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Restriction on the re-export of medicinal products and the supervision of compliance with it by public administration bodies

Restriction on the re-export of medicinal products and the supervision of compliance with it by... Eur. Pharm. J. 2018, 65 (1): 24-30. ISSN 1338-6786 (online) and ISSN 2453-6725 (print version), DOI: 10.1515/afpuc-2017-0009 euR opean phaRM aceutical JouRnal Restriction on the re-export of medicinal products and the supervision of compliance with it by public administration bodies Original Paper 1 2 3 3 4 3 Peráček T. , Vojtech F. , Srebalová M. , Pekár B. , Mikušová-Meričková B. , Horvat M. Comenius University in Bratislava, Faculty of Management Department of Information Systems, Bratislava, Slovak Republic School of Economics and Management of Public Administration in Bratislava Department of Small and Medium Entrepreneurship, Bratislava, Slovak Republic Comenius University in Bratislava, Faculty of Law Department of Administrative Law and Enviromental Law, Bratislava, Slovak Republic Matej Bel University, Faculty of Economics in Bratislava, Department of Public Economics and Regional Development, Banská Bystrica, Slovak Republic Received 4 April, 2017, accepted 12 May, 2017 a bstract After years of mainly expert discussions (not only in the Slovak legal environment), the concept of and legislation on re-export offer a sort of solution provided for in the Act no. 306/2016 Coll. Said act amends the key legislation in this field, namely the Act no. 362/2011 Coll. on Medicinal Products and Medical Devices and on the amendment of certain acts, as amended (hereinafter referred to as the “Act on Medicinal Products”) and the Act no. 363/2011 Coll. on the Scope and Conditions of Payments for Medicinal Products, Medical Devices and Dietetic Foods from Public Health Insurance and on the amendment of certain acts, as amended (hereinafter referred to as the “Act on Payments”). The topic of the paper belongs in the area of medicinal products and pharmaceutical services, it offers, however, significant overlaps in the area of the constitutional, administrative and European law and is aimed at multidisciplinary research into the issue of the reverse export (re-export) of medicinal products. Besides these laws, also the Constitution of the Slovak Republic (“SR”) and the sources of the European Law have to be taken into account in relation to the subject in question. The main aim of legislation in this area of law was restriction on the re-export of selected products and protection of patients from adverse impacts of such business activity. The aim of the paper is the authors’ effort to analyse the issue of the re-export of medicinal products within the context of the adopted Act no. 306/2016 Coll., whose legislative solution is inevitable for the protection of life and health of the population of the Slovak Republic. Keywords Re-export of medicinal products – pharmaceutical services – protection of life and health – right to free enterprise – administrative law Methods intR oduction Paper contains analysis and comparison of the legislation – The organisation of health care, provision of health care or Slovak law and European Union law - in the field of medicinal the assurance of the right to health from the point of view products. of the comparative constitutional law constitutes only Paper defines problems of legislation in terms of legal a rare subject of legislation in the member states of the practice. European Union. If the Constitution of the Slovak Republic Paper gives synthesis of the findings, summarisation and contains provisions that prove that its proposers did not fully drawing of conclusions (in order to protect a  public interest understand social changes that were supposed to have taken (patient)). place after the November of 1989 as a natural and inevitable * E-mail: tomas.peracek@fm.uniba.sk © European Pharmaceutical Journal OR 24 Eur. Pharm. J. 2018, 65 (1): 24-30 Restriction on the re-export of medicinal products and the supervision of compliance with... Peráček T. et al. transition from the socialist to the capitalist society, then such to the unavailability of certain medicinal products in Slovakia, provisions especially include the blunt wording of Article 40 especially includes medicinal products for treatment of of the Constitution of the SR. If in the phase of interpretation serious diseases such as epilepsy, schizophrenia, Parkinson’s and application of the law the SR has legal provisions on disease or several medicinal products for treatment of fundamental rights and freedoms that are far from being oncologic diseases. applied, thus indicating shortcomings in the fulfilment of Also the Slovak Chamber of Pharmacists has been pointing the model of material rule of law, it is again the provisions of to this negative trend for years, saying that significantly Article 40 of the Constitution of the SR. When the Constitution lower prices in comparison to other EU states, the ability of of the SR was being adopted, the then Slovak National Council pharmacies to sell medicinal products also to entities other contented itself with a wording granting everybody the right than patients, as well as the ability of distributors to export to the protection of health. On the basis of health insurance, medicinal products abroad were the basis for the re-export of the right to free health care and to medical devices is only medicinal products, which were subsequently unavailable to guaranteed to citizens of the SR under conditions set out in Slovak patients. It is possible to agree with the opinion of the the law. Pharmaceutical care, i.e. especially the availability Association of Innovative Pharmaceutical Industry (Asociácia of medical products, forms an integral part of this right inovatívneho farmaceutického priemyslu - AIFP), which says guaranteed by the constitution. (Drgonec, 2012) that this situation was caused mainly by the fact that prices However, via Article 55 (2) of the Constitution of the SR the of medicinal products in Slovakia are some of the lowest in Slovak Republic protects and supports competition, which the world, which makes our market attractive for distribution is an inevitable part of every market economy. However, the firms. Member companies of the AIFP do not take part in behaviour of undertakings is not always in conformity with the re-exports and always import a sufficient quantity of ethical principles. The right to conduct free enterprise is also medicinal products to Slovakia as determined by statistical interpreted very extensively by many distributors of medicinal estimates of morbidity. products, who aim to maximise their profits and seek to The Slovak Republic was the only one of member states of export selected types of medicinal products abroad after the European Union to legislatively introduce the possibility their import into to the territory of the SR instead of supplying to prohibit the export of medicinal products, which is why them to pharmacies and hospitals. Available information their export has been monitored since 2013. The European shows that more medicinal products were re-exported in Commission believes that this legislative measure is contrary 2015 than in 2014, when this figure exceeded one million to the legal order of the European Union, which led to the packages. These alarming figures were provided by the State launch of infringement proceedings against the Slovak Institute for Drug Control (Štátny ústav pre kontrolu liečiv - Republic. By letter of March 2015 the European Commission ŠÚKL), to which planned exports have to be reported. Its asked the SR to provide an answer to justify its viewpoint and figures show that 589 medicinal products numbering nearly demonstrate the compliance of the Slovak legislation with the 1.4 million packages were exported from the Slovak Republic EU law, especially in relation to the rules on free movement of in 2015, which is nearly 400 thousand more than in 2014. In goods. (Dôvodová správa, 2016) 2016 these figures grew again, with 700 medicinal products in more than 1.2 million packages in the first two quarters of 2016. The exporters’ target was countries of Western Europe, legislative MeasuRes where their price is incomparably higher. (TERAZ.SK, 2016) The State Institute for Drug Control was authorised to Despite the opposition by the European Commission the prohibit the export of a medicinal product pursuant to Ministry of Health of the SR developed a draft law amending: already ineffective legislation, i.e. only until 31 December − the Act no.  362/2011 Coll. on Medicinal Products and 2016, however, only if it threatened to be unavailable on the Medical Devices and on the amendment of certain domestic market. For comparison, according to the opinions acts, as amended (hereinafter referred to as the “Act on of the ŠÚKL, on the basis of