The main purpose of this thesis is to analyse the possible application of criminal liability instruments within pharmacy. Chapter 1 introduces the general aspects and processes within pharmacy, general terms, and short preview to the life cycle of innovative medicinal products. Chapter 2 contains the general definition and requirements of liability. There is also a short comparison of additional types of liability (such as civil, employee's, administrative and disciplinary) that can be applicable within pharmacy. The purpose of this comparison is to specify differences between individual liabilities and to prove that they can be applied conjointly. As an example of such a use I have described the "heparin murder" case. Chapter 3 is dedicated to criminal liability, with the explanation of general terms, especially crime, unlawfulness, offender, or grounds of justification. Chapter 4 focuses on the criminal liability of natural persons. After the general introduction in the first part, a list of potential crimes committable within pharmacy is given. Chapter 5 summarizes the criminal liability of legal persons. The first part focuses on the history of implementation in the Czech Republic, general terms, and definition of a legal person as a subject of criminal liability. The second part contains...

La pharmacovigilance est une discipline fondamentale pour la sécurité et la confiance dans le médicament. Cette discipline a évolué au fil du temps et s’est renforcée, mais souffre encore d’imperfection. Nous nous sommes proposés dans ce travail d’apporter une solution originale d’amélioration.Dans une première partie, nous décrivons et analysons l’évolution de la pharmacovigilance et son fonctionnement actuel tant du point de vue juridique que du point de vue scientifique, et ce, tant au niveau national qu’au niveau de l’Union Européenne. Nous avons analysé les insuffisances juridiques et pratiques puis avons fait des propositions pour les combler. Nous avons donc formulé un certain nombre de possibilités, avant de développer dans la deuxième partie une approche originale : la pédagogie. En partant du constat que la pharmacovigilance de terrain repose sur les professionnels de santé, nous avons étudié l’offre de formation de ces derniers et proposer d’apporter une formation universitaire plus qualitative et suffisamment quantitative, en pharmacovigilance et iatrogénie, le tout en s’appuyant sur des méthodes pédagogiques et des outils adaptés aux étudiants actuels. Le paradigme pédagogique proposé s’appuie sur une pédagogie d’explication, qui se base sur la recherche en droit pharmaceutique et sur une pédagogie innovante hybride, alliant cours en présentiel et ressources en e-learning. Les outils utilisés sont notamment des exposés magistraux complétés par des évaluations formatives sous forme de tests par boîtiers de vote électroniques et des cas cliniques en e-learning disponible sur une plateforme. Cette pédagogie doit mener les étudiants vers une meilleure compréhension de la pharmacovigilance et une pratique de la gestion des évènements iatrogènes médicamenteux. En conséquence le travail mené permet de mieux former les professionnels de santé à une gestion du risque médicamenteux avec un objectif final de confortation du système de pharmacovigilance. Ce dispositif sera complété dans le futur par de la simulation et de jeux de rôle. / Pharmacovigilance is a fundamental discipline for safety and confidence in the medicines. This discipline has evolved over time, and has been strengthened, but still suffers from imperfections. We proposed through this work to provide an original solution for its improvement.In the first part, we describe and analyze the evolution of pharmacovigilance and its current functioning from both the legal and the scientific point of view and at both national and European levels. We analyzed the legal and practical weaknesses and have formulated proposals to address them. Then we review a number of possibilities before developing in the second part an original approach: pedagogy. Having established that the field pharmacovigilance is based on health professionals, we studied the provision of training of these professionals and offering to provide more qualitative and enough quantitative academic training in pharmacovigilance and iatrogenic, keeping in mind that we must rely on teaching methods and tools that should be adapted to current students. The proposed pedagogical paradigm is based on a pedagogy of explanation, on research in pharmaceutical law and a hybrid innovative pedagogy, combining face to face courses and e-learning resources. The tools used include lectures supplemented by formative assessments as tests done with electronic voting boxes and clinical cases in e-learning available on a platform. This education should lead students to a better understanding of pharmacovigilance and practical management of iatrogenic drug events.Consequently, the work done, allows us to better train, health professionals for drug risk management with an ultimate goal of strengthening the pharmacovigilance system. This will be complemented in the future by simulation and role-playing.

The issue of legislative and ethical requirements on research of innovative medicines became more intense in connection to the expansion of the pharmaceutical industry in last few decades. This master thesis aims to complexly describe and analyse theoretical bases of current legislative regulating the process of clinical trials of medicinal products for human use in the Czech Republic, as well as to take a closer look to the issue of ethical review administered by specialized ethical review committees. The author also deals with some specific responsibilities of the committees from the perspective of administrative law, especially focusing on aspects of legal nature of the positive opinions, which are one of the conditions for commencement of a clinical trial. The thesis is divided into nine chapters and the introductory chapter is focused on the general outline of the issue of clinical trials of medicines for human use in the Czech Republic. The aim of the second chapter is to define the basic concepts stated in the Czech medicinal products act, which are specific for this area of pharmaceutical law. The next chapter analyses the relevant competencies of individual state authorities over the clinical studies. The fourth chapter contains the list of sources of law, whereas a particular emphasis is...

