Universities Allied for
Essential Medicines
December 1, 2007
Why We Are Here
 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
The 90/10 Gap *
Annual Disease Research
Expenditures (USD Billions)
• There is an access-tomedicines crisis in poor
countries
60
0
90%
10%
Proportion of World Disease
Burden
* 1996 Report of The World Health
Organization Ad Hoc Committee on Health
Research
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 school
Direct 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:





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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 GAP
RESEARCH & 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 2001-2006).
• 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
(www.essentialmedicine.org/cs)
• 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.
ethan.guillen@essentialmedicine.org
www.essentialmedicine.org