import, export and planned export Medicinal Products”) and figures, it prohibited the export of 27 medicinal products in − the Act no. 363/2011 Coll. on the Scope and Conditions 2014 with 182 decisions, which represented 57,446 packages of Payments for Medicinal Products, Medical Devices and and in 2016 it prohibited the export of a medicinal product as Dietetic Foods from Public Health Insurance and on the many as 1,700 times. (Dôvodová správa, 2016) amendment of certain acts, as amended (hereinafter The Ministry of Health of the SR identified several problems referred to as the “Act on Payments”). causing the unavailability of medicinal products. These especially include bad logistics between the pharmacy and the The aim of this law is to prevent the re-export of medicinal distributor, problems in the production of a medicinal product products and remove the reservations of the European or in the distribution chain, as well as the undeniable fact that Commission, thus bringing the Slovak legislation regarding imported medicinal products are re-exported abroad. The re- medicinal products for human use into compliance with export of medicinal products, which substantially contributed the Treaty on the Functioning of the European Union. Said 25 26 Eur. Pharm. J. 2018, 65 (1): 24-30 Restriction on the re-export of medicinal products and the supervision of compliance with... Peráček T. et al. draft law was submitted by the Government of the SR to the New obligations are imposed on a holder of a licence for the National Council of the SR for approval as part of its legislative wholesale distribution of medicinal products for human use. A initiative. The Parliament approved this draft law, which holder of a licence for the wholesale distribution of medicinal was subsequently promulgated under document number products for human use is, just as a holder of the registration 306/2016 in the Collection of Laws of the Slovak Republic on of a medicinal product, obliged to supply a categorised 23 November 2016 with an effective date from 1 January 2017 medicinal product only to a holder of a licence to provide (hereinafter referred to as the “amendment”). The vacation legis, pharmaceutical care in a public pharmacy or in a hospital i.e. the time period for the addressees to acquaint themselves pharmacy or to another holder of a licence for the wholesale with the content of this new act, is 38 days, which is sufficient distribution of medicinal products for human use. Should it given the extensive nation-wide discussion (Mrva et al., 2009) supply a categorised medicinal product to another holder of a licence for the wholesale distribution of medicinal products for human use, it is obliged to supply the medicinal product c ontent and significance of the to it only for the purposes of final delivery to a holder of a aMendMent licence to provide pharmaceutical care in a public pharmacy Right at the outset the amendment supplements the Act on or in a hospital pharmacy. Medicinal Products with the new term “medical prescription As part of resale, a holder of a licence for the wholesale in an anonymised form”. It is a copy of an issued medical distribution of medicinal products for human use is prescription through which a medicinal product for human authorised to return excessively categorised medicinal use included in the list of categorised medicinal products was products to the holder of their registration, which constitutes prescribed to a patient and on which the holder of a licence the only exception when these medicinal products may be to provide pharmaceutical care in a public pharmacy or in a directed elsewhere than to a pharmacy or another wholesale hospital pharmacy or a person authorised by a holder of a distributor. Upon request, a holder of a licence for the licence to provide pharmaceutical care in a public pharmacy wholesale distribution of medicinal products for human or in a hospital pharmacy anonymises the patient’s personal use is obliged to submit to the Ministry of Health of the SR information. The pharmacy subsequently attaches this records of the receipt of medicinal products for human use copy of a medical prescription to the order addressed to included in the list of categorised medicinal products and the registration holder via an information system providing their deliveries: automated electronic placement, reception and confirmation - to holders of a licence to provide pharmaceutical care in of orders of medicinal products for human use included in the a public pharmacy or in a hospital pharmacy, list of categorised medicinal products created and operated - to other holders of a licence for the wholesale distribution by the registration holder. of medicinal products for human use and  The Act toughens sanctions regarding when after a repeated - to holders of the registration of these medicinal products infringement of an obligation imposed by this act a licence in the case of their resale issued to a holder of a licence for the wholesale distribution of medicinal products for human use and to a holder of a licence or data from these records in an electronic format allowing to provide pharmaceutical care in a public pharmacy or in a automated processing. Furthermore, a holder of a licence for hospital pharmacy is obligatorily legally revoked. Further, the the wholesale distribution of medicinal products for human words “exporter of a medicinal product” were deleted from the use is obliged to keep and retain documentation showing to Act on Medicinal Products, because only a holder of a licence which qualified entities it has supplied categorised medicinal to manufacture medicinal products may be an applicant for products and is obliged to submit this documentation or the issue of a certificate that the manufacturer of a medicinal requested data therefrom upon request to the Ministry of product is a holder of a licence to manufacture medicinal Health of the SR in an electronic format. These new obligations products and that the holder of a licence to manufacture imposed on a holder of a licence for the wholesale distribution medicinal products meets applicable provisions of the World of medicinal products for human use, relating to categorised Health Organization relating to the manufacture of medicinal medicinal products, are meant to prevent the export of these products intended for export to third states. It is specified medicinal products and are in compliance with Article 81 of more precisely, to which entities a holder of a licence for the the Directive 2001/83/EC of the European Parliament and of wholesale distribution of medicinal products for human use the Council on the Community code relating to medicinal may supply medicinal products for human use included in products for human use. We believe that this provision does the list of categorised medicinal products. The obligation to not prevent the application of stricter requirements laid deliver an ordered medicinal product to a pharmacy within down by the member states in relation to the wholesale 24 hours imposed on a holder of a licence for the wholesale distribution of: narcotic drugs or psychotropic substances in distribution of medicinal products for human use has been their territory, medicinal products manufactured from blood, deleted, too. This obligation is only imposed on the holder of immunological medicinal products and radioactive medicinal the registration of the ordered medicinal product. products. 25 26 Eur. Pharm. J. 2018, 65 (1): 24-30 Restriction on the re-export of medicinal products and the supervision of compliance with... Peráček T. et al. expoRt of a Medicinal pR oduct foR huM an which the export is supposed to take place. Furthermore, the use included in the list of categoRised holder of the registration of the medicinal product for human use is obliged to notify its export in an electronic format to Medicinal pR oducts the State Institute not later than seven days after the export Legal philosophy notes that no power may reach further than takes place. After the reception of this notification, the State its purpose requires. The power holder - in this case the state - Institute immediately publishes the export of the medicinal must respect the dignity of every person and its fundamental product for human use included in the list of categorised civil rights, i.e. also the right to conduct business, which may medicinal products on its website. A special situation applies be statutorily restricted but cannot be abolished (Peráček to the export of a medicinal product for human use included 2014). This doctrine was respected also by the legislator and in the list of categorised medicinal products for the needs the provision of Section 19a of the Act on Medicinal Products of the Armed Forces of the Slovak Republic, Armed Security was substantially changed by the amendment with the aim Corps and the Fire and Rescue Corps to