Course topics: 1. Sources of legal regulation and definition of basic terms and institutions. 1.1. Who makes the drug policy of the state and how do others intervene in it? The roles of the WHO, the EU and the Slovak Republic. 1.2. What is the difference between ibalgin, vitamin C, plaster, crutches or a heart machine? He is not a flexor like a flexor. Generic, biosimilar or original...are we talking about the same thing? 2. Testing of drugs and medical devices, registration of drugs and medical devices, use of unregistered drugs and off-label use of registered drugs. 2.1. The drug\'s path to clinical trials is long and winding. Can any drug do it? Clinical trial participants - are they also healthy persons and children? Clinical trial watchdogs. 2.2. The administrative cord of obtaining a \"stamp\" of the drug\'s effectiveness and safety? Will you cross the entire EU at once or gradually? 2.3. Can the patient get access to a breakthrough therapy that has not yet arrived in Europe? 3. Patent protection of medicines. 3.1. Who enjoys longer patent protection? Iphone or new medicine? 3.2. Arrival of a generic on the market. Disputes and their settlements (pay for delay). 4. Production, import and distribution of medicines and medical devices. 4.1. Does the manufacturer of the drug also decide on its allocation and at what price will it be sold? 4.2. Distribution models – DHP/DTP - credit risk of pharmacies and hospitals. Emergency system. Home delivery. 5. Current challenges of drug distribution. 5.1. Is this medication out of date? Why? For how long? Can we predict it? Can we prevent it? Is it a problem of Slovakia, Europe or the whole world? 5.2. Who and what does to ensure the availability of medicines? Is that enough? Can we do more? 6. Prescription and dispensing of medicines. 6.1. Prescriptive restrictions. Who can prescribe the medicine? When is a general practitioner sufficient and when is a specialist needed? Can they represent themselves? Mandatory prescription of medication upon discharge from hospital. 6.2. Generic prescription vs. generic substitution. Can the pharmacy dispense a medicine other than the one prescribed by the doctor? 6.3. Dispensing medicine in a pharmacy vs. home delivery (in some countries also by bicycle). Pharmacy vs. pumps, drugstores or Alza boxes. Home delivery, in some countries even by bicycle. 7. Pricing and reimbursement of medicines and medical devices - Part 1. 7.1. Dilemma - price and payment regulation of the state vs. free hand of the market. 7.2. Limited budget. Ethical issues and priorities in the reimbursement of medicines and medical devices. Expensive vs. inexpensive therapies. Orphan drugs vs. drugs intended for a large group of patients. 7.3. Introduction to the regulation of pricing and reimbursement of medicines and medical devices in Slovakia. 8. Pricing and reimbursement of medicines and medical devices - Part 2. 8.1. Drug prices in Slovakia are among the lowest in Europe. Is that a positive? Two worlds of drug price regulation (standard vs. special price regulation). 8.2. The chaos of medical device price regulation – duplicate regulation of one price. 9. Pricing and reimbursement of medicines and medical devices - Part 3. 9.1. The patient does not have the right to request payment of the medicine from the VZP. So who? Exceptional vs. standard mode of payment by health insurance companies. 9.2. How much is the state willing to pay for one year of a patient\'s life? Categorization and its rules. 9.3. Referencing vs. revision of payments. Why was the Minister of Health sued? 10. Advertising of medicines and medical devices. 10.1. Advertising on stoptusin vs. advertisement for vaccinations vs. advertisement for antidepressants. 10.2. Donation of medicines. 10.3. Tax regime. 11. Human blood and human blood components. 11.1. Donation of blood and human blood components. 11.2. Processing and surplus of human blood or its components (ethical issues). 12. Protection of personal data.
