{"id":3253,"date":"2021-06-02T07:03:15","date_gmt":"2021-06-02T10:03:15","guid":{"rendered":"https:\/\/sites.usp.br\/netiusp\/?p=3253"},"modified":"2021-08-18T19:49:08","modified_gmt":"2021-08-18T22:49:08","slug":"a-importacao-de-vacinas-genericas-contra-o-covid-19-pela-bolivia-conhecendo-a-flexibilidade-especial-do-artigo-31bis-do-trips","status":"publish","type":"post","link":"https:\/\/sites.usp.br\/netiusp\/pt\/a-importacao-de-vacinas-genericas-contra-o-covid-19-pela-bolivia-conhecendo-a-flexibilidade-especial-do-artigo-31bis-do-trips\/","title":{"rendered":"A importa\u00e7\u00e3o de vacinas gen\u00e9ricas contra o COVID-19 pela Bol\u00edvia: conhecendo a flexibilidade especial do artigo 31bis do TRIPS"},"content":{"rendered":"\t\t
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Posts<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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A importa\u00e7\u00e3o de vacinas gen\u00e9ricas contra o COVID-19 pela Bol\u00edvia: conhecendo a flexibilidade especial do artigo 31bis do TRIPS <\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Photo: Bra\u0148o (@3dparadise) | https:\/\/unsplash.com\/photos\/QSuou3VAtf4<\/figcaption>\n\t\t\t\t\t\t\t\t\t\t<\/figure>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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O governo da Bol\u00edvia notificou formalmente a OMC sobre a necessidade do pa\u00eds de importar vacinas contra o COVID-19, buscando usar as flexibilidades nas regras de propriedade intelectual da OMC como estrat\u00e9gia de resposta \u00e0 pandemia. O pa\u00eds notificou a OMC que precisa importar 15 milh\u00f5es de doses da vacina, de acordo com o sistema legal introduzido em uma emenda de 2017 ao Acordo sobre Aspectos dos Direitos de Propriedade Intelectual Relacionados ao Com\u00e9rcio (TRIPS). Essa emenda, que criou o Artigo 31bis do Acordo TRIPS, fornece um instrumento jur\u00eddico adicional para pa\u00edses dependentes de importa\u00e7\u00e3o terem acesso a medicamentos, vacinas e outros produtos farmac\u00eauticos a pre\u00e7os acess\u00edveis.[1]<\/a><\/p>

A Bol\u00edvia deu seguimento, pois, a notifica\u00e7\u00e3o anteriormente apresentada em fevereiro, quando sinalizou que pretendia exercer as flexibilidades permitidas pela emenda ao TRIPS.[2]<\/a> A notifica\u00e7\u00e3o do pa\u00eds abre a possibilidade de importa\u00e7\u00e3o das vacinas necess\u00e1rias de qualquer um dos membros da OMC que implementaram leis nacionais que prev\u00eaem a produ\u00e7\u00e3o e exporta\u00e7\u00e3o de medicamentos feitos sob licen\u00e7a compuls\u00f3ria por meio deste sistema.<\/p>

Cerca de 50 membros da OMC implementaram tais modifica\u00e7\u00f5es em sua legisla\u00e7\u00e3o interna, dentre os quais: Alb\u00e2nia, Austr\u00e1lia, Botswana, Canad\u00e1, China, Cro\u00e1cia, Cuba, Uni\u00e3o Europeia, Hong Kong, \u00cdndia, Jord\u00e2nia, Cazaquist\u00e3o, Nova Zel\u00e2ndia, Noruega, Om\u00e3, Filipinas, Republica da Coreia, Singapura, Su\u00ed\u00e7a, Taip\u00e9 Chin\u00eas e Jap\u00e3o.[3]<\/a><\/p>

\u00c9 importante destacar a evolu\u00e7\u00e3o da mat\u00e9ria e a diferen\u00e7a desta situa\u00e7\u00e3o para a circunstancia de concess\u00e3o de licen\u00e7as compuls\u00f3rias \u201cordin\u00e1rias\u201d, albergada por motivos de sa\u00fade p\u00fablica, j\u00e1 permitida antes de 2017.<\/p>

Ocorre que as regras do TRIPS originalmente restringiam as licen\u00e7as compuls\u00f3rias – autoriza\u00e7\u00f5es emitidas por uma autoridade governamental ou um tribunal para fazer determinado uso de uma inven\u00e7\u00e3o patenteada sem o consentimento do detentor da patente – para atender principalmente ao mercado dom\u00e9stico. [4]<\/a><\/p>

