Use this url to cite ETD: https://hdl.handle.net/20.500.12259/107706
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Ar Lietuvos Respublikos farmacijos įstatyme įtvirtinti slaptieji kontroliniai pirkimai atitinka Lietuvos Respublikos teisėkūros pagrindų įstatymo numatytam tikslingumo principui?
Field of Science
Teisė / Law (S001)
Type of publication
type::text::thesis::master thesis
Title
Ar Lietuvos Respublikos farmacijos įstatyme įtvirtinti slaptieji kontroliniai pirkimai atitinka Lietuvos Respublikos teisėkūros pagrindų įstatymo numatytam tikslingumo principui?
Other Title
Does the secret control procurement established in the Law on Pharmacy of the Republic of Lithuania comply with the principle of expediency provided in the Law on Legislative Framework of the Republic of Lithuania?
Author
Zeniauskaitė, Raventa |
Advisor
Extent
44 p.
Date Issued
2020-06-19
Abstract
Viešojo intereso užtikrinimas bei ūkinės veiklos reguliavimas – tai neatsiejama demokratinės valstybės pareiga, kuria yra prisidedama prie visuomenės gerovės puoselėjimo. Svarbu, ne tik, kad verslo priežiūra užtikrintų deramą pridėtinę vertę, bet ir išlaikytų proporcingas veiklos priežiūros priemones. Farmacijos sektoriui, kaip vienam iš sparčiausiai besivystančių ūkio subjektų veiklos sričių, yra atitinkamai skiriamas griežtesnis veiklos priežiūros reguliavimas, kadangi teikiamos paslaugos tiesiogiai susijusios su žmonių sveikata, teikiamais vaistiniais preparatais. Problematika pasireiškia tuomet, kai siekiant aukštų veiklos priežiūros tikslų yra keičiami bei griežtinami įstatymai, teisės aktai, kurie trikdo ūkinės veiklos veikimą, nors tokių pačių tikslų galima pasiekti ir kitomis priemonėmis. Lietuvos Respublikos farmacijos įstatyme įtvirtinus slaptus kontrolinius pirkimus, visuomenėje kilo nemažai diskusijų dėl tokių priežiūros priemonių proporcingumo, reikalingumo bei tikslingumo, kas yra numatyta pačioje teisėkūroje ir jos nuostatuose.
Šio darbo tikslas yra išanalizuoti kontrolinių pirkimų probleminius aspektus farmacijos sektoriuje, nustatyti, ar toks priežiūros vykdymas atitinka teisėkūros pagrindų numatytus principus, o labiausiai- tikslingumą. Atlikus sisteminę šios problemos analizę, pateikti rekomendacijas dėl farmacijos priežiūros alternatyvų, kurių pagalba kontroliniai pirkimai nėra būtini norint užtikrinti, kad farmacijos veikla būtų sėkmingai vykdoma. Kontrolinių pirkimų samprata bei reguliavimas, nuo 2017 metų yra reglamentuotas Lietuvos Respublikos farmacijos įstatymo nuostatuose, tačiau tiesioginis kontrolinių pirkimų vykdymas vaistinėse prasidėjo 2018 metais.
Pirmajame skyriuje bus apžvelgiamas farmacijos priežiūros vykdymas bei reglamentavimas Lietuvos Respublikoje, Europos Sąjungoje bei tarptautiniame lygmenyje. Bus siekiama išsiaiškinti – kontrolinio pirkimo sampratą, jo teisinį reguliavimą bei santykį su Lietuvos Respublikos Konstitucijos nuostatomis. Antrajame skyriuje bus analizuojamas farmacijos priežiūros vykdymas prieš kontrolinių pirkimų įteisinimą bei jiems įsigaliojus. Taip pat bus analizuojama „slaptojo pirkėjo“ metodinė priežiūros samprata farmacijoje, jos principai bei veikimas, Lietuvos ir kitų šalių vaistinių praktika. Trečiajame skyriuje apžvelgiami kontrolinių pirkimų probleminiai aspektai, Lietuvos Respublikos farmacijos įstatyme įtvirtintų kontrolinių pirkimų santykis su teisėkūros pagrindų numatytais principais, analizuojama, ar kontroliniai pirkimai yra tikslinga priežiūros priemonė. Siekiama atskleisti, ar kontrolinių pirkimų įteisinimas Lietuvos Respublikos viešojo administravimo įstatyme užtikrina visus ūkio subjektų veiklos priežiūros principus. Galiausiai pateikiamos rekomendacijos dėl kontrolinių pirkimų taikymo alternatyvų, farmacinės veiklos priežiūros užtikrinimui.
