Registration & quality assurance

The national regulatory authority (NRA) in each of the eight countries approved the MA products shown in Fig. 1 While NRAs have their own quality standards, for the purpose of the assessments, a product with quality assurance is defined as one that is either WHO PQ-listed or approved by a SRA. Central African Republic had no MA medicines registered, whereas Democratic Republic of the Congo and Uganda had the greatest number of registered MA medicines with and without quality assurance, at 14 and 11 products, respectively (Fig. 1). Only one country, Burkina Faso, had a combi-pack (Medabon®, Sun Pharmaceuticals) that met the quality assurance criteria of the assessment. In Democratic Republic of the Congo and Uganda, the combi-packs that are currently registered are not WHO PQ-listed or SRA-approved but are approved for medical termination of pregnancy up to 63 days or amenorrhea; they are made by the Indian manufacturers, Naari, Synochem, and Acme Formulations. Democratic Republic of the Congo is the only country to have a registered mifepristone product (Prevent™ 10 mg and 50 mg/Synochem) in our sample, which is neither SRA-approved nor WHO PQ-listed, nor is it the correct dose used for MA.

Fig. 1

Number of registered MA medicines with and without quality assurance by country. *Health products are imported, not formally registered given the NRA is not fully operational

We found that the use of WHO’s Collaborative Registration Procedure (CRP), which can enable accelerated regulatory approval in countries, was only used for MA medicines in Namibia. In Namibia, both misoprostol products, Celprotec™ and Avertiso™ (Acme Formulations), followed the WHO CRP pathway, and regulatory approval was granted within 90 days. In Lesotho and Eswatini the NRAs are not fully operational and the governments rely upon importation mechanisms of health products, not formal product registrations. Current importation requirements specify WHO PQ or SRA status of medicines, which will also be required for registration of new products when their NRAs are established. In both countries, Cytotec™ (Pfizer Pharmaceuticals) is imported, which is the originator misoprostol product and is not SRA-approved for MA, only the treatment of gastric ulcers. In Lesotho, a consignment of Cytomis™ misoprostol (Incepta Pharmaceuticals) was recently imported when the government could not secure Cytotec™ owing to global COVID-19 supply chain issues.

Policy & financing

Standard treatment guidelines (STG) indicate rational and judicious use of medicines for specific health indications and national essential medicines lists (NEML) prioritize medicines to be procured for the public healthcare system [13]. National abortion care guidelines define who, when, where, and how abortion services are delivered in the country, and may be separate policy documents or included in STGs. The inclusion of the combination regimen in NEML, STGs, and abortion care guidelines varied across the countries assessed (Table 1). Mifepristone and misoprostol regimen for induced abortion is included on the NEML and abortion care service and delivery guidelines for Burkina Faso (2020) and Democratic Republic of the Congo (2020). Misoprostol regimens for prevention and treatment of postpartum hemorrhage and postabortion care (PAC) management are listed in the NEML and STG for Eswatini (2012), Lesotho (2017), and Namibia (2021), as well as the NEML of Uganda (2016). Botswana excludes misoprostol and mifepristone on its NEML; however, a Ministry-approved guideline and trainers’ manual on PAC (2013) includes the combination and misoprostol-alone regimens for induced abortion. In Uganda, national guidelines for abortion care and service delivery are outdated, and revised guidelines have been stayed by the Ministry of Health since 2015, owing to disagreements on the content and a need to consult further with stakeholders, including religious leaders [14, 15].

Table 1 Inclusion of MA medicines or protocols for their use in national policy documentsProcurement & distribution

MA medicines are not manufactured in any of the countries we assessed. We identified whether MA medicines are being procured for the public sector by a country’s central medical stores or imported by social marketing organizations (SMOs) and/or wholesale commercial distributors for the private sector. In all countries, misoprostol for postpartum hemorrhage and/or PAC had been procured at least once in the past three years for the public sector (Table 2). Only Democratic Republic of the Congo had ever procured a combi-pack product (Mifepak™) for its public health facilities.

