- In 2015, the Philippine Supreme Court listened to opponents of the RH Law and did not accept the Food and Drug Administration's (FDA) science-based statement that implants DO NOT cause abortions.
- This led to a temporary restraining order (TRO) on two implants and eventually, the pill. This means their product registrations can't be renewed and they'll run out soon. New product registrations can't be processed too. Contraceptives are running out.
- Hormonal contraceptives work before pregnancy can even begin—before implantation—and they do not work when pregnancy starts. They DO NOT cause abortion.
- President Duterte must convince the Supreme Court to lift the TRO.
- The Filipinos must clamor that the TRO be lifted. Letting our voices be heard is our responsibility.
- The TRO is anti-poor. Lifting it can help ease poverty.
- Contraceptives are used not just for birth control, but to treat medical conditions as well.
In 2015 and 2016, the registration of 14 contraceptive brands have expired. This year, as of May 21, the certificates of 10 have already gone, and there will be four more before the year ends. Some of you have started hoarding contraceptives. Some of you who have stocked up know that the whole thing feels surreal—really, contraceptives will be banned as long as the Supreme Court doesn’t lift the temporary restraining order? And you can’t believe that you’re stockpiling and getting other women’s share of their brand of pills—it feels so wrong because you’re not the only one who doesn’t want to get pregnant, who needs to treat her PCOS, or needs to regulate her period. But this TRO puts all of us in this messy situation.
The TRO on contraceptives is a pain. Unfair and unjust? You have no idea. Here’s your complete guide to understanding just how crazy it is that our country even has it.
The Legal Aspect
In 2015, opponents of the Responsible Parenthood and Reproductive Health Law (RPRH Law, aka RH Law) petitioned two things to the Supreme Court:
- That the Food and Drug Administration (FDA) had disregarded due process for not conducting a public hearing that listened to them, the opposition;
- That the FDA had certified and distributed Implanon and Implanon NXT, two contraceptive implants that allegedly have abortifacient characteristics.
The Supreme Court heeded the complaint; it did not accept the FDA’s statement that Implanon and Implanon NXT are not abortifacients, and then it issued a temporary restraining order (TRO) on contraceptives.
From restricting the Department of Health (DOH) and the FDA from “procuring, selling, distributing, dispensing, advertising, and promoting the hormonal contraceptive Implanon and Implanon NXT,” the TRO escalated to prohibiting the DOH and the FDA from registering and recertifying contraceptives.
This means that the drug warehouses in the Philippines have not been restocked with contraceptives since 2015, and that contraceptives will run out one day—DOH estimates 2020—if the Supreme Court does not lift the TRO.
To be clear, the TRO requires the FDA to conduct a “protracted registration process” to all new contraceptives. This means that we can have access to new contraceptives, but that will not be the case until after at least two to three years (the duration of FDA’s registration process if the decision is not challenged in court). If the FDA’s decisions were brought to court again as in the case of Implanon and Implanon NXT—which is likely to happen—the delays on registration can last for more than a decade. In other words, the complaints of the opposition that led to the TRO on Implanon and other contraceptives in the Philippine market can lead to more TROs, this time on new contraceptives.
So is having public hearings part of FDA’s due process for drug regulation? The FDA has refused to comment, stating that they do not want to violate the Supreme Court’s sub judice rule. Their representative explains, “In essence, the sub judice rule restricts comments and disclosures pertaining to pending judicial proceedings.”
The FDA does disclose their regulation process, however.:
1. Drug establishments (e.g., manufacturers, distributors, outlets, research groups) must prove their compliance with pertinent good practices (in the manufacturing, distributing, storing, clinical, or laboratory aspect). If it finds them compliant, the FDA will issue the drug establishments with a license to operate. Establishments need the license to operate before they can engage in any activity concerning drugs.
2. The licensed establishments also need to have their products registered. They must then prove that they comply with the standards set by the Association of Southeast Asian Nations (ASEAN) and the International Conference on Harmonization (ICH).
