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 D

isease

R

ese

arc

h E

xpendit

ure

s (U

SD

Bill

ions)

* 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

1. 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:

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

AAMCCIT  Cornell   Duke Harvard   Michigan   MIT  Stanford Univ  The Assoc of Univ Technology Managers (AUTM)

U Texas Medical Branch UNCUniv of British ColumbiaUniv of California   Univ of Illinois Univ of WashingtonUniv Wisconsin Alumni Research Foundation   VanderbiltYale  

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 buildingTrade-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