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.41 N° 76
Enero
Marzo
2023
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
Hu ma nas y So cia les, a tra vés de la di vul ga ción de los re sul ta dos lo gra dos por sus in ves-
ti ga do res; es ti mu lar la in ves ti ga ción en es tas áreas del sa ber; y pro pi ciar la pre sen ta-
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.
ESTA PU BLI CA CIÓN APA RE CE RE SE ÑA DA, EN TRE OTROS ÍN DI CES, EN
:
Re vicyhLUZ, In ter na tio nal Po li ti cal Scien ce Abs tracts, Re vis ta In ter ame ri ca na de
Bi blio gra fía, en el Cen tro La ti no ame ri ca no para el De sa rrol lo (CLAD), en Bi blio-
gra fía So cio Eco nó mi ca de Ve ne zue la de RE DIN SE, In ter na tio nal Bi blio graphy of
Po li ti cal Scien ce, Re vencyt, His pa nic Ame ri can Pe rio di cals In dex/HAPI), Ul ri ch’s
Pe rio di cals Di rec tory, EBS CO. Se en cuen tra acre di ta da al Re gis tro de Pu bli ca cio-
nes Cien tí fi cas y Tec no ló gi cas Ve ne zo la nas del FO NA CIT, La tin dex.
Di rec to ra
L
OIRALITH
M. C
HIRINOS
P
ORTILLO
Co mi té Edi tor
Eduviges Morales Villalobos
Fabiola Tavares Duarte
Ma ría Eu ge nia Soto Hernández
Nila Leal González
Carmen Pérez Baralt
Co mi té Ase sor
Pedro Bracho Grand
J. M. Del ga do Ocan do
José Ce rra da
Ri car do Com bel las
An gel Lom bar di
Die ter Nohlen
Al fre do Ra mos Ji mé nez
Go ran Ther born
Frie drich Welsch
Asis ten tes Ad mi nis tra ti vos
Joan López Urdaneta y Nil da Ma rín
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. 41, Nº 76 (2023), 682-698
IEPDP-Facultad de Ciencias Jurídicas y Políticas - LUZ
Recibido el 10/10/22 Aceptado el 25/12/22
History of formation and
development of legal guaranteeing of
Pharmacia in Ukraine
DOI: https://doi.org/10.46398/cuestpol.4176.40
Serhii
Knysh *
Zoryana Knysh **
Lesia Bilovus ***
Oksana Homotiuk ****
Petro Kravchuk *****
Abstract
The purpose of the article was to characterize the processes
related to the genesis of the legal guarantee of the Ukrainian
pharmacy. The methodological basis meant a set of general
scientic and special legal methods of scientic knowledge, the use
of which was determined by the purpose, objectives and specics
of the subject. It has been concluded that the emergence and formation of
the legal guarantee of pharmacy has ancient origins, but its development is
taking place at the present time, as new standards of Ukrainian pharmacy
are still being formed. Four stages in the formation of pharmaceutical
relations have been distinguished. It has been emphasized that the current
state of the legal guarantee of pharmacy begins its development from the
moment when Ukraine gained independence. That led to the emergence of
new forms of economic management within the pharmacy, which aected
its formation of legal guarantee. In particular, it was necessary to create
the system of state control over the quality of medicines. The processes of
globalization of the markets of production and sale of medicines required
the updating of technologies for the production of drugs by domestic
manufacturers.
* Doctor in Law, Professor, Professor, head of the Department of constitutional, administrative and
international law, Lesya Ukrainka Volyn National University, Lutsk, Ukraine. ORCID ID: https://
orcid.org/0000-0002-0717-1430
** Senior Lecturer at the Department of Civil Law Disciplines, Lesya Ukrainka Volyn National University,
Lutsk, Ukraine. ORCID ID: https://orcid.org/0000-0002-6548-3301
*** Doctor of Historical Science, Associate professor, Professor of the Department of Information and
Socio-Cultural Activities, West Ukrainian National University, Ternopil, Ukraine. ORCID ID: https://
orcid.org/0000-0003-4882-4511
**** Doctor of Historical Science, Professor, Professor of the Department of Information and Socio-Cultural
Activities, West Ukrainian National University, Ternopil, Ukraine. ORCID ID: https://orcid.org/0000-
0002-2856-8541
***** PhD. in Law, Associate Professor, Dean of the Law Faculty of the Private higher educational institution
“European University”, Kyiv, Ukraine. ORCID ID: https://orcid.org/0000-0003-4246-974X
683
CUESTIONES POLÍTICAS
Vol. 41 Nº 76 (2023): 682-698
Keywords: pharmaceutical area; pharmaceutical business;
pharmaceutical legal relations; health sector; legal guarantee.
Historia de la formación y desarrollo del soporte legal
de la farmacia en Ucrania
Resumen
El propósito del artículo fue caracterizar los procesos relacionados
con la génesis de la garantía legal de la farmacia ucraniana. La base
metodológica signico un conjunto de métodos cientícos generales y
legales especiales del conocimiento cientíco, cuyo uso estuvo determinado
por el propósito, los objetivos y las especicidades del tema. Se ha llegado
a la conclusión de que el surgimiento y la formación de la garantía legal de
la farmacia tiene orígenes antiguos, pero su desarrollo se está produciendo
en la actualidad, ya que todavía se están formando nuevos estándares de
la farmacia ucraniana. Se han distinguido cuatro etapas en la formación
de las relaciones farmacéuticas. Se ha enfatizado que el estado actual de
la garantía legal de la farmacia comienza su desarrollo desde el momento
en que Ucrania obtuvo la independencia. Eso llevó al surgimiento de
nuevas formas de gestión económica dentro de la farmacia, lo que afectó
su formación de garantía legal. En particular, era necesario crear el sistema
de control estatal sobre la calidad de los medicamentos. Los procesos de
globalización de los mercados de producción y venta de medicamentos
requirieron la actualización de las tecnologías para la producción de
fármacos por parte de los fabricantes nacionales.
