Press release - September 15th 2016
Fundación Grupo Efecto Positivo (FGEP) -
Associação Brasileira
Interdisciplinar de AIDS (ABIA) -
Grupo de Trabalho sobre Propriedade Intelectual (GTPI)
United Nations’ High Level Panel on Access to Medicines Report released: BIG PHARMA’S COURT CASES IN BRAZIL & ARGENTINA THREATEN TO DISMANTLE THE NATIONAL LAWS CONSIDERED AS IMPORTANT PUBLIC HEALTH SAFEGUARDS IN THE UN HLP REPORT
JOIN THE CAMPAIGN DEMANDING BIG PHARMA TO DROP THE CASES!
Buenos Aires, Rio de Janeiro, September 15th, 2016 -
The United Nation’s High Level Panel (UN HLP) on Access to Medicines released yesterday its final report. The Panel was mandated in November 2015 by UN’s Secretary-General Mr. Ban-Ki Moon to find solutions for the “incoherence” between human rights and public health and rules on intellectual property that hinders innovation and access to medicines. Although the recommendations of the report could have been stronger, it clearly recommends the use of pro public health safeguards to promote the human right to health. The report describes some of the challenges faced by countries to make use of those safeguards, however it fails on addressing the responsibility of
pharmaceutical companies.
Court cases filed by Big Pharma in Brazil and Argentina are
threatening the access to medicines, and acting against the
recommendations of the UN HLP.
Brazil and Argentina have adopted public health safeguards in their
national laws to reduce the negative impacts of intellectual property
rules on access to medicines. These measures are strongly recommended by the UN HLP report released yesterday. However, Big Pharma has filed court cases challenging these pro-public health provisions in both countries.
Civil society organizations in Argentina and Brazil have launched a
joint campaign to fight back Big Pharma’s attacks. Fundación Grupo
Efecto Positivo (FGEP), Associação Brasileira Interdisciplinar de AIDS (ABIA) & Grupo de Trabalho sobre Propriedade Intelectual (GTPI) are calling for Interfarma and CAEME to cease their attack on Brazil and Argentina for using their right to ensure the access to health of their population and to protect them from the abuses of pharmaceutical companies.
Both countries have adopted universal public health programs that
guarantee free distribution of essential medicines to all. In order to
secure the access to these medicines, there is a need to ensure
sustainable prices for the health systems. While the UN’s HLP report
acknowledges that high pricing of medicines is an obstacle for access to medicines and that patents create obstacles to public health objectives, the report fails in going further and acknowledging the responsibility of transnational pharmaceutical companies in respecting public policies that aims to reduce those obstacles and trying to shape laws to put their profits before people’s rights.
In 2014 and 2015, the associations of transnational pharmaceutical
companies (Interfarma - Associação da Indústria Farmacêutica de
Pesquisa in Brazil and CAEME - Cámara Argentina de Especialidades Medicinales in Argentina) went to court suing the national governments for adopting pro public health measures in intellectual property laws in the two countries. In Argentina, Big Pharma is challenging the national patent examination guidelines. In Brazil, the major pharmaceutical companies are challenging the participation of health authorities in the analysis of pharmaceutical patent applications (known as “ANVISA’s prior consent”). Both provisions aim to avoid the granting of unmerited patents, that is, those that do not fulfill the patentability requirements established under international and national laws. Those provisions were strongly recommended by the UN HLP and have shown over the years to be critical to enable access to medicines.
If the corporation’s associations succeed, millions of people in our
countries will be threatened to be left without access to low cost
generics and prevent the universal access to medicines programs
adopted in both countries. The consequences on public expenditures will also be dramatic. So far, low cost generic medicines have been the only way to ensure the access to key essential medicines in our countries given the very high prices set by originator companies in middle income and high income countries.
As the dramatic increases on the price of new medicines is linked to
the way pharmaceutical patents are examined and granted, Brazil and Argentina have created strict standards and procedures for patent examination in the pharmaceutical sector and have successfully blocked several undeserved patents, ensuring generic competition and price reductions. The HLP report states that “TRIPS flexibilities – for example, the freedom to determine patentability criteria (…) can ensure that patents are only awarded for genuine innovation. (…) Many governments have not used the flexibilities available under the TRIPS Agreement for various reasons ranging from capacity constraints to undue political and economic pressure from states and corporations, both express and implied” (p.8). The court cases filed by transnational pharmaceutical companies association in Brazil and in Argentina are a concrete illustration of the political and economical pressures mentioned in the HLP report.
The protection of the public health safeguards available under the
Brazilian and the Argentinean laws is now more important than ever to ensure access to medicines. The HLP report explicitly recommends countries to “make full use of the policy space available in Article 27 of the TRIPS Agreement by adopting and applying rigorous definitions of invention and patentability that are in the best interests of the public health of the country and its inhabitants.
This includes amending laws to curtail the evergreening of patents and awarding patents only when genuine innovation has occurred” (p.9).
But how can the right to health be protected when governments who try to implement this recommendation are being sued by pharmaceutical companies? The current cases faced by Brazil and Argentina represent a good example of “general countries applying a public health-based
interpretation of patentability criteria have faced pressure against
such an interpretation and application in their national laws” (p.22).
The court cases filed by pharmaceutical companies in Argentina and
Brazil are a violation of the human right to health and a disrespect
to the sovereignty of countries to adopt measures to protect the
public health, as recognized once again in the UN’s HLP report. As
such, international community should join forces to demand Big Pharma to respect the right of countries to adopt measures to protect
people’s rights.
Join the “Drop the case” campaign, and demand Interfarma and CAEME to drop the cases!
The “Drop the case” campaign on social medias :
On twitter : @Dropthecase2016 -
On facebook facebook.com/dropthecase2016
Website : www.redlam.org/
Online petition :
www.change.org/p/corporaciones-farmac%C3%A9uticas-a
...