Information sheetSupervisors and educators:
JUDr. Veronika Zoričáková, PhD. - Zabezpečuje, Skúšajúci, Zodpovedný za elearning, Kogarant, Cvičiaci
prof. PhDr. JUDr. Tomáš Gábriš, PhD. - Zabezpečuje, Hlavný garant
Ing. Jana Koprlová, PhD. - Kogarant, Schvaľujúci zápis
Mgr. Ján Dulovič - Zabezpečuje, Zodpovedný za elearning, Skúšajúci, Kogarant, Cvičiaci
Code: YNDVm889
Period: LS
Credits: 3
- Pedagóg: Ján Dulovič
- Pedagóg: Jana Koprlová
- Pedagóg: Veronika Zoričáková
Course topics: The course refers to the common substantive civil law, commercial law, labour law and international private law. It also covers important public (administrative) law implications regarding especially the constitutional law, administrative law, international public law, criminal law and financial law as well. Besides the mentioned legal disciplines the course refers also to the courses of the theory of laws, legal philosophy, ethics and history. This is interdisciplinary course focused also on the actual culture, economical, scientific and international relations development. IPRs are recognised as the one of the top priorities in the EU policies. The course covers the author´s rights (copyright) and related rights, industrial property rights including the denominations and other related rights including also the common protection of personality rights and competition law. The teaching method is based on the modern pedagogical method focusing the dynamics of the whole area of interest from the perspective of the economy models changes, new ways of creativity, competition and related theoretical and practical legal issues. The course is particularly focused on the questions of the effectiveness of the IPR protection and enforcement in the national, European and international context, especially regarding the Slovakian WIPO and WTO membership and the obligations stipulated in the TRIPS agreement.
Information sheetSupervisors and educators:
prof. PhDr. JUDr. Tomáš Gábriš, PhD. - Zabezpečuje, Hlavný garant
Ing. Jana Koprlová, PhD. - Schvaľujúci zápis, Kogarant
JUDr. Zuzana Adamová, PhD. - Zabezpečuje, Cvičiaci, Prednášajúci, Zodpovedný za elearning, Skúšajúci, Kogarant
Code: YDVm401
Period: ZS
Credits: 5
- Pedagóg: Zuzana Adamová
- Pedagóg: Jana Koprlová
Course topics: An interdisciplinary legal subject connected with the latest cultural, economic, scientific, technical and international developments. It includes copyright and related rights, industrial property rights, technical designations and a range of other rights. The course also includes issues of competition law, new technologies, use on the Internet, etc. Special attention is also paid to issues of the effectiveness of legal protection of intellectual property and law enforcement in a broader international context, especially in connection with the Slovak Republic\'s membership in WIPO, WTO. The course is related to the basics of civil, commercial, labor and private international law. It also has important public relations; in addition to constitutional law, it relates mainly to the field of administrative law and public international law, but also to criminal and financial law. In addition to positive legal disciplines, it also builds on the teaching of law theory, legal philosophy, legal ethics and legal history. The following topics form the basic syllabus: 1. Systematic classification of intellectual property rights and basic principles of protection; 2. Copyright and authors\' rights; 3. Computer programs and databases; 4. Items protected by copyright; 5. Trademark and rights of trademark owners; 6. Technical solution protected by patent and utility model; 7. Design and design owner rights; 8. Contractual intellectual property law; 9. Employment and other special arrangements; 10. Limitations of the intellectual property rights; 11. Protection and enforceability; Directive on the enforcement of intellectual property rights; 12. Application problems of intellectual property protection (e.g., issues of plagiarism, open access, etc.).
