Microsoft word - expert opinion on house bill 4643 on abortive substances and devices in the philippines _7nov06_.doc
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
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. 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
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).
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.
Reproductive and sexual health and rights as defined in the Programme of Action of 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)
_______________ 1 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
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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