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(Brazilian Interdisciplinary Association of AIDS) (Working Group on Intellectual Property) Enough of attacks to Health protection measures!
The case of the drug lopinavir/ritonavir expose the poor functioning of the patent system, distorted attack from pharmaceutical companies and lag of the judiciary. Given the disappointing outcome of a trial held this week at the Court of the 2nd district of Rio
de Janeiro, the Working Group on Intellectual Property of the Brazilian Network for Peoples
Integration (GTPI/Rebrip), collective of civil society organizations acting in defense of the
access to drugs, repudiate the claims filed by transnational corporations in order to weaken
the mechanisms established in Brazil to protect health policies from the negative impact of
pharmaceutical patents. It is still worth to remember that improperly granted patents
unnecessarily raise the price of drugs and high prices drain public resources. Many
international bodies have already concluded in their studies that the combination unlawful
patents-high prices frequently lead to systematic branches of the Human Rights.
The case hereof refers to the drug lopinavir/ritonavir, used by approximately 70 thousand
people in Brazil
to HIV/Aids treatment. Since its incorporation in SUS (Unified Heath System),
the drug is under private monopoly, despite the several questioning on patents validity that
sustain and can enlarge such monopoly. In 2013, Anvisa, as part of its performance established
by the article 229-C of the Law 9279/96 and governed by the RDC No. 21/2013, has decided to
reject one of the many patent applications filed by ABBVIE in order to extend the monopoly,
which has now lasted 18 years. The company has then brought it to judiciary, attempting to
annul ANVISA decision. The first instance decision was favorable to the company. ANVISA
presented an appeal which has just been dismissed as unfounded by the 1st specialist class of
the TRF of the 2nd District.
This result indicates that the attempts from the transnational pharmaceutical companies to extend their monopolies on essential drugs can be successful and that the mechanisms created in Brazil to protect health from the threat from patents are being violated. Organizations that part of GTPI presented an amicus curiae in an effort to bring to the attention of the judiciary the positions of the organizations acting to ensure the rights of people living with HIV/Aids, presenting technical arguments with the reasons why the Anvisa's decision should be maintained, but also bringing considerations regarding the relevance and essentiality of the drug lopinavir/ritonavir object matter of the action. Attacks against Prior Consent of ANVISA: distorted innovation, disrespected sovereignty and
threatened health.

The big pharmaceutical companies like Abbvie that proclaim themselves as innovative and on
the service of global health, has dedicated much of his research efforts to little relevant
innovations that are unfound in "low" quality patents, as proved by several studies and
publications1 2. These companies rely on this type of strategy to sustain and extend
1 Pharmaceutical Sector Inquiry, European Comission, 2009: 2 The current patente system favours coorporations, Carlos Correa, 2012 Av. Presidente Vargas, 446 / 13° andar – Centro - 20071 907. Rio de Janeiro/RJ [State of Rio de Janeiro]. Brazil Phone: +55 21 2223 1040. Fax: +55 21 2253 8495