Press release - September 15th 2016 Fundación Grupo Efecto Positivo (FGEP) - Associação Brasileira Interdisciplinar de AIDS (ABIA) - Grupo de Trabalho sobre Propriedade Intelectual (GTPI) United Nations’ High Level Panel on Access to Medicines Report released: BIG PHARMA’S COURT CASES IN BRAZIL & ARGENTINA THREATEN TO DISMANTLE THE NATIONAL LAWS CONSIDERED AS IMPORTANT PUBLIC HEALTH SAFEGUARDS IN THE UN HLP REPORT JOIN THE CAMPAIGN DEMANDING BIG PHARMA TO DROP THE CASES! Buenos Aires, Rio de Janeiro, September 15th, 2016 - The United Nation’s High Level Panel (UN HLP) on Access to Medicines released yesterday its final report. The Panel was mandated in November 2015 by UN’s Secretary-General Mr. Ban-Ki Moon to find solutions for the “incoherence” between human rights and public health and rules on intellectual property that hinders innovation and access to medicines. Although the recommendations of the report could have been stronger, it clearly recommends the use of pro public health safeguards to promote the human right to health. The report describes some of the challenges faced by countries to make use of those safeguards, however it fails on addressing the responsibility of pharmaceutical companies. Court cases filed by Big Pharma in Brazil and Argentina are threatening the access to medicines, and acting against the recommendations of the UN HLP. Brazil and Argentina have adopted public health safeguards in their national laws to reduce the negative impacts of intellectual property rules on access to medicines. These measures are strongly recommended by the UN HLP report released yesterday. However, Big Pharma has filed court cases challenging these pro-public health provisions in both countries. Civil society organizations in Argentina and Brazil have launched a joint campaign to fight back Big Pharma’s attacks. Fundación Grupo Efecto Positivo (FGEP), Associação Brasileira Interdisciplinar de AIDS (ABIA) & Grupo de Trabalho sobre Propriedade Intelectual (GTPI) are calling for Interfarma and CAEME to cease their attack on Brazil and Argentina for using their right to ensure the access to health of their population and to protect them from the abuses of pharmaceutical companies. Both countries have adopted universal public health programs that guarantee free distribution of essential medicines to all. In order to secure the access to these medicines, there is a need to ensure sustainable prices for the health systems. While the UN’s HLP report acknowledges that high pricing of medicines is an obstacle for access to medicines and that patents create obstacles to public health objectives, the report fails in going further and acknowledging the responsibility of transnational pharmaceutical companies in respecting public policies that aims to reduce those obstacles and trying to shape laws to put their profits before people’s rights. In 2014 and 2015, the associations of transnational pharmaceutical companies (Interfarma - Associação da Indústria Farmacêutica de Pesquisa in Brazil and CAEME - Cámara Argentina de Especialidades Medicinales in Argentina) went to court suing the national governments for adopting pro public health measures in intellectual property laws in the two countries. In Argentina, Big Pharma is challenging the national patent examination guidelines. In Brazil, the major pharmaceutical companies are challenging the participation of health authorities in the analysis of pharmaceutical patent applications (known as “ANVISA’s prior consent”). Both provisions aim to avoid the granting of unmerited patents, that is, those that do not fulfill the patentability requirements established under international and national laws. Those provisions were strongly recommended by the UN HLP and have shown over the years to be critical to enable access to medicines. If the corporation’s associations succeed, millions of people in our countries will be threatened to be left without access to low cost generics and prevent the universal access to medicines programs adopted in both countries. The consequences on public expenditures will also be dramatic. So far, low cost generic medicines have been the only way to ensure the access to key essential medicines in our countries given the very high prices set by originator companies in middle income and high income countries. As the dramatic increases on the price of new medicines is linked to the way pharmaceutical patents are examined and granted, Brazil and Argentina have created strict standards and procedures for patent examination in the pharmaceutical sector and have successfully blocked several undeserved patents, ensuring generic competition and price reductions. The HLP report states that “TRIPS flexibilities – for example, the freedom to determine patentability criteria (…) can ensure that patents are only awarded for genuine innovation. (…) Many governments have not used the flexibilities available under the TRIPS Agreement for various reasons ranging from capacity constraints to undue political and economic pressure from states and corporations, both express and implied” (p.8). The court cases filed by transnational pharmaceutical companies association in Brazil and in Argentina are a concrete illustration of the political and economical pressures mentioned in the HLP report. The protection of the public health safeguards available under the Brazilian and the Argentinean laws is now more important than ever to ensure access to medicines. The HLP report explicitly recommends countries to “make full use of the policy space available in Article 27 of the TRIPS Agreement by adopting and applying rigorous definitions of invention and patentability that are in the best interests of the public health of the country and its inhabitants. This includes amending laws to curtail the evergreening of patents and awarding patents only when genuine innovation has occurred” (p.9). But how can the right to health be protected when governments who try to implement this recommendation are being sued by pharmaceutical companies? The current cases faced by Brazil and Argentina represent a good example of “general countries applying a public health-based interpretation of patentability criteria have faced pressure against such an interpretation and application in their national laws” (p.22). The court cases filed by pharmaceutical companies in Argentina and Brazil are a violation of the human right to health and a disrespect to the sovereignty of countries to adopt measures to protect the public health, as recognized once again in the UN’s HLP report. As such, international community should join forces to demand Big Pharma to respect the right of countries to adopt measures to protect people’s rights. Join the “Drop the case” campaign, and demand Interfarma and CAEME to drop the cases! The “Drop the case” campaign on social medias : On twitter : @Dropthecase2016 - On facebook facebook.com/dropthecase2016 Website : www.redlam.org/ Online petition : www.change.org/p/corporaciones-farmac%C3%A9uticas-abandonen-el-caso-big-pharma-drop-the-case

