Access to Medicines

August 17, 2010

Universities Allied for Essential Medicines

Presentation for Universidade de SÃO

PAULO - USP

A Role for Our Universities

• 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

Why Access to Medicines?

In perspective…

Real People; Real Lives

• 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.

A Fatal Imbalance.

• 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

Medicines unaffordable.C

o

s

t

• 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

Basic notions on patents.C

o

s

t

• 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.

C

• 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”

HIV/AIDS in Brazil in 1990s.

.

Co

• World Trade Organisation officially began work 1 January 1995

• Included an agreement on intellectual property rights (Trade-Related Intellectual Property Rights)

• TRIPs provides a timeline within which all WTO members are obliged to allow product patents on pharmaceuticals

• Transitional periods for developing countries (2005), least developed countries – LDCs (2016)

• Includes exceptions to protect the public interest (public health)

Enter TRIPS….

.

Co

I

m

p

a

c

t

o

f

t

r

a

• 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.

Impact of TRIPS on access to medicines

.

.

Co

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.

Our Ask

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.

Uuniversities Allied for Essential Medicines: Our Vision

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

Universities Allied for Essential Medicines

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

o

s

t

• US (50)

• Canada (11)

• UK (14)

• Germany (7)

• Norway(1)

• Norway

• Australia (2)

New chapters in Global South

University of Lagos, Nigeria

National University of Singapore

National University of Rwanda

Makarere University, Uganda

Weill-Bugando University

College of Health Sciences,

Tanzania

Institute of Medicine, Nepal

And we hope now Brazil!

UAEM Member Universities

• 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

Why act?

Consensus Statement

Seed signatories:

Paul Farmer, Presley Professor of Medical Anthropology, Harvard University

John Sulston, Nobel Laureate in MedicineEdwin Cameron, Justice, South African Supreme Court of Appeal

Bernard Pecoul, Executive Director, Drugs for Neglected Diseases Initiative

Jonathan Quick

Former Director of Essential Drugs and Medicines Policy at the WHO

President and CEO of Management Sciences for Health

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

I support “the adoption of humanitarian

licensing policies that ensure medications

developed with U.S. taxpayer dollars are

available off-patent in developing

countries.”

Obama-Biden Plan to Combat HIV/AIDS

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

Statement of Principles and Strategies for the Equitable

dissemination of Medical Technologies

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.

Technology Transfer at Sao Paolo

Discovery at Johns HopkinsExamples of exciting (patented)

discoveries at USP

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‐AMINE 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.

Discovery at Johns HopkinsExamples of medical patents at USP

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

• 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.

What can USP do for Access to Medicines?

$1600

$55

96%

Global Access Licensing Impact

Visit

• www.essentialmedicine.org

Want to know more?