By Joshua Blume
Antimicrobial resistance is on the rise, and a new
antibiotic has not been invented since Eli Lilly & Co.
invented daptomycin in 1984. A recent WHO
report indicates that resistance to antibiotics
currently reduces worldwide GDP by around 1.5 percent, but drug companies are
not able to recover enough of that lost productivity to pay the $2.558
billion in development costs for inventing a new drug.
As it stands, not only is the antibiotic market
saturated with dozens of products, but the return on investment for antibiotic
medicines—which is used in only short-term doses—is projected by
most companies to be less valuable than medicines for chronic
illnesses, such as heart disease or diabetes. Another problem is that while many
underdeveloped nations have a greater need for new antibiotic treatments, they
are some of the greatest
contributors to antibiotic resistance and have almost
exclusive access to compulsory licenses—as provided by the WTO TRIPS Agreement
and the paragraph 6 framework
to Article 31.
As the WTO
explains, a compulsory occurs “when a government allows” another country to
produce a patented product “without the consent of the patent owner.” It was
originally included in the 1995 TRIPS
Agreement, but was expanded
to allow wider access. While there are some
restrictions they mostly have to do with notice and attempts to negotiate a
voluntary license, it is not restricted to national health emergencies, as many
believe. Even if it were, the WTO
has clearly stated that “[e]ach member has the right to determine what
constitutes a national emergency.” It is available to all nations except the
several dozen who have opted out or limited their use to extreme necessity. These
vast differences in consumption, regulation, law, and access for less-developed
countries creates an uphill battle for companies to recoup their research and
development costs.
The problem is worsened by the growing antibiotic
resistance disparity between developed and less-developed countries. Antibiotic
consumption is decreasing in many
developed countries, while growing exponentially in much of the
developing world. This growing disparity will also increase the incentive for
less-developed countries to announce compulsory licenses. Canada’s production
of TriAvir for
Rwanda to combat the HIV/AIDS crisis is one
prominent example of such compulsory licensing.
Antibiotic-resistant tuberculosis is on the rise and poses exactly this type of
threat. Current WHO numbers show that 480,000
people globally develop multi-drug resistant TB each year.
This is not to say that the developed world is not affected—gonorrhea acts as
one of three drug-resistant “urgent
threats” in the United States according to the CDC, with
only 0.3 percent
of cases exhibiting resistance in 2011, multiplying by
more than 8 times that percentage in just three years—but many developed
countries have opted out
of compulsory licensing.
That said, considering the differences
in regulation and law in many underdeveloped countries, compulsory
licenses should not be the main concern for corporations. Instead, the worry is
that countries will simply refuse to grant patents to newly invented
pharmaceuticals within their borders, so that their citizens can receive
treatment at a greatly reduced cost, such as happened with the $84,000
Hepatitis C drug cure Sovaldi in
2014. Sovaldi—the
generic name is Sofosbuvir—was heralded as a miracle cure for Hepatitis C, a
liver disease spread by blood. Studies have shown that
an estimated six million people in Egypt have this deadly disease, and for years
it was incurable. The problem was that due to the high costs of developing
the drug, Gilead, the patent holder, needed to find a way to get returns on a
drug that is disproportionately needed in less-developed nations. Gilead ended
up negotiating a 99
percent reduction in price so that they could sell their product in Egypt. One article
even recommended that patients leave the United States and seek treatment in
Egypt for a few months, where it was available for only $900. If patents are
not respected where the medicine is being used, the downside risk for originating
companies is even more immense than for compulsory licensing.
Thus, the question remains, what ways are available to encourage sustainable antibiotic production? The WHO has recommended international prize funds using 0.01 percent of worldwide GDP. Others have agreed to the principle of prize funds to create “delinkage” from the typical sales revenue, but there is disagreement on how to implement it, how much to contribute, and who to put in charge. While delinkage could prove extremely successful as an incentive—after all 80 different companies are asking for it—it does not change the fact that approximately 80 percent of all antibiotics in the United States are used for farming, nor does it structure proper incentives for the developing world to prevent antibiotic pollution. In the meantime, however, we should not let the perfect become the enemy of the good, especially on a ticking clock where pharmaceutical research often takes years and billions of dollars of expense. Such a prize fund may be the best solution to prevent 300 million premature deaths before 2050.
Thus, the question remains, what ways are available to encourage sustainable antibiotic production? The WHO has recommended international prize funds using 0.01 percent of worldwide GDP. Others have agreed to the principle of prize funds to create “delinkage” from the typical sales revenue, but there is disagreement on how to implement it, how much to contribute, and who to put in charge. While delinkage could prove extremely successful as an incentive—after all 80 different companies are asking for it—it does not change the fact that approximately 80 percent of all antibiotics in the United States are used for farming, nor does it structure proper incentives for the developing world to prevent antibiotic pollution. In the meantime, however, we should not let the perfect become the enemy of the good, especially on a ticking clock where pharmaceutical research often takes years and billions of dollars of expense. Such a prize fund may be the best solution to prevent 300 million premature deaths before 2050.
