Civil Society Against EU-INDIA Free Trade Agreement sign now

Tratado de Livre Comйrcio entre Нndia e Uniгo Europйia pode afetar acesso a medicamentos no Brasil e demais paнses da Amйrica Latina

Esta carta aberta tem a intenзгo de manifestar a preocupaзгo do Grupo de Trabalho sobre Propriedade Intelectual da Rede Brasileira de Integraзгo dos Povos(GTPI/Rebrip) e dos grupos da sociedade civil abaixo-assinados com as negociaзхes do Tratado de Livre Comйrcio (TLC) entre Нndia e Uniгo Europйia (UE) e as possнveis conseqькncias negativas para a aquisiзгo de medicamentos genйricos indianos mais baratos e sua importвncia para a sustentabilidade de polнticas de acesso a medicamentos no Brasil e nos demais paнses na Amйrica Latina.

A Нndia tem papel chave para tornar possнvel o acesso a medicamentos nos paнses em desenvolvimento - uma conquista de lutas intensas dos movimentos de saъde nos ъltimos anos em diferentes partes do mundo. Como exemplo, pode-se citar que 92\% das pessoas que vivem com HIV/AIDS nos paнses de rendas baixa e mйdia utilizam medicamentos anti-retrovirais comercializados pela Нndia a preзos mais acessнveis. Como exemplo da importвncia da Нndia para o acesso a medicamentos cabe lembrar o exemplo da emissгo da licenзa compulsуria do medicamento contra AIDS Efavirenz no Brasil em 2007. O imediato fornecimento deste medicamento apуs a licenзa sу foi possнvel porque o Brasil pode importar uma versгo genйrica indiana atй a que produзгo da versгo brasileira se concretizasse em 2009.

Apуs a entrada em vigor do Acordo TRIPS da OMC e, principalmente, apуs a adequaзгo da Нndia em 2005 аs exigкncias de reconhecimento de patentes no setor farmacкutico, o cenбrio traz sйrias preocupaзхes para a sustentabilidade das polнticas de acesso a medicamentos. Tal fato ocorre, pois os novos tratamentos passam a estar sujeitos а proteзгo patentбria gerando incertezas quanto а rбpida disponibilidade de versхes genйricas. O cenбrio se agrava ainda mais com as negociaзхes de Tratados de Livre Comйrcio (TLCs) que contemplam clбusulas mais restritivas em matйria de propriedade intelectual que no Acordo TRIPS (TRIP-plus).

Desde 2007, a UE tem negociado a portas fechadas com a Нndia um TLC que prevк medidas extremamente danosas а saъde pъblica nгo somente da populaзгo Нndia, mas de muitos outros paнses em desenvolvimento que dependem da aquisiзгo de medicamentos genйricos indianos. Alйm da oferta de medicamentos a preзos acessнveis, a indъstria de genйricos indiana й responsбvel por grande parte da produзгo de terapias de combinaзхes de doses fixas e termoestбveis, de suma importвncia para paнses em desenvolvimento.

Й importante ressaltar que a UE estб negociando TLCs em diferentes partes do mundo, tal como com paнses Andinos (Colфmbia, Peru), Corйia do Sul e Mercosul. Alйm disso, vem exercendo pressгo unilateral para que outros paнses adotem o mesmo nнvel de proteзгo а propriedade intelectual que na UE. Grupos da sociedade civil da regiгo jб manifestaram sua oposiзгo а incorporaзгo de medidas TRIPS-plus.Manifestamos que tais clбusulas nгo devem ser incorporadas no TLC Нndia-EU, quais sejam:

- Exclusividade de dados: a proteзгo exclusiva das informaзхes clнnicas necessбrias para obter a autorizaзгo para comercializar determinado medicamento no paнs representa uma barreira para alйm da proteзгo patentбria e nгo estб prevista no Acordo TRIPS (TRIPS-plus). Esse tipo de medida pode retardar significativamente - ou mesmo bloquear - a entrada de genйricos no mercado e, ainda, enfraquecer sensivelmente a possibilidade de emissгo de licenзas compulsуrias nos paнses em desenvolvimento.

