a detailed description of the access dimension and the concepts,
laws and policies underlying it, as well as data on availability and
access to health technologies and methodological approaches
to their measurement. It also offers an overview of the main
determinants of access related to health systems, IP and trade
policy.
191
B. Access to health products in specific areas 217
C. Intellectual-property-related determinants of access 229
D. Other trade-related determinants of access 262
192
A. The context: health-systems-related determinants of access
Key points
•
• Access to health technologies is part of a broader challenge of ensuring access to health care, which requires a functioning health-care system. This includes: the delivery of quality health services; a well-performing health workforce; access to reliable and timely information on health determinants, health system performance and health status; health financing; and good leadership and governance.
•
• Universal health coverage (UHC) to ensure access to quality health services without financial hardship by all patients has become a leading goal for health in the context of the Sustainable Development Goals (SDGs) but can require trade-offs between the various dimensions of coverage.
•
• Inadequate financing, high prices and ineffective policy interventions to manage expenditure represent challenges in achieving UHC.
•
• The WHO Essential Medicines List provides helpful guidance on the selection of medicines for procurement and use in health systems. The WHO also publishes similar lists for other types of health technology.
•
• Price is a critical determinant of access to health technologies, especially in countries where the public health sector is weak and where treatment is often purchased on the private market and paid for by people out of their own pockets.
•
• In general, generic products are cheaper than originator products, but even low-priced generic medicines are often still unaffordable for large sections of the population in many low- and middle-income countries (LMICs).
•
• Countries use a variety of measures to increase the market share of affordable generics in order to control health budgets.
•
• A range of policy tools is available to governments for controlling pharmaceutical expenditures, including:
supply-side and demand-side measures that aim to increase and/or accelerate the use of generics; price controls and reference pricing; health technology assessments; volume limitations and health outcome-based agreements; improved transparency of price and costs across the pharmaceutical value chain;
reducing or eliminating taxes and tariffs on medicines; regulating mark-ups; and effective procurement mechanisms.
•
• Differential pricing can make medicines more affordable to larger segments of the population.
•
• Procurement systems should be designed to obtain needed health technologies of good quality, at the right time, in the required quantities and at favourable costs. Tendering and pooled procurement can contribute to cost savings in the procurement process.
•
• Local production is supported in a number of LMICs through national efforts and numerous regional and international initiatives. Policy coherence is crucial to achieving public health and industrial development benefits.
•
• Regulation should promote access to medical technologies of proven quality, safety and efficacy and should not unnecessarily delay the market entry of products.
•
• Challenges for regulatory systems that impact access include lack of political support and adequate resources, a focus on regulating products without effective oversight of the whole supply chain, poorly developed systems for post-marketing surveillance, and different standards for locally produced versus imported products.
•
• The WHO Prequalification Programme has greatly facilitated access to quality essential medicines in LMICs.
•
• Regulatory convergence of different national systems can remove many of the costs associated with multiple regulatory submissions and multiple testing.
•
• Substandard and falsified (SF) medical products pose serious public health problems, especially in regions where the regulatory and enforcement systems are weak. Both regulatory and IP tools can be used in a complementary way to combat SF products.
193
A. the conteXt: heAlth-sYstems-relAted determinAnts oF Access
Access to medicines and other medical technologies rarely depends entirely on a single factor. This section describes the main health-systems-related determinants of access to medicines and medical technologies at the interface of health, intellectual property (IP) and trade. The section first explains the importance of a well-functioning health system as an overarching determinant of access. It then presents the concept of universal health coverage and, as one way of conceptualizing the determinants of access to medicines, the model of a pharmaceutical value chain.
It then explains how the WHO measures access and affordability, and describes generic medicines policies. It explains pricing issues with respect to access to medical technologies and outlines how taxes, duties and high mark-ups can impact affordability and access to medical technologies. It then describes the importance of effective and efficient procurement mechanisms and of sustainable health financing, considers access issues related to local manufacturing and associated technology transfer, presents regulatory mechanisms and access to medical technologies and concludes with a summary of access issues linked to substandard and falsified medical products.