The issue of launching medical devices on the market became more intense in the last few decades in connection to the expansion of the pharmaceutical industry and legal area. This legal area is still mostly undescribed and it stands in the shadow of known and more discussed medical products. Proper legal theoretical analysis is often completely absent. This master thesis aims to complexly describe and analyse theoretical bases of current legislative regulating the launching of the medical devices on the market, including other processes related to this issue. Emphasis is places on the concept of medical device, the responsibility of the manufacturer and the nature of notified body. The author focuses on the subsequent conformity assessment process and process of registration. The process of notification and exemption from this obligation and administrative nature of selected documents. The thesis is divided into eleven chapters and the introductory chapter focuses on a general introduction to the field of pharmaceutical law, namely the regulation of medical devices, including the definition of basic questions in the work under study. The second chapter deals with the analysis of sources of legal regulation of medical devices. The chapter is divided into sources of the law of the Czech Republic and...

L'ingérence croissante des impératifs de protection de la santé sur le marché des biens et services, ainsi que l'émergence du consumérisme dans la sphère médicale témoignent du rapprochement réel de deux univers et des deux branches du droit qui les régissent : le droit de la santé et le droit de la consommation. Ainsi, la loi entend protéger le consommateur et le patient, et bien souvent ces deux catégories sont confondues d'où l'inéluctable rapprochement et complémentarité de ces deux droits spéciaux. L'ordre public, contenu par certaines consommations spéciales, a requis une adaptation du marché de la consommation et une rationalisation des opérations réalisées par le droit de la santé. Cet assainissement du marché de la consommation se prolonge par une supervision de l'opération de consommation jusqu'à sa réalisation. Le droit de la santé, telle une police du marché de la consommation, poursuit une action de sécurisation, de protection des consommateurs et de maîtrise des risques. Ces finalités justifieront l'élévation de restrictions aux libertés du marché et l'imposition d'une modération dans la conclusion des actes de consommation. Aussi, le droit de la santé repose sur une approche collective et solidariste, sa propension au renouvellement et sa capacité d'expérimentation en font une source d'inspiration pour le droit de la consommation / The increasing interferences of health protection requirements on the market, and the emergence of consumerism in the medical sphere reflect the real reunion of two domains and branches of the law: the Health Law and the Consumer Law. Thus, the Law seeks to protect consumers and patients, and these two categories are often combined which explains the inevitable closeness and complementarity of these laws. The public order involved in some special consumption requires an adaptation of the consumer market and the rationalization of the operations performed by Health Law. This consolidation of the consumer market is extended by a supervision of the consumer transaction which goes until its achievement. Health Law, such as a consumer market police, designed to perform security, protection and to manage risks. These goals justify the elevation of restrictions against economic liberties and the moderation of the market. Also, Health Law adopts a collective and solidaristic conception of consuming that's why its ability to renew is a considerable source of inspiration and experimentation to Consumer law.

1 ABSTRACT SPECIFIC OF PATENT LAW IN PHARMACEUTICAL INDUSTRY This thesis scopes on particularities of patent law with regard to pharmaceuticals. It describes the basics of patent law while focusing mainly on international treaties, in particular on systems established by EPC and TRIPS. The patent system in USA and in the Czech Republic is also noted. This thesis is divided into seven chapters. In the first chapter named sources of law international institutions, treaties and situation in European union, USA and Czech Republic are described here. This chapter also deals with basic legal instruments such as patent, corporate invention or utility model. The next chapter is focused on individual conditions that need to be met in order to grant a certain patent - the most basic are novelty, inventive step and industrial applicability. The following chapter deals with problems associated with costly development of new drugs and the need of companies to get the longest possible protection for their inventions. A special chapter addresses exceptions to the stiff patent regulation. Described in the next chapter is the compulsory license, a legal instrument not very particular in the Czech Republic but relevant in some developing countries used in order to secure better availability of drugs to society. Other...

