Panel 2 jorque beloqui

AIDS: NGO initiatives for the access to
treatment and intellectual property

•
Jorge A Beloqui
•
GIV (Grupo de Incentivo à Vida/ Group for Life Incentive)
•
5511-5084-0255 giv@giv.org.br
•
ABIA (Associação Brasileira Interdisciplinar de AIDS/ Brazilian
Interdisciplinary AIDS Association) 5521-2223-1040
•
RNP+
•
IME-USP
•
GTPI (Rebrip)

Jorge Beloqui, agosto
2010

(preventive or therapeutic) against the HIV
virus or Hepatitis C ? What are the current
access issues experienced by the HPV
vaccine?

•
Would they be available to everyone in the
world who needs them?
•
Or would there be the same access problems
that we experience with antiretrovirals?
•
In Brazil, should the Unified Health System
SUS) import these drugs from developed
nations paying the same price as them?
•
Would the manufacturing technology be
transferred to Brazil or other developing
nations?
2010

HPV Vaccine
•
Tested in Phase III in Brazilian women
•
Mass vaccination in Europe for young
women
•
In Brazil it is available in private clinics, not
through public services
•
Price: around 1000R$ (more than 500U$S)
•
Conclusion: Brazilian women participated in
the risk of the trial but not in the benefit of the
results

2010

Brazil and Patents (I)
•
There was no transferring of technology
•
Increased the amount of money spent in foreign
markets for the purchase of products patented in
Brazil
•
There are few Brazilian patents in demand. The
greater part comes from developed nations.
•
This caused the closure of several factories and
prevented the investment of new ones in Brazil

2010

PARALYZED AND UNIMPLEMENTED UNITS
INDUSTRIAL COMPLEX OF FINE CHEMISTRY
PERÍOD 89-99 (D. Barbosa)

Pharmaceutical Pharmo- Agro- Additives,
Type Intermediaries chemicals chemicals Aromatic TOTAL
and Dyes
Paralyzed 241 407 73 375 1.096

Not Implemented 208 110 10 27 355

TOTAL 449 517 83 402 1.451

2010

How can patents create a barrier
to access?
•
Because they establish a (temporary) monopoly,
which is often widened over time
•
This monopoly presents an opportunity to skyrocket
prices to unreasonable amounts
•
And thus diminishes access to treatment
•
This is the concern of NGOs working in the HIV/AIDS
sector, as well as that of the people living with the
virus
•
It is key to highlight that this access issue affects
everyone using a new, patented drug:
psychopharmaceuticals; chemotherapy;
antihypertensive, asthma, and cholesterol
medications; antibiotics; contraceptives; vaccines;
etc.
•
Paid by the Public System agosto our own pockets
Jorge Beloqui, or from
2010

Effects of the distribution policy of
antiretroviral drugs
Brazil

üReduction in mortality rates  40 - 70%

ü Reduction in morbidity rates  60 - 80%

ü Decrease of new HIV/AIDS cases 58.000 (until 2002)

ü Decrease of HIV/AIDS-related deaths  90.000
ü Reduction of hospitalizations: 7x decreas
2010

In
Brazil

Universal access policy. The Ministry of
Health is the only buyer. Budget 2008 = US$
640 million
December 2008 - 190.000 persons using
ARVs

2010

ARVs distributed in Brazil - 2008
I
P
ITRN and ITRNt
§ RITONAVIR (1996)*
§ ZIDOVUDINA (1993)* § SAQUINAVIR (1996)*
§ ESTAVUDINA (1997)* § INDINAVIR (1997)*
§ DIDANOSINA (1998)* § NELFINAVIR (1998)**
§ LAMIVUDINA (1999)* § AMPRENAVIR (2001)
§ ABACAVIR (2001) § LOPINAVIR/r (2002)
§ TENOFOVIR (2003) § ATAZANAVIR (2004)
§ DIDANOSINA EC (2005) § FOSAMPRENAVIR (2007)
ITRNN § DARUNAVIR (2008)

Fusion Inhibitors
§ NEVIRAPINA (2001)*
§ EFAVIRENZ (1999) § ENFUVIRTIDE
* national manufacturing– not protected by patents (2005)
**excluded in 2007 2010

•
2009 Raltegravir
•
2009 Maraviroc
•
2010 Etravirine

2010

Getting close to Universal Access

ü 94,8% coverage of ARVs – universal access
ü Average Cost
ü First line (AZT – 3TC – D4T – DDI – TDF – EFZ – NVP) – US$ 667
per patient/per year
ü Second line (LPV/r – SQV – IDV – ATV – FOS – RTV)

