[Ip-health] BMJ: The price of joining the middle income country club: reduced access to medical innovation

Joanna Keenan-Siciliano joanna.l.keenan at gmail.com
Mon Oct 13 08:05:06 PDT 2014

The price of joining the middle income country club: reduced access to
medical innovation
10 Oct, 14

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 of low income countries remain huge, there are large—and
growing—populations excluded from access to healthcare who now live in
countries classified as middle income countries (MIC). This shift presents
enormous challenges, particularly in accessing new lifesaving 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
of 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 five billion of the world’s 7.1 billion people, and hold more than
three quarters of the world’s poorest people, who live on less than $2 per
day—largely owing 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, because of tiered pricing and other market
segmentation strategies employed by pharmaceutical companies—and,
increasingly, by donors, governments, and international organizations too.
In many MICs, healthcare costs are primarily paid out of pocket, so it
follows that many poor and marginalized people have little or no access to

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 substantial government and philanthropic funding to support
the 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 payat
least sixfold more for PCV when they lose access to negotiated prices. And,
even more worryingly, 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 nine 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 countries with the highest burden
of the disease are MICs, including Armenia, India, Ukraine, Uzbekistan, and
South Africa, where MSF has DR-TB programs. After a decades long drought of
new TB medicines, two new medicines were recently approved for treating the
most severe forms of DR-TB: bedaquiline (from Janssen) and delamanid (from

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
United States 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$3000 for a course of

Groundbreaking new medicines for hepatitis C are yet another example of the
access challenge facing MICs. An estimated 150 million people worldwide
have hepatitis C, 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 hepatitis C drug (ledipasvir). But the
agreement excludes 51 MICs, which collectively have more than 50 million
people estimated to be living with hepatitis C  Among them, China,
Thailand, and Ukraine account for approximately 30 million, 1.5 million,
and 1.9 million people with hepatitis C, respectively.

What can be done to reduce these barriers for people in MICs whose lives
depend on access to these and other lifesaving 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

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—and in line with multinational
pharmaceutical company ambitions, which seek 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 efforts to reform patent law, such as those
underway 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 US manager and legal
policy advisor of the Access Campaign at Médecins Sans Frontières/Doctors
Without Borders in New York.
Competing interests: Nothing to declare.

Rohit Malpani, also a lawyer, serves as director of policy and analysis at
the Access Campaign and is based in Paris.
Competing interests: Nothing to declare.

Joanna Keenan
Press Officer
Médecins Sans Frontières - Access Campaign
P: +41 22 849 87 45
M: +41 79 203 13 02
E: joanna.keenan[at]geneva.msf.org
T: @joanna_keenan


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