Palabras clave: área farmacéutica; negocio farmacéutico; relaciones
jurídicas farmacéuticas; sector salud; garantía jurídica.
Introduction
Pharmaceutical activities have a long history. It is due to the fact that
Pharmacia is a systemic entity that covers phenomena of dierent content.
In particular, we are talking about the development and manufacture of
medicines, their sale through specialized institutions, the training of
pharmacists, pharmaceutical science and pharmaceutical legislation.
Therefore, the formation and development of Pharmacia as a legal
phenomenon includes such phenomena as the actual occurrence of
medicines, their use and the processes of legal regulation of pharmaceutical
684
Serhii Knysh, Zoryana Knysh, Lesia Bilovus, Oksana Homotiuk y Petro Kravchuk
History of formation and development of legal guaranteeing of Pharmacia in Ukraine
relations, the formation of the system of state government agencies in the
pharmaceutical sector.
One of the rst pharmaceutical reference books that pointed to the
independence of pharmaceutical activity was Sushruta Samhita, an Indian
Ayurvedic treatise of the VI century B.C. There were also Sumerian cuneiform
clay tablets (end of the VI century B.C. – early II century B.C.) containing
recipes for medicine (History of pharmacy, 2021). Pharmaceutical activity
actively developed in the Ancient Egypt. The papyri found testify to the
development and use of medicines. For example, the Ebers Papyrus
describes 811 recipes for medicinal products, where many of them consist
of 5-13 components, and one recipe includes 37 ingredients (Guzev, 2017).
Pharmaceutical activity was developed even more intensively over time,
and the ancient Roman physician Dioscorides Pedanius was the rst to
single out medicinal substances as a separate area of medical knowledge
in the I century A.D. At the same time, he provided a complete description
of all known medicines in his work “Hospital Remedies”. The physician
and philosopher Claudius Galen (131-201 A.D.) also made a signicant
contribution to the emergence of pharmacia.
He was the rst who pointed out that a pharmacia is a place where
medicines are both stored and produced (Ohar et al., 2011). Despite the
scientic approach to the discovery and use of medicinal products, this area
of activity was one of the most mysterious for human beings. Therefore,
both alchemists and monks, who opened pharmacies at monasteries, were
involved in that activities.
Pharmaceutical specialty was rst singled out in 1178 in France. It was
from this time that the rst pharmacies began to open. At the same time,
the pharmacist simultaneously performed the function of a therapist and
a pharmacist. Pharmaceutical education emerged in the XIV century in
European countries. The rst public pharmacies emerged in 1490 on the
territory of modern Ukraine, and the rst private pharmacies appeared in
1578 in Lutsk.
Their legal regulation raised simultaneously with the actual formation
of pharmaceutical relations, in particular, the Herbalist’s Charter adopted
in 1543 in England (Flannery, 2001). This indicates the relevance of the
research of scientic issues in the eld of pharmacia, which are directly
related not only to the development of a segment of the state economy, public
administration of the pharmaceutical sector, but also to the fundamental
human right to life and health care (Teremetskyi and Khovpun, 2020).
The purpose of the article is to study and characterize the processes
related to the emergence, formation and development of legal guaranteeing
of pharmacia in Ukraine. The main objective is to reveal the genesis of the
legal guaranteeing of pharmacia in Ukraine and its role in improving the
685
CUESTIONES POLÍTICAS
Vol. 41 Nº 76 (2023): 682-698
provision of the country’s population with aordable and most necessary
medicines in the course of implementing the medical reform.
1. Methodology of the study
Theoretical basis of the article is the scientic achievements of national
and foreign scholars in various branch and related sciences. The empirical
basis was certain provisions of the Constitution of Ukraine, the Association
Agreement between Ukraine and the EU, international legal acts and
legislation of Ukraine regulating relations in the healthcare sector in general
and pharmacia in particular.
The methodological basis of the article is a set of general scientic and
special legal methods of scientic cognition, whose use is determined by
the purpose, objectives, specics of the subject matter and object of the
research.
Thus, the dialectical method was used to clarify the current status of legal
regulation of relations in the eld of pharmacy, as well as to determine the
perspectives for its further development and improvement. The historical
and legal method was used to study the origin, formation and development
of legal guaranteeing of pharmacia in Ukraine.
Theoretical provisions of the article were formulated with the help of the
formal and logical method. The comparative and legal method, as well as the
method of structural and functional analysis made it possible to distinguish
and analyze the various stages for the formation and development of legal
relations that arose in the eld of pharmacia in Ukraine.
The application of the method of legal modeling allowed developing
a number of suggestions aimed at improving scientic views on the
optimization of legal relations in the eld of pharmacia. The axiological
method was used in determining the importance and value of legal
regulation of pharmacia for the vital activity of Ukrainian society, as well
as the formation of new standards for the development of Ukrainian
pharmacia in the context of European integration. Generalization and
forecasting methods were used to formulate the conclusions to the article.