The FDA reviews the full quality, safety, and efficacy of the establishments’ documents to see if they meet the ASEAN’s and ICH’s standards.
As for identifying abortifacients, the FDA assesses each contraceptive’s dosage (for drugs) or intended use (for devices) before including the contraceptive in the Essential Drugs List. This process complies with the RH Law.
The FDA issues the certificate of product registration (CPR) to establishments that pass the assessment. This CPR is FDA’s authorization that the specific drug can be marketed in the country.
3. The FDA monitors the licensed establishments for continuous compliance to standards and product registration policies through Post Marketing Surveillance (PMS). PMS involves:
- Routine quality monitoring the products in the market
- Collecting samples
- Lab testing the collected samples
- Practicing pharmacovigilance (detecting, assessing, understanding, and preventing adverse effects or any other drug-related problem)
- Processing adverse drug reactions or events following immunization
- Monitoring the advertisements, promotions, and claims on drugs
- Issuing health advisories, warning, and alerts
- Enforcing regulatory action (seizing unregistered, substandard, and counterfeit drugs)
4. The FDA collaborates with international agencies like the World Health Organization, United States Pharmacopeia–Promoting the Quality of Medicines, European Union, Asia Pacific Economic Cooperation, and other drug regulatory authorities in terms of capacity building, updating standards, streamlining procedures and requirements.
5. The FDA collaborates with local government agencies in enforcing and regulating products.
All that said, according to the Supreme Court’s transcribed decision, the Office of the Solicitor General argued that the FDA is not required by law to conduct a hearing or give notice on its recertification process, because FDA’s decisions are based on “scientific determination of fact.” And sure enough, what body is more credible in doing that on contraceptives than the FDA?
Nonetheless the FDA did give notice “inviting Marketing Authorization Holders of 50 contraceptive drugs to apply for reevaluation/recertification of their contraceptive products” and did ask “all concerned to give their written comments to said [reevaluation/recertification applications] on or before October 8, 2014.”
Contraceptives vs. Abortifacients
One of the strongest opponents of the RH Law and contraception is the organization Alliance for the Family Foundation Philippines (ALFI).
According to the Supreme Court’s decision, “ALFI, in the belief that the contraceptives enumerated in the [FDA notice] fell within the definition of ‘abortifacient,’ filed its preliminary opposition dated October 8, 2014 to all 50 applications with the FDA.”
The RH Law defines “abortifacient” as any drug or device that induces:
- The destruction of a fetus inside the mother’s womb
- The prevention of the fertilized ovum to reach and be implanted in the mother’s womb
The reason behind the third definition is that human life is widely accepted to start in fertilization. There are still those who disagree, but there’s a scientific explanation behind the belief: a maternal protein called the early pregnancy factor (EPF). The embryo, being a foreign entity in the body, should be rejected by the body’s immune system like any other foreign entity is. However, the embryo is not. The EPF has been found to suppress the mother’s immune system to let the embryo develop and the pregnancy ensue. Meaning, there is already a “cross-talk” between the mother and the embryo even before implantation. With this, one cannot simply alter the definition of an abortifacient or say that we change when human life begins.
So do contraceptives exhibit abortifacient characteristics?
To answer that accurately, we’ll first need to know how our reproductive system works in terms of ovulation, fertilization, and implantation, and how contraceptives affect these processes.
Briefly, ovulation happens when the ovary releases a mature egg cell to the fallopian tube for fertilization. For ovulation to begin, the brain (the hypothalamus, in particular) secretes the sex hormone GnRh. The GnRH stimulates another part of the brain (the anterior pituitary) to release two more hormones: FSH and LH. FSH stimulates the growth of a follicle (where an egg cell is) in the ovary, and the follicle growth stimulates the brain to secrete more LH to boost the growth. When mature, the follicle pushes against the ovary wall, ruptures, then releases one egg cell.