Šio darbo tikslas yra išanalizuoti kontrolinių pirkimų probleminius aspektus farmacijos sektoriuje, nustatyti, ar toks priežiūros vykdymas atitinka teisėkūros pagrindų numatytus principus, o labiausiai- tikslingumą. Atlikus sisteminę šios problemos analizę, pateikti rekomendacijas dėl farmacijos priežiūros alternatyvų, kurių pagalba kontroliniai pirkimai nėra būtini norint užtikrinti, kad farmacijos veikla būtų sėkmingai vykdoma. Kontrolinių pirkimų samprata bei reguliavimas, nuo 2017 metų yra reglamentuotas Lietuvos Respublikos farmacijos įstatymo nuostatuose, tačiau tiesioginis kontrolinių pirkimų vykdymas vaistinėse prasidėjo 2018 metais.
Pirmajame skyriuje bus apžvelgiamas farmacijos priežiūros vykdymas bei reglamentavimas Lietuvos Respublikoje, Europos Sąjungoje bei tarptautiniame lygmenyje. Bus siekiama išsiaiškinti – kontrolinio pirkimo sampratą, jo teisinį reguliavimą bei santykį su Lietuvos Respublikos Konstitucijos nuostatomis. Antrajame skyriuje bus analizuojamas farmacijos priežiūros vykdymas prieš kontrolinių pirkimų įteisinimą bei jiems įsigaliojus. Taip pat bus analizuojama „slaptojo pirkėjo“ metodinė priežiūros samprata farmacijoje, jos principai bei veikimas, Lietuvos ir kitų šalių vaistinių praktika. Trečiajame skyriuje apžvelgiami kontrolinių pirkimų probleminiai aspektai, Lietuvos Respublikos farmacijos įstatyme įtvirtintų kontrolinių pirkimų santykis su teisėkūros pagrindų numatytais principais, analizuojama, ar kontroliniai pirkimai yra tikslinga priežiūros priemonė. Siekiama atskleisti, ar kontrolinių pirkimų įteisinimas Lietuvos Respublikos viešojo administravimo įstatyme užtikrina visus ūkio subjektų veiklos priežiūros principus. Galiausiai pateikiamos rekomendacijos dėl kontrolinių pirkimų taikymo alternatyvų, farmacinės veiklos priežiūros užtikrinimui.
Ensuring the public interest and regulating economic activities is an inseparable a priori duty of a democratic state which contributes to the welfare of society. It is important for business supervision to provide adequate added value as well as to maintain proportionate supervision measures.
Since the adoption of the Resolution of the Seimas of the Republic of Lithuania “On Approval of the Lithuanian Health Program” in 1998, the aim was to ensure only safe, effective, cheap and affordable medicines for the population. Such a state goal continues to be pursued in a targeted manner, only to much higher standards of pharmaceutical care. The 2003 Resolution of the Seimas of the Republic of Lithuania on the legal, social and economic development of the State of Lithuania in the field of pharmacy provided for the main directions and objectives of the pharmaceutical policy. The use of the specified rational medicines and the proper provision of the quality of the pharmaceutical service was one of the main goals pursued in the pharmaceutical policy. The pharmaceutical sector, as one of the fastest growing areas of activity of economic operators, is subject to a correspondingly stricter regulation of performance supervision, as the services provided are directly related to human health and the medicines provided. The problem arises when, in order to achieve high goals of activity supervision, laws and legislation are changed and tightened, which disturb the operation of economic activity, while the same goals can be achieved by other means.
After the establishment of secret control procurement in the Law on Pharmacy of the Republic of Lithuania, a number of discussions arise in the society regarding the proportionality, necessity and expediency of such supervision measures, which are provided for in the legislation itself. Amendments to Articles 2 and 364 of the Law on Public Administration have made it possible to extend the powers of control procurement. In other words, the responsible authorities supervising the activities of economic operators may, using the “mystery shopper” principal, carry out inspection visits without informing the entity in advance. As public health is of great importance in the Lithuanian health care system, special attention was paid to pharmacy and its supply. Hence, from 2018, “mystery shoppers” could already visit pharmacies. It is emphasized that the main purpose of secret control procurement is to ensure that medicines are sold in pharmacies in accordance with the established requirements and to enable the choice of cheaper medicines. Taking into account the activities of the health sector, carried out by the European Union countries, especially the practice of pharmaceutical supervision, international recommendations, statistics, and the case law, Lithuanian pharmaceutical policy can be compared at the international level. In the case of an exclusive right of secret control procurement, which has no analogy, it is possible to analyze whether control procurement as a means of supervision is proportionate and whether it does not contradict the principles provided for in the Legislative Framework Law.
