Access to Medicines
A Role for Our Universities
August 17, 2010
Universities Allied for Essential Medicines
Presentation for Universidade de SÃO
PAULO - USP

Why Access to Medicines?
• 2 billion lack access to life saving drugs.
• Ten million people die needlessly each year because
they lack access to medicines: 1 in 3 have no access to
medicines, rising to 1 in 2 in Sub Saharan Africa
• Over 90% of these people live in developing countries
and have to cover up to 90% of treatment costs
• Essential drugs are either unaffordable, unavailable or
inappropriate

In perspective…

Real People; Real Lives

A Fatal Imbalance
• Over the past thirty years, global health has transformed at an
unprecedented rate, with life expectancy increasing at an
average of four months every year in developed countries.
• However, with few exceptions, people living in developing
countries have not benefited from this revolution.
• Millions continue to die from preventable and treatable
diseases, such as HIV/AIDS, malaria and tuberculosis; and
many tropical diseases have been all but forgotten.
.

Medicines unaffordable
• Cost of medicines is the main barrier to accessing essential
medicines
• Pharmaceutical patenting in developing countries is the most
important factor which leads to an increase in the price of
medicines
C .
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s

Basic notions on patents
• Patents confer a 20-year monopoly on a medicine
product/process/formulation
• International patents do not exist – patents are granted
nationally or regionally
• Drug patents allow their owners to exclude others from using
or producing the drug until patent expiration (usually 20 years
form the date patent is filed)
• By excluding generic competition, patents keep prices high
C .
o
s

HIV/AIDS
• 33.2 million people living with AIDS
• 2.1 million of these are children
• 2007 – 2.5 million new infections and 2.1 million AIDS-related
deaths
• Only 31% of those who needed ARV treatment had access to it.
(WHO/UNAIDS/UNICEF 2007)
• 6.5 million people urgently in need of treatment but because of
high prices only 1.3 million can afford treatment.
• Nearly 80% of the 3 million who die each year from AIDS had no
access to treatment
Information quoted by Renata Reis, Marcela Foçaça Vieira and Gabriela Chaves in .
“Access to Medicines and Intellectual Property in Brazil: A Civil Society Experience”
in Intellectual Property Rights and Access to ARV Medicines: Civil Society
Resistance in the Global South ABIA. 2009.

HIV/AIDS in Brazil in 1990s
• Implementation of universal access to ARV produced some
important results : 1997 – 2004 saw a 40% reduction in mortality
and 70% reduction in morbidity.
• 1993 – 2003, average life expectancy of AIDS patient rose by 5
years; reduction of 80% in hospitalizations (saving $2.3 billion)
• How?
- work of public health movement inputting into the reform of constitution in
1988, collaboration between state and PLWHA, creation of National AIDS
Policy, creation of ABIA and GAPA leading to prevention campaigns and
growing solidarity movements/role of civil society, legal developments
especially Sarney Law which improved structure for purchasing medicines
- but also largely due to ability to produce ARV medicines locally at lower cost
.
From Renata Reis, Marcela Foçaça Vieira and Gabriela Chaves. 2009. “Access to
.
Medicines and Intellectual Property in Brazil: A Civil Society Experience”

r
Enter TRIPS… t
f
• World Trade Organisation officially began work 1 January
o
1995
• Included an agreement on intellectual property rights (Trade-
Related Intellectual Property Rights)
t
• TRIPs provides a timeline within which all WTO members are
obliged to allow product patents on pharmaceuticals
c
• Transitional periods for developing countries (2005), least
a
developed countries – LDCs (2016)
• Includes exceptions to protect the public interest (public
p
health) m
I .
.

Impact of TRIPS on access to
medicines
• Before TRIPs, many developing countries (such as Brazil) did not allow
product patents on pharmaceuticals.
• Conscious policy decision that benefits of low cost access would
outweigh potential negative impact that lack of patents would have on
R&D.
• TRIPs overturned this domestic public health policy making and
countries are compelled to allow product patents in pharmaceuticals.
• In Brazil these international agreements led to an overhaul of the
existing legal regime which undermined the policy of universal access
• Competition on manufacture of pharmaceuticals is only possible
.
through use of TRIPs exceptions/flexibilities by developing countries.
• Implementation of TRIPS has rapidly eroded access to affordable .
medicines internationally especially since 2005 when India introduced
pharmaceutical patents.

Where do universities fit in?
• Of the 21 drugs with the greatest therapeutic impact, 15 were
developed using publically funded research, most of which occurs at
universities. [The benefits of medical research and the role of the
NIH. United States Joint Economic Committee, 2000]
• Every single vaccine brought to market in the past 25 years has a
contribution from university research. [Ashley Stevens, President of
AUTM; Access to Medicines panel discussion, Yale University March
25, 2008]
• More than 1/3 of HIV drugs introduced between 2002 and 2006
involve a university patent.
• Universities are increasingly seen by pharmaceutical companies as
the best (and cheapest) place to carry out discovery. Interesting data
on the increased importance of licensing agreements to pharma
sales www.pharmafield.co.uk/article.aspx?issueID=40&
articleID=315 predicts that 26% of pharma sales by 2009 will come
from licensing rather than in house R&D.

