Theoretical Problems of Legal Regulation of Innovations in the Medical Field: Experience in Counteracting Covid-19

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Ius Humani: Revista de Derecho, ISSN 1390-440X, Vol. 9, Nº. 2, 2020 (Ejemplar dedicado a: Ius Humani. Law Journal), pags. 251-289

English

The work is devoted to identifying the main problems of legal regulation of innovations in the medical field and developing the best options for solving them in the context of the Covid-19 pandemic. Thus, the research methodology is based on general and special scientific methods, in particular: formal legal, historical and legal, comparative analysis, and modeling. So, the procedure and issues to be considered are as follows. In the introduction, we will briefly highlight the origins of intellectual property rights issues in the medical field and the overall state of the pharmaceutical industry. In the first subsection of the third section, we will consider the positions of the main players in the pharmaceutical industry and the contradictions between them. In the second subsection, we will highlight the international obligations under TRIPS. In the third subsection, we will consider the consequences of their direct violation. In the fourth subsection, the impact of Covid-19 and the methods of legal regulation of medical innovations and patents under the TRIPS agreement will be discussed. In the fifth subsection, we will propose a way out and a compromise according to the Indian scenario. As a result of the study, contradictions were identified in the aspect of maintaining the balance of private and public interests between states and international pharmaceutical companies in the context of a pandemic and proposed ways to resolve them within the existing legal methods under the TRIPS agreement to achieve an acceptable compromise.

Article

Fedorov, Valentyn
Kravchenko, Sergii
Reznichenko, Hanna
Opara, Nataliia
Tsybokhin, Oleg

Fedorov, Valentyn
Kravchenko, Sergii
Reznichenko, Hanna
Opara, Nataliia
Tsybokhin, Oleg
Theoretical Problems of Legal Regulation of Innovations in the Medical Field: Experience in Counteracting Covid-19

Fedorov, Valentyn
Kravchenko, Sergii
Reznichenko, Hanna
Opara, Nataliia
Tsybokhin, Oleg

Fedorov, Valentyn

Theoretical Problems of Legal Regulation of Innovations in the Medical Field: Experience in Counteracting Covid-19

Theoretical Problems of Legal Regulation of Innovations in the Medical Field: Experience in Counteracting Covid-19

Theoretical Problems of Legal Regulation of Innovations in the Medical Field: Experience in Counteracting Covid-19

Theoretical Problems of Legal Regulation of Innovations in the Medical Field: Experience in Counteracting Covid-19

Theoretical Problems of Legal Regulation of Innovations in the Medical Field: Experience in Counteracting Covid-19

theoretical problems of legal regulation of innovations in the medical field: experience in counteracting covid-19

2020

https://dialnet.unirioja.es/servlet/oaiart?codigo=8229353

1722690066261737472

dialnet-ar-18-ART00015030282022-01-21Theoretical Problems of Legal Regulation of Innovations in the Medical Field: Experience in Counteracting Covid-19Fedorov, ValentynKravchenko, SergiiReznichenko, HannaOpara, NataliiaTsybokhin, OlegThe work is devoted to identifying the main problems of legal regulation of innovations in the medical field and developing the best options for solving them in the context of the Covid-19 pandemic. Thus, the research methodology is based on general and special scientific methods, in particular: formal legal, historical and legal, comparative analysis, and modeling. So, the procedure and issues to be considered are as follows. In the introduction, we will briefly highlight the origins of intellectual property rights issues in the medical field and the overall state of the pharmaceutical industry. In the first subsection of the third section, we will consider the positions of the main players in the pharmaceutical industry and the contradictions between them. In the second subsection, we will highlight the international obligations under TRIPS. In the third subsection, we will consider the consequences of their direct violation. In the fourth subsection, the impact of Covid-19 and the methods of legal regulation of medical innovations and patents under the TRIPS agreement will be discussed. In the fifth subsection, we will propose a way out and a compromise according to the Indian scenario. As a result of the study, contradictions were identified in the aspect of maintaining the balance of private and public interests between states and international pharmaceutical companies in the context of a pandemic and proposed ways to resolve them within the existing legal methods under the TRIPS agreement to achieve an acceptable compromise.El artículo está dedicado a identificar los principales problemas de regulación legal de las innovaciones en el campo médico y desarrollar las mejores opciones para solucionarlos en el contexto de la pandemia Covid-19. Esta investigación utiliza los métodos científicos generales y especiales, en particular: formal legal, histórico y legal, análisis comparativo y modelización. Se consideran las siguientes cuestiones, en el siguiente orden. En la introducción, se mencionan los orígenes de los problemas de derechos de propiedad intelectual en el campo médico y el estado general de la industria farmacéutica. En la primera subsección de la tercera sección, consideraremos las posiciones de los principales actores de la industria farmacéutica y las contradicciones entre ellos. En la segunda subsección, destacaremos las obligaciones internacionales bajo los ADPIC. En la tercera subsección, consideraremos las consecuencias de su violación directa. En la cuarta subsección, se discutirá el impacto de Covid-19 y los métodos de regulación legal de las innovaciones médicas y las patentes bajo el acuerdo ADPIC. En la quinta subsección, propondremos una salida y un compromiso de acuerdo con el escenario indio. Como resultado del estudio, se identificaron contradicciones en el aspecto de mantener el equilibrio de los intereses públicos y privados entre los estados y las empresas farmacéuticas internacionales en el contexto de una pandemia y se propusieron formas de resolverlas dentro de los métodos legales existentes en el marco del acuerdo ADPIC para lograr un compromiso aceptable.2020text (article)application/pdfhttps://dialnet.unirioja.es/servlet/oaiart?codigo=8229353(Revista) ISSN 1390-7794(Revista) ISSN 1390-440XIus Humani: Revista de Derecho, ISSN 1390-440X, Vol. 9, Nº. 2, 2020 (Ejemplar dedicado a: Ius Humani. Law Journal), pags. 251-289engLICENCIA DE USO: Los documentos a texto completo incluidos en Dialnet son de acceso libre y propiedad de sus autores y/o editores. Por tanto, cualquier acto de reproducción, distribución, comunicación pública y/o transformación total o parcial requiere el consentimiento expreso y escrito de aquéllos. Cualquier enlace al texto completo de estos documentos deberá hacerse a través de la URL oficial de éstos en Dialnet. Más información: https://dialnet.unirioja.es/info/derechosOAI | INTELLECTUAL PROPERTY RIGHTS STATEMENT: Full text documents hosted by Dialnet are protected by copyright and/or related rights. This digital object is accessible without charge, but its use is subject to the licensing conditions set by its authors or editors. Unless expressly stated otherwise in the licensing conditions, you are free to linking, browsing, printing and making a copy for your own personal purposes. All other acts of reproduction and communication to the public are subject to the licensing conditions expressed by editors and authors and require consent from them. Any link to this document should be made using its official URL in Dialnet. More info: https://dialnet.unirioja.es/info/derechosOAI