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TAG is releasing 'Activist Strategies for Increasing Access to HCV Treatment in Low- and Middle-Income Countries' (by Karyn Kaplan). This guide presents key strategies through real-world case studies, and shows how strategies used to combat the AIDS epidemic can be—and have been—adapted to increase HCV treatment. www.treatmentactiongroup.org/…/Activist%20Strategies… ...

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Réaction des associations marocaines ALCS-Maroc, Collectif droit à la santé Maroc, et ITPC-MENA à la licence de Gilead sur Sofosbuvir et Ledipasvir "ITPC-MENA, l’ALCS et le CDSM dénoncent la licence GILEAD qui va priver 625 000 personnes infectées par le VHC au Maroc du traitement" www.itpcmena.org/?73-millions-de-personnes-touchees ...

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HCV/Gilead/Sofosbuvir : Press release from Civil Society Organizations in Thailand : "Voluntary License on Sofosbuvir and Ledipasvir between Gilead Sciences Limited and Generic-medicine Manufacturers in India" ...

Statement of Civil Society Organizations in Thailand Voluntary License on Sofosbuvir and Ledipasvir between Gilead Sciences Limited and Generic-medicine Manufacturers in India September 16, 2014 Civil society organizations working on access to HIV and HCV treatment in Thailand, as listed at the end of the statement, are appalled by the announcement of the voluntary license agreed between Gilead Sciences Limited and a number of generic-medicine manufacturers in India. We were hoping that Gilead's new drug, sofobruvir, would be both a life-line to the almost one and half million people infected with the hepatitis C virus (HCV) in Thailand and a potential means of eradicating this disease worldwide. Instead we are now faced with corporate greed building yet another barrier to access to a new medicine needed by millions of people with HCV infection in middle-income countries, instead of a mechanism promoting access to this life saving treatment for ALL who need it. Gilead announced its great contribution to the promotion of access to HCV treatment by signing an agreement on licensing a new HCV medicine, known as sofosbuvir, to Indian generic-drug manufacturers yesterday. In fact, the agreement is a disastrous threat to the lives of people with HCV infection, particularly those in middle-income countries where 73% of people with HCV live. Due to restrictive conditions set down by Gilead, the Indian licensees are only allowed to supply affordable generic version of sofosbuvir to 91 low and middle income countries. In those middle-income countries not included in the deal, millions of people will be effectively handed a death sentence as Gilead's new lifesaving medicine will be unaffordable. On the one hand, Gilead is filing patent applications on sofosbuvir in India. But the ground for these patents are questionable under Indian patent law and India civil society organizations have filed patent oppositions with the Intellectual Property Office of India and the patents have not yet been granted. In Egypt, the sofosbuvir patent was rejected. On the other hand, Gilead is attempting to maintain their market monopoly by undermining generic competition and locking Indian low cost generic manufacturers into voluntary licenses that exclude many middle income countries such as Thailand, Brazil, Ukraine, Russia, Turkey, Romania, Mexico, Philippines, and China, where people with HCV infection is higher than 1 million. More than 49 million people in the excluded MICs with high HCV prevelence are not able to access affordable sofosbuvir. This tactic has been used in the past with voluntary licenses on HIV/AIDS medicines such as tenofovir. Pegylated interferon (PEG-INF) and ribavirin (RBV) is the treatment for HCV infection that is currently widely used in developing countries. However, this treatment has a poor cure rate and many patients experience very unpleasant side effects. Gilead's sofobuvir is a new HCV treatment that gives better cure rates with less side effects but it is priced beyond the reach of most people. In the USA, the cost is US$ 84,000 per treatment or US$ 1,000 per pill. The generic version, to be made available under Gilead's licensing agreement, will cost in the region of US$900 per treatment or US$10 per pill for those 