Information sheetSupervisors and educators:
Mgr. Martin Pogádl - Zabezpečuje, Cvičiaci, Kogarant, Prednášajúci, Skúšajúci, Zodpovedný za elearning
prof. PhDr. JUDr. Tomáš Gábriš, PhD. - Zabezpečuje, Hlavný garant
Ing. Jana Koprlová, PhD. - Kogarant, Schvaľujúci zápis
JUDr. Zuzana Adamová, PhD. - Zabezpečuje, Zodpovedný za elearning, Prednášajúci, Skúšajúci, Cvičiaci, Kogarant
Code: YNDVm401
Period: LS
Credits: 4
- Pedagóg: Zuzana Adamová
- Pedagóg: Jana Koprlová
- Pedagóg: Martin Pogádl
Course topics: 1. Food law and international food law (right to food as a fundamental human right, food law in the system of law, self-regulation, definition of food law, basic national law, international law, Codex Alimentarius, international institutions - FAO, WTO, WHO). 2. History of food law, food law within the EU internal market (History of food law in the EU and Slovakia, measures having equivalent effect on quantitative restrictions on free movement of foodstuffs, taxes and duties related to free movement of goods). 3. Basic principles and requirements of food law (basic concepts, definition of food, general principles and requirements of food law, state administration in the field of food law, European Food Safety Authority, Rapid Alert System). 4. Food information law (principles of food labeling, geographical indications and designations of origin, traditional specialty, labeling of spirit drinks and aromatised wine products, quality label, labelling for promotion and marketing purposes). 5. Food law and nutrition of the population (nutrition and health claims, food supplements, addition of vitamins and minerals to foods, foods for specific groups - infants, people with celiac disease, diabetics, organic farming and animal welfare). 6. Food safety and hygiene (basic terms, hygiene requirements, HACCP, microbiological criteria for food, contaminants in food, food enhancers, food contact materials and articles, Food Code). 7. Official food controls (regulation of EU official food controls - competent authorities, general and additional requirements for official controls, reference laboratories and centers, law enforcement measures, official food controls in Slovakia). 8. Origin and traceability of foods (genetically modified foods - basic concepts, authorization and surveillance, labelling, novel foods - novel food concept, authorization procedures, marketing requirements). 9. Food law and consumer protection (consumer contract for sale, sale of food at order, distance selling, yard sale, market sale, internet sale, packaging, defect liability, liability for damage, food advertising, misleading advertising). 10. Food law and competition (unfair conditions in the food trade, trade conditions for food and protection of competition, economically justifiable costs, abuse of a dominant position). 11. Penalties in food law, food fraud (administrative punishment under the Food Act and other regulations, offense of threatening health with harming food and other selected offenses, sanctions in EU law). 12. Administrative justice in the area of food law, current issues of food law (analysis of selected decisions of the Administrative Branch of the Supreme Court of the Slovak Republic in matters of food law).
Information sheetSupervisors and educators:
JUDr. Jana Venhartová - Zabezpečuje, Prednášajúci, Skúšajúci, Cvičiaci, Kogarant, Zodpovedný za elearning
Mgr. Martin Pogádl - Zabezpečuje, Prednášajúci, Zodpovedný za elearning, Cvičiaci, Skúšajúci
prof. PhDr. JUDr. Tomáš Gábriš, PhD. - Zabezpečuje, Prednášajúci, Kogarant, Zodpovedný za elearning, Cvičiaci, Skúšajúci, Hlavný garant
JUDr. Katarína Eliášová - Zabezpečuje, Zodpovedný za elearning, Kogarant, Prednášajúci, Cvičiaci, Skúšajúci
Mgr. Samuel Rybnikár, PhD. - Zabezpečuje, Cvičiaci, Prednášajúci, Skúšajúci, Kogarant, Zodpovedný za elearning
Ing. Jana Koprlová, PhD. - Schvaľujúci zápis, Kogarant
JUDr. Zuzana Adamová, PhD. - Kogarant, Zodpovedný za elearning
Code: XNSPb002
Period: LS
Credits: 3
- Pedagóg: Zuzana Adamová
- Pedagóg: Tomáš Gábriš
- Pedagóg: Jana Koprlová
- Pedagóg: Martin Pogádl
- Pedagóg: Samuel Rybnikár
- Pedagóg: Jana Venhartová
Course topics: Cybernetic law, which also includes the law of information and communication technologies, is a legal subject associated with the latest technical developments and its positive legal regulation. It is an interdisciplinary subject with overlaps into public and private law; thematically related to criminal law, administrative law, intellectual property law, civil law, commercial law and private and public international law. The teaching of the subject is based on a modern scientific and pedagogical method, which places the whole subject in the dynamic context of an open market economy, in the whole complexity of theoretical and practical issues. The following topics form the basic syllabus: 1. Technology & law. The impact of the Internet and new technologies on the law. 2. Intellectual property rights as a support for technologies (software and database protection). 3. Human rights as a general limit of technologies. Right to privacy and right to the protection of personal data. 4. Human rights as a general limit of technologies. The right to freedom of expression. 5. Liability of information society service providers. 6. Digital market in the EU (principles, bans, net neutrality). 7. Domain names (in general, types of collisions). 8. Resolution of domain disputes in Slovakia. 9. Electronic identity. 10. Personal data protection. 11. Cyber-criminality. 12. Cyber security.