- Extensгo da vigкncia das patentes farmacкuticas: a intenзгo da UE com essa medida й "compensar" as empresas farmacкuticas pelo atraso que os escritуrios de patentes nacionais ou autoridades sanitбrias levam para examinar um pedido de patente ou registro sanitбrio. Possibilita, assim, a prorrogaзгo da vigкncia das patentes para alйm dos 20 anos de proteзгo patentбria - tempo mбximo de previsto no Acordo TRIPS.

- Enforcement de Propriedade Intelectual e Medidas de fronteiras: medidas de fronteira que possam bloquear o livre trвnsito de medicamentos essenciais - importaзгo e exportaзгo - sobre a alegaзгo de infraзгo de direitos de propriedade intelectual devem ser rechaзadas.

Esse tipo de medida й de grande preocupaзгo para o GTPI/Rebrip, pois pode afetar fortemente o acesso a medicamentos nos paнses em desenvolvimento, que dependem em grande medida dos genйricos oriundos da Нndia. A UE objetiva por meio do TLC alinhar a Нndia а sua regulamentaзгo aduaneira, em especial a resoluзгo n1383/2003. Cumpre lembrar que, baseadas nessa resoluзгo, foram feitas diversas apreensхes em solo europeu de medicamentos - nгo protegidos por direitos de propriedade intelectual nem em sua origem nem em seu destino - em trвnsito da Нndia para outros paнses em desenvolvimento, incluindo o Brasil, Peru, Colфmbia e Equador. A inclusгo desse tipo de aparato legal na lei indiana serб ainda mais danosa ao acesso a medicamentos nos paнses em desenvolvimento, pois legitimarб na Нndia medidas que, atualmente, estгo sendo tomadas em paнses da Europa e vem sendo objeto de crнticas inclusive no prуprio Parlamento Europeu.

A luta pelo acesso a medicamentos й a mesma em qualquer lugar do mundo, seja na Нndia, no Brasil ou no Peru. Nуs rechaзamos o TLC entre UE e Нndia tendo a absoluta certeza de que essa aзгo serб um retrocesso nas conquistas alcanзadas pela sociedade civil de todos os paнses em desenvolvimento, para a ampliaзгo do acesso a medicamentos.

A rejeiзгo desse tratado certamente ressoarб por todos os paнses em que o acesso a medicamentos й posto em cheque cotidianamente por causa de prбticas restritivas e monopolistas. Devido ao fato de que a UE clama na sua Resoluзгo de 12 de Julho de 2007 ter como compromisso o acesso a medicamentos e a nгo adoзгo de regras restritivas de propriedade intelectual, retire de seus TLCs todas clбusulas que representam obstбculos para o acesso a medicamentos. Ademais, acreditamos que este apelo serб acolhido pelo governo indiano que nгo recuarб e continuarб em seu caminho, o de ampliar ao acesso de milhхes de pessoas a inъmeros medicamentos essenciais.

Grupo de Trabalho sobre Propriedade Intelectual (GTPI/REBRIP)
http://bit.ly/bpbjZR
http://www.twitter.com/gtpi

____________________________________________________________________________

Free Trade Agreement between India and the European Union may affect access to medicines in Brazil and other Latin American countries

This open letter has the intent to manifest the concerns from the Working Group on Intellectual Property (GTPI) from the Brazilian Network for the Integration of Peoples (REBRIP) and other civil society groups in regards to the negotiations of a Free Trade Agreement (FTA) between India and the European Union (EU). The concern refer to its possible negative consequences for the procurement of cheaper generic Indian medicines and its importance for the sustainability of policies for guaranteed access to medicines in Brazil and other Latin American countries.

India has an important role in making access to medicines possible in developing countries a conquest which resulted from intense struggle from health-related movements in the last few years in several parts of the world. As an example, 92\% of the people living with HIV/AIDS in low and middle-income countries use antiretroviral medicines produced by India at more affordable prices. Indias importance in access to medicines is illustrated in Brazils compulsory license for AIDS medicine, efavirenz, in 2007. The immediate provision of the medicine after the license was issued was only made possible because Brazil could import its Indian generic version until the production of a Brazilian version began in 2009.