2. Results and Discussion
2.1. Origin of legal guaranteeing of Ukrainian pharmacia
We believe that it is advisable to consider pharmacia as a legal
phenomenon not from ancient times, but from the moment of the
686
Serhii Knysh, Zoryana Knysh, Lesia Bilovus, Oksana Homotiuk y Petro Kravchuk
History of formation and development of legal guaranteeing of Pharmacia in Ukraine
emergence of systemic pharmaceutical activity, which led to the need for its
legal regulation. Moreover, legal guaranteeing of pharmacia in Ukraine has
a long retrospective.
Thus, the pharmacy ordination “Lekta digna” was introduced in Lviv in
1609. This document dened the rights and obligations of pharmacists. The
King Sigismund III approved the Charter of the Lviv Pharmacy Workshop
(Perfumery Workshop) in February 1611, which, in particular, determined
responsibility and limited competition in the pharmacy business
(Fedushchak, 2011).
The indicated facts emphasize that legal guaranteeing of Ukrainian
pharmacia was formed along with the development of pharmacology, the
formation of a pharmacist profession. It is due to the fact that the free
functioning of pharmaceutical activities without an element of public
provision is practically impossible, since pharmacia is directly related to
human life and health.
Legal guaranteeing of pharmacia has gradually expanded with the
development of human civilization. It is evidenced by the following historical
facts. Thus, the undations of pharmacological science in Ukraine were laid
at the Kiev-Mohyla Academy in 1682-1817. A graduate of this Academy N.
Ambodyk wrote the rst textbook on pharmacology and pharmacognosy
called “Medical Speech, or Description of Medicinal Plants”, where he
systematized information about medicinal plants.
The pharmacist H. Ventsel started the rst private pharmacy in 1810
in Kharkiv, which was included in the “Russian Medical List”. Its activities
were regulated by the Pharmaceutical Charter of 1789. It is noteworthy
that permission to work in a pharmacy was granted by the Minister of
Internal Aairs after passing the exam by a pharmacist at the Department
of Medical Speech, Pharmacy and Medical Literature of Kharkiv University.
Due to a systematic approach to the development of legal guaranteeing of
pharmacia in Ukraine there were 1067 pharmacies as of 1913, including 714
rural and 353 urban ones, and there were already 1096 pharmacies in 1927
(Borishchuk et al., 2014).
A professional direction – pharmaceutical activity has begun to be
formed along with the opening of pharmacies. There was a tendency at the
end of the XIX century in increasing the number of people wishing to receive
a pharmaceutical education. Thus, the Department of Pharmacology at
Academician O.O. Bohomolets Kyiv Medical Institute was founded in 1842,
where the general problems of pharmacology were studied. It was opened
at St. Volodymyr University under the title “Medical Veshchestvosloviie
with a Recipe”.
Not more than 5 people per year received the title of pharmacist and 10-
15 people became pharmacy assistants at Kharkiv University in the 1860s.
687
CUESTIONES POLÍTICAS
Vol. 41 Nº 76 (2023): 682-698
Kharkiv University trained 30 pharmacists and 31 pharmacy assistants in
1872, in 1874 – 32 pharmacists and 26 pharmacy assistants, in 1877 – 16
pharmacists and 38 pharmacy assistants. 700 pharmacists were trained on
the basis of the pharmaceutical laboratory of Kharkiv University in 1916
(Prokopenko et al., 2015).
2.2. Stages of formation and development of pharmacia on the
territory of modern Ukraine
Two interrelated processes took place simultaneously in the Soviet
period of the formation of pharmacia (1920-1923): the withdrawal of the
private sector of pharmacies from civil circulation (by nationalization
on the basis of the Decree of the Council of People’s Commissars of the
Ukrainian SSR “On the nationalization of the pharmacy business” in 1920)
and the development of legal guaranteeing for pharmaceutical activities
(the Pharmacy Department was created under the People’s Commissariat
of Health of the Ukrainian SSR, which was in charge of the pharmacy
personnel and the pharmaceutical subdivision of the Health Department
of the provincial executive committee including the management of the
pharmacy warehouse, as well as the control and analytical laboratory).
The activity for the production of medicines arose directly from the
moment of the formation of management activity. “Krasnaya Zvezda”
Chemical Pharmaceutical Plant was launched in Kharkiv in 1923, the
branch of the Ukrainian Institute of Experimental Endocrinology was
founded in Kyiv in 1930, which began to produce medicines since 1932
(today it is the well-known pharmaceutical company “Darnitsa”). The Kyiv
Vitamin Plant hs begun its work since 1937. The artel named after Kirov
was registered in 1947, which was transformed into the Borshchahovskyi
chemical-pharmaceutical plant in 1957 (Illiashenko, 2016).
Due to the systematic development of the pharmaceutical industry
Ukraine, among other Soviet Republics, was second in terms of drug
production. The country produced about 30% of all pharmaceutical
products in the state, which represented 800 types of drugs. Despite
this situation, industrial production had diculties after Ukraine gained
independence. “Enterprises experienced an acute shortage of raw materials
in the middle of 1992. Production of more than 50 items of vital medicinal
products was discontinued. The level of provision of medical institutions
and the population with them was decreased to 35%” (Chernykh, 2002).
In order to overcome the critical state that arose in the pharmaceutical
industry in 1992, the Comprehensive Program for the Development of
the Medical, Veterinary and Microbiological Industry, Improvement
of Providing the Population and the Needs of Livestock Farming with
Medicinal Products was approved by the Resolution of the Cabinet of
Ministers (hereinafter referred to as the Cabinet of Ministers) of Ukraine.
