Legal, Ethical and Regulatory Aspects of Introducing Emergency ...
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76 International Family Planning Perspectives
where abortion is legally prohibited,2 thesale of hormonal drugs for emergencycontraception is permitted. Such regula-tory approval for emergency contracep-tion enables health providers, includingpharmacists, to be trained to help womenuse such methods safely and effectively.
The question of when contraception endsand abortion begins may affect how legis-lation related to emergency contraceptionis framed.3 Many countries have no legaldefinition of abortion or pregnancy. In ad-dition, reproductive health and rights ad-vocates have often sought to separate theconcepts of abortion and contraception.However, opponents of contraception andabortion can be expected to incorrectlyequate emergency contraception with abor-tion to create confusion between the two inboth the legal and political arenas.
Restrictive abortion laws are likely tohave only a limited impact on the actualuse of the most common emergencymethods (combined pills and the IUD).However, antiabortion laws could in-crease the likelihood that certain emer-gency methods will be restricted to con-trolled distribution points.
In practice, easy access to hormonalmethods in many developing countrieshas enabled women to use these drugs toprevent pregnancy on their own, despitethe presence of laws or religious edicts re-stricting their use. Policies and laws thatprohibit or curtail dissemination of healthinformation on emergency methods canalso drive women to use them withoutproper counseling from trained healthproviders or pharmacists.
Emergency contraception administeredimmediately after unprotected intercoursewould probably be legal in countries withsomewhat restrictive abortion laws that usethe medical definition of pregnancyi.e., apregnancy is not achieved until implanta-tion is completed. (Such countries includeGermany, Liberia and New Zealand.) Thiswould be true even in cases when fertiliza-tion had most likely occurred, since pre-venting a fertilized ovum from completingthe process of implantation does not con-stitute an abortion in these countries.
Attempts at preventing implantationare not governed or restricted by abortion
Florence M. Tadiar is associate professor at the Collegeof Public Health, University of the Philippines, Manila,the Philippines. Elizabeth T. Robinson is associate directorof information programs at Family Health Internation-al, Research Triangle Park, N. C., USA.
Legal, Ethical and Regulatory Aspects of IntroducingEmergency Contraception in the PhilippinesBy Florence M. Tadiar and Elizabeth T. Robinson
Emergency contraception is the useof drugs or devices to prevent preg-nancy within a few days after un-protected coitus. A variety of legal and political obstacles may hamper the intro-duction of emergency contraception intodeveloping countries. Many of these ob-stacles are rooted in a basic lack of knowl-edge about the mode of action of emer-gency methods, the indications for theiruse and their availability.
The most common methods of emer-gency contraception, combined oral con-traceptives (estrogen-progestin pills) andcopper IUDs, are legal for regular contra-ceptive use in most countries, and areavailable through public health services,private physicians and pharmacies. Morethan 20 countries* have licensed existingdrugs for emergency contraception; inmost developing nations, however, thereare no laws specifically governing the useof emergency contraception.
Furthermore, the legal status of otherdrugs considered safe and effective foremergency contraceptionsuch as certainantiprogestins1 and androgensvariesmarkedly by country. These methods mustbe used within a few days of unprotectedintercourse to be effective as emergencycontraception. Such compounds must bedistinguished from various analgesics, an-timalarial drugs, antibiotics and other drugsthat women in many developing countriesuse to induce menstruation or early abor-tion, none of which have been tested forsafety or efficacy for these purposes, or asmethods of emergency contraception.
Whether regulatory agencies in a givencountry will formulate specific policies onemergency contraception depends on anumber of factors. In some countries, ap-proval of emergency contraceptives maybe dictated largely by the interpretationof abortion laws, despite their use to pre-vent pregnancy. In others, abortions legalstatus may have no connection to the gov-ernments willingness to approve emer-gency methods. In Nigeria, for example,
laws in other countries, such as the Unit-ed Kingdom,4 in part because legal proofof criminality would rest on proof of preg-nancy; physical trauma from an abortionprocedure would also be required forprosecution or conviction of criminality.5In addition, emergency contraception mayalso be legally acceptable in countrieswhere menstrual regulation (vacuum as-piration) is permitted, such as Bangladesh,or where pregnancy is defined as begin-ning as late as 35 days after intercourse.
