[Ip-health] Statement of Brazilian CSO (GTPI) on Gilead VL on sofosbuvir

Pedro Villardi pedro at abiaids.org.br
Wed Sep 17 15:04:21 PDT 2014


Please find below the GTPI positioning on the Gilead VL.

Regards,

Pedro Villardi

Coordenador/Coordinator
GTPI/Rebrip - Grupo de Trabalho sobre Propriedade Intelectual da Rede
Brasileira pela Integração dos Povos
ABIA - Associação Brasileira Interdisciplinar de Aids

GTPI/Rebrip - Working Group on Intellectual Property of the Brazilian
Network for Integration of Peoples
ABIA - Brazilian Interdisciplinary Aids Association www.abiaids.org.br /
www.deolhonaspatentes.org.br

September, 17, 2014
(also available at:
http://www.deolhonaspatentes.org.br/media/file/GTPI_statement_Gilead_license_sofosbuvir.pdf
)

*Brazil is excluded from license authorizing production of generic medicine
for hepatitis C*



The pharmaceutical company Gilead Sciences announced last Monday
(September, 15th) a license that allows the production of generic versions
of sofosbuvir, a medicine used in the treatment of hepatitis C. The license
authorizes seven generic manufacturers in India to produce the drug[1]
<file:///C:/Users/pedro/Desktop/PEDRO%20REDE/Advocacy%20GTPI/Cartas/GTPI_statement_Gilead_license_sofosbuvir.docx#_ftn1>,
which will be sold at lower prices than those charged by Gilead. However,
these prices will be offered only to a limited number of countries, defined
by Gilead. Brazil, like most middle-income countries in Latin America and
other regions, is out of the list of countries for which the generic
version can be sold.



Sofosbuvir is the new hope for many people infected with the hepatitis C
virus, including in co-infection with HIV. The new treatment can provide
increased cure rate up to 90% of cases. The most commonly used treatment in
Brazil, currently consists of pegylated interferon and ribavirin, cures
around 45% of cases, generates many adverse effects and is difficult to use
because it is injectable. In Brazil, the commercialization of the new drug
is still pending approval from ANVISA - National Agency for Sanitary
Vigilance, which should be announced soon. The registration of the drug in
Brazil must be followed by the publication of guidelines for their
distribution in the public health system, but the astonishing high price
charged by Gilead (US$ 84,000 for 12 weeks of treatment) and which has
generated debates about sustainability even in the USA and Europe, can
become a barrier to expanded access, especially with the recent exclusion
of many developing countries from the list of those who can access the
generic version. So it becomes increasingly pertinent the question: how
many people will have access to sofosbuvir?



Gilead, once again, proves much more interested in segmented countries and
ensure their astronomical profits than to allow millions of people who need
the medicine to have access to it. In the United States and Europe there
are already a large public outcry around the price of sofosbuvir. The drug
became known as the 1,000 dollars pill, because of the price Gilead,
producer of the drug, charges in the United States. That price is not
accessible to the people and not for even for governments of any country.
This finding triggered a major campaign to reduce the price of the drug and
increased access.



Currently, Gilead is the sole producer of the drug because of the rules of
intellectual property protection. Gilead filed patent applications for
sofosbuvir in countries around the world. In Brazil, the application has
not yet been granted by INPI - National Institute of Industrial Property,
the body responsible for granting or not granting a patent in the country.
If the patent is granted, Gilead will be the only company that can produce
and market the drug sofosbuvir in Brazil. While the patent application is
still pending analysis, the patent is not valid, but in practice no other
producer venture to produce and market the drug in this period. This is
because if the patent is granted, the validity of the patent is retroactive
to the date of filing, and the patent holder could sue other producers.



Because of this pending patent application in Brazil, the Brazilian
government opted for negotiating prices exclusively with Gilead. There is
no official information about the price that sofosbuvir will be sold in
Brazil, but there are rumors that it would be somewhere around US$ 7,000
for each 12-week treatment. The estimated production price of the generics
is between US$ 135-400 for the same treatment, which already includes the
company's profit, according to the NGO I-MAK - Initiative for Medicines,
Access and Knowledge[2]
<file:///C:/Users/pedro/Desktop/PEDRO%20REDE/Advocacy%20GTPI/Cartas/GTPI_statement_Gilead_license_sofosbuvir.docx#_ftn2>.
The price being negotiated with Gilead in Brazil could be *52 times more
expensive* than the generic version. This would represent an *additional
cost of at least US$ 1 billion* to treat all people with hepatitis C in
Brazil[3]
<file:///C:/Users/pedro/Desktop/PEDRO%20REDE/Advocacy%20GTPI/Cartas/GTPI_statement_Gilead_license_sofosbuvir.docx#_ftn3>
.