688
Serhii Knysh, Zoryana Knysh, Lesia Bilovus, Oksana Homotiuk y Petro Kravchuk
History of formation and development of legal guaranteeing of Pharmacia in Ukraine
The enterprises for the manufacture of medicinal products were
re-equipped according to this Program, and the production of semi-
nished products was launched. The Pharmacological and Pharmacopeial
Committees, the State Inspectorate for Quality Control over Medicinal
Products were formed.
That contributed to the renewal of the pharmaceutical sector of the
economy. “In particular, the production of 120 drugs and prophylactic
agents that were not previously produced in Ukraine was mastered from
1992 to 1996, where 10 of them were fundamentally new” (Chernykh,
2002: 3). Thus, the system of public administration entities in the eld of
circulation of medicinal products was created during this period.
The State Committee of Ukraine for the chemical, petrochemical
industry and medicinal products was established in 1991, which was the
central government agency subordinated to the Cabinet of Ministers of
Ukraine.
Its activities were aimed at organizing an independent chemical cycle in
Ukraine, which assisted in producing drug ingredients. The Pharmacopoeia
Center was established in 1992, whose task was to develop national
standards for medicinal products.
The State Committee for the Medical and Microbiological Industry
was established in 1993, whose powers include: performing tasks aimed
at improving the provision of the population and the needs of animal
agriculture with medicinal products, medical and veterinary equipment;
solution of issues of providing the industry with material and technical
resources; implementation of a unied scientic, technical and investment
policy and coordination of foreign economic activity in the eld of medical
and microbiological industries.
The enterprises and organizations of the national form of ownership,
which were part of the liquidated concern “Ukrmedbioprom”, were
transferred to the sphere of its management. The system of legal guaranteeing
for pharmacia was developed due to its activities, in particular, the system
for managing the pharmaceutical industry and the sale of medicines.
Ukraine adopted the fundamental law of the pharmaceutical sector
“On Medicinal Products” in 1996. This law established legal regulation
of relations associated with the creation, registration, production, quality
control and sale of medicinal products, dened the rights and obligations
of enterprises, institutions, organizations and citizens, as well as the powers
of state authorities and ocials in this area (On Medicinal Products, 1996).
It was also determined that the management of pharmacy was entrusted
to the Ministry of Health of Ukraine, the State Committee of Ukraine for
the Medical and Microbiological Industry and specially authorized state
agencies.
689
CUESTIONES POLÍTICAS
Vol. 41 Nº 76 (2023): 682-698
Summarizing it should be noted that the next stage of the formation and
development of legal guaranteeing of pharmaceutical legal relations was
formed in 1991-1996, which we oer to name: “The emergence of independent
Ukrainian state agencies for legal guaranteeing of pharmaceutical legal
relations and the creation of the pharmaceutical sector in the economy of
independent Ukraine”.
The next stage in the formation and development of legal guaranteeing
of pharmacia was marked by the adoption of the Comprehensive Program
for the Development of the Medical Industry for 1997-2003 approved
by the Resolution of the Cabinet of Ministers of Ukraine in 1996, which
determined the development of medical equipment and the production of
medicinal products.
The Program xed the directions and nancing for the development
of production bases for the nished medicinal products and their
substances. Pharmaceutical production was expanded in the state due to
the implementation of that Program. Thus, about 800 types of medicinal
products were produced in 1992, then more than 4000 were produced in
2005 (Almakaieva, 2011).
The Resolution of the Cabinet of Ministers of Ukraine “On streamlining
the activities of pharmacies and approving the Rules for the retail sale of
medicinal products” was adopted in 1997. According to that Resolution,
the Ministry of Internal Aairs, the Licensing Chamber, the State Tax
Administration, the State Committee for Standardization, Metrology
and Certication, the State Inspectorate for Quality Control of Medicinal
Products, the Council of Ministers of the Autonomous Republic of Crimea,
the regional, Kyiv and Sevastopol city state administrations were charged
with the obligation to strengthen control over the sale of medicinal products.
To take measures on preventing trade in places not specied in the
license, to prosecute persons violating the rules for the sale of medicinal
products in accordance with the law. Having analyzed the content of that
Resolution, one can argue that there was a practice of distributing medicinal
products outside pharmacies at the time of its adoption, as well as massive
falsication of medicines. Overcoming those violations became possible
due to the active development of legal guaranteeing of pharmacia.
At the same time, agencies for monitoring the quality of medicinal
products were created. Thus, the State Inspectorate for Quality Control of
Medicinal Products of the Ministry of Health (hereinafter referred to as the
Ministry of Health) of Ukraine began its functioning in accordance with the
Decree of the Cabinet of Ministers of Ukraine “On State Control over the
Quality of Medicinal Products”.
The process of providing medicines has received a new development
due to that direction. The order of the General Directorate of Health,
690
Serhii Knysh, Zoryana Knysh, Lesia Bilovus, Oksana Homotiuk y Petro Kravchuk
History of formation and development of legal guaranteeing of Pharmacia in Ukraine
Pharmacy Association “On the regulation of free and preferential provision
of medicinal products on physicians’ prescription in case of outpatient
treatment” was adopted in 1999. It laid the foundation for the existence of
the system of aordable medicinal products for the population.
