Access to medical abortion medicines in the South-East Asia Region - a status report

Access to medical abortion medicines in the South-East Asia Region A status report

Access to medical abortion medicines in the South-East Asia Region A status report Access to medical abortion medicines in the South-East Asia Region - A status report ISBN 978-92-9022-825-7 © World Health Organization 2021 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. 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Printed in India Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 1 Contributors The report was developed by the Reproductive, Maternal, Newborn, Child and Adolescent Health and Healthy aging and Essential Medicines & other Drugs unit of Department of Health Systems Development (HSD) of the South East Asia Regional office of World Health Organization (SEARO). We acknowledge contributions of staff and consultants who contributed towards this effort; including staff of the WHO country offices, MOHs, regulatory bodies and partners in all 11 countries. The report on “Assessment of the Availability of Medical Abortion Commodities in Eight Countries” by Venture Strategies, which was published in January 2020, also provided valuable inputs for this publication. Besides the situation analysis on Nepal and Bangladesh, this report also provided a useful framework of assessment and analysis for access to medical abortion medicines. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 2 Acronyms & abbreviations ANM auxiliary nurse midwife DPR Korea Democratic People’s Republic of Korea ICPD International Conference on Population and Development MA medical abortion MoH Ministry of Health MRM Menstrual regulation with medication NEML National Essential Medicines List NGO nongovernmental organizations NRA National Regulatory Authorities PAC post-abortion care SBA skilled birth attendant POC point of care SEA South-East Asia UNFPA United Nations Population Fund VEN vital, essential, necessary WHO World Health Organization Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 3 Contents Contributors ............................................................................................................................1 Acronyms & Abbreviations ................................................................................................... 2 Foreword ................................................................................................................................ 5 1. Executive Summary ......................................................................................................... 7 2. Introduction......................................................................................................................9 Background ............................................................................................................9 Objectives & Scope .............................................................................................. 10 3. Methodology ................................................................................................................... 11 Approach – Five Pillar MA Medicines Availability Framework ............................ 11 Methods ................................................................................................................. 11 4. Overview of Laws, Policies & Guidelines .......................................................................12 Legal Status Across Countries ..............................................................................12 Policies, Guidelines & Strategies ...........................................................................13 5. Overview of National Essential Medicines Lists and Regulatory Status .....................14 NEML Status ..........................................................................................................14 Market Authorisation & Regulatory Process .......................................................15 6. Overview of Medical Abortion Medicines Financing and Supply Chain Management ............................................................................................16 Financing ................................................................................................................17 Procurement & Distribution .................................................................................17 7. Overview of Access Model Used Across Countries ......................................................18 8. Learnings & Key Recommendations for the Region ................................................... 20 Summary of Successful MA Medicine Access & Supply Chain Practices in the Region .............................................................................. 20 Recommendations for the Region .......................................................................21 9. Annexure ........................................................................................................................ 22 Country profiles .................................................................................................... 22 Bangladesh ........................................................................................................... 22 Bhutan ................................................................................................................... 25 DPR Korea ............................................................................................................. 28 Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 4 India .......................................................................................................................31 Indonesia .............................................................................................................. 34 Maldives ................................................................................................................ 37 Myanmar ...............................................................................................................40 Nepal ..................................................................................................................... 43 Sri Lanka ................................................................................................................46 Thailand ................................................................................................................49 Timor-Leste ........................................................................................................... 52 Compendium of Primary & Secondary Information Sources ............................................. 55 Scoring Criteria for snapshot chart (Figure A) ....................................................................59 Key Contacts .........................................................................................................................60 Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 5 Improving maternal health is key to achieving Sustainable Development Goal (SDG) 3 – health and well-being for all. A healthy mother is the foundation of a healthy child and a healthy family. One of the most important SDG3 targets is to reduce the maternal mortality ratio to less than 70 per 100 000 live births by 2030 (SDG 3.1). Women die because complications during pregnancy, childbirth and the postpartum period go unrecognized or are inadequately managed. An important cause of maternal deaths is complications arising as a result of unsafe abortion. Unsafe abortions remain a major public health issue and are estimated to cause 8–11% of global maternal deaths. Women die because they seek to end unwanted pregnancies and lack knowledge, and have limited access to family planning services and appropriate safe abortion services. For this reason, another critical SDG3 target is to ensure universal access to sexual and reproductive health-care services, including for family planning by 2030 (SDG 3.7). Between 2015 and 2019, on average, 73.3 million induced (safe and unsafe) abortions occurred worldwide each year. 3 out of 10 (29%) pregnancies and 6 out of 10 (61%) unintended pregnancies ended in an induced abortion. Among these, 1 out of 3 were carried out in the least safe or dangerous conditions. Between 2015-19 over half of all estimated unsafe abortions globally were in Asia. A sizeable number of these happen in the South-East Asia Region (SEAR), especially in South Asia. If women survive unsafe abortions, they face many other potential risks to their health and well- being. Unsafe abortions are often associated with serious health consequences which include reproductive tract infections, infection of the upper genital tract and temporary or lifelong disability requiring medical care. Evidence shows that major physiological, financial, emotional and legal reprisals are incurred by women who undergo unsafe abortion. The strain caused on the public health system by unsafe abortions is immense. Around 7 million women are admitted to hospitals every year in developing countries as a result of unsafe abortion. The annual cost of treating major complications from unsafe abortion is estimated at US$ 553 million. Abortions are safe when they are carried out by a person with the necessary skills, using a WHO-recommended method appropriate to the pregnancy duration. Almost every abortion death and disability could be prevented through sexuality education, use of effective contraception, provision of safe, legal induced abortion, and timely care for complications. Across the SEAR region, as globally, cultural and societal concerns still exist towards abortion as a means of family planning. However, more and more countries now see safe abortion as an important maternal health intervention under certain circumstances, such as saving the woman’s life, relief to victims of rape or incest, and to handle issues arising out of foetal Foreword Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 6 impairment etc. The human rights imperative has strengthened the call for making safe abortion services accessible to women who need it. WHO recommends Medical Abortion (MA) as a safe and effective option for termination of pregnancies where legal conditions are met and post-abortion care is available. The advantages of MA are many. It is not only a cost-effective option, but also being a non-invasive procedure is often a woman’s first choice. It is also easier to administer and can be offered with the help of trained para-medical staff and field level health workers. An important pre-condition to offering MA services however is providing reliable access to MA medicines. This document maps the access situation of MA medicines in the SEAR countries of Bangladesh, Bhutan, Democratic People’s Republic of Korea, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand and Timor-Leste. Besides summarising the findings, it also provides key recommendations for the countries to move forward in improving access to MA medicines. I urge all stakeholders in the Region to leverage this document to forge ahead and achieve the 2030 SDG targets, and to usher in an era of healthy mothers, children and populations in the decades to come. Dr Poonam Khetrapal Singh Regional �irector WHO South-East Asia Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 7 1. Executive summary Unsafe abortions remain a major public health issue across the world. The World Health Organization (WHO) South-East Asia (SEA) region is no exception. Medical abortion (MA) is a proven and effective method of providing safe abortion services. For it to succeed, access to MA medicines is crucial. This outcome in turn requires supportive laws, policies, guidelines, inclusion of the National Essential Medicines List (NEML), extensive market authorization of MA medicines, robust and well-regulated public and private supply chains and greater point of care (POC) coverage of MA. This regional report and associated country-wise situation reports on access to MA medicines will help in shaping policy as well as advocacy for strengthening the MA framework. Figure A gives a snapshot of the current situation. While some countries such as India, Timor Leste and Nepal have generally satisfactory scores on most MA access criteria, in other countries there is scope for making the system stronger. Figure A: Snapshot of MA access in the SEA Region * * refer to Annexure for scoring chart - 1 2 3 Bangladesh Bhutan DPR Korea India Indonesia MaldivesMyanmar Nepal Sri Lanka Thailand Timor Leste Legal Status Policies & Guidelines Market Authorisaon NEML Inclusion Financing Supply Chain Access Model Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 8 Across the region, more finance and greater adoption of the NEML inclusion process are required, as well as the strengthening of the market authorization systems. There is a need to reform laws so that an effective legal framework for safe abortion may be created and the use of MA based on comprehensive policies and guidelines enabled. Market authorization of more effective and quality assured MA medicines (misoprostol 100/200 mcg, mifepristone 200 mg and a combination pack of the two) is required and all of them should be included in NEMLs. With proper training and infrastructure, MA services with post abortion care can be extended to peripheral health facilities and beyond (through community health workers). While increasing coverage, we must of course ensure access to post-abortion care (PAC) services to handle the uncommon cases of post-abortion complications. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 9 2. Introduction Background Unsafe abortions are the cause of 8–11% of global maternal deaths and remain a major public health issue. They occur predominantly in low-income and middle-income countries, where the most restrictive abortion policies exist. The World Health Organization (WHO) guidelines recommend the use of mifepristone followed by misoprostol 24 to 48 hours later, for early medical abortion. They also state that in order to contribute to achieving access to safe abortion these medicines should be included in the NEMLs, in all countries where abortion is legal and acceptable. A comprehensive set of policies and interventions aimed at ensuring availability and easy access to safe, effective and quality-assured MA medicines is the key to improving and expanding access to safe abortion services. For this aim to be achieved, MA medicines should be registered and marketed in the country and made available both in private, public and non-governmental sectors, according to the country context. Figure B below depicts the key steps in providing safe abortion services including MA with a health systems approach. Figure B: Health system approach to expanding and upscaling access to medical abortion Country situation & strategic plan Law & policy considerations Integration into primary care services Monitoring & evaluation For the purposes of this comprehensive health system approach, the first step was to conduct a review and summarize information on current accessibility of medical abortion medicines in the South-East Asia Region and to develop a strategy for the road ahead. This review documents the first step which focussed on reviewing the current situation with regards to access to MA medicines in the region. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 10 Besides contributing to the overall step 1 of the approach above, it is expected that the outputs will also aid in product and policy dialogues in the countries concerned. Objectives and scope The main objective is to review and document the current situation on access to MA medicines (misoprostol and mifepristone alone or in combination) in all the 11 Member States of the WHO South-East Asia (SEA) Region and to prepare short country reports and a regional summary report on the same, as well as support policy dialogues with countries on how to expand access to MA as part of safe abortion services. The specific objectives were to summarize: a) The current relevant policies, regulations that govern the availability of medical abortion medicines, based on publicly available information and data shared by WHO b) The status of the market authorization of mifepristone and misoprostol, alone or in combination, by the National Regulatory Authorities (NRA) and their inclusion in the NEML, formularies or reimbursement lists c) Succinct description of current access models used/ implemented in the countries of the region The scope and method of research for this report are defined as follows:  Geography: The project was focused on the 11 countries in the WHO-South East Asia Region, namely Bangladesh, Bhutan, Democratic People’s Republic of Korea, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand and Timor Leste, and the region as a whole. Best practices from the rest of the world were to be incorporated in the recommendations only if they were found to be relevant to the context of these 11 countries.  Health area: The research for this project was limited to medical abortion using the medicines misoprostol, mifepristone and their combination packs. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 11 3. Methodology Approach – Five-Pillar MA Medicines Availability Framework We deployed the five-pillar availability framework (refer to Figure C below) to design both our research as well as the outputs reports. The framework consists of five areas or “pillars” – Registration & Quality Assurance, Policy & Financing, Procurement and Distribution, Provider Knowledge and End-User Knowledge. These areas span all aspects of availability and use of MA medicines from the upstream supply chain to the point of care dispensation and use of medicines. Figure C: The five pillars of availability of a service related to a medical product This study focused more on the first three pillars as compared to the last two pillars, which are shaded in Figure C. Methods  First, information was gathered by desk review of existing documents and databases to draw a broad overview picture of the current MA access situation.  In addition, a written country questionnaire was sent to the 11 WHO country offices for providing information. They further gathered information from key stakeholders such as MoH officials, national regulatory authority officials, Central Medical Store officials, etc. Registration and quality assurance • QA products registered Policy and financing • MA integrated in policies and programmes. Financial commitment Procurement and distribution • Total product procurement and distribution meet national need Provider knowledge • Health providers provide quality MA care End-user knowledge • Knowledge of MA laws • Appropriate, timely health seeking behaviour Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 12 4. Overview of Laws, Policies & Guidelines Legal Status Across Countries It is well documented that countries with highly restrictive abortion laws also have high rates of morbidity and mortality resulting from abortions3. All 11 countries of SEA regions are signatories to the Programme of Action of the 1994 International Conference on Population and Development (ICPD), which established abortion as a major public health issue. Even though there has been on-the-ground advocacy in the region over the years, access to comprehensive, safe abortion services and care is still a challenge in several countries. All countries in the SEA region permit abortion to save a woman’s life. India and Nepal permit abortion beyond medical or sexual violence reasons. In the remaining countries, abortion services are permitted under special medical conditions or cases of sexual violence such as rape/ incest or genetic malformations. Table 1 highlights the grounds on which abortion is permitted in each country. Table 1: Grounds on which abortion is permitted Country To save a woman’s life To preserve a woman’s physical health To preserve a woman’s mental health In cases of rape or incest Because of foetal impairment For economic or social reasons On request Bangladesh Bhutan DPR Korea* India ** Indonesia Maldives Myanmar *** Nepal Sri Lanka Thailand Timor Leste Permitted Not permitted * As per old WHO Mapping abortion policies, programmes and services in the South-East Asia Region; DPR Korea allows abortion on request ** If pregnancy occurred as a result of failure of contraception (but this is only applicable to married women) *** Confirmed by Dr Myint Myint than , DyDG (RMNCAHSHN)DOPH, MOHS Source: WHO Global Abortion Policy Database AND World Health Organization, Regional Office for South-East Asia. Mapping abortion policies, programmes and services in the WHO South-East Asia Region. 1. Abortion, Induced 2. Abortion, Legal – trends 3. Maternal Mortality – statistics and numerical data 4. Contraception Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 13 Included Not included Policies, Guidelines & Strategies National policies and strategies on reproductive and maternal health, as well as, evidence-based standard treatment guidelines are essential components of national health plans. Such policies and guidelines should be developed and updated with the intent of eliminating barriers to safe abortion and obtaining the highest attainable standards of sexual and reproductive health. Not all SEAR countries currently have comprehensive national policies and guidelines in place. Moreover, it is challenging to access and verify the documents which do exist, especially in countries with restrictive laws. Very few countries have comprehensive guidelines on safe abortion care. In the SEAR region, only Bangladesh, DPR Korea, India, Nepal and Thailand have them. Among countries that do not permit abortion legally, a few have guidelines on post- abortion care, e.g.: Bhutan, Indonesia, Myanmar and Sri Lanka. Data provided in this section was gathered through secondary literature review of documents and verified articles from the web. Table 2 below, provides a snapshot of the policy and guidelines landscape. Table 2: Inclusion of MA in national policies and guidelines Country Reproductive health policy/strategy/ guidelines Guidelines on safe abortion care Guideline on post- abortion care Training manuals Bangladesh Bhutan DPR Korea* India Indonesia Maldives Myanmar Nepal Sri Lanka Thailand Timor Leste * No recent data available. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 14 5. Overview of National Essential Medicines Lists and Regulatory Status NEML Status In 2005, mifepristone and misoprostol were included in the 14th edition of the WHO Model List of Essential Medicines4 because of their proven safety and efficacy. They continue to be part of the latest list under the “22.1 Oxytocics” section. The use of these medications does not require specialised diagnostic or monitoring facilities and/or specialist care and/or training. All of these medicines are important for preventing the leading causes of maternal morbidity and mortality5. Yet, in the SEA region, very few countries have these drugs included in the National Essential Medicine List. The combipack (mifepristone 200 mg+misoprostol 200 mcg) is included in the NEML of only Thailand and Nepal. None of the drugs are included in the NEML of Sri Lanka and Bangladesh. Other countries in SEA Region, have one or more of the drug compositions included in the NEML. In Indonesia, misoprostol 200 mcg and 100 mcg are currently under review and a decision regarding their inclusion in the NEML is awaited. Table 3: NEML status of MA drugs in SEAR Country �ifepristone 200 mg �isoprostol 200 mcg/100 mcg Combipack (mifepristone 200 mg+misoprostol 200 mcg) Bangladesh (2016)    Bhutan (2018)    DPR Korea (2019)    India (2015)    Indonesia (2019)  Application under review  Maldives (2018)    Myanmar (2016)    Nepal (2016)    Sri Lanka (2014)    Thailand (2019)    Timor Leste (2015)    4 In section 22.1, Oxytocics 5 WHO, 22nd Expert Committee on the Selection and Use of Essential Medicines – Application for mifepristone-misoprostol, 2018. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 15 Ba ng lad es h 25 20 15 10 5 0 15 7 5 4 3 5 23 0 0 0 2 1 1 44 3 11 2 0 0 0 0 0 0 000 0 0 0 0 0 Bh ut an DP R K or ea Ind ia Ind on es ia Ma ldi ve s My an ma r Ne pa l Sr i L an ka Th ail an d Tim or Le ste Market Authorization & Regulatory Process The graph below (Figure E) demonstrates the number of MA products legally available in the market. Figure E: Market authorization status of MA drugs in countries of the South-East Asia Region misoprostol 100 mcg/200 mcg mifepristone 200 mg Combipack (mifepristone 200 mg + misoprostol 200 mcg) Countries in SEA Many countries such as Indonesia & Sri Lanka where abortion alternatives are limited by law and even in countries where abortion is less restricted there are additional challenges of controlling counterfeit and illegally supplied MA medicines. * Myanmar does not use the term Medical Abortion Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 16 6. Overview of Financing and Supply Chain Management of Medical Abortion Medicines FINANCING • No specific public health budget for MA medicines in the countries except for Timor Leste and India • Countries where the MA medicines are used in the public health system, they are often financed through a broader budget which does not specifically list them (e.g. Nepal) • As many clients prefer to use the private sector – legally or illegally – financing is often out-of- pocket • In cases where the private sector is restricted, the costs can be high for the clients6 PROCUREMENT • Low level of inclusion in NEMLs and unclear procurement policies on MA have resulted in purchases not occurring via the central public procurement process in most countries. Timor Leste, Bangladesh, DPR Korea and Bhutan do have centralized tendering of misoprostol, though it may be for other uses. • In other countries where MA is practiced, the procurement is decentralized to local hospitals or procurement units such as in the case of Nepal DISTRIBUTION • Lack of central procurement is linked to corresponding low levels of public sector distribution of MA drugs • In countries such as Thailand, where the private sector is allowed to sell MA medicines, but is also regulated, robust commercial distribution systems have been set up 6 Abortions are becoming safer and easier to obtain—even where they are illegal, The Economist, March 2020. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 17 Financing The appropriate use of MA medicines is a more cost-effective and safer approach compared to surgical procedures due to the saving on costs of surgery, qualified clinicians, infrastructure, etc. However, given the low socio-economic status of large sections of the population in SEA region, the cost of MA medicines can still be prohibitive, if women have to purchase them out of pocket. When MA is accessed through the private sector, whether legal or illegal, this is especially true. The UNFPA catalogue prices of mifepristone 200 mg is USD 15 and misoprostol 200 mcg is USD 0.967. There are anecdotal reports of high costs in Timor Leste e.g. of misoprostol 200 mcg (10 tabs) retailing at USD 130. However, the retail prices in India, Bangladesh and Nepal can be as low as USD 3.5 for the combipack in some cases. These countries also have relatively more registered products and greater legal access to MA. A market that has multiple generic products usually also has more competitive prices that can contribute to reducing out-of-pocket expenditure significantly. Procurement and distribution Generally, in public procurement, bulk purchasing can lead to lower unit prices. Lack of centralized purchasing or bulk buying therefore is one of the key challenges to ensuring low prices and to obtaining a reliable supply, given the fact that most countries do not have many registered MA products. Almost all countries are facing issues of illegal private sector distribution of MA medicines. This appears to be due more to poor regulatory oversight, rather than the permission given to the private sector to distribute MA medicines in pharmacy and healthcare chains. For example, in India which has less restrictive regulation on MA access through the private sector, the regulatory authority has banned the open sale of AM medicines pointing to widespread misuse8. 