For a more in-depth look into ovulation, check out this video below:
Fertilization occurs when the egg fuses with the sperm. For it to occur, the woman must have ovulated five days before to one day after sexual intercourse; and there must be sperm in the reproductive tract (it remains there for three to five days after ejaculation).
Implantation is the process where the fertilized egg implants into the uterine lining. It usually occurs five to nine days after fertilization.
The hormonal contraceptive is believed to have three mechanisms of action:
- It inhibits ovulation. It does this by inhibiting the release of the sex hormone GnRH from the brain. This then reduces the levels of LH and FSH, so follicles don’t develop in the ovary. The second LH secretion is also absent, which removes the stimulus for follicle rupture and ovulation.
- It thickens the cervical mucus. This adds an additional barrier to sperm penetration if ovulation occurs.This blocks the sperm from meeting an egg to fertilize it.
- It prevents the implantation of the fertilized egg. The action of the progestins in the pill makes the uterine lining unreceptive to implantation. This means that the uterine lining becomes thinner, reducing the chances of implantation.
As you can see, hormonal contraceptives work before pregnancy can even begin—before implantation—and they do not work when pregnancy starts.
That said, they cannot end pregnancy by killing the fetus; the first two RH Law definitions of abortifacients are then out.
The first two are proven mechanisms of action of the hormonal contraceptive. The third mechanism of action (apart from religious reasons) is most likely what makes religious groups criticize contraceptives or makes pro-life advocates ambivalent about contraceptives. After all, the third mechanism does end human life and is an abortifacient following the RH Law’s definition.
Those who are pro-contraceptives have claimed that the third mechanism of action only works in theory, and that it is not likely to happen—if it will at all—because of the pill’s effectiveness in preventing ovulation and thickening the cervical mucus. Some of them also believe that the third mechanism of action was merely advertised to boost sales, since women who are considering contraceptives want to make sure they work perfectly.
Studies have challenged the third mechanism of action by:
- Presenting the effectiveness of contraceptives in suppressing ovulation. If ovulation does not occur, then the egg cannot be fertilized, which also means that there is nothing to prevent from implanting.
Published in the journal Reproductive Biology and Endocrinology in 2013, one study found that using certain hormonal contraceptives produces significantly fewer egg cells. That’s because the ovaries barely respond to stimulation when a woman takes a certain contraceptive. The researchers concluded that the reduced number of egg cells lowers pregnancy chances.
Published in Obstetrics and Gynecology in 2014, another study found that certain hormones in contraceptives work better than others in suppressing ovarian function and inhibiting ovulation. And when the contraceptives were discontinued, the contraceptive users began ovulating again.
When it comes to oral contraceptives (the pill), chances of ovulating range from 8% to 0%, depending on the hormones present and their dose. As for the contested implant Implanon? It’s been found to suppress ovulation for 30 months; no pregnancies occurred in the three years of its intended use. Approved by the World Health Organization, the tiny implant also thickens the mucus in the user’s cervix, hence blocking the sperm from swimming to an egg cell. Making the uterine lining thin is not a mechanism of action.
- Stating that a thin uterine lining does not prevent implantation. Women who use contraceptives have been observed to have a thinner uterine lining than women who don’t. As a study finds, 18% of pill users have uterine linings that become thin (less than seven millimeters), and that happens after being on the pill for five years or more. Unfortunately, the researchers did not have information on what pills caused the thinning. Researchers of the same study suggest that the thinning is a side effect, not an intended effect, of the pill. As a side effect, the thinning does not happen to all pill users. But it is difficult to predict who will experience this side effect and who will not.
Some studies have found that a uterine lining that is less than six or seven millimeters will not let implantation occur, and that the optimum lining must be eight to ten millimeters for successful implantation.
However, there are also studies that show that a thin uterine lining does not hinder implantation. Their researchers found that there is no significant or statistical difference in pregnancy and live birth rates in women with different uterine lining measurements.