Information sheetSupervisors and educators:
prof. PhDr. JUDr. Tomáš Gábriš, PhD. - Zabezpečuje, Hlavný garant
Ing. Jana Koprlová, PhD. - Kogarant, Schvaľujúci zápis
JUDr. Zuzana Adamová, PhD. - Zabezpečuje, Prednášajúci, Kogarant, Skúšajúci, Cvičiaci, Zodpovedný za elearning
Code: YNDVm403
Period: ZS
Credits: 3
- Pedagóg: Zuzana Adamová
- Pedagóg: Jana Koprlová
Course topics: 1. Food law and international food law (right to food as a fundamental human right, food law in the system of law, self-regulation, definition of food law, basic national law, international law, Codex Alimentarius, international institutions - FAO, WTO, WHO). 2. History of food law, food law within the EU internal market (History of food law in the EU and Slovakia, measures having equivalent effect on quantitative restrictions on free movement of foodstuffs, taxes and duties related to free movement of goods). 3. Basic principles and requirements of food law (basic concepts, definition of food, general principles and requirements of food law, state administration in the field of food law, European Food Safety Authority, Rapid Alert System). 4. Food information law (principles of food labeling, geographical indications and designations of origin, traditional specialty, labeling of spirit drinks and aromatised wine products, quality label, labelling for promotion and marketing purposes). 5. Food law and nutrition of the population (nutrition and health claims, food supplements, addition of vitamins and minerals to foods, foods for specific groups - infants, people with celiac disease, diabetics, organic farming and animal welfare). 6. Food safety and hygiene (basic terms, hygiene requirements, HACCP, microbiological criteria for food, contaminants in food, food enhancers, food contact materials and articles, Food Code). 7. Official food controls (regulation of EU official food controls - competent authorities, general and additional requirements for official controls, reference laboratories and centers, law enforcement measures, official food controls in Slovakia). 8. Origin and traceability of foods (genetically modified foods - basic concepts, authorization and surveillance, labelling, novel foods - novel food concept, authorization procedures, marketing requirements). 9. Food law and consumer protection (consumer contract for sale, sale of food at order, distance selling, yard sale, market sale, internet sale, packaging, defect liability, liability for damage, food advertising, misleading advertising). 10. Food law and competition (unfair conditions in the food trade, trade conditions for food and protection of competition, economically justifiable costs, abuse of a dominant position). 11. Penalties in food law, food fraud (administrative punishment under the Food Act and other regulations, offense of threatening health with harming food and other selected offenses, sanctions in EU law). 12. Administrative justice in the area of food law, current issues of food law (analysis of selected decisions of the Administrative Branch of the Supreme Court of the Slovak Republic in matters of food law).
Information sheetSupervisors and educators:
JUDr. Jana Venhartová - Zabezpečuje, Kogarant, Zodpovedný za elearning, Prednášajúci, Skúšajúci, Cvičiaci
Mgr. Martin Pogádl - Zabezpečuje, Cvičiaci, Zodpovedný za elearning, Skúšajúci, Prednášajúci
prof. PhDr. JUDr. Tomáš Gábriš, PhD. - Zabezpečuje, Cvičiaci, Kogarant, Skúšajúci, Hlavný garant, Zodpovedný za elearning, Prednášajúci
JUDr. Katarína Eliášová - Zabezpečuje, Prednášajúci, Kogarant, Skúšajúci, Zodpovedný za elearning, Cvičiaci
Mgr. Samuel Rybnikár, PhD. - Zabezpečuje, Cvičiaci, Zodpovedný za elearning, Prednášajúci, Skúšajúci, Kogarant
Ing. Jana Koprlová, PhD. - Schvaľujúci zápis, Kogarant
JUDr. Zuzana Adamová, PhD. - Kogarant, Zodpovedný za elearning
Code: YNSPm002
Period: ZS
Credits: 3
- Pedagóg: Zuzana Adamová
- Pedagóg: Tomáš Gábriš
- Pedagóg: Jana Koprlová
- Pedagóg: Martin Pogádl
- Pedagóg: Samuel Rybnikár
- Pedagóg: Jana Venhartová