ensure the fulfilment to regulate the issue of the export of a medicinal product for of their tasks outside the territory of the Slovak Republic human use with a new wording deleting provisions which under specific legislation. the European Commission criticized most as discriminatory The resale of medicinal products, which pharmacies normally and unfair. Pursuant to Section 19a of the Act on Medicinal used to perform as one of their activities, namely to any Products, the export of a medicinal product for human use holder of a licence for the wholesale distribution of medicinal included in the list of categorised medicinal products from products for human use, is deleted from the pharmaceutical the Slovak Republic is understood to mean the export of care. The medicinal product may only be resold to the licence a medicinal product for human use included in the list of holder the pharmacy purchased the medicinal product from. categorised medicinal products to another member state The exchange of medicinal products for human use from or to a third state. However, the legislator also defined this the list of categorised medicinal products is only possible concept negatively enshrining in the legislation that the between holders of a licence to provide pharmaceutical care resale of a medicinal product for human use included in in a public pharmacy or in a hospital pharmacy, but only for the list of categorised medicinal products or the return of the purposes of their issue in a public or hospital pharmacy. a medicinal product for human use included in the list of The aim of these measures delimiting the scope of activities categorised medicinal products, namely due to the assertion carried out in a public or hospital pharmacy is to prevent the of claims for defects of the medicinal product for human use export of categorised medicinal products, which a holder of delivered or due to the withdrawal of a medicinal product registration supplied to the market in the Slovak Republic for for human use from the market, is not considered as export. the purposes of their issue to the patient in said pharmacies. It would constitute disproportionate interference with the The problem was that many holders of a licence for the buyer’s rights, especially in the case of liability for the seller’s, wholesale distribution of medicinal products for human use i.e. the distributor’s defects. A medicinal product for human purchased categorised medicinal products from holders of a use included in the list of categorised medicinal products may licence to provide pharmaceutical care in a public pharmacy only be exported by the holder of a licence to manufacture or in a hospital pharmacy and subsequently exported them. medicinal products that has manufactured the medicinal New obligations are imposed on a holder of a licence to product being exported, the holder of the registration of this provide pharmaceutical care in a public pharmacy or in a medicinal product or a holder of a licence for the wholesale hospital pharmacy. The most important of them is the issue distribution of medicinal products for human use may also of a categorised medicinal product to a patient. The following only export if it has been authorised to export a medicinal are also allowed: product for human use included in the list of categorised - the resale of these medicinal products to a holder of medicinal products by the holder of the registration of this a licence for the wholesale distribution of medicinal medicinal product via a written power of attorney. From products for human use who supplied them to a holder the point of view of the civil law theory, power of attorney of a licence to provide pharmaceutical care in a public constitutes a unilateral legal act addressed to third persons pharmacy or in a hospital pharmacy, which certifies the existence and scope of the authorised - the exchange of medicinal products for human use representative’s authorisation to act on behalf and for the included in the list of categorised medicinal products person represented. (Cirák et al., 2009) Act is issued separately between holders of a licence to provide pharmaceutical for each export of a medicinal product for human use included care in a public pharmacy or in a hospital pharmacy in the list of categorised medicinal products and must contain for the purposes of their issue in a public or hospital the name of the medicinal product for human use, its code pharmacy. assigned by the State Institute, the size, the number of packages of the medicinal product for human use and the Another obligation imposed on a holder of a licence to provide batch number, the name of the state into which the medicinal pharmaceutical care in a public pharmacy or in a hospital product for human use is being exported and the date by pharmacy is the obligation to order medicinal products for 27 28 Eur. Pharm. J. 2018, 65 (1): 24-30 Restriction on the re-export of medicinal products and the supervision of compliance with... Peráček T. et al. human use included in the list of categorised medicinal The registration holder is obliged to maintain records of products from the holder of their registration via an information holders of a licence for the wholesale distribution of medicinal system providing automated electronic placement, reception products for human use and of holders of a licence to provide and confirmation of orders of medicinal products for human pharmaceutical care in a public pharmacy or hospital use included in the list of categorised medicinal products if it pharmacy to which it supplied medicinal products included requires the holder of the registration of a medicinal product in the list of categorised medicinal products. It is obliged to for human use to deliver a medicinal product for human use retain also these records for 10 years and submit these records included in the list of categorised medicinal products within or data therefrom upon request to the Ministry of Health of 24 hours after the order reception. An anonymised medical the SR in an electronic format allowing automated processing prescription has to be attached to the order. of these data. The registration holder is obliged to supply a A holder of a licence to provide pharmaceutical care in a public mandatory medicinal product for human use included in pharmacy or in a hospital pharmacy is obliged to maintain the list of categorised medicinal products to a holder of a for 10 years records of holders of a licence for the wholesale licence for the wholesale distribution of medicinal products distribution of medicinal products for human use and holders for human use solely for the purposes of final delivery to a of the registration of medicinal products for human use from holder of a licence to provide pharmaceutical care in a public whom it acquired medicinal products for human use included pharmacy or in a hospital pharmacy. in the list of categorised medicinal products and submit these The Act grants the Ministry of Health of the SR new powers records or data therefrom upon request to the Ministry of to publish on its website the name, surname and address of Health of the SR in an electronic format allowing automated the person responsible for the delivery of medicinal products processing of these data. within 24 hours if it is a natural person or the name or business The registration holder has some more obligations e.g. the name and registered office of the person responsible for the creation and operation of an information system for ordering delivery of medicinal products within 24 hours if it is a legal medicinal products for which it holds registration. The person and its contact details consisting of the e-mail address database provides the holder of the registration of medicinal and the mobile phone number. products for human use with an overview of holders of a licence to provide pharmaceutical care in a public or hospital supeR vision by adMinistR ation bodies and pharmacy to which it supplied medicinal products included in iMposition of sanctions foR infRingeMent the list of categorised medicinal products within 24 hours on of the a ct the basis of an anonymised medical prescription. It is obliged   to maintain this information system in operable condition and The application of the Act added several subject matters of in case of its outage it is obliged to receive and confirm orders different administrative offences for the infringement of new of medicinal products for human use included in the list of obligations imposed on the registration holder contained in categorised medicinal products also in a different manner that Section 138 of the Act on Medicinal Products. The Ministry of will allow it to ensure the delivery of the medicinal product to Health of the SR has new powers to impose fines for different the pharmacy within 24 hours. administrative offences regarding the new obligations It is further