Suchergebnisse

Doctoral dissertation "Theoretical and practical aspects of legal regulations concerning parallel import of medical products" analyses assumptions enabling parallel import of medical products – medicinal products intended for human use, veterinary medicinal products and medical devices – in the internal market of the European Union together evaluating specific formal requirements characteristic to the parallel trade of the just mentioned products while considering that the use of medical products is linked to the protection of public health and life. This work evaluates legal regulation concerning the parallel import of medical products, with particular focus on the regulatory interpretation of jurisprudence of the Court of Justice of the European Union and systematic analysis of laws and regulations of the Republic of Lithuania. The scientific study concludes, that in general the term "parallel import" can be defined as a legal form of trade within European Union internal market, which results from different price levels within the Member States, and which is based on Article 34 of the Treaty of the European Union and is carried out in accordance with the restrictions related to the protection of public health and safety and intellectual property rights which is based on Article 36 of the Treaty of the European Union. Dissertation research indicates that legal presumptions of parallel import of medical products derive from principle of freedom of trade enshrined in the Treaty of the Functioning of the European Union and from exhaustion of intellectual property rights. It is noted, that specificity of the parallel trade of medical products is also determined by the fact that these products are protected by intellectual property rights (patents, trademarks). When analysing the application of the principle of freedom of trade in the pharmaceutical sector dissertation states that Member States of the European Union has a different interpretation of this principle, thus, as shown by the practise of the Court of Justice of the European Union, such different interpretations lead to restrictions of freedom of trade especially when Member States make decisions regarding authorization of parallel import of medicinal products. According to the survey and analysis of jurisprudence of the Court of Justice of the European Union hindrances leading to the unfounded restrictions of parallel import of medical products are identified and proposals enabling better use of advantages coming from parallel import when intending to increase availability of medical products to the patients are given.

Doctoral dissertation "Theoretical and practical aspects of legal regulations concerning parallel import of medical products" analyses assumptions enabling parallel import of medical products – medicinal products intended for human use, veterinary medicinal products and medical devices – in the internal market of the European Union together evaluating specific formal requirements characteristic to the parallel trade of the just mentioned products while considering that the use of medical products is linked to the protection of public health and life. This work evaluates legal regulation concerning the parallel import of medical products, with particular focus on the regulatory interpretation of jurisprudence of the Court of Justice of the European Union and systematic analysis of laws and regulations of the Republic of Lithuania. The scientific study concludes, that in general the term "parallel import" can be defined as a legal form of trade within European Union internal market, which results from different price levels within the Member States, and which is based on Article 34 of the Treaty of the European Union and is carried out in accordance with the restrictions related to the protection of public health and safety and intellectual property rights which is based on Article 36 of the Treaty of the European Union. Dissertation research indicates that legal presumptions of parallel import of medical products derive from principle of freedom of trade enshrined in the Treaty of the Functioning of the European Union and from exhaustion of intellectual property rights. It is noted, that specificity of the parallel trade of medical products is also determined by the fact that these products are protected by intellectual property rights (patents, trademarks). When analysing the application of the principle of freedom of trade in the pharmaceutical sector dissertation states that Member States of the European Union has a different interpretation of this principle, thus, as shown by the practise of the Court of Justice of the European Union, such different interpretations lead to restrictions of freedom of trade especially when Member States make decisions regarding authorization of parallel import of medicinal products. According to the survey and analysis of jurisprudence of the Court of Justice of the European Union hindrances leading to the unfounded restrictions of parallel import of medical products are identified and proposals enabling better use of advantages coming from parallel import when intending to increase availability of medical products to the patients are given.

Parallel import of medicinal products is being defined as an import into the Republic of Lithuania outside the distribution network of the authorised distributor of the product granted marketing authorisation in another EEA Member State, which is identical to the medicinal product already granted marketing authorisation in the Republic of Lithuania or sufficiently resembling it. The majority of parallel import of medicinal products related cases in the Court of Justice of the European Union (hereinafter – CJEU) are dealing with barriers for parallel trade that occur in license issuance procedure. Therefore, the main goal of this article is to identify and analyse regulatory peculiarities of parallel import of medicinal products licence (hereinafter – parallel import licence or licence) issuance procedure that may create barriers for the parallel trade of medicinal products in the Republic of Lithuania. In order to achieve this task, the article evaluates the necessity of parallel import licence, analyses separate elements of this procedure, identifies its regulatory peculiarities and discusses whether these regulatory peculiarities are acceptable for the EU The article concludes that domestic law of the Republic of Lithuania creates challenges for a parallel trader, as the EU law and the CJEU jurisprudence were not taken into account during the implementation of sufficient similarity criteria. A lack of detailed secondary legislation together with administrative problems may reduce the accessibility of the procedure and challenge the implementation of the requirement of the CJEU that this procedure should last "a reasonable time".

Parallel import of medicinal products is being defined as an import into the Republic of Lithuania outside the distribution network of the authorised distributor of the product granted marketing authorisation in another EEA Member State, which is identical to the medicinal product already granted marketing authorisation in the Republic of Lithuania or sufficiently resembling it. The majority of parallel import of medicinal products related cases in the Court of Justice of the European Union (hereinafter – CJEU) are dealing with barriers for parallel trade that occur in license issuance procedure. Therefore, the main goal of this article is to identify and analyse regulatory peculiarities of parallel import of medicinal products licence (hereinafter – parallel import licence or licence) issuance procedure that may create barriers for the parallel trade of medicinal products in the Republic of Lithuania. In order to achieve this task, the article evaluates the necessity of parallel import licence, analyses separate elements of this procedure, identifies its regulatory peculiarities and discusses whether these regulatory peculiarities are acceptable for the EU The article concludes that domestic law of the Republic of Lithuania creates challenges for a parallel trader, as the EU law and the CJEU jurisprudence were not taken into account during the implementation of sufficient similarity criteria. A lack of detailed secondary legislation together with administrative problems may reduce the accessibility of the procedure and challenge the implementation of the requirement of the CJEU that this procedure should last "a reasonable time".

