Investments in this strategy aim to improve access to quality, affordable medicines and vaccines by inventing new products for emerging market contexts – often through product development partnerships and other innovative collaborations – or strengthening existing health systems infrastructure and supply chains to better deliver existing products. The sections below include an overview of the strategy for achieving desired goals, supporting evidence, core metrics that help measure performance toward goals, and a curated list of resources to support collecting, reporting on, and using data for decision-making.

What

Dimensions of Impact: WHAT

Investors interested in deploying this strategy should consider the scale of the addressable problem, what positive outcomes might be, and how important the change would be to the people (or planet) experiencing it.

Key questions in this dimension include:

What is the problem the investment is trying to address? For the people experiencing the problem, how important is this change?

An estimated one-third of the world's population (up to half in some regions of Asia and Africa) can neither regularly receive nor purchase essential medicines (1). This represents more than two billion people in emerging markets without adequate access to essential medicines. Many medicines (i.e., drugs and vaccines) are unaffordable to populations in need, especially in the low-income and also, increasingly, in middle-income countries.

Many stakeholders have joined forces to ensure essential medicines are manufactured, authorized, and affordably distributed in emerging markets. But various challenges remain in these markets, including difficulty guaranteeing high-distribution coverage, lack of affordability, and low adoption of essential medicines at both provider and end-user levels. Lack of air conditioning, stable electrical power, or reliable refrigeration make it challenging to store samples, medicines, and chemicals (2).

Unless greatly improved, unequal access to essential, high-quality medicines in emerging markets will persist (3). Investments in this strategy can improve access by:

  1. accelerating collaborative research and development through partnerships to develop essential medicines and vaccines for emerging-market contexts, and
  2. strengthening external healthcare infrastructure and enhancing in-country supply networks to improve access to high-quality medical commodities and decrease the spread of counterfeit products.

What is the scale of the problem?

Up to 90% of people in emerging markets purchase medicines out-of-pocket, comprising the largest category of family expenditure after food (4). Moreover, the cost of newer vaccines has risen from about USD 0.57 per child in 2001 to approximately USD 21-35 per child in 2016 (5). The current nominal cost of vaccines alone for one child is or exceeds per capita spending by many low- and middle-income countries on all public-health programs combined. This spending has ranged from USD 21 to 24 per capita on average since 2010 (6).

The medical supply chains in many emerging markets continue to underperform, leading to shortages and impeding the delivery of quality services. In addition, substandard and counterfeit medical products pose an increasing and unacceptable risk to public health. According to one estimate, in sub-Saharan Africa in 2013, at least 122,000 children died due to counterfeit and substandard anti-malarial medicines (7). In Pakistan in late 2011 and early 2012, contaminated medical products were responsible for more than 200 deaths (8).

Who

Dimensions of Impact: WHO

Investors interested in deploying this strategy should consider whom they want to target, as almost every strategy has a host of potential beneficiaries. While some investors may target women of color living in a particular rural area, others may set targets more broadly, e.g., women. Investors interested in targeting particular populations should focus on strategies that have been shown to benefit those populations.

Key questions in this dimension include:

Who/What is helped through this strategy?

Improving access to quality, affordable essential medicines and vaccines could not just greatly improve population health but also help providers themselves. Some of the groups most directly impacted by this strategy are below.

Vulnerable Populations: Developing medicines and vaccines that address the needs of vulnerable populations can also help address inequality of access to appropriate health care and increase gender equality. For example, African women aged 15 to 24 are twice as likely as their male counterparts to be infected with HIV (13). Further investment to increase access to effective microbicides could help women in low- and middle-income countries protect themselves and their partners from HIV and unplanned pregnancies.

Infants and Children: The bacillus Calmette–Guérin (BCG) vaccine is the only option against tuberculosis for use with infants. Although the most widely used vaccine in the world, BCG is only partially effective for a small window of time, losing its efficacy by late adolescence. Investments to develop new vaccines with longer-term and higher efficacy—for tuberculosis or for other diseases—could greatly improve the health of infants and children worldwide.

People in Rural Areas: Making medicines and vaccines more affordable, available, and accessible leads to more equitable health outcomes. For example, vaccines that remain viable without refrigeration can improve health in remote communities that lack access to energy (for clean energy–related investments toward health care, see Clean Energy Access: Improved Alternatives for Healthcare).