required to deliver medicinal products for imposed on a holder of a licence for the wholesale distribution human use included in the list of categorised medicinal of medicinal products for human use. The procedure for products within 24  hours to holders of a licence to provide accountability for a different administrative offence is based pharmaceutical care in a public or hospital pharmacy on on the Act on Medicinal Products (special act) in combination the basis of an order via an information system with an with proceedings pursuant to the Code of Administrative anonymised medical prescription attached. This obligation Procedure (general legislation) (Horvat, 2014).The Act no. does not apply to a holder of the registration of a medicinal 363/2011 Coll. on the Scope and Conditions of Payments product for human use who has claims against a holder of a for Medicinal Products, Medical Devices and Dietetic Foods licence to provide pharmaceutical care in a public or hospital from Public Health Insurance and on the amendment of pharmacy for delivered medicinal products included in the certain acts has been amended by the Act no. 460/2012 Coll. list of categorised medicinal products after double expiration and the Act no. 265/2015 Coll. has been amended with the of the contracted payment due date. The registration holder is aim to bring sanctions pursuant to this act into compliance obliged to designate as well as notify to the Ministry of Health with different administration offences pursuant to the Act on of the SR a person responsible for the delivery of medicinal Medicinal Products. products for human use included in the list of categorised The Act on Medicinal Products provided significant room for medicinal products residing or having its registered office the exercise of the powers of state administration bodies in in the territory of the Slovak Republic, if the holder of the the field of health care even before the adoption of the Act. registration of medicinal products for human use does nor The exercise of state administration in the field of human reside or does not have its registered office in the territory of pharmacy is performed by the Ministry of Health of the the Slovak Republic. SR and the State Institute for Drug Control and the state 27 28 Eur. Pharm. J. 2018, 65 (1): 24-30 Restriction on the re-export of medicinal products and the supervision of compliance with... Peráček T. et al. administration in the field of human pharmacy in a self- is one of the fundamental principles of the Treaty (Article governing region is performed as its transferred exercise 28 of the TFEU). Originally, the free movement of goods was also by the self-governing region. The Act contains a fairly considered to be part of the customs union between the broad range of sanctions for offences in its eighth part. member states, which included the abolition of customs Proceedings on offences in the field of human pharmacy duties, quantitative restrictions and measures having and their hearing are covered by the Act no. 372/1990 Coll. equivalent effect and the introduction of a common customs on Oenc ff es, as amended. Besides, public administration tariff of the Community. Later, attention was focused on the bodies may impose sanctions (a fine) up to EUR 1 million for abolition of all remaining constraints of free movement with different administrative offences according to the gravity of the aim to create an internal market - space without internal the misconduct using the procedure laid down in the Act borders in which goods could move just as freely as on the no.  71/1967 Coll. on Administrative Proceedings (Code of national market (Nováčková & Milošovičová, 2011). Administrative Procedure), as amended. However, within the administrative judicial system, persons concerned may c onclusion require the court to review the lawfulness of the decision to impose a sanction. (Ficová et al., 2010) Legal opinions of the issue of the limitation of the free movement of medicinal products within member states are not and will never be uniform. It is possible to agree bRinging the a ct into coMpliance with with the view that freedom to conduct business cannot be euR opean union law understood as an absolute right without any limitation. One of the fundamental principles of the functioning of the (Mucha et al., 2016) It is because this freedom also has its European Union is the development of social policy also in own content, which may be affected by a state intervention member states. This idea is contained in the Treaty of Rome which may not necessarily be unlawful or discriminatory from of 1957 establishing the European Economic Community the point of view of the Community law. From the point of (Vojtech & Levický, 2016). Pursuant to the second sentence of view of exporters of medicinal products, it is evident that they Article 7 (2) of the SR Constitution, legally binding acts of the understand such intervention by the legislator as a denial of European Communities and European Union take precedence the foundation of free enterprise when they are stripped of over the laws of the Slovak Republic, which was also respected the possibility to export medicinal products from the Slovak by the legislator, which is why the wording of the Act is fully in Republic to another EU member state. Such intervention may, accordance with European Union law (Gregušová & Peráček, however, only be justified by legitimately invoking the general 2015). The free movement of goods, which includes medicinal nation-wide interest because the task of a fair society and its products, constitutes the first of the four fundamental institutions, on which it is based, is to develop a framework freedoms of the internal market, which derives its legal basis where individuals will be guaranteed conditions inevitable from Articles 26, 28 to 37 of the Treaty on the Functioning for them to achieve what they themselves consider good, i.e. of the European Union. It is guaranteed especially by the the right to available health care (Chovancová, 2009). The abolition of the customs duties and quantitative restrictions right to conduct business in the area of import and export as well as by the prohibition of measures having equivalent of medicinal products is not generally being prohibited by effect. To support the completion of the internal market, the legislator; it is only being limited in certain situations as principles of mutual recognition, abolition of physical and the Slovak Republic guarantees everybody the right to the technical constraints and standardisation support were protection of health pursuant to the first sentence of Article added. The adoption of the new legislative framework in 40 of the SR Constitution. This right, which applies both to the 2008 significantly reinforced the marketing of products, the citizens of the Slovak Republic and to foreigners regardless of free movement of goods, the system of surveillance over the their nationality, must always take precedence over anybody’s European Union market and the CE marking. The right to the right to conduct business and make profit regardless of free movement of goods originating in member states and possible consequences (Peráček et al., 2016). third countries that are in free circulation in member states References [1] Cirák J et al. Občianske právo : všeobecná časť. Šamorín, Heuréka; a dietetických potravín na základe verejného zdravotného 2008 poistenia a o zmene a doplnení niektorých zákonov v znení [2] Dôvodová správa k návrhu zákona č. 306/2016 Z. z., ktorým sa neskorších predpisov, mení a dopĺňa zákon č. 362/2011 Z. z. o liekoch a zdravotníckych [3] Drgonec J. Ústava Slovenskej republiky. Komentár. 3. vydanie. pomôckach a o zmene a doplnení niektorých zákonov v znení Šamorín, Heréka; 2012 neskorších predpisov a ktorým sa mení zákon č. 363/2011 Z. z. o [4] Ficová S et al. Občianske súdne konanie. - 1. vyd. Praha, C. H. rozsahu a podmienkach úhrady liekov, zdravotníckych pomôcok BECK; 2010 29 30 Eur. Pharm. 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Brno, Tribún; 2016 Bratislava, Eurounion; 2011 Legislation − zákon č. 71/1967 Zb. o  správnom konaní (správny poriadok) − zákon č. 362/2011 Z. z. o liekoch a zdravotníckych pomôckach v znení neskorších predpisov a o zmene a doplnení niektorých zákonov v znení neskorších − zákon SNR č. 372/1990 Zb. o  priestupkoch v  znení neskorších predpisov, predpisov − zákon č. 363/2011 Z. z. o rozsahu a podmienkach úhrady − ústavný zákon SNR č. 460/1992 Zb. Ústava Slovenskej republiky liekov, zdravotníckych pomôcok a dietetických potravín na v znení neskorších predpisov základe verejného zdravotného poistenia a o zmene a doplnení − zákon č. 306/2016 Z. z., ktorým sa mení a  dopĺňa zákon č. niektorých zákonov v znení neskorších predpisov. 362/2011 Z. z. o liekoch a zdravotníckych pomôckach a o zmene a doplnení niektorých zákonov v znení neskorších predpisov a  ktorým sa mení zákon č. 363/2011 Z. z. o rozsahu a podmienkach úhrady liekov, zdravotníckych pomôcok a dietetických potravín na základe verejného zdravotného poistenia a o zmene a doplnení niektorých zákonov v znení neskorších predpisov, 29 30 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Acta Facultatis Pharmaceuticae Universitatis Comenianae de Gruyter

