Legal Protection for Consumer of Pharmaceutical Products

The overall focus of the thesis involves the legal protection for consumers of pharmaceutical products.The work on “Legal Protection for Consumers of Pharmaceutical Products” is undertaken to study the legal framework that is existing for this purpose and the functioning of regulating mechanism that is envisaged under it. The purpose of the study is to analyse how far these measures are effective in adequately protecting various aspects of consumer interest. Methodology adopted for the study is analytical.The present study revealed that the theory of freedom of contract is only an ideal relevant when the parties are assumed to be on equal footing.In a more complicated social and economic society, it ceased to have any relevance. Many countries in the world enacted legislations to protect the consumers of pharmaceutical products.The meaning of ‘consumers of drugs’ provided in the law is inclusive and not exhaustive one. The definition of ‘drug’ as interpreted by the courts is comprehensive enough to take in it not only medicines but also substances. The meaning of the word substances has been widened by the interpretation of the courts so as to include all the things used in treatment.The definition of the word ‘consumer’ has been liberally interpreted by the courts so as to provide protective net to a large section of the public.The studies subsequent to this report also revealed that there is a shortage of essential drugs necessary to cure local diseases like tuberculosis and malaria where as drugs containing vitamins and other combinations which are more profitable for the manufacturers are produced and marketed in abundance.The study of the provisions in this regard revealed that the duty of the drug controlling authorities is confined to scrutinize the data of the clinical test already conducted by the sponsor of the drug.Study of the clinical trial procedure under the U.S. law revealed that there is a continuous supervision over clinical trials and controls are provided on the treatment use of an investigational productStudy of the clinical trial procedure under the U.S. law revealed that there is a continuous supervision over clinical trials and controls are provided on the treatment use of an investigational product.the study of the provisions of the Drugs and Cosmetics Act and the rules framed under it revealed that the law in this regard is comprehensive to protect the consumer provided it is sufficiently supported by adequately equipped enforcement machinery.

Agribusiness Opportunity Costs and Environmental Legal Protection: Investigating Trade-Off on Hotspot Preservation in the State of So Paulo, Brazil

Prior to deforestation, So Paulo State had 79,000 km(2) covered by Cerrado (Brazilian savanna) physiognomies, but today less than 8.5% of this biodiversity hotspot remains, mostly in private lands. The global demand for agricultural goods has imposed strong pressure on natural areas, and the economic decisions of agribusiness managers are crucial to the fate of Cerrado domain remaining areas (CDRA) in Brazil. Our aim was to investigate the effectiveness of Brazilian private protected areas policy, and to propose a feasible alternative to promote CDRA protection. This article assessed the main agribusiness opportunity costs for natural areas preservation: the land use profitability and the arable land price. The CDRA percentage and the opportunity costs were estimated for 349 municipal districts of So Paulo State through secondary spatial data and profitability values of 38 main agricultural products. We found that Brazilian private protected areas policy fails to preserve CDRA, although the values of non-compliance fines were higher than average opportunity costs. The scenario with very restrictive laws on private protected areas and historical high interest rates allowed us to conceive a feasible cross compliance proposal to improve environmental and agricultural policies.

Landscape changes in Serra do Japi: legal protection or scientific expectation?

The creation of new legally protected areas brings many conflicts that distance the real landscape from the expected according to environmental law or conservation researchers. In this study, we mapped and compared the changes in Serra da Japi (Sao Paulo State, Brazil) throughout 40 years with scenarios of legal protection and scientific expectation on forest conservation, to evaluate the distance between them. This may allow us to infer the direction of historical changes and assist in the debate among decision makers. The results showed that most legal requirements on forest protection in the current landscape have been met. The 1960s was the period when the forest cover was closest to the desirable conservation stage. Although the Serra do Japi has maintained large areas of forests during the entire study period, human interference increased with the expansion of reforestation and urban areas, and access roads were identified as a primary potential driving forces of change. In addition, habitat loss was observed in the landscape, which can represent the first phase of a sequence of modifications detrimental to the environmental conservation of this protected area, including decision changes to land use. In conclusion, the changes evolved toward conservation expectations, but not toward the forest configuration of scientific expectation.