Administrators and Policymakers: New and more affordable preventive vaccines allow policymakers and health systems administrators in emerging markets to protect more children and communities through wider distribution and delivery. Greater vaccine coverage also reduces disease incidence, enabling health systems to direct more resources to treat existing patients.

What are the geographic attributes of those who benefit?

Though many places around the world have limited access to medicines and vaccines, low-income countries face disproportionately limited access. People living in developing, resource-limited settings generally need access to safe and effective medicines and vaccines the most, suffering both higher rates of infectious and non-communicable diseases and less access to treatment.

According to the World Health Organization (WHO), an estimated two billion people lack access to essential medicines. This estimate rises to over 40% in low-income countries and over 50% in the poorest countries in Asia and Africa, where infectious diseases such as tuberculosis, malaria and AIDS are the leading cause of death (1).

Contribution

Dimensions of Impact: CONTRIBUTION

Investors considering investing in a company or portfolio aligned with this strategy should consider whether the effect they want to have compares to what is likely to happen anyway. Is the investment's contribution ‘likely better’ or ‘likely worse’ than what is likely to occur anyway across What, How much and Who?

Key questions in this dimension include:

Is the investment’s contribution ‘likely better’ or ‘likely worse’ than what is likely to occur anyway across What, How Much and Who?

Many low- and middle-income countries struggle to put even the most basic, foundational elements of a modern health system in place, grappling with interlocking challenges such as political agendas, scarce resources to allocate, underinvestment in health by national budgets, and inadequate capacity in the health system. All of these exacerbate the more widespread problem of inadequate access to affordable medicines.

A survey in several African countries found that drugs considered essential according to national lists of essential medicines in each country are often unavailable in either public or private health facilities, and even the lowest-cost generics are highly unaffordable at 290–360% of benchmark international prices. Hence, in the surveyed countries, one month of generic reference medications for a household costs between five and seven days' wages for the lowest-paid government employees (10).

Countries with strong innovation capabilities in the pharmaceutical sector have the ability to move ahead by discovering and manufacturing medicines more suited to their own problems. Further, innovative locally manufactured medicines create added value and are key to the economic and well-being advancement of developing countries. No single approach suffices. As such, investments in this strategy have the potential to significantly impact partnerships promoting knowledge and technology transfer in assuring essential medicines to be manufactured, authorized, and distributed in developing countries in an effort to make them available at affordable and acceptable conditions.

How Much

Dimensions of Impact: HOW MUCH

Investors deploying capital into investments aligned with this strategy should think about how significant the investment's effect might be. What is likely to be the change's breadth, depth, and duration?

Key questions in this dimension include:

How many can receive the outcome through this strategy?

Despite notable progress, approximately two billion people worldwide still face tremendous obstacles in accessing the medicines they need (1), though the exact number of potential beneficiaries depends on the scope and focus of the investment.

How much change can beneficiaries experience through this strategy?

Access to essential medicines and vaccines is often binary: patients either receive or do not receive a certain vaccine or medicine that, if received, may directly save lives.

Considering the vast scale of the global pharmaceutical industry and the incidence of potentially fatal diseases, any amount of poor-quality medicine is unacceptable because it increases morbidity and mortality, especially in the poorest populations. The available evidence suggests that poor-quality essential medicines are having a very important (but avoidable) toll on health in the developing world, and that this issue clearly needs to be taken much more seriously. As such, strengthening medicine regulatory authorities, improving quality of production, and facilitating the increased availability of high-quality, affordable essential medicines are likely to be key factors in improving the pervasive access issues facing developing countries.

For example, Sayana Press aims to make long-acting, injectable contraception more widely available to women in low-resource settings, especially in remote areas. Sayana Press provides three months of safe, effective pregnancy prevention in an easy-to-use, pre-filled injection device designed to allow low-level health workers and even users themselves to inject the product. As of the end of 2016, 6.4 million units had been shipped to 20 developing countries around the world, reaching more than 1.5 million women. The reach of this reproductive health innovation grew from 350,000 women as of the end of 2014 (11). In clinical trials, Sayana has been shown to effectively suppress ovulation for at least three months; among 2,042 women using the injectable contraceptive, no pregnancies were detected for up to one year (11).

Risk

Dimensions of Impact: RISK

Key questions in this dimension include:

What risks do investments in this strategy run in terms of either people/planet experiencing impact or society as a whole? What is the probability that those risks happen?