With these opposing conclusions, one must note that there are other factors besides a thin uterine lining that contribute to implantation failure: embryos with genetic abnormalities that make the womb reject them; genetic expression of the endometrium; presence of polyps and myomas; and sperm abnormalities. In other words, there’s much more to getting pregnant than having a thick uterine lining.
Anti-contraceptive groups need to present scientific studies to back their claim that contraceptives are abortifacients, especially when their intention is to block a country’s contraceptive use.
Their research must answer these questions: How often do contraceptive users ovulate and have an egg fertilized? If fertilization happens, what is the chance that the fertilized egg will fail to implant?
Studies have found that about 75% of fertilized eggs fail to implant naturally. And as stated earlier, there are several reasons behind this failure.
If oral contraceptives add to the rate of implantation failure, it follows that research would show evidence of a failure rate higher than the 75% that happens naturally.
We contacted ALFI to ask how it understands the law’s definition of an abortifacient, how they identified Implanon and other contraceptives as abortifacients, and what their sources are. ALFI did not respond.
Some contraceptives, considering the hormones they have and the dose of hormones, have been proven to not exhibit abortifacient characteristics. Implanon is one of them. The judicious among us can all agree that those contraceptives are not rightfully banned.
What Would It Take To Lift The TRO?
The science was not enough to convince the Supreme Court that some contraceptives are not abortifacients, which is why the TRO still stands today. (The studies presented in the previous section of this article are just other research out there; FDA has presented its own to Congress and to the Supreme Court.) Because of this, it’s inevitable to feel helpless.
The Philippine Legislators’ Committee on Population and Development (PLCPD), one of the proponents and supporters of the RH Law back when it was still a bill in 2012, states that two things must happen to increase the chances of the Supreme Court’s lifting the TRO:
- The President must convince the Supreme Court to lift the TRO.
- The Filipinos must clamor that the TRO be lifted.
As an independent branch of the Philippine government, the judiciary is the only entity that can lift or reverse the TRO. “Yet the President is the most powerful individual in the country,” states PLCPD executive director Romeo Dongeto. “Hence he has the political muscle to convince the justices.”
Dongeto expounds: “The President must do this as part of his mandate; the move will be in accordance to his executive order [Executive Order 12], where he states that the goal is to have zero unmet needs when it comes to modern family planning methods by 2022. It will also abide by the RH Law, which seeks to protect every woman’s right to choose the family planning method she wants and to have access to it.”
Also, it is the President who appoints Supreme Court justices. It’s possible that the decision to keep the TRO will change with the new justices.
Dr. Esperanza Cabral, who chairs the national implementation team of the RH Law, says that we need to let the President know we want him to appoint justices who are committed to upholding women’s rights, which include sexual and reproductive health rights.
And this is where the second point comes in: We need to create buzz. This issue needs to be viral.
While the President himself and his allies understand the issue, the President needs to hear the people’s clamor to remind him that we are all affected and that we are afraid of the consequences the TRO brings on a personal and national level.
Letting our voices be heard is our responsibility as citizens in making sure there will be as little government neglect as possible.
So let’s create buzz by telling our friends about the issue. Share articles about the TRO on contraceptives. If you know anyone who works in a foreign news outlet, tell them to cover this story as well; international spotlight does get more people talking and hopefully concerned. Write your own commentary or open letter on a blog or on social media. Sign the petition urging the Supreme Court to lift the TRO and tell other people to sign it too.
Let’s also urge the DOH and the FDA to be more aggressive in dispelling misinformation on the contraceptives they have certified, and in disseminating the benefits of contraceptives and how each of these work in our bodies. As the experts, the DOH and the FDA have the facts. Only by knowing these facts can people make informed choices on using contraceptives or joining their peers in petitioning that the Supreme Court lift the restraining order.