A Declara\u00e7\u00e3o de Doha sobre o TRIPS e a Sa\u00fade P\u00fablica de 2001 reconheceu que essa restri\u00e7\u00e3o ao licenciamento compuls\u00f3rio poderia prejudicar seu uso efetivo por pa\u00edses com capacidade de fabrica\u00e7\u00e3o insuficiente ou inexistente no setor farmac\u00eautico. Consta do paragrafo 6 desta declara\u00e7\u00e3o, que acabou \u201cbatizando\u201d informalmente este tipo de flexibilidade:[5]<\/a><\/p>

\u201c6. We recognize that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002.\u201d<\/em><\/p><\/blockquote>

Assim, foi realizada uma altera\u00e7\u00e3o do Acordo TRIPS em 2005, que entrou em vigor apenas em 2017, [6]<\/a> com a aceita\u00e7\u00e3o de dois ter\u00e7os dos membros da organiza\u00e7\u00e3o. A altera\u00e7\u00e3o, portanto, foi realizada com o objetivo de afastar essa dificuldade identificada, criando uma forma adicional de licen\u00e7a compuls\u00f3ria especialmente adaptada para a exporta\u00e7\u00e3o de medicamentos para pa\u00edses necessitados, consistindo, na pr\u00e1tica, numa licen\u00e7a compuls\u00f3ria \u201crelacionada ao com\u00e9rcio\u201d. [7]<\/a><\/p>

O mecanismo, conhecido como “sistema do par\u00e1grafo 6”, foi autorizado pela incorpora\u00e7\u00e3o do Artigo 31bis do Acordo TRIPS[8]<\/a>, permitindo que medicamentos gen\u00e9ricos de baixo custo sejam produzidos e exportados sob licen\u00e7a compuls\u00f3ria exclusivamente para o prop\u00f3sito de atender \u00e0s necessidades de pa\u00edses que n\u00e3o podem fabricar esses produtos eles pr\u00f3prios.<\/p>

Segundo a OMC, o uso desta licen\u00e7a compuls\u00f3ria especial requer notifica\u00e7\u00e3o formal \u00e0 Organiza\u00e7\u00e3o, existindo tr\u00eas tipos de notifica\u00e7\u00e3o:[9]<\/a><\/p>

      1. Notifica\u00e7\u00e3o geral \u00fanica do membro importador sobre a inten\u00e7\u00e3o de usar o sistema do Par\u00e1grafo 6 (n\u00e3o exigida para membros menos desenvolvidos);<\/li>
      2. Notifica\u00e7\u00e3o espec\u00edfica do membro importador dos detalhes dos produtos farmac\u00eauticos necess\u00e1rios e outros detalhes exigidos pelo sistema do Par\u00e1grafo 6;<\/li>
      3. Notifica\u00e7\u00e3o do membro exportador de concess\u00e3o de licen\u00e7a compuls\u00f3ria para exporta\u00e7\u00e3o e condi\u00e7\u00f5es a ela associadas.<\/li><\/ol><\/li><\/ol><\/li><\/ol>

        Antony Taubman, Diretor da Divis\u00e3o de Propriedade Intelectual da OMC, refor\u00e7a a estrat\u00e9gia legitima escolhida pelo pa\u00eds latino-americano:<\/p>

        \u201cEste \u00e9 um exemplo de um membro da OMC que busca fazer uso das ferramentas dispon\u00edveis no Acordo TRIPS para responder \u00e0 pandemia do COVID-19, mesmo quando os membros buscam expandir o leque de op\u00e7\u00f5es por meio da proposta de isen\u00e7\u00e3o do TRIPS<\/em>\u201d[10]<\/a>.<\/p><\/blockquote>

        Segundo a OMC, o Secretariado da Organiza\u00e7\u00e3o foi incentivado pelos membros do Conselho do TRIPS a fornecer qualquer assist\u00eancia t\u00e9cnica necess\u00e1ria para facilitar o uso do sistema para importar produtos farmac\u00eauticos fabricados sob licen\u00e7a compuls\u00f3ria,[11]<\/a> o que \u00e9 de especial relev\u00e2ncia no contexto atual de enfrentamento a pandemia do COVID-19. \u00a0<\/p>