Table 2 Importation of MA medicines for the public sector, private commercial sector and by social marketing organizations

Public sector distribution of MA medicines for induced abortion is limited to use by doctors at tertiary-level hospitals in all countries except Burkina Faso and Democratic Republic of the Congo. In both countries, national abortion care service delivery guidelines stipulate that trained providers at lower levels of the healthcare system can provide abortion services. Democratic Republic of the Congo also permits the use of MA at home according to the provider's monitoring instructions, if prescribed by a competent healthcare provider.

Distribution and use of misoprostol for treatment of incomplete abortion and miscarriage is permitted at lower levels of the healthcare system in Burkina Faso (Health and Social Promotion Centers and above), Central African Republic (NGO-use in humanitarian/ refugee settings), Democratic Republic of the Congo (Health Posts and above) and Uganda (Health Center 2 and above). In Botswana, Eswatini, Lesotho, and Namibia, distribution and use of misoprostol for PAC is restricted to hospitals by doctors. In these countries, misoprostol is often characterized as a “controlled drug, kept in a locked cupboard” with key informants citing concerns about potential pilfering and misuse.

Misoprostol is procured for the private sector in all countries assessed, except for Central African Republic. In Central African Republic, misoprostol is imported by NGOs and donated for public sector and humanitarian aid programs, not the commercial sector. The combi-pack is imported for the private sector in Burkina Faso and Democratic Republic of the Congo. Despite multiple combi-pack registrations in Uganda, including by SMOs for private sector use, distribution is limited owing to a restrictive policy environment and a lack of updated Ministry-approved safe abortion service delivery guidelines [14]. In Botswana, Eswatini, Lesotho, and Namibia, Cytotec™ is imported from neighboring South Africa for distribution in the private sector by a small number of commercial distributors; no SMOs socially market a product in these countries.

Provider knowledge

Provider knowledge was assessed using proxies such as availability of ministry-approved training manuals and curricula and documented training efforts of healthcare workers [9]. Botswana, Burkina Faso, and Democratic Republic of the Congo have nationally approved training manuals that included MA regimens available [16,17,18]. In Namibia, at the time of the assessment, the Ministry of Health stated future plans to develop a training package that includes abortion care.

In Burkina Faso and Democratic Republic of the Congo, public–private partnerships have led to the development of a comprehensive abortion care roadmap and implementation and training plan specific to the public health context and workforce of each country. SMOs also have conducted several in-service trainings for private sector providers and pharmacists. In Botswana, Central African Republic, Eswatini, Lesotho, and Namibia, no government-supported training on comprehensive abortion care for public sector providers nor NGO-led in-service trainings for private sector providers, had occurred at the time of the assessment. According to one key informant in Lesotho, “abortion would need to be legalized before national or district level training of providers would be possible.” However, in each of these countries, abortion is legally permitted in cases of rape, incest, fetal anomaly, and to save a woman’s life or preserve her general health.

In Botswana, the Comprehensive PAC Trainer’s Manual (2013) includes mention of MA regimens but annual ministry-led trainings on PAC for public sector doctors, midwives, and nurses focus on misoprostol and MVA for treatment of incomplete abortion and post-abortion family planning, not induced abortion [16]. Moreover, neither mifepristone, nor combi-pack is available in the country. The ministries of health of Eswatini, Lesotho, and Namibia have trained a limited number of providers, mostly doctors and midwives at hospitals, on misoprostol and MVA as part of public–private supported PAC trainings. PAC is already included as part of pre-service training for nurses in Lesotho and in Burkina Faso, MVA and misoprostol protocols for treatment of incomplete abortion is taught at the National School of Public Health and to health attachés in obstetric and gynecological care.

In Uganda, the government focuses its training efforts on PAC, despite previously validated national abortion care guidelines that define the legal grounds and medical conditions for termination of pregnancy to save a woman’s life. Key informant interviews suggest that there has never been a national level training for public sector providers on comprehensive abortion care and there are currently no trainings planned, owing to the restrictive policy environment and continued disagreement on the content of revised national abortion care guidelines. According to the Ministry, “With regard to in-service training, PAC and post abortion family planning refreshers are undertaken all the time. The only one that is not done is termination of pregnancy or MA due to the legal barriers and criminalization of abortion.” In Uganda, as in Democratic Republic of the Congo and Burkina Faso, NGOs are taking the lead on training on MA and MVA for abortion care within the legal framework, with the majority financed and facilitated by SMOs in the private sector.