7 https://www.unfpaprocurement.org/catalog 8 Citing rampant misuse, government bans open retail sale of abortion drugs, Livemint, 2019, https://www.livemint.com/science/ health/citing-rampant-misuse-government-bans-open-retail-sale-of-abortion-drugs-1568391358998.html Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 18 7. Overview of Access Model Used Across Countries The administration of medical abortion is often heavily regulated. The medical abortion regimen is low-risk and easy to follow, and the process can be safely managed by patients and health workers. Despite these facts, some countries impose restrictions on it that hinder access for potential patients and that do not reflect its long record of safe use. If there is policy support, it is not very difficult to provide wider distribution and hence access to MA medicines in SEAR countries as almost all of them have an extensive network or health centres, remote health posts, mobile clinics and community health workers already providing reproductive health services. In most SEA region countries, registered medical practitioners and/or specialists, such as obstetricians/gynaecologists with minimum experience and training, are allowed to provide medical abortion. This is true for India, Bangladesh, Myanmar, and Sri Lanka. Some countries in the South East Asia Region allow health workers-skilled birth attendants (SBA), community workers, nurses and accredited midwives to administer MA. Nepal allows skilled birth attendants, Thailand allows nurses, and Bhutan allows community workers, ANMs, Photo courtesy: WHO website Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 19 9 Source: Susheela Singh et al. The incidence of abortion and unintended pregnancy in India, 2015. Lancet Global Health. Vol 6, Issue 1, E111–E120, 01 Jan 2018 (https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(17)30453-9/fulltext) midwives and nurses who are trained in abortion complications to do so. In Timor Leste the number of health professionals is inadequate for meeting the demands of the population. Accredited midwives can be trained to provide post-abortion care in these settings. This is an example of expanding access to abortion care and services. In countries where legal provisions are favourable, the private sector and NGOs also support access to medical abortion information and drugs. Such countries are India, Nepal and Thailand. In India, 75% of surgical abortions occur in private facilities and 91% of medical abortions happen outside facilities despite the country providing free abortion services and having some of the least restrictive laws. Availability of MA medicines in private pharmacies is very low across the Region, except in a few countries such as Nepal and India. Despite restrictions some NGOs are also working towards providing improved access to MA both directly and indirectly, most notably MSI reproductive choices in Bangladesh, India, Nepal, Sri Lanka and Timor-Leste. Photo courtesy: Paul Prescott Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 20 8. Learnings & Key Recommendations for the Region Summary of Successful Access to MA Medicines & Supply Chain Practices in the Member States of the SEA Region  Bangladesh: Menstrual regulation using the medical method as an alternative to medical abortion when there are legal and cultural barriers present, could be an innovative practice. Menstrual regulation using medical method is followed as a family planning service too and thus provides much needed access to MA medicines in a controlled manner while also overcoming cultural barriers.  Bhutan: Task sharing is an effective practice for increasing access to post abortion care. Staff at all levels, including community health workers, ANMs, midwives and nurses are trained in management of abortion complications.  DPR Korea: Ease of access to abortion services and comprehensiveness of policy, guidelines and standards for abortion care allow for extensive coverage and effective service delivery.  India: The Union government provides specific budgets to states for procurement of MA medicines. Expansion into the private sector for services helps better coverage.  Indonesia: Consistent and creative advocacy efforts have led to the review process for inclusion of misoprostol into the NEML.  Maldives: Inclusion of MA medicines in the NEML is an example to other countries where restricted use of MA is allowed.  Myanmar: Use of misoprostol is allowed for PAC cases.  Nepal: Comprehensive and extensive laws, policies and guidelines exist and are well documented. The product registration, inclusion in the NEML, and public procurement of combipacks are good practices as they aid in improved and correct dispensing, and use of medicines. MA services are provided free of cost and are spread to district level hospitals thus removing a major barrier to access.  Sri Lanka: Post-abortion care includes contraceptive counselling on family planning for women/couples, who are informed that all methods are available free of cost at most of the health institutions providing post-abortion care.  Thailand: Access to MA services is widespread and is provided by public facilities, general practitioners, private providers, and NGO’s. Training facilities are available for the health workforce for service delivery programs. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 21  Timor Leste: There is an allocation in the national budget for centralized procurement and distribution of misoprostol 200 mcg, which indicates good supply chain support. Recommendations for the Region Area Status Laws, policy and regulations  MA should be promoted as a safe, non-invasive and inexpensive procedure. WHO guidance recommends MA as a desirable method of abortion for pregnancies up to 14 weeks gestation age10 as long as backup care is available for post-abortion complications if required.  The implementation of awareness campaigns regarding existing policy regulatory guidelines on MA medicines will help to facilitate activities to promote safe and reliable access to them.  Greater regulatory oversight and inter-country cooperation is possible to jointly tackle the menace of illegal and counterfeit trade in MA medicines. NEML inclusion and market authorization  As use of MA medicines is allowed in most countries for legal abortion cases, misoprostol 200 mcg, mifepristone 200 mg and their combipack should be included in the NEMLs.  The policy makers should encourage registration of multiple sources of products for each MA medicine so as to ensure sustainable access and encourage market competition for better pricing.  All MA medicines should be classified as “vital” within the vital-essential- necessary (VEN) system of medicine classification and considered for priority procurement Financing & supply chain  There should be forecasting of requirements and specific provisions for MA medicines within health budgets. In countries where centralized procurement exists for essential medicines, MA medicines should also be tendered centrally. For decentralized medicine supply systems, the use of national framework contract mechanisms to facilitate access by states and provinces should be considered.  The private sector, where allowed, should be encouraged to expand distribution. Access model  Task-sharing, and the potential use of telemedicine, to expand the provider base in the provision of abortion services will require strengthening and expanding the capacity of the supply chain to ensure that such providers have access to the medicines they need. For the public sector access to medicine through non-physician health workers such as nurses and midwives should be considered, and for the private sector, access through certified pharmacists. 10 Clinical practice handbook for safe abortion. Geneva: World Health Organization; 2014. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 22 9. Annexure Country profiles BANGLADESH About half of Bangladesh’s total population of 158 million is female. Among married females, 52% are in the reproductive age group (Bangladesh Demographic and Health Survey 2014) Area Status Laws, policy and guidelines Abortion is permitted under limited circumstances. Menstrual regulation (MR) services have been available in the government’s family planning programme since the 1970s. The government also supports these services as a family planning method and not as an abortifacient (United Nations, 2002). NEML MA medicines are included in the National Essential Medicines List (NEML), 2016. Financing and supply chain No public financing, procurement or distribution of MA medicines. misoprostol is procured and distributed for other uses Access to medicines MA medicines are accessible only from designated public hospitals. Overview of Laws, Policies & Guidelines Legal Status: Under Bangladesh’s penal code of 1860, induced abortion is illegal except to save a woman’s life. MR, however, has been part of Bangladesh’s national family planning program since 1979. MR is a procedure that uses manual vacuum aspiration or a combination of mifepristone and misoprostol to “regulate the menstrual cycle when menstruation is absent for a short duration.” MR performed using medication is referred to as MRM. Policies, Guidelines and Strategies: The National Menstrual Regulation Guidelines prepared in September 2011 adapted the latest WHO guidance document (WHO, 2012b) to the Bangladesh setting (Directorate General of Family Planning, 2011). The Guidelines indicate the norms, policy statements and regulations to be adhered to, and offers technical support to providers to help them make evidence- Percent distribution of ever-married women age 15-49 who have used menstural regulation in the last three years by source of service. Bangladesh Source of service Percent Public sector 47.5 Medical college hospital/ district hospital 12.9 Maternal and child welfare center 4.6 Upazila health complex 22.3 Family welfare center 6.3 Family welfare visitor 1.1 Other public sector 0.3 Private sector 33.0 Private hospital/clinic 22.3 Qualified doctor’s chamber 9.0 Non-qualified doctor’s chamber 1.1 Other private medical sector 0.6 NGO sector 5.6 NGO static clinic 5.6 Other 0.4 Don’t know 6.7 Missing 6.8 Total 100.0 Number of women 251 Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 23 based decisions as well as on the medical management of clients for MR procedures. The Bangladesh National Service Delivery Guidelines on Menstrual Regulation with Medication (MRM), September 2015, focus specifically on the combipack for MRM. National Essential Medicines List and Regulatory Status MA medicine Strength Administration route Market authorization NEML status �ifepristone 200 mg Oral tablet 13 products  �isoprostol 100 mcg Oral tablet 5 products  200 mcg Buccal tablet 22 products  600 mcg Oral tablet 6 Products  Combipack mifepristone 200 mg + misoprostol 200 mcg, (1+4 tablets pack) Oral for misoprostol, sublingual/ intra-vaginal for mifepristone 10 products  Bangladesh National Formulary (2015) includes mifepristone for termination of pregnancy, but misoprostol is not included for any obstetric indication. The combipack is the only government approved MA method in Bangladesh. Financing and Supply Chain Management of Medical Abortion Medicines in Bangladesh Access Model Used FINANCING No specific public funding for MA medicines PROCUREMENT DGDA (Directorate General of Drug Administration) does tenders for misoprostol DISTRIBUTION Only misoprostol is distributed for other obstetric indications. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 24 Any registered medical practitioner trained on MR procedures, or having working experience in the obstetrics (subject to minimum standards) can provide MR services where the gestational age is 10 weeks or less. Additionally, female welfare visitors (FWV) or other categories of paramedical personnel (e.g. NGO paramedics) who have undergone a formal and recognised 18-month paramedical training course are also permitted to provide MR services. Salient features of MA Medicine Access in Bangladesh  Large number of local and international brands are registered in Bangladesh for all MA medicines including combipacks.  MRM is followed as a family planning service too and thus provides much needed access to MA medicines in a controlled manner while overcoming cultural barriers. Potential access & supply chain recommendations for discussion with bangladesh Area Recommendations Laws, policy and regulation  Increase awareness and promotion of laws and policies for MRM as many providers still use surgical interventions11.  Expedite the release of the guideline document12 under-development that combines MR, MRM and PAC Financing and supply chain  Monitoring and tracking of private sector providers to ensure that authorized and quality MA medicines are distributed and available widely at affordable rates  MoHFW should start forecasting, procurement and distribution of all MA medicines for MRM, besides misoprostol Access model  To meet the needs of the population, the health workers must be made aware of, familiar with, and trained in MRM through regular training and mandated certifications.  Leverage the strong NGOs and social marketing organization  Use network in Bangladesh to expand access. For e.g. facilitate Marie Stopes Bangladesh (MSB) to start extending MA services 11 Anadil Alam et al. Acceptability and Feasibility of mifepristone-misoprostol for Menstrual Regulation in Bangladesh. International Perspectives on Sexual and Reproductive Health 2013. 39(2):79-87. 12 Venture Strategies. Assessment of the Availability of Medical Abortion Commodities in Eight Countries. 