Chapter 1. Introduction
Health system considerations (1.4, 1.4.1, 1.4.2, 1.4.3, 1.4.4, 1.4.5)
The health system refers to all organizations, people and actions whose primary intent is to promote, restore or maintain health (77). The health system consists of the six core building blocks, as listed in Figure 1.2, which support four overall goals and outcomes, as shown below. This section addresses in detail health system considerations relevant to an enabling environment for abortion care.
Figure 1.2: The WHO health system framework
A well functioning health system, with all the “blocks” working in harmony, depends upon having trained and motivated health workers, a well maintained infrastructure and a reliable supply of medicines and technologies, backed by adequate financing, strong health plans and evidence-based policies. Health-care services provided via the health system are not restricted to those provided at a health-care facility; health care and services can also be received through community-based providers (e.g. health visitors, pharmacists), digital interventions or self-care approaches (e.g. telemedicine).
1.4.1 Universal health coverage and primary health care
Universal health coverage (UHC) means ensuring that all people have access to the promotive, preventive, curative, rehabilitative and palliative health services they need, which must be of sufficient quality to be effective, while also ensuring that the use of these services does not expose any users to financial hardship (30). UHC is integral to the achievement of SDG target 3.8: Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all. The aim of this target is to accelerate efforts to ensure that all people and communities receive the full spectrum of essential, quality health services they need across the life course, without suffering financial hardship.
To establish an enabling environment, there is a need for abortion care to be integrated into the health system across all levels (including primary, secondary and tertiary) – and supported in the community – to allow for expansion of health worker roles, including self-management approaches. Such integration is a complex process that can occur through service delivery, financing mechanisms and/or inclusion in health benefits packages. While inclusion in health benefits packages may enhance access to and delivery of abortion care, in many countries abortion care is not explicitly recognized in the standard package, contributing to inequitable access to services (78).
From a health financing perspective, improving access to comprehensive abortion care, as part of UHC, requires shifting the burden of financing away from individuals towards domestic public funding, which combines tax revenue and prepayment schemes to cover the costs of care (78). Further information is provided in section 1.4.2 below. Meanwhile, from a service-delivery perspective, integrating abortion care within national maternal care and family planning programmes is technically the most straightforward option as abortion services require few, if any, additional provider skills, medicines, equipment or supplies. Furthermore, it is the most efficient option, as it minimizes any additional/marginal costs of implementing abortion services.
Health systems strengthening, by improving performance across all six health system building blocks (see above), is essential to progress towards UHC (77). The use of new and innovative technologies and approaches for providing, facilitating or supporting abortion services must be incorporated into country programmes and health benefits packages. WHO’s UHC Compendium provides a list of all interventions related to abortion care to be considered for inclusion within a country’s UHC package (79).
To ensure both access to abortion and achievement of UHC, abortion must be centred within primary health care (PHC), which itself is fully integrated within the health system, facilitating referral pathways for higher-level care when needed. PHC is a multisectoral, societal approach to health that aims to ensure the highest possible level of health and well-being for all individuals, by focusing on people’s needs and preferences (as individuals, families and communities) along the continuum of care from health promotion and disease prevention to treatment, rehabilitation and palliative care (30). Quality PHC is evidence-informed, community-delivered and person-centred. Making abortion available and accessible within PHC is a safe and effective strategy to advance equitable access to, and provide an enabling environment for, abortion.
1.4.2 Health financing
Health financing is a core function of health systems that can enable progress towards UHC by improving effective service coverage and financial protection. To improve effective service coverage, health financing arrangements for abortion services should ensure the production costs are met so that health-care providers have the means to carry out these activities without financial constraints. To improve financial protection, the health system must guarantee that the share of the costs – production costs and the costs of access to services – borne by patients is not a barrier to full use of services. WHO’s approach to health financing focuses on the following core functions:
- raising revenue – establishing sources of funds, including government budgets, compulsory or voluntary prepaid insurance schemes, direct out-of-pocket payments by users, and external aid;
- pooling funds – the accumulation of prepaid funds on behalf of some or all of the population; and
- purchasing services – the payment or allocation of resources to health-care providers.
