Misoprostol and women’s health in Sri Lanka

by Ramya Kumar

The absence of safe abortion services in the public sector has obvious implications for both gender and class. First abortion, a health service required only by women, continues to be criminalized and second "safe" abortion services are currently only accessible to women who can afford them in the private sector. With the clamp down on Marie Stopes clinics that had provided abortion services at relatively low cost for more than 20 years, medical abortion has become an alternative that women in Sri Lanka have begun to explore. The drugs used for medical abortion, mifepristone and misoprostol, are reportedly available in private hospitals and pharmacies across the country at exorbitant prices. Both of them are currently unregistered for use in Sri Lanka although misoprostol was recently considered for registration. Their use in Sri Lanka is therefore technically illegal. Further, since Article 303 of the Penal Code states that abortion is permitted only to save a woman’s life, the use of these drugs for medical abortion (except to save a woman’s life) is unlawful in Sri Lanka. Why are these drugs not registered although widely available? And why is there no public debate on abortion law reform in Sri Lanka today?

Swarna: a forgotten statistic

The case of a woman, who I will call Swarna, illustrates some of the social problems associated with unsafe abortion. Swarna was admitted to the Surgical Intensive Care Unit (SICU) of a provincial hospital where I worked as a medical officer. Swarna, a resident of the Uva province, had three children, was poor and could neither read nor write. She had been transferred from a base hospital where she was suspected to have had a reaction to blood transfusion. While family planning services were provided free of charge through the public sector to Swarna, her social situation made her vulnerable to an unintended pregnancy. Criminalized abortion and the fear of law enforcement prevented Swarna from accessing post-abortion care until she was very ill and when she did she strongly denied having had any such intervention. The consultant obstetrician who had seen a similar clinical picture in other women who were admitted after unsafe abortion, decided Swarna should undergo a lifesaving surgical procedure in spite of her denying that she had had an induced abortion. Swarna remained in the SICU for two weeks with multi-organ failure and was lucky to have survived. Swarna and other such women who face the consequences of unsafe abortion are not included in the tally of deaths from unsafe abortion because they survive. When we talk about low mortality from unsafe abortion in Sri Lanka, the stories of Swarna and many others like her are overlooked or forgotten.

Global abortion politics

Abortion is a contentious issue globally. Intergovernmental organizations like the United Nations and the World Health Organization (WHO) are restricted in their dealings with the issue due to strong pro-life lobbies in powerful countries like the United States that impose funding restrictions on providing abortion services. The International Conference on Population and Development Programme of Action (1994) that was endorsed by Sri Lanka and many other countries incorporated a rights perspective on population issues including reproductive health. Although it was considered a watershed for reproductive rights, this document did not address abortion in any significant way. While its focus is on the prevention of unintended pregnancies and implementation of post-abortion care, it states that safe abortion services should be provided in countries where abortion is not against the law. This leaves women in countries like Sri Lanka, where abortion laws are very restrictive, with limited options.

Situation in Sri Lanka

Sri Lanka is doing extremely well in terms of maternal health. We have been able to achieve reductions in maternal mortality without addressing unsafe abortion. In fact our maternal mortality rate is the lowest in the South Asian region. Research shows that there is a high prevalence of abortion (a 1998 estimate suggests 650 abortions per day) and that most women resort to abortion to limit or space their families. In 2006, unsafe abortion became the second highest cause of maternal mortality in the country. While unsafe abortion was identified to be a problem on a review on maternal mortality published by the Ministry of Healthcare and Nutrition in 2009, the strategies they recommended included improving access to family planning and improving post-abortion care. There was no recommended strategy for abortion law reform. It is perhaps surprising that a government that shows much commitment to providing healthcare would leave unsafe abortion off the health agenda. Why does abortion law reform remain on the backburner? And could the potential use of misoprostol for medical abortion have influenced the recent decision on misoprostol registration?

Medical abortion and misoprostol

The WHO recommended regime for medical abortion includes two medications: mifepristone and misoprostol. While the combined regime has a success rate of over 95% in the first 9 weeks of gestation, misoprostol has been used alone for medical abortion in many settings with success rates roughly between 85 and 90%. Although less effective, it is used alone for medical abortion because it is cheaper and also because in many countries misoprostol is registered and freely available while mifepristone is not. The WHO does not recommend misoprostol alone regimens for medical abortion claiming the evidence for such a recommendation is inadequate.

Misoprostol is listed in the WHO Essential Medicines List (EML) for many indications. In 2005, misoprostol was listed for labour induction and with mifepristone for medical abortion, where legal and culturally acceptable (other drugs on the WHO EML do not include notes on cultural acceptability). In 2009, the EML listed misoprostol for incomplete abortion and this year in May for post-partum hemorrhage. Since misoprostol was initially developed for the treatment and prevention of gastric ulcers in 1988, it had been registered without controversy in many countries before its use for medical abortion was discovered. Therefore, today it is widely used by women for abortion in countries where it is registered but abortion laws restrictive. Such use without access to information could result in incorrect dosing with adverse consequences such as increasing rates of incomplete abortion and the occurrence of birth defects in fetuses that are not aborted.

