WomanCare Global announced today that mifepristone has been added to their reproductive healthcare portfolio.

Through an agreement with Linepharma, WomanCare Global will provide sales, marketing, provider training and distribution of mifepristone in seven European and seven African countries. Linepharma’s mifepristone is labeled for use as a single 200mg tablet of mifepristone to perform medical abortion in conjunction with a prostaglandin, in compliance with the World Health Organization’s recommendation.

Linepharma’s mifepristone is manufactured in Europe and is currently approved in five E.U. countries. The planned distribution of mifepristone by WomanCare Global in 14 countries will ensure that close to 55 million women will have another safe, quality product to manage their reproductive health.

Please read the entire press release at http://ow.ly/8W2Wz

August 2, 2011, 5:53 pm 

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.

Emergency contraception pill was made available over the counter in Czech Republic . While before it was necessary to present a prescription to buy the pill, now it will be sufficient to present the ID. The data of the person who purchased the pill will be stored in database. The emergency contraception won’t be available for minors of 16 years.

Source: http://www.novinky.cz/domaci/249447-postinor-se-bude-v-cr-prodavat-bez-receptu.html


Dr Sim-Poey Choong Chair, ASAP

Malaysia in the Asian context
The Malaysian situation clearly doesn’t have the urgency that is seen in other countries in Asia in such as India, Nepal, Indonesia or the Philippines where the high mortality and morbidity rates from unsafe abortions provide a dramatic argument for change.

This is seen for example, in our low MMR (<15/100,000) and our low mortality rates for abortion complications (2-5/year).

Malaysia is seen as a very progressive nation with good living standards, health care, and infrastructure; the iconic Petronas Twin Towers stands in the heart of KL, our capital city. Women have free access to education and high career achievements as ministers and CEOs which says a lot for the progress we have made in social development.

Other indicators are however a matter of concern –e.g. the incidence of teen pregnancies remains high, and contraceptive prevalence rate is low. As pointed out by Prof. Low in her article, social changes taking place in Malaysia has made teen pregnancies a very visible problem. This has resulted in the recent media hype over teen pregnancies and baby ‘dumping’.

But, like many economically developed countries, as in the USA, the stigma attached to abortion makes it the last ‘right’ for women to achieve in terms of equality in decision making and control of her own bodies and their sexuality.

Abortion within the Medical Fraternity
As a young doctor, I was truly puzzled over the medical profession’s irrational attitude to women’s sexual and reproductive health issues; evident from their early objections to the pill and IUCD as posing a danger to women ‘abusing their freedom’. A similar situation has now arisen over the introduction of medical abortion with mifepristone and misoprostol.

The stigmatization of abortion has made efforts to open up this issue, a long and difficult journey. Trying to bring up the subject for rational discussion, until recently, was virtually impossible, even within medical circles. This is despite the overwhelming evidence that abortion is widely available and practiced here.

Surprisingly, even doctors who provided abortions ‘on the quiet’ were ignorant of the penal code on abortion, amended in 1989. A survey done by RRAAM in 2008 revealed that only 57% of doctors and nurses knew the law and while a survey of client seeking abortions, more than half thought it was illegal.

A recent experience with a colleague illustrated this point dramatically; an O&G in charge of a local maternity home who performed occasional abortions came to me in great distress; he had dismissed a nurse for misconduct and she had then threatened to ‘expose’ him. I was surprised he had never bothered to examine the penal code on abortion until I brought it up!

Situation in the 70’s
In the 70s, the concern for abortion access came not from statistics (there were none) but from grassroots healthcare providers who meet women faced with unwanted pregnancies daily. Those facts were evident in my early years as a family planning volunteer. But somehow most women then found a way out, often by accessing competent abortion providers which presumably accounted for the relatively low complication rates.

Exploitation by the profession
At that time, the penal code permitted abortion only ’to save the mother’s life’ (1971). However, as happens everywhere else, it was available for anyone who could afford it, often at exorbitant fees. While working as a consultant anaesthetist in private hospitals it became obvious to me that fees for abortions were often ‘disproportionate’ in relation to other similar procedure. (That was my main occupation for the 8 years of my professional life). At that time all abortions were D&Cs performed under a general anaesthetic.

Sneaking in Abortion Services via MR
In the 60s, the Karman Cannula had been established as a cheaper safer method for abortion under local anaesthetic, but it remained untapped in Malaysia until in the mid 70s, when the late Prof I. S. Puvan of University Malaya had the vision to see its potential and decided to introduce it as ‘menstrual regulation’ (called MR) thus by-passing the penal code by performing the procedure in early pregnancy without confirming it with a urine pregnancy test.

Thus in the mid 70s, as a result of his position and influence, MR gained some acceptance as a legal way of providing abortions. It was even practiced at certain government clinics officially for a time. Sadly, it was not taken up in a big way but MRs remained a low key service provided by some private clinics with charges remaining high.

FFPAM1 and Abortion services in Penang
Although the IPPF supported this move and introduced it to the Family Planning Associations of Malaysia (FFPAM), it was never taken up because of the sentiment of the grass roots members. However, on Prof Puvan’s advice, I agreed to set up a service in my group GP practice in Penang for the equivalent of US$20/- when the standard charge was then US$100/-.

