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The Issue of Reimbursement and Price Regulation of Medicinal Products during Provision of Health Services
Elišáková, Gabriela ; Morávek, Jakub (advisor) ; Lang, Roman (referee)
The Issue of Reimbursement and Price Regulation of Medicinal Products during Provision of Health Services This master thesis deals with the price and reimbursement regulation of medicinal products in the Czech Republic and with selected problematic aspects of this field. The thesis describes and analyzes the issue in broader, especially economic, contexts and aims to give the reader a comprehensive view of the subject. The work itself is divided into nine chapters. The introductory chapter outlines the issue of prices of medicinal products in general and outlines healthcare reforms that have attempted to focus more or less successfully on problematic aspects of the field. The following chapter is devoted to explaining the terms that are key or somehow unclear to health or pharmaceutical law. The third chapter deals with an economic approach to regulation and aims to explain to readers why regulation by state authorities in modern society is in some cases important and in some cases even necessary. There are also described and explained the tools of regulation and at the conclusion of the chapter the economic approach is directly reflected in the situation of the market of medicinal products in the territory of the Czech Republic. The following chapter characterizes the actual entry of a particular...
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Current issues of supplementary protection certificates for medicinal products in the case law of the European court of justice
Révész, Filip ; Petrlík, David (advisor) ; Dobřichovský, Tomáš (referee)
1 Current Issues of Supplementary Protection Certificates for Medicinal Products in the Case Law of the European Court of Justice Abstract Supplementary protection certificates (SPCs) are a sui generis industrial property right. Under the conditions, which are explained in more detail in this thesis, they can be obtained for the active ingridients of certain products. The type of products eligible for SPC protection are, inter alia, medicinal products which are characterized by their social importance and therefore by the need to ensure their safety, efficacy and quality. Given that the process of providing these guarantees is both costly and time consuming and that the commercialization of the product is conditional on such guarantees, the period for which medicinal products can benefit from patent protection is therefore shortened. The aim of the SPCs is to compensate for this shortening by an additional period of protection in order to incentivise research that has a positive effect on human health and quality of life. This work analyzes the evolution of the case law of the Court of Justice with regard to an interpretative shift or clarification, in particular as regards the substantive conditions for obtaining a certificate and provisions pertaining to the term of the SPC as laid down in the SPC...
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Price regulation of preparations for medical treatment
Beutlová, Lenka ; Staša, Josef (advisor) ; Svoboda, Petr (referee)
Price regulation of preparations for medical treatment Abstract The present master thesis describes and analyzes the system of medicinal product's pricing regulation in the Czech Republic after the year 1989. The aim is to execute an analysis of the current legal regulation in the context of previous regulation, of particular phases of the process of regulation of medicinal product's prices and to provide a summary of the principles and recommendations as well as to attempt a proposition of future development possibilities. The thesis focuses on Czech legal regulation, decision-making by the judicial bodies, public bodies' activity, as well as on European legislative and jurisdiction. The thesis is divided into five chapters. The first chapter involves the system of pricing and reimbursement regulation of medicinal products into pharmaceutic legislation. The second chapter is divided into two sub-chapters. The first presents the current legal regulation of pricing and reimbursement regulation of medicinal products in the context of international legislation, European legislation and European jurisdiction, as well as domestic legislation. The second chapter also considers public bodies - the Ministry of Health of the Czech Republic and the State Institute for Drug Control - and their activity regarding this...
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Legal regulation of healthcare in the Czech Republic
Rajchlová, Denisa ; Vysokajová, Margerita (advisor) ; Štangová, Věra (referee)
5 Abstract Legal regulation of healthcare in the Czech Republic The subject matter of this thesis is legal analysis of provision of healthcare in the Czech Republic and outline of basic problems of provision of healthcare, including proposals for their possible solution and comparison with Supreme Court and Constitutional Court jurisprudence. The thesis deals not only with the specific legal regulations in which the provision of healthcare is regulated, but also with the interpretation of their content, as well as with the legal relations between the entities involved in the provision of healthcare. In addition, the thesis discusses the introduction of the electronization of healthcare, which has the potential to improve the healthcare system in the Czech Republic and make the provided healthcare better, cheaper and more accessible. The thesis is divided into five chapters, which are further subdivided into subchapters. The first chapter is about the basic sources of legal regulation of healthcare at international, European and national level. The second chapter deals with the methods of financing the provided healthcare with a particular emphasis on the public health insurance system in the Czech Republic. Subsequently, chapter three deals more closely with healthcare itself and with the interpretation of...
