Katherine L. Record (photo below) is a Senior Fellow at Harvard Law School’s Center for Health Law & Policy Innovation.
The US is pushing its patent laws on trade partners, forcing them to adopt the most robust and longest monopoly rights in the world. The result is a move away from the World Trade Organization’s safeguards against prohibitive pricing of lifesaving drugs in low-income nations, deferring any hope of an “AIDS-free generation.”
In just two weeks, the International AIDS Society (IAS) convenes in Washington, DC, bringing HIV professionals from around the world to our nation’s capital. New developments in the field will surely spur lively meetings – from vaccines to cures to oral prophylactics. Even standard antiretroviral treatment (ART) is stirring new excitement; it alone slows the spread of HIV, allowing providers to curb transmission just by treating patients. The fight against AIDS is now at a “turning point” – science is closer than ever to transitioning HIV from a deadly to chronic disease and, for the first time, curbing the epidemic.
Yet test-tube discoveries are not immediately relevant to people living with or at risk for HIV. The real question for the IAS this summer is practical rather than academic: can scientific breakthroughs be applied in the field?
No convention could be better placed to address this issue. The District is a microcosm of the global picture of HIV/AIDS; the conference convenes directly between two worlds. To the east sits a neighborhood scarred by a higher prevalence of HIV than most nations, as this Global Post series has aptly reported. Due west are some of the most expensive shops and homes in the world – where the cost of a patient’s ART is nominal compared to the cost of rent, parking spaces, tuition, and socializing.
Barriers to treatment
Yet most importantly, for the IAS, is the proximity of the Hill, where lawmakers and the judiciary stand between the science and the epidemic, determining when progress in the lab will become progress in the field. The walls they build between treatment and patients should be the primary concern of conference attendees.
Treatment-as-prevention works by suppressing viral levels; when infection does not progress, the likelihood of transmission falls by nearly 96 percent, even in the presence of unprotected sex or needle sharing. Scaling up this approach to prevention means diagnosing patients earlier and enrolling and retaining them in uninterrupted care. This requires point-of-care testing (lab-free diagnostics), drugs that survive without refrigeration, simpler treatment regimens with manageable side effects, and access to providers and services that support treatment adherence.
The difficulties with patents
The pharmaceutical industry has developed treatments that work in nations with purchasing power, but not where market forces have little sway. Many factors limit access to what individuals living with HIV need, but most alarming are the increasingly lengthy and robust patents that extend anticompetitive pricing periods, making it difficult for donors or public assistance programs to cover the cost of everyone in need.
These are typical market failures, around which countries work all the time (e.g., with publicly funded research or compulsory licenses). Yet within the US, legislators and the judiciary (interpreting the Patent Act), have recently failed to make any significant progress when it comes to HIV.
For instance, the US is resisting proposals to spur development of affordable and accessible treatment that would reduce transmission among low-income populations, where incidence of HIV is still increasing at a disproportionate rate. It opposes binding commitment to a global research and development fund, even though, as taxpayers, we shoulder the greatest burden of the cost of global ART. Moreover, the US Trade Representative (under the executive) resists a Senate bill that would create a “prize fund,” rewarding innovations with cash rather than patents, keeping drug prices low from the start.
US pushing patent laws, hurting AIDS fight
Worse still, the US is pushing its patent laws on trade partners, forcing them to adopt the most robust and longest monopoly rights in the world. Inserting our laws into trade agreements is a tactic we use to impose strong intellectual property protection around the world (i.e., stronger than required by international law).
This allows pharmaceutical companies to bypass the World Trade Organization’s safeguards against monopolies barring access to lifesaving drugs. For example, our trade negotiations include provisions requiring nations to grant 20-year patent extensions for non-efficacious alterations to drugs, such as changes in dosage or delivery form. Requiring low-income countries to extend monopoly pricing of ART by decades (when generic production is legal under international law) flies in the face of the Secretary of State’s vision of an AIDS-free generation.
High costs ahead for ‘second-line’ treatment
The consequences of these policies are grave. Worldwide, over 14 million HIV-positive individuals await treatment, including tens of thousands of Americans. The untreated get progressively ill, bringing them closer to death and creating higher risk of transmission every day. Initiating treatment is increasingly affordable, but about 10 percent of patients develop drug resistance each year, requiring access to new regimens, many of which are still under patent.
These “second-line” treatments cost our global HIV program (PEPFAR), twice as much as first-line options, but account for only 3 percent of the drugs it buys. In other words, although PEPFAR purchases 90 percent of its drugs from generic manufacturers, incommensurate spending on second-line branded regimens means that comprehensive treatment still demands more money and more affordable ART, neither of which US policy facilitates.
Where’s the hope?
In short, as the Obama administration tries to undo the economic and international damage it inherited, it is letting lapse the strongest contribution of the Bush administration: renewed hope in the fight against HIV. This might not be intentional, but we can do better.
Yes, in the midst of a global recession, the leaders of the free world must choose their battles. Congressional and executive concessions to the pharmaceutical industry may have been a small price to pay in exchange for industry support of the biggest expansion of healthcare coverage we have seen in over 40 years.
Yet while compromising on AIDS may be politically expedient in the United States, where HIV has become an infection of mostly the poor and vulnerable, in hindsight it will prove foolish. We now have the means to save lives and stop the spread of a disease that has gripped the world in fear and devastation for 30 years. IAS, remind President Obama he could be the one to take the lead.
Yes you can, Mr. President.
More from GlobalPost: AIDS: A Turning Point