EXPERT OPINION ON HOUSE BILL 4643 ON ABORTIVE SUBSTANCES AND

DEVICES IN THE PHILIPPINES

UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and

Research Training in Human Reproduction (HRP)

Department of Reproductive Health and Research

World Health Organization

Geneva, Switzerland

7 November 2006
BACKGROUND

The Committee on Revision of Laws, House of Representatives, Republic of the

Philippines requested a position paper on House Bill 4643 (abortive substances and
devices) from the World Health Organization (WHO) Philippines Country Office. The
WHO Country Office forwarded this request to the WHO Regional Office, which in turn
forwarded the request to WHO Headquarters in Geneva.

This Expert Opinion on House Bill 4643 includes three sections:

1. Abortifacient drugs and devices

2. Public health concerns related to "banning the use, production, sale, distribution
or dispensation of abortive drugs" as defined in House Bill 4643
3. International standards on sexual and reproductive health.

The proposed House Bill defines "abortive drug" and "abortive device" as follows:

"Abortive drug shall be defined as any medicine, drug, chemical, or potion that
acts to or has potential either to interfere with the implantation of the fertilized
ovum (embryo) onto the mother's womb or to interrupt pregnancy after
implantation. It shall be included but not be limited to such groups of abortive
drugs as the Oral Contraceptives, Prostaglandins (not to be confused with
Prostaglandins with the beneficial use) and Antiprogesterones. Also included are
the Morning-after pills, Misoprostol, Levonorgestrel, Lerronogestrel 2, patch Evra,
and Injectables like Depo Provera."

"Abortive device shall be defined as any instrument, device, material or agent

introduced into the female reproductive system whose primary mechanism of
action is either to interfere with the implantation of the fertilized ovum onto the
mother's womb or interrupt pregnancy after implantation."

ABORTIFACIENT DRUGS AND DEVICES

There should be consistency in the definitions of abortifacient drugs and devices. Under
abortifacient drugs, HB4643 refers to the "potential" to interfere with the implantation of
the fertilized ovum or interrupt pregnancy after implantation; whereas, under
abortifacient devices no such mention is made. Medical methods of abortion use
pharmacological drugs to terminate pregnancy, including mifepristone, a synthetic steroid
compound, and misoprostol, a prostaglandin. Surgical methods of abortion use
transcervical procedures for terminating pregnancy, including vacuum aspiration (with
electric or manual vacuum source), dilatation and curettage, and dilatation and evacuation
(WHO 2003). Many other drugs and devices, if used inappropriately, can cause harm to
a fetus and/or cause an unsafe abortion. Contraceptives are not abortifacients.

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Mechanisms of action for selected contraceptive drugs and devices

1. Combined Hormonal Methods (oral contraceptives and Evra patch): There has
been a growing body of evidence for more than four decades indicating that
administration of combined oral contraceptives (COC) inhibits follicular
development and ovulation, and that this is their primary mechanism of action
(Mishell et al. 1977; Killick et al. 1987; Rivera et al. 1999). They also affect
cervical mucus, making it thicker and more difficult for sperm to penetrate. This
effect may also contribute to their high efficacy (Rivera et al. 1999). Although it
is known that there are changes in the endometrium during combined oral
contraceptive (COC) use, no evidence to date has supported the hypothesis that
these changes lead to disruption of implantation. Given the high efficacy of
COCs in preventing ovulation, it is very unlikely that "interference with
implantation" is a "primary mechanism" of contraceptive action.

The same mechanism of action also applies to the Evra patch.

2. Progestin-only Methods (Depo Provera, minipills, implants): Progestin-only

methods also inhibit follicular development and ovulation although the level of
this effect varies for different progestin-only methods and among individuals. For
Depo Provera, the level of ovarian suppression is very high; therefore inhibition
of ovulation is the primary mechanism of action (Rivera et al. 1999). However,
about 40% of women on the minipill may ovulate (Landgren and Diczfalusy
1980).

A second contraceptive effect of progestin-only methods is the change they make

to cervical mucus, including increasing its viscosity and cell content, reducing its
volume, and altering its pH, proteins and molecular structure. This makes it
"hostile" and impenetrable to sperm (Moghissi et al. 1973). These changes are
likely to play a more important role in the mechanism of contraceptive action of
minipills and implants.

Progestin-only methods also cause changes in the endometrium. However, these

changes show great variability among patients, from atrophy to normal secretory
structures. There is no direct evidence that suggests a relationship between
endometrial structure and contraceptive effectiveness of these methods.

3. Emergency Contraception (morning-after pills, levonorgestrel, levonorgestrel 2):

Levonorgestrel emergency contraceptive pills (ECPs) have been shown to prevent
ovulation and they do not have any detectable effect on the endometrium (uterine
lining) or progesterone levels when given after ovulation. ECPs are not effective
once the process of implantation has begun, and will not cause abortion (WHO
2005; Marions L et al. 2002; Durand M et al. 2001; Croxatto HB et al. 2004).

