We received responses to the structured document from eight of the 11 countries (Bangladesh, Bhutan, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, and Timor-Leste), and a further two countries provided responses during the regional technical consultation workshop (India and Thailand). The WHO Country Office for DPR Korea provided information for the desk review.

National health laws, policies, and standard treatment guidelines

Our desk review of national reproductive health policies, standard treatment guidelines for safe abortion care and post abortion care, and training manuals for safe abortion or post abortion care for each country revealed that it was often difficult to access these documents or determine whether these documents existed, particularly in restrictive legal contexts.

Not all countries in the Region currently have comprehensive national policies and guidelines in place for safe abortion (Table 1). Comprehensive abortion care guidelines for safe abortion care existed in Bangladesh, DPR Korea, India, Maldives, Nepal, and Thailand. Bhutan, Indonesia, Myanmar, and Sri Lanka only had guidelines for post-abortion care. Maldives and Timor-Leste did not have either a safe abortion guideline or a post-abortion care guideline (Table 1).

Table 1 Inclusion of MA in national policies and guidelines related to reproductive health

Stakeholders participating in the technical consultation workshop supported the finding of availability of national guidelines for comprehensive abortion care that are evidence based, regularly updated, and provide the necessary guidance to achieve equitable access to quality care. Where guidelines, policies and/or strategies exist, stakeholders agree that increasing awareness among relevant government agencies, providers and the public is critical to increasing access and minimizing the use of unsafe methods. Where the legal context is restrictive, an enabling policy and regulatory environment is necessary for ensuring that women who are legally eligible have access to safe abortion care and MA medicines.

Inclusion in national essential medicines lists

We collected information on the inclusion of mifepristone, misoprostol, and the combi-pack (mifepristone 200 mg + misoprostol 200mcg) in the NEMLs of each SEA Region country. For misoprostol, we reported on all formulations, including the 100-mcg formulation which is used for other obstetric indications, such as prevention or management of post-partum hemorrhage among others. Therefore, our analysis includes misoprostol formulations that may not be indicated for use in MA (Table 2).

Table 2 National EML status of MA medicines in SEA Region

Although mifepristone and misoprostol have been included in the WHO Model List of Essential Medicines for several years [7], of the 11 SEA Region countries, only Bangladesh has included mifepristone, misoprostol, and the combi-pack in its NEML. In addition to either mifepristone and misoprostol, the combi-pack is also included in the NEMLs of only Nepal, and Thailand. None of the medicines have been included in the NEML for Indonesia, although at the time of the study, misoprostol 200 mcg and 100 mcg were under review for inclusion. The remaining countries in the SEA Region have one or more of the compositions included in their NEML (Table 2).

Marketing authorization status

Figure 1 illustrates the number of MA products that have been granted approval and registered for market in each of the SEA Region countries. Bangladesh, India, and Nepal have the greatest number of MA products authorized for the market (Fig. 1). Among the remaining countries, DPR Korea and Indonesia have not granted market authorization for any of the essential MA medicines to be used within their respective jurisdictions. In five other countries, namely Bhutan, Maldives, Myanmar, Sri Lanka, and Timor-Leste, the regulatory authority has granted market authorization solely to misoprostol. Stakeholders attending the technical consultation workshop highlighted that in addition to the lack of availability of legally registered products, many countries struggle with the challenges associated with presence of falsified and illegally supplied MA medicines and require increased regulation.

Fig. 1

Number of market authorized MA medicines in countries of the Southeast Asia Region. *Note: these are actual numbers. Legend: Misoprostol 100/200mcg (Blue colour in the graph). Mifepristone 200 mg (Green colour in the graph). Combi pack (Mifepristone 200 mg + Misoprostol 200mcg) (Yellow colour in the graph)

Financing, procurement, and distribution

In conjunction with the varied market authorization status of MA medicines, countries have adopted diverse approaches to public financing, procurement, and distribution needed to ensure the broad accessibility of these medicines to the general public. In Bangladesh there is no public financing, procurement, or distribution of medicines for MA. However, it is noteworthy that misoprostol is procured for alternative obstetric indications. Similarly in Bhutan, there is no public procurement of MA medicines, apart from misoprostol, which is procured for alternative purposes. Although there is no specific budget for MA medicines in DPR Korea, misoprostol, for other uses, is centrally procured and distributed to government hospitals. In India, states procure and distribute MA medicines, as part of the National Health Mission budget, to hospitals and registered health facilities at the sub-district level. There is no public budget, procurement, or distribution of MA medicines. In Maldives, misoprostol is procured centrally and distributed in designated government hospitals. Misoprostol is procured for active management of third stage of labor and prevention of postpartum hemorrhage through the government annual budget in Myanmar. There is no specific budget or financing for MA medicines in the country, but misoprostol is widely available. In Nepal, funding for MA medicines is decentralized to municipal level health facilities. Medicines are stocked and dispensed at approved health facilities. There is no public budget or procurement for MA medicines in Sri Lanka. In Thailand, there is centralized procurement of MA by specific public hospitals. In Timor Leste, there is no public procurement of MA medicines.

Stakeholders during the workshop reported that there is no standardized forecasting of service requirements and specific provisions for MA medicines within health budgets in any of the countries except India and Nepal. The consultation additionally revealed that there was no incentive in the countries in the Region to support the private sector to expand distribution.

Access models used across countries

Although MA regimens are safe and can be managed by a broad range of health workers at primary care level, in the SEA Region, who is authorized to provide services is heavily regulated, limiting access. In most countries, registered medical practitioners and/or specialists, such as obstetrician-gynecologists, with specific experience and training can provide MA, as is the case for India, Bangladesh, Myanmar, and Sri Lanka. Nepal allows skilled birth attendants and auxiliary nurse midwives to provide MA after undergoing abortion care training and being certified as MA providers. India, Nepal and Thailand permit pharmacies to dispense MA with a prescription, while Bhutan allows trained nurses to conduct post abortion care in addition to medical practitioners and/or specialists.

In India, Nepal, and Thailand private sector and non-governmental organizations (NGOs) also support access to MA information and medicines. 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. Participants in the technical consultation workshop recommended that, for countries such as Bangladesh, Bhutan and Timor Leste, existing strong social marketing organizations and NGO networks should be leveraged to expand access to information and services.

To expand access to points of care, key stakeholders recommended advocacy to increase awareness of national guidelines on safe abortion, the availability of MA medicines, regular training, and mandated certification for service providers. They furthermore suggested widening the geographic coverage of provision to include all public facilities and hospitals, as in the cases of DPR Korea and Thailand, and urban low-income settlements, rural areas and underserved areas through pharmacies and a broader range of health care workers, for example, in India.

Countries in the Region can also learn from successful access models in other countries. For example, in India, Nepal, and Thailand the private sector and NGOs support access to MA information and medicines. In India, 91% of MA occurs outside of facilities [9, 11]. In Maldives MA is fully covered by the social insurance scheme. Another example of an innovative approach to expanding access is the inclusion of the menstrual regulation program in the family planning service in Bangladesh. Other countries in the Region can learn from these models.