Where do universities fit in?
• Though already significant role in drug R&D, the importance of
universities in pharmaceutical discovery is projected to continue
increasing with the growing importance of biologic drugs (e.g. cellular
products that have the potential for achieving an exquisite target-
specificity that is difficult or impossible to attain with many chemically-
based drugs).
• The vast majority of currently available biologic drugs were
developed with significant university participation: Epogen (University
of Washington), Insulin (University of Toronto), human growth
hormone (UC Berkley), Remicade (NYU), Avastin (USC).
• Universities have a critical role to play in the future of pharmaceutical
innovation, and the decisions being made now regarding the
patenting and licensing policies surrounding publicly funded research
have important implications for the future of global public health.

Uuniversities Allied for Essential
Medicines:Ask Vision
Our Our
Universities and publicly funded research institutions will be part of
the solution to the access to medicines crisis by promoting medical
innovation in the public interest and ensuring that all people
regardless of income have access to essential medicines and other
health-related technologies.

Universities Allied for Essential Medicines
Our Mission:
As a private non-profit organization rooted in a movement of university
students, UAEM aims to
• promote access to medicines for people in developing countries by
changing norms and practices around university patenting and licensing
• ensure that university medical research meets the needs of the majority
of the world’s population
• empower students to respond to the access and innovation crisis

Yale and d4T
• In 2001, d4T costs $1,600/patient/year
– Doctors Without Borders (MSF) seeks Yale’s permission to
use generic d4t in South Africa
– Yale balks, claiming its “hands are tied” by licensee
– Students at Yale organize
– NY Times editorial written by discoverer William Prusoff
• March 24, 2001: Yale asks BMS to grant “patent
relief” and price cuts
• Generic competition drops the price of d4t in
South Africa 96% within a year, allowing Médecins
sans Frontières to scale-up HIV treatment
programs across Africa

Effects of Generic competition
C .
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s

UAEM Member Universities
• US (50) New chapters in Global South
• Canada (11) University of Lagos, Nigeria
• UK (14) National University of Singapore
• Germany (7) National University of Rwanda
• Norway(1) Makarere University, Uganda
• Norway Weill-Bugando University
• Australia (2) College of Health Sciences,
Tanzania
Institute of Medicine, Nepal
And we hope now Brazil!

Why act?
• Moral and ethical obligation
• Commitment to creating and disseminating
knowledge for the public good
• University research is heavily funded by taxpayers
• Maintain competitiveness in attracting talent
– Top research scientists and students drawn to
schools with demonstrated global public
commitment
• Global impact through institutional policies, not just
scholarship

Consensus Statement
Seed signatories:
Jonathan Quick
Former Director of Essential Drugs and Medicines Policy at the WHO
Paul Farmer, Presley Professor of Medical Anthropology, Harvard University
President and CEO of Management Sciences for Health
Edwin Cameron, Justice, South African Supreme Court of Appeal
John Sulston, Nobel Laureate in Medicine
Bernard Pecoul, Executive Director, Drugs for Neglected Diseases Initiative
Zackie Achmat, Founder and Chairman, Treatment Action Campaign

Universities Know They Need to Change
“Universities should strive to construct
licensing arrangements in ways that ensure
that these underprivileged populations have
low- or no-cost access to adequate
quantities of these medical innovations.”
White Paper “In the Public Interest”
AKA “The Stanford Nine Points”

World Health Organization
The Netherlands and Kenya, on behalf of the
WHO African member states, explicitly
recommended that UAEM’s policies be included in
the final WHO “Plan of Action” on IP and Health
(2007)
Endorsing countries included:
Algeria, Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde,
Central African Republic, Chad, Comoros, Congo, Côte d'Ivoire, Democratic
Republic of the Congo, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Ghana,
Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali,
Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, Sao Tome
and Principe, Senegal, Seychelles, Sierra Leone, South Africa, Swaziland, Togo,
Uganda, United Republic of Tanzania, Zambia, Zimbabwe

Obama-Biden Plan to Combat HIV/AIDS
I support “the adoption of humanitarian
licensing policies that ensure medications
developed with U.S. taxpayer dollars are
available off-patent in developing
countries.”