4. Intrauterine Devices (IUD): The major effect of all IUDs is to induce a local
inflammatory reaction in the uterine cavity. During the use of copper-releasing

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 IUDs the reaction is enhanced by the release of copper ions into the luminal fluids
of the genital tract, which is toxic to sperm (Ortiz 1978; Seseru and Carnacho-
Ortega 1972; Ullman and Hammerstein 1972). In these users, it is likely that few
sperm reach the tubes and those that do reach them have low fertilizing power.

In addition, studies on recovery of eggs from women using copper-bearing IUDs

and from women not using any method of contraception show that rates of
embryos formed in the tubes are much lower in copper-bearing IUD users than
those not using contraception (Alvarez et al. 1988). Thus, the hypothesis that the
primary mechanism of copper-bearing IUDs in women is destruction of embryos
in the uterus (i.e., abortion) is not supported by available evidence.

When used appropriately by adequately trained staff, an IUD does not cause
abortion, as it is not going to be inserted unless it is certain that the woman is not
pregnant.

All the above-mentioned methods (combined hormonal methods, including pills and Evra
patch; progestin-only methods, including Depo Provera, implants, and minipills;
emergency contraception pills; and, intrauterine devices) directly or indirectly have
effects on the endometrium that may hypothetically prevent implantation, however there
is no scientific evidence supporting this possibility. When used appropriately and in
doses/ways recommended, none of these methods have been shown to cause the abortion
of an implanted fetus. Therefore they cannot be labelled as abortifacients. The
contraceptive drugs and devices highlighted in the HB4643 definitions of abortifacient
drugs and devices contradict both WHO's evidence-based international standards on the
mechanisms of action and the drug and device labelling in the WHO Model List of
Essential Medicines (2005).

5. Prostaglandins such as misoprostol can be used to induce abortion. But at the

same time they are lifesaving medications (Blanchard et al. 2002; Weeks et al.
2005). Misoprostol is an inexpensive drug that can be used for evacuation of the
uterus for incomplete abortion, missed abortion, intrauterine fetal death, severe
eclampsia, labour induction, post-partum haemorrhage, and cervical ripening
prior to obstetrical/gynaecological procedures such as therapeutic curettage and
insertion of intrauterine devices (Blanchard et al. 2002).

6. Vacuum aspiration, including electric and manual vacuum aspiration (MVA) is a

technique for inducing early abortion (WHO 2003). However, it is also an
essential emergency lifesaving procedure for treating incomplete abortion (WHO
1995). MVA is also an effective, convenient, cost-saving technology for
performing endometrial biopsy for detection of endometrial hyperplasia and
cancers (Suarez Rincon et al. 2000; Ekwempu 1990).

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PUBLIC HEALTH CONCERNS RELATED TO "BANNING THE USE,
PRODUCTION, SALE, DISTRIBUTION OR DISPENSATION OF ABORTIVE
DRUGS" AS DEFINED IN HOUSE BILL 4643

It is universally recognized that contraception is the most effective intervention to prevent

unintended pregnancy, abortion, child and maternal mortality and morbidity. For
example, in 2000, 90% of global abortion-related and 20% of obstetric-related mortality
and morbidity could have been averted by use of effective contraception by women
wishing to postpone or limit childbearing. A total of 150,000 maternal deaths
(representing 32% of all such deaths) and about one million of the 11 million deaths of
children under age five could be avoided by effective use of contraception (Cleland et al.
2006).

The evidence indicates that when restrictions on access to contraception are enforced and
other pronatalist policies are put in place, unsafe abortion-related maternal morbidity and
deaths increase (WHO 2004a). This was the case in Romania where such restrictions
were imposed in 1966, resulting in increased maternal morbidity and mortality due to
unsafe abortion, but declined sharply after these restrictions were withdrawn in December
1989 (see Figure 1).

The Philippines is characterized as a country with a medium population growth rate and
medium unmet need for contraception (Cleland et al. 2006). Given its restrictive law on
abortion, it would be harmful from both a public health and human rights perspective to
do anything that would decrease use of contraception and increase recourse to abortion.
The proposed House Bills (4643 and 5458) would appear to severely discourage
provision and use of common modern methods of contraception, such as oral pills,
injectables, and IUDs, if not completely restrict their availability and prohibit use.