The Legal Protection of Fundamental Human Values in Central and Eastern Europe and Modern Biotechnology: Towards European Harmonization

The protection of the fundamental human values (life, bodily integrity, human dignity, privacy) becomes imperative with the rapid progress in modern biotechnology, which can result in major alterations in the genetic make-up of organisms. It has become possible to insert human genes into pigs so that their internal organs coated in human proteins are more suitable for transplantation into humans (xenotransplantation), and micro-organisms that cam make insulin have been created, thus changing the genetic make-up of humans. At the end of the 1980s, the Central and Eastern European (CEE) countries either initiated new legislation or started to amend existing laws in this area (clinical testing of drugs, experiments on man, prenatal genetic diagnosis, legal protection of the embryo/foetus, etc.). The analysis here indicates that the CEE countries have not sufficiently adjusted their regulations to the findings of modern biotechnology, either because of the relatively short period they have had to do so, or because there are no definite answers to the questions which modern biotechnology has raised (ethical aspects of xenotransplantation, or of the use of live-aborted embryonic or foetal tissue in neuro-transplantation, etc.). In order to harmonise the existing regulations in CEE countries with respect to the EU and supranational contexts, two critical issues should be taken into consideration. The first is the necessity for CEE countries to recognise the place of humans within the achievements of modern biotechnology (a broader affirmation of the principle of autonomy, an explicit ban on the violation of the genetic identity of either born or unborn life, etc.). The second concerns the definition of the status of different biotechnological procedures and their permissibility (gene therapy, therapeutic genomes, xenotransplantation, etc.). The road towards such answers may be more easily identified once all CEE countries become members of the Council of Europe and express their wish to join the EU, which in turn presupposes taking over the entire body of EU legislation.

Better than nothing? : dowry in the absence of the legal protection of women's inheritance rights

The practice of dowry is often thought to be the root cause of the unequal treatment of women in India. For women without inheritance rights, however, dowry may function as their only source of protection. Using a nationwide dataset and exploiting a natural experimental situation, this study explores the effects of dowry on women's empowerment in India, a society where women do not have inheritance rights. In such a society, dowry seems to enhance women's status in the marital household. The effects reverse when women have equal inheritance rights as their brothers. Empirical analysis suggests that the outright ban on dowry that ignores the context may not necessarily benefit women.

Legal protection for the consumer

Mode of access: Internet.

Is the legal protection for the foetus adequate in clinical trials?

In 2009 and 2010, the major drug regulatory bodies, the European Medicines Agency and the Food and Drug Administration in the USA, issued requests for the generation of information relating to the absorption, distribution, metabolism, excretion, efficacy and safety of investigational drugs in pregnant women prior to approval. In the wake of thalidomide, research involving pregnant women other than for obstetric or gynaecologic purposes became rare, and studies of investigational drugs practically unknown. Consequently, none of the legislation applicable in the UK and few of the guidelines introduced in the last 40 years properly addresses the conduct of clinical trials of investigational drugs in this population. This thesis questions whether the legal protection for the foetus is adequate in clinical trials. The answer appears to be a qualified “no”. Arguments persist regarding the moral standing of the foetus, particularly regarding abortion. That will not be the intent of such trials, and a moral case is made for the conduct of clinical trials in this population by analogy with the neonate, and the pregnant woman’s autonomy. Legally, we already recognise the foetus has ‘interests’ which crystallise upon live birth, and that compensation is recoverable for harm inflicted in utero manifesting as congenital injury. The essence of research is quite different from medical practice, and the extent to which this is understood by trial participants is unclear. The approvals processes contain a number of inadequacies which have the potential to expose the foetus to harm and affect the consent of the pregnant woman. The recovery of compensation in the event of children born injured following clinical trials during pregnancy in many ways may be more complex than other personal injury cases.. The conclusions of this thesis are that the existence of a foetus does merit recognition by the law in this setting and that morally such studies are justifiable. However, the present legislation and approval processes potentially expose the foetus to avoidable risk and may not be appropriate to enable the recovery of compensation, thereby creating potential to deter future trial participants. A proposal is made regarding an approach to simplify the process for recovery of compensation, and thereby strengthen the approval and consent processes.

From The Hague to Geneva: The protection of civilians and refugees in the perspective of legal history, 1899-1951

The presentation proposed here shall focus on international (and as far as possible some cases of national) legal protection of civilians and refugees between the first Hague Convention of 1899 and the Geneva Convention for the Protection of Refugees in 1951. An analysis of international legal texts as well as, if possible, some exemplary national constitutions will form the core of the presentation, which will try to find out, to what extent not only the civilian population remaining close to front-line fighting, but also under occupation was supposed to be protected by legal norms, but also to what extent the issue of forcing civilian to leave their homes became part of the international legal discourse as well as of international legal norms.

