Instituto de Estudios Políticos y Derecho Público "Dr. Humberto J. La Roche"
de la Facultad de Ciencias Jurídicas y Políticas de la Universidad del Zulia
Maracaibo, Venezuela
Esta publicación cientíca en formato digital es continuidad de la revista impresa
ISSN-Versión Impresa 0798-1406 / ISSN-Versión on line 2542-3185Depósito legal pp
197402ZU34
ppi 201502ZU4645
Vol.39 N° 68
Enero
Junio
2021
Recibido el 14/12/2020 Aceptado el 19/02/2021
ISSN 0798- 1406 ~ De pó si to le gal pp 198502ZU132
Cues tio nes Po lí ti cas
La re vis ta Cues tio nes Po lí ti cas, es una pu bli ca ción aus pi cia da por el Ins ti tu to
de Es tu dios Po lí ti cos y De re cho Pú bli co “Dr. Hum ber to J. La Ro che” (IEPDP) de la Fa-
cul tad de Cien cias Ju rí di cas y Po lí ti cas de la Uni ver si dad del Zu lia.
En tre sus ob je ti vos fi gu ran: con tri buir con el pro gre so cien tí fi co de las Cien cias
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ción, dis cu sión y con fron ta ción de las ideas y avan ces cien tí fi cos con com pro mi so so cial.
Cues tio nes Po lí ti cas apa re ce dos ve ces al año y pu bli ca tra ba jos ori gi na les con
avan ces o re sul ta dos de in ves ti ga ción en las áreas de Cien cia Po lí ti ca y De re cho Pú bli-
co, los cua les son so me ti dos a la con si de ra ción de ár bi tros ca li fi ca dos.
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Fabiola Tavares Duarte
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Re vis ta Cues tio nes Po lí ti cas. Av. Gua ji ra. Uni ver si dad del Zu lia. Nú cleo Hu ma nís ti co. Fa-
cul tad de Cien cias Ju rí di cas y Po lí ti cas. Ins ti tu to de Es tu dios Po lí ti cos y De re cho Pú bli co
“Dr. Hum ber to J. La Ro che”. Ma ra cai bo, Ve ne zue la. E- mail: cues tio nes po li ti cas@gmail.
com ~ loi chi ri nos por til lo@gmail.com. Te le fax: 58- 0261- 4127018.
Vol. 39, Nº 68 (Enero - Junio) 2021, 476-490
IEPDP-Facultad de Ciencias Jurídicas y Políticas - LUZ
Public and Private Interests in the
Sphere of Administration of
Vaccination in a Pandemic
DOI: https://doi.org/10.46398/cuestpol.3968.30
Iryna Drobush *
Liudmila Kornuta **
Olha Shmyndruk ***
Olena Kurhanska ****
Tetiana Polishchuk *****
Abstract
COVID-19 has posed challenges to the global community at
large and to jurisprudence in particular. In the current context,
it is of paramount importance to nd the best possible solutions
in the eld of legal regulation that help minimize the harmful
effects of the global multisectoral crisis, save lives and restore
the well-being of society. The work aims to clarify the theoretical problems
in the legal status of medical innovations in the context of the COVID-19
pandemic. The subject of research is anticoronavirus innovations in the
medical eld. The research methods used were the dialectical method,
the system method, the formal-legal method, the historical-legal method,
and the structural method. As a result of this work, the current state of
legal regulation of anti-ronavirus medical innovations was analysed, in
particular the international legal framework, as well as national legislation
in this area; contradictions in the observance of the balance of public and
private interests under the conditions of a pandemic are revealed and,
consequently, some ways of resolving them are suggested.
