The Lancet Commission on diagnostics: transforming access to diagnostics
Authors: Kenneth A Fleming, Susan Horton, Michael L Wilson, Rifat Atun, Kristen DeStigter, John Flanigan, Shahin Sayed, Pierrick Adam, Bertha Aguilar, Savvas Andronikou, Catharina Boehme, William Cherniak, Annie NY Cheung, Bernice Dahn, Lluis Donoso-Bach, Tania Douglas, Patricia Garcia, Sarwat Hussain, Hari S Iyer, Mikashmi Kohli, Alain B Labrique, Lai-Meng Looi, John G Meara, John Nkengasong, Madhukar Pai, Kara-Lee Pool, Kaushik Ramaiya, Lee Schroeder, Devanshi Shah, Richard Sullivan, Bien-Soo Tan, Kamini Walia
Journal: The Lancet (2021)

At the end of 2019, the first reports of a new respiratory virus appeared in China. The subsequent COVID-19 pandemic has affected every person, in every country, in the world. One early lesson was the crucial importance of timely accurate diagnosis. A second lesson was the widespread scarcity of such diagnostic capacity and capability. The second lesson supported the findings of the 2018 Lancet Series on Pathology and Laboratory Medicine in Low-Income and Middle-Income Countries, namely that despite diagnostics being central to health care, access to diagnostic testing in pathology and laboratory medicine (PALM) is poor and inequitable in many parts of the world. In diagnostic imaging (DI), the other major diagnostic discipline, data are scarce, but what data are available suggest the situation is similar or even worse. Poor accessibility of diagnostics is not a new issue. In 2008, the Maputo Declaration on Strengthening of Laboratory Systems identified the need to address the problems of poor accessibility to diagnostic testing. Although progress has been slow, there is now a conjunction of factors that has the potential to accelerate change. First, three major global health priorities—universal health coverage, antimicrobial resistance, and global health security—all require better access to diagnostics. Second, the publication of an essential diagnostics list (EDL) for priority settings by WHO in 2018 has been a key step in recognising the importance of diagnostics. Third, the COVID-19 pandemic has greatly raised awareness of the crucial importance of diagnostics. Lastly, within the past 15 years, extraordinary innovations in technology and informatics promise transformation across all aspects of diagnostics. The combination of all these factors can fuel political will to accelerate change. This Lancet Commission on Diagnostics was set up with the remit of analysing the issues and identifying solutions for both PALM and DI, in part because these are the two major diagnostic disciplines and in part because, increasingly, optimum patient care (eg, in cancer) depends on the integration and synthesis of the results of both disciplines. Also, both disciplines share many of the same issues; for example, insufficient financial support, staff shortages, infrastructure problems, and low visibility and, hence, low priority. In this Commission, we analyse the current status of diagnostics with the use of the six WHO building blocks of health systems, namely health service delivery, health workforce, health information systems, access to diagnostics (analogous to essential medicines), financing, and leadership and governance, as the basis. Given the dearth of reliable and comprehensive data, the Commission's first step was to quantify, where possible, the current state of diagnostics globally. We use six tracer conditions (diabetes, hypertension, HIV, and tuberculosis in the overall population, plus hepatitis B virus infection and syphilis for pregnant women) and show that the diagnostic gap (ie, the proportion of the population with the condition who remain undiagnosed) is, at 35–62%, the single largest gap in the care pathway (the cascade of care comprising screening, diagnosis, treatment, and cure or successful management). We also examine the current availability of diagnostics by level of health care facility, geography, and socioeconomic group. The diagnostic gap is most severe at the level of primary health care, in which only about 19% of populations in low-income and lower-middle-income countries have access to the simplest of diagnostic tests (other than those for HIV and malaria). Even in hospitals, this figure only rises to 60–70%. DI is essentially absent outside of hospitals. People who are poor, marginalised, young, or less educated have the least access to diagnostics. Key messages147% of the global population has little to no access to diagnostics.2Diagnostics are central and fundamental to quality health care. This notion is under-recognised, leading to underfunding and inadequate resources at all levels.3The level of primary health care is the diagnostic so-called last mile and particularly affects poor, rural, and marginalised communities globally; appropriate access is essential for equity and social justice.4The COVID-19 pandemic has emphasised the crucial role of diagnostics in health care and that without access to diagnostics, delivery of universal health coverage, antimicrobial resistance mitigation, and pandemic preparedness cannot be achieved.5Innovations within the past 15 years in many areas (eg, in financing, technology, and workforce) can reduce the diagnostic gap, improve access, and democratise diagnostics to empower patients.6As an example of the potential impact, 1·1 million premature deaths in low-income and middle-income countries could be avoided annually by reducing the diagnostic gap for six priority conditions: diabetes, hypertension, HIV, and tuberculosis in the overall population, and hepatitis B virus infection and syphilis for pregnant women.7The economic case for such investment is strong. The median benefit–cost exceeds one for five of the six priority conditions in middle-income countries, and exceeds one for four of the six priority conditions in low-income countries, with a range of 1·4:1 to 24:1.Given the depth and breadth of the problems, sustained access to quality, affordable diagnostics will require multi-decade prioritisation, commitment, and investment. Incorporating diagnostics into universal health coverage packages will begin this process. 