the public would avail safe drugs or devices. Further subjecting this scientific evaluation to quasi-judicial and judicial rules of procedure would, however, defeat the purpose of the RH Law and would have practical detrimental effects to the public who will have difficulty of availing safe and non-abortifacient contraceptive drugs and devices. 25. For the foregoing reasons, respondents plead the Honorable Court to urgently lift the TRO and to reverse the Decision dated 24 August 2016. PRAYER WHEREFORE, premises considered, respondents respectfully pray of the Honorable Court to: 1) REFER THE PRESENT CASE to the Honorable Court En Banc; 2) URGENTLY RESOLVE the Omnibus Motion dated 10 October 2016; 3) LIFT the Temporary Restraining Order dated 17 June 2015; and 4) REVERSE the Decision dated 24 August 2016 in G.R. No. 217872. Other just and equitable reliefs are also prayed for. Makati City for the City of Manila, 01 March 2917. — segeCam ‘sdtetor Before! ose Sater IBP Lifetime No. 1015360 - 08/18/16 MCLE Exemption No. VI-000016 -08/28/16HENRY 5. ANGELES Assistant Solicitor General Roll No. 45837 IBP No. 1050040, 10/13/16 MCLE Compliance No. V-0026001, 10/14/16 ( ) C- GERMAINE L. CHUA Associate Solicitor Roll No. 59797 IBP Lifetime No. 014616, 4/1/16 MCLE Compliance No. V-0011787, 11/10/15, Y Pas dapoen~ ‘Associate Solicitor Roll No, 62511 IBP Lifetime No. 014614, 04/01/16 MCLE Compliance No. V-000327 tom LILIBETH C. PEREZ-DE GUZMAN Associate Solicitor Roll No. 62428 18P Lifetime No. 014618 MCLE Compliance No. V-0011786, 11/10/15 OFFICE OF THE SOLICITOR GENERAL 134 Amorsolo St., Legaspi Village 1229 Makati City Tel. No.: 8186301 to 09 (Trunkline) Fax No.: 8176037 Website: www.0s9.gov.ph Email: docket@osa.gov.phCopies furnished: Paulyn Jean B. Rosell-Ubi ‘Secretary-Designate Department of Health ‘Sta. Cruz, Manlla |, MD, MPH, CESO 1 Nicolas 8. Lutero ‘Assistant Secretary Department of Health Charge, Food and Drug Administration Nela Charade G. Puno, RPh Director-General, Food and Drug Administration Civic Drive, Filnvest Corporate City Maria Concepcion S. Noche Counsel for Petitioners 91 Melehor Street Loyola Heights, 1108 Quezon city EXPLANATION (Pursuant to Rule 13, Section 11 of the 1997 Rules of Civil Procedure) This Urgent Motion to Resolve is being served by registered mail due to lack of sufficient personnel in the Office of the Solicitor General to effect personal service. 5 LILIBETH C. PEREZ-DE GUZMAN