        \u00a0<\/p>

        \u00a0<\/p>

        [1]<\/a> WTO. Bolivia outlines vaccine import needs in use of WTO flexibilities to tackle pandemic. COVID-19 AND WORLD TRADE. 12 mai 2021. Dispon\u00edvel em: https:\/\/www.wto.org\/english\/news_e\/news21_e\/dgno_10may21_e.htm<\/a> Acesso em: 31 mai. 2021.<\/p>

        [2]<\/a> WTO. Bolivia outlines vaccine import needs in use of WTO flexibilities to tackle pandemic. COVID-19 AND WORLD TRADE. 12 mai 2021. Dispon\u00edvel em: https:\/\/www.wto.org\/english\/news_e\/news21_e\/dgno_10may21_e.htm<\/a> Acesso em: 31 mai. 2021.<\/p>

        [3]<\/a> WTO. Members\u2019 laws implementing the \u2018Paragraph 6\u2019 system. INTELLECTUAL PROPERTY: TRIPS AND HEALTH. Dispon\u00edvel em: https:\/\/www.wto.org\/english\/tratop_e\/trips_e\/par6laws_e.htm<\/a> Acesso em: 31 mai. 2021.<\/p>

        [4]<\/a> WTO.\u00a0 Guide to Notifications. TRIPS: SPECIAL COMPULSORY LICENCES FOR EXPORT OF MEDICINES. Dispon\u00edvel em: https:\/\/www.wto.org\/english\/tratop_e\/trips_e\/par6_modelnotifs_e.htm<\/a> Acesso em: 31 mai. 2021.<\/p>

        [5]<\/a> WTO. Declaration on the TRIPS agreement and public health. DOHA WTO MINISTERIAL 2001: TRIPS. WT\/MIN(01)\/DEC\/2, 20 nov. 2001. Dispon\u00edvel em: https:\/\/www.wto.org\/english\/thewto_e\/minist_e\/min01_e\/mindecl_trips_e.htm<\/a> Acesso em: 31 mai. 2021.<\/p>

        [6]<\/a> INPI Emenda de TRIPs permite licen\u00e7a compuls\u00f3ria para exportar medicamentos. 10 fev. 2017. Dispon\u00edvel em: https:\/\/www.gov.br\/inpi\/pt-br\/assuntos\/noticias\/emenda-de-trips-permite-licenca-compulsoria-para-exportar-medicamentos<\/a> Acesso em: 31 mai. 2021.<\/p>

        [7]<\/a> WTO.\u00a0 Guide to Notifications. TRIPS: SPECIAL COMPULSORY LICENCES FOR EXPORT OF MEDICINES. Dispon\u00edvel em: https:\/\/www.wto.org\/english\/tratop_e\/trips_e\/par6_modelnotifs_e.htm<\/a> Acesso em: 31 mai. 2021.<\/p>

        [8]<\/a> \u201cArticle 31bis: 1. The obligations of an exporting Member under Article 31(f) shall not apply with respect to the grant by it of a compulsory licence to the extent necessary for the purposes of production of a pharmaceutical product(s) and its export to an eligible importing Member(s) in accordance with the terms set out in paragraph 2 of the Annex to this Agreement. 2. Where a compulsory licence is granted by an exporting Member under the system set out in this Article and the Annex to this Agreement, adequate remuneration pursuant to Article 31(h) shall be paid in that Member taking into account the economic value to the importing Member of the use that has been authorized in the exporting Member. Where a compulsory licence is granted for the same products in the eligible importing Member, the obligation of that Member under Article 31(h) shall not apply in respect of those products for which remuneration in accordance with the first sentence of this paragraph is paid in the exporting Member. 3. With a view to harnessing economies of scale for the purposes of enhancing purchasing power for, and facilitating the local production of, pharmaceutical products: where a developing or least developed country WTO Member is a party to a regional trade agreement within the meaning of Article XXIV of the GATT 1994 and the Decision of 28 November 1979 on Differential and More Favourable Treatment Reciprocity and Fuller Participation of Developing Countries (L\/4903), at least half of the current membership of which is made up of countries presently on the United Nations list of least developed countries, the obligation of that Member under Article 31(f) shall not apply to the extent necessary to enable a pharmaceutical product produced or imported under a compulsory licence in that Member to be exported to the markets of those other developing or least developed country parties to the regional trade agreement that share the health problem in question. It is understood that this will not prejudice the territorial nature of the patent rights in question. 4. Members shall not challenge any measures taken in conformity with the provisions of this Article and the Annex to this Agreement under subparagraphs 1(b) and 1(c) of Article XXIII of GATT 1994.
        5. This Article and the Annex to this Agreement are without prejudice to the rights, obligations and flexibilities that Members have under the provisions of this Agreement other than paragraphs (f) and (h) of Article 31, including those reaffirmed by the Declaration on the TRIPS Agreement and Public Health (WT\/MIN(01)\/DEC\/2), and to their interpretation. They are also without prejudice to the extent to which pharmaceutical products produced under a compulsory licence can be exported under the provisions of Article 31(f).\u201d WTO. GENERAL COUNCIL. Amendment of the TRIPS Agreement. WT\/L\/641, 8 dez. 2005. Disponivel em:         https:\/\/www.wto.org\/english\/tratop_e\/trips_e\/wtl641_e.htm<\/a> Acesso em: 31 mai. 2021.<\/p>