91 low and middle income countries included in the agreement. But what about those countries excluded from this licensing agreement? And, experts have shown that sofosbuvir can be produced generically for mass scale-up, including a profit margin, for $101 for a 12-week course. In Thailand, people with HCV infection are entitled to PEG-INF/RBV medication at no cost under the Universal Coverage Scheme. But, with such barriers (both patent protection and voluntary licenses), it is difficult for the Thai government to provide sofosbuvir for its own citizens with HCV infection. According to the global Hepatitis C prevalence data of 2010, it is estimated that approximate 1.45 million Thais having HCV infection (2.2% of the total population). Due to a lack of access to generic sofosbuvir to be sold by Indian manufacturers under the voluntary license, if the Thai government wants support a national HCV treatment programme with sofosbuvir, it will cost at least US$ 121 billion, which is much higher than the Thailand’s annual health budget of USD 8.4 billion in 2014, insteaf of US$ 1.3 billion (generic version’s price under the license). Generic medicines’ competition is the most effective mechanism to ensure significant reduction in drug prices. The Gilead voluntary licenses agreed with the Indian generic-medicine industry are restrictions that will jeopardize competition by selectively limiting countries who can purchase the medicines from India. Therefore, prices will remain high and large numbers of people with HCV infection globally will be denied access to this treatment. Gilead must stop undermining the generic-medicine industry’s competition and repeal the conditions in voluntary licenses that exclude millions of people in order to fulfill their stated commitment to addressing the unmet medical needs of patients living with life-threatening diseases around the world. AIDS ACCESS Foundation Drug Study Group Foundation for AIDS Rights (FAR) Foundation for Consumers (FFC) FTA Watch People’s Health System Movement Thai AIDS Treatment Action Group (TTAG) Thai Network of People living with HIV/AIDS (TNP+) Thai NGO Coalition on AIDS (TNCA) Thai Holistic Health Foundation The Rural Pharmacist Association The Rural Pharmacist Foundation 12 D Thai Coalition on Harm Reduction

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HCV / Myths and facts regarding Gilead's voluntary license on Sofosbuvir ...

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A report from the 1st Hepatitis C Virus World Community Advisory Board Meeting in Bangkok. Participants came from a wide range of countries and experiences, but shared a common goal. They gathered to advocate for universal access to the highest quality diagnostics, care, and treatment for HCV—regardless of income, geographic location, drug use, or HIV status. They agreed that countries have the right to pursue the full range of strategies for securing access to affordable, quality HCV DAAs, and peginterferon (PEG-IFN). ...

A report from the 1st Hepatitis C Virus World Community Advisory Board Meeting in Bangkok. Participants came from a wide range of countries and experiences, but shared a common goal. They gathered to advocate for universal access to the highest quality diagnostics, care, and treatment for HCV—regardless of income, geographic location, drug use, or HIV status. They agreed that countries have the right to pursue the full range of strategies for securing access to affordable, quality HCV DAAs, and peginterferon (PEG-IFN). www.treatmentactiongroup.org/hcv/publications/wcab-report-2014

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The initiative


Treat People Right is an initiative of the International Treatment Preparedness Coalition. It aims to emphasise and promote community action on the right to treatment at the International AIDS Conference in Washington DC 2012.
What does treating people right look like? It looks like:

• A world where everyone who needs them has access to better, simpler and affordable medicines for HIV, TB and Hepatitis C
• A world where everyone has access to affordable diagnostics to test and manage treatment.
• A world where everyone has access to health services free from stigma and discrimination
• A world where communities are central to the decision making processes that affect their lives.