147% of the global population has little to no access to diagnostics.2Diagnostics are central and fundamental to quality health care. This notion is under-recognised, leading to underfunding and inadequate resources at all levels.3The level of primary health care is the diagnostic so-called last mile and particularly affects poor, rural, and marginalised communities globally; appropriate access is essential for equity and social justice.4The COVID-19 pandemic has emphasised the crucial role of diagnostics in health care and that without access to diagnostics, delivery of universal health coverage, antimicrobial resistance mitigation, and pandemic preparedness cannot be achieved.5Innovations within the past 15 years in many areas (eg, in financing, technology, and workforce) can reduce the diagnostic gap, improve access, and democratise diagnostics to empower patients.6As an example of the potential impact, 1·1 million premature deaths in low-income and middle-income countries could be avoided annually by reducing the diagnostic gap for six priority conditions: diabetes, hypertension, HIV, and tuberculosis in the overall population, and hepatitis B virus infection and syphilis for pregnant women.7The economic case for such investment is strong. The median benefit–cost exceeds one for five of the six priority conditions in middle-income countries, and exceeds one for four of the six priority conditions in low-income countries, with a range of 1·4:1 to 24:1. Given the depth and breadth of the problems, sustained access to quality, affordable diagnostics will require multi-decade prioritisation, commitment, and investment. Incorporating diagnostics into universal health coverage packages will begin this process. Our conclusion is that just under half (47%) of the world's population have little to no access to diagnostics. We estimate that reducing the diagnostic gap for the six tracer conditions from 35–62% to 10% would reduce the annual number of premature deaths in low-income and middle-income countries (LMICs) by 1·1 million (2·5% of total annual deaths in LMICs), and annual disability-adjusted life-year (DALY) losses by 38·5 million (1·8% of losses from all conditions). In this Commission, we examine the policy environment and conclude that the fundamental cause for the current situation is the low visibility and prioritisation of diagnostics. Diagnostics are not explicitly mentioned in proposals for universal health coverage and are largely missing from national strategic plans for health, and the focus on diagnostics in the National Action Plans for Health Security is limited primarily to epidemic infectious diseases. Although corruption is a problem across any health system, diagnostics are particularly susceptible because they require acquisition of expensive equipment and supplies. Although data are particularly scarce at the operational level, the necessary physical infrastructure is clearly deficient in many facilities, resulting in weak services of inadequate quality. Similarly, support capabilities, such as management and procurement systems, technical support, information technology, and supply chains, are widely insufficient. Regarding workforce, we estimate there is a global shortfall of around 840 000 diagnostics staff (using the UK as the benchmark), noting that current education and training is not even enough to maintain current levels. Quality and safety mechanisms for standards are scarce, particularly for LMICs. For example, a 2019 study suggested that India has only 1151 accredited medical laboratories, whereas the USA, with a quarter of India's population, has 260 000 accredited medical laboratories. Because low political prioritisation is the key cause of poor access to diagnostics, we explore how we can use the framework of Shiffman and Smith to achieve political change. With the importance of diagnostics fresh in people's minds from the COVID-19 pandemic, and with the 2018 EDL (a useful tool for prioritisation and a way forward), there might now be an opportunity for progress. This Commission offers potential solutions to the problems associated with the poor access to diagnostics. We have developed an evidence-based template for a national EDL as the basic core of all integrated tiered networks, designed to meet the diagnostic needs of the predicted top 20 conditions in the global burden of disease for 2030 and 2040 (the GBD-20 EDL). Because technology is an enabler of many of the putative solutions in this Commission, we discuss the crucial role of technological innovation and also propose solutions via changes in policy, governance, and finance, and in infrastructure, workforce, and quality. The key aspects of the solutions proposed are summarised in following paragraphs under the relevant recommendation. This Commission also outlines the economic case for investing in diagnostics. We provide a benefit–cost analysis for the same aforementioned six tracer diagnostic tests. Although costs are relatively simple to calculate, measuring the benefits is difficult and the benefit–cost is context-specific, varying with several factors, such as country income, disease prevalence, and availability of more effective treatment. Although little work has been done in this area, by making several assumptions, we show that the median benefit–cost in LMICs for all but one of the six tracer tests exceeds one, with a range of 1·4:1 to 24:1. Our conclusion is that there is a strong case for investment to improve access to diagnostics. There is no single effective means (eg, technology) to address the multiplicity of challenges in improving the access to diagnostics. As solutions, we propose 10 recommendations. Although each recommendation is important in its own right, they are also highly interdependent. If implemented as a group, these recommendations will make a substantial difference. In the relative absence of national strategic plans for diagnostics, it is unsurprising that access is poor for many countries. Therefore, we recommend that countries develop a national diagnostics strategy and do so with an evidenced-based integrated and tiered network and a national EDL (this EDL can be based on our template) as the model (recommendation 1). Diagnostics would be allocated across the different health system tiers: point-of-care investigations to primary health care, basic analysers and x-ray to first-level hospitals, and more sophisticated diagnostics (eg, MRI, CT, flow cytometers, nucleic acid analysers, and microbial identification) to higher level facilities. Implementation of this model would serve to drive investment in all of the resources (eg, staff, equipment, and finance) of an effective diagnostics system. Because each country