US$ 2,114 per patient/per year– 25% of all patients

* Excluding costs from Darunavir and T20
2010

Compulsory Licensing 2007
- Efavirenz
End of 2006: Thailand implements compulsory licensing for
EFV, Lopinavi/r and Plavix. Beginning of 2007: another 3
compulsory licenses are issued (Glivec among them)

Brazil: EFV becomes the most widely used, imported ARV –
75.000 patients

Long negotiation process – stable price since 2003 - US$
1,59/pill
–
Thailand – 1.2% prevalence, 17.000 patients – US$
0,67/pill
–
Dominican Republic – 1.1% prevalence
• Jorge Beloqui, agosto
1,500 patients- US$ 0,67/pill
2010

Compulsory Licensing 2007 -
Efavirenz
Annual Cost – from US$ 580.00 to US$166.36 per
patient/per year
–
US$ 0,46 (including royalties and freightage)

“Savings” estimated up to 2012 - US$ 237 millions
In 2007 – from US$ 42 millions to US$ 12 millions

Current National Manufacturing

2010

ANVISA Report 2010

n ANVISA is the Brazilian National
Sanitary Agency
n Selected Prices of selected
Medicines during 2009
n in R$
n 1 US dollar ~ 1.8 R$

ARVs

ARV Br US Sp It Gr Ca Au Fr

amp 536 693 546 742

mar 681 871 942 1221 1093

ral 1011 1879 2451 1540 1787 2505

kal 1029 1158 1234 794 1154 1184 947 1392

GLIVEC (Imatinib, in R$)

BR US Sp It Gr Ca Au Fr
3978 3040 3660 2329 3359 2919 2988 3562

NGO (HIV/AIDS) Initiatives

2010

NGO (HIV/AIDS) Initiatives (II)
•
The Latin American and Caribbean Forum on HIV/AIDS (Río de Janeiro- November 5th and 6th,
2000)
•
2001: demonstrations staged outside the US Consulates in SP, Recife, Rio de Janeiro , due to the
handing over of a letter about ‘a contentious Brazil’ by the US in the WTO
•
2001 June: lobby in the US Congress
•
The Brazilian Ministry of Health threatens to grant compulsory
licensing to two antiretrovirals (Nelfinavir y Efavirenz); and Glivec
(for leukemia)
•
A group of 39 pharmaceutical companies take action against the
South African government to prevent the parallel importing of ARVs;
•
Doha Declaration (WTO)
•
The United Nations Commission on Human Rights: access to
essential medicines as a human right;
•
UN GA: launches the Global Fund to Fight AIDS, Tuberculosis, and
Malaria;

2010

NGO (HIV/AIDS) Initiatives (III)
•
State Health Conference (SP, 2001)
•
Letter to the US Treasury Secretary
(August 2002)
•
XII ENONG (SP, 2003)
•
Government Transition Team (Nov.
2003)
•
National Conference of Science, Technology
and Innovation in Health (CNCTIS)
•
National Conference on Pharmaceutical
Assistance (2004)
2010

Key action: December 1st,
2004
•
On the World AIDS day, the State of São
Paulo AIDS/NGO Forum requested President
Lula to implement a compulsory licensing
(called ‘patent-breaking’) of AIDS drugs that
formed a large part of the budget for ARVs.
•
The AIDS/NGO Forums of the States of
Goiás and Ceará did the same

2010

Future Prospects: Access to Antiretrovirals

• Second-line treatments are becoming more and more
important
• Current second-line treatments may become first-line
treatments in the future
•The prices of third-line drugs can skyrocket (i.e. T-20)
• According to 2005 and 2008 surveys, there are
approximately 700,000 persons living with HIV in Brazil

2010

Demo in São Paulo

2010

February 2005 crisis (I)

•
In this month there was a lack of
diverse ARVs in Brazil
•
This crisis presented itself from the
beginning of Lula’s term of government
(2003), with localized and each time
more frequent ARVs scarcity
•
There was a lack of nationally produced
drugs, as well as imported ones
•
The first case was due to low quality
and a scarcity of raw materials
2010

The crisis of February, 2005 (II)

•
Exhibited the great dependency that
Brazil has on drugs
•
The crisis has not been completely
overcome, but it has significantly
improved
•
Some people think that Brazil will never
return to its previous stock rates and
stability
2010