(Brazilian Interdisciplinary Association of AIDS) (Working Group on Intellectual Property) monopolies on drugs, even because they are not being able to make their investment in
research to result in increasing to the amount of genuine innovations. Such genuine
innovations, which should be the main social counterpart of the patent system, are on the
contrary, in a free fall.
For them, the only option is to dismantle policies and mechanisms that promote a more
rigorous examination of patent applications in pharmaceutical area. The most rigorous
analysis privileges only genuine innovations,
increasingly scarce in the companies' portfolio.
Instead of reorganizing their research efforts, large companies in pharmaceutical industry
prefer to invest in lawsuits to attack and delegitimize mechanisms that promote a more
rigorous examination. Thus, legal arena becomes much more important than the laboratory
bench in the search for controlling the market, through the infinite extension of the
monopolies on essential drugs.
Make the patents examination most rigorous in Brazil is precisely the function of the Prior
Consent of ANVISA
, the mechanism created in Brazil in order to ensure the rejection of patent
applications in disagreement with the legal requirements of novelty, inventive step and
industrial application.
It is clear that the Provisional Measure 2006 of 1999, in its explanatory
statement, which gives rise to prior approval, aims to establish the cooperative effort between
INPI and ANVISA, in order to ensure "the best technical standards in the pharmaceutical patent
decision process
".
However, through distorted interpretations of the law, pharmaceutical companies whose patents are rejected by ANVISA, have claimed that it is not the organ liability to analyze the patentability requirements, being this assignment the INPI's liability only. Even more worrying is the fact that such attacks continue to occur even after the alleged conflict of competences between INPI and ANVISA has been resolved by the Interministerial Ordinance MS/MDIC/AGU no. 1065, of May 24, 2012, and its subsequent developments. However, the most alarming is that such unfounded attacks still find an echo on the judiciary, which has acted based on outdated jurisprudence. All these items can be verified in the process 0102042-47.2014.4.02.0000, moved by the company ABBVIE against Anvisa in order to annul the decision of the Agency that determined the rejection of the patent application PI 0413882-1, authored by the company itself. In the pharmaceutical field, patent protection has important implications for public health,
since the grant of an improper patent can generate large distortions in the competition and
reduce the access to essential drugs.
This was one of the foundations of the creation of the
Prior Consent and which remains highly relevant, as demonstrated by the very case of
lopinavir/ritonavir, in which the same company filed 11 patent applications for a single
product. The lack of appropriate mechanisms to deal with these abuses in the patent system
opens more space for patented drugs with high prices to impact on health policies and that
can completely hinder them.
We, therefore, reiterate the importance and the legality of ANVISA's prior effective measure
on the right to health (art. 6 the Federal Constitution and art. 48 of the Universal Declaration
of Human Rights) and economic and social development policies of the country.
Av. Presidente Vargas, 446 / 13° andar – Centro - 20071 907. Rio de Janeiro/RJ [State of Rio de Janeiro]. Brazil Phone: +55 21 2223 1040. Fax: +55 21 2253 8495



(Brazilian Interdisciplinary Association of AIDS) (Working Group on Intellectual Property) The Case of the drug Lopinavir/Ritonavir: Questionable patents, dubious benefits and
assured losses.

In this case, the patent application does not meet the requirements of novelty and inventive step, having originated from an attempt to extend the most the monopolistic exclusivity over the production and sale of the drug formed by the combination of lopinavir and ritonavir active principles, generating undue adverse effects on the competition, to industrial policy and to the realization of the right to health. Currently, it is estimated that 70,000 patients are using the LPV/r, which represents about 35%
of people under treatment in Brazil.
Annual cost of the treatment made available by the
Ministry of Health in 2013 was US$ 658.00 by patient every year. This price has represented
almost three times the price of the cheapest generic in international market that was U$
268.00 patient/year3.
In a comparison with the price of the drug acquired from Abbvie and the
price of the lowest international generic for the year 2013, in case Brazil had purchased with
such lower price, there would be an economy of more than US$ 26 million only with the
purchase of the LPV/r in one year.

With the perspective of an increase in the number of people with intolerance to the first line of treatment, the use of the lopinavir/ritonavir combination will be higher and the granting of such patent application may represent the impossibility of a country to access the lower costs versions available in international market or that could be produced in the country, increasing the risk to sustainability of the policy of universal and free access to the treatment of AIDS in Brazil. 3 Information available in: MSF. Médicines sans frontières. Untangling the web of price reductions. 17th Edition. 2014. Av. Presidente Vargas, 446 / 13° andar – Centro - 20071 907. Rio de Janeiro/RJ [State of Rio de Janeiro]. Brazil Phone: +55 21 2223 1040. Fax: +55 21 2253 8495

Source: http://www.rebrip.org.br/system/uploads/ck/files/migracao//4392-nota-gtpi-kaletra-final-eng-us-1.pdf

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