Universities Allied for Essential MedicinesUniversity of Florida

The Role of Universities in Essential Medicine

“The right to life includes the right to health and access to treatment.”

Articles 1&25, Universal Declaration of Human Rights, 1948.

Montreal Statement on the Human Right to Essential Medicines. www.accessmeds.org

The Problem• 1/3 of the world lacks access to essential medicines1

• Essential Medicines are “those that satisfy the priority health care needs of the population”2

• “It is estimated that by improving access to existing essential medicines and vaccines, about 10 million lives per year could be saved.” 3

1. Medecins Sans Frontieres. http://www.accessmed-msf.org/campaign/faq.shtm2. World Health Organization. http://www.who.int/medicines/services/essmedicines_def/en/3. World Health Organization. Equitable access to essential medicines: a framework for collective action. Geneva: 2004.

Access Gap

Ten million people die needlessly each year because they do not have access to existing medicines and vaccines

90% of the world’s Research & Development costs are spent addressing 10% of the global disease burden.

Research Gap

Source: IMS Health, 2002

The World Market

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Three Gaps to Access

Pecoul, PLoS Med. 2004

“The Scientist’s Story”

NYTimes Editorial: March 19, 2001 By William Prusoff.

“I once helped create a drug that could enable millions of people to lead better and longer lives…More recently, it became apparent that the drug Dr. Lin and I had developed was not reaching millions of desperately suffering people because they lacked the money to purchase it.”

Questions?

“ What role do universities play?”

• Universities’ role increasing as an important part U.S. R&D

U.S. universities are responsible for more than 50% of the country’s basic research science

• Growth in patenting and commercialization

1970 to 2001, ten-fold increase in number of U.S. patents issued annually to U.S. academic institutions

AUTM data show significant increase in licensing activity

• Major players in the biopharmaceutical arena

40%-50% of the drug industry’s new products rely heavily upon academic research

How this applies to UF

• Bob is a researcher at UF

• Bob invents a vaccine for AIDS

• Bob (UF) patents his invention– Technically, Bob is working for UF– Therefore, Bob doesn’t own the patent, UF does

• UF now has an exclusive right to AIDS vaccine which it licenses to the highest bidder for production

Conventional Pipeline

IP Patent Drug patents

Licensing Agreement

LMI Countries

High-income countries

Exclusive MarketingRights

University Patents

Innovations at various universities…

• Yale: d4t (Zerit)• U Minn: abacavir (Ziagen)• Emory: 3TC (Epivir), emtricitabine (Emtriva)• Duke: t20 (Fuzeon)• Columbia: latanoprost (Xalatan); cotransformation patent• U of Washington: Hep B Vaccine• Michigan State: Cysplatin and Carboplatin• Others with key university input: Epogen, Erbitux,

Prilosec, streptomycin, penicillin, insulin

So, what is UAEM doing?

UAEM Goals

• Student body awareness of the access to medicines gap

• Educate members about the issue and ways we can help through speakers and events

• Encourage UF to look for proactive solutions the university can implement

Allies @ UF

Robert Hatch, M.D., MPHAssociate Professor Department of Community Health and Family Medicine

Marta Wayne, Ph.D.Assistant professor of zoology

Mary Ann Burg, Ph.D., L.C.S.W.Director of UF’s Women’s Health Research Center

Faculty Senate Member

Danaya Wright, J.D., Ph.D. Law Professor

Incoming Faculty Senate President

Get Involved!

• Through classes – many have international/research focus

• Through research – check out the undergraduate research database or browse faculty webpages

• Through organizations – UAEM among a host of others

Questions?

Case StudyYale: the d4T story

In 2001, Yale students protested their university’s refusal to yield its patent rights to the HIV drug d4T, or Stavudine, in Africa.

In Africa, an estimated 25 million people are infected with the HIV virus.

This quickly snowballed into a battle over the place of university research in modern medicine.

D4T, was discovered by Yale pharmacology professor and licensed exclusively to drug giant Bristol-Myers Squibb Co.

Yale administrators argued Yale had already ceded its licensing rights to Bristol-Myers, but acted quickly to push the company to allow generic drug makers to sell low-cost versions of the drug

Impact of Generic Competition: Uganda

Implications

For South Africa• Rapid, thirty-fold reduction in the price of d4t in

South Africa (from more than $1600 to $55 per patient per year)

• August 2003, Aspen began selling generic d4t in South Africa for up to 40% less than the reduced BMS price

• The national ARV program being rolled out in South Africa will rely upon generic versions of d4t

For Yale• No loss of income associated• Subsequent major Pfizer investment

Universities have an opportunity and a responsibility

dissemination of knowledgepublic health university innovation

Ball is in our court

“As a large research university, the University of Florida has a

responsibility to improve global access to public health goods they develop.”

“Biomedical knowledge and achievement is growing at a tremendous pace, but is unmatched by ethical thinking about how to apply the results equitably, humanely and wisely. The universities are forgetting their role as guardians of human wisdom, and instead are selling out to the highest bidders. UAEM has created consensus. Now it is time for the policy makers to act."

Sir John Sulston, Nobel Laureate in Medicine