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Harvard as Big Pharma

By Karolina Maciag, Shamsher S. Samra, and Sarah E. Sorscher, Nones

This month, the world’s second largest pharmaceutical company, GlaxoSmithKline, startled the drug industry and the public-health world by announcing a groundbreaking program intended to extend access to medicines for millions of people living in developing countries. GSK’s proposal is not a perfect solution: Millions of patients in middle-income countries, such as India and Brazil, will be left out of the deal. HIV research is also excluded from parts of the program, and even at reduced prices GSK products may remain out of reach for most patients in Least Developed Countries. Nevertheless, the announcement represents a remarkable willingness by a pharmaceutical company to change the way it does business in the developing world.

The plan, announced by CEO Andrew Witty on February 13 in a speech delivered at Harvard Medical School, would limit prices in the 50 least developed countries and give back a portion of the profits gained in these countries toward programs to expand their health-care capacity. More surprisingly, GSK also announced that it would allow outside researchers access to some of its patented medical technologies in an effort to facilitate more research aimed at so-called “neglected diseases,” or diseases that currently suffer from a severe lack of research funding.

Why can’t Harvard act more like “Big Pharma”? Ordinarily, it would seem strange to push Harvard to follow the lead of a for-profit corporation like GSK. The influence of pharmaceutical companies at universities is a controversial topic. We are often rightly cautioned that becoming too closely tied with industry may lead us to lose sight of our public interest mission. Yet when a major pharmaceutical company takes the lead in promoting access to medicines in developing countries, following Big Pharma would bring us more in line with our own core values as an educational nonprofit.

As a research center, we carry out an important role in developing innovative health technologies that can have an enormous potential impact around the globe. Inventions produced today in Harvard laboratories may lead to revolutionary new treatments, not just for neglected diseases, but for conditions such as AIDS, heart disease, and cancer, which are problems for developing and developed countries alike. Publicly funded research, carried out at institutions like Harvard, produces key inputs to the drug development pipeline: In the past century, 15 out of the 21 most important therapeutic drugs were developed with public funds.

In spite of their important role in producing new drugs, universities have taken a back seat to pharmaceutical companies in determining the policy agenda for access to medicines. Patentable technologies created in universities are typically licensed to pharmaceutical companies to facilitate the development of useful, marketable end products. In addition to providing product development, these partnerships also frequently guarantee that the institution and the researcher will share in the profits through royalties. Yet, too often, the agreements used to create these partnerships contain no provisions preserving the rights of universities to grant access to the finished products. This means that, in most cases, health technologies created in Harvard labs will be priced out of reach for millions of people in developing countries. It also means that researchers wishing to build on Harvard’s work may be prevented from studying and improving upon the ideas forged by Harvard faculty.

There are better ways for Harvard to work with industry. Yale made headlines in 2001 when it partnered with Bristol-Myers Squibb to jointly announce that they would permit the sale of low-priced generic drugs in South Africa, which led to a 96-percent reduction in the price of one first-line HIV treatment. More recently, the University of British Columbia has formalized a policy that will incorporate global access wherever possible into agreements with industry. These licensing policies for global access cost a negligible amount because markets in developing countries generate so little revenue. The benefits of these policies are significant: potentially life-saving interventions for millions of patients.

Global access licensing is not a burden on industry relations, and it is appealing for donors seeking to fund university research. For example, in the year following UBC’s implementation of its global access policy in 2007, UBC increased the number of new technologies licensed, industry funding remained steady, and research funding from all sources, including government and non-profit, increased by over 15 percent.

At Harvard, we have not yet developed a public and transparent global access policy, and our licensing agreements remain hit-or-miss. While a few individual researchers, working collaboratively with the Harvard Office of Technology Development, occasionally make the news with access-savvy agreements, most of Harvard’s closed-door licensing deals do not include terms for global access. In place of this patchwork approach, Harvard has the potential to implement a broad, forward-looking, and relatively cost-neutral licensing policy that would ensure appropriate access measures for the technology we create.

GSK has shown that industry is willing to re-envision the way it does business in developing countries. Instead of lagging behind, universities should be taking the lead in promoting policies in line with our public-interest mission. GSK’s announcement comes as a wake-up call for corporations engaging in medical research to recognize our responsibility to patients and the public. It presents a challenge to the entire Harvard community, including faculty, administrators, overseers, technology development officers, and students, to build a better access policy that will allow us to meet and surpass Big Pharma in the arena of good global citizenship.

Karolina Maciag ’04 is an MD/PhD candidate at Harvard Medical School, Shamsher S. Samra is an MD candidate at Harvard Medical School, and Sarah E. Sorscher is a JD/MPH candidate at Harvard Law School and Harvard School of Public Health.

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