This article describes the complex influ-ences of regulatory laws, religion, politicsand ethics on the provision of emergencycontraception in one large developing na-tionthe Philippines, which has no lawspecifically governing the use of emergencycontraception. Although emergency meth-ods are little-known in the country, sever-al factors suggest that they may be wellsuited to the Philippines.
Philippine Legal ContextIn the Philippines, estrogens, progestinsand their combinations are included in theNational Drug Formularys EssentialDrug List, which specifies routes of ad-ministration, pharmaceutical forms andstrengths.6 These drugs are also includedin the reference manual for prescribingpharmaceutical products commonly usedby physicians and pharmacies. There isnothing specific to bar a physician fromprescribing combined pills in the higherdosages necessary for emergency use. IUDinsertion for emergency contraceptionwould probably also be acceptable froma legal standpoint, as long as it could notbe established that fertilization had oc-curred. (Of course, pregnancy is a con-traindication for all contraceptives, in-cluding emergency methods.)
In addition, it is unlikely that womensaccess to the pill and IUD could be reduced.Since 1973, pills, IUDs and other fertilityregulation methods have become general-ly available through the Philippine familyplanning program in public and private
*These countries include Bulgaria, the Czech Republic,Ecuador, Finland, Hong Kong, Hungary, Jamaica, Kenya,Malaysia, the Netherlands, Nigeria, Pakistan, Poland,Russia, Singapore, Slovakia, Thailand, the United King-dom, Uruguay and Vietnam.
77Volume 22, Number 2, June 1996
from sales clerksby requesting pam-paregla. No questions were asked or pre-scriptions required.
The most popular remedy prescribed fortreating delayed menstruation (especial-ly in areas outside the city limits) was anoral contraceptive brandcontaining mestranoland norethindrone(Gestex, manufacturedby the drug companyMedichem). This drug isalso indicated for treat-ment of secondaryamenorrhea of short du-ration; doctors prescribeit and other formula-tions upon request.These pills are often referred to as preg-nancy test pills because of the notionamong both women and doctorsthat ifsuch pills do not successfully bring onmenstruation, then a woman must bepregnant.
Thus, Philippine women use pills suchas Gestex to induce menses, deliberatelytaking twice the prescribed dosage ormore. The two women investigators werenever informed by pharmacists or doctorsabout the compounds contraindicationsor its possible effects on a developing fetus.Some of these drugs are relatively inex-pensive. (Gestex, for example, costs US$1.00$1.50 per tablet.) Other mestranol-norethindrone combinations are far cost-lier, however, with one (marketed as Pro-seckon) costing US $4.50$7.80 per tablet.Some pharmacy clerks, especially thoseworking in poorer areas, also prescribedherbal potions and remedies for delayedmenstruation.
Anecdotal evidence suggests that prosti-tutes take other drugs, such as Fansidar (anantimalarial drug) and Methergine (used tocontrol uterine bleeding), which are ru-mored to be effective for inducing menses.An over-the-counter remedy for stomach-aches (Esencia Maravillosa), whose activeingredient is unknown, is also said to becommonly used by low-income women be-cause it is cheap and easy to obtain.
According to a community-based studyin Davao conducted among urban poorwomen, nearly 71% said they had evertried to induce menstruation.9 Most hadused high doses of combined pills; othershad tried prostaglandins such as miso-prostol, an antiulcer drug that is used insome countries with mifepristone in med-ical abortion, as well as analgesics and bit-ter herbal concoctions.
Our examination of the medical recordsof women attending a clinic in Metro
hospitals, clinics and pharmacies. The factthat these methods are so accessible towomen and represent the standard optionin the public and private sectors suggeststhat it would be difficult to prevent theiruse for emergency contraception.
However, some legislators who opposeartificial family planning on religiousgrounds have made repeated attempts,through bills and resolutions submitted inthe Philippine congress, to classify all oralcontraceptives and IUDs as abortifacients.Thus, methods used for emergency con-traception are clearly vulnerable to the samelegal challenges as regular contraceptives.
Given this background, it may be use-ful to examine the Philippine experiencewith the use of oral contraceptives con-taining estrogen and progestin to inducemenses. Many Filipino women have themistaken belief that such drugs can act asabortifacients: A number of studies haveshown that Filipino women sometimesdevise their own remedies for protectionfrom unwanted pregnancy through thewidespread use of very high doses of com-bined oral contraceptives.7 These studiesalso revealed that women and healthproviders distinguish between contra-ception, induction of delayed menstrua-tion (before pregnancy status is deter-mined) and abortion, although the samedrugs in varying amounts may be usedwith varying degrees of efficacy for thesedifferent purposes.
