Univ. must democratize access to key drugs

For five years, students at Yale and across the country have been calling on their universities to make the life-saving drugs discovered in campus laboratories available in the developing world. This weekend, a chorus of stentorian voices joined the cause.

On Friday, Sen. Patrick Leahy (D-Vt.) introduced legislation requiring all federally-funded research institutions, including Yale, to ensure the drugs they develop are supplied to poor countries at the lowest possible cost. Just two days later, Universities Allied for Essential Medicines released a consensus statement signed by health policy luminaries, calling on universities to take the same steps voluntarily. Signatories include Paul Farmer, whose paradigm-shifting treatment projects in Haiti were made famous in Mountains Beyond Mountains; Judge Edwin Cameron of the South African Supreme Court; and Jonathan Quick, former director of Essential Drugs and Medicines Policy at the World Health Organization. This list is only growing.

Each year an estimated 10 million people die from diseases that are treatable with existing drugs, according to the WHO. But these medicines instead sit on the shelves, priced far beyond the reach of many of the sick and dying.

This problem could be solved by giving generic drug companies the right to manufacture and distribute patented drugs in the developing world. Patents are temporary monopolies granted by the government to encourage innovation. But rewarding innovation need not always mean limiting access to the fruits of these discoveries — especially where millions of lives hang in the balance. Allowing the generic production of life-saving drugs for low-income countries harnesses the logic of the market, driving down drug prices in those countries so that more people can afford them.

At the same time, both Leahy’s bill and the UAEM consensus statement call for safeguards to ensure these cheaper drugs are not imported back into the United States or other lucrative markets. This combination of measures gets the incentives right: protecting the profits that drive pharmaceutical companies to pursue new drugs, while maximizing access to medicines developed right here.

As we have seen at Yale, America’s universities have a critical role to play in delivering affordable medicines to the sick worldwide. Like many premier research institutions, Yale holds patent rights to an ever-increasing number of compounds discovered by its scientists. In 2001, an unprecedented campaign by students, scientists, and the organization Medecins Sans Frontieres erupted over Yale’s patent on stavudine, a key HIV/AIDS drug.

Yale had licensed stavudine to Bristol-Myers Squibb, which marketed the drug for $1,600 per patient per year. Meanwhile, generics manufacturers promised to produce the same drug at a fraction of the price. MSF urged Yale to help increase access to this urgently needed drug. It was at this moment that MSF approached Yale, as the patent-holder, to help widen access to an urgently needed drug. Under pressure from students and researchers, Yale and Bristol-Myers Squibb agreed to permit the sale of generics in certain markets, lowering the price of stavudine throughout sub-Saharan Africa to $55 per patient per year — a 96 percent reduction. The stavudine campaign revealed the immediate, substantial price reductions that universities can secure for those who need their drugs the most.

But this was five years ago. The stavudine success was a moment of enormous importance for which Yale deserves much credit, but it also heralded an opportunity that remains unfulfilled without a wider commitment to equitable access. Today, missed chances with very real human costs continue to pile up. Last year, Emory University sold emtricitabine — a second-generation AIDS therapy — to the pharmaceutical company Gilead absent any provisions for access. Similarly, Yale has licensed 13 drug candidates for cancer, three for AIDS and one for Hepatitis B — all of which are currently in development. Stavudine proved that universities like Yale can wield substantial leverage in their negotiations with pharmaceutical companies. But these research institutions, including Yale, have failed to embrace a forward-looking policy that guarantees access.

Yale, again, has the opportunity to be a leader among its peer institutions, and to leave its footprint on an intellectual property regime responsive to human need. But students, faculty and alumni must demand this sense of responsibility from their university. In the fight for access to medicines, we stand at a unique pressure point: We belong to a community engaged in world-class innovation supported by strong ethical commitments. If one mission of a research university like Yale is to improve the human condition by developing powerful cures to disease, the University must take an interest in ensuring that its discoveries reach the sick and dying.

Yale should not need an act of Congress to revive its sense of public mission. But Leahy’s bill represents a growing consensus that universities themselves have failed to act on an issue uniquely within their power. We urge Yale to heed this call and to take the lead at another watershed moment, by leveraging its most innovative assets to save lives worldwide.

Patrick Toomey LAW ’08 is a second-year Yale law student. He is a member of Universities Allied for Essential Medicines. Sara Crager MED ’12 is a second-year M.D./Ph.D. candidate.

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