Universities Allied for Essential Medicines December 1, 2007

Why We Are Here There is an access-to- medicines crisis in poor countries  According to the WHO, 10 million people die every year because they do not have access to medicines that already exist  90% of research resources are put towards only 10% of diseases  Current treatments are often inadequate 10%90% Proportion of World Disease Burden 60 0 Annual Disease Research Expenditures (USD Billions) * 1996 Report of The World Health Organization Ad Hoc Committee on Health Research The 90/10 Gap *

The Crisis Has Two Important Causes 1.Access Gap: Existing medicines are too expensive 2.Research & Innovation Gap: Too few resources are put toward neglected disease research and innovation is often cut off by IP considerations Neglected disease: Diseases affecting those in the developing world for which current treatments do not exist, are not adequate or not appropriate for the developing country setting.

UAEM ’ s Goal To get low-cost medicines to those in the developing world

The Basics of University Research & Licensing University researcher receives funding Overhead to schoolDirect funding of research Researcher makes discovery (e.g. molecule, method) Discovery is patented by university Tech transfer office markets discovery and licenses it to company Discovery becomes product

UAEM’s Roots Began in 2001 at Yale with students working with MSF to obtain d4T at low-cost for patients in South Africa Successful campaign led to thirty-fold drop in price of d4T in South Africa In 1999, $40M out of $46.12M in Yale royalties came from d4t, almost none of it from developing countries No associated loss of royalty income for Yale

UAEM ’ s Short-Term Goal Instead of fighting the same fight over and over, we ’ re working for systematic change University policies have a real human cost. They currently harm Access and Innovation. Working together, we can get universities to bring policies in line with the Philadelphia Consensus Statement planks:  Promoting equal access to research  Promoting research and development for neglected diseases  Measuring research success according to effect on global public health

Promoting Equal Access to Research When university-related/publicly funded IP is needed for development of a health-related end product, universities should ensure access by:  Mandatory humanitarian or sublicensing terms in licenses  Participation in patent pools  Considering nonpatenting  Developing a case-by-case global access strategy This will:  Ensure end-products are available at the lowest possible cost to those in the developing world  Encourage generic competition, further lowering costs

Promoting Research and Development for Neglected Diseases In addition to increasing the resources for neglected disease research, universities should:  Compile and share compound libraries  Create comprehensive curricula for students in the area of neglected diseases  Make all publicly funded published research freely available without delay  Licenses on patents produced with publicly funding should reserve the right to perform further research  Create North-South partnerships and technology transfer to amplify the resources of all universities  Take a differential level of overhead for ND research

Measuring Research Success by Effect on Global Health Universities must change how they measure the success of their research by:  Examining ways tenure policies affect research and patenting approaches  Adopting metrics to measure the success of their research based primarily on improvement to human lives Currently the universities rely heavily on monetary considerations based on royalties earned

The Philadelphia Consensus Statement Adopted by UAEM in November 2006 Initial signatories included:  Paul Farmer  Jeffrey Sachs  Victoria Hale (One World Health)  Five Nobel Laureates in Science and Medicine  Former deans of public health at Yale and at Harvard  2 former editors of the New England Journal of Medicine  Patients groups from Thailand, India and South Africa  And many others …

Examining the Problem… There exists an access-to-medicines crisis in poor countries ACCESS GAPRESEARCH & INNOVATION GAP Universities can help address both aspects of the problem Licensing Provisions/IP Management Measures Progressive Tech Transfer Metrics Neglected-Disease Research Policy Proposals

… and Solutions Persuading universities to adopt these policy changes requires: STRONG CAMPUS CAMPAIGNS UNITED, COHERENT INTERNATIONAL CAMPAIGN

Why Focus on Universities? University research is heavily funded by taxpayers Universities are committed to creating and disseminating knowledge for the public good Students are ideally placed to influence their universities Reasoned argument rather than politics and lobbying can influence decision making Universities are important innovators for new technologies (e.g. vaccines and HIV/AIDS drugs)

Universities and HIV/AIDS Drugs The share of new drug applications with academic patents is increasing over time Approximately 25% of all FDA-classified “[d]rugs used in the treatment of HIV infections” include a university or hospital-held patent on the Orange Book (35.7% for ). HIV/AIDS drugs with academic patents: Emtriva, Videx, Atripla, Truvada, Fuzeon, Videx EC, Zerit, HIVID

Universities and HIV/AIDS Drugs Generic competition is THE most important factor in lowering the price of HIV/AIDS drugs In last 6 years, generic competition has lowered the price of HIV/AIDS drugs from $15,000 to $99 per patient-year

Universities and HIV/AIDS Drugs UAEM ’ s policies encourage Access (generic competition) + Innovation (opening up research avenues)

UAEM Activities Policy development (e.g. EAL, Access metrics) Philadelphia Consensus Statement S 4040: Make funding contingent on access provisions ‘08 Stop AIDS Platform: Portion of platform devoted to humanitarian licensing WHO IGWG: Lobbying for inclusion of PCS planks in global health strategy Drug specific campaigns (e.g. Zemplar, HPV vaccine) Individual Chapter Campaigns

From Inconceivable to Inevitable Stanford White Paper  Resulted from a meeting of AAMC and top research universities regarding the most pressing technology transfer issues; released March 2007 Key Points  Point 1: “Universities should reserve the right to practice licensed inventions, and to allow other nonprofit and governmental organizations to do so”  Point 9: “Consider including provisions that address unmet needs, such as those of neglected patient populations or geographic areas, giving particular attention to improved therapeutics, diagnostics and agricultural technologies for the developing world”

From Inconceivable to Inevitable More From Point Nine:  “Universities have a social compact with society. As educational and research institutions, it is our responsibility to generate and transmit knowledge, both to our students and the wider society.”  “There is an increased awareness that responsible licensing includes consideration of the needs of people in developing countries and members of other underserved populations.”

Stanford whitepaper signatories AAMC CIT Cornell Duke Harvard Michigan MIT Stanford Univ The Assoc of Univ Technology Managers (AUTM) U Texas Medical Branch UNC Univ of British Columbia Univ of California Univ of Illinois Univ of Washington Univ Wisconsin Alumni Research Foundation Vanderbilt Yale

2008 Meeting of SROs Meeting of University Senior Research Officers:  Small group of top research institutions in the US and Canada  The group of invited universities is likely to grow  Very early in the planning process  Meeting will focus on the three planks of the PCS

But the Fight Doesn ’ t End There … Capacity building  Trade-Related Aspects of Intellectual Property Rights (TRIPS) and TRIPS-Plus  Bayh-Dole North-South partnerships International fora

Take Action University policies have a real human cost. We need a united, coherent international campaign to make change.

What You Can Do Sign onto the Philadelphia Consensus Statement ( Find out about your school ’ s policies Learn about the issues Start a campaign on your campus to ensure your university is positively impacting global health

Thank you.