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

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