2020 Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 25 BHUTAN With a total population of about 754 000 (World Bank), Bhutan has 216 871 women in the reproductive age group and an MMR ratio of 183. Area Status Laws, policy and guidelines Abortion is allowed only under specific circumstances. Medical abortion (MA) in institution/hospitals is allowed based on medical indications NEML While mifepristone and misoprostol are registered and included in the NEDL, they are not available in the market. MVA syringes are available through the government procurement system. Financing and supply chain There is no public procurement and distribution Access to medicines MA medicines are not accessible to the general public. Overview of Laws, Policies & Guidelines Legal Status: As per section 146 of the Penal Code, abortion is unlawful, unless performed “in good faith for the purpose of saving the life of the mother or when the pregnancy is the result of rape or incest or when the mother is of unsound mental condition”. The punishment is not specified, but under section 147 of the Code, the offence of illegal abortion is graded as a “misdemeanour”, for which the sentence specified under section 12 is the minimum of one year imprisonment to a maximum of three years.13 Additional conditions for abortion include a substantial risk to the child, such as chances of being born with a serious handicap or congenital, physical, or mental abnormalities. However, medical abortion in institution/hospitals is allowed based on medical indications. (Abortion Laws of the World; Centre for Reproductive Rights, 2011). Policies, Guidelines and Strategies: Bhutan has no standard national guidelines on the provision of abortion services; however, they do have a standard guideline on management of abortion complications. The National Medical Standard for Contraceptive Services and Standard Guidelines on Management of Complications of Abortion Manual includes guidelines on medical termination of pregnancy. National Essential Medicines List and Regulatory Status MA medicine Strength Administration route Market authorization NEML status �ifepristone 200 mg – –  �isoprostol 200 mcg – 2 products  100 mcg Oral Tablet 2 products  (Oxytocics) 13 Penal Code of Bhutan, 2004, available at https://www.wipo.int/edocs/lexdocs/laws/en/bt/bt019en.pdf (accessed 17.10.20) Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 26 Combipack mifepristone 200 mg + misoprostol 200 mcg, (1+4 tablets pack) Oral for misoprostol, sublingual/ intra-vaginal for mifepristone –  Despite MA being allowed under certain circumstances, MA medicines are absent from NEML and there is no market authorization for them. While misoprostol 100 mcg and Prostaglandins are used for induced abortions, their application in the NEML14 is under Oxytocics. Financing and Supply Chain Management of Medical Abortion Medicines in Bhutan FINANCING Financing and Supply Chain Management of Medical Abortion Medicines in Bhutan PROCUREMENT There is no centralized procurement of MA medicines except for misoprostol for other uses DISTRIBUTION There is no distribution of MA medicines except for misoprostol for other uses There is no supply chain support for the limited use of permitted MA medicines in hospitals and institutions. Access Model Used Currently in Bhutan medical termination of pregnancy is allowed only where maternal health is in danger or there is evidence of fetal abnormality. Staff at all levels, including community health workers, ANMs, midwives and nurses, are trained in handling situations arising out of complications from abortions. Medical abortion in institutions/hospitals are allowed when legal. Post-abortion services are provided by hospitals. Salient features of MA Medicine Access in Bhutan  Abortion services and MA are legal and available under all circumstance except where it is because of personal choice.  Guidelines exist for termination of pregnancy and managing complications. 14 http://www.moh.gov.bt/wp-content/uploads/afd-files/2019/02/National-Essential-Medicines-List-2018.pdf Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 27 Potential access & supply chain recommendations for discussion with Bhutan Area Recommendations Laws, policy & regulation  Awareness and advocacy efforts on the health risks faced by pregnant women, as well as the benefits of MA is required should be increased. WHO recommends MA up to 14 weeks of gestational age.  Advocacy efforts should be aimed at MA techniques and comprehensive MA treatment and care guidelines. National standards and guidelines for safe abortion care should be evidence based and periodically updated, and should provide the necessary guidance for achieving equitable access to good-quality care. NEML  MA medicines should be allowed market authorization in the country since their use is permitted.  Inclusion in NEML of mifepristone 200 mg, misoprostol 200 mcg and also combipack (mifepristone 200 mg and misoprostol 200 mcg) should be considered. Financing and supply chain  There should be budget and funding allocated specifically for MA medicines.  There should be centralized forecasting, procurement and distribution of MA medicines for permitted uses and needs. Access Model  To meet the needs of the population, the health cadre needs to be trained and certified in abortion complication management and post-abortion care. Special focus should be given to community health workers and nurses.  Alternate sources of abortion care, either through hotlines or international NGOs could be leveraged to provide basic support to women regarding information, laws and standard guidelines. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 28 DPR KOREA DRP Korea has a population of 25.7 million (UNFPA, 2019). The contraceptive prevalence rate for any method is 75% and the unmet need for family planning is 8%. Area Status Laws, policy and guidelines Abortion is allowed only under specific circumstances. Medical abortion (MA) in institution/hospitals is allowed based on medical indications. NEML misoprostol 200 mcg was recently included in the national EML. Financing and supply chain There is no procurement and distribution of misoprostol 200 mcg in the country used for MA. Access to medicines MA medicines are accessible in designated hospitals, but the programme is presently in the pilot phase. Overview of Laws, Policies & Guidelines Legal Status: DPR Korea provides abortion up to a gestational age of seven months on request without any restrictions. The law does not require authorization or certification by doctors for abortion except in cases of fetal malformation, uterine deformation of the mother, tuberculosis, hepatitis, cardiac diseases that could endanger the mother’s health during pregnancy and delivery. Furthermore, in case of potential risks to a woman’s health due to pregnancy, three doctors need to certify the need for abortion. As per the law, only the woman undergoing abortion needs to give her consent for the procedure. In case of minors or the mentally challenged, a guardian can provide consent for the procedure. Policies, Guidelines and Strategies: DPR Korea has developed national abortion standards and guidelines including guidelines on safe abortion care, which have been translated and introduced in the system, and guidelines on comprehensive safe abortion (for clinics). As per the guidelines, abortion can be provided only by doctors in an obstetrics/gynaecology department. Graduates from medical colleges undergo a three-month training under senior doctors at the service delivery points at the country level or higher-level facilities. National-level training manuals are available. National Essential Medicines List and Regulatory Status MA medicine Strength Administration route Market authorization NEML status �ifepristone 200 mg – –  �isoprostol 200 mcg Oral Tablet –  (Draft revised NEML 2019) 100 mcg – –  25 mcg –  Combipack mifepristone 200 mg + misoprostol 200 mcg – –  Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 29 Financing and Supply Chain Management of Medical Abortion Medicines in DPR Korea FINANCING There is no specific budget or funding for MA medicines PROCUREMENT The procurement of misoprostol 200 mcg is centralized DISTRIBUTION �isoprostol 200 mcg is distributed to government hospitals There is no private sector health system or distribution for MA in DPR Korea. UNFPA plays a key role in supporting the public MA supply chain. Access Model Used Abortion can be provided free of charge at public health settings of country-level hospitals or above. Main methods of abortion include vacuum aspiration. Electric vacuum aspiration (EVA) was the main method of abortion procedure and it is only since 2007 that manual vacuum aspiration (MVA) is provided in select sites. Medical abortion is still in a pilot phase and has not yet been introduced in the system. Salient features of MA Medicine Access  Abortion laws allow easy access to abortion including MA; policies and guidelines have been developed for abortion services  MA is being piloted and misoprostol 200 mcg was recently included in the NEML Potential access & supply chain recommendations for discussion with DPR Korea Area Recommendations Laws, policy & regulation  Monitoring and tracking of public providers should be carried out to ensure that quality abortion and post- abortion services are being provided and quality is maintained. Increased awareness and knowledge by government agencies, health professionals and the public are necessary to promote and ensure access to safe MA medicines. This would facilitate activities to promote safe and reliable access. NEML  Advocate for the listing of combipack and mifepristone 200 mg in the NEML Financing and supply chain  Prepare the supply chain for national rollout of MA services Access model  Educate providers about the national guidelines on MA and post-abortion care  Extend MA to all hospitals and public health facilities to improve geographical access Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 30 INDIA As per a 2012 study of the more than 1.2 billion15 people living in India, approximately 26% (328 million) were women of reproductive age (15–49 years). In 2015–16, approximately 12.9% of married women had an unmet need for contraception16. Area Status Laws, policy and guidelines Abortion including MA is legal up to a gestational age of seven months without any restrictions. NEML MA drugs are included in the NEML list. Combipack not included. Financing and supply chain The states procure and distribute MA medicines as part of the National Health Mission (NHM) budget Access to medicines MA drugs are available at licensed pharmacies by prescription only and from designated public and primary health care centres and clinics, as well as private clinics. Overview of Laws, Policies & Guidelines Legal Status: In India, the Medical Termination of Pregnancy (MTP) Act, 1971 governs the provision of abortion. Under the Act, abortion can be sought for a range of conditions related to the mental and physical well-being of mother and child. The rules and regulations governing the MTP Act were further amended in May 2003 to specify that medical abortion may be provided by certified providers in their clinics (even if an unapproved site), as long as there is access to a registered and approved facility for back-up care and a certificate from the owner of the approved site is displayed. A major concern is the misuse of MA in the private sector for termination of pregnancy with a motive of infant sex selection. Policies, Guidelines and Strategies: Guidelines for Medical Officers on Provision of Manual Vacuum Aspiration at the primary health centre Level up to eight weeks have been published (Ministry of Health and Family Welfare, 2001) as well as Use of RU-486 with misoprostol for Early Abortion in India – Guidelines for Medical Officers (WHO, AIIMS, 2003). In 2010, Comprehensive Abortion Care Guidelines were published; they include additional key elements such as counselling, PAC and contraception. National Essential Medicines List and Regulatory Status MA medicine Strength Administration route Market authorization NEML status �ifepristone 200 mg – 23  (Oxytocics and abortifacients) �isoprostol 200 mcg Oral Tablet 3 100 mcg Oral tablet – Combipack mifepristone 200 mg + misoprostol 200 mcg – 5  Citing misuse, the Drug Controller General of India (DCGI) banned open retail sale of abortion drugs in 2019.17 17 https://www.livemint.com/science/health/citing-rampant-misuse-government-bans-open-retail-sale-of-abortion- DRUGS-1568391358998.HTML Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 31 Financing and Supply Chain Management of Medical Abortion Medicines in India 18 Source: Susheela Singh et al (JAN, 2018), The incidence of abortion and unintended pregnancy in India, 2015. Lancet Global Health. Vol 6, Issue 1, E111–E120, 01 Jan 2018 (HTTPS://WWW.THELANCET.COM/JOURNALS/LANGLO/ARTICLE/PIIS2214- 109X(17)30453-9/FULLTEXT) (AQ. Please provide access date) FINANCING Funding is available under NHM (Maternal Health) and state budgets specifically for MA medicines in annual plans PROCUREMENT Procurement is done through competitive tenders by states DISTRIBUTION Medicines are distributed to hospitals and registered health facilities at the sub- district level Funding and supply chain systems are well established, but supply chain performance varies across states. Access Model Used In India, abortion can be carried out only by trained and certified physicians. Abortion for pregnancy up to 12 weeks of gestation can be provided by a registered MBBS doctor who has completed MTP training or has a postgraduate degree or diploma in obstetrics and gynaecology. Certified providers can carry out abortions in their own facilities provided they have access to a registered facility as back-up. However, MVA can only be provided in facilities established and maintained by the government, or approved by the government or an Empowered District Level Committee. MA is the most popular method of abortion but there is greater dependence on “Outside facilities” for MA (refer figure on the right18). Salient features of MA Medicine Access  Abortion services and MA are legal and easily available with guidelines and policies in place.  