Restriction on the re-export of medicinal products and the supervision of compliance with it by public administration bodies

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de Gruyter
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© 2018 Peráček T. et al., published by Sciendo
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1338-6786
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DOI
10.1515/afpuc-2017-0009
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Abstract

Eur. Pharm. J. 2018, 65 (1): 24-30. ISSN 1338-6786 (online) and ISSN 2453-6725 (print version), DOI: 10.1515/afpuc-2017-0009 euR opean phaRM aceutical JouRnal Restriction on the re-export of medicinal products and the supervision of compliance with it by public administration bodies Original Paper 1 2 3 3 4 3 Peráček T. , Vojtech F. , Srebalová M. , Pekár B. , Mikušová-Meričková B. , Horvat M. Comenius University in Bratislava, Faculty of Management Department of Information Systems, Bratislava, Slovak Republic School of Economics and Management of Public Administration in Bratislava Department of Small and Medium Entrepreneurship, Bratislava, Slovak Republic Comenius University in Bratislava, Faculty of Law Department of Administrative Law and Enviromental Law, Bratislava, Slovak Republic Matej Bel University, Faculty of Economics in Bratislava, Department of Public Economics and Regional Development, Banská Bystrica, Slovak Republic Received 4 April, 2017, accepted 12 May, 2017 a bstract After years of mainly expert discussions (not only in the Slovak legal environment), the concept of and legislation on re-export offer a sort of solution provided for in the Act no. 306/2016 Coll. Said act amends the key legislation in this field, namely the Act no. 362/2011 Coll. on Medicinal Products and Medical Devices and on the amendment of certain acts, as amended (hereinafter referred to as the “Act on Medicinal Products”) and the Act no. 363/2011 Coll. on the Scope and Conditions of Payments for Medicinal Products, Medical Devices and Dietetic Foods from Public Health Insurance and on the amendment of certain acts, as amended (hereinafter referred to as the “Act on Payments”). The topic of the paper belongs in the area of medicinal products and pharmaceutical services, it offers, however, significant overlaps in the area of the constitutional, administrative and European law and is aimed at multidisciplinary research into the issue of the reverse export (re-export) of medicinal products. Besides these laws, also the Constitution of the Slovak Republic (“SR”) and the sources of the European Law have to be taken into account in relation to the subject in question. The main aim of legislation in this area of law was restriction on the re-export of selected products and protection of patients from adverse impacts of such business activity. The aim of the paper is the authors’ effort to analyse the issue of the re-export of medicinal products within the context of the adopted Act no. 306/2016 Coll., whose legislative solution is inevitable for the protection of life and health of the population of the Slovak Republic. Keywords Re-export of medicinal products – pharmaceutical services – protection of life and health – right to free enterprise – administrative law Methods intR oduction Paper contains analysis and comparison of the legislation – The organisation of health care, provision of health care or Slovak law and European Union law - in the field of medicinal the assurance of the right to health from the point of view products. of the comparative constitutional law constitutes only Paper defines problems of legislation in terms of legal a rare subject of legislation in the member states of the practice. European Union. If the Constitution of the Slovak Republic Paper gives synthesis of the findings, summarisation and contains provisions that prove that its proposers did not fully drawing of conclusions (in order to protect a  public interest understand social changes that were supposed to have taken (patient)). place after the November of 1989 as a natural and inevitable * E-mail: tomas.peracek@fm.uniba.sk © European Pharmaceutical Journal OR 24 Eur. Pharm. J. 2018, 65 (1): 24-30 Restriction on the re-export of medicinal products and the supervision of compliance with... Peráček T. et al. transition from the socialist to the capitalist society, then such to the unavailability of certain medicinal products in Slovakia, provisions especially include the blunt wording of Article 40 especially includes medicinal products for treatment of of the Constitution of the SR. If in the phase of interpretation serious diseases such as epilepsy, schizophrenia, Parkinson’s and application of the law the SR has legal provisions on disease or several medicinal products for treatment of fundamental rights and freedoms that are far from being oncologic diseases. applied, thus indicating shortcomings in the fulfilment of Also the Slovak Chamber of Pharmacists has been pointing the model of material rule of law, it is again the provisions of to this negative trend for years, saying that significantly Article 40 of the Constitution of the SR. When the Constitution lower prices in comparison to other EU states, the ability of of the SR was being adopted, the then Slovak National Council pharmacies to sell medicinal products also to entities other contented itself with a wording granting everybody the right than patients, as well as the ability of distributors to export to the protection of health. On the basis of health insurance, medicinal products abroad were the basis for the re-export of the right to free health care and to medical devices is only medicinal products, which were subsequently unavailable to guaranteed to citizens of the SR under conditions set out in Slovak patients. It is possible to agree with the opinion of the the law. Pharmaceutical care, i.e. especially the availability Association of Innovative Pharmaceutical Industry (Asociácia of medical products, forms an integral part of this right inovatívneho farmaceutického priemyslu - AIFP), which says guaranteed by the constitution. (Drgonec, 2012) that this situation was caused mainly by the fact that prices However, via Article 55 (2) of the Constitution of the SR the of medicinal products in Slovakia are some of the lowest in Slovak Republic protects and supports competition, which the world, which makes our market attractive for distribution is an inevitable part of every market economy. However, the firms. Member companies of the AIFP do not take part in behaviour of undertakings is not always in conformity with the re-exports and always import a sufficient quantity of ethical principles. The right to conduct free enterprise is also medicinal products to Slovakia as determined by statistical interpreted very extensively by many distributors of medicinal estimates of morbidity. products, who aim to maximise their profits and seek to The Slovak Republic was the only one of member states of export selected types of medicinal products abroad after the European Union to legislatively introduce the possibility their import into to the territory of the SR instead of supplying to prohibit the export of medicinal products, which is why them to pharmacies and hospitals. Available information their export has been monitored since 2013. The European shows that more medicinal products were re-exported in Commission believes that this legislative measure is contrary 2015 than in 2014, when this figure exceeded one million to the legal order of the European Union, which led to the packages. These alarming figures were provided by the State launch of infringement proceedings against the Slovak Institute for Drug Control (Štátny ústav pre kontrolu liečiv - Republic. By letter of March 2015 the European Commission ŠÚKL), to which planned exports have to be reported. Its asked the SR to provide an answer to justify its viewpoint and figures show that 589 medicinal products numbering nearly demonstrate the compliance of the Slovak legislation with the 1.4 million packages were exported from the Slovak Republic EU law, especially in relation to the rules on free movement of in 2015, which is nearly 400 thousand more than in 2014. In goods. (Dôvodová správa, 2016) 2016 these figures grew again, with 700 medicinal products in more than 1.2 million packages in the first two quarters of 2016. The exporters’ target was countries of Western Europe, legislative MeasuRes where their price is incomparably higher. (TERAZ.SK, 2016) The State