universities allied for essential medicines university of florida august 31, 2006 thanks to upenn...
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Universities Allied for Essential MedicinesUniversity of Florida
August 31, 2006Thanks to UPenn & Berkeley
to medicines
The Access ^ Gap
Key Global Diseases• AIDS
• Diabetes in Eastern Africa & India
• Heart disease in South & Southeast Asia
• Hepatitis in Eastern Europe & Russia
• Neglected diseases in Latin America and Africa
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.
Terminology• LMIs: Low- and middle-income countries
– World Bank designation based on gross national income (GNI) per capita• Low-income countries
– E.g. Haiti, Rwanda, Vietnam
• Middle-income countries– E.g. China, Brazil, Botswana
• High-income countries– E.g. Japan, USA, Israel
http://web.worldbank.org/WBSITE/EXTERNAL/DATASTATISTICS/0,,contentMDK:20421402~pagePK:64133150~piPK:64133175~theSitePK:239419,00.html
Source: IMS Health, 2002
The World Market
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Three Gaps to Access
Pecoul, PLoS Med. 2004
Yamey, Brit. Med. J. 2002
What is a neglected disease?
Molyneux et al., PLoS Med 2005
The landscape of R&D for neglected diseases
• Push and pull incentives– Push: direct funding or facilitation of research
and development (grants)– Pull: promise downstream rewards by
organizing a market for eventual end products (patents)
• Public-private partnerships (PPPs)– Virtual R&D management
Bridging the research gap
• ND research exemptions– Univ. gives research data to nonprofits for use
in researching NDs
• ND research promotion– Incentives for researchers, Univ. marketing
• Progressive technology transfer metrics– Money for university and impact on global
human welfare
Questions?
Gap 2: Development• Public Domain
– Belongs to no one/ everyone
– Can be freely used for any purpose (make, use, sell, modify, build upon)
– Creates a “commons” of knowledge and culture from which everyone can draw
• Intellectual property– Private rights create
incentives to research, create, develop, and market products
• What you give: description of invention, explain how it works, disclose how to make it
• What you get: set of exclusive rights for 20 years to prevent others from making, using, selling, offering to sell or importing a claimed invention
• Since your patent expires in twenty years, it encourages you to make your invention widely available to extract maximum profit before it enters the public domain
Basics of a Patent
“ 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
Increase in Patenting and Commercialization:
Bayh-Dole Act (1980)• Goal: • Increase technology transfer and utilization of
federally-funded research• What did it do?
• Universities given right to retain the property rights to inventions made under federal funding; exclusive licensing permitted
•Growth in Patenting (faster than other patenting in the United States)
•Surge in Licensing Activity
•Increase in Royalties from Licensing
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
Pricing and PatentsWhy Focus on Pricing?• Pharmaceutical purchasing is large economic
burden• Drugs comprise the largest share of
household expenditures in developing countries
World Health Organization. http://www.who.int/medicines/services/essmedicines_def/en/
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DevelopedCountries
DevelopingCountries
Percentage ofTotal HealthSpending onPharmaceuticals
Pricing and Patents• How do patents raise drug prices?
– Patents grant temporary monopolies on drug sales• Without competition, no incentive for price reduction
HMS, 2002
Pricing and PatentsWhy Focus on Pricing?
• When drugs are cheaper, more people can use them
• When people know that they can afford the treatment, they will get tested.– Rate of HIV testing rises when AIDS
treatments are more available*
*Castro A and Farmer P. Understanding and addressing AIDS-related stigma: from anthropological theory to clinical practice in Haiti. Am J Public Health. 2005 Jan;95(1):53-9.
Effects of Generics
MSF 2003
The Equitable Access License(EAL)
IP Patent Drug patents
Licensing Agreement
LMI Countries
High-income countries
Marketing
Generic Manufacturer(s)
LMIMarketingRights
Marketing
Exclusive
The Equitable Access License (EAL)
Why is it promising?– Simple– Requires no institutionalized oversight or enforcement– PR potential for Universities– Vast majority of pharmaceutical revenue unaffected
• Only 5-7% revenue from LMIs*• All of Africa accounts for just over 1%**
– No negative impact post-d4t
*Pharmaceutical Research and Manufacturers of America. Pharmaceutical Industry Profile 2005 – From Laboratory to Patient: Pathways to Biopharmaceutical Innovation. Washington, DC: 2005**Medicins Sans Frontieres. http://www.accessmed-msf.org/campaign/faq.shtm
UF’s Bottom Line
Potential BENEFIT to UF
– Possible financial benefits: small but significant revenue stream from its share of royalties for generic end products that would otherwise not be sold in poor countries
– Combining access-oriented licensing policies with an augmented neglected-disease research agenda can help UF aggressively position itself as a research center for foundation-sponsored partnerships.
– Intangible Benefits: UF can establish itself as a leader in defining the role universities can play in closing the global access gap.
Questions?
The Price Is Right
The case of Berkeley
• Berkeley’s Socially Responsible Licensing Initiative aims to: a) promote widespread availability of technology and healthcare in the developing world, b) share revenue with a contributor of the research and/or to give proper attribution to a source or collaborator, and c) stimulate additional investment by others to achieve these goals.
• "In the new reality we can have a double bottom line, we can have the financial bottom line, and we can have the societal-impact bottom line.” Carol Mimura
Berkeley – an example
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
ImplicationsFor 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
Estimated TB Incidence Rates, 2001
25 - 49
50 - 99
100 - 299
< 10
10 - 24
No estimate
per 100 000 pop
300 or more
Gap 3: Delivery
Lingering Problems• Limited resources of humanitarian
organizations
• Generic motivation is still profit
• Lack of existing infrastructure such as roads
• Political climate
• Other related problems such as food
Carter Center Video
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
FL Tech Transfer Conference
• Licensing difficulties of generic biologics; different federal regulatory paths
• Better World Project to increase innovation• Lack of existing infrastructure and cultural
barriers• How to lower the price of R&D
More at uaemuf.wordpress.com
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
Last Questions?
Upcoming Dates• Journal Club – September 14th
Every 2nd Thursday following
• Meeting – September 21st 1st and 3rd Thursdays of the month
• Elections – November 30th
http://uaemuf.wordpress.com/calendar/
See you there!