As it happened, the demand for MR services raised so quickly that within a year my GP services were discontinued to focus on abortions for unintended pregnancies and post abortion contraception. Some government objections to my ‘open’ concept abortion clinic were expected, but none came. Actually, from the legal records, no doctor in Malaysia had ever been charged for performing an uncomplicated early abortion, even though, under the 1971 penal code, they clearly breached the law.

Legal Reform and after
There was a breakthrough in legal reform in 1989, when more abortion complications surfaced through the media, possibly one effect of urbanization and the need for smaller families. The clause added in was in line with the British Penal Code that they had amended in 1957 which is to allow abortion for threat of injury to the ‘mental or physical health of the woman’.

Many of us heaved a sigh of relief and I had hoped this was the cue for the family planning associations to take a leading role in providing this service; at that time I was in the executive council of the Federation of FPAs Malaysia, later becoming chairman (1992-6). Despite all my efforts, this never came through; such was the conservative sentiment amongst members at the time.

New Players in Abortion Advocacy
From FIGO, Ipas to RRAAM

There were few developments in advocacy in Malaysia until the FIGO conference took place in Malaysia in 2006 and the APCRSH/FFPAM conference a year later. Prof Anibal Faundes, a past president of FIGO, made a strong stand on the blight of unsafe abortions and the absolute need to recognize it as a major factor in women’s health, in consonance with her basic human rights. At those conferences, Ipas was promoting their safe abortion initiatives while the Asian-pacific Research and Resource centre for Women (ARROW), through an initiative by Ms Rashidah Abdullah, had put up a side symposium to address unmet needs in Malaysia.

All this together created an opportunity to discuss with Ipas the possibility of a project to address the abortion issue; the coalition was formally started in 2007 drawing members who had been activists working directly or indirectly with the family planning associations. Called the Reproductive Rights Advocacy Alliance Malaysia (RRAAM), it was committed to promoting women’s reproductive rights and services (particularly, to contraceptive access for youths and marginalized groups and to safe abortions).

Further developments were initiated in 2008 when International Consortium on Medical Abortion (ICMA) and IPPF (ESEAOR) organized a regional forum on abortion access in Kuala Lumpur. Major players in reproductive health from 15 countries attended including some donor agencies to discuss and share ideas on the situation in Asia.

The members at the meeting concluded that while different countries faced different obstacles in making safe abortion assessable, there were many individual activists and agencies promoting the same cause in each country. However, there was no central coordinating group that could harness the different experiences to help each other. This became the rationale for creating the new coalition. The Asia Safe Abortion Partnership (ASAP) was thus formed to provide an active network of advocates.

For RRAAM, this provided us opportunity to become part of a regional and global movement. The network has obviously benefited members through it regular email forums, organizing workshops in abortion technology, advocacy strategies and values clarification. But apart from this, the realization of being members of an international movement has significant internal and external impacts.

Speaking for RRAAM members, we have broken out of a shell that labeled us as an isolated ‘eccentric non-conformist group’ and for the general public, RRAAM is now seen as part of an international movement in sync with the efforts of international agencies like IPPF, ICMA, Ipas, Gynuity, etc. and prominent regional players from Vietnam to Nepal. The gratifying response to the joint ASAP/RRAAM seminar on Abortion Access in January 2011 in Kuala Lumpur is, I believe, a testimony to this.

1. Now changed to Federation of Reproductive Health Associations Malaysia (FRHAM)

December 9, 2010 — Although most women seeking medical abortions receive an ultrasound, a recent study suggests that this step is not medically necessary and could serve as a barrier to the procedure, Reuters reports. Medical abortion, which involves taking a dose of the drug mifepristone followed by misoprostol, can be performed in the U.S. within nine weeks of a woman’s last menstrual period. The drugs are about 97% effective. While there are no official guidelines that women should first receive ultrasounds, the practice is common because it is the most precise way to determine how long a woman has been pregnant.

The study — published in the British Journal of Obstetrics and Gynecology — explored whether a woman’s estimate of her last menstrual period and a physical exam would be adequate to determine her eligibility for a medical abortion early in pregnancy. For the study, Gynuity Health Projects researchers examined data on 4,484 women seeking medical abortions at one of 10 family planning clinics, including eight operated by Planned Parenthood. The women provided the date of their last period and received a physical exam and an ultrasound.

The study found that based on the reported date of the last period and a physical exams alone, a medical abortion would have been performed beyond nine weeks for only 1.6% of the women, all of whom but one were within the 11th week of their last period. Studies show that medical abortion is still effective with no increased risk of complications at 11 weeks.

Possible Implications

Lead researcher Hillary Bracken of Gynuity said the study’s findings suggest that abortion providers and physicians who do not have ultrasound equipment can still “feel safe” in offering medical abortion. She added that this could also expand access to medical abortion in rural areas of the U.S. and developing countries, where ultrasounds are not available.

Eliminating ultrasounds before medical abortions also could reduce cost barriers. According to Planned Parenthood, ultrasounds in the U.S. range from $350 to $650 or more depending on what tests or exams are performed (Norton, Reuters, 12/8).