In addition, all countries have policies indicating which services the population is entitled to, even if not explicitly stated by the government, and by extension any services not covered are usually paid for out of pocket by patients as user fees or co-payments.
To provide an enabling environment, financing of abortion services should take into account costs to the health system while ensuring that services are free or affordable and readily available to all who need them, in support of the goal of achieving UHC. A recent scoping review captured the costs to the health system and to the woman by categorizing the economic consequences of abortion and abortion policies through three levels: micro-, meso- and macroeconomic. Assessment of the micro-, meso- and macroeconomic levels provided insight into the documented economic consequences of abortions at the individual, community and health system levels (80-82).
Cost to the facility or health system
In regard to costs to the health-care facility and health system, the findings of the review on the mesoeconomic outcomes confirmed that limited resources negatively affect facilities’ ability to meet demand and provide quality services (81). Furthermore, the costs of post-abortion care, including treatment of post-abortion complications, consume a disproportionate amount of facilities’ resources in many settings, posing a burden to health systems by further depleting their overstretched resources. Therefore, financial savings can be made by maintaining or even improving the quality of abortion care services, and also by decentralizing services and legalizing abortion, as indicated in the macroeconomic assessment (82).
Providing access to quality abortion care is considerably less costly than treating the complications of unsafe abortion (83-87). Costs for providing abortion care with vacuum aspiration include infrequent, modest capital investments, such as purchase of a suction machine for electric vacuum aspiration (EVA) or manual vacuum aspiration (MVA) equipment, an examination table, a steam sterilizer or autoclave, and possibly also renovation of waiting, consultation and recovery rooms, and toilets. Recurrent costs for surgical or medical abortion include those associated with purchasing instruments and supplies that will need to be restocked regularly, such as cannulae and MVA aspirators, antiseptic solutions and high-level disinfectants used for instrument processing, and medicines for pain management, infection prevention and medical abortion.
Decisions about which abortion methods to offer and how to organize services directly influence the cost of providing services and their affordability. Two organizational issues are of particular importance for both increasing safety and reducing costs: (i) preferential use of either vacuum aspiration or medical abortion, and (ii) facilitating the provision of abortion (e.g. improved access to abortion services, integration into primary health care). Expanding the role of health workers in abortion provision and exploring innovative modes of service-delivery, such as telemedicine and hotlines, have also been identified as cost-saving strategies for national health systems (82).
Making services affordable for women
In countries where legal access to abortion is available, it remains a challenge to provide abortion services that are publicly funded and free at the point of care (88). Furthermore, in some settings, financial protection is restricted to specific demographic groups of individuals seeking abortion or certain legal categories of abortion. Abortion seekers may be charged substantial additional fees (on top of the official charges), creating a barrier for many, especially when combined with travel expenses and opportunity costs, such as time lost from paid and unpaid work. In some settings, reimbursement rates for private or public providers working with nongovernmental organizations are well below the cost of providing care. The barrier of high costs of abortion medicines and/or services is likely to generate higher costs for the health system, since these costs force many – especially among the adolescent population (89) – to present at a later gestational age or to use unsafe providers or methods, thus increasing the rates of hospitalization for serious complications (80, 90-92). Higher rates of complications, additional fees and high costs all also contribute to the stigmatization of abortion.
Respect, protection and fulfilment of the right to health requires States to guarantee, at a minimum, universal and equitable access to affordable, acceptable and quality SRH services, goods and facilities, in particular for women and disadvantaged and marginalized groups (3, para. 49). Thus, in order to provide an enabling environment for abortion care, ability to pay should not have any bearing on women’s ability to access legal abortion services (3 [para. 17], 35 [para. 31], 39 [Ch.1, para. 21]).