A health system consists of all organizations, people and actions whose primary intent is to promote, restore or
maintain health (WHO, 2000). The WHO conceptualizes health systems in terms of six building blocks, the interplay among which helps in achieving desired health outcomes through ensuring universal coverage and equitable access to quality-assured and safe health care (see Figure 4.1).
One important building block of any health system is equitable access to essential medical products of assured quality, safety, efficacy and cost-effectiveness, and their scientifically sound and cost-effective use (WHO, 2007a). All six building blocks of the health system are interdependent (see Figure 4.1). The issue of access to medicines is one aspect of a broader problem of access to health care. Delivering access requires a functioning national health-care system, as recognized in the WHO Road Map for Access to Medicines, Vaccines and Other Health Products, 2019–2023, which takes a health systems approach to improving access to health products.1
1. Universal health coverage
The concept of universal health coverage (UHC) has been increasingly recognized in international fora since WHO published the World Health Report: Health Systems Financing: The Path to Universal Coverage2 in 2010,
Figure 4.1: The WHO Health System Framework
LEADERSHIP/GOVERNANCE service deliverY heAlth WorKForce inFormAtion
medicAl ProdUcts, vAccines &
technologies FinAncing
leAdershiP/governAnce
Access coverAge
QUAlitY sAFetY
OVERALL GOALS/OUTCOMES imProved heAlth (level and equity) resPonsiveness
sociAl And FinAnciAl risK Protection
imProved eFFiciencY
THE SIX BUILDING BLOCKS OF A HEALTH SYSTEM: AIMS AND DESIRABLE ATTRIBUTES
• Good health services are those which deliver effective, safe, quality personal and non-personal health interventions to those who need them, when and where needed, with a minimum waste of resources.
• A well-performing health workforce is one which works in ways that are responsive, fair and efficient to achieve the best health outcomes possible, given available resources and circumstances, i.e. there are sufficient numbers and mix of staff fairly distributed; they are competent, responsive and productive.
• A well-functioning health information system is one that ensures the production, analysis, dissemination and use of reliable and timely information on health determinants, health systems performance and health status.
• A well-functioning health system ensures equitable access to essential medical products, vaccines and technologies of assured quality, safety, efficacy and effectiveness, and their scientifically sound and cost-effective use.
• A good health financing system raises adequate funds for health, in ways that ensure people can use needed services, and are protected from financial catastrophe or impoverishment associated with having to pay for them.
• leadership and governance involves ensuring strategic policy frameworks exist and are combined with effective oversight, coalition-building, the provision of appropriate regulations and incentives, attention to system design, and accountability.
Source: WHO.
194
and has become a leading, unifying goal for health in the context of sustainable development. UHC means that all individuals and communities have access to quality health services without financial hardship (WHO, 2017h).
It includes the full spectrum of essential, quality health services, from health promotion to prevention, treatment, rehabilitation and palliative care. Protecting people from the financial consequences of paying for health services out of their own pockets reduces the risk that people will be pushed into poverty because unexpected illness requires them to use up their life savings, sell assets or borrow – destroying their futures and often those of their children (WHO, 2019e).
Achieving UHC is one of the targets the nations of the world set when adopting the Sustainable Development Goals (SDGs) in 2015. It is captured directly in 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” – where it explicitly notes the key role of access to health products. Many of the other health-related SDG targets contribute to UHC.3 The path to universal coverage thus involves important policy choices. Universal coverage involves trade-offs between different dimensions of coverage: the proportion of health costs covered by the government and/or insurance, the proportion of services covered and the proportion of the population covered (see Figure 4.2).
These dimensions of coverage reflect a set of policy choices about benefits and their rationing that are among the critical decisions facing countries in their reform of health financing systems towards universal coverage.
WHO projections found that most middle-income countries should be able to mobilize the necessary funding to advance systems towards UHC by 2030 from domestic resources, while many low-income countries would face a funding gap (Stenberg et al., 2017).