On October 6th, 2021, the Lancet Commission on Diagnostics launched the “Transforming access to diagnostics” commission report with a virtual program and release of several publications. One of the publications included a study led by Dr. Sue Horton on access to diagnostics using data from 14 countries, mostly in Africa, from 2004 to 2018 with single timepoint data used to evaluate the relationship of access to diagnosis with a variety of factors. The diagnostics that were evaluated did not include histopathology, crucial for the diagnosis of cancer; however, the study did show importantly that income and population density had demonstrable relationships with access to diagnostics at the primary care level. For hospital-based access, there was no relationship which led the authors to conclude, among many other and relevant points, that access to diagnostics in “primary health care is the diagnostic so-called last mile and particularly affects poor, rural, and marginali[z]ed communities globally; appropriate access is essential for equity and social justice.” In the Commission report, the authors describe a tiered system with three levels that countries should incorporate into a national laboratory strategy and suggest that the burden of affording this system should fall on the governments. Moreover, they demonstrate the extremely important data around use of global markets to show that while the top four countries supply nearly 50% of all diagnostics, those same four countries only supply 24% of pharmaceuticals. In the opening statements to the Lancet Commission launch, Dr. John Nkengasong espoused very strongly the importance of manufacture of diagnostics WITHIN LMICs as one much needed solution.
For example, I was assisting a colleague with access to immunohistochemistry antibodies for which they were currently paying $700 USD for one vial of CD20. I traced the manufacture back to the US supplier (where the antibody was produced) and attempted to buy a vial as a private citizen with a credit card and was surprised to see that I could do so for $220 USD. This is the exact same vial of CD20 antibody. Why was my colleague paying a 218% markup? When I inquired with the company of manufacture, they reported that they had existing contracts to supply 2nd, 3rd, and 4th party vendors that they could not violate (i.e., they could not sell directly to a purchaser on the continent of Africa). The local supplier charging the $700 USD suppled a very large number and breadth of medical supplies including other diagnostic tests and reagents. Those reagents were reasonably priced, and several were on sustained government contracts. However, the CD20 antibody was not. Why is that the case? Let’s assume you are a supplier of widgets and wobbles. Your demand for widgets is huge and you sell more than 100,000 widgets per month to 20 different consumers. For wobbles, one person orders one wobble once per year. Your widgets ship room temperature but your wobbles require a cold chain, lest they be destroyed. What would you do? You could choose not to sell wobbles. You could choose to charge a ridiculous price for wobbles so that the excess time, energy, and expense of getting one wobble to your consumer is worth the effort. But you would not sell the wobbles for a similar profit margin as your widgets. It just wouldn’t make business since. Now imagine that the wobbles are manufactured in a country other than your own and to get them, you buy them from a country supplier who buys them from a regional supplier. So, wobbles already come with additional markups. You do have a third choice which is to manufacture wobbles locally, cut out the middle people, and charge much less but still make more profit. This is a great model if wobbles can be easily manufactured; however, when wobbles require an enormous capital investment, is it worth it to sell a couple of wobbles a year? Of course not. This business-based example is one of the drivers for a $700 USD vial of CD20. If a local manufacturer, in country or in a neighboring country, could manufacture and sell, this reagent would be more affordable and feasible as an available diagnostic. Specifically, patients with lymphoma would have access to rituximab for CD20.
But note the Commissions finding that almost 50% of diagnostics are made in the top 4 countries. This means, naturally, that the pricing for these reagents and supplies will be based on that economy and/or GDP, not on the economy or GDP of every country down to the lowest on any given scale. Consider the Big Mac Index, which looks at buying power relative to the US dollar. The only African country used in the Big Mac Index is South Africa and it is third from the bottom. To be clearer, if you have 100 South African Rand, you could get about $6.69 USD if you exchanged it directly (ignoring fees). If you want to buy a Big Mac in the USA, the average consumer price is $5.65; however, in South Africa, it’s 33.50 Rand. Based on the Dollar:Rand exchange rate, we are paying only $2.24 USD in South Africa for the same sandwich that would cost us $5.65 in the US. So, the Rand is undervalued. Now, let’s look at our vial of CD20 (not revealing the country to protect identities). According to the current exchange rate, you get $4.34 USD for every 10,000 units of this countries currency. Based on this model, if the CD20 was being EVENLY exchanged with cash (as opposed to being undervalued or discounted as we saw with South Africa), it should cost 450,586 units of this country’s currency. Instead, it is costing them 1,612,053 units. If we assume that this country could/should achieve a Big Mac Index equivalent discounted of the CD20 as we see with the Big Mac itself in South Africa, it should cost them 307,057 units or $133 USD. The difference? The Big Mac is manufactured and locally distributed directly to the customer in South Africa. The CD20 is not. So, one step to achieving an equitable pricing structure in healthcare for LMICs, especially in Africa, needs either direct discounted by US- and European-based manufacturers—unlikely to occur because of fear of alternative market access—or these products need to be manufactured and supplied locally.