Risk factors for this strategy include:

  1. Execution Risk: Investments in this strategy require tailoring based on context. The spread of infectious disease is unpredictable and this creates fluctuations in global demand. When a sudden outbreak occurs, it is challenging for market authorization holders to ensure a continuous supply of vaccines. This change in demand can result in prioritizing vaccine production for current outbreaks, potentially leading to shortages of other products that the organization supplies. Further, entering the market is a business decision, and low market prices make production of some vaccines unattractive to manufacturers, leading in some cases to fewer manufacturers entering the market in the first place (non-availability) or some existing manufacturers withdrawing from the market entirely, resulting in shortages.

    Beyond tailoring, a weak cold chain limits how far a vaccine can be effectively transported and therefore how many people can access the lifesaving intervention. Keeping perishable vaccines at a specific temperature range as they travel from manufacturer to beneficiary is vital for immunization programs—and extremely challenging, especially in low-resource settings. Unreliable electricity, poorly maintained equipment, and long distances between health care facilities can compromise temperature control efforts, exposing vaccines to unsuitable temperatures that negatively impact potency. Overheating and accidental freezing can result in vaccine wastage (when vaccines are discarded due to suspected damage) or the inadvertent administration of sub-potent vaccines, which increases the risk that beneficiaries are not fully protected from disease.


  2. External Risk: Essential medicines and vaccines are biological products requiring technical knowledge on complex manufacturing processes. This technical requirement, combined with uncertain demand, has resulted in a limited supplier base. Sudden technical issues, manufacturing problems, or other shocks can increase the risk of shortages. This risk is particularly high when the manufacturer has few manufacturing sites or production lines. Corruption and other inefficiencies can also contribute to high expenditure on medicines, threatening the sustainability of health systems. 

    A further external element is the presence of counterfeit medicines. Presently, there aren’t many systems in place for detecting counterfeit medicines in global supply chains before they reach consumers. Ensuring drug quality might require regulators to use an assay to detect drugs with wrong or missing active pharmaceutical ingredients. Or, regulators might have to analyze drug packaging, serial numbers, and inserts to determine legitimacy. As a result, verifying the integrity of a given medicine is often a laborious process. Furthermore, markets for counterfeit medicines exacerbate existing disease burdens. As a result, many who fall sick are often unable to access effective treatment. This often leads to poorer patient outcomes, contributes to the emergence and spread of drug-resistant pathogens, and weakens health systems.

What are likely consequences of these risk factors?

Medicines promote trust and participation in health services. Medicine stock-outs and low-quality products can decrease demand for services, increase staff attrition, and ultimately compromise program effectiveness. The distribution and consumption of substandard or falsified medicines can contribute to the spread of antimicrobial resistance and can harm consumers by prolonging illness or causing death. Corruption and mismanagement can also lead to inflated medicine prices and the waste of scarce health system resources.

Illustrative Investment

The development and deployment of the innovative, low-cost vaccine MenAfriVac, through mass vaccination campaigns, has immediately and dramatically broken the cycle of Group A meningococcal epidemics. MenAfriVac, the first vaccine developed specifically for use in Africa, was developed extraordinarily quickly and at less than 10% of the cost of a typical new vaccine. To enable widespread use, the vaccine is manufactured at less than USD 0.50 per dose. In the years since its first introduction in Burkina Faso, MenAfriVac has saved an estimated 142,000 lives, averted an estimated 284,000 permanent disabilities, and prevented more than 1 million meningitis cases over a decade in the 26 endemic countries of Africa's Meningitis Belt (12).

Draw on Evidence

This mapped evidence shows what outcomes and impacts this strategy can have, based on academic and field research.

NESTA: 3
Evaluation of a mHealth Data Quality Intervention to Improve Documentation of Pregnancy Outcomes by Health Surveillance Assistants in Malawi: A Cluster Randomized Trial

Joos O, Silva R, Amouzou A, Moulton LH, Perin J, Bryce J, et al. (2016) Evaluation of a mHealth Data Quality Intervention to Improve Documentation of Pregnancy Outcomes by Health Surveillance Assistants in Malawi: A Cluster Randomized Trial. PLoS ONE 11(1): e0145238.