There is a well-established funding and supply chain mechanism in place.  There are a large number of products registered for all MA medicines and the supply side is competitive. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 32 Potential access & supply chain recommendations for discussion with India Area Recommendations Laws, policy & regulation  To ensure effective implementation, awareness about existing laws, policies and guidelines should be increased. Increased awareness and knowledge by government agencies, health professionals and the public are necessary to promote and ensure access to safe MA services. NEML  Advocate for combipack in the NEML and encourage states to include it in state EMLs as well. Financing and supply chain  Health facilities in states should be audited for availability of MA medicines and accordingly oversight, technical assistance and training provided for strengthening the supply chain.  Allow retail sales of MA again with greater oversight to prevent misuse. Access model  Rolling out programmes for the provision of medical abortion in urban slums, rural and underserved areas through out-of-clinic settings such as pharmacies and via mid-level healthcare professionals  Monitor and track whether quality abortion and post-abortion care services are being provided at designated hospitals by qualified professionals, especially in the context of the rational use of medicines. Implementation of such a plan will encourage greater preference for safe public abortion Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 33 INDONESIA Indonesia has a total population of 267,663,435 (World Bank, 2018) and 70,053,102 (UNICEF 2016) women of reproductive age. This creates a huge potential need for abortion- related services. Area Status Laws, policy and guidelines Abortion is permitted under limited circumstances. NEML MA medicines are not technically included in the National Essential Medicines List (NEML), 2019. Misoprostol 100 mcg and 200 mcg (oral tablets) are included under the category of stomach ulcer drugs and are under review for NEML application. Financing and supply chain There is no public procurement. Access to medicines MA medicines are accessible only from designated public hospitals. Overview of Laws, Policies & Guidelines Legal Status: Continuous attempts have been made in Indonesia to reform the abortion law since the 1970s. Although Indonesia’s Penal Code provides no exceptions, Articles 75, 76 and 77 of the Law Concerning Health No. 36/2009 set out the limited circumstances under which abortion may be carried out. Abortion is permitted only when a “medical emergency [is] detected from the early age of pregnancy, threatening the life of the mother and/or foetus, [or the foetus is] suffering from severe genetic diseases and/or congenital defects, or that cannot be repaired so as to cause difficulty for the infant to survive out the womb,” or “pregnancy due to rape that may result in psychological trauma for the rape victim.” Abortion can be performed only up to six weeks of gestational age, except in cases of medical emergency. In such case counselling is mandatory, pre- and post-procedure. The punishment for illegal abortion is imprisonment for a period of four to 15. Policies, Guidelines and Strategies: Indonesia has no standard national guidelines on abortion Photo courtesy: International Campaign for Women’s Right to Safe Abortion/Joe Cantrell. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 34 services. While training manuals for abortion services are not available, manuals on PAC are. National Essential Medicines List and regulatory status MA medicine Strength Administration route Market authorization NEML status �ifepristone 200 mg – –  �isoprostol 200 mcg Oral Tablet – (Application under review)100 mcg Oral tablet – Combipack mifepristone 200 mg + misoprostol 200 mcg, (1+4 Tablets pack) – –  In Indonesia, misoprostol has been widely used in obstetric practice, both for termination of pregnancy, induction of labour and management of post-partum haemorrhage. misoprostol products are available for other indication such as gastrointestinal disorder. However, the use of misoprostol for these conditions is not indicated on drug packaging (off label). The indications of misoprostol are still listed as related to stomach ulcer drugs and some local products are also registered as such. The application process for obtaining approval for the use of misoprostol for obstetric and gynaecological indications which will be used in the standard guidelines (abortion standard services) is ongoing. The approval process has involved the ministry of health, professional organizations (obstetric society/POGI), and the Indonesian Food and Drug Authority (BPOM). FINANCING There is no specific budget and funding for MA medicines PROCUREMENT There is no centralized procurement of MA medicines DISTRIBUTION There is no distribution of MA medicines except misoprostol for other uses Financing and Supply Chain Management of Medical Abortion Medicines in Indonesia Access Model Used Abortion can be provided by a medical doctor or obstetrician-gynaecologist with a certificate issued by the ministry of health once they have been trained by accredited training providers. Private sector distribution is not allowed but there is a challenge posed to MoH regarding Internet-based illegal and unregulated sales. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 35 Abortion services are available only in the public sector and in designated public hospitals only. Doctors providing the service are required to undergo five days of PAC training given by the ministry of health. While training manuals for abortion services are not available, manuals on post-abortion care are. Salient features of MA Medicine Access in Indonesia  Termination of pregnancy is allowed for medical emergencies, in cases of rape victims and MA medicines have been used as a procedure.  Persistent advocacy has led to a review process for inclusion of misoprostol in the NEML. Potential access & supply chain recommendations for discussion with Indonesia Area Recommendations Laws, policy and regulations  An enabling regulatory and policy environment is needed to ensure that every woman who is legally eligible has ready access to safe abortion care and MA. Policies should be geared to respecting, protecting and fulfilling the human rights of women, in order to achieve positive health outcomes for them and provide them good-quality contraceptive information and services.  National standards and guidelines for safe abortion care should be evidence based and periodically updated, and should provide the necessary guidance to achieve equitable access to good-quality care.  Greater regulatory oversight is needed for use of internet and “dark web” for illegal supply of MA medicines. NEML  Expedite the inclusion of misoprostol 100 mcg and 200 mcg in NEML.  Advocate for the registration and inclusion of mifepristone and combipack for use in legally allowed cases. Financing and supply chain  There should be a budget specifically for MA medicines.  There should be procurement and dispensing of MA medicines for permitted uses and needs, at least at the hospital level. Access model  Advocacy efforts aimed at MA techniques and standard treatment guidelines should be escalated and reviewed.  To meet the needs of the population, the health workers must be made aware, familiarized with, and trained in MA and post-abortion care at all public hospitals. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 36 MALDIVES Over the past few decades, Maldives has made significant progress in human and social development. According to the 2014 census, the total population of Maldives is 407,660 out of which the number of youths is 79,246. About 60 per cent of the women are of reproductive age and the unmet need for family planning in 2009 was 28.1% (UNFPA Youth Analysis) Area Status Laws, policy & guidelines Maldives permits abortion except for preserving woman’s mental health, social/economic reasons or on request. There are penalties for illegal provision of abortion, both for the service provider as well as for the women who access these services. NEML MA medicines are not technically included in the NEML, 2015. Financing & supply chain There is no centralized public procurement and distribution. Access to medicines MA medicines are not accessible to the general public and are restricted to hospital use (secondary and tertiary) only. Overview of Laws, Policies & Guidelines Legal Status: - Abortion is a highly restricted in the Maldives and is permitted for two purposes – to save a woman’s life or to preserve her physical health. it is also permitted up to 120 days of gestational age where thalassaemia has been diagnosed and for cases where major congenital anomalies are reported. A doctor is required to certify the need for abortion. The Ministry of Health and Gender approached the Ministry of Islamic affairs to update the ruling for abortion publicized in 1999. This appeal was reviewed by the Fiqh Academy of Maldives and a Fathwa was issued a few years ago allowing abortion in cases of rape and incest.19 Since then abortion has been permitted in these circumstances. Policies, Guidelines and Strategies: No policy for guidelines exist for medical abortion. There is no specialized training for abortion. While women undergo post-abortion contraceptive counselling, there is no PAC policy in place. The Vital Registration System captures the total number of abortions performed, but there are no studies on actual abortion rates. The National Reproductive Health Strategy 2014–2018 has a half-page section on “Preventing unsafe abortion”. 19 Fathimath Shamah Society for Health Education (2017), Country Profile on Universal Access to Sexual and Reproductive Rights: Maldives Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 37 National Essential Medicines List and Regulatory Status MA Medicine Strength Administration Route Market Authorization NEML Status �ifepristone 200 mg – Primordial product (pre-authorization before import)  (Restricted to hospital use) �isoprostol 200 mcg Oral tablet 2 Product  (Restricted to hospital use)100 mcg Oral tablet 1 Products 50 mcg Oral tablet 25 mcg Pessary tablet Combipack mifepristone 200 mg + misoprostol 200 mcg – –  One misoprostol 200 mcg product has been registered on a temporary basis; the registration is due to expire in 2020. Financing and Supply Chain Management of Medical Abortion Medicines in the Maldives FINANCING There is no central funding specific to MA medicines PROCUREMENT Designated government hospitals can procure/ import MA medicines DISTRIBUTION Designated government hospitals can dispense, but cannot distribute MA medicines Access Model Used Medical abortion is permitted and restricted to secondary and tertiary care hospitals as long as the legal requirements are met. Many women and their families are known to also access abortion services including medical abortion through illegal means in or outside Maldives, especially in India. There are tertiary care private hospitals in Maldives, but MA is not a priority service for them. Photo courtesy: http://www.retireinasia.com/ Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 38 The pre-authorization required for import of mifepristone makes it a difficult to use MA over other abortion techniques. Salient features of MA Medicine Access in the Maldives  The Fiqh Academy fathwa expanding the circumstances for legal abortion, demonstrates the openness to abortion reforms in the country  Inclusion of MA medicines in NEML is an example to other countries where restricted use of MA is allowed Potential access & supply chain recommendations for discussion with the Maldives Area Recommendations Laws, policy and regulation  An enabling regulatory and policy environment is needed to ensure that every woman who is legally eligible has ready access to safe abortion care and MA.  To ensure effective implementation, there is a need to increase awareness about the laws, policies and guidelines. Increased awareness and knowledge of government agencies, health professionals and the public are necessary to promote and ensure access to safe MA medicines. This would facilitate activities to promote safe and reliable access. NEML  Government should encourage non-temporary registration for a greater number of MA medicines in the country including mifepristone and the combipack  The combipack should be included in NEML. Financing and supply chain  There should be centralized procurement and distribution including pre- stocking of MA medicines in the country. Access model  �isoprostol 200 mcg, 100 mcg and mifepristone 200 mg are used only in secondary and tertiary hospitals. More facilities should be upgraded and approved so that they may be equipped to provide access to women in remote atolls.  To meet the needs of the population, the health workers must be made aware of, familiarized with, and trained in post-abortion care and services through regular training and mandated certifications. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 39 MYANMAR In Myanmar, out of the total population of 51.4 million as per the 2014 census, 28% is made up of young people (aged 10–24 years) and 27% consists of women of the reproductive age group (15–49 years). Abortion is illegal in Myanmar and it is one of the leading causes of maternal mortality, with at least 13% of maternal deaths (2018 MDSR report) and 12.2% of all hospital pregnancy admissions resulting from complications due to unsafe abortion (Hospital Statistics Report 2016). Area Status Laws, policy and guidelines Abortion is not permitted, except under limited circumstances. NEML �isoprostol 25mcg pessary and misoprostol 200 mcg are included un NEML 2016 under Oxytocics and Myometrial relaxants. Financing and supply chain �isoprostol is procured for active management of third stage of labour and prevention of postpartum haemorrhage, through the government budget annually, both at the central and state/regional levels. Access to medicines MA medicines are accessible only from designated public hospitals. Overview of Laws, Policies & Guidelines Legal Status: As per Articles 312, 313 and 314 of the Myanmar Penal Code, abortion is illegal except when “performed in good faith for the purpose of saving the life of the woman”. Abortion can be provided up to 22 weeks of gestational age and a doctor needs to certify the need for it. The Protection and Prevention of Violence Against Women (PoVAW) Bill is under review. The bill allows abortion under certain conditions for rape victims. Policies, Guidelines and Strategies: In Myanmar abortion can be provided by obstetrics and gynaecology specialists who, in their postgraduate training, had abortion as a subject and are working in public hospitals. Post-abortion contraceptive counselling is undertaken, including spacing between births. PAC is available at all health facilities through health-care providers, including doctors and midwives. A manual on post-abortion care is available (Post Abortion Care Reference Manual, 2015). The Five-year Strategic Plan for Reproductive Health (2014-2018) states that management of post-abortion complications is provided at health facilities. Medical abortion is practiced where abortion is legal. Management of termination of pregnancy is being covered as one of the components in trainings for post-abortion care. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 40 National Essential Medicines List and Regulatory Status MA Medicine Strength Administration Route Market Authorization NEML Status �ifepristone 200 mg – –  �isoprostol 200 mcg Oral tablet 1 product  (Oxytocics and Myometrial relaxants) 25 mcg Pessary tablet 1 product 100 mcg Oral tablet –  Combipack mifepristone 200 mg + misoprostol 200 mcg – –  �isoprostol is registered only for treatment of gastritis and prevention of postpartum haemorrhage/active management of the third stage of labour (PPH/AMTSL). �isoprostol is allowed for termination of pregnancy only in good faith, i.e. to save the life of the woman. Financing and Supply Chain Management of Medical Abortion Medicines in Myanmar FINANCING There is no specific budget or funding for MA medicines PROCUREMENT There is no centralized/ state/regional procurement of MA medicines except misoprostol for across-the- board uses DISTRIBUTION There is no distribution of MA medicines except misoprostol for across-the- board uses There is no substantive supply chain support for financing, procurement and distribution of MA medicines. In Myanmar, “medical abortion medicines” are not used as a legal term. Access Model Used Abortion services can be provided only in public hospitals or specialist hospitals at the obstetrics and gynaecology departments. Doctors in private facilities are not authorized to provide services. National standards and guidelines are not available and hence it is difficult to indicate methods that may be suggested to health workers. Private sector is not allowed to distribute and dispense MA medicines. Photo courtesy: Eleven Media Group Co./Kyi Naing Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 41 Salient features of MA Medicine Access in Myanmar  The PoVAW Bill is evidence that the country is moving towards greater legal reforms in relation to MA.  The use of misoprostol is allowed for termination of pregnancy in cases which are approved by the clinical management committee to save the life of the mother. Potential access & supply chain recommendations for discussion with Myanmar Area Recommendations Laws, policy and regulation  Advocate for the expedited passing of PoVAW bill. Policies should be geared to respecting, protecting, and fulfilling the human rights of women, to achieve positive health outcomes for women and providing good-quality contraceptive information and services.  Modification of laws should be made less restrictive and clear in terms of conditions under which abortion is illegal. For e.g. a clear and more inclusive definition of “saving a woman’s life” is required. NEML  All MA drugs should be included in the NEML.  More MA medicine suppliers should be encouraged to register in the country. Financing and supply chain  There should be separate budgets, procurement and distribution for MA medicines for situations in which abortion is allowed. Access model  Monitoring and tracking of public providers to ensure that post-abortion services are being provided and quality is maintained should be put in place.  More community health workers should be trained to administer MA. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 42 NEPAL With a population of 30 million, Nepal has been one of the frontrunners in the region with regard to introducing and propagating medical abortion for women in the reproductive age group. Area Status Laws, policy and guidelines Nepal legalized abortion in 2002 and soon put in place a comprehensive set of policy documents. Medical abortion was introduced in 2009 by the Ministry of Health and Population; MA medicines are registered in the country and available in the public and private health systems NEML MA medicines are included in the NEML, 2016 Financing and supply chain Public procurement is allowed and decentralized. MOHP is the key source of funding for MA medicines. Access to medicines MA medicines are accessible at municipal level hospitals and a portion of primary health centres (PHCs) Overview of Laws, Policies & Guidelines Legal Status: Nepal permits abortion by request, for any reason up to 12 weeks, or in cases of rape and incest up to 18 weeks, and at any gestational age if the pregnancy poses a danger to a woman’s life or mental or physical well-being, and in case of fetal anomalies. Policies, Guidelines and Strategies: The Safe Motherhood and Reproductive Health Act (2018) outlines the right of women to safe abortion. Reproductive Health Regulations have been operationalized at the facility level by the Safe Abortion Service Programme Procedure Guidelines, 2018. National Reproductive Health Protocol, (2010) defines government-approved methods of safe abortion, including MA up to 9 weeks. Strategy documents that cover MA, include National Reproductive Health Commodity Security Strategy (2015) and Comprehensive Abortion Care – Integrated Reference Manual (2015). National Essential Medicines List and Regulatory Status MA Medicine Strength Administration Route Market Authorization NEML Status �ifepristone 200 mg Sublingual/intra-vaginal 3 brands  �isoprostol 200 mcg Oral tablet 4 brands  (Oxytocics)25 mcg Pessary Combipack mifepristone 200 mg + misoprostol 200 mcg, (1+4 tablets pack) Oral for misoprostol, sublingual/intra-vaginal for mifepristone 4 brands  (Oxytocics) Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 43 Financing and Supply Chain Management of Medical Abortion Medicines in Nepal FINANCING Funding is decentralized to municipal level health facilities under a broad head that includes MA medicines PROCUREMENT SAS approved facilities buy NEML listed MA medicines from a medical stockist by using prescriptions DISTRIBUTION Medicines are stocked and dispensed to clients at the SAS approved health facilities The decentralisation of health services and procurement is a recent development in Nepal (2017-18) and hence the quality of procurement and supply varies across the country depending on local capacity and capabilities. Access Model Used MOHP remains committed towards access to safe abortion services (SAS), notably in 2016 initiating free abortion services throughout the public sector. Comprehensive Abortion Care (MVA and MA) services have been expanded to all 75 districts hospital and to over 50% of PHC centres in the country. Second trimester abortion services are available in 22 hospitals and MA services are being expanded at health posts and additional training is being provided to the skilled birth attendants (SBA)20. MA medicines (registered and unregistered) are also available through private pharmacies21 and hospitals. Designated and licensed nongovernmental organizations/social marketing organizations such as Marie Stopes Nepal and PSI Nepal also provide/facilitate MA medicines. Various studies22 show that a large percentage of clients prefer private health facilities. 20 Safe Abortion Services (NSAS), Ministry of Health and Population, Government of Nepal 21 Tamang et al (2015), Pharmacy workers in Nepal can provide the correct information about using mifepristone and misoprostol to women seeking medication to induce abortion 22 CREHPA (2020), Rapid Assessment of Surveillance System of Medical Abortion (MA) Drugs in Nepal, Puri M et al. (2015) Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 44 23 CREHPA (2017) First National Study on the Incidence of Abortion and Unintended Pregnancy in Nepal, Puri M et al. (2015), CREHPA (2020), Rapid Assessment of Surveillance System of Medical Abortion (MA) Drugs in Nepal Successful MA medicine access & supply chain practices  Nepal has clear and extensive laws, policies, guidelines and strategies which are well documented.  The product registration, inclusion in NEML, and public procurement of combipacks are good practices as they aid in improved and correct dispensing, as well as in the use of medicines  Expansion of free of cost MA services to remote areas and across all 75 district hospitals has provided widespread access. Potential access & supply chain recommendations for discussion with Nepal Nepal has made good progress in terms of laws, regulation, policies and strategies. However, the incidence of unsafe abortion is still high. Various studies23 confirm this fact. Area Recommendations Laws, policy & regulation  Monitoring and enforcement measures on the medicines available in the private sectors should be increased along with education and awareness, so that the access to medical abortion though these channels is safe and affordable. NEML  While the combipack is preferable, inclusion of mifepristone 200 mg should be considered as an alternative for procurement teams in case the combipack is not available. There should be a clear guideline that the separate medicines are only a fallback to the combipack. Financing and supply chain  To address existing gaps and future scale-up of public abortion services, the decentralized procurement mechanism needs strengthening so that it is not a bottle-neck. Local procurement officers must be capacitated to allocate sufficient budgets for MA needs. Access model  To meet increasing demand for medical abortion, we need to invest in parallel supply efforts by encouraging a greater number of registered SAS stockists, pharmacies and NGOs/SMOs. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 45 SRI LANKA The total population of Sri Lanka in 2012 was 20.3 million with approximately 10.5 million women. 58.1% of all women were of the reproductive age (15–49 years). Overall, 7.3% of married women had an unmet need for family planning (DHS 2006–2007). Area Status Laws, policy and guidelines Abortion laws are restrictive, even in circumstances where a woman’s life is in danger. Otherwise it is completely illegal. NEML MA drugs are not included in the NEML. Financing and supply chain There is no public procurement and distribution of MA medicines. Access to medicines MA medicines are accessible in designated hospitals. Overview of Laws, Policies & Guidelines Legal Status: Despite a series of efforts to legalize abortion since the 1970s, abortion laws remain restrictive and abortion is permitted only to save the life of the woman. Access is further restricted since the procedure has to be certified by two obstetricians/gynaecologists and/ or a psychiatrist. The law does not specify the gestational age up to when abortion can be sought and provided. Consent for abortion has to be given by the woman concerned and the procedures are similar to other surgical procedures. Policies, Guidelines and Strategies: There are no standard or national guidelines, therefore limited information is available regarding providers or methods used for abortion. Board certified gynaecologists can provide abortion services. In 2015, the Sri Lankan Ministry of Health issued new guidelines for healthcare workers on comprehensive post-abortion care. The guidelines stipulate that any woman who undergoes an illegal abortion can seek medical care for complications, if needed, at any government facility without fear of prosecution. National Essential Medicines List and regulatory status MA Medicine Strength Administration Route Market Authorization NEML Status �ifepristone 200 mg – –  �isoprostol 200 mcg Oral tablet 1 product  Combipack mifepristone 200 mg + misoprostol 200 mcg – –  �isoprostol is registered for use in miscarriage, mid-trimester foetal death, cervical ripening, induction of labour and treatment of post-partum haemorrhage only. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 46 Financing and Supply Chain Management of Medical Abortion Medicines in Sri Lanka FINANCING There is no specific budget or funding for MA medicines PROCUREMENT There is no centralized procurement of MA medicines DISTRIBUTION There is no distribution of MA medicines There is no public or private distribution of MA medicines in Sri Lanka. �isoprostol is available in public hospitals and private health care for other uses Access Model Used Legal abortion services with clear medical indication to save the life of the woman are available at government hospitals that have specialized maternity and gynaecology units. These services are free of charge when certified by two obstetricians/ gynaecologists and/or a psychiatrist. Women presenting with abortion complications are hospitalized and the treatment is free of charge. PAC includes contraceptive counselling for the woman/couple on family planning, who are informed that all methods are available free of cost at most of the health institutions providing post-abortion care. Salient features of MA Medicine Access in Sri Lanka  The Sri Lanka College of Gynaecology and Obstetricians recommended the use of misoprostol for post-abortion care as per the Ministry of Health 2015 guidelines, which is a positive change in the direction of safe abortion services in the country. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 47 Potential access & supply chain recommendations for discussion with Sri Lanka Area Recommendations Laws, policy & regulation  An enabling regulatory and policy environment is needed to ensure that every woman who is legally eligible has ready access to safe abortion care and MA. Policies should be geared to respecting, protecting and fulfilling the human rights of women, achieving positive health outcomes for women and providing good-quality contraceptive information and services.  Awareness and knowledge about laws should be provided to the general population in order to minimise the use of unsafe and illegal methods. NEML  Re-evaluate status of MA drugs in the NEML especially inclusion of misoprostol which is registered in the country.  Greater registration of MA medicines should be advocated as their use is allowed under certain circumstances Financing and supply chain  Hospitals should be provided separate budgets and technical assistance for procuring misoprostol for PAC Access model  Health workers should be educated about the national guidelines on post- abortion care and use of misoprostol.  Monitoring and tracking of public providers should be carried out to ensure that quality post-abortion care is being provided.  Training of abortion health workers must ensure that they have the competencies to provide good-quality care in accordance with national standards and guidelines. Ensuring good-quality abortion care requires ongoing supervision, quality assurance, monitoring and evaluation. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 48 THAILAND In Thailand, the total population is 64.224 million. Of this total 49% are female with a majority of them are in the child bearing age group (15–49 years). Area Status Laws, policy and guidelines Abortion is illegal in Thailand unless the woman’s health is at risk or pregnancy is due to rape. NEML Combipack (mifepristone 200 mg+misoprostol 200 mcg) is included in the NEML list. Financing and supply chain There is no centralized procurement or distribution. Access to medicines MA medicines are accessible in designated hospitals. Overview of Laws, Policies & Guidelines Legal Status: In Thailand, abortion can be provided for a range of conditions. The abortion law is nested within Section 305 of the Penal Code, which states that abortion can be provided if “it is necessary for the sake of the health of such woman” or if she is pregnant as a result of a criminal offence. In 2006, the law was slightly modified to bring in a Regulation on Criteria for Performing Therapeutic Termination of Pregnancy in accordance with Section 305, whereby termination of pregnancy could be performed for a period of up to 12 weeks of gestation, and only by a medical practitioner. Section 301 of the penal code, criminalises abortion for the woman herself. Recently, Thailand’s constitutional courts have ruled that banning abortion is unconstitutional and asked for amendments in section 301 and 305.25 Policies, Guidelines and Strategies: In Thailand, no national standards or guidelines are available for provision of abortion services. Under the law only obstetricians, gynaecologists and physicians are permitted to provide abortion services. In the absence of national standards and guidelines, it is not possible to indicate which methods are recommended. There does exist a clinical practice handbook for safe abortion care. The methods suggested for first trimester abortion are mainly MVA or EVA, while MA is used in the second trimester (Country Profiles, Asian Safe Abortion Partnership). 24 See Central Intelligence Agency (CIA), U.S. Government, Thailand, in The World Factbook (2005), http://www.cia.gov/cia/ publications/factbook/geos/th.html (last modified June 14, 2005) 25 https://www.reuters.com/article/us-thailand-abortion/thai-court-says-anti-abortion-laws-unconstitutional-idUSKBN20E1LI Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 49 National Essential Medicines List and Regulatory Status MA Medicine Strength Administration Route Market Authorization NEML Status �ifepristone 200 mg – –  �isoprostol 200 mcg Oral tablet 2 products  Combipack mifepristone 200 mg + misoprostol 200 mcg, (1+4 tablets pack) Oral tablet 1 product  Prostaglandin antagonists and Oxytocics �isoprostol is imported and registered for non-obstetric use while mifepristone is not registered. A combipack was registered in Thailand in late 2014. It is also included in the NEML 2019. Financing and Supply Chain Management of Medical Abortion Medicines in Thailand FINANCING There is no specific budget or funding for MA medicines PROCUREMENT There is a centralized procurement of MA which is procuring by the specific public hospital DISTRIBUTION There is no distribution of MA medicines, it is dispensed at a limited number of public hospitals There is a much more well-developed supply chain in the private sector. Access Model Used Terminations of pregnancy in accordance with the regulations can be performed only in specified medical premises. The main providers are private NGOs, general practitioners’ clinics, private hospitals and gynaecologists in private clinics and hospitals. The government provides adequate funding to run training and service delivery programmes and the department of health is responsible for training physicians and nurses. Further, in-service training of five days undertaken by the Department of Health, Ministry of Public Health is available at government hospitals. Salient features of MA Medicine Access in Thailand  The private sector being allowed to extend abortion services including MA, improves overall access.  The authorization and inclusion of combipack in NEML makes MA administration easier.  The recent court ruling is a positive step forward towards ensuring improved access to MA. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 50 Potential access & supply chain recommendations for discussion with Thailand Area Recommendations Laws, policy and regulation  Laws should be modified to make them less restrictive and clearer in terms of conditions under which abortion is illegal, keeping in mind the recent court ruling and directive. An enabling regulatory and policy environment is needed to ensure that every woman who is legally eligible has ready access to safe abortion care and MA.  Monitoring and oversight of private providers is necessary to ensure that quality abortion and post-abortion services are being provided with quality and affordable rates. NEML  More MA medicines suppliers should be encouraged to register in the country.  misoprostol and mifepristone should also be included in NEML Financing and supply chain  There should be separate budgeting, MA medicines to public hospitals and facilities Access model  Monitoring and tracking should be carried out to find out whether quality abortion and post-abortion care services are being provided at the designated hospitals.  Coverage should be expanded to a greater number of hospitals, as well as larger public health facilities, and more staff trained accordingly. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 51 TIMOR-LESTE According to the 2010 census, the population of Timor-Leste was 1.07 million. Only 26% of married women were using any method of family planning. (Demographic and Health Survey 2016) Area Status Laws, policy & guidelines Abortion is permitted under limited circumstances. There are no national guidelines available in Timor-Leste NEML MA medicines are not technically included in the NEML, 2015. �isoprostol is used only in delivery management, and hence included as vital in NEML. Financing and supply chain There is no public procurement Access to medicines MA medicines are not accessible to the general public. In special cases, it is available at designated public hospitals and any private retail or private hospital pharmacies. Overview of Laws, Policies & Guidelines Legal Status: Abortion is highly restricted and remains a sensitive issue. It is only allowed in cases where “interruption of pregnancy is the only means to counter the risk of death or irreversible lesion to the body and physical or psychological health of the mother or the foetus, as long as the procedure is authorised and monitored by a medical team and performed by a doctor or health professional in a public health institution with the consent of the pregnant woman and/or her life partner” (Article 141, Paragraph 4 of the Timor-Leste Penal Code promulgated by the President in April 2009). It is also stipulated that three doctors must agree to the procedure and sign a certificate. A fourth doctor, not one of the original three, should perform the abortion and at least one of the doctors should be an obstetrician/gynaecologist Policies, Guidelines and Strategies: Post abortion care and prevention of unsafe abortion at the community health centre level is mentioned in the National Strategy on Reproductive, Maternal, Newborn, Child and Adolescent health 2015–2019. Timor Leste has drafted the post abortion guidelines under support from UNFPA in December 2019. It is expected to be approved and disseminated in 2021. Photo courtesy: Martine Perret/United Nations Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 52 National Essential Medicines List and Regulatory Status MA Medicine Strength Administration Route Market Authorization NEML Status �ifepristone 200 mg – –  �isoprostol 200 mcg Oral tablet 1 product  Combipack mifepristone 200 mg + misoprostol 200 mcg – –  �isoprostol 200 mcg was included in the 2015 NEML as a “vital” drug. Financing and Supply Chain Management of Medical Abortion Medicines in Timor-Leste FINANCING USD 1.32 million was budgeted in 2019 for misoprostol 200 mcg under delivery management PROCUREMENT In 2019, 18,750 tablets of misoprostol 200 mcg were procured by SAMES (Central Medical Store) DISTRIBUTION These were distributed to major public hospitals in the country by SAMES Private health care providers and pharmacies are also allowed to provide misoprostol under strict regulation for non-MA use. Access Model Used Authorised providers of abortion services are doctors or health professionals based in public health institutions or accredited midwives who have undergone training in Emergency Obstetric Care (EmOC). Salient features of MA Medicine Access in Timor Leste  Despite cultural reservations, abortion is allowed in Timor Leste under certain circumstances and use of misoprostol is allowed for delivery management. The drug is also included in NEML.  There is an allocation in the budget for MA medicine. Procurement and distribution of misoprostol 200 mcg is centralized, which indicates good supply chain support. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 53 Potential access & supply chain recommendations for discussion with Timor Leste Area Recommendations Laws, policy and regulation  An enabling regulatory and policy environment is needed to ensure that every woman who is legally eligible has ready access to safe abortion care. Policies should be geared to respecting, protecting and fulfilling the human rights of women, to achieve positive health outcomes for women and providing good-quality contraceptive information and services.  While misoprostol 200 mcg is indicated for delivery management, its use for MA is not clearly mentioned. The indication should be set out in detail in separate guidelines. National standards and guidelines for safe abortion care should be evidence based and periodically updated, and should provide the necessary guidance for achieving equitable access to good-quality care NEML  Market authorization of all MA drugs should be encouraged with multiple options.  �ifepristone 200 mg and the combipack of misoprostol 200 mcg + mifepristone 200 mg should also be included in the NEML for use in situations where abortion is allowed. Financing and supply chain  Budget, forecasting, procurement and distribution support, similar to that provided for misoprostol 200 mcg, should be extended to more MA medicines, as and when they are added to the NEML. Access model  To meet the needs of the population, the health cadre and service providers must be educated in post-abortion care and services through regular training and mandated certification. Post abortion, family planning counselling must be provided.  Alternate sources of abortion care, either through hotlines or international NGOs can be leveraged to provide basic support to women regarding information, laws and standard guidelines. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 54 Compendium of Primary & Secondary Information Sources Websites 1. WHO, Global Abortion Policies Database. Last updated 2017 (https://abortion-policies.srhr. org/) Has a compendium of abortion related policies, guidelines, standards etc. for all 11 SEAR countries. 2. Medical Abortion Commodities Database (https://www.medab.org/) data and details about 96 countries on registration and availability of MA medicines 3. WHO: Overview, health impact and role of WHO with regard to abortion (https://www.who. int/health-topics/abortion#tab=tab_1:) 4. Zauba: https://www.zauba.com/: Site providing data on export prices of drugs from India to SEA Region countries based on customs records 5. Guttmacher Institute: 2020 (https://www.guttmacher.org/) 6. UNFPA: Procurement Services, 2020 (https://www.unfpaprocurement.org/catalog) References 1. Venture Strategies for Health Development (). Assessment of the Availability of Medical Abortion Commodities in Eight Countries. Jan 2020.