December 1, 2003

Acting on principle

Nick Menzies is an MPH student in international health.

I come from New Zealand, a small developed country that feels itself to be a comfortable distance away from most of the world’s 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 all.

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 social justice.

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.