Institute for Drug Control was authorised to Despite the opposition by the European Commission the prohibit the export of a medicinal product pursuant to Ministry of Health of the SR developed a draft law amending: already ineffective legislation, i.e. only until 31 December − the Act no.  362/2011 Coll. on Medicinal Products and 2016, however, only if it threatened to be unavailable on the Medical Devices and on the amendment of certain domestic market. For comparison, according to the opinions acts, as amended (hereinafter referred to as the “Act on of the ŠÚKL, on the basis of import, export and planned export Medicinal Products”) and figures, it prohibited the export of 27 medicinal products in − the Act no. 363/2011 Coll. on the Scope and Conditions 2014 with 182 decisions, which represented 57,446 packages of Payments for Medicinal Products, Medical Devices and and in 2016 it prohibited the export of a medicinal product as Dietetic Foods from Public Health Insurance and on the many as 1,700 times. (Dôvodová správa, 2016) amendment of certain acts, as amended (hereinafter The Ministry of Health of the SR identified several problems referred to as the “Act on Payments”). causing the unavailability of medicinal products. These especially include bad logistics between the pharmacy and the The aim of this law is to prevent the re-export of medicinal distributor, problems in the production of a medicinal product products and remove the reservations of the European or in the distribution chain, as well as the undeniable fact that Commission, thus bringing the Slovak legislation regarding imported medicinal products are re-exported abroad. The re- medicinal products for human use into compliance with export of medicinal products, which substantially contributed the Treaty on the Functioning of the European Union. Said 25 26 Eur. Pharm. J. 2018, 65 (1): 24-30 Restriction on the re-export of medicinal products and the supervision of compliance with... Peráček T. et al. draft law was submitted by the Government of the SR to the New obligations are imposed on a holder of a licence for the National Council of the SR for approval as part of its legislative wholesale distribution of medicinal products for human use. A initiative. The Parliament approved this draft law, which holder of a licence for the wholesale distribution of medicinal was subsequently promulgated under document number products for human use is, just as a holder of the registration 306/2016 in the Collection of Laws of the Slovak Republic on of a medicinal product, obliged to supply a categorised 23 November 2016 with an effective date from 1 January 2017 medicinal product only to a holder of a licence to provide (hereinafter referred to as the “amendment”). The vacation legis, pharmaceutical care in a public pharmacy or in a hospital i.e. the time period for the addressees to acquaint themselves pharmacy or to another holder of a licence for the wholesale with the content of this new act, is 38 days, which is sufficient distribution of medicinal products for human use. Should it given the extensive nation-wide discussion (Mrva et al., 2009) supply a categorised medicinal product to another holder of a licence for the wholesale distribution of medicinal products for human use, it is obliged to supply the medicinal product c ontent and significance of the to it only for the purposes of final delivery to a holder of a aMendMent licence to provide pharmaceutical care in a public pharmacy Right at the outset the amendment supplements the Act on or in a hospital pharmacy. Medicinal Products with the new term “medical prescription As part of resale, a holder of a licence for the wholesale in an anonymised form”. It is a copy of an issued medical distribution of medicinal products for human use is prescription through which a medicinal product for human authorised to return excessively categorised medicinal use included in the list of categorised medicinal products was products to the holder of their registration, which constitutes prescribed to a patient and on which the holder of a licence the only exception when these medicinal products may be to provide pharmaceutical care in a public pharmacy or in a directed elsewhere than to a pharmacy or another wholesale hospital pharmacy or a person authorised by a holder of a distributor. Upon request, a holder of a licence for the licence to provide pharmaceutical care in a public pharmacy wholesale distribution of medicinal products for human or in a hospital pharmacy anonymises the patient’s personal use is obliged to submit to the Ministry of Health of the SR information. The pharmacy subsequently attaches this records of the receipt of medicinal products for human use copy of a medical prescription to the order addressed to included in the list of categorised medicinal products and the registration holder via an information system providing their deliveries: automated electronic placement, reception and confirmation - to holders of a licence to provide pharmaceutical care in of orders of medicinal products for human use included in the a public pharmacy or in a hospital pharmacy, list of categorised medicinal products created and operated - to other holders of a licence for the wholesale distribution by the registration holder. of medicinal products for human use and  The Act toughens sanctions regarding when after a repeated - to holders of the registration of these medicinal products infringement of an obligation imposed by this act a licence in the case of their resale issued to a holder of a licence for the wholesale distribution of medicinal products for human use and to a holder of a licence or data from these records in an electronic format allowing to provide pharmaceutical care in a public pharmacy or in a automated processing. Furthermore, a holder of a licence for hospital pharmacy is obligatorily legally revoked. Further, the the wholesale distribution of medicinal products for human words “exporter of a medicinal product” were deleted from the use is obliged to keep and retain documentation showing to Act on Medicinal Products, because only a holder of a licence which qualified entities it has supplied categorised medicinal to manufacture medicinal products may be an applicant for products and is obliged to submit this documentation or the issue of a certificate that the manufacturer of a medicinal requested data therefrom upon request to the Ministry of product is a holder of a licence to manufacture medicinal Health of the SR in an electronic format. These new obligations products and that the holder of a licence to manufacture imposed on a holder of a licence for the wholesale distribution medicinal products meets applicable provisions of the World of medicinal products for human use, relating to categorised Health Organization relating to the manufacture of medicinal medicinal products, are meant to prevent the export of these products intended for export to third states. It is specified medicinal products and are in compliance with Article 81 of more precisely, to which entities a holder of a licence for the the Directive 2001/83/EC of the European Parliament and of wholesale distribution of medicinal products for human use the Council on the Community code relating to medicinal may supply medicinal products for human use included in products for human use. We believe that this provision does the list of categorised medicinal products. The obligation to not prevent the application of stricter requirements laid deliver an ordered medicinal product to a pharmacy within down by the member states in relation to the wholesale 24 hours imposed on a holder of a licence for the wholesale distribution of: narcotic drugs or psychotropic substances in distribution of medicinal products for human use has been their territory, medicinal products manufactured from blood, deleted, too. This obligation is only imposed on the holder of immunological medicinal products and radioactive medicinal the registration of the ordered medicinal product. products. 