There were also changes in the system of pharmaceutical legal relations
management in 1999, in particular, the Resolution of the Cabinet of
Ministers of Ukraine “Issues of the Committee for the Medical and
Microbiological Industry” was adopted. It allowed the Committee for the
Medical and Microbiological Industry to have 5 deputies, including one rst
deputy chairman and deputy chairman of the Committee – the director of
the state enterprise “Expert Center of the Committee of the Medical and
Microbiological Industry”, as well as the board of eleven people.
The National Agency for Controlling the Quality and Safety of Food,
Medicinal Products and Medical Devices was established in the same year,
as a result of which the Coordinating Expert Committee on Food Quality
and Safety, the Committee on Hygienic Regulation, the Committee on
Immunobiological drugs, the Committee for New Medical Technology, the
Pharmacopoeia Committee, the Bureau of Registration of Medicines and
the State Inspectorate for Quality Control of Medicines were liquidated. The
above indicates the ongoing development of the pharmacia management
system and the optimization of the management of the pharmaceutical
sector.
The Decree of the President of Ukraine of 2000 approved the Concept
for the Development of Public Health in Ukraine, which determined the
priority of the development of medical and pharmaceutical industries. The
Health Departments of regional state administrations were entrusted with
control over the quality and sales of medicinal products and medical devices.
It was also determined that the public health care sector should provide the
population with the most necessary medicinal products (Concept for the
Development of Public Health in Ukraine, 2000).
2.3. Development of pharmaceutical activity and formation of
special state agencies in this area
The legal guaranteeing of pharmacia continued to be formed along with
the development of pharmaceutical activities, in particular, through the
formation of special state agencies in this area. Thus, the Resolution of the
Cabinet of Ministers of Ukraine “On the formation of the State Department
for Quality Control, Safety and Production of Medicinal Products and
Medical Devices” was adopted in 2000.
The Department managed and controlled the quality, safety and
production of medicinal products including active substances, excipients,
medicinal plant materials and medical cosmetics, immunobiological
691
CUESTIONES POLÍTICAS
Vol. 41 Nº 76 (2023): 682-698
preparations, biomaterials, medical equipment and medical products (On
the approval of the Provisions on the State Department of Control, 2020).
The State Pharmacopoeia of Ukraine has launched its activities
in Ukraine since the beginning of October 2001 – the rst national
pharmacopoeia among the CIS countries, which had been developed since
1998. That document established national standards for the development,
manufacture of medicinal products, their testing and quality compliance.
The quality control system of medicinal products has received the basis for
further development in the direction of the safety of using medicines due to
this, and hence the support of public health.
Summing up the results of the development of pharmacia from 1997 to
2003 within the framework of the implementation of the Comprehensive
Program for the Development of the Medical Industry for 1997–2003,
it is advisable to single out another stage in the formation of legal
guaranteeing of pharmaceutical legal relations in 1997–2003 and name it
as “Comprehensive development of pharmaceutical production and control
over the quality and safety of medicinal products”.
The next stage in the formation and development of legal guaranteeing
of pharmacia began in 2003. The State Program for the Development of
Industry for 2003-2011 was adopted in July of the same year, which was
approved by the Resolution of the Cabinet of Ministers of Ukraine. It laid
down the mechanisms for the formation of competition among the entities
of production, in particular, in the pharmaceutical sector of the economy.
Achieving this became possible due to the principles laid down for the
modernization of existing enterprises, the development of new technologies
for the development of medicinal products, changes in the product
certication system and production standards. The basis for that was both
changes in ideas, business standards and the renewal of legal guaranteeing
of pharmacia, which began to be transformed from a control system into a
support system and creation of favourable conditions for the development
of the pharmaceutical sector of the economy.
The State Service for Medicinal Products and Medical Devices was
established in 2003, which became the successor of the State Department
for Quality Control, Safety and Production of Medicinal Products and
Medical Devices. It should be noted that constant changes in the pharmacy
management system lead to destabilization of legal guaranteeing statics.
The procedures for the sale of medicinal products are improved
simultaneously with the renewal of the pharmacia management system.
Thus, new Rules for the sale of medicinal products in pharmacies approved
by the Resolution of the Cabinet of Ministers of Ukraine have come into
eect since 2004 (Rules of trade in medicinal products in drugstores, 2004).
Wholesale and retail trade in medicinal products without a license was
692
Serhii Knysh, Zoryana Knysh, Lesia Bilovus, Oksana Homotiuk y Petro Kravchuk
History of formation and development of legal guaranteeing of Pharmacia in Ukraine
prohibited according to these Rules. Only medicines registered in Ukraine
could be sold. The provisions of these Rules have established additional
requirements for entrepreneurial activities in the eld of pharmacia, as well
as for the quality of medicines.
The Procedure for the state registration (re-registration) of medicinal
products and the amount of the fee for their state registration (re-
registration) approved by the Resolution of the Cabinet of Ministers of
Ukraine as of May 26, 2005 was additionally adopted in order to implement
these Rules (On the approval of the Procedure of state registration (re-
registration) of medicinal products, 2005).
The state registration of a medicinal product according to this Procedure
is carried out by the Ministry of Health of Ukraine on the basis of an
application and the results of an examination of registration materials
for such a product, carried out by the State Expert Center of the Ministry
of Health of Ukraine. This provision was justied, it made it possible to
improve the quality of medicinal products, to establish the system for
ensuring pharmaceutical activities.
An important Resolution of the Cabinet of Ministers of Ukraine “On
Measures to Stabilize Prices for Medicines” was adopted in October 2008.