* Doctor of Jurispridence, Professor, Head of Department of State and Legal Disciplines of National
University of Ostroh Academy. ORCID ID: https://orcid.org/0000-0002-0006-8676. Email: iruna.
drobush@ukr.net
** Ph. D. in Law, Associate Professor; Associate Professor of Administrative and Financial Law, National
University “Odesa Law Academy” ORCID ID: https://orcid.org/0000-0001-7130-6347. Email:
Kornuta02@gmail.com
*** Ph.D. in Law, Senior Lecturer, Department of Civil Law, National University of Ostroh Academy.
ORCID ID: https://orcid.org/0000-0002-7135-2594. Email: Olha.shmyndruk@oa.edu.ua.
**** Senior Lecturer, Department of State and Legal Disciplines, Institute of Law named after I. Malinovskyi,
National University of Ostroh Academy, lawyer. ORCID ID: https://orcid.org/0000-0002-6364-7114.
Email: O.kurganska@gmail.com
***** Ph. D. candidate of Department of State and Legal Disciplines, Institute of Law named after I.
Malinovskyi, National University of Ostroh Academy, lawyer. ORCID ID: https://orcid.org/0000-
0001-9010-7474. Email: Polischuk.tatyana@ukr.net
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Keywords: medical innovation; intellectual property; international
health crisis; COVID-19; public administration.
Intereses públicos y privados en el ámbito de la
administración de la vacunación en una pandemia
Resumen
El COVID-19 ha planteado desafíos a la comunidad mundial en general
y a la jurisprudencia en particular. En el contexto actual, es de suma
importancia encontrar las mejores soluciones posibles en el campo de la
regulación legal que ayuden a minimizar los efectos nocivos de la crisis
multisectorial global, salvar vidas y restaurar el bienestar de la sociedad.
El trabajo tiene como objetivo esclarecer los problemas teóricos en el
estatus legal de las innovaciones médicas en el contexto de la pandemia de
COVID-19. El tema de la investigación son las innovaciones anticoronavirus
en el campo médico. Los métodos de investigación empleados fueron el
método dialéctico, el método del sistema, el método formal-legal, el método
histórico-legal y el método estructural. Como resultado de este trabajo, se
analizó el estado actual de la regulación legal de las innovaciones médicas
anticoronavirus, en particular se caracterizó el marco legal internacional, así
como la legislación nacional en esta materia; se revelan las contradicciones
en el aspecto de la observancia del equilibrio de los intereses públicos y
privados en las condiciones de una pandemia y, en consecuencia, se
sugieren algunas las formas de resolverlos.
Palabras clave: innovación medicas; propiedad intelectual; crisis
sanitaria internacional; COVID-19; administración
pública.
Introduction
The right to health is one of the fundamental human rights. However,
during the pandemic, the problem of access to medicines for all social
groups becomes extremely relevant. In particular, as of now, vaccination
has already begun, mainly in the richest countries in the world. While
citizens of poor countries do not currently have access to the vaccine.
On the other hand, there is the problem of the cost of medicines. In
particular, the world’s leading pharmaceutical companies seek to make
money on their innovative products, so their products are often too
expensive.
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Public and Private Interests in the Sphere of Administration of Vaccination in a Pandemic
The high cost of medicines, however, is quite justied – the investment
of pharmacological companies in the development and testing of the drug
forces the manufacturers of original products to set such a price. The
production of cheaper analogs is impossible until the expiration of the
patent for the original drug.
Since the outbreak of the COVID-19 pandemic, this problem has become
increasingly important, as the speed of overcoming the disease depends on
the availability of drugs. Obviously, restricting the rights of patent owners
without fair compensation in favor of the public interest is not the best
solution. Therefore, there is a need to develop and implement mechanisms
that will end restrictions on everyone’s right to health care and offset the
negative effects of such restrictions on the intellectual property rights of
patent holders of medicinal products.
However, such mechanisms should be developed and implemented as
soon as possible. After all, every day without a vaccine costs thousands
of lives around the world. Accordingly, all governmental and non-
governmental actors involved in the vaccination process should join forces
to provide the vaccine to every inhabitant of the planet who wishes to use it.