NESTA: 3
Can a community health worker administered postnatal checklist increase health-seeking behaviors and knowledge?: evidence from a randomized trial with a private maternity facility in Kiambu County, Kenya

McConnell M, Ettenger A, Rothschild CW, Muigai F, Cohen J. Can a community health worker administered postnatal checklist increase healthseeking behaviors and knowledge?: evidence from a randomized trial with a private maternity facility in Kiambu County, Kenya. BMC Pregnancy Childbirth. 2016 Jun 04;16(1):136.

NESTA: 2
Improvement in Integrated Management of Childhood Illness (IMCI) Implementation through use of Mobile Technology: Evidence from a Pilot Study in Tanzania

Mitchell M, Hedt B, Msellemu D, Mkaka M, Lesh N. Improvement in Integrated Management of Childhood Illness (IMCI) Implementation through use of Mobile Technology: Evidence from a Pilot Study in Tanzania. BMC Med Inform Decis Mak. 2013;13:95.

NESTA: 2
Short message service (SMS) reminders and real-time adherence monitoring improve antiretroviral therapy adherence in rural Uganda

Haberer JE, Musiimenta A, Atukunda EC, Musinguzi N, Wyatt MA, Ware NC, et al. Short message service (SMS) reminders and real?time adherence monitoring improve antiretroviral therapy adherence in rural Uganda. AIDS. 2016;30(8): 1295.

NESTA: 2
Early BCG vaccine to low-birth-weight infants and the effects on growth in the first year of life: a randomised controlled trial

Biering-Sorensen S, Andersen A, Ravn H, Monterio I, Aaby P, Benn CS. Early BCG vaccine to low-birth-weight infants and the effects on growth in the first year of life: a randomised controlled trial. BMC Pediatr. 15, 137 (2015).

NESTA: 3
Introducing rapid diagnostic tests for malaria to drug shops in Uganda: a cluster-randomized controlled trial

Mbonye AK, Magnussen P, Lal S, Hansen KS, Cundill B, Chandler C, et al. (2015) A Cluster Randomised Trial Introducing Rapid Diagnostic Tests into Registered Drug Shops in Uganda: Impact on Appropriate Treatment of Malaria. PLoS ONE 10(7): e0129545.

NESTA: 3
The impact of training informal health care providers in India: A randomized controlled trial

Das J, Chowdhury A, Hussam R, Banerjee AV. The impact of training informal health care providers in India: A randomized controlled trial. Science2016;354:aaf7384.

NESTA: 3
Effect of a micro entrepreneur-based community health delivery program on under-five mortality in Uganda: a cluster-randomized controlled trial

Nyqvist, M. B., Guariso, A., Svensson, J., Yanagizawa-Drott, D. Effect of a Micro Entrepreneur Based Community Health Delivery Program on Under-Five Mortality in Uganda: A Cluster-Randomized Controlled Trial (CEPR Discussion Paper Series DP 11515). London: Centre for Economic Policy Research.

NESTA: 1
Measuring What Works: An Impact Evaluation of Women’s Groups on Maternal Health Uptake in Rural Nepal

Sharma S, Van Teijlingen E, Belizán JM, Hundley V, Simkhada P, Sicuri E. Measuring What Works: An impact evaluation of women’s groups on maternal health uptake in rural Nepal. PloS one. 2016;11(5):e0155144.

NESTA: 4
The Advance Market Commitment Pilot for Pneumococcal Vaccines: Outcomes and impact evaluation

Boston Consulting Group (BCG). The Advance market commitment pilot for Pneumococcal Vaccines: Outcomes and impact evaluation, 2015.

NESTA: 2
A low-cost ultrasound program leads to increased antenatal clinic visits and attended deliveries at a health care clinic in rural Uganda

Ross, et al, 2013. A Low-Cost Ultrasound Program Leads to Increased Antenatal Clinic Visits and Attended Deliveries at a Health Care Clinic in Rural Uganda. PloS One. 2013.

Each resource is assigned a rating of rigor according to the NESTA Standards of Evidence.

Define Metrics

Core Metrics

This starter set of core metrics — chosen from the IRIS catalog with the input of impact investors who work in this area — indicate performance toward objectives within this strategy. They can help with setting targets, tracking performance, and managing toward success.

Additional Metrics

While the above core metrics provide a starter set of measurements that can show outcomes of a portfolio targeted toward this goal, the additional metrics below — or others from the IRIS catalog — can provide more nuance and depth to understanding your impact.