In 1992, a survey was conducted of theavailability of, use of and regulations im-posed on combined pills in the city ofDavao and its surrounding areas, in thesouthern Philippines.8 The survey wasconducted about one year after the Philip-pine government passed the GenericDrugs Act, which requires that oral con-traceptives containing estrogen and prog-estin be prescribed only by a doctor. Theprescription must indicate the genericname of the active ingredients and the spe-cific chemical form (and brand name, ifdesired), the dosage, the delivery modeor system and the appropriate dosefrequency.
To collect the data in this survey, twowomen (one dressed poorly, the otherwell-dressed) posed as clients in need ofa substance to induce menstruation (lo-cally known as pamparegla) and sought as-sistance from pharmacies and doctors inthe Davao area. Even though the Gener-ic Drugs Act restricts prescription re-sponsibility to doctors, the women easilyobtained a variety of combined pills (Ges-tex, Duphaston, Femenal, Promolut N andProseckon) from pharmaciesand even
Manila in 1994 confirmed this practice oftaking combined pills to induce men-struation (in the belief or hope that theamenorrhea was not caused by pregnan-cy) or an abortion (when a pregnancy wasstrongly suspected or confirmed). Among
the 237 women who wanted to inducemenstruation or terminate their preg-nancy, 40% had already attempted to doso. (Sixty percent had done nothing.)Among the 40%, 12% said they had triedcombined pills (and this proportion wasprobably larger, since some women re-ported having injected or ingested an un-known compound); 9% had resorted toabdominal massage or acupressure and7% had taken misoprostol. The remaining11% had taken a variety of other drugs (in-cluding analgesics and antibiotics) orherbal medicines. Most of these women(75%) had used more than one of thesemethods to induce bleeding.
These studies suggest that both womenand health providers in the Philippineswould welcome having the option ofemergency contraception. They also in-dicate that there would likely be little com-pliance with any law restricting emer-gency contraception in case of potentialclaims that it is an abortifacient.
Barriers to Emergency MethodsAlthough emergency methods may bewell suited to the Philippines, their intro-duction will doubtless encounter a num-ber of obstacles, including those relatedto the countrys laws, the influence of for-eign agencies, medical barriers, a widerange of ethical issues and the Philippinepolitical situation.
Regulatory ObstaclesThe Philippine governments reaction tothe widespread use of misoprostol to in-duce menstruation and abortion may il-lustrate how regulations could restrictemergency contraceptives. In June 1994,newspapers reported that the Bureau ofFood and Drugs had confirmed the drugsabortion-inducing effect.10 The secretaryof health then directed the bureau to con-
Easy access to hormonal methods in manydeveloping countries has enabled women touse these drugs to prevent pregnancy ontheir own, despite the presence of laws orreligious edicts restricting their use.
78 International Family Planning Perspectives
Legal, Ethical and Regulatory Aspects
dicated method of emergency contracep-tion might be expected to pave the way forpossible approval in other countries. Onthe other hand, some products may besuitable for one population but not for oth-ers, given the cultural, social and even bi-ological variations in populations. Sup-port for locally-based research on specificissues related to emergency contraceptionwould probably be helpful to local regu-latory processes.
The U. S. Food and Drug Administra-tion has no explicit policy regarding spe-cific labeling for use of oral contraceptives
or copper IUDs in emer-gency contraception;thus, these methods areexported to developingcountries without a list-ing of the additional in-dication for emergencyuse. In the Philippines,the indication for anyproduct is the one ap-proved by the Bureau ofFoods and Drugs. How-
ever, no provision in the Generic DrugsAct prevents use of a drug beyond thelabels stated indicationas the use ofcombined pills in the Philippines for pur-poses other than their approved indica-tion attests.
But U. S. Food and Drug Administrationapproval, or the lack of it, can clearly af-fect use, as when the agency previouslywithheld approval for depot medroxy-progesterone acetate, which was subse-quently banned in the Philippines. On theother hand, if the U. S. Food and Drug Ad-ministration were to list emergency con-traception as an indication for some fam-ily planning methods, conservative forcesin the Philippines might respond by en-couraging the stricter regulation of or evenan outright ban on these contraceptives.
Medical ObstaclesPrescribing practices that hinder access tocontraceptives or that er...