1. Results and discussion
1.1 Review of International and National Legislation
Concerning Legal Regulation of Innovations in the Medical
Field
The Universal Declaration of Human Rights (United Nations, 1948)
in Article 25 emphasizes the importance of the connection between an
adequate standard of living, medical and social security for the health and
normal development of the individual and individual’s family. In part 2
of Art. 29, there is a caveat, which postulates that in the exercise of their
rights and freedoms, everyone can experience only such restrictions as are
necessary to respect the rights and freedoms of others, public morals, the
welfare of a democratic society.
Subsequently, the International Covenant on Economic, Social, and
Cultural Rights (United Nations, 1966) in Art. Article 12 enshrines the right
of everyone to the highest attainable standard of physical and mental health,
and, to exercise this right, States Parties have established the obligation to
create all necessary conditions for the provision of medical care and in the
case of illness.
In 1994, the Declaration on Patient Rights Policy in Europe was adopted,
which establishes the right of everyone to receive health care commensurate
with his or her health, including preventive and curative care. Moreover,
the provision of medical services must correspond to the nancial, human,
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and material resources of a particular society and ensure the constant
availability of the necessary medical care for all equally, without any
discrimination (World Health Organization, 1994).
The main normative legal act of the Ukrainian people (Constitution,
1996) in Article 3 enshrines the duty of the state to take care of the main
social value – the person, its health, honor, and dignity; prioritizes the
approval of its rights. In Art. 27 of the Constitution, the legislator explicitly
prohibits the deprivation of human life, establishes the obligation of the
state to protect it. Article 49 of the Constitution of Ukraine afrms the
right of everyone to health care, medical assistance, and insurance. These
constitutional provisions are detailed in the Fundamentals of the Legislation
of Ukraine on Health Care.
Thus, the right to life and health as inalienable natural rights of everyone
is reected in international legal treaties and national regulations. Ukraine
is moving towards the harmonization of its legislation with the legal
framework and the recommended EU standards in civil protection (Pavlova
et al., 2020).
On the other hand, international and national regulations protect
intellectual property, including innovations in the medical eld. In
particular, the Protocol to the Convention for the Protection of Human
Rights and Fundamental Freedoms of March 20, 1952, enshrines the right
of individuals and legal entities to peacefully possess their property, and this
provision protects also intellectual property. However, intellectual property
rights began to be regulated long before that. As Ponkin (2013) indicated
in his work “History of the development of intellectual property law. The
rst regulations concerning copyright issues”, the need to consolidate
intellectual property rights has long been discussed by scientists and
lawyers as a way to protect the results of intellectual activity. Even in the VI
century BC, in ancient Greece, there was a rule according to which a chef
who rst prepared a new dish had an exclusive monopoly on cooking it for
a certain period.
The oldest registered codied normative act, which contained the basic
provisions on patent law, is the Venetian Patent Statute, dated 1474. This act
is unique because it established the rst patent system in Europe (Samyuta,
2020). However, already in 1812, the rst patent law on the territory of the
Russian Empire was signed – the Manifesto “On the privileges of various
inventions and discoveries in crafts and arts.” It established the procedure
for obtaining, at that time, privileges for inventions, terms of their validity,
and exclusive rights of the owner (Presidential Library, 2020).
The next stage in the development of patent law was determined by the
signing of numerous Conventions, Declarations, and Treaties in this area
at the international level. Extremely important provisions concerning the
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protection of patents, including the provisions on compulsory licensing,
were enshrined in the Paris Convention for the Protection of Industrial
Property of March 20 (World Intellectual Property Organization, 1883).
Subsequently, for the development of the patent system on June 19,
1970, the Patent Cooperation Agreement was adopted. The agreement
was designed to harmonize many of the then existing patent systems by
establishing a set of rules for ling and processing patent applications.
The subsequent adoption of international regulations, which detailed
and updated the provisions of previous treaties, was also extremely
important. For example, the Patent Law Treaty of June 1, 2000, established
the basic requirements for patent applications, the grounds for revocation
of a patent. Chapter Five of Part Two of the Agreement on Trade-Related
Aspects of Intellectual Property Rights (TRIPS Agreement) (World Trade
Organization, 1994) addressed general patenting issues.