25 26 Eur. Pharm. J. 2018, 65 (1): 24-30 Restriction on the re-export of medicinal products and the supervision of compliance with... Peráček T. et al. expoRt of a Medicinal pR oduct foR huM an which the export is supposed to take place. Furthermore, the use included in the list of categoRised holder of the registration of the medicinal product for human use is obliged to notify its export in an electronic format to Medicinal pR oducts the State Institute not later than seven days after the export Legal philosophy notes that no power may reach further than takes place. After the reception of this notification, the State its purpose requires. The power holder - in this case the state - Institute immediately publishes the export of the medicinal must respect the dignity of every person and its fundamental product for human use included in the list of categorised civil rights, i.e. also the right to conduct business, which may medicinal products on its website. A special situation applies be statutorily restricted but cannot be abolished (Peráček to the export of a medicinal product for human use included 2014). This doctrine was respected also by the legislator and in the list of categorised medicinal products for the needs the provision of Section 19a of the Act on Medicinal Products of the Armed Forces of the Slovak Republic, Armed Security was substantially changed by the amendment with the aim Corps and the Fire and Rescue Corps to ensure the fulfilment to regulate the issue of the export of a medicinal product for of their tasks outside the territory of the Slovak Republic human use with a new wording deleting provisions which under specific legislation. the European Commission criticized most as discriminatory The resale of medicinal products, which pharmacies normally and unfair. Pursuant to Section 19a of the Act on Medicinal used to perform as one of their activities, namely to any Products, the export of a medicinal product for human use holder of a licence for the wholesale distribution of medicinal included in the list of categorised medicinal products from products for human use, is deleted from the pharmaceutical the Slovak Republic is understood to mean the export of care. The medicinal product may only be resold to the licence a medicinal product for human use included in the list of holder the pharmacy purchased the medicinal product from. categorised medicinal products to another member state The exchange of medicinal products for human use from or to a third state. However, the legislator also defined this the list of categorised medicinal products is only possible concept negatively enshrining in the legislation that the between holders of a licence to provide pharmaceutical care resale of a medicinal product for human use included in in a public pharmacy or in a hospital pharmacy, but only for the list of categorised medicinal products or the return of the purposes of their issue in a public or hospital pharmacy. a medicinal product for human use included in the list of The aim of these measures delimiting the scope of activities categorised medicinal products, namely due to the assertion carried out in a public or hospital pharmacy is to prevent the of claims for defects of the medicinal product for human use export of categorised medicinal products, which a holder of delivered or due to the withdrawal of a medicinal product registration supplied to the market in the Slovak Republic for for human use from the market, is not considered as export. the purposes of their issue to the patient in said pharmacies. It would constitute disproportionate interference with the The problem was that many holders of a licence for the buyer’s rights, especially in the case of liability for the seller’s, wholesale distribution of medicinal products for human use i.e. the distributor’s defects. A medicinal product for human purchased categorised medicinal products from holders of a use included in the list of categorised medicinal products may licence to provide pharmaceutical care in a public pharmacy only be exported by the holder of a licence to manufacture or in a hospital pharmacy and subsequently exported them. medicinal products that has manufactured the medicinal New obligations are imposed on a holder of a licence to product being exported, the holder of the registration of this provide pharmaceutical care in a public pharmacy or in a medicinal product or a holder of a licence for the wholesale hospital pharmacy. The most important of them is the issue distribution of medicinal products for human use may also of a categorised medicinal product to a patient. The following only export if it has been authorised to export a medicinal are also allowed: product for human use included in the list of categorised - the resale of these medicinal products to a holder of medicinal products by the holder of the registration of this a licence for the wholesale distribution of medicinal medicinal product via a written power of attorney. From products for human use who supplied them to a holder the point of view of the civil law theory, power of attorney of a licence to provide pharmaceutical care in a public constitutes a unilateral legal act addressed to third persons pharmacy or in a hospital pharmacy, which certifies the existence and scope of the authorised - the exchange of medicinal products for human use representative’s authorisation to act on behalf and for the included in the list of categorised medicinal products person represented. (Cirák et al., 2009) Act is issued separately between holders of a licence to provide pharmaceutical for each export of a medicinal product for human use included care in a public pharmacy or in a hospital pharmacy in the list of categorised medicinal products and must contain for the purposes of their issue in a public or hospital the name of the medicinal product for human use, its code pharmacy. assigned by the State Institute, the size, the number of packages of the medicinal product for human use and the Another obligation imposed on a holder of a licence to provide batch number, the name of the state into which the medicinal pharmaceutical care in a public pharmacy or in a hospital product for human use is being exported and the date by pharmacy is the obligation to order medicinal products for 27 28 Eur. Pharm. J. 2018, 65 (1): 24-30 Restriction on the re-export of medicinal products and the supervision of compliance with... Peráček T. et al. human use included in the list of categorised medicinal The registration holder is obliged to maintain records of products from the holder of their registration via an information holders of a licence for the wholesale distribution of medicinal system providing automated electronic placement, reception products for human use and of holders of a licence to provide and confirmation of orders of medicinal products for human pharmaceutical care in a public pharmacy or hospital use included in the list of categorised medicinal products if it pharmacy to which it supplied medicinal products included requires the holder of the registration of a medicinal product in the list of categorised medicinal products. It is obliged to for human use to deliver a medicinal product for human use retain also these records for 10 years and submit these records included in the list of categorised medicinal products within or data therefrom upon request to the Ministry of Health of 24 hours after the order reception. An anonymised medical the SR in an electronic format allowing automated processing prescription has to be attached to the order. of these data. The registration holder is obliged to supply a A holder of a licence to provide pharmaceutical care in a public mandatory medicinal product for human use included in pharmacy or in a hospital pharmacy is obliged to maintain the list of categorised medicinal products to a holder of a for 10 years records of holders of a licence for the wholesale licence for the wholesale distribution of medicinal products distribution of medicinal products for human use and holders for human use solely for the purposes of final delivery to a of the registration of medicinal products for human use from holder of a licence to provide pharmaceutical care in a public whom it acquired medicinal products for human use included pharmacy or in a hospital pharmacy. in the list of categorised medicinal products and submit these The Act grants the Ministry of Health of the SR new powers records or data therefrom upon request to the Ministry of to publish on its website the name, surname and address of Health of the SR in an electronic format allowing automated the person responsible for the delivery of medicinal products processing of these data. within 24 hours if it is a natural person or the name or business The registration holder has some more obligations e.g. the name and registered office of the person responsible for the creation and operation of an information system for ordering delivery of medicinal products within 24 hours if it is a legal medicinal products for which it holds registration. The person and its contact details consisting of the e-mail address database provides the holder of the registration of medicinal and the mobile phone number. products for human use with an overview of holders of a licence to provide pharmaceutical care in a public or hospital supeR vision by adMinistR ation bodies and pharmacy to which it supplied medicinal products included in iMposition of sanctions foR infRingeMent the list of categorised medicinal products within 24 hours on of the a ct the basis of an anonymised medical prescription. It is obliged   to maintain this information system in operable condition and The application of the Act added several subject matters of in