The state according to that Resolution establishes the system for stabilizing
prices at the pharmaceutical market, in particular, it determines marginal
supply and marketing allowances in the amount of not more than 10%
charged to wholesale selling price, taking into account taxes and fees, and
marginal trade (retail) allowances (On measures to stabilize the prices for
medicinal products, 2008).
Price stabilization is one of the most important forms of legal
guaranteeing for pharmacia, since it is aimed at creating the system of
access to medicines for the population with the purpose to ensure the public
health of the country’s population.
The State Inspectorate for Quality Control of Medicinal Products under
the Ministry of Health of Ukraine has begun its work since 2010. Control
over the quality of medicines was carried out by checking the compliance by
business entities with the requirements of the legislation on the quality of
medicinal products by using laboratory analysis of the quality of medicines,
visual control, verication of related documents. In general, regulation on
the selection of medicine samples to check their quality has been introduced
since 2010.
Summing up, we should dene that the stage of formation of legal
guaranteeing of pharmaceutical legal relations from 2003 to 2011 can
be named as “The formation of legal guaranteeing of pharmacia and
stabilization of prices in the pharmaceutical market”.
693
CUESTIONES POLÍTICAS
Vol. 41 Nº 76 (2023): 682-698
A new stage in the formation and development of legal guaranteeing of
pharmaceutical legal relations has begun to be formed since 2011, which
was associated with providing the population with aordable medicines
as part of implementing medical reform. Thus, the Ministry of Health of
Ukraine announced in 2011 the publication of the draft Concept of the state
target-oriented program “Development of import-substituting industries
in Ukraine and substitution of imported medicinal products with domestic
ones including biotechnological drugs and vaccines for 2011-2021” (Draft
Concept of the State Target-Oriented Program, 2011). The above Concept
testied to an attempt of creating an import-substituting production of
medicines in Ukraine, which would make it possible to make medicines
more accessible to the population.
The Government of Ukraine approved in 2013 the Concept of the
National Target-Oriented Economic Program for the Development of
Industry for the period up to 2020, the purpose of which is:
A comprehensive solution of problematic issues for the functioning of the
industrial sector of the Ukrainian economy by developing an organizational
and economic mechanism and attracting resources to implement the tasks of
structural and technological modernization of domestic industry in the direction
of increasing the share of high-tech activities in the volume of production and
exports, meeting the needs of the domestic market for products of own production,
increasing employment and thereby improving the well-being of the population
(The Cabinet of Ministers of Ukraine, 2013: 06).
National producers received tax benets and the opportunity to
introduce science-intensive technologies as innovations due to the adoption
of this Concept.
The drug quality control system continues to be improved along with the
support of the national pharmaceutical manufacturers. Thus, an updated
Procedure for quality control of medicinal products during wholesale and
retail trade was approved in 2014. The conduct of input state control and
quality control of medicinal products by business entities having licenses to
carry out economic activities for the wholesale and retail trade in medicinal
products has been determined in accordance with that Procedure.
The purpose of this control is to detect trade in low-quality medicinal
products, unregistered drugs in Ukraine, narcotic drugs, etc. (On the
approval of the Procedure to control over the quality of medicinal products,
2014).
2.4. Impact of medical reform on legal provision of pharmacia
in Ukraine
The medical reform began in Ukraine in 2016, which was directly
related to the legal guaranteeing of pharmacia. In this regard the Cabinet
694
Serhii Knysh, Zoryana Knysh, Lesia Bilovus, Oksana Homotiuk y Petro Kravchuk
History of formation and development of legal guaranteeing of Pharmacia in Ukraine
of Ministers of Ukraine approved the Concept for the Development of the
Public Health System, the expected result of which (among others) was
the increase in the medical literacy of the population by counteracting the
uncontrolled and irrational use of medicinal products.
Besides, the reform of medicine also meant providing the population
with access to medicinal products and medical care. It is to achieve this
result the Resolution of the Cabinet of Ministers of Ukraine “On ensuring
the availability of medicinal products” was adopted in March 2017 (On
ensuring the availability of medicinal products, 2017). Patients with
cardiovascular diseases, bronchial asthma or type II diabetes were able to
receive free of charge medicines or with a small additional payment.
The Ministry of Health of Ukraine in order to implement this project
has developed the Register of aordable medicines. In this case two factors
were taken into account: the prevalence of the disease among the population
and the production of medicines by national manufacturers. That approach
led to the receipt of state assistance to citizens and pharmaceutical
manufacturers.
In addition to the drug availability program, the program of state
guarantees of medical care for the population began to be formed, which
also provided a list of medicinal products, where the state guarantees to
patients the full payment for their provision at the expense of the State
Budget of Ukraine according to the tari for the prevention, diagnosis,
treatment and rehabilitation related to diseases, injuries, poisonings and
pathological conditions, as well as in regard to pregnancy and childbirth
(On State Financial Guarantees of Medical Care for the Population, Art. 1).
The content of the activity of drug sales establishments has also been
changed as a result of the implementation of the medical reform. Thus,
the provisions of the 2001 WHO Guidelines for the Development and
Implementation of Standards of Good Pharmacy Practice (Pharmaceutical
Services) – GPP began to be implemented in pharmaceutical practice. In
particular, the pharmaceutical establishment should help to ensure the
correct use of prescripted drugs and medical products, as well as to prevent
self-medication.