As part of an enabling environment, considerations of gender equality, human rights and equity should guide the design of health financing policy to reduce if not eliminate the financial barriers for the most vulnerable, and to ensure equitable access to good-quality services (93). The CEDAW Committee has described fees for abortion as being burdensome to women’s informed choice and autonomy (94, para. 37). Where user fees are charged for abortion, this should be based on careful consideration of ability to pay, and fee waivers should be available for those who are facing financial hardship and adolescent abortion seekers. It should be noted, however, that evidence on the success of fee waivers in addressing financial barriers and improving access to quality abortion care is mixed and inconclusive (95). Numerous treaty monitoring bodies (see Annex 2) have recognized that abortion services must be economically accessible, recommending that States lower the cost of abortion or otherwise provide financial support when needed 96 [paras 37(b), 38(b)], 97 [para. 24], 98 [paras 38, 39]). Relatedly, the Committee against Torture (CAT) has called on States to ensure free access to abortion in cases of rape (99, para. 15a). With the above in mind, as far as possible, abortion services and supplies should be mandated for coverage under insurance plans as inability to pay is not an acceptable reason to deny or delay abortion care. Furthermore, having transparent procedures in all health-care facilities can ensure that informal charges are not imposed by staff.
1.4.3 Health workforce competencies and training
Health workers are all people engaged in actions whose primary intent is to enhance health (100). The delivery of high-quality care requires an adequate supply of competent health workers, who are equitably distributed, and with an optimal skills mix at the facility, outreach and community levels (101). All health workers need to be adequately supported to provide competent care. The competencies required to provide or support abortion care align with competencies required in many different areas of health (102, 103). WHO is currently developing a global competency framework for universal health coverage (UHC), which identifies the required competencies for primary health care workers to provide the full spectrum of promotive, preventive, diagnostic, curative and palliative care (104, 105).
Delivery of care and treatment services should be accomplished in a people-centred, non-judgemental and non-directive way, allowing individuals to lead the decision-making about their own care in an informed and supported fashion (106). As part of ensuring an enabling environment, it is particularly important that training for health workers involved with SRH services incorporates:
- the unique competencies required for SRH services, in particular for abortion care;
- provision of people-centred care;
- human rights, and the content and meaning of the law, and how to interpret and apply law and policy in rights-compliant ways;
- communication to enable informed decision-making;
- values clarification;
- interprofessional teamworking; and
- empathetic and compassionate approaches to care (105).
These skills should be included in training programmes and promoted by professional societies. It is especially critical that the attitudes and behaviours of health workers be inclusive, non-judgemental and non-stigmatizing, and that they promote safety and equality. Managers of health care – whether in the public or private sector – are responsible for delivering services appropriately and meeting standards based on professional ethics and internationally agreed human rights principles.
Provision of primary health care includes access to safe, effective, quality-assured and affordable medicines, including medicines for abortion and post-abortion care (i.e. antibiotics and pain control medicines as well as abortion medicines and post-abortion contraceptives). The WHO Model List of Essential Medicines (also known as the Essential Medicines List, or EML) includes the minimum medicines needed for a basic health-care system, listing the most efficacious, safe and cost-effective medicines for priority conditions. Priority conditions are selected based on current and estimated future public health relevance, and potential for safe and cost-effective treatment. Both mifepristone and misoprostol have been included in the WHO Model Lists of Essential Medicines since 2005. In 2019, these medicines were moved from the complementary to the core list of essential medicines in the 21st EML and the requirement for “close medical supervision” for their use was removed (107). The relevant abortion medicines included in the 21st EML and also the more recent 22nd EML are indicated in Table 1.1.
Table 1.1 Medicines included in the WHO Model List of Essential Medicines (EML) and their indications
|Indication included in EML||Medicines included in the EML|
|Induced abortion||Mifepristone (200 mg) and misoprostol (200 μg)
The medicines are available individually or co-packaged.
The EML specifically mentions the following co-packaged formulation: 1 tablet mifepristone (200 mg) + 4 tablets misoprostol (200 μg).
|Management of incomplete abortion and miscarriage||Misoprostol (200 μg)|
Within a country, the key elements of a commodity strategy include policy, regulation, procurement and supply chain, as well as links to financing and reimbursement systems (109).
