IN THE LATE 1980s, while fear and prejudice stymied global progress against the AIDS pandemic, the National Institutes of Health (NIH) launched a publicly funded program to translate basic HIV research into lifesaving medicines.
One grant went to a team led by John Erickson at Abbott Laboratories, where, in his words, it “catalyzed the development of [Abbott’s] antiviral program” at a time when such efforts “were largely nonexistent in the pharmaceutical industry.” The government money “facilitated the research that led directly to the development” of ritonavir—one of the most important HIV medicines to date. Ritonavir, taken in combination with other HIV medicines, makes them more effective. It’s a key treatment for people who have developed resistance to first-line drugs.
In many countries Abbott patented ritonavir and numerous variations; one of Abbott’s patents for a combination product will not expire until 2026. Despite the public’s investment, Abbott aggressively asserts a high-priced monopoly around the world, charging many times what generics would cost. (In some of the few countries where ritonavir combinations are not patented—through Abbott’s inaction or the government’s refusal—a combination drug runs only about $450 per year.)
The biggest problem: Abbott’s patents and prices prevent economies of scale in generic drug production and donor purchasing, restricting the world’s ability to improve HIV treatment and prevention in countries from Vietnam to Colombia. What’s more, Abbott’s behavior discourages development of lifesaving combination therapies that bundle the drug with non-Abbott HIV medicines.
The U.S. government is the world’s leading funder of medical research—but, as with ritonavir, pharmaceutical companies typically gain exclusive rights to the medicines that result. Countless lives could be saved if such publicly funded inventions could be made available in low-cost generic form for humanitarian use in developing countries.
And indeed they could be. The U.S. government has rights under existing law to license patented medical inventions, if their research had federal sponsorship, to international organizations. For example, if the Obama administration chooses, it can make licenses for ritonavir available to the newly created nonprofit Medicines Patent Pool, the World Health Organization, and UNICEF. Generic competition could then reduce the global price. Exercising these rights would not authorize generic competition in wealthy countries or override Abbott’s patents; it would simply help meet humanitarian needs through a now-dormant government authority.
These federal rights are not new, but the U.S. has never exercised them. The Clinton and Bush administrations declined, citing companies’ monopoly expectations as important to encouraging drug research. This line of argument seems particularly strained when applied to medical inventions sparked by federal grants: Current U.S. policy amounts to public subsidies for private pharmaceutical monopolies.
In fact, in the case of ritonavir, exclusive patent licensing has most likely stifled combination drug development. A better explanation for government reluctance to use NIH medical licensing rights may be the political power of the pharmaceutical industry.
This fall, a coalition of nonprofit organizations, including Public Citizen, Knowledge Ecology International, Doctors Without Borders, Oxfam America, and many others, asked the administration to fulfill Obama’s pre-election pledge to “support the adoption of humanitarian licensing policies that ensure medications developed with U.S. taxpayer dollars are available off-patent in developing countries.”
The time is right for a change. Over the past 10 years, generic competition has spurred a revolution, reducing costs of the first HIV drugs by 99 percent and enabling 6 million people in low- and middle-income countries to access lifesaving medicine. Humanitarian licensing could produce a similar effect for patented second-line HIV drugs such as ritonavir, as well as for federally sponsored cancer treatments and more.
It will take a citizens’ movement to overcome the pharmaceutical industry’s influence. The co-signatories of the humanitarian licensing request comprise an unprecedented coalition and an important step toward a much stronger “global access to medicines” movement. Perhaps when we lead, our leaders will follow. n
Peter Maybarduk is Global Access to Medicines Program director at Public Citizen (citizen.org/access) in Washington, D.C.