To achieve a positive eect from the implementation of medical reform,
it was necessary to amend the legal guaranteeing of pharmacia. The
Pharmaceutical Directorate has been established in the structure of the
Ministry of Health of Ukraine since 2018 for this purpose. It includes the
Expert Group on Market Admission of Medicinal Products, which ensures
the formation and implementation of the state policy in the eld of creation,
production, quality control and sale of medicinal products, medical
immunobiological preparations, in the eld of narcotic drugs, psychotropic
substances circulation (Regulations on the Expert Group, 2018).
695
CUESTIONES POLÍTICAS
Vol. 41 Nº 76 (2023): 682-698
Changes in the administrative and legal guaranteeing of pharmacia in
2020 were due to the ght against the COVID-19 pandemic. One of the
directions was the development of the possibility of electronic retail trade
in medicinal products. The Resolution of the Verkhovna Rada of Ukraine
“On the adoption of the draft Law of Ukraine on amending the Art. 19
of the Law of Ukraine “On Medicinal Products” as a basis regarding the
implementation of electronic retail trade in medicinal products” was
adopted for this purpose. The Law was eventually adopted.
Conclusion
Summarizing the above, we note that the formation and development
of legal guaranteeing of pharmacia has ancient origins. It has been
established that the systemic pharmaceutical activity was formed, its legal
regulation was formalized, state management of the pharmaceutical sector
was launched in Ukraine in the XVIII century. The current status of legal
guaranteeing of pharmacia begins its retrospective development from the
moment Ukraine gained independence.
That led to the emergence of new forms of economic management
in pharmacia, which aected the formation of its legal guaranteeing.
In particular, there was a need to create the system of state control over
the quality of medicinal products. Globalization processes at the markets
for the production and sale of medicinal products required updating the
technologies for the production of medicines by domestic manufacturers.
All that inuenced the development of the legal guaranteeing of pharmacia.
It has been emphasized that the state policy, as well as the model of
implementation of pharmaceutical legal relations available in the country
plays an important role in the process of establishing the legal guaranteeing
of pharmaceutical legal relations. The formation and development of the
specied relations is characterized by the gradual emergence of medicines,
pharmacies, the production of medicines, state regulation of the pharmacy
business.
We believe that the formation of the legal guaranteeing of pharmaceutical
legal relations continues due to the formation of new standards for the
development of Ukrainian pharmacia. Based on the foregoing, we can
suppose the following stages for the formation and development of legal
guaranteeing of pharmacia:
1. from 1991 to 1996 – the emergence of independent Ukrainian state
agencies for legal guaranteeing of pharmaceutical legal relations
and the creation of the pharmaceutical sector in the economy of
independent Ukraine;
696
Serhii Knysh, Zoryana Knysh, Lesia Bilovus, Oksana Homotiuk y Petro Kravchuk
History of formation and development of legal guaranteeing of Pharmacia in Ukraine
2. from 1997 to 2003 – comprehensive development of pharmaceutical
production and control over the quality and safety of medicinal
products;
3. from 2003 to 2011 – the formation of legal guaranteeing of pharmacia
and the stabilization of prices at the pharmaceutical market;
4. from 2011 to the present day – the formation of legal guaranteeing
for the availability of medicinal products for the population of
Ukraine.
Bibliographic References
ALMAKAIEVA, Liudmyla; MASLOVA, Nataliia; HEORHIIEVSKYI, Viktor.
2011. “90 anniversary of the agship of domestic pharmacia – the State
enterprise «State scientic center of medicinal products and medicines»”
In: Farmatsevtychnyi zhurnal. No.2, pp. 3-8.
BORISHCHUK, Volodymyr; SOLOVYEV, Oleksii; ZAGORIY, Hlib;
KRASNYANSKAYA, Tetiana; KLYMENKO, Iryna; AUGUNAS, Sabina;
KYRPACH, Oleh; BATTALOVA, Rymma. 2014. “Historical Genesis in
Establishment of Pharmaceutical Business in Ukraine in an Diferens
Stages of its Social-Economic and Political Develo. Part I. Study of the
Period 1917–1930” In: Farmatsevtychnyi zhurnal. No. 5, pp. 29-35.
CABINET OF MINISTERS OF UKRAINE. 2000. Resolution of the Cabinet
of Ministers of Ukraine of June 05, 2000 No. 917 On the approval of
the Provisions on the State Department of Control over the Quality,
Safety and Production of Medicinal Products and Medical Devices.
Available online. In: https://zakon.rada.gov.ua/laws/show/917-2000-
%D0%BF#Text. Consultation date: 04/10/2022.
CABINET OF MINISTERS OF UKRAINE. 2004. Resolution of the Cabinet of
Ministers of Ukraine No. 1570 “On the approval of the Rules of trade in
medicinal products in drugstores”. Available online. In: https://zakon.
rada.gov.ua/laws/show/1570-2004-%D0%BF#top. Consultation date:
01/10/2022.
CABINET OF MINISTERS OF UKRAINE. 2005. Resolution of the Cabinet
of Ministers of Ukraine of May 26, 2005 No. 376 “On the approval
of the Procedure of state registration (re-registration) of medicinal
products and fee amounts for their state registration (re-registration)”
Available online. In: https://zakon.rada.gov.ua/laws/show/376-2005-
%D0%BF#Text. Consultation date: 02/10/2022.
697
CUESTIONES POLÍTICAS
Vol. 41 Nº 76 (2023): 682-698
CABINET OF MINISTERS OF UKRAINE. 2008. Resolution of the Cabinet
of Ministers of Ukraine of October 17, 2008 No. 955 “On measures to
stabilize the prices for medicinal products” Available online. In: https://
zakon.rada.gov.ua/laws/show/955-2008-%D0%BF. Consultation date:
04/10/2022.