will have different existing facilities and varying disease prevalence, countries can adapt this template to their own context. However, it is key that whatever model is adopted is evidence-based. Given that the biggest gap is in provision of diagnostics at the level of primary health care, which is also the entry point to the care cascade, we also recommend that, as a priority, a set of key point-of-care diagnostics (point-of-care tests and point-of-care ultrasound) be made available at all primary health-care centres (recommendation 2). Health workforce expansion is key to improving access to diagnostics and diagnostic services. Expansion of the health workforce with current approaches alone will be insufficient. New approaches are needed to ensure expansion of workforce capacity and acquisition of contemporary skills, including more competency-based education, greatly expanded access to continuing professional development, telehealth for remote services, and greater use of task shifting and sharing. We recommend that each country use these approaches to expand the size and effective capacity of its health workforce (recommendation 3). Without systems to ensure diagnostic safety and quality, expanded access is of questionable value, potentially causing harm and wasting resources. A national regulatory framework that addresses safety and quality is essential. Device regulation could be simplified by regional harmonisation or by expansion of programmes such as WHO prequalification. The implementation of quality services will need regulation for both laboratory accreditation and for professional standards and competencies. We recommend each country develops an appropriate governance and regulation framework (recommendation 4). Without adequate infrastructure, the provision of diagnostic services will always be insufficient. A number of approaches supporting improvement are outlined in this Commission. These approaches include more efficient use of current resources through better management, regional pooled procurement and equipment standardisation, fostering of regional and national manufacturing capacity, and development of public–private partnerships with manufacturers. However, additional financing for diagnostics more generally is essential, for which the majority will need to be domestic and primarily public. Higher taxes on tobacco (so-called sin taxes) are one possibility. Other potential sources include financing instruments, such as Social Impact Bonds or Development Impact Bonds, which have rarely been used for diagnostics, and borrowing from multilateral banks. We recommend that each country develops mechanisms to finance sustainable diagnostics (recommendation 5). Complementing improved financing, there also needs to be national and international action to increase the affordability of diagnostics generally. Supporting more production in LMICs and pooled procurement (market shaping) can increase affordability. Therefore, we recommend global action to improve the affordability of diagnostics (recommendation 6). A key reason why now is an apposite time to address the issues with the accessibility of diagnostics is the transformative potential of innovation in many areas of diagnostics. In this Commission, we identify three broad approaches relating to technology that offer the greatest potential—namely, digitalisation, point-of-care diagnostics, and democratisation of diagnostics. By enabling diagnostic testing outside of the hospital (eg, self-testing or self-sampling), the first two approaches democratise diagnostics and empower the patient, particularly those patients who are marginalised. To ensure equity, privacy, and alignment with other social and political factors, we briefly review the general principles of implementation. These principles include designing technologies with, and for, the end user, generating data that can be integrated into the patient record and into national monitoring indicators, and a standards-based approach to increase system interoperability and reduce potential for conflict and confusion. As many of the Commission's recommendations depend on innovation in education, management, communications, and financing, as well as technology, to achieve their transformative effect, one of our main recommendations is the continued fostering of innovation, especially in LMICs (recommendation 7). A particular challenge is the provision of diagnostics for that third of the world's population living in fragile and conflict situations. These are complex, challenging settings and have very different health actors involved. Within the past 15 years, innovations in areas such as information technology and point-of-care testing can address some of the challenges, but more coordination of the civilian and security sector is needed, and humanitarian staff and affected populations need to be involved to define needs (recommendation 8). Considering that low visibility is probably the single most important global barrier to the adequate resourcing of diagnostics, there will need to be a major advocacy drive, combining efforts at both national and international levels and alignment of the activities of diverse stakeholders. Therefore, we recommend a coordinated advocacy programme for diagnostics at national and international levels, including adopting a World Health Assembly resolution on diagnostics (recommendation 9). Finally, as the effort in transforming diagnostics will need to be focused, persistent, multi-year, and sustainable, we recommend the creation of an international Diagnostics Alliance to work with relevant national and international agencies to promote and support this effort (recommendation 10). To build on the findings of this Commission, key next steps should be the initiation of national and international advocacy programmes, the creation of an international Diagnostics Alliance as an advocate, and the adoption of a World Health Assembly resolution on the need for diagnostics to be an integral part of any universal health coverage programme. Continued research is also needed to fill key data gaps; for example, research on the health workforce and the benefit–cost of diagnostics. The COVID-19 pandemic must be a turning point. Implementation of our recommendations over the next 20 years would transform the world from one where close to half of the population has little to no access to diagnostics, to one where the great majority does.