Bill 22/2003

•
Several letters were sent by NGOs
(AIDS) supporting Bill 22/2003 by
Congressman R Gouveia, that declared
that HIV treatments should not be
patentable
•
Bill was approved by several
Commission in the House of
Representatives. But it needs to be
voted in plenary due to a requirement.
2010

2005: Approved motions on compulsory
licensing and Bill 22 (PL22)

•
RNP+ SE (Cedral (SP), march)
•
ERONG SE (Guarapari (ES), august)
•
ERONG Sul (SC, august)
•
RNP+ (Florianópolis (SC), august)
•
XIII ENONG (Curitiba, september)

2010

Resolutions

•
2005 : The NHC approved a resolution
for the issuing of compulsory licenses
for tenofovir, efavirenz and lopinavir/rtv
•
The Ministry refused to sanction the
resolution
•
Regional Council of Medicine of the
State of Sao Paulo’s (CREMESP)
2010

May 2007

2010

The Working Group on
Intellectual Property (WGIP)
visits the Civil House (I)
•
In February of 2005, a meeting of
advisors from the Presidency of the
Republic Civil House (similar to the
head of the Cabinet Ministers) took
place to discuss the regulations of the
previous resolution by Anvisa (National
Health Surveillance Agency) (law
10196)
2010

The Working Group on
Intellectual Property (GTPI)
visits the Civil House (II)
•
This law establishes that patent
applications for medicines submitted to
INPI (National Industrial Property Institute)
must have the previous approval of
Anvisa
•
Anvisa would not grant its approval for
second use or for new formulations
•
Thus, we supported this law’s regulations
2010

What is the WGIP?

2010

Brazilian Network for the
Integration of Peoples (REBRIP) –
2001

Network formed by non-governmental organizations
and social movements.

Divided into Work Groups- Agriculture, Commerce,
Environment, Services, Intellectual Property, Gender, and
Parliament.

Monitoring of free trade agreements, encouragement
of public debate, NGO training and awareness-raising
about topics related to multilateral organizations.

2010

Working Group on Intellectual
Property - 2001/2002

Membership – Brazilian Interdisciplinary AIDS
Association (coordinators), HIV/AIDS NGOs
and Brazilian human rights groups (GIV,
GAPA-RS & SP, Conectas, RNP+), Intellectual
Property researchers, Oxfam, Doctors without
Borders, and other NGOs
2010

The WGIP and Rebrip aim
to minimize the negative
impact of the patent system
for the access to medicines
in Brazil
2010

Action in the different spheres of government

TRIPS Context
Mobilização da opinião pública e capacitação
Pressure against
Legislativ projects
derived from
e TRIPS-plus
Opposition to laws
the undue Public Demand for
granting of Compulsory
patents Licensing

Executiv Judicial
e Jorge Beloqui, agosto
2010

Publication: Brazil is a “Tiger
without Teeth”

2010

Public Civil Action (ACP) - 2005

Actors
5 NGOs (AIDS)
1 Human rights group
1 Consumer Protection group
Federal Public Prosecutor’s Office

A demand to the National Attorney to oblige
the Executive branch of government to issue
a compulsory license for Lopinavir/ritonavir
(Kaletra®)
2010

Technical Consultancy by the WGIP
and MSF
Verification of the national capacity to manufacture AIDS
medicines (public and private laboratories)

http://www.abiaids.org.br/media/ARV.pdf

2010

Booklet on Patents and Access to
Medicines

Spanish Version:
http://www.abiaids.org.br/media/cartilh
a_patentes_es.pdf

www.abiaids.org.br/media/cartilha_patent
es.pdf

2010

WGIP: prevent the undue granting of
patents (2006)

•
Presented technical arguments to subsidize the
exam applied to patent applications by the
National Industrial Property Institute (INPI)
n Aimed to prevent the issuing of patents that do not
meet the requirements for patentability
n And to avert the widening of the drug monopoly,
through the acquirement of patents for old (and
widely used) medicines
2010

WGIP: prevent the undue granting of
patents (2006)

•
Tenofovir (TDF) – does not meet the
inventive step criterion
•
2nd patent for Lopinavir/ritonavir – illegal
request, as it already possesses the first
pipeline patent (includes arguments about
the unconstitutional nature of the pipeline
patent system)
2010

Tenofovir – 2008/09
first-line ARV – quick increase – 33.000 patients.

Patent was issued in Brazil in 1995. The Ministry of
Health declared TDF as part of the ‘public interest’ in
April, 2008. TDF patent was denied in July, 2009.