End-user knowledge

In the countries assessed there is limited data on women’s knowledge of their country’s respective abortion laws or services. In Botswana, a 2019 study found that most respondents had limited or no knowledge of the country’s abortion law, irrespective of background and location. Where there was no knowledge, the default was to assume that abortion was illegal [19]. This was the general perspective of key informants working in government, NGOs, pharmacies, and service provision in the other countries as well. Key informants generally believed that the level of information available to women on abortion is very low and the majority are unaware that abortion is possible and permitted by law to save a woman’s life, preserve general health or in cases of rape and incest (in all countries except Uganda). Key informants across all countries reported that abortion stigma was common and driving the practice towards less safe methods or to self-induce with medications in the absence of knowledge of how to self-manage or of quality products and how to use them.

Key informants report increasing awareness among abortion-seekers of MA medicines, specifically misoprostol, and that awareness is generally higher in the capital cities. They suggested that women living in more urban settings with access to technology are more informed about MA. A 2020 unpublished study in Democratic Republic of the Congo found that the majority of girls and women interviewed in Kinshasa knew of at least one method of abortion, with misoprostol/Cytotec™ being the best known [20].

“The combi-pack is an extremely new drug on the market and you can only find it in very few pharmacies, not in drug-shops, not in clinics, not in public health facilities. Very few women and even health workers know about it and how to use it well. It is expensive, so many prefer to use the more known misoprostol that is more available and cheaper. Most girls and young women get information about these pills from Google, peers and referrals. They access these commodities without much knowledge about them.”

- Key Informant Interview, Uganda.

“Women and adolescent girls in cities are increasingly aware and know mostly misoprostol as a MA product because they have more channels of information through social media platforms disseminated by human rights associations and NGOs.”

-Key Informant Interview, Burkina Faso.

“The vast majority of the cases we see in the hospital are from backstreet abortions… they come in having had an intervention. For example, having used misoprostol they bought on the black market – it can be found anywhere.”

-Key Informant Interview, Botswana.

Women’s awareness of misoprostol was corroborated by a limited number of pharmacy visits in each country. Every pharmacy visited in Burkina Faso (n = 2), Democratic Republic of the Congo (n = 6), Lesotho (n = 2), Namibia (n = 2), and Uganda (n = 4) reports multiple clients requesting misoprostol monthly. In Botswana, three of the five pharmacies visited declined to share any information on MA products, while one pharmacy stated they did not carry misoprostol because there is “too much conflict and not enough demand”; the fifth shared that one to two clients a month request Cytotec™ specifically. In Eswatini, five of six pharmacies sampled, report up to 10–12 women a month requesting misoprostol, but only one pharmacy carries misoprostol, which was out of stock at the time of the assessment. MA medicines are unavailable in the private sector in Central African Republic. In Botswana, Eswatini, and Namibia, fear of legal retribution for dispensing misoprostol is cited by pharmacists surveyed, which prompted some pharmacies to not stock misoprostol or to create additional barriers to availability.

“Women must have a prescription for misoprostol, and we usually require the doctor to call ahead in advance to say they are sending a patient ahead to us, rather than a patient walking in with a prescription with no advanced warning. If someone came in requesting misoprostol or had a prescription but no way of contacting the doctor who prescribed it, we would tell them that misoprostol is not available.”

-Private pharmacist, Botswana.

Community awareness activities on abortion rights and services, including MA, have been limited in scope across the countries assessed or non-existent. Generally, across all countries, governments focus information, education, and communication efforts on comprehensive sexuality education aimed at reducing unintended pregnancy, omitting information on abortion rights and services specifically, as abortion is considered “taboo” and “fraught with stigmatization.”

“There is absolutely zero community engagement. None whatsoever; as the perception is that it would be deemed as though [the Ministry] would be promoting abortion.”

- Key Informant Interview, Botswana.

Small-scale efforts to sensitize communities on abortion rights and services via online campaigns, telemedicine and mobile apps, helplines, and/or community health workers are being utilized in Burkina Faso, Democratic Republic of the Congo, Namibia, and Uganda. Key informants also cite informal networks, the internet, pharmacies, and word of mouth as sources for women’s knowledge and access to abortion, including MA.