I come from New Zealand, a small developed country
that feels itself to be a comfortable distance away from most of
major problems. Yet even so distant, the threat of HIV is commanding
increasingly more concern. Working in a dental hospital in my home
town of Dunedin, our staff training frequently focused on how to
treat patients with HIV infection.
So it was a great privilege to come and study at Emory at the start of this semester,
a University that has made some of the great advances in treating HIV. Re-searchers
here were central in the development of the antiviral Lamivudine (otherwise known
as 3TC), one of the groundbreaking drugs that have changed the course of HIV
disease over the past 10 years. With the aid of these drugs, infection now can
be dealt with as a controllable chronic infection, with strict adherence to treatment
instructions allowing the possibility of a future that, although uncertain, is
not damned by the sure deterioration that previously was the rule.
The importance of Emory in the fight against HIV has not stopped with 3TC. Researchers
led by Raymond Schinazi and Dennis Liotta are working on a drug called Reverset,
which has shown tremendous potential, and the Emory Vaccine Center houses some
of this country’s leading work in HIV vaccine development.
Of course, the efforts of large pharmaceutical companies like Glaxo Wellcome
and Bristol-Myers Squibb also have been essential. Their investment has taken
promising yet unproven medications through the stringent clinical trials required
by FDA regulators and made the drugs available to prescribing physicians.
For newly developed HIV drugs, the transfer of intellectual property from universities
to drug companies is governed by the Bayh-Dole Act of 1980. This allows university
research to be patented and allows for licenses to use that research to be sold
to drug companies. Since the development of a drug involves a lot of risk, ‘exclusive
licensing’ (only one company can use the patent) is the rule, putting the
company in a monopoly position when it comes to selling the drug. Able to charge
much more without the influence of competition, the company can reap a large
profit off one successful drug, making up for all the losses taken on other drugs
that never made it through the development process.
This collaboration has been successful, with the profit derived from drug sales
providing strong financial incentives for research and innovation within both
universities and drug companies, as well as ensuring the speedy and effective
transition of new developments from the laboratory to the medical clinic.
Yet the benefits of this research have not been accessible to all. Although
HAART (Highly Active Anti-Retroviral Therapy), the most recent advance in HIV
medication, is quickly becoming the standard treatment in developed countries
such as the United States or New Zealand, the huge majority of HIV-infected
people in this world are denied the possibility of getting these drugs. They
live in developing countries, where the current high price of HIV medication
contrasts starkly with low average yearly incomes. For these people, the new
medications are not just an expensive option—they are not an option at
This problem is most severe in Africa, where the World Health Organization
estimates that of the 4.1 million who would benefit from HIV medications, only
one out of every 100 is able to get them. The suffering and premature death
that results is staggering and is only set to balloon as the ever-increasing
cohort of HIV carriers (now standing at more than 30 million) progress through
the asymptomatic phase of the disease and begin to experience the infections,
tumors and general deterioration that characterize full-blown AIDS. The developed
world’s ability to provide relief to these
people, and its failure to do so through the protection of drug patents, bears
the same baleful ethical ramifications as if these people had been killed by
our active intervention.
Patent law, although occasionally defended as the natural right of the individual
over the product of his or her intellect, finds its primary justification in
the benefits it confers to society through providing incentives to develop and
propagate useful ideas and products. Thus it is only a worthwhile institution
to uphold when society gains out of the deal. It has been argued that this no
longer holds true with regard to the protection of essential drug patents in
developing countries, and pressure has been mounting to ignore patent rights
in these situations and allow the production of generic drugs.
The large international pharmaceutical companies that hold exclusive licenses
to many essential drugs have defended their rights vigorously, through both
legal and political means. Criticism of their actions by social commentators
has been equally vigorous.
Yet to criticize drug companies for acting in a profit-seeking manner is akin
to yelling at a rock for rolling down a hill: rocks—and companies—respond
to the incentives presented to them. Even though many companies express the
desire to do good (and act on it when they can), their fundamental incentive
is to make profit, and they cannot be expected to act otherwise. The criticism
is based on notions of social justice, and businesses are poor tools for achieving
So why is Emory important? Unlike businesses, universities do consider social
justice to be one of their fundamental objectives. Emory’s mission statement
makes this clear, saying that the University should act “through the quest
for new knowledge and public service, to improve human well-being,” as
well as imbuing scholarship with “a global perspective on the human condition.”
The groundbreaking nature of local drug research already has been mentioned,
and this puts Emory in a position to act on these humanitarian ideals through
the licensing agreements it makes with drug companies. A recently formed student
group of which I am a member, Universities Allied for Access to Essential Medicines
(UAAEM), has come up with a number of possibilities for this, such as not to
patent (or to patent nonexclusively) in poor countries. Given that it would be
the university which takes out patents in other countries (at the behest of the
drug companies), Emory and its fellow research universities have a lot of influence
over this issue.
It has been suggested that this would interfere with the incentives for drug
companies to develop the drugs and they would choose simply not to do so. Yet
despite the fact that most people who need these drugs live in poor countries,
only a small fraction (around 6 percent) of actual drug sales occur there, so
the market share that drug companies will be missing out on is similarly small.
Although this 6 percent is large enough to make drug companies balk at the idea
of making this decision on their own, imposing it on them will not substantively
change their incentives: HIV drugs still will be good earners.
Our group is proposing this be done through a change to the University’s
Technology Transfer Policy, which guides how licenses for drug patents are
sold to companies. Preliminary discussions have been positive, and in a recent
meeting President Jim Wagner expressed enthusiasm to make this proposal work.
Although other universities have successfully changed
their licensing arrangements for individual drugs, Emory would
be the first to consider these issues as a matter of policy, and
through doing so would demonstrate how the general ideals that
universities hold about improving human well-being can be translated
into real action.