What I have trouble agreeing with completely and, in some cases, even it part, is the concept of all healthcare costs falling on the government of a population with the expectation that they deploy a “one size fits all” approach to any aspect of healthcare. When we consider the US and Europe (again, the top four producers of diagnostics), we find one as a largely private commercial system driven by government pricing for elder care and the other a socialist system with universal healthcare enhanced by private care. For both systems, there is a huge economic base which either drives capitalism across the system from raw materials to final product or an enormous tax base that can cover the bulk of the costs of the systems. As we move from these four down the GDP ladder to LMICs, we don’t see, despite that we would like to nicely categorize countries into clear groups, a solution that would work “globally” because major pieces of economic development are needed as pre-requisites for a capitalist open market or one payer system. Each country has a unique set of circumstances (e.g., history, genetic diversity, geography, natural resources, tourism, disease burden, language, population size, etc.) that cannot be reduced to simply a GDP value or Big Mac Index factor. Moreover, it is wholly within the realm of colonialism, which we supposedly abandoned 70 to 80 years ago, to think that we can propose a system for “all countries” that would even remotely approach the solving the problems of these countries. Although it is an excellent mental exercise to idealize a healthcare system as having something as simple as three tiers and trying to allocate what tools and resources are needed at each level to accommodate the population, the reality is that such a framework is only a starting point with a lot of work needed to fully realize what type of system would be best for a given country. Very small islands and small nations may have only one hospital to serve its entire population and insufficient patients of a given type to justify the expense of certain tools. Extremely large countries with large populations will need a myriad of systems with their own tiers that support patients based on location, socioeconomic status, language, etc. and these systems likely overlap in geography. And the expertise to best determine that system is the health and government leadership of that country, not an external set of non-specific instructions. The external set of instructions, however, are extremely important, as noted, as a starting point, but each country that identifies a gap in their diagnostics, for example, has to assess their specific situation. At the heart of this problem is the need to stop talking about the challenges of global healthcare and start (or continue) directly working on fixing them.
At ASCP, we approach our global outreach through assessment, gap identification, implementation planning, and execution (AGIE). Through that approach, we have deployed and/or support 19 sites in 15 countries with telepathology; however, in an additional 10 countries, we have active programs that have not yet reached a point of telepathology deployment. Had we said, from the beginning, “We are going to give everyone telepathology”, we would have wasted an enormous amount of time and money. By following an AGIE approach, we have navigated to the specific problems of each site with whom we collaborate and attempted to solve them. And we do so with more than 80 collaborative partners. The Lancet Commissions on Diagnostics most recent launch is an excellent first alert for those who have not been engaged in global health for the last 20 years that there are still major challenges and problems in global healthcare and diagnostics. Our hope is that funders, governments, industry, health system members, patients, and advocates will view this as a rallying cry to direct resources and energy to join those of us who have been engaged in this work to move the needle even further. Access to diagnostics for every patient everywhere. It is ASCP’s simple mantra, and we hope, together, we can achieve that goal.
-Dan Milner, MD, MSc, spent 10 years at Harvard where he taught pathology, microbiology, and infectious disease. He began working in Africa in 1997 as a medical student and has built an international reputation as an expert in cerebral malaria. In his current role as Chief Medical officer of ASCP, he leads all PEPFAR activities as well as the Partners for Cancer Diagnosis and Treatment in Africa Initiative.