Mifepristone and misoprostol should be listed in relevant national EMLs (NEMLs) or their equivalent, and should be included in the relevant clinical care/service delivery guidelines. In the case of pregnancy tests and MVA equipment, countries may have an Essential Medical Devices List or a similar list for medical devices. Pregnancy tests and quality MVA devices should be included on these lists as part of a commodity strategy.
Inclusion in the NEML is one important component of ensuring that quality medicines are available. Misoprostol, mifepristone, surgical abortion equipment and other relevant health products should be included in national procurement tenders as well as in supply chain monitoring activities. Procurement activities should include forecasting methods that are appropriate to the products and to the country context with a goal of ensuring continuous supply (110). Central Medical Stores (CMS) entities should ensure that specifications for the procurement of safe abortion medicines are coordinated with national medicines regulatory authorities (NMRAs) and that they clearly specify quality assurance standards and all other requirements, such as strength, packaging and shelf life.
WHO recommends that the highest level of quality assurance be pursued but recognizes that risk-based approaches may be needed in countries where access to international markets is limited. Risk-based approaches will depend on the context of a given country but may include exceptions based on prior information about a manufacturer, or reliance on information from other regulators (111). Quality-assured medicines include those approved by stringent regulatory authorities (SRAs) (112) or listed through WHO Prequalification (PQ). Where such medicines are not available, approval by an NMRA that includes inspection and testing according to accepted standards should be undertaken for mifepristone and misoprostol.
NMRAs are the bodies that provide registration and market authorization for specific products. The NMRA reviews the safety, efficacy and quality of medicines as part of granting market authorization. Such authorization is specific to each medicine made in a particular location by a particular manufacturer. Market authorizations are granted based on an evaluation of a technical dossier presented by the manufacturer, or their agent, confirming the efficacy, quality and safety of the product. Through prequalification, WHO supports a regulatory reliance mechanism where it provides detailed assessment information to NMRAs on products that have been prequalified by WHO, so that the regulatory decision can be made based on WHO’s assessment rather than having to duplicate it. Based on the same principle, WHO also supports the sharing of assessment information for SRA-approved products. These processes are both known as WHO Collaborative Registration Procedures (CRPs).
Regulators make determinations regarding the authority to prescribe and dispense medicines. There are examples, including emergency contraception, where regulators have made decisions to change the prescribing authority to improve access and appropriate use, including “over the counter” sales or prescription by a pharmacist without physician consultation. The information that is typically considered includes whether a condition can be reasonably self-diagnosed, the overall safety of the medicine, and the likelihood of misuse or complications with less supervised or unsupervised use of the medicine, among others (113, 114). National programmes should work with regulators to determine the most appropriate evidence-based prescribing and dispensing authorities for the medicines. Restrictions on prescribing authority for some categories of health workers may need to be modified or other mechanisms put in place to make the medicines available for these health workers within the regulatory framework of the health system.
A comprehensive commodity strategy and effective approach to access will require: inclusion of the necessary commodities in the NEML; approval from the NMRA (i.e. market authorization or registration); development of mechanisms for forecasting, procurement, distribution and guidance on prescribing and dispensing; and a plan for post-marketing surveillance.
1.4.5 Monitoring and evaluation of quality abortion care
Effective monitoring and evaluation (M&E) are essential for measuring abortion quality and trends, as a basis for policy dialogue and evidence-based decision-making to further improve service delivery and quality. To support national scale M&E of the quality of abortion care, WHO is developing a quality abortion care M&E framework based on WHO’s Monitoring and evaluation of health systems strengthening: an operational framework (115). The structure, domains and indicator areas of the framework, categories for inequality disaggregation and standard data sources are presented in Table 1.2. A set of abortion care indicators is under development and will be published in the near future (see Annex 6 for a summary about the progress of this M&E work).
The quality abortion care M&E framework will support M&E at the levels of health system input, service delivery, population outcome and impact. M&E of abortion-related services remains weak in most national health systems. Specific gaps in data collection and use must be identified and addressed.