L'influence européenne, notamment politique et juridique, la globalisation des échanges de médicaments de même que les conséquences de la globalisation - des crises sanitaires, économiques, financières - affectent les modalités d'organisation et d'exercice de la pharmacie d'officine française, italienne et anglaise. La convergence étant généralement présentée comme figurant au titre des conséquences possibles de l'européanisation et de la globalisation, les régimes français, italien et anglais de distribution de médicament à l'officine évoluent-ils vers une forme de « modèle juridique » commun, dépassant leur opposition historique ? En réalité, non seulement l'on assiste à l'émergence de modèles juridiques d'organisation et d'exercice de la pharmacie qui ne sont pas porteurs d'une unité susceptible de réduire de manière significative les différences entre les législations nationales, mais encore, cette unité n'est pas opportune. En effet, le maintien de spécificités nationales ainsi que l'adaptation des réglementations aux contextes nationaux apparaissent comme des éléments garants de l'efficacité des régimes nationaux de distribution officinale des médicaments. Pour autant, l'efficacité des réglementations ne se résume pas à la garantie des spécificités nationales de l'encadrement du secteur, comme l'illustrent les obstacles à la réparation des dommages imputables aux médicaments et à la protection du monopole pharmaceutique. Si certains apparaissent justement liés aux caractéristiques nationales, d'autres concernent de manière spécifique la lutte contre les ventes illégales de médicaments / European influence, especially political and legal, the globalisation of drug trade as well as the consequences of the globalisation of health, economic and financial crises impact the organisation and practice of French, Italian and English retail pharmacy. Convergence is generally presented as one of the possible consequences of europeanisation and globalisation. In effect, are the legal regimes of drug distribution in retail pharmacies in France, Italy and England evolving towards a common « legal model », beyond their historical opposition ? In reality, not only are we witnessing the emergence of organisational and operational retail pharmacy legal models that do not carry a unicity that would enable significantly reducing differences between national legislations, but this unicity would not be timely. Indeed, the preservation of national specificities, as well as the adaptation of regulations to national contexts appear as key guarantors of the efficacy of retail pharmacy drug distribution national legal regimes. However, the efficacy of regulations cannot be summarised to guaranteeing the sector’s national specificities, as illustrated by the obstacles to compensation for damages attributable to medicines and to the protection of the pharmaceutical monopoly. While some of these obstacles appear precisely linked to national characteristics, others relate specifically to the war against illegal drug sales

La recherche dans le domaine des maladies sans traitement existant obéit à plusieurs impératifs définis par le législateur européen dans le règlement (CE) n° 141/2000 du 16 décembre 1999 concernant les médicaments orphelins. Les patients atteints de maladies rares et négligées ont le droit à « la même qualité de traitement que les autres » ce qui suppose de prendre les mesures d'incitation nécessaires pour « promouvoir la recherche, le développement et la commercialisation de traitements adéquats ». C'est un « domaine prioritaire ». Après avoir désigné les médicaments concernés, l'Union européenne veut « éviter la dispersion de ressources limitées » notamment par la promotion d'une « coopération transnationale ». Dans une démarche téléologique, cette recherche décrit les effets de la législation européenne sans ignorer la réception de ce droit par les États membres. Des fondements théoriques à même d'assurer une meilleure performativité du droit et des propositions concrètes en vue de conformer le droit positif à l'intention du législateur et aux attentes des parties prenantes sont proposés. En se focalisant sur le seul levier de la propriété intellectuelle, ce droit spécial et incitatif ne semble pas en mesure d'apporter aux patients la plupart des traitements attendus. La régulation de la concurrence et la compétence nationale sur le prix des médicaments perpétuent un seuil de rentabilité éloignant de nombreuses recherches de la phase du développement. L'accès aux médicaments orphelins demeure très restreint. Un changement de paradigme dans la construction de ce droit apparaît nécessaire afin qu'un modèle économique favorable se mette en place. Il convient que le profit des pharmaciens de l'industrie ne dépende plus de la conquête de parts de marché, mais de l'intérêt de leurs inventions pour les besoins de santé non satisfaits. / Research in the field of diseases without an existing treatment is governed by several requirements defined by the European legislator in Regulation (CE) No 141/2000 of 16 December 1999 on orphan medicinal products. Patients with rare and neglected diseases have the right to "the same quality of treatment as other patients" which means taking the necessary incentives to stimulate research, development and bringing to the market of appropriate medications". It is a "priority area". After designating the drugs concerned, the European Union wants to "avoid the dispersion of limited resources", in particular by promoting "cross national co-operation". In a teleological approach, this research analyses the positive law endeavouring to implement the objectives of Orphan Drug Law. It describes the effects of European legislation without ignoring the receipt of this law by the Member States. Theoretical foundations that can ensure a better performativity of the law, as well as concrete proposals to conform the positive law to the intention of the legislator and to the stakeholders' wills are proposed. By focusing solely on the leverage of intellectual property rights, this special and incentive law does not seem to be able to provide patients with many of the expected treatments. Competition regulation and setting of the price which is a national competency perpetuate a high profitability threshold, often withholding research projects from reaching the development phase. Access to orphan drugs remains very limited. A paradigm shift in the construction of this law appears necessary in order for a favorable economic model to emerge. The profit of the industry's pharmacists should no longer depend on the conquest of market shares, but on the value of their inventions for unmet health needs.