To harmonize Ukrainian legislation and bring it in line with international
standards, the Constitution of Ukraine enshrines the right of everyone to
engage in scientic and technical creativity, approves the protection of
intellectual property. The general provisions governing the fundamental
issues of protection and enforcement of intellectual property rights were
established in the Civil Code of Ukraine (2003). In particular, Chapter
39 denes the concept of subjects of intellectual property rights to an
invention or utility model, outlines the basic intellectual property rights to
an invention or utility model, and sets the validity of such rights.
Issues of the legal protection of inventions and utility models, the
procedure for obtaining, invalidation, termination of a patent and other
important issue related to this area were regulated by the Law of Ukraine
“On protection of rights to inventions and utility models” (1993). It is also
impossible not to note the presence of a large number of bylaws that in
one way or another relate to this area of legal regulation. For example, the
Order of the Ministry of Education and Science of Ukraine “On Approval of
the Regulations on the State Register of Patents of Ukraine for Inventions”
of April 12, 2001 No 291, establishes the main provisions concerning the
maintenance of such a Register, the procedure for granting a patent for an
invention.
With regard to the wider context of the development of world processes,
it is thanks to globalization, as a deliberate policy of the developed countries
of the world, aimed at the gradual integration of economic, political, socio-
cultural and other systems, that any person can satisfy his needs in any
sphere (Shyshka and Tkalych, 2020).
Thus, there is no doubt about the importance of protecting both the
right to health care and intellectual property rights, in particular patents for
inventions in the medical eld. This is evidenced by the history of adoption
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and the number of extremely important international regulations. However,
despite such a variety of legal documents, there has been a debate for many
years about balancing the public interest of the public with the right to
health care and the private interests of pharmaceutical companies, which
appeal to the importance of intellectual property rights and protection of
patents for medicines. Outbreaks of new diseases, such as COVID-19, keep
the controversy going and force states and the international community to
nd solutions. New innovative products are created for the implementation
of inventions, and therefore it is important to understand how innovations
in the medical eld are regulated in the legislation, and what problems arise
due to the shortcomings of the existing legal regulation.
1.2 Legal Regulation of Innovations in the Medical Field and
Related Problems
Legal regulation of innovation in the medical eld has long been under
the close supervision of scholars and lawyers, which is not surprising
because the legislation in this area is actively updated in accordance with
international standards. However, sometimes, insufcient legal regulation
of certain issues leads to signicant economic and legal problems.
The Law of Ukraine “On Innovation” (2002) in Part 1 of Art. 1 denes
the concept of innovation as products or services, as well as organizational
and technical solutions of production, administrative, commercial, or other
nature, which signicantly improve the structure and quality of production
and (or) social sphere.
From the legislative denition of the concept of innovation the following
features can be distinguished:
1. it is a thing, information, or process.
2. its mandatory attribute is novelty – such a quantitative and
qualitative characteristic that gives reasonable grounds to consider a
thing, information or process different from the level of development
that preceded them.
3. a prerequisite is the improvement of technological, scientic, etc.
level of development due to the emergence of innovation.
4. focus on improving the production and/or social sphere.
According to Art. 4 of this Law, the objects of innovative (aimed at the
use and commercialization of research results and developments and which
determines the release of new competitive goods and services) activities are:
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1. innovative programs and projects.
2. new knowledge and intellectual products.
3. production equipment and processes.
4. production and business infrastructure.
5. organizational and technical solutions of production, administrative,
commercial or other nature, which signicantly improve the
structure and quality of production and (or) social sphere.
6. raw materials, means of their extraction and processing, and;
7. marketable products; mechanisms for the formation of the consumer
market and sales of marketable products.
An innovative product is the realization (implementation) of an object of
intellectual property, in particular, an invention, utility model, or industrial
design. Thus, to develop a certain innovative product in the medical eld, it
is necessary to acquire intellectual rights to the invention, which, following
Art. 462 of the Civil Code of Ukraine, certied by a patent.