Health system input monitoring covers governance, health financing, health workforce, health commodities and health information. Within these five categories, quality abortion care health system inputs to track over time include among others:
- Governance: clarification of the legal status of abortion, adherence of induced abortion protocols in national guidelines to global normative guidance (see also section 1.3.1[vii]);
- Financing: inclusion of health financing arrangements for abortion-related care in leading health benefits packages (see section 1.4.2 above);
- Health workforce: inclusion of competency-based induced abortion care (in line with global normative guidance) in national curricula for relevant categories of health workers (see section 1.4.3 above);
- Health commodities: inclusion in national essential medicines lists (NEMLs) of mifepristone and misoprostol, monitoring of stock-outs of abortion service commodities at service-delivery points (see section 1.4.4 above);
- Health management information systems (HMIS): integration of indicators for quality abortion care into the national HMIS.
For this level of input monitoring, data are typically available from administrative sources, including national policy documents, health finance tracking systems, national curricula, logistics management information systems (LMIS) and HMIS.
Service-delivery monitoring tracks the availability of providers trained in and providing induced abortion care, availability of necessary medicines and products at service-delivery points, readiness of the system to provide abortion care to a defined minimum standard, and quality of service delivery, including person-centred care, assessed in part through user and community perspectives. National-level abortion service-delivery monitoring data should be included in health-care facility-level assessments, HMIS and population-based surveys.
Population outcome monitoring for abortion care assesses coverage including (i) access to quality, affordable abortion care, and (ii) population knowledge of access to quality, affordable abortion care. Efforts should be made to disaggregate data by dimensions of inequality, such as ability, age, caste, education, ethnicity, gender, geography and wealth. Population outcome data sources typically include health-care facility-level assessments and population-based surveys and can include HMIS and education management information systems. In many settings, abortion-related population outcome data is a neglected area of data collection and reporting.
Impact measurement for quality abortion care includes abortion-related mortality and morbidity. Estimates in these areas should be disaggregated by dimensions of inequality as much as possible. Data sources include population-based surveys, HMIS and civil registration and vital statistics (CRVS) registries.
Where gaps in data availability are identified, investment should be made to address these. In the short term, statistical modelling may be required to estimate indicator values, particularly at the impact level.
Table 1.2 Monitoring and evaluation of the quality of abortion care
|Categories||Indicator areas||Inequality disaggregation||Data sources|
|Health system input||Governance
|Geography: intranational, international||Administrative sources (including national policy documents, health finance tracking systems, national curricula, LMIS and HMIS)|
|Service delivery||Availability of services
Readiness for service delivery
Quality of services
|Geography: intranational, international||Health-care facility assessment (including patient interviews), population-based survey, HMIS|
|Population outcome||Access to quality, affordable abortion care
Population knowledge of access to quality, affordable abortion care
|Ability, age, caste, education, ethnicity, gender, geography, wealth||Health-care facility assessment, population-based survey, HMIS, education management information systems|
|Ability, age, caste, education, ethnicity, gender, geography, wealth||CRVS, HMIS, population-based survey|
- Available by selecting "Sexual and reproductive health" on the linked page, or by searching the database. ↩
- SRAs are listed at this web page: https://www.who.int/initiatives/who-listed-authority-reg-authorities/SRAs. In the cited reference (pp. 34–35), SRAs are defined as “a regulatory authority which is a member or an observer of ICH [International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use], or is associated with an ICH member through a legally-binding mutual recognition agreement” (as before 23 October 2015). ↩
- WHO Prequalification is one standard for all types of products, including medicines (pharmaceuticals and biotherapeutics), vaccines and immunization devices, in vitro diagnostics and vector control products. This listing implies a recommendation but not market authorization. ↩
- For further information, refer to The International Pharmacopoeia, available at: https://digicollections.net/phint/2020/index.html#p/home ↩
- For further information, see: https://extranet.who.int/pqweb/medicines/collaborative-procedure-accelerated-registration ↩