THE CABINET OF MINISTERS OF UKRAINE. 2013. Resolution of the Cabinet
of Ministers of Ukraine of December 25, 2013 No. 603-р. “On Approving
the Concept of the National Target-Oriented Economic Program for the
Development of Industry for the Period up to 2020” Available online.
In: https://zakon.rada.gov.ua/laws/show/603-2013-%D1%80#Text.
Consultation date: 29/09/2022.
CABINET OF MINISTERS OF UKRAINE. 2017. Resolution of the Cabinet
of Ministers of Ukraine of March 17, 2017 No. 152. “On ensuring the
availability of medicinal products” Available online. In: https://zakon.
rada.gov.ua/laws/show/152-2017-%D0%BF#Text. Consultation date:
04/10/2022.
CHERNYKH, Valentyn. 2002. “Pharmaceutical sector during the independence
period” In: News of pharmacy. Vol. 31, No. 3, pp. 03-12.
FEDUSHCHAK, Andriy. 2011. “Pharmacopoeias as Regulatory Factors in
Pharmacy Development” In: Clinical Pharmacy, Pharmacotherapy and
Medical Standardization. No. 3-4, pp. 101-109.
FLANNERY, Michael. 2001. “Building a retrospective collection in pharmacy:
a brief history of the literature with some considerations for U.S. health
sciences library professionals” In: Bull Med Libr Assoc. Apr. Vol. 89,
No 2, pp. 212-221.
GUZEV, Konstantin. 2017. “The Pharmacy of Ancient Egypt” In: Drug
development and Registration. No. 3, pp. 184-189.
HISTORY OF PHARMACY. 2021. In: The Pharma Innovation Journal.
Available online. In: http://www.thepharmajournal.com/history_of_
pharmacy. Consultation date: 02/09/2022.
ILLIASHENKO, Inna. 2016. “History of Development and Current State of
the Medical Industry of Kyiv” In: Global and National Problems of
Economics. No 10, pp. 591-595.
LAW OF UKRAINE. 1996. Verkhovna Rada Of Ukraine. No. 123/96 On Medicinal
Products. (Edited as of June 08, 2022). Available online. In: https://
zakon.rada.gov.ua/laws/show/123/96-%D0%B2%D1%80#Text.
Consultation date: 02/10/2022.
698
Serhii Knysh, Zoryana Knysh, Lesia Bilovus, Oksana Homotiuk y Petro Kravchuk
History of formation and development of legal guaranteeing of Pharmacia in Ukraine
MINISTRY OF HEALTH OF UKRAINE. 2011. Draft concept of the State target-
oriented program “Development of import-substituting industries in
Ukraine and replacement of imported medicinal products with domestic
ones including biotechnological drugs and vaccines for 2011-2021”. 2011
In: Weekly edition Pharmacy. No. 15 (786). Available online. In: https://
www.apteka.ua/article/78579. Consultation date: 02/10/2022.
MINISTRY OF HEALTH OF UKRAINE. 2014. Order of the Ministry of
Health of Ukraine of September 29, 2014 No. 677. “On the approval of
the Procedure to control over the quality of medicinal products during
wholesale and retail trade” Available online. In: https://zakon.rada.gov.
ua/laws/show/z1515-14#Text. Consultation date: 04/10/2022.
MINISTRY OF HEALTH OF UKRAINE. 2018. Order of the Ministry of Health
of Ukraine of May 18, 2018 No. 950 Regulations on the Expert Group
on Admission of Medicinal Products of the Pharmaceutical Directorate
to the Market. Available online. In: https://ips.ligazakon.net/document/
MOZ30856?an=16&ed=2019_01_08. Consultation date: 01/10/2022.
OHAR, Svitlana; CHERNYKH, Valentin. 2011. “Historical Origins and
Development of Pharmaceutical Education” In: Medical Education.
No. 4, pp. 12-16.
PRESIDENT OF UKRAINE. 2000. Decree of the President of Ukraine of
December 7, 2000 No. 1313/2000 Concept of public health development
of Ukraine. Available online. In: https://zakon.rada.gov.ua/laws/
show/1313/2000#top. Consultation date: 02/10/2022.
PROKOPENKO, Tina; KOTVITSKA, Alla; HORBANYOV, Valerii. 2015.
“The Study of the Historical Aspects of Pharmaceutical Education
Development in Ukraine in the Second Half of XIX – Early XX Century”
In: Management, economy and quality assurance in pharmacy. No 5,
pp. 54-59.
TEREMETSKYI, Vladyslav; KHOVPUN, Oleksii. 2020. “Modern conceptual
interpretations of the term of “Pharmacia” as administrative and legal
category” In: Subcarpathian Law Herald. Vol. 2, No. 31, pp. 121-124.
VERKHOVNA RADA OF UKRAINE. 2017. Law of Ukraine of October 19,
2017 No. 2168-VIII On state nancial guarantees of medical care of
the population. Available online. In: https://zakon.rada.gov.ua/laws/
show/2168-19#Text. Consultation date: 03/10/2022
www.luz.edu.ve
www.serbi.luz.edu.ve
www.produccioncienticaluz.org
Esta revista fue editada en formato digital y publicada
en enero de 2023, por el Fondo Editorial Serbiluz,
Universidad del Zulia. Maracaibo-Venezuela
Vol.41 Nº 76