case of its outage it is obliged to receive and confirm orders different administrative offences for the infringement of new of medicinal products for human use included in the list of obligations imposed on the registration holder contained in categorised medicinal products also in a different manner that Section 138 of the Act on Medicinal Products. The Ministry of will allow it to ensure the delivery of the medicinal product to Health of the SR has new powers to impose fines for different the pharmacy within 24 hours. administrative offences regarding the new obligations It is further required to deliver medicinal products for imposed on a holder of a licence for the wholesale distribution human use included in the list of categorised medicinal of medicinal products for human use. The procedure for products within 24  hours to holders of a licence to provide accountability for a different administrative offence is based pharmaceutical care in a public or hospital pharmacy on on the Act on Medicinal Products (special act) in combination the basis of an order via an information system with an with proceedings pursuant to the Code of Administrative anonymised medical prescription attached. This obligation Procedure (general legislation) (Horvat, 2014).The Act no. does not apply to a holder of the registration of a medicinal 363/2011 Coll. on the Scope and Conditions of Payments product for human use who has claims against a holder of a for Medicinal Products, Medical Devices and Dietetic Foods licence to provide pharmaceutical care in a public or hospital from Public Health Insurance and on the amendment of pharmacy for delivered medicinal products included in the certain acts has been amended by the Act no. 460/2012 Coll. list of categorised medicinal products after double expiration and the Act no. 265/2015 Coll. has been amended with the of the contracted payment due date. The registration holder is aim to bring sanctions pursuant to this act into compliance obliged to designate as well as notify to the Ministry of Health with different administration offences pursuant to the Act on of the SR a person responsible for the delivery of medicinal Medicinal Products. products for human use included in the list of categorised The Act on Medicinal Products provided significant room for medicinal products residing or having its registered office the exercise of the powers of state administration bodies in in the territory of the Slovak Republic, if the holder of the the field of health care even before the adoption of the Act. registration of medicinal products for human use does nor The exercise of state administration in the field of human reside or does not have its registered office in the territory of pharmacy is performed by the Ministry of Health of the the Slovak Republic. SR and the State Institute for Drug Control and the state 27 28 Eur. Pharm. J. 2018, 65 (1): 24-30 Restriction on the re-export of medicinal products and the supervision of compliance with... Peráček T. et al. administration in the field of human pharmacy in a self- is one of the fundamental principles of the Treaty (Article governing region is performed as its transferred exercise 28 of the TFEU). Originally, the free movement of goods was also by the self-governing region. The Act contains a fairly considered to be part of the customs union between the broad range of sanctions for offences in its eighth part. member states, which included the abolition of customs Proceedings on offences in the field of human pharmacy duties, quantitative restrictions and measures having and their hearing are covered by the Act no. 372/1990 Coll. equivalent effect and the introduction of a common customs on Oenc ff es, as amended. Besides, public administration tariff of the Community. Later, attention was focused on the bodies may impose sanctions (a fine) up to EUR 1 million for abolition of all remaining constraints of free movement with different administrative offences according to the gravity of the aim to create an internal market - space without internal the misconduct using the procedure laid down in the Act borders in which goods could move just as freely as on the no.  71/1967 Coll. on Administrative Proceedings (Code of national market (Nováčková & Milošovičová, 2011). Administrative Procedure), as amended. However, within the administrative judicial system, persons concerned may c onclusion require the court to review the lawfulness of the decision to impose a sanction. (Ficová et al., 2010) Legal opinions of the issue of the limitation of the free movement of medicinal products within member states are not and will never be uniform. It is possible to agree bRinging the a ct into coMpliance with with the view that freedom to conduct business cannot be euR opean union law understood as an absolute right without any limitation. One of the fundamental principles of the functioning of the (Mucha et al., 2016) It is because this freedom also has its European Union is the development of social policy also in own content, which may be affected by a state intervention member states. This idea is contained in the Treaty of Rome which may not necessarily be unlawful or discriminatory from of 1957 establishing the European Economic Community the point of view of the Community law. From the point of (Vojtech & Levický, 2016). Pursuant to the second sentence of view of exporters of medicinal products, it is evident that they Article 7 (2) of the SR Constitution, legally binding acts of the understand such intervention by the legislator as a denial of European Communities and European Union take precedence the foundation of free enterprise when they are stripped of over the laws of the Slovak Republic, which was also respected the possibility to export medicinal products from the Slovak by the legislator, which is why the wording of the Act is fully in Republic to another EU member state. Such intervention may, accordance with European Union law (Gregušová & Peráček, however, only be justified by legitimately invoking the general 2015). The free movement of goods, which includes medicinal nation-wide interest because the task of a fair society and its products, constitutes the first of the four fundamental institutions, on which it is based, is to develop a framework freedoms of the internal market, which derives its legal basis where individuals will be guaranteed conditions inevitable from Articles 26, 28 to 37 of the Treaty on the Functioning for them to achieve what they themselves consider good, i.e. of the European Union. It is guaranteed especially by the the right to available health care (Chovancová, 2009). The abolition of the customs duties and quantitative restrictions right to conduct business in the area of import and export as well as by the prohibition of measures having equivalent of medicinal products is not generally being prohibited by effect. To support the completion of the internal market, the legislator; it is only being limited in certain situations as principles of mutual recognition, abolition of physical and the Slovak Republic guarantees everybody the right to the technical constraints and standardisation support were protection of health pursuant to the first sentence of Article added. The adoption of the new legislative framework in 40 of the SR Constitution. This right, which applies both to the 2008 significantly reinforced the marketing of products, the citizens of the Slovak Republic and to foreigners regardless of free movement of goods, the system of surveillance over the their nationality, must always take precedence over anybody’s European Union market and the CE marking. The right to the right to conduct business and make profit regardless of free movement of goods originating in member states and possible consequences (Peráček et al., 2016). third countries that are in free circulation in member states References [1] Cirák J et al. Občianske právo : všeobecná časť. Šamorín, Heuréka; a dietetických potravín na základe verejného zdravotného 2008 poistenia a o zmene a doplnení niektorých zákonov v znení [2] Dôvodová správa k návrhu zákona č. 306/2016 Z. z., ktorým sa neskorších predpisov, mení a dopĺňa zákon č. 362/2011 Z. z. o liekoch a zdravotníckych [3] Drgonec J. Ústava Slovenskej republiky. Komentár. 3. vydanie. pomôckach a o zmene a doplnení niektorých zákonov v znení Šamorín, Heréka; 2012 neskorších predpisov a ktorým sa mení zákon č. 363/2011 Z. z. o [4] Ficová S et al. Občianske súdne konanie. - 1. vyd. Praha, C. H. rozsahu a podmienkach úhrady liekov, zdravotníckych pomôcok BECK; 2010 29 30 Eur. Pharm. 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Journal

Acta Facultatis Pharmaceuticae Universitatis Comenianaede Gruyter

Published: Jun 1, 2018

Keywords: Re-export of medicinal products; pharmaceutical services; protection of life and health; right to free enterprise; administrative law

References