INTERNATIONAL STANDARDS ON SEXUAL AND REPRODUCTIVE

HEALTH

The global mandate for sexual and reproductive health derives from international
consensus agreements such as the Programme of Action of the International Conference
on Population and Development (ICPD, 1994) and the Platform for Action of the Fourth
World Conference on Women (Beijing 1995). Both consensus documents were signed
by the Government of the Philippines. The most recent mandate is given by World
Health Assembly Resolution 57.12 which was adopted by WHO Member States,
including the Government of the Philippines, in May 2004. This Resolution endorses the
strategy entitled, Reproductive health: a strategy to accelerate progress towards the
attainment of international development goals and targets.

The Strategy reaffirms the definition of reproductive health agreed upon in ICPD and
FWCW (see box). It emphasizes that the various dimensions of sexual and reproductive
ill-health - maternal and newborn morbidity and mortality, lack of access to family
planning, unsafe abortion, sexually transmitted infections and gynaecological morbidities
- account for 20% of the global burden of disease for women and 14% for men.

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 Reproductive and sexual health and rights as defined in the Programme of Action of
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the International Conference on Population and Development

“Reproductive health is a state of complete physical, mental and social well-being and not
merely the absence of disease or infirmity, in all matters relating to the reproductive
system and to its functions and processes. Reproductive health therefore implies that
people are able to have a satisfying and safe sex life and that they have the capability to
reproduce and the freedom to decide if, when and how often to do so. Implicit in this last
condition are the rights of men and women to be informed and to have access to safe,
effective, affordable and acceptable methods of family planning of their choice, as well as
other methods of their choice for regulation of fertility which are not against the law, and
the right of access to appropriate health-care services that will enable women to go safely
through pregnancy and childbirth and provide couples with the best chance of having a
healthy infant. In line with the above definition of reproductive health, reproductive
health care is defined as the constellation of methods, techniques and services that
contribute to reproductive health and well-being by preventing and solving reproductive
health problems. It also includes sexual health, the purpose of which is the enhancement
of life and personal relations, and not merely counselling and care related to reproduction
and sexually transmitted diseases.” (Paragraph 7.2)

“Bearing in mind the above definition, reproductive rights embrace certain human rights
that are already recognized in national laws, international human rights documents and
other consensus documents. These rights rest on the recognition of the basic right of all
couples and individuals to decide freely and responsibly the number, spacing and timing
of their children and to have the information and means to do so, and the right to attain the
highest standard of sexual and reproductive health. It also includes their right to make
decisions concerning reproduction free of discrimination, coercion and violence, as
expressed in human rights documents. ...” (Paragraph 7.3)
_______________
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United Nations document A/CONF.171/13: Report of the ICPD.

The WHO Strategy on Reproductive Health affirms that accelerating progress rests on
internationally agreed instruments and global consensus declarations on human rights.
These include the Covenant on Civil and Political Rights, the Covenant on Economic,
Social and Cultural Rights, the Convention on Elimination of all forms of Discrimination
against Women and the Convention of the Rights of the Child, all of which have been
ratified by the Philippines. The rights enshrined in these treaties include the right of all
persons to the highest attainable standard of health; the basic right of all couples and
individuals to decide freely and responsibly the number, spacing and timing of their
children and to have the information and means to do so; the right of women to have
control over and decide freely and responsibly on matters related to their sexuality,
including sexual and reproductive health, free of coercion, discrimination and violence;
the right of men and women to choose a spouse and to enter into marriage only with their
free and full consent; the right of access to relevant health information; and the right of
everyone to enjoy the benefits of scientific progress and its applications. In order to
ensure that these rights are respected, policies, programmes and interventions must

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promote gender equality, give priority to poor and underserved populations and
population groups, especially adolescents, and provide special support to those countries
that bear the largest burden of reproductive and sexual ill-health. (Paragraphs 33-34,
Reproductive Health Strategy, 2004)

The core aspects of reproductive and sexual health include the provision of high-quality
services for family planning, including infertility services and eliminating unsafe abortion.
(Paragraphs 35-41, Reproductive Health Strategy, 2004). One of the five key actions to
accelerate progress is the creation of supportive legislative and regulatory frameworks in
order to ensure that they facilitate universal and equitable access to reproductive and
sexual health education, information and services. The Strategy asserts that the creation
of such a supportive legislative framework may require the removal of unnecessary
restrictions from policies and regulations. In addition, regulations are needed to ensure
that commodities (medicines, equipment and supplies) are made available on a consistent
and equitable basis and that they meet international quality standards. (Paragraphs 57-59,
Reproductive Health Strategy, 2004)

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REFERENCES

Alvarez F, Brache V, Fernandez E. New insights on the mode of action of intrauterine

contraceptive devices in women. Fertil Steril, 1988;49:768-773.

Blanchard K, Clark S, Winikoff B, et al. Misoprostol for women's health: a review.

Obstetrics and Gynecology, 2002, 99(2):316-332.

Cleland J, Bernstein S, Ezeh A, Faundes A, Glasier A, Innis J. Family planning: the

unfinished agenda. Lancet, 2006 Sexual and Reproductive Health 3. Published online 1
November 2006.