–
Brazil – US$ 3,25/pill = US$ 1.186/year
–
Thailand – US$ 1,24/pill = US$ 454/year
–
Gilead Access Price - US$ 0,567/pill = US$
207/year

2010

TRIPS flexibilities and their use (2007)

•
Great importance of the compulsory licenses
issued by Thailand (efv, lop/r, plavix, imatinib and
others) for the access to these drugs by
developing countries and for the effective use of
TRIPS flexibilities
•
Open letter of solidarity to Thailand (on compulsory
licenses) was signed by 80 Latin American
organizations and social movements
•
Letter denouncing Novartis’ actions in India
2010

Questions and answers about the compulsory
licensing of Efavirenz in Brazil

http://www.abiaids.org.br/media/EFAVIRENZ.pd
f

2010

Other Activities (I)
•
Workshop on Pipeline patents
and access to medicines in São
Paulo (2007): provided widespread
coverage and criticism of the topic
in conjunction with politicians, the
media, activists, and specialists.

2010

Other Activities (II)
•
In May 2009, the Federal General
Attorney filed a legal action claiming the
unconstitutionality of pipeline patents
(ADI) 4234
•
Diverse Amicus Curiae (among them:
ABIFINA, WGIP, Pró-Genéricos,
Abrasem, etc)

2010

Other Activities (III)
•
Cooperation with India, Thailand, China,
Colombia and South Africa was launched
to undertake a study on access to
medicines, and joint actions to oppose
patents (India) and lend solidarity
(compulsory licensing in Thailand and
Colombia) since 2008
•
Satellite Events at the IAS and AIDS
Conferences
2010

The case of Truvada (I)
•
Truvada (Gilead, tenofovir + emtricitabine)
is a combination of ARVs, widely used as
first line regime for HIV
•
Licensed by FDA and EMEA in 2005
•
Though used in clinical trials in Brazil
Gilead did not apply for a license in Brazil
till September 25th, 2009. This in part due
to a solicitation by GTPI, and SP
AIDS/NGOs FOrum
2010

The case of Truvada (II)
•
Tenofovir was also licensed for Hep B
treatment by FDA in August 2008
•
And also by EMEA
•
Due to an agreement with Glaxo, which
produces Hepsera (for Hep B), they did
not ask for a license in Brazil for this use.
•
It was a kind of Tordesilhas Treaty!

2010

The case of Truvada (III)

n So the M o H asked for an “ex
officio” license to ANVISA for the
use of Tenofovir for Hep B.
n Of course in developed countries
both drugs are licensed for Hep
B!

52

Freedom and Necessity

•
The issue of access to medicines does not only encompass
health needs (sensu stricto), but is also a matter of individual and
collective freedom;
•
There needs to be a wide choice range (freedom) for patients;
•
The fight for universal access to ARVs and other pharmaceutical
products (vaccines) is also an opportunity to publicly participate
and be socially included;
•
The implementation of TRIPS flexibilities is fundamental to sustain
the universal access policy for AIDS drugs and to promote the
transfer of technology in the pharmaceutical sector; freedom to
R&D, production and commerce
•
The real challenge is to create new mechanisms for the protection
of intellectual property that do not interfere with the necessities of
the population, specially the low-income portion

2010

University, patents and
access (I)

•
Universities should stress the importance of
REAL INNOVATION instead of helping
pharma to obtain evergreening patents
•
This is one of the natural effects of the current
patent system: try to extend the monopoly!
•
Here we have a clear conflict between
MARKET and PUBLIC INTERESTS

2010

University, patents and access
(II)
•
performing only clinical trials in Brazil whose
results will be useful for Brazilians: this was
not the case with HPV vaccine, for example.
•
It is not acceptable that Brazilians participate
in the risks but not in the benefits
•
divulgating and presenting alternatives to the
existing monopolies system as a way to
reward innovation
2010

University, patents and access
(III)
•
Universities should become aware that there
are persons with many health needs in the
Universities, among students, employees
and professors
•
access for all citizens as a right superior to
intellectual property and monopolies.
Especially in case of health

2010

Patenting the Sun

•
A journalist asked Jonas Salk: "Who
has the right to patent the anti-polio
vaccine?"
•
Salk responded: "The people. Patenting
the vaccine would be like patenting the
sun"

2010

Thank You!

•
Phone #: 011-5084-0255
•
Fax: 011-3814-4135
•
giv@giv.org.br

2010

Panel 2 jorque beloqui

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