According to the general rule provided for in Part 3 of Art. 465 of the
Civil Code of Ukraine, the term of validity of exclusive intellectual property
rights to the invention expires twenty years from the date of ling the
application for the invention. Original medicines (innovative medicines)
are also subject to patenting, which, unlike generic drugs (analogues of
original drugs) undergo many pre-clinical and clinical trials before entering
the market. It is clear that the synthesis of a new formula, the manufacture
of drugs, the above tests are expensive for the manufacturer, and therefore,
after such a procedure, the manufacturer has the right to certify its exclusive
property right to this invention by patenting it.
Given all the effort and material resources that a patent owner has to
obtaining a patent, after entering the market, the cost of such an original
drug should be quite signicant. That is why there are much cheaper
generic drugs, which, however, cannot be produced until the expiration of
the patent on the original drugs. Such a legal approach, taking into account
the above reasons, is quite justied, objective, and fair. However, the
imperfection of domestic patent law has caused the abuse of patenting by
certain manufacturers.
We are talking about the so-called “evergreen patents” – a statement
that describes the process of obtaining several patents for different forms
of active substance and its use of the same drug for a long time. Thus, the
release of alternative generic drugs on the Ukrainian market is suspended,
and the price of the original drug does not change (Ilyk, 2018). If we turn
to the statistics of the World Intellectual Property Organization (1883), it
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becomes clear that the real number of scientic discoveries in Ukraine does
not correspond to the number of patents issued in the eld of medicine.
Abroad, the main driving force in the ght against “evergreen patents”
is to give certain entities the right to challenge manufacturers’ patents. In
the United States, for example, a special law has been passed that provides
a “reward” for a generic company that is the rst to challenge such a patent
– the ability to sell a generic drug exclusively by that company for a short
period of time (Orlova, 2019). This problem has always provoked heated
discussions in the domestic legislation, and the ways to solve it have been
constantly worked out by many researchers, but until the outbreak of the
coronavirus pandemic it was not solved, which negatively affects the speed
of overcoming the disease.
However, despite such steps by the US legislature, it should be noted that
patent law in the US is developing in a positive direction for patent owners.
In particular, amendments were made to the legislation, which provided for
the possibility of extending the validity of a patent for medicinal products.
Such changes are because the patent owner usually loses a signicant part
of the term of the patent in order to obtain permission from the regulatory
body for commercial marketing and use (Androschuk and Rabotyagova,
2018).
Indian legislation, on the other hand, has long changed in line with the
priority of ensuring the public interest. In 1970 an act was issued according
to which the inventors of innovative medicines had the right to obtain
only a patent for the process of production of such a means. This allowed
several companies to produce the same drug at the same time, changing the
production process. This has led to lower drug prices and increased access
to them (Gupta, 2011).
However, under pressure from the world community, changes were
made in 2005 that still gave inventors the right to obtain a patent for the
drug itself, and not just for the manufacturing process (Buletsa, 2020).
Thus, we can talk about the different priorities of states in solving the
problem of balancing private and public interests in this area. Unlike
the United States, where patent law is evolving to protect the intellectual
property rights to medical inventions. India, despite global pressures,
seeks primarily to ensure that everyone’s right to health care is respected
and to create a competitive market. The numerous changes in Ukrainian
legislation, which are designed to introduce mechanisms for balancing
private and public interests in this area, which will be discussed below, also
bring Ukraine closer to declaring the priority of public interests. However,
the imperfection of the legislation eliminates the possibility of creating an
optimal balance.
Problems of Legal Regulation of Innovations in the Medical
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2. Sphere and Ways to Overcome Them in a COVID-19
Pandemic
The beginning of 2020 was such a shocking year for many countries of
the planet. In early 2020, an outbreak of acute respiratory illness caused by
the new SARS CoV-2 coronavirus was reported in Wuhan, Hubei Province,
China. The new disease is called COVID-19. On March 11, 2020, the WHO
declared the situation with the spread of the pandemic infection.