Convention on the Elimination of All Forms of Discrimination Against

Women (CEDAW), 18 December 1979, G.A. Res.34/180, UN GAOR, 34th Sess.,
Supp. No. 46 at 193, UN Doc. A/34/46, entered into force 3 September 1981.

Convention on the Rights of the Child (CRC), 20 November 1989, G.A. Res.
44/25 (XLIV), UN GAOR, 44th Sess., Supp. No. 49 at 167, UN Doc. A/44/49, entered
into force 2 September 1990.

Croxatto HB, Brache V, Ravez M et al. Pituitary-ovarian function following the standard
levonorgestrel emergency contraceptive dose or a single 0.75 mg dose given on the days
preceding ovulation. Contraception, 2004;70:442–50.

Durand M, del Carmen Cravioto M, Raymond EG et al. On the mechanisms of action of

short-term levonorgestreol administration in emergency contraception. Contraception,
2001;64:227–234.

Ekwempu CC. Uterine asperation using the Karman cannula and syringe. Trop J Obstet
Gynaecol, 1990; 8(2):37-38.

Fourth World Conference on Women, Beijing, China, 4-15 September 1995,

UN Document A/CONF.177/20.

General Assembly Special Session on the International Conference on Population

and Development (ICPD + 5), General Assembly A/Res/S-21/2, 8 Nov 1999.

International Covenant on Civil and Political Rights (ICCPR), 16 December 1966,

999 U.N.T.S. 171, entered into force 23 March 1976.

International Conference on Population and Development (ICPD), Cairo, Egypt,

13-15 September 1994, UN Document A/Conf. 171/13.

International Covenant on Economic, Social and Cultural Rights (ICESCR), 16

December 1966, 993 U.N.T.S. 3, entered into force 3 Jan. 1976.

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Juarez F, Cabigon J, Singh S, Hussain R. The incidence of induced abortion in the
Philippines: current level and recent trends. International Family Planning Perspectives,
2005; 31(3):140-149.

Killick S, Eyong E, Elstein M. Ovarian follicular development in oral contraceptive

cycles. Fertil Steril, 1987;48:409-13.

Landgren B-M, Diczfalusy E. Hormonal effects of the 300 mcg norethisteron minipill.
Contraception, 1980;21:87-113.

Marions L, Hultenby K, Lindell I et al. Emergency contraception with mifepristone and

levonorgestrel: mechanism of action. Obstetrics and Gynecology, 2002;100:65–71.

Mishell DR, Kletzky OA, Brenner PF, Roy S, Nicoloff J. The effect of contraceptive
steroids on hypothalamic-pituitary function. Am J Obstet Gynecol, 1977;128:60-74.

Moghissi KS, Syner FN, McBride LC. Contraceptive mechanism of microdose

norethindrone. Obstet Gynecol, 1973;41(4):585-94.

Ortiz ME, Croxatto HB, Bardin CW. Mechanism of action of Intrauterine Devices.
Obstet Gynecol Survey, 1996;51(Supp):S42-S51.

Rivera R, Yakobson I, Grimes D. The mechanism of action of hormonal contraceptives

and intrauterine contraceptive devices. Am J Obstet Gynecol, 1999;181:1263-9.

Seseru E, Carnacho-Ortega P. Influence of metals on in vitro sperm migration in the

human cervical mucus. Contraception,1972;6:231-240.

Suarez Rincon AE, Arevalo Lagunas I, Cerpa Batres MG, Diaz Rodriguez MC.
Diagnostic evaluation of endouterine manual aspiration for the detection of endometrial
hyperplasia and cancer in patients with abnormal uterine bleeding. Gineco Obstet Mex,
2000; 68:1-6

Ullman G, Hammerstein J. Inhibition of sperm motility in vitro by copper wire.

Contraception, 1972;6:71-76.

Weeks A, Alia G, Blum J, Winikoff B, Ekwaru P, Durocher J, Mirembe F. A

randomized trial of misoprostol compared with manual vacuum aspiration fo incomplete
abortion. Obstetrics and Gynecology, 2005;106(3): 540-547.

World Health Organization. World Health Organization model list of essential

medicines. 14th edition. Geneva: WHO, 2005.

World Health Organization. Unsafe abortion: global and regional estimates of the
incidence of unsafe abortion and associated mortality in 2000. Fourth edition. Geneva:
WHO, 2004a.

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World Health Organization. Reproductive health strategy to accelerate progress towards
the attainment of international development goals and targets. Geneva: WHO, 2004b.

World Health Organization. Safe abortion: technical and policy guidance for health
systems. Geneva: WHO, 2003.

World Health Organization. Complications of abortion: technical and managerial

guidelines for prevention and treatment. Geneva: WHO, 1995.

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