(Covers Bangladesh and Nepal among SEARO countries) 2. Stillman, Melissa, Jennifer J. Frost, Susheela Singh, Ann M. Moore and Shveta Kalyanwala. . Abortion in India: A Literature Review – A 2014 report more focused on the programmatic side of abortion. Guttmacher Institute. Dec 2014 (https://www.guttmacher.org/sites/ default/files/report_pdf/abortion-india-lit-review.pdf) 3. Ipas. Roots of Change: A step-by-step advocacy guide for expanding access to safe abortion. Chapel Hill: Ipas. 2018. (A detailed advocacy guide for abortion) (https://ipas. azureedge.net/files/ADVGDE18-RootsOfChange.pdf) 4. Huda, F. A., Mahmood, H. R., Alam, A., Ahmed, F., Karim, F., Sarker, B. K., et al. Provision of menstrual regulation with medication among pharmacies in three municipal districts of Bangladesh: a situation analysis. Contraception. 2018; 97(2), 144–151. doi: 10.1016/j. contraception.2017.11.006 (A research paper that assesses the provision of the combination of mifepristone–misoprostol for menstrual regulation (MR) in randomly selected urban pharmacies in Bangladesh). Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 55 5. Parashar, R., Gupta., Bajpayee, D., Gupta, A., Thakur, R., Sangwan, A., et al. Implementation of community based advance distribution of misoprostol in Himachal Pradesh (India): Lessons and way forward. BMC Pregnancy and Childbirth. 2018;18(1). doi: 10.1186/s12884- 018-2036-2 (Lessons learnt document) 6. Boler, T, Marston C, Corby N and Gardiner E. Medical Abortion in India: A model for the rest of the world? (An old 2009 study on practices of pharmacists and healthcare providers in 2 Indian states) London: Marie Stopes International; 2009 (https://www.mariestopes.org/ media/2131/medical-abortion-in-india.pdf) 7. IPPF. International Medical Advisory Panel (IMAP) Statement on medical abortion – Intended to support and guide those providing information and services, engaged in advocacy and/or partnering with government and other key stakeholders. Oct 2018 (https:// www.ippf.org/sites/default/files/2019-10/IPPF_IMAP_Statement%20on%20medical%20 abortion%20-%20English.pdf) 8. Jelinska, K., Yanow, S. Putting abortion pills into women’s hands: realizing the full potential of medical abortion. Contraception. 2018; 97(2), 86–89. doi: 10.1016/j. contraception.2017.05.019 (Activist strategies to actualize the full potential of abortion pills are highlighted) 9. Rogers, C., Sapkota, S., Tako, A., & Dantas, J. A. R. Abortion in Nepal: perspectives of a cross-section of sexual and reproductive health and rights professionals. BMC Womens Health. 2019;19(1). doi: 10.1186/s12905-019-0734-1 - Perspectives of a cross-section of sexual and reproductive health and rights professionals 10. Rogers, C., Sapkota, S., Paudel, R., & Dantas, J. A. R. Medical abortion in Nepal: a qualitative study on women’s experiences at safe abortion services and pharmacies. Reproductive Health. 2019; 16(1). doi: 10.1186/s12978-019-0755-0 (A study on provider and end-use behaviour) 11. Office of the High Commissioner for Human Rights (2015). Access to Medicines in the context of the Right to Health - A summary of discussions and recommendations of the 2015 Social Forum. (In accordance with Human Rights Council resolution 26/28) 12. World Health Organization. Mapping abortion policies, programs and services in the South- East Asia Region – (A 2013 WHP document that maps the legal situation of abortion in the 11 countries) 2013 (file:///C:/Users/Volted%20User/Downloads/B5034.pdf) 13. World Health Organization (2018). Medical management of abortion Updated Recommendations for the use of mifepristone and misoprostol for inducing abortion and for managing incomplete abortion. – 2018 (file:///C:/Users/Volted%20User/ Downloads/9789241550406-eng.pdf) 14. World Health Organization (2003). Safe Abortion - Technical and Policy Guidance for Health Systems (old 2003 document) 15. World Health Organization (2020). Improving access to medical abortion services in South East Asia region - A concept note developed by WHO SEARO in 2020 providing an overview of the MA access landscape 16. The Economist. Abortions are becoming safer and easier to obtain—even where they are illegal (An article that shares insights into medical provider and end-use practices across the globe, including SEAR countries). Mar 2020. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 56 17. Jhpiego Corporation (2014). Business Case: Investing in Production of High-Quality misoprostol for Low-Resource Settings (A USAID sponsored document highlighting market status and market shaping activities with regards to MA medicines) (https://www. rhsupplies.org/uploads/tx_rhscpublications/BusinessCase_Oxytocin.pdf) 18. Belton, Suzanne, Andrea Whittaker, Zulmira Fonseca, Tanya Wells-Brown & Patricia Pais. Attitudes towards the legal context of unsafe abortion in Timor-Leste. Reproductive Health Matters. 2009; 17:34, 55-64, DOI: 10.1016/S0968-8080(09)34470-5 (Document covering socio-legal matters with regards to MA) 19. Loi, U. R., Gemzell-Danielsson, K., Faxelid, E., & Klingberg-Allvin, M. Health care providers’ perceptions of and attitudes towards induced abortions in sub-Saharan Africa and Southeast Asia: a systematic literature review of qualitative and quantitative data. BMC Public Health. 2015; 15(1). doi: 10.1186/s12889-015-1502-2 (Provides some insights on provider behaviour and end-use) 20. Mittal S, Bahadur A, Sharma JB. Survey of the Attitude to, Knowledge and Practice of Contraception and Medical Abortion in Women Attending a Family Planning Clinic. (Provides some insights on provider behaviour and end-use in India). JTGGA. November, 2007 (http:// cms.galenos.com.tr/Uploads/Article_12970/JTGGA-29-342.pdf) 21. Tran, N. T., Jang, M. C., Choe, Y. S., Ko, W. S., Pyo, H. S., & Kim, O. S.. Feasibility, efficacy, safety, and acceptability of mifepristone-misoprostol for medical abortion in the Democratic People’s Republic of Korea. International Journal of Gynaecology & Obstetrics, 2010; 109(3), 209–212. doi: 10.1016/j.ijgo.2010.01.012 ( An end-use study in North Korea). 22. Ramya Kumar misoprostol and the politics of abortion in Sri Lanka. Reproductive Health Matters. 2012; 20:40, 166-174, DOI: 10.1016/S0968-8080(12)40652-8 (Details on policy and legal environment). 23. Perera, J., Silva, T. D., Gange, H. Knowledge, behaviour and attitudes on induced abortion and family planning among Sri Lankan women seeking termination of pregnancy. Ceylon Medical Journal. 2011; 49(1), 14. doi: 10.4038/cmj. v49i1.3278 (Provides some insights on provider behaviour and end-use in Sri Lanka) 24. World Health Organization. Health worker roles in providing safe abortion care and post-abortion contraception. 2015.(A WHO 2015 document on provider behaviour across countries) (https://apps.who.int/iris/bitstream/handle/10665/181041/9789241549264_eng. pdf?sequence=1) 25. Alam, Anadil et al. Acceptability and Feasibility of mifepristone-misoprostol for Menstrual Regulation in Bangladesh. Int Perspect Sex Reprod Health. 2013; 39(2):79-87. doi: 10.1363/3907913. PMID: 23895884. 26. Department of Social Affairs, Population Division, United Nations (UN), World Population Prospects: The 2012 Revision, Volume II: Demographic Profiles, New York: UN. 2012. 27. Susheela Singh et all.The incidence of abortion and unintended pregnancy in India. Lancet Global Health. 2015; Vol 6, Issue 1, E111–E120, 01 Jan 2018. https://www.thelancet.com/ journals/langlo/article/PIIS2214-109X(17)30453-9/fulltext. 28. Fathimath Shamah. Country Profile on Universal Access to Sexual and Reproductive Rights: Maldives. Society for Health Education. 2017. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 57 29. Safe Abortion Services (NSAS), Ministry of Health and Population, Government of Nepal 30. Tamang, Anand, et al. Pharmacy workers in Nepal can provide the correct information about using mifepristone and misoprostol to women seeking medication to induce abortion. Reproductive Health Matters. 2014; 22:sup44, 104-115, DOI: 10.1016/S0968- 8080(14)43785-6 T. 31. Puri M et al. Rapid Assessment of Surveillance System of Medical Abortion (MA) Drugs in Nepal. CREHPA. 2020 (http://origin.searo.who.int/nepal/documents/health_systems/tor- rapid_assessment_of_surveillance_system_of_medical_abortion_drugs.pdf) 32. Central Intelligence Agency (CIA). Thailand, in The World Factbook (last modified June 14, 2005). (http://www.cia.gov/cia/publications/factbook/geos/th.html) 33. World Health Organization. 22nd Expert Committee on the Selection and Use of Essential Medicines - Application for mifepristone-misoprostol, 2018 (https://www.who.int/selection_ medicines/committees/expert/22/applications/s22.1_mifepristone-misoprostol.pdf?ua=1) 34. Setboonsarng, Chayut. Thai court says anti-abortion laws unconstitutional. Reuters, 20 February 2020. https://www.reuters.com/article/us-thailand-abortion/thai-court-says-anti- abortion-laws-unconstitutional-idUSKBN20E1LI) 35. Thacker, Teena. Citing rampant misuse, government bans open retail sale of abortion drugs. Livemint. 13 September 2019. (https://www.livemint.com/science/health/citing- rampant-misuse-government-bans-open-retail-sale-of-abortion-drugs-1568391358998.html) 36. National Family and Health Survey, India 4, Country Factsheet 3, 2015–16 (http://rchiips.org/ NFHS/pdf/NFHS4/India.pdf) Latest Country NEML URLs (where available) • Thailand: https://tinyurl.com/ThNLEM • Timor-Leste: https://abortion-policies.srhr.org/documents/countries/03-Timor-Leste- Essential-Medicines-List-2015.pdf • Bhutan: http://www.moh.gov.bt/wp-content/uploads/afd-files/2019/02/National-Essential- Medicines-List-2018.pdf • India: https://abortion-policies.srhr.org/documents/countries/05-India-National-List-of- Essential-Medicines-2015.pdf • Myanmar: https://mohs.gov.mm/Main/content/publication/essential-medicine-national-list- of-essential-medicines-2016 Response to Country Questionnaires Responses by countries to questionnaire survey are available at this link. Contact WHO for access. Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 58 Scoring Criteria for snapshot chart (Figure A) Legal Status: Grounds on which abortion is permitted 0 Not permitted 1 To save a woman’s life 2 To save a woman’s life, to preserve a woman’s health, to preserve a woman’s mental health, in case of rape or incest, or because of foetal impairment 3 To save a woman’s life, to preserve a woman’s health, to preserve a woman’s mental health, in case of rape or incest, because of foetal impairment, For economic or social reasons and on request. Policies, guidelines and strategies 0 No policy, guideline or strategy exists 1 Either one is present – Abortion is included in national reproductive health policy/ strategy/guidelines and guidelines on safe abortion care/post abortion care exists 2 Both are present – Abortion is included in national reproductive health policy/ strategy/guideline and guideline on safe abortion care/post abortion care exists 3 Comprehensive abortion guidelines along with training manuals for providers. NEML Inclusion 0 None of the MA drugs are included in the NEML 1 Either one is included in the NEML (misoprostol 100 mcg + misoprostol 200 mcg ) 2 Either one of misoprostol (200 mcg, 100 mcg) along with either mifepristone 200 mg or combipack included in the NEML 3 All 3 should be included in NEML combinations of misoprostol 100 mcg + misoprostol 200 mcg, misoprostol (200 mcg, 100 mcg) + mifepristone 200 mg Market authorization 0 No MA drug has market authorization 1 One or more combinations of misoprostol has market authorization status 2 One or more combinations of misoprostol, mifepristone and Combipack (misoprostol +mifepristone) has market authorization status 3 5 or more products for each MA drug are registered Financing 0 MA medicine purchase is restricted 1 Purchase allowed, but no specific budget 2 Specific budget for MA 3 Specific budget for MA and competitive prices in private sector Ac ce ss to m ed ic al a bo rt io n m ed ic in es in th e So ut h- Ea st A si a Re gi on 59 Supply chain for MA drugs 0 No procurement allowed 1 Procurement allowed at the periphery, but no central tendering 2 Centralized tendering with public distribution where required 3 Public centralized tendering and distribution with private sector distribution Access model 0 MA services are not accessible 1 MA and post MA services available at public facilities only through registered doctors/specialists 2 MA and post MA services available at public facilities, private sector and NGOs by registered doctors/specialists 3 MA and post-MA services available at public facilities/private sector facilities and through NGOs by registered doctors/specialists/community workers/skilled birth attendants/accredited midwives Key Contacts For any support or clarification please write to: Dr. Meera Thapa Upadhyay Technical Officer (Reproductive Health) upadhyaym@who.int

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Over half of all estimated unsafe abortions globally in 2015–2019 were in Asia. A sizeable number of these happened in the WHO South-East Asia (SEA) Region. Unsafe abortion remains a major public health issue and is the cause of about one in 10 global maternal deaths. Maternal mortality and poor maternal health due to unsafe abortions are one of the key challenges for the SEA Region on the road to achieving the SDG 3.1 target of reducing the ‘maternal mortality ratio to less than 70 per 100 000 live births by 2030’. Medical abortion (MA) is a safe alternative for abortion and is recommended by WHO where post-abortion care is available. To ensure access and effective use of MA medicines, policy, regulation, registration, NEML inclusion, financing and supply chain management must be conducive to legal frameworks in the countries. This report provides an overview of the current situation with regard to MA medicines and provides practical recommendations for countries to strengthen access to MA. This document provides a way forward for the Region and countries to advocate towards greater access to medical abortion services for needy women.