Statement of Principles and Strategies for the Equitable
dissemination of Medical Technologies
Signed by Harvard, Yale, Boston, Brown, Oregon and
Pennsylvania on 9 November 2009 “after campus student groups
pushed for policies to make new drugs available at low cost to
poor patients. The statement commits the schools to make
“vigorous efforts” to promote global access to drugs through
licensing strategies.” John Lauerman at Bloomberg.com
“We agree that it’s important that our intellectual property doesn’t
serve as a barrier -- and in some cases should be used as
leverage -- to help ensure that drugs, vaccines and other
technologies reach the developing world,” Maryanne Fenerjian,
Harvard’s director of technology-transfer policy

Technology Transfer at Sao Paolo
USP is a public university
Missão Agencia USP de inovação
Promover a utilização do conhecimento científico, tecnológico e
cultural produzido na Universidade de São Paulo em prol do
desenvolvimento sócio-econômico do Estado de São Paulo e do País.
Objetivos
Identificar, apoiar, promover, estimular e implementar parcerias com
os setores empresariais, governamentais e não governamentais na
busca de resultados para a sociedade.

Examples of exciting (patented)
Discovery at Johns USP
discoveries at Hopkins
http://www.patentes.usp.br/Catalogo/pdf/6.pdf last download 11 August 2010
PI0502172‐3TITLE: FORMULATION PROCESS OF INCLUSION COMPLEX
OF3‐(4‐BROMINE‐(1,1‐BYPHENYL)‐4‐IL)‐3‐(4‐BROMOFENIL)‐N,N‐DIMETHYL‐2‐PROPEN‐1‐A
MINE AND ß‐CYCLODEXTRIN AND TRYPANOCIDAL ACTIVITY, ANTI‐ LEISHMANIASIS AND
ANTI-MYCOBACTERIALACTIVITY.
PI0805492‐4: TITULO: SIGILO ‐ DESCRIÇÃO: TERAPIA PARA PREVENÇÃO E TRATAMENT DA
DOENÇA DE CHAGAS. TITLE: SECRET ‐ DESCRIPTION: PREVENTION THERAPY AND
TREATMENT OF CHAGAS DISEASE. RESUMO: SIGILO
PI0804314‐0: TITULO: SIGILO ‐ DESCRIÇÃO: FORMULAÇÃO FARMACÊUTICA E SEU USO,
PARA DOENÇA NEGLIGENCIADA. TITLE: SECRET ‐ DESCRIPTION: PHARMACEUTICAL
FORMULATION AND ITS USE FOR NEGLECTED DISEASE. RESUMO: SIGILO
PI0802164‐3: TITULO: SIGILO ‐ DESCRIÇÃO: PROCESSO DE PRODUÇÃO DE NANO
PARTÍCULAS PARA TRATAMENTO DE TUBERCULOSE POR MEIO DE AEROSSÓIS,
INALADORES E NEBULIZADORES. TITLE: SECRET ‐ DESCRIPTION: PRODUCTION
PROCESS OF NANOPARTICLES TO TREAT TUBERCULOSIS BY AEROSOL, INHALERS
AND NEBULIZERS. RESUMO: SIGILO.

Examples of medical patents at USP
Discovery at Johns Hopkins
http://www.patentes.usp.br/Catalogo/pdf/6.pdf last download 11 August 2010
PI0802285‐2: TITLE: SECRET ‐ DESCRIPTION: SYMBIOTIC FUNCTIONAL NURTURE PRODUCT
WITH REDUCED CALORY CONTENT AND ITS MANUFACTURING PROCESS.
PI0801094‐3: TITLE: SECRET ‐ DESCRIPTION: PREPARATION PROCESS OF MOLECULES TO
PRODUCE BIOPROSTHESIS.
PI0700698‐5: TITULO: USO DE BAIXAS DOSES DE DNA PLASMIDEAL NO CONTROLE DA
RESPOSTA IMUNE E VACINA PARA TRATAR DOENÇAS AUTO‐IMUNES, INFLAMATÓRIAS,
ALÉRGICAS E/OU INFECCIOSAS.TITLE: USE OF PLASMID DNA LOW DOSIS IN
CONTROLLING THE IMMUNE RESPONSE AND VACCINE TO TREAT SELF-IMMUNE,
INFLAMMATORY, ALLERGIC AND/OR INFECTIOUS DISEASES.
PI0705395‐9: TITULO: SISTEMA DE DETECÇÃO DE PARVOVÍRUS, ANTÍGENO
RECOMBINANTE, MÉTODO DE OBTENÇÃO DEANTÍGENOS E USO. TITLE: DETECTION
SYSTEM OF PARVOVIRUS, RECOMBINING ANTIGEN, ANTIGEN OBTAINMENT METHOD
AND USE.

Technology Transfer Statistics 2009

What can USP do for Access to
Medicines?
• Follow its mission - The mission of USP is “do
desenvolvimento sócio-econômico do Estado de São Paulo
e do País.” A Global Access Licensing Policy is an essential
step.
• Invest Ethically - Make sure the hard work and investment
of USP research pays off for the greatest number of people
and the people who need it most.
• Be part of the solution – a leader at the forefront not only of
innovation, but also of access for all.

Global Access Licensing Impact
$1600
96%
$55

Want to know more?
Visit
• www.essentialmedicine.org