Just keep in mind that when you voice out your thoughts or feelings, do it with kindness. At this point of needing to convince the mind of a branch of government, we need to be gracious as we deliver our feelings or our reasoning based on science. It’s too risky to meet others with pride, anger, and superiority, because that will just cause the opposition to repeat their arguments and shun our points. And with a limited stock of contraceptives on our shores, we can’t afford to keep antagonizing others.
If the TRO stays with us until the next election period, or if you want to prevent something like this from surfacing in the future, Dr. Cabral advises that we “vote oppressive and bigoted government officials out of office” or we “don’t elect them into office.”
That means we must inform ourselves about our rights and about the candidates who champion them. So when our rights are violated or we want to exercise our right to choose—our freedom—we know whom to vote for. Let’s use this TRO as an opportunity to be informed and to inform others on who truly has our best interests at heart and is capable of delivering them.
Why We Need To Do Something!
Our right to choose is trampled on.
We need to fight for this right, and not just our right as women to have access to safe, highly effective, and modern family planning methods. Since it has issued a TRO on contraceptives, what would prevent the Supreme Court from issuing TROs on other things we consume when a group complains about their life-threatening characteristics? The government is dictating to us what we can and cannot use—and for our own health and welfare—instead of allowing us, with the help of medical professionals, to exercise our freedom to decide what is best for ourselves.
There is a demand for effective family planning methods.
A survey released by the research and policy organization Guttmacher Institute shows that in 2008, among married Pinays (or Pinays living with their partners), 24.5 percent of them want to space their next birth, while 62.7 percent of them want no more children.
Yet the contraceptives that might be left for women to use—condoms, the rhythm method, and withdrawal—are the three most ineffective methods. Women’s chances of getting pregnant with these methods (failure rates) are relatively high.
In the Philippines, considering typical use, condoms have a failure rate of 10.9%; rhythm method, 14.1%; and withdrawal having the highest rate of 20.4%. On the other hand, the pill has a low failure rate of 4.8%.
All over the world, the most effective contraceptive is the implant, with a failure rate of 0.6%. Implant use in the country was growing in 2015, from 120,000 users to more than 150,000 users. But because a TRO was issued on the implant Implanon on the same year, the DOH had to remove it from women and make it unavailable. The Commission on Population (POPCOM) estimates that there have been additional 500,000 unintended pregnancies since.
Contraceptives are needed to treat certain medical conditions.
Some of these medical conditions include but are not limited to dysmenorrhea (menstrual cramps), menorrhagia (heavy menstrual bleeding), polycystic ovary syndrome, and endometriosis.
50% of menstruating women—and 90% of adolescents—suffer from dysmenorrhea. It’s the leading cause of women’s absence from school or work. Studies have found that contraceptives considerably reduce the pain that comes with menstruation. The contraceptives do this by inhibiting or lessening the release of prostaglandins, which are compounds that, when released, cause the uterus to contract.
Polycystic ovary syndrome (aka, PCOS)—which causes irregular periods, excess body hair, ovarian cysts, and infertility—can be treated by contraceptives.
10% of fertile women suffer from menorrhagia. Women with this debilitating health condition bleed more than 80 mL per cycle, so they can develop iron deficiency anemia. The pill has been widely used to treat this condition, since it effectively reduces menstrual blood flow and increases levels of hemoglobin (the protein in red blood cells that carry oxygen throughout the body).
Polycystic ovary syndrome (aka, PCOS)—which causes irregular periods, excess body hair, ovarian cysts, and infertility—can be treated by contraceptives. The primary treatment of women who have PCOS—contraceptives—regulate menstruation, reduce the level of testosterone produced by the ovaries, and help reduce excess hair growth. They have also been found to reduce the risk of endometrial cancer, which is higher for women with PCOS.
Endometriosis, a disease where the uterine lining grows outside of the uterus (instead of inside the uterus), affects up to 10% of fertile women. Its symptoms include dysmenorrhea, chronic pelvic pain, and infertility. Contraceptives prevent the growth of cells on the pelvic cavity and control the pain of the symptoms.
