panel 2-jorque-beloqui

Jorge Beloqui, agosto 2010

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 [email protected]• ABIA (Associação Brasileira Interdisciplinar de AIDS/ Brazilian

Interdisciplinary AIDS Association) 5521-2223-1040• RNP+• IME-USP• GTPI (Rebrip)

mailto:[email protected]


What would happen if we had a vaccine (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?


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


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


TypePharmaceuticalIntermediaries

Pharmo-chemicals

Agro- chemicals

Additives, Aromatic and Dyes

TOTAL

Paralyzed 241 407 73 375 1.096

Not Implemented 208 110 10 27 355

TOTAL 449 517 83 402 1.451

PARALYZED AND UNIMPLEMENTED UNITSINDUSTRIAL COMPLEX OF FINE CHEMISTRY

PERÍOD 89-99 (D. Barbosa)


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 or from our own pockets


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

ü358.000 hospitalizations prevented between 1997 and 2001

ü Increase of survival rates after HIV/AIDS diagnosis

üon average greater than 9 years for patients diagnosed with HIV/AIDS in 1998-1999

ü Estimated savings US $ 2,2 millions (until 2002) (Cuidados ambulatoriales e hospitalares)Fonte: Greco, 2007


Universal access policy. The Ministry of Health is the only buyer. Budget 2008 = US$ 640 million

December 2008 - 190.000 persons using ARVs

In Brazil


* national manufacturing– not protected by patents

**excluded in 2007

§ RITONAVIR (1996)*

§ SAQUINAVIR (1996)*

§ INDINAVIR (1997)*

§ NELFINAVIR (1998)**§ AMPRENAVIR (2001)§ LOPINAVIR/r (2002)§ ATAZANAVIR (2004)§ FOSAMPRENAVIR (2007)§ DARUNAVIR (2008)

§ ZIDOVUDINA (1993)*

§ ESTAVUDINA (1997)*

§ DIDANOSINA (1998)*

§ LAMIVUDINA (1999)*

§ ABACAVIR (2001)§ TENOFOVIR (2003)

§ DIDANOSINA EC (2005)

§ NEVIRAPINA (2001)* § EFAVIRENZ (1999)

ITRN and ITRNt

§ ENFUVIRTIDE (2005)

IP

Fusion Inhibitors

ITRNN

ARVs distributed in Brazil - 2008


• 2009 Raltegravir• 2009 Maraviroc• 2010 Etravirine


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


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• 1,500 patients- US$ 0,67/pill


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 millionsIn 2007 – from US$ 42 millions to US$ 12 millions

Current National Manufacturing

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 3978

US3040

Sp3660

It2329

Gr

3359

Ca

2919

Au

2988

Fr

3562


NGO (HIV/AIDS) Initiatives


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;


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)


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


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


Demo in São Paulo


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


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


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.


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)


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)


May 2007


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)


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


What is the WGIP?


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.

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


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

Working Group on Intellectual Property - 2001/2002


The WGIP and Rebrip aim to minimize the negative

impact of the patent system for the access to medicines

in Brazil


Action in the different spheres of government

TRIPS Context

Executive

Judicial

Legislative

Opposition to the undue granting of patents

Public Demand for Compulsory Licensing

Mobilização da opinião pública e capacitação

Pressure against projects derived from TRIPS-plus laws


Publication: Brazil is a “Tiger without Teeth”


Actors 5 NGOs (AIDS)1 Human rights group1 Consumer Protection groupFederal Public Prosecutor’s Office

Public Civil Action (ACP) - 2005

A demand to the National Attorney to oblige the Executive branch of government to issue a compulsory license for Lopinavir/ritonavir

(Kaletra®)


Verification of the national capacity to manufacture AIDS medicines (public and private laboratories)

Technical Consultancy by the WGIP and MSF

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


www.abiaids.org.br/media/cartilha_patentes.pdf

Booklet on Patents and Access to Medicines

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

a_patentes_es.pdf


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


• 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)

WGIP: prevent the undue granting of patents (2006)


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


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


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

Questions and answers about the compulsory licensing of Efavirenz in Brazil


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.


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)


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


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


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!



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


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


University, patents and access (II)

• Universities should stress the importance of 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

• Universities should stress the importance of divulgating and presenting alternatives to the existing monopolies system as a way to reward innovation


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

• Universities should stress the importance of access for all citizens as a right superior to intellectual property and monopolies. Especially in case of health


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"


Thank You!

• Phone #: 011-5084-0255• Fax: 011-3814-4135• [email protected]

mailto:[email protected]

Education

panel 2-jorque-beloqui