After WTOs TRIPS Agreement came into force and especially after Indias adaptation, in 2005, to the requirements in relation to patent recognition in pharmaceutical sector, the scenario is one of apprehension. Concerns regarding the sustainability of access policies are brought about because new treatments are to receive patent protection, increasing the uncertainty as to the availability of generic versions. An aggravation of the current circumstances is caused by the negotiations of Free Trade Agreements (FTAs) which contemplate far more restrictive clauses in regards to intellectual property than those included in the TRIPS Agreement (known as TRIPS Plus).

Since 2007, the EU has negotiated behind closed doors a FTA with India which foresees extremely hazardous measures for public health, not only for the Indian population, but also for many other developing countries which depend on the procurement of generic Indian medicines. Besides the offer of affordable medicines, the Indian industry of generic versions is responsible for manufacturing great part of fixed-dose combination and thermostable therapies, of vast importance to developing countries.

It is important to emphasize that the EU is negotiating FTAs in different parts of the world, such as the Andean countries (Colombia and Peru), South Korea, and members of the MERCOSUR. Moreover, it has been unilaterally pressuring other countries to adopt a similar level of intellectual property protection as its own. Civil society groups of the region have already manifested their opposition in relation to the incorporation of TRIPS-Plus measures. We have manifested that clauses regarding the following topics should not be included in the FTA between India and the EU:

- Data exclusivity: The exclusive protection of clinical information, necessary for the obtainment of marketing approval for medicines, represents a barrier which goes beyond patent protection and the TRIPS Agreement. Measures of this kind may significantly delay or even block generic versions from entering the market, and weakens the possibility of issuing compulsory licenses in developing countries.
- Extension of the pharmaceutical patent term: The EUs intention with this measure is to compensate pharmaceutical companies for the delay that national patent or sanitary authorities may have in examining a patent application or sanitary registry. It allows the patent protection period to be extended beyond the 20 years, foreseen as the maximum period of protection in the TRIPS Agreement.
- Enforcement of Intellectual Property and Boarder Measures: Boarder measures which may block the free transit of essential medicines importation and exportation under the allegation that it is an infraction of intellectual property rights have to be rejected.

Measures of this kind are of great concern to GTPI/Rebrip for they might strongly affect the access to medicines in developing countries, which largely depend on Indian generic versions. The EU attempts to align India to its customs regulations, especially with resolution nє. 1383/2003. It is important to note that, based on this resolution, several seizures of medicines were made in European territory not protected by intellectual property rights in their origin or destination transiting from India to other developing countries, including Brazil, Peru, Colombia, and Ecuador. The inclusion of this mechanism in the Indian law will be even more detrimental to access to medicines in developing countries, since it will legitimize in India measures which currently are being taken in European countries and have been criticized even in the European Parliament.

The struggle for access to medicines is the same anywhere in the world, be it in India, Brazil or Peru. We reject the FTA between the EU and India with absolute certainty that this agreement represents a regression in the conquests of increasing access to medicines; conquests which were achieved by civil society in all developing countries.

The rejection of this treaty will certainly reverberate in all countries where access to medicines is jeopardized daily by monopolistic and restrictive practices. The EU claims in its July 12th, 2007 Resolution that they are committed to improve access to medicines, and not to the adoption of restrictive intellectual property rules. For this reason, the UE should remove all clauses from their FTAs which may represent obstacles for the access to medicines. Furthermore, we believe that this appeal will be recognized by the Indian government, which will not give up and will continue in its path to increase access to essential medicines for millions of people.

Brazilian Working Group of Intellectual Property (GTPI/REBRIP)
http://bit.ly/bpbjZR
http://www.twitter.com/gtpi


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Emily BoyerBy:
Justice, rights and public orderIn:
Petition target:
European Comission, European Parlament, Indian Embassy in Brazil

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