Database Rights in Safe European Home: The Path to More Rigorous Protection of Information

1. Introduction "The one that has compiled ... a database, the collection, securing the validity or presentation of which has required an essential investment, has the sole right to control the content over the whole work or over either a qualitatively or quantitatively substantial part of the work both by means of reproduction and by making them available to the public", Finnish Copyright Act, section 49.1 These are the laconic words that implemented the much-awaited and hotly debated European Community Directive on the legal protection of databases,2 the EDD, into Finnish Copyright legislation in 1998. Now in the year 2005, after more than half a decade of the domestic implementation it is yet uncertain as to the proper meaning and construction of the convoluted qualitative criteria the current legislation employs as a prerequisite for the database protection both in Finland and within the European Union. Further, this opaque Pan-European instrument has the potential of bringing about a number of far-reaching economic and cultural ramifications, which have remained largely uncharted or unobserved. Thus the task of understanding this particular and currently peculiarly European new intellectual property regime is twofold: first, to understand the mechanics and functioning of the EDD and second, to realise the potential and risks inherent in the new legislation in economic, cultural and societal dimensions. 2. Subject-matter of the study: basic issues The first part of the task mentioned above is straightforward: questions such as what is meant by the key concepts triggering the functioning of the EDD such as presentation of independent information, what constitutes an essential investment in acquiring data and when the reproduction of a given database reaches either qualitatively or quantitatively the threshold of substantiality before the right-holder of a database can avail himself of the remedies provided by the statutory framework remain unclear and call for a careful analysis. As for second task, it is already obvious that the practical importance of the legal protection providedby the database right is in the rapid increase. The accelerating transformationof information into digital form is an existing fact, not merely a reflection of a shape of things to come in the future. To take a simple example, the digitisation of a map, traditionally in paper format and protected by copyright, can provide the consumer a markedly easier and faster access to the wanted material and the price can be, depending on the current state of the marketplace, cheaper than that of the traditional form or even free by means of public lending libraries providing access to the information online. This also renders it possible for authors and publishers to make available and sell their products to markedly larger, international markets while the production and distribution costs can be kept at minimum due to the new electronic production, marketing and distributionmechanisms to mention a few. The troublesome side is for authors and publishers the vastly enhanced potential for illegal copying by electronic means, producing numerous virtually identical copies at speed. The fear of illegal copying canlead to stark technical protection that in turn can dampen down the demand for information goods and services and furthermore, efficiently hamper the right of access to the materials available lawfully in electronic form and thus weaken the possibility of access to information, education and the cultural heritage of anation or nations, a condition precedent for a functioning democracy. 3. Particular issues in Digital Economy and Information Networks All what is said above applies a fortiori to the databases. As a result of the ubiquity of the Internet and the pending breakthrough of Mobile Internet, peer-to-peer Networks, Localand Wide Local Area Networks, a rapidly increasing amount of information not protected by traditional copyright, such as various lists, catalogues and tables,3previously protected partially by the old section 49 of the Finnish Copyright act are available free or for consideration in the Internet, and by the same token importantly, numerous databases are collected in order to enable the marketing, tendering and selling products and services in above mentioned networks. Databases and the information embedded therein constitutes a pivotal element in virtually any commercial operation including product and service development, scientific research and education. A poignant but not instantaneously an obvious example of this is a database consisting of physical coordinates of a certain selected group of customers for marketing purposes through cellular phones, laptops and several handheld or vehicle-based devices connected online. These practical needs call for answer to a plethora of questions already outlined above: Has thecollection and securing the validity of this information required an essential input? What qualifies as a quantitatively or qualitatively significant investment? According to the Directive, the database comprises works, information and other independent materials, which are arranged in systematic or methodical way andare individually accessible by electronic or other means. Under what circumstances then, are the materials regarded as arranged in systematic or methodical way? Only when the protected elements of a database are established, the question concerning the scope of protection becomes acute. In digital context, the traditional notions of reproduction and making available to the public of digital materials seem to fit ill or lead into interpretations that are at variance with analogous domain as regards the lawful and illegal uses of information. This may well interfere with or rework the way in which the commercial and other operators have to establish themselves and function in the existing value networks of information products and services. 4. International sphere After the expiry of the implementation period for the European Community Directive on legal protection of databases, the goals of the Directive must have been consolidated into the domestic legislations of the current twenty-five Member States within the European Union. On one hand, these fundamental questions readily imply that the problemsrelated to correct construction of the Directive underlying the domestic legislation transpire the national boundaries. On the other hand, the disputes arisingon account of the implementation and interpretation of the Directive on the European level attract significance domestically. Consequently, the guidelines on correct interpretation of the Directive importing the practical, business-oriented solutions may well have application on European level. This underlines the exigency for a thorough analysis on the implications of the meaning and potential scope of Database protection in Finland and the European Union. This position hasto be contrasted with the larger, international sphere, which in early 2005 does differ markedly from European Union stance, directly having a negative effect on international trade particularly in digital content. A particular case in point is the USA, a database producer primus inter pares, not at least yet having aSui Generis database regime or its kin, while both the political and academic discourse on the matter abounds. 5. The objectives of the study The above mentioned background with its several open issues calls for the detailed study of thefollowing questions: -What is a database-at-law and when is a database protected by intellectual property rights, particularly by the European database regime?What is the international situation? -How is a database protected and what is its relation with other intellectual property regimes, particularly in the Digital context? -The opportunities and threats provided by current protection to creators, users and the society as a whole, including the commercial and cultural implications? -The difficult question on relation of the Database protection and protection of factual information as such. 6. Dsiposition The Study, in purporting to analyse and cast light on the questions above, is divided into three mainparts. The first part has the purpose of introducing the political and rationalbackground and subsequent legislative evolution path of the European database protection, reflected against the international backdrop on the issue. An introduction to databases, originally a vehicle of modern computing and information andcommunication technology, is also incorporated. The second part sets out the chosen and existing two-tier model of the database protection, reviewing both itscopyright and Sui Generis right facets in detail together with the emergent application of the machinery in real-life societal and particularly commercial context. Furthermore, a general outline of copyright, relevant in context of copyright databases is provided. For purposes of further comparison, a chapter on the precursor of Sui Generi, database right, the Nordic catalogue rule also ensues. The third and final part analyses the positive and negative impact of the database protection system and attempts to scrutinize the implications further in the future with some caveats and tentative recommendations, in particular as regards the convoluted issue concerning the IPR protection of information per se, a new tenet in the domain of copyright and related rights.