Although there is no patent granted in Brazil, the government cannot buy
the generic version that will be produced in India, because of unfair and
abusive restrictions imposed by Gilead voluntary license of the patent for
the Indian generic manufacturers.



*But, should the sofosbuvir patent be granted?*



Although this new treatment can increase the quality of life of people
infected with HCV, there is however doubt that SOF meets patentability
criteria to justify the grant of a patent. In Egypt, the patent application
for the molecule was denied. In India, an opposition to the patent
application was submitted, presenting technical arguments showing that the
application does not meet the requirements for the granting of a patent. A
similar opposition is being prepared by civil society organizations in
Brazil, with arguments that the patent application should be denied here.



In addition to toughening negotiation with Gilead, since US$ 7,000 per
treatment is absolutely unacceptable, the Brazilian government must also
take other initiatives. Investment in domestic production of sofosbuvir by
public laboratories is urgent. We cannot forget that it was the public
production of generic drugs for the treatment of HIV/AIDS that enabled
universal access to treatment in Brazil at the beginning of the epidemic.
In addition to producing various ARVs, public laboratories were important
to estimate production costs of patented drugs, which allowed the
government to negotiate better prices with suppliers of these drugs. The
rules of intellectual property protection allow other producers to have
generic versions of the drug ready for use immediately after the patent
expires, or in case of granting a compulsory license, for example.





Thus, GTPI/Rebrip - Working Group on Intellectual Property of the Brazilian
Network for the Integration of Peoples:

•          Vehemently repudiates the license from Gilead and any other
agreements exclusively commercial based, treating medicines as commodities
and preventing millions of people to have access to medicines;

•          Requires that the Brazilian government negotiate a fair price
for the incorporation of sofosbuvir, taking into account mainly the cost of
production of the drug;

•          Asks the Brazilian government to create treatment protocols to
ensure that all people who need sofosbuvir, including in coinfection with
HIV, have access to the medicine;

•          Demands that the Brazilian government immediately begin efforts
to enable the production of sofosbuvir by the public sector;

•          Asks INPI to speed the analysis of the patent application;

•          Claims that the INPI denies the application because it does not
meet minimum requirements of patentability for the grant of a patent;

•          Requires that if the patent is granted, the Brazilian government
to immediately issue a compulsory license, allowing local production of the
drug or importation of generic versions.









*Who we are:*

The Working Group on Intellectual Property of the Brazilian Network for the
Integration of Peoples (GTPI/Rebrip) is a group formed by civil society
organizations, researchers and activists, which works from a public
interest perspective. Since 2003, GTPI develops activities aimed at
reducing the negative impacts of pharmaceutical patents on public policies
of access to health in Brazil and in the Global South. Learn more about
GTPI and our actions: www.deolhonaspatentes.org.br.

------------------------------

[1]
<file:///C:/Users/pedro/Desktop/PEDRO%20REDE/Advocacy%20GTPI/Cartas/GTPI_statement_Gilead_license_sofosbuvir.docx#_ftnref1>
The
Indian companies entering the license are: Cipla, Hetero, Ranbaxy, Strides,
Mylan, Sequent and Cadila Healthcare.More information about the license and
the countries that were included can be found at:
http://www.gilead.com/~/media/Files/pdfs/other/HCVGenericAgreementFactSheet.pdf

[2]
<file:///C:/Users/pedro/Desktop/PEDRO%20REDE/Advocacy%20GTPI/Cartas/GTPI_statement_Gilead_license_sofosbuvir.docx#_ftnref2>
Available
at:
http://i-mak.squarespace.com/storage/FINAL_I-MAK%20Press%20Backgrounder_SOF%20Cost.pdf
.

[3]
<file:///C:/Users/pedro/Desktop/PEDRO%20REDE/Advocacy%20GTPI/Cartas/GTPI_statement_Gilead_license_sofosbuvir.docx#_ftnref3>
The
calculation considered the estimate that 1.5 million people are infected
with hepatitis C in Brazil, used by the Ministry of Health. We used the
estimated value of the generic medicines (US$ 400) and the probable price
being negotiated between the Brazilian government and Gilead (US$ 7,000).
The treatment time period of 12 weeks was considered in the calculation.



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