Women with the listed conditions are just some of those who need contraceptives for better health and pain management, so that they can participate in society.
Lifting the TRO on contraceptives helps lessen infant and maternal deaths.
Dr. Cabral states that the risk of infant and child mortality rises dramatically when there are four or more children in the family and when birth intervals are short. Birth intervals of less than two years are associated with an increased risk of infant death by 60%, according to the World Health Organization. These deaths are most likely caused by the absence of breastfeeding and by the competition among infants over the same resources such as food and medicine—and these are scarce for indigent families.
Studies have seen that birth spacing through modern family planning methods can save the lives of more than two million newborns and children every year.
Family planning can also prevent a third of maternal deaths. Apart from staving off unintended pregnancies and subsequent abortions, which are usually unsafe, family planning controls the number of children in the family or delays motherhood.
If in 2011, 221 mothers died for every 100,000 live births, now, with more contraceptives becoming inaccessible, POPCOM sees that maternal deaths can reach up to 8,000 in 2022.
“The mortality rate of women with [four or more] children is three times higher during pregnancy than that of women with two or three children only,” Dr. Cabral explains. “Complications can occur for the mother-of-many, including rupture of the uterus, high blood pressure, kidney disease, and hemorrhage.”
Effective family planning also becomes more important considering that POPCOM observes that more 15- to 19-year-old Pinays have been getting pregnant. The Philippine Statistics Authority has found that one in every 10 Filipino girls in that age group is already a mother. These girls, because of teenage pregnancy, have higher incidences of having adverse maternal outcomes such as postpartum hemorrhage, infections, and death.
Another age group that POPCOM sees to have an increased fertility rate is women who are 45 to 49 years old. And women who are over 40 years old and pregnant are more likely to experience complications like gestational diabetes (diabetes that affects the pregnancy and the baby’s health) and high blood pressure with kidney and liver damage.
If in 2011, 221 mothers died for every 100,000 live births, now, with more contraceptives becoming inaccessible, POPCOM sees that maternal deaths can reach up to 8,000 in 2022.
The TRO is anti-poor. Lifting it can help ease poverty.
“While the lifting of the TRO on contraceptives is important to all of us, it is of utmost importance to indigent women and families,” Dr. Cabral states. “They are the ones with the most urgent need to plan their families.”
Since one in every 10 Filipino girls is already a mother and bearing children, the consequences of such an early pregnancy extends to the economic aspects of the teen’s life. Teen moms are more likely to be single and have fewer years of education. So how can they provide for their child and raise their child when there are only low-wage jobs for high school graduates or those who stopped their secondary schooling altogether? Even if we assume that their partners stay with these teen moms, how can the teen mothers contribute more to their family and society, especially if we consider that they will be pregnant again, bear another child, and would have to stay home to take care of another baby? Having few years of education (and being unable to continue studying) not only makes them vulnerable to being abused by other people. With a poor background it sets these very young women back—to a “lifelong downward cycle of poverty,” as the UN phrases it—and so does having more children to take care of with very little means to do so.
Big families are also another obstacle to overcoming poverty. Studies have shown that children with fewer siblings receive longer schooling, because the parents can invest more in each child. And we all know that with education comes empowerment and opportunities—education allows people to move up the socio-economic ladder and improve the quality of their lives.
Family planning “unlocks the door to other rights and opportunities.” - United Nations Population Fund
Safe, effective, and modern family planning, although not the only solution to poverty reduction, presents an opportunity for women, especially poor women, to take control of their lives, continue and finish school, and participate in public life and economic activities—it’s also an opportunity to promote and exercise gender equality. These women’s children can in turn benefit from attending school regularly (rather than skipping school to peddle) and receiving proper health care.
The UN also deems that family planning is a human right. As a human right, it should be accessible to all regardless of their wealth and religious beliefs—or lack thereof.
*This story originally appeared on Cosmo.ph. Minor edits have been made by the Preview.ph editors.