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Options of Digital and Social Media Utilization in Pharmaceutical Marketing
Dordová, Alžběta ; Huněk, Filip (advisor) ; Hrabánková, Markéta (referee)
The bachelor thesis Options of Digital and Social Media Utilization in Pharmaceutical Marketing focuses on the specific aspects of a connection between social media and commercial communication related to the over-the-counter medicinal products. The principal aim of the theoretical part of this thesis is to introduce the topic of pharmaceutical advertising, while the practical part is designed to answer the questions of if and how is it suitable to use social media such as Facebook, Instagram or YouTube as channels for distribution of commercial content related to a medicinal product called Skinoren cream. The theoretical part consecutively puts advertising into the context of marketing and media, introduces the importance of the new media including the social media and describes the challenges of legal and ethical regulation of pharmaceutical advertising. The whole topic is then demonstrated in the practical part as an analysis of two real advertising campaigns. The practical part of this thesis then deals with the attitudes of a chosen target group towards advertising utilization of Facebook. The research was executed as a case study using in-depth interviews as a qualitative method of data collection. The interpretation of the collected data shows that - as a strong marketing tool - Facebook...
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The Issue of Reimbursement and Price Regulation of Medicinal Products during Provision of Health Services
Elišáková, Gabriela ; Morávek, Jakub (advisor) ; Lang, Roman (referee)
The Issue of Reimbursement and Price Regulation of Medicinal Products during Provision of Health Services This master thesis deals with the price and reimbursement regulation of medicinal products in the Czech Republic and with selected problematic aspects of this field. The thesis describes and analyzes the issue in broader, especially economic, contexts and aims to give the reader a comprehensive view of the subject. The work itself is divided into nine chapters. The introductory chapter outlines the issue of prices of medicinal products in general and outlines healthcare reforms that have attempted to focus more or less successfully on problematic aspects of the field. The following chapter is devoted to explaining the terms that are key or somehow unclear to health or pharmaceutical law. The third chapter deals with an economic approach to regulation and aims to explain to readers why regulation by state authorities in modern society is in some cases important and in some cases even necessary. There are also described and explained the tools of regulation and at the conclusion of the chapter the economic approach is directly reflected in the situation of the market of medicinal products in the territory of the Czech Republic. The following chapter characterizes the actual entry of a particular...
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Decision-making practice of the Ministry of Health on administrative delicts under the Act on Pharmaceuticals
Heflerová, Markéta ; Svoboda, Petr (advisor) ; Millerová, Ivana (referee)
Ministry of Health Decision Practice in the area of Administrative Offences according to The Act on Pharmaceuticals Key Words: Medicinal Products, Administrative Offence, Ministry of Health In the first chapter of this master thesis I dealt with the general issue of administrative offences. I also introduced the Act on Pharmaceuticals and explained the fundamental term "a pharmaceutical," which includes medicinal products and active substances. The state administration is provided by State Institute for Drug Control which adjudicates in administrative offences in the first instance, and Ministry of Health that hears appeals against these decisions. In the second chapter, there is interpreted a material law part of the Act on Pharmaceuticals. I also introduced the elements of administrative offences, responsibility for them, sanctions, speciality and subsidiarity, analogy within the administrative sentencing etc. The third chapter is dedicated to procedural matters concerning the Act on Pharmaceuticals. The whole procedure starts with a control of an operator. If he/she does not abide the relevant rules of law, State Institute for Drug Control will initiate an administrative procedure and after finding necessary facts this institution renders a meritorious decision. If the operator was not satisfied...
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Legal regulation of advertising of medicinal products in the Czech Republic
Kučerová, Jana ; Patěk, Daniel (advisor) ; Eichlerová, Kateřina (referee)
Legal regulation of advertising of medicinal products in the Czech Republic Abstract This thesis deals with the advertising of medicinal products for human use and its development and legislation. The introductory part is set the objectives of this thesis and the reasons for choosing this topic. The first chapter is devoted to advertising, its legislation, the definition of advertising, history of advertising and this chapter also highlights the institution supervising advertising. The second chapter is to set the legal regulation of advertising in the Czech Republic. Regulation can be divided into the regulation of advertising public and private, together are in this dividing developed individual laws regarding advertising and is not omitted non-legal regulation of advertising. Ethical self-controller in this case especially the Rada pro reklamu and professional organizations. The third chapter is devoted to advertising of medicinal products for human use. This part is essential, because interpret basic definition related to medicinal products for human use. Further subdivision is dividing of medicinal product for human use. The basic consideration is whether product is successively authorised as a human medicinal product or not. In the case of an authorized as a human medicinal product dividing is...
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Consumer protection in the food supplements area
Luptáková, Marcela ; Vavrečka, Jan (advisor) ; Grmelová, Nicole (referee)
The topic of this diploma thesis is the Consumer protection in the food supplements area. The work has been devided into three parts. The first part is devoted to the overview about categorization of the products with the impact on health. This part of this work also includes the elementary terms, which are: food, food supplements, medicinal products, cosmetics products and medical devices. The second chapter is devoted to the matter of food supplements as such. The third chapter deals with the terms health and nutrition claims. The last chapter includes the survey between the consumers of the food suplements and also the survey between the pharmacies.
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