Advanced Global Access

The recent op-ed called “Harvard as Big Pharma,” published on Mar. 1, outlined good reasons for Harvard’s involvement with private pharmaceutical companies. It demonstrated a vital engagement with the national conversation about the best means to ensure global access—particularly in the developing world—to the fruits of medical research performed within the academic community. This was accompanied by a call to deliver essential medicines to the developing world at a symposium held at Harvard Law School this week. Harvard should maintain momentum in its quest for new therapies and new strategies aimed at their broad dissemination especially to those in greatest need.

Harvard and its students envision a world in which global access to new medicines is determined more by human need than by economic imperative. No potentially life-saving technology invented at Harvard should go undeveloped or remain inaccessible for want of creative thinking on our part. As a recipient of government funding for research, Harvard is committed to fulfill its responsibility of public service to advance our mission by means of a vigorous and effective technology transfer program. In heading this program at Harvard’s Office of Technology Development, I have seen OTD become a leader in crafting and, more important, implementing creative strategies to effectively address these issues.

Harvard has endorsed the sentiments of the Mar. 1 editorial in both its public statements and actualized them in many agreements with industry. In one policy example, OTD co-authored a position paper entitled “In the Public Interest: Points to Consider in Drafting Technology Licenses” with colleagues at several of Harvard’s peer institutions of higher education. It is an exhortation directed at the critical role that universities must play in serving the world’s most vulnerable populations. OTD also helped to develop a master agreement amongst all Massachusetts research institutions relating to the management of jointly owned intellectual property (IP) that contains specific language requiring its stewards to carefully consider its patenting and licensing strategy in order to enhance the availability of new medicines in the developing world.

Harvard’s objective to deliver socially beneficial outcomes to the public from discoveries made by its faculty is embodied in, and advanced by, OTD’s core mission. We actively foster innovation, identify appropriate industrial partners to develop new inventions made at Harvard, and negotiate license agreements that enable the translation of such inventions into new products in the hope of benefiting society. Every relevant invention made at Harvard is an opportunity to contribute to global health and well-being. We take very seriously our commitment to serve the public good.

In order to deliver the greatest benefit to at-risk populations in the developing world, OTD’s strategy focuses on two areas that act as force multipliers: infectious disease (the leading cause of preventable infant and child mortality in poor countries) and diagnostic technologies. A single dose of vaccine may confer upon its recipient a lifetime of immunity against a deadly infectious disease. A diagnostic test that can be adapted for use in a challenging field environment outside of the traditional “high-tech” clinical laboratory setting stands to deliver the greatest benefit in the developing world.

For such technologies, Harvard must retain the right to grant licenses directly to NGOs and not-for-profit organizations to practice Harvard’s patent rights to develop and manufacture products for humanitarian distribution in developing countries. Contrary to what was stated in the editorial on Mar. 1, the reservation of academic research rights is a non-negotiable term of every exclusive license granted by Harvard.

Moreover, Harvard’s agreements provide incentives whereby the obligation to make royalty payments to Harvard for licensed products that are distributed on a charitable or affordable basis are either significantly reduced or completely eliminated. Harvard actually exerts leverage on the licensee by imposing strict obligations with respect to the distribution of products to those in need, where the penalty for non-performance is a loss of license rights, and the imposition of mandatory sublicensing and other march-in provisions.

Another example of Harvard’s commitment to global health is the Technology Development Accelerator Fund. Launched in 2006, the TDAF provides (on a competitive basis) dedicated research support to Harvard faculty in order to perform key experiments that enable early stage inventions to achieve “proof-of-concept,” thereby increasing the probability that they can be licensed to industry for commercial development. To date, the TDAF has awarded close to $3 million to support applied research being performed by Harvard scientists.

Central to its mandate, the TDAF actively seeks out and solicits proposals from the faculty that have a direct bearing upon neglected diseases endemic to the developing world. For example, as a result of TDAF funding, a faculty member at the Harvard School of Public Health has been able to advance his efforts to develop new drugs against tuberculosis, a neglected disease that remains a major threat to public health.

Thus, Harvard has done more than merely take its cue from private industry. It has taken the lead in developing a new conceptual framework. It has spearheaded the implementation of innovative practices and agreements that serve the public interest and aims to ensure that even the world’s poorest and most disadvantaged will receive a tangible benefit from new inventions and discoveries arising from Harvard’s research enterprise—a fact of which I am, and the greater Harvard community should be, justifiably proud.


Isaac T. Kohlberg is a senior associate provost and the chief technology development officer of the Office of Technology Development.