La protection légale des connaissances traditionnelles des peuples autochtones Mapuches, par rapport à l’utilisation des organismes génétiquement modifiés (OGM) au Chili

Devant le manque de ressources économiques et la pauvreté, les « OGM » apparaissent comme un outil visant à contribuer à la croissance économique et alimentaire, notamment dans les pays en voie de développement et sous-développés. Cependant, nous devons nous pencher sur un sujet tout aussi fondamental, à savoir la protection juridique, accordée par la législation tant nationale qu’internationale en lien avec les « connaissances traditionnelles » quand elles sont aux prises avec l’utilisation des OGM. Connaître cette interaction et évaluer ses effets sur la culture est un sujet d’une ampleur considérable à l’heure actuelle, principalement lorsque l’on considère les « savoirs locaux » comme des éléments fondamentaux pour la conservation de la « biodiversité » et le « développement durable ».

La protection des cyberconsommateurs en droit congolais

Il n’existe présentement aucun code de la consommation dans la législation de la République Démocratique du Congo. Au vu de ce manque d’intérêt du législateur congolais pour les droits des citoyens consommateurs, il ne faut pas s’étonner du mutisme des deux textes réglementaires y régissant le secteur informatique quant à la protection des consommateurs internautes. Le citoyen congolais désireux de faire respecter les droits que lui a conférés un contrat conclu par voie électronique devra s’astreindre (lui ou son procureur) à colliger un certain nombre de textes éparpillés dans la législation de ce pays. La protection juridique accordée au consommateur congolais traditionnel (acheteur de biens matériels en général) se limite en ce moment à quelques dispositions législatives traitant de la publicité dans le secteur pharmaceutique, de l’affichage des prix, de l’interdiction de refuser de vendre un produit une fois que celui-ci a fait l’objet d’une offre et que les conditions de la vente ont été réunies, et de l’interdiction également de refuser de fournir une prestation de services une fois que celle-ci est devenue exigible. À certains égards, et prises dans leur ensemble, les normes éparses relatives à la consommation que la législation congolaise comporte protègent. mais de façon très partielle, les intérêts des consommateurs. Elles sont tout à fait inadéquates quant à la protection des intérêts des « cyberconsommateurs ». La solution à ce vide législatif consiste évidemment à faire adopter une loi en la matière, mais il s’agit là d’une solution imparfaite à cause de son aspect sectoriel. Une solution définitive, à nos yeux, devrait nécessairement être de nature internationale.