Parallel import of medicinal products is being defined as an import into the Republic of Lithuania outside the distribution network of the authorised distributor of the product granted marketing authorisation in another EEA Member State, which is identical to the medicinal product already granted marketing authorisation in the Republic of Lithuania or sufficiently resembling it. The majority of parallel import of medicinal products related cases in the Court of Justice of the European Union (hereinafter – CJEU) are dealing with barriers for parallel trade that occur in license issuance procedure. Therefore, the main goal of this article is to identify and analyse regulatory peculiarities of parallel import of medicinal products licence (hereinafter – parallel import licence or licence) issuance procedure that may create barriers for the parallel trade of medicinal products in the Republic of Lithuania. In order to achieve this task, the article evaluates the necessity of parallel import licence, analyses separate elements of this procedure, identifies its regulatory peculiarities and discusses whether these regulatory peculiarities are acceptable for the EU The article concludes that domestic law of the Republic of Lithuania creates challenges for a parallel trader, as the EU law and the CJEU jurisprudence were not taken into account during the implementation of sufficient similarity criteria. A lack of detailed secondary legislation together with administrative problems may reduce the accessibility of the procedure and challenge the implementation of the requirement of the CJEU that this procedure should last "a reasonable time". ; Lygiagretus vaistinių preparatų importas – kitoje EEE valstybėje registruoto vaistinio preparato, kuris yra tapatus Lietuvos Respublikoje jau registruotam vaistiniam preparatui ar pakankamai į jį panašus, įvežimas į Lietuvos Respubliką nesinaudojant vaistinio preparato rinkodaros teisės turėtojo platinimo tinklu – Lietuvoje yra įmanomas nuo tada, kai Lietuva tapo ES nare. Tačiau iki šiol lygiagretus vaistinių preparatų importas nėra paplitęs. Antra vertus, straipsnyje atkreipiamas dėmesys į tai, jog lygiagretus vaistinių preparatų importas kyla iš laisvos prekybos principo. Šio principo taikymą farmacijos sektoriuje valstybės narės interpretuoja labai skirtingai. Kaip rodo Europos Sąjungos Teisingumo Teismo praktika, toks skirtingas interpretavimas lemia ir prekybos laisvės suvaržymus, ypač tada, kai valstybėse narėse yra priimami sprendimai dėl lygiagretaus importo leidimų išdavimo. Dėl to straipsnio tyrimų objektu pasirinktas lygiagretaus vaistinių preparatų importo leidimų išdavimo reguliavimas. Straipsnio tikslas – nustatyti ir nagrinėti lygiagretaus vaistinių preparatų leidimų išdavimo reguliavimo ypatumus, įvertinant, ar jie nesukuria kliūčių lygiagrečiam vaistinių preparatų importui į Lietuvos Respubliką. Siekiant užsibrėžto tikslo straipsnyje pirmiausiai analizuojama, ar valstybėse narėse taikoma leidimų sistema yra būtina ir priimtina ES teisės atžvilgiu. Padarius išvadą, jog ši sistema nesukelia ES teisės pažeidimo, nagrinėjami atskiri leidimų sistemos elementai, daugiausiai dėmesio skiriant vaistinių preparatų pakankamo panašumo vertinimo kriterijų analizei. Straipsnyje, remiantis Europos Sąjungos Teisingumo Teismo jurisprudencija, atkreipiamas dėmesys į tai, jog atskirų pakankamo panašumo vertinimo kriterijų (pvz., identiškos vaistinio preparato formos, identiško veikliosios medžiagos kiekio reikalavimas) taikymas gali pažeisti laisvo prekių judėjimo principą. Taip pat analizuojami ir leidimų išdavimo terminai bei administracinio pobūdžio apribojimai. Daroma išvada, jog rengiant nacionalinės teisės aktus, reguliuojančius lygiagretaus vaistinių preparatų importo leidimo išdavimo sistemą, o ypač nustatant pakankamo panašumo kriterijus, nebuvo atsižvelgta į Europos Sąjungos Teisingumo Teismo praktiką. Išsamaus poįstatyminio reguliavimo trūkumas drauge su administracinėmis problemomis – personalo stygiumi – gali apsunkinti lygiagretaus vaistinių preparatų leidimų išdavimo prieinamumą ir kelti problemų siekiant, kad leidimai būtų išduodami "per protingą laiko tarpą", kaip kad reikalauja Europos Sąjungos Teisingumo Teismas. Todėl įstatymų leidėjas turėtų imtis priemonių, kurios užtikrintų tinkamą procedūros prieinamumą. Taip pat, atsižvelgiant į Europos Sąjungos Teisingumo Teismo praktiką, reikėtų svarstyti apie Lietuvos Respublikos farmacijos įstatymo pataisas, kuriomis būtų įgyventinti minėtojo teismo sprendimai, susiję su vaistinių preparatų pakankamo panašumo vertinimu.