        [9]<\/a> WTO. Guide to Notifications. TRIPS: SPECIAL COMPULSORY LICENCES FOR EXPORT OF MEDICINES. Dispon\u00edvel em: https:\/\/www.wto.org\/english\/tratop_e\/trips_e\/par6_modelnotifs_e.htm<\/a> Acesso em: 31 mai. 2021.<\/p>

        [10]<\/a> WTO. Bolivia outlines vaccine import needs in use of WTO flexibilities to tackle pandemic. COVID-19 AND WORLD TRADE. 12 mai 2021. Dispon\u00edvel em: https:\/\/www.wto.org\/english\/news_e\/news21_e\/dgno_10may21_e.htm<\/a> Acesso em: 31 mai. 2021.<\/p>

        [11]<\/a> WTO. Bolivia outlines vaccine import needs in use of WTO flexibilities to tackle pandemic. COVID-19 AND WORLD TRADE. 12 mai 2021. Dispon\u00edvel em: https:\/\/www.wto.org\/english\/news_e\/news21_e\/dgno_10may21_e.htm<\/a> Acesso em: 31 mai. 2021.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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        Outras publica\u00e7\u00f5es de Camilla Capucio<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

        Posts A importa\u00e7\u00e3o de vacinas gen\u00e9ricas contra o COVID-19 pela Bol\u00edvia: conhecendo a flexibilidade especial do artigo 31bis do TRIPS Photo: Bra\u0148o (@3dparadise) | https:\/\/unsplash.com\/photos\/QSuou3VAtf4 O governo da Bol\u00edvia notificou formalmente a OMC sobre a necessidade do pa\u00eds de importar vacinas contra o COVID-19, buscando usar as flexibilidades nas regras de propriedade intelectual da OMC […]<\/p>\n","protected":false},"author":22467,"featured_media":3257,"comment_status":"open","ping_status":"open","sticky":false,"template":"elementor_header_footer","format":"standard","meta":{"footnotes":"","_links_to":"","_links_to_target":""},"categories":[19],"tags":[171,31],"class_list":["post-3253","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-posts","tag-camilla-capucio","tag-mecanismo-de-solucao-de-controversias-da-omc","entry","has-media"],"_links":{"self":[{"href":"https:\/\/sites.usp.br\/netiusp\/wp-json\/wp\/v2\/posts\/3253","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sites.usp.br\/netiusp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sites.usp.br\/netiusp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sites.usp.br\/netiusp\/wp-json\/wp\/v2\/users\/22467"}],"replies":[{"embeddable":true,"href":"https:\/\/sites.usp.br\/netiusp\/wp-json\/wp\/v2\/comments?post=3253"}],"version-history":[{"count":4,"href":"https:\/\/sites.usp.br\/netiusp\/wp-json\/wp\/v2\/posts\/3253\/revisions"}],"predecessor-version":[{"id":3906,"href":"https:\/\/sites.usp.br\/netiusp\/wp-json\/wp\/v2\/posts\/3253\/revisions\/3906"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sites.usp.br\/netiusp\/wp-json\/wp\/v2\/media\/3257"}],"wp:attachment":[{"href":"https:\/\/sites.usp.br\/netiusp\/wp-json\/wp\/v2\/media?parent=3253"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sites.usp.br\/netiusp\/wp-json\/wp\/v2\/categories?post=3253"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sites.usp.br\/netiusp\/wp-json\/wp\/v2\/tags?post=3253"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}