Problemas teóricos de la regulación legal de las innovaciones en el cuidado de la salud: experiencia de contrarrestar el Covid-19

AutorValentyn Fedorov, Sergii Kravchenko, Hanna Reznichenko, Nataliia Opara, Oleg Tsybokhin
CargoPh. D., Associate Professor of Department of General Theoretical Jurisprudence of National University 'Odesa Law Academy' (Odesa, Ukraine)/Director of the Center for Distance and Distance Learning, Ph.D., Associate Professor of General Theoretical Jurisprudence of National University 'Odesa Law Academy' (Odesa, Ukraine)/Ph. D., Odesa State ...
Páginas251-289
Revista de Derecho. Vol. 9 (II) (2020), pp. 251-289. ISSN: 1390-440X eISSN: 1390-7794
Recepción: 6-7-2020. Aceptación: 30-8-2020. Publicación electrónica: 15-10-2020
https://doi.org/10.31207/ih.v9i2.254
vol. 9 (II) (2020), p. 251
THEORETICAL PROBLEMS OF LEGAL REGULATION OF
INNOVATIONS IN THE MEDICAL FIELD: EXPERIENCE IN
COUNTERACTING COVID-19
PROBLEMAS TEÓRICOS DE LA REGULACIÓN LEGAL DE LAS INNOVACIONES EN EL CUIDADO DE
LA SALUD: EXPERIENCIA DE CONTRARRESTAR EL COVID-19
Valentyn Fedorov*
Sergii Kravchenko**
Hanna Reznichenko***
Nataliia Opara****
Oleg Tsybokhin *****
Abstract: 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
* Ph. D., Associate Professor of Department of General Theoretical Jurisprudence of
National University Odesa Law Academy (Odesa, Ukraine). https://orcid.org/0000-0003-
3130-2602. pom.president@gmail.com
** Director of the Center for Distance and Distance Learning, Ph.D., Associate Professor of
General Theoretical Jurisprudence of National University Odesa Law Academy (Odesa,
Ukraine). https://orcid.org/0000-0001-6252-3243. murineus@gmail.com
*** Ph. D., Odesa State University of Internal Affairs (Odesa, Ukraine).
http://orcid.org/0000-0001-6386-4154. anna24@ukr.net
**** Ph. D. candidate of Department of Labor Law and Social Security Law of National
University Odesa Law Academy (Odesa, Ukraine). https://orcid.org/0000-0 003-1157-
5013. nataliiapara@gmail.com
***** Master of Public Administration o f National University Odesa Law Academy
(Odesa, Ukraine). https://orcid.org/0000-0003-0827-9432. turistos3333@gmail.c om
Valentyn Fedorov, Sergii Kravchenko, Hanna Reznichenko, Nataliia Opara & Oleg Tsybokhin
| v. 9 (II) (2019), p. 252
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.
Keywords: Innovation, Coronavirus, Intellectual Property, Health, TRIPS
Agreement
Resumen: 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.
Theoretical problems of legal regulation of innovations in health care
| v. 9 (II) (2019), p. 253
Palabras clave: Innovación, Coronavirus, propiedad intelectual, salud,
Acuerdo sobre los ADPIC
Summary. I. Introduction. I.1. Corruption in prescribing medicines. I.2.
Distributor monopoly. I.3. “Patent trolling”. I.4. Trade imbalance. I.5. Authorities’
reaction to the current state of pharmaceutical market. II. Analysis of recent
research. III. Results and discussion. III.1. Discussion on evergreen patents. III.2.
Ukraine’s international obligations under TRIPS. III.3. Guarantees for the
protection of foreign investments in the field of industrial property. III.4. Impact of
Covid-19 and regulatory practices for medical innovation and patents . a) Appeal
to emergency conditions. b) Compulsory licensing. c) Parallel import. d) Expedited
generic application. e) Managed entry agreements. III.5. Proposal to resolve the
evergreen patent problem: an Indian compromise. IV. Conclusions. References.
I. INTRODUCTION
The priority of every state is to ensure the inalienable rights and
freedoms of man and citizen. Therefore, enshrining the right of everyone to
health care at the international and national levels imposes appropriate
responsibilities on states to ensure it.
However, the results of the USAID (2018) (Not)expensive Medicine
study indicate that every second patient in Ukraine refuses treatment due to
a lack of funds. 65% of Ukrainians surveyed resorted to borrowing money
or selling the valuable property to cover the cost of medicines. And
medicines purchased with payment from the patients pocket account for
88.2%. There is no other country in Europe with such low coverage of drugs
by the state. Such disappointing data indicate that the right to health care in
Ukraine is insufficient.
There are enough reasons for this state of affairs: the stagnation of the
economy and the fall in the exchange rate of the national currency, falling
incomes of the population for several years in a row, the outflow of
specialists, and, as a result, the high cost of medicines and medical services.
Consider the general state of affairs and what is the place of legal regulation
of innovations in the medical field.
After the shock fall in 2014, the Ukrainian pharmaceutical market
shows a steady growth of 5-7% per year. The market for dietary supplements
stands out as it has doubled in volume since 2017. Market growth, imperfect
regulation, the fierce competition of many internal and external players have
led to a number of abuses and scandals that have shaken Ukrainian society
over the past few years (cf. Kirsanov, 2020).

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