European countries use a variety of measures to control the supply and regulation of medicines. One of the main measures in controlling pharmaceutical activity is the regulation of the pricing of medicines and the provision of information to patients about the specifics and use of medicines. Some of the European Union countries have less clear financial instruments that would be effective in reducing the cost of medicines. However, more and more member countries are obliging their specialist pharmacists to inform buyers about the possibility of purchasing a cheaper medicine. Comparing the activities of pharmacies in Lithuania with other countries, the main principles of activity remain the same, only the regulation of supervision differs. For example, the concentration of control in the Netherlands focuses on supervising the production of medicines in pharmacies, while secret control procurement in Lithuania focus on consumer information and an alternative to a cheaper medicine.
Also, the worldwide “mystery shopper” methodological research supervision tool is seen as a facilitator and consultant to the public and private sectors, with no legal consequences. Currently, secret control procurement by pharmacy supervisors, using the “mystery shopper” methodology, automatically have certain legal consequences for the economic operator (pharmacy), as the principle of control procurement itself is enshrined in laws and regulations. Assessing the current regulation of control procurement in Lithuanian pharmacy and the provisions of the Articles of the Law on Public Administration, it can be stated that the “mystery shopper” methodology, from established world practice, was indirectly transferred into legislation together with control procurement of medicinal products. This, in turn, raises doubts as to whether control procurement based on the “mystery shopper” methodology are necessary and effective means of activity supervision.
The aim of this work is to analyze the problematic aspects of control procurement in the pharmaceutical sector. It is necessary to find out whether such supervision complies with the provisions of the principles of supervision of the economic operators’ activities as well as with the principles provided for in the legislative framework, and most of all with expediency. Following a systematic analysis of this problem, make recommendations on alternatives to pharmaceutical care that would not make control procurement necessary to ensure the success of pharmaceutical activities. The concept and regulation of control procurement is regulated in the provisions of the Law on Pharmacy of the Republic of Lithuania since November 1, 2017. However, the direct execution of control procurement in pharmacies started only half a year later, on May 1, 2018.
The first chapter reviews the implementation and regulation of pharmaceutical supervision in Lithuania, the European Union and at the international level. The aim is to clarify the concept of control procurement, legal regulation and the relationship with the provisions of the Constitution of the Republic of Lithuania. The second chapter analyzes the implementation of pharmaceutical supervision before and during the legalization of control procurement. The methodological concept of “mystery shopper” supervision in pharmacy, its principles and operation as well as the practice of pharmacies in Lithuania and other countries are also analyzed. The third chapter reviews the problematic aspects of control procurement as well as the relationship between control procurement established in the Law on Pharmacy of the Republic of Lithuania and the principles provided by the legislative framework, and whether there is an appropriate supervision measure. The aim is to reveal whether the legalization of control procurement in the Law on Public Administration of the Republic of Lithuania ensures all the principles of supervision of the activities of economic operators. Finally, recommendations are provided on the application of alternatives to control procurement to ensure the supervision of pharmaceutical activities.
Since the adoption of the Resolution of the Seimas of the Republic of Lithuania “On Approval of the Lithuanian Health Program” in 1998, the aim was to ensure only safe, effective, cheap and affordable medicines for the population. Such a state goal continues to be pursued in a targeted manner, only to much higher standards of pharmaceutical care. The 2003 Resolution of the Seimas of the Republic of Lithuania on the legal, social and economic development of the State of Lithuania in the field of pharmacy provided for the main directions and objectives of the pharmaceutical policy. The use of the specified rational medicines and the proper provision of the quality of the pharmaceutical service was one of the main goals pursued in the pharmaceutical policy. The pharmaceutical sector, as one of the fastest growing areas of activity of economic operators, is subject to a correspondingly stricter regulation of performance supervision, as the services provided are directly related to human health and the medicines provided. The problem arises when, in order to achieve high goals of activity supervision, laws and legislation are changed and tightened, which disturb the operation of economic activity, while the same goals can be achieved by other means.