Registration of misoprostol in Sri Lanka

Why was misoprostol, a drug with several obstetric indications, not registered in Sri Lanka? In my study, I focused on the misoprostol policy because it is the only policy related to abortion currently under review. Ten medically qualified experts engaged in women’s health policymaking and four women’s rights advocates with expertise in the social sciences and law were interviewed for this study.

Misoprostol (and mifepristone) is available although unregistered in Sri Lanka and is being widely used in the private sector. An application to register misoprostol was submitted to the National Drug Regulatory Authority (NDRA) by a pharmaceutical company in 2010. The decision to approve a drug for registration lies with the Drugs Evaluation Subcommittee of the National Drug Regulation Authority (NDRA) which consists of medical specialists from various fields and pharmacists. The misoprostol situation was described by one participant to be "tricky" because obstetricians have access to the drug through representatives of pharmaceutical companies who supply the drug to them directly. The drug is also believed to be smuggled into the country from India and Pakistan in "suitcases". The NDRA wished to register the drug for regulatory purposes and quality assurance because it was known to be widely available in the country. The obstetricians probably wanted it registered so that they could use it legally in their obstetric practice.

The NDRA sought the opinion of the Sri Lanka College of Obstetricians and Gynaecologists (SLCOG) on registering misoprostol due to a conflict of opinion within the Drugs Evaluation Subcommittee. In November 2010, the SLCOG recommended misoprostol be registered with restrictions to be used only in the public sector. However, when the Drugs Evaluation Subcommittee met a month later, they could not reach a consensus on registration due to opposition from within the subcommittee. While complications of misoprostol (specifically maternal deaths from using misoprostol for labour induction) had been discussed at the meeting, the potential for using misoprostol for medical abortion had not come up for discussion. Eventually it was decided to keep the decision pending and the decision is still pending today.

Implications on health policymaking

The policy decision on misoprostol appears to have been a result of an undemocratic process based on obscure social values held by a few members of the Drugs Evaluation Subcommittee at the NDRA. Under these circumstances, it seems unlikely that misoprostol will be registered anytime soon.

It would be unfair to say that this policy making process exemplifies health policymaking in general in Sri Lanka. The controversial nature of this drug is likely to have influenced the process. But note that this was a closed process with little input from nonmedical experts. Even the recommendation of the SLCOG, the professional body of obstetricians and gynaecologists in the country, was overlooked. There was no contribution from women’s advocacy groups to the decision making process. Many policymakers in the sample believed that the policy decision on misoprostol was influenced by its possible use for medical abortion.

I would argue that the reason misoprostol registration became controversial in Sri Lanka was because both the NDRA and the SLCOG wished to register the drug for different reasons. Health policymaking is controlled by the Ministry of Health; the public has little access to information on who and how these decisions are made.

Implications for abortion policy

The Ministry of Health’s strategy to address unsafe abortion focuses on preventing unintended pregnancies and providing post-abortion care (PAC). Arguably, this narrow focus may be justified given the restrictive abortion legislation in Sri Lanka. Under these circumstances, one would expect a dynamic family planning programme and accessible sexual and reproductive health education and services. One would also anticipate the institution of effective PAC. However there is no evidence to show that this is happening.

Participants expressed concerns about contraceptive services targeting only married women and the absence of a state sponsored comprehensive sexual and reproductive health education program for adolescents. There is in fact a complete silence on sexual health in existing policy documents. Further, participants expressed concerns about the inadequacy of existing PAC services and the stigma and discrimination experienced by women who seek PAC. The interviews also demonstrated gaps in research on unsafe abortion, specifically current prevalence and groups most vulnerable to the problem. Significantly, Ministry of Health has not taken an official position on the need for abortion law reform in their policy documents. To compound the situation, in 2007 the government closed down clinics that were providing abortion services or "menstrual regulation" to a less well-off clientele while turning a blind eye on less affordable abortion services provided in private hospitals. All this suggests that addressing unsafe abortion even within the existing legal framework has not been prioritized in state policy. Addressing issues of health equity and gender/class based discrimination are clearly not on the health agenda.

Given this situation, leaving unsafe abortion to be addressed as a policy level debate restricted to the Ministry of Health is unlikely to be effective. The issue of unsafe abortion will not be addressed unless the debate becomes far more broad based than it is now. We need to advocate abortion law reform and the registration of abortion medicines now instead of reinforcing the silence by pretending that abortion does not take place in Sri Lanka. In reality women will access abortion services if they need them whether we like it or not. Decriminalization and registration will only make existing services cheaper and safer.

Ramya Kumar, MBBS is a graduate student in Public Health. This article is based on a presentation she made at the International Centre for Ethnic Studies, Colombo on July 13, 2011.

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