No matter how much the epidemiological situation caused by the new
coronavirus infection, has a negative impact on the world economy, the
social sphere, and the collapse of large cultural projects, clever doctors,
engineers and scientists are developing inventions that give hope for a
global ght against the crisis. Therefore, of special scientic and legal
interest are innovations that have become extremely relevant against the
background of opposition to the expansion of the disease. To combat the
coronavirus, human civilization must mobilize all available resources and
develop a common strategy of action, which should be based on a new ethics
of relations in the plane of «man-man» and «man-state» (Tkalych, 2020).
Nevertheless, this raises the question: how should medical innovations
related to the spread of the new coronavirus be regulated in the legal eld?
This work tries to nd a solution to this problem.
Intellectual property and health care are two interrelated areas when it
comes to the coronavirus pandemic.
The fact is that the right holders of medicines used in the ght against
COVID-19 may refer to the new use (scope) of their drugs or indicate the
exclusivity of the properties of the active substance as a basis for penalties
for probation in such categories of cases, indicate unfair commercial use of
their intellectual property under the Trade-Related Aspects of Intellectual
Property Rights (TRIPS) Agreement as the basis of their claims. In this
case, from a moral and ethical point of view, how to assess the restriction of
public access to medicines during a pandemic and how will pharmaceutical
companies behave after its cessation, when social pressures begin to
weaken?
Fortunately, there are arguments in the legal eld that give hope that
possible disputes will be resolved without harming health care or drug
manufacturers.
First, Art. 39.3 of the TRIPS Agreement stipulates that the parties to the
agreement, “requiring, as a condition for obtaining marketing authorization
for pharmaceuticals or agrochemicals using new chemicals, the provision
of undisclosed test data or other data that requires considerable effort.
Besides, members shall protect such data from disclosure, except when
necessary to protect the public or if no measures are taken to protect such
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data from unfair commercial use.” It should be noted here that if patent
holders appeal for the protection of trade secrets, are the new chemicals
listed in the drugs whose use is disputed? Did the data of the original trials
of these drugs remain undisclosed? The last sentence of the mentioned
article allows us to use it directly in denying the claims of patent owners
because if no measures have been taken to protect trade secrets or public
access to information is justied by the urgent need to protect life and
health, the obligation to ensure the observance of intellectual property
rights does not apply to the signatory state of the TRIPS Agreement, as
these are exceptional cases specied in Art. 39.3 of the Agreements.
Secondly, Art. 27.2 of the Agreement TRIPS authorizes WTO
members not to allow the patenting of inventions whose commercial use
is detrimental to public order or public morals, including the life and
health of the population, provided that such prohibition is not limited to
restrictions which contained in national law, and paragraph “a” of Art. 27.3
of the Agreement TRIPS provides an opportunity for signatory countries to
prohibit the patenting of diagnostic, therapeutic, and surgical treatments
for humans or animals. Similar principles are contained in Art. 53 of the
European Patent Convention. It is very likely that the German government
was guided by these rules, limiting the patenting of some objects under the
inuence of the pandemic.
As an example of such a restriction, we can cite changes to the German
Law governing patent relations. Such changes were proposed in connection
with the announcement of the COVID-19 pandemic and provided for
the possibility for the state to impose restrictions on the validity of
patents for medicines if the state recognizes the existence of the so-called
“epidemiological situation of national importance.” However, the proprietor
of a patent which has been restricted in this way is entitled to receive fair
compensation, the amount of which may be challenged in court (Musmann,
2020).
It can be assumed that in the near future the number of cases of
compulsory licensing will increase signicantly. For example, Canada
has already taken advantage of the exibility of such a legal algorithm.
Compulsory licensing is permitted by the relevant Canadian Bill, however,
the Act has recently been amended to expedite the issuance of such licenses.