After the establishment of secret control procurement in the Law on Pharmacy of the Republic of Lithuania, a number of discussions arise in the society regarding the proportionality, necessity and expediency of such supervision measures, which are provided for in the legislation itself. Amendments to Articles 2 and 364 of the Law on Public Administration have made it possible to extend the powers of control procurement. In other words, the responsible authorities supervising the activities of economic operators may, using the “mystery shopper” principal, carry out inspection visits without informing the entity in advance. As public health is of great importance in the Lithuanian health care system, special attention was paid to pharmacy and its supply. Hence, from 2018, “mystery shoppers” could already visit pharmacies. It is emphasized that the main purpose of secret control procurement is to ensure that medicines are sold in pharmacies in accordance with the established requirements and to enable the choice of cheaper medicines. Taking into account the activities of the health sector, carried out by the European Union countries, especially the practice of pharmaceutical supervision, international recommendations, statistics, and the case law, Lithuanian pharmaceutical policy can be compared at the international level. In the case of an exclusive right of secret control procurement, which has no analogy, it is possible to analyze whether control procurement as a means of supervision is proportionate and whether it does not contradict the principles provided for in the Legislative Framework Law.
European countries use a variety of measures to control the supply and regulation of medicines. One of the main measures in controlling pharmaceutical activity is the regulation of the pricing of medicines and the provision of information to patients about the specifics and use of medicines. Some of the European Union countries have less clear financial instruments that would be effective in reducing the cost of medicines. However, more and more member countries are obliging their specialist pharmacists to inform buyers about the possibility of purchasing a cheaper medicine. Comparing the activities of pharmacies in Lithuania with other countries, the main principles of activity remain the same, only the regulation of supervision differs. For example, the concentration of control in the Netherlands focuses on supervising the production of medicines in pharmacies, while secret control procurement in Lithuania focus on consumer information and an alternative to a cheaper medicine.
Also, the worldwide “mystery shopper” methodological research supervision tool is seen as a facilitator and consultant to the public and private sectors, with no legal consequences. Currently, secret control procurement by pharmacy supervisors, using the “mystery shopper” methodology, automatically have certain legal consequences for the economic operator (pharmacy), as the principle of control procurement itself is enshrined in laws and regulations. Assessing the current regulation of control procurement in Lithuanian pharmacy and the provisions of the Articles of the Law on Public Administration, it can be stated that the “mystery shopper” methodology, from established world practice, was indirectly transferred into legislation together with control procurement of medicinal products. This, in turn, raises doubts as to whether control procurement based on the “mystery shopper” methodology are necessary and effective means of activity supervision.
The aim of this work is to analyze the problematic aspects of control procurement in the pharmaceutical sector. It is necessary to find out whether such supervision complies with the provisions of the principles of supervision of the economic operators’ activities as well as with the principles provided for in the legislative framework, and most of all with expediency. Following a systematic analysis of this problem, make recommendations on alternatives to pharmaceutical care that would not make control procurement necessary to ensure the success of pharmaceutical activities. The concept and regulation of control procurement is regulated in the provisions of the Law on Pharmacy of the Republic of Lithuania since November 1, 2017. However, the direct execution of control procurement in pharmacies started only half a year later, on May 1, 2018.
The first chapter reviews the implementation and regulation of pharmaceutical supervision in Lithuania, the European Union and at the international level. The aim is to clarify the concept of control procurement, legal regulation and the relationship with the provisions of the Constitution of the Republic of Lithuania. The second chapter analyzes the implementation of pharmaceutical supervision before and during the legalization of control procurement. The methodological concept of “mystery shopper” supervision in pharmacy, its principles and operation as well as the practice of pharmacies in Lithuania and other countries are also analyzed. The third chapter reviews the problematic aspects of control procurement as well as the relationship between control procurement established in the Law on Pharmacy of the Republic of Lithuania and the principles provided by the legislative framework, and whether there is an appropriate supervision measure. The aim is to reveal whether the legalization of control procurement in the Law on Public Administration of the Republic of Lithuania ensures all the principles of supervision of the activities of economic operators. Finally, recommendations are provided on the application of alternatives to control procurement to ensure the supervision of pharmaceutical activities.
Language
Lietuvių / Lithuanian (lt)
Defended
Taip / Yes
Access Rights
Prieigos embargo / Embargoed Access
File(s)raventa_zeniauskaite_md.pdf (1.11 MB) Embargo Accessuntil 2025-06-19