The Price of Joining the ‘Middle Income Country’ Club: Reduced Access to Medical Innovation
On November 5, 2014, the WHO, WIPO and WTO will hold a joint symposium to discuss innovation and access to medical technologies in middle-income countries. In this post, Judit Rius Sanjuan and Rohit Malpani of Médecins Sans Frontières discuss the barriers to health care access for poor people in middle-income countries.
When people think about medical humanitarian aid, the usual association is with war zones and natural disasters, and the assumption is that the most critical medical needs are concentrated in the world’s poorest countries. That’s mostly right, but not entirely: while the needs in low-income countries remain huge, large—and growing—populations excluded from access to health care now live in countries classified as Middle Income (MIC). This shift presents enormous challenges, particularly in accessing new life-saving drugs and vaccines for diseases that take a disproportionately high toll on poor, marginalized populations.
For us at Médecins Sans Frontières (MSF), an organization providing emergency medical aid to people in acute need, the bulk of our resources are placed in countries classified as low-income economies. But over half the countries where we now have programs are classified as middle- or high-income economies. These programs range from short-term emergency responses, for example after last year’s Typhoon Haiyan in the Philippines, to aid for ongoing refugee emergencies in Iraq, Jordan, and Lebanon, to treatment programs for chronic and neglected diseases in India and South Africa.
Today, more than 100 diverse economies are classified as MIC. They are home to about 5 billion of the world’s 7.1 billion people, including more than three-quarters of the poorest people living on less than $2 per day, largely due to enormous and rising levels of inequality.
Yet the rising economic indicators that land a country in the MIC club in turn often exclude those countries from accessing the lowest prices for medicines and vaccines, due to tiered pricing and other market segmentation strategies employed by pharmaceutical companies, and increasingly by donors, governments and international organizations. In many MICs, health care costs are primarily paid out of pocket, so it follows that many poor and marginalized people have little or no access to care.
A good illustration of the problem comes from many of the newer, more expensive vaccines, such as the pneumococcal conjugate vaccine (PCV) against pneumonia, rotavirus vaccine against diarrhea, or human papillomavirus vaccine against cervical cancer. Gavi, the Vaccine Alliance, which receives significant government and philanthropic funding to support introduction of new vaccines in low-income countries, has negotiated some of the lowest known prices for these vaccines. However, Gavi’s current policies mean these price discounts are only available to a select group of the poorest “Gavi-eligible” countries. More than 25% of Gavi-eligible countries will soon lose Gavi support when they pass the eligibility threshold of $1570 gross national income (GNI) per capita. When these countries are no longer ‘Gavi-eligible’, according to what we consider a GAVI conservative estimate, countries will have to pay at least 6 fold more for PCV when they lose access to negotiated prices. Even more worrisome, a 2013 report concluded that many MICs are lagging behind in introducing some or all of these vaccines and that price was an important barrier for 9 of the 15 countries examined. As of September 2012, 84% and 80% of the birth cohort in MICs had not benefited from PCV and rotavirus vaccine introduction, respectively.
Another example is the difficulty faced by MICs in accessing the first new medicines approved for drug-resistant tuberculosis (DR-TB) in over 40 years—despite the fact that some of the highest-burden countries are MICs, including Armenia, India, Ukraine, Uzbekistan and South Africa, where MSF has DR-TB programs. After decades-long drought without new TB medicines, two new medicines were recently approved for treating the most severe forms of DR-TB: bedaquiline (from Janssen) and delamanid (from Otsuka). However several barriers, including the lack of research on using these drugs in regimens, the lack of registration in endemic countries, and high prices, mean that these two drugs are not yet routinely used outside the U.S. and Europe except through compassionate use or clinical access programs. MSF recently signed an open letter from leading public health officials and civil society groups asking Janssen to lower the MIC price for bedaquiline, which is currently US$3,000 for a course of treatment.
Groundbreaking new medicines for hepatitis C (HCV) are yet another example of the access challenge facing MICs. An estimated 150 million people worldwide have HCV, 73% of whom live in MICs. While MSF’s medical response has been limited so far, we will soon open treatment programs in several MICs, including Egypt, India, Iran and Ukraine. The introduction of new oral direct-acting antivirals (DAAs) has the potential to substantially simplify and improve treatment of the disease, but high prices threaten to restrict scale-up. Very recently, Gilead signed voluntary license agreements with several Indian generic manufacturers to produce affordable versions of a DAA, sofosbuvir, and another new HCV drug (ledipasvir). But the agreement excludes 51 MICs with, collectively, have more than 50 million people estimated to be living with HCV. Among them, China, Thailand and Ukraine account for approximately 30 million, 1.5 million and 1.9 million people with HCV, respectively.
What can be done to reduce these barriers for people in MICs whose lives depend on access to these and other life-saving medical innovations? Countries, patients and treatment providers should be empowered to use a range of legal and policy tools, including the promotion of robust generic competition. But MICs are increasingly the target of intense pressure to move in the opposite direction by increasing intellectual property protection in ways that keep medicine prices high, in line with multinational pharmaceutical company ambitions to tap into profitable, rapidly growing market segments within MICs. This makes it even more important for governments, global health institutions and organizations like MSF to work towards overcoming these barriers, for example by preventing the adoption of harmful rules that would stifle generic competition (through trade deals such as the Trans-Pacific Partnership) and by supporting important patent law reform efforts such as those under way in South Africa and Brazil.
Today, millions of people can’t benefit from groundbreaking new treatments and vaccines. We need solutions and strategies that promote affordable access for all people based on medical need rather than their country’s macroeconomic classification, because innovation without access cannot truly be counted as innovation.
Judit Rius Sanjuan, a lawyer from Barcelona, Spain, is U.S. Manager and Legal Policy Advisor of the Access Campaign at Médecins Sans Frontières/Doctors Without Borders in New York.
Rohit Malpani, also a lawyer, serves as Director of Policy and Analysis at the Access Campaign and is based in Paris.
[…] On November 5, 2014, the WHO, WIPO and WTO will hold a joint symposium to discuss innovation and access to medical technologies in middle-income countries. In this post, Judit Rius Sanjuan and Rohit Malpani of Médecins Sans Frontières discuss the barriers … Continue reading » […]
It is true indeed that the MIC classification is currently preventing many of the world’s poorest people to have access to medicines and vaccines. Yet, let’s not forget that a MIC classification infers that the country may have the means to pay for most of those treatments, but simply funds are channeled somewhere else (war, corruption, …). A big issue here is inequality of internal resources distribution and how to ‘force’ those countries to address their people’s most eminent needs in the first place as any proper nation should do. It is not by chance that there is a Gavi eligibility threshold for Gavi support – it is understood that by reaching a certain economical status a country should be able to afford those vaccines at a price higher than the Gavi one but still a sustainable one. I don’t think that anyone seriously believes that the South African government has no means at all to fund HIV treatment for their people. Of course there is more to it than just willingness to pay, such as infraestructure deficiencies, cultural issues, etc. but again, treating those countries as poor ones when they are not such won’t do much to address those problems on the long term.
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