Such innovations, as specied in the bill, will work only for the period of the
current crisis in the health care system. Such steps indicate the readiness of
states to use this method in the ght against a pandemic (Silverman, 2020).
In this regard, a bill was introduced, which should provide such an
opportunity. The pharmaceutical community has long been discussing
the draft law No 2089 “On Amendments to Certain Legislative Acts of
Ukraine to Increase the Availability of Medicines for Citizens” (2020),
which was sent for revision by the decision of the relevant Verkhovna Rada
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Committee. In particular, among its shortcomings, the problem of the
lack of a quality control mechanism for new drugs is rightly emphasized
(Pharmacy Professional Association of Ukraine, 2019).
Conclusions
The main problem, in the context of the subject of the study, is the
conict of private interests of large pharmacological companies – patent
holders and the public interest of society in the context of the right
to health care. On this background, there are conicts between such
companies and small manufacturers who seek to compete in the market of
coronavirus drugs with maximum speed and minimum production costs.
It is clear that to solve these problems it is not enough to limit the rights
of pharmacological companies-patent holders. Therefore, to maintain the
optimal balance of interests, certain legal mechanisms, the implementation
of which in Ukraine, in the absence of proper legal regulation, can cause
serious problems were analyzed.
In particular, the following conclusions were drawn as a result of the
study.
1. Abuse of the right of patent owners to certify their property rights
to inventions by constantly obtaining new patents for different
properties of the same drug delays cheaper analogues to entry into
the market. The solution to this problem, which has been vital for
our society for a long time, can only be reforming the legislation,
which will eliminate the possibility of such abuse. By analogy with
many foreign countries (including the United States), it is necessary
to allow certain entities to challenge patents of manufacturers.
2. The use of a compulsory licensing mechanism, according to many
researchers, is currently risky. Due to the lack of court precedents
and explanations of the relevant state bodies, such conditions as
the groundlessness of the patent owner’s refusal to grant a license,
the terms of such compulsory licenses, and the proportionality of
compensation are estimated. It will be a good idea to ask the state
or the judiciary to publish ofcial explanations that will provide
answers to such questions.
3. The main problem with the introduction of the parallel import
mechanism in Ukraine is the possibility of certain negative
consequences, in particular, an increase in the ow of counterfeit
products. To mitigate such effects, it is necessary to prescribe at the
legislative level the entire procedure for parallel imports, up to the
admission of such drugs to the market. As one of the solutions to the
situation of the distribution of counterfeit products, we can propose
the creation of specialized customs posts for such importers.
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4. The mechanism of accelerated ling by manufacturers for registration
of generic versions of patented drugs is quite positive but does not
seem effective enough in counteracting the coronavirus pandemic,
as some patents have only entered into force and will not expire for a
signicant period of time.
5. The conclusion of controlled access agreements, due to their
condentiality, is accompanied by certain corruption risks. To
solve this problem, by analogy with countries such as Sweden and
the United Kingdom, it is possible to create appropriate registers of
controlled access agreements with open information about drugs for
which such agreements have been concluded. Also, there is always
a problem of lack of funds in the state and local budgets for the
purchase of drugs under such agreements.
6. Besides, one of the possible solutions to the main problem of
maintaining the balance of private and public interests may also be
the conclusion of exclusive long-term contracts with pharmaceutical
companies for the use of their means to combat coronavirus, which
will provide appropriate legal support and royalties in the long run.
Another possible vector of development is the reform and increase
of funding for the eld of national pharmacology, which will aim to
create high-quality drugs at affordable prices from the manufacturer.
Therefore, to prevent restrictions on the right of everyone to health care
we consider it necessary to introduce the above-mentioned mechanisms.
However, in order not to affect the intellectual property rights and interests
of patent owners, it is important to properly and accurately regulate them
in the legal eld. This will not only protect the interests of all stakeholders,
but also prevent abuse.
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Esta revista fue editada en formato digital y publicada
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Universidad del Zulia. Maracaibo-Venezuela
Vol.39 Nº 68
