Submitted by Luiz Felipe Barbosa (luiz.fbabreu2@ufpe.br) on 2015-03-05T12:22:16Z No. of bitstreams: 2 wanilza marques de almeida cerqueira, mestrado em Direito,PPGD_UFPE, 2012.pdf: 1317192 bytes, checksum: 30fb83d65c8c46a12f9afae40d417f72 (MD5) license_rdf: 1232 bytes, checksum: 66e71c371cc565284e70f40736c94386 (MD5) / Made available in DSpace on 2015-03-05T12:22:16Z (GMT). No. of bitstreams: 2 wanilza marques de almeida cerqueira, mestrado em Direito,PPGD_UFPE, 2012.pdf: 1317192 bytes, checksum: 30fb83d65c8c46a12f9afae40d417f72 (MD5) license_rdf: 1232 bytes, checksum: 66e71c371cc565284e70f40736c94386 (MD5) Previous issue date: 2012-02-24 / A regulamentação da propriedade intelectual pela Organização Mundial do Comércio (OMC) repercutiu nas questões de saúde pública dos Estados Membros. O princípio de single undertaking conferiu unidade à regulamentação da OMC e obrigou a aceitação de todos os acordos da organização. Um dos temas mais controversos regulamentados pela OMC foi propriedade intelectual. A OMC estipulou a regra que obriga os Membros a concederem patentes a medicamentos, anteriormente cada Estado era livre para dispor sobre a matéria conforme entendesse conveniente. A obrigação de patentear medicamentos pode inviabilizar políticas de promoção à saúde pública pelos Estados, por isso o TRIPS prevê o uso legítimo de flexibilidades à regra geral de patenteamento. No cenário pós-TRIPS, observa-se o fenômeno TRIPS-plus, que são regras elaboradas à margem da regulamentação da OMC e que diminuem ou inviabilizam a utilização das flexibilidades previstas no TRIPS. O objetivo da dissertação é analisar o TRIPS-plus, ponderar sobre seu impacto no acesso a medicamentos, demostrar como ele agride o sistema multilateral de regulamentação do comércio internacional traçado pela OMC e examinar as soluções propostas para a questão.

This thesis argues that international copyright law should play a stronger role in the implementation of authors’ and users’ international human rights. In international human rights law, authors’ and users’ human rights are two sides of the same coin: both derive from human dignity and contribute to the development of the human personality. Authors have a set of moral and material interests that entitle them, as a minimum, to an adequate standard of living, to be (or not to be) associated with their intellectual works, and to object to any distortion or mutilation of those works. These entitlements receive a viable back up protection from authors’ human rights to freedom of expression and property. At the same time, users have human rights in culture, arts, and science that entitle them to access, use, and share intellectual works. Also, their human rights to freedom of expression and education reinforce these entitlements. Authors’ and users’ human rights are reciprocal, mutually-reinforcing, and mutually-limiting. Thus, their balanced implementation—by means of legislation or adjudication—depends on three rules: authors’ and users’ human rights are limited, they are not hierarchal, and they are interdependent on and indivisible from other human rights and freedoms. On the other hand, despite its practicality and predominance, the exclusive-right system of international copyright law does not necessarily enable authors to achieve an adequate standard of living, and TRIPS has explicitly overlooked their moral interests. Similarly important, the nature and nurture of international copyright law do not give due weight to users’ human rights. International copyright law includes very few mandatory exceptions and limitations, which are supposed to address users’ rights by granting them some liberties or immunities when using intellectual works, but states’ ability to devise new exceptions and limitations is curtailed by the three-step test. Overall, international copyright law fails to meet the balance requirements of international human rights law since it creates a set of hierarchies between the rights it regulates, sometimes fails to recognize the limited nature of authors’ rights, and is inattentive of copyright’s impact on the whole corpus of international human rights. The thesis suggests that international copyright law should become clearer— and more interested—in implementing the international human rights of authors and users of intellectual works. It can do so by incorporating as an objective the implementation of authors’ and users’ human rights in a balanced manner. This objective can function as a ground rule on which further measures necessary for the implementation of authors’ and users’ human rights may rely. In addition, it can provide normative support to some scholars’ proposals for reforming international copyright law. The new objective of international copyright law may become part of the regime through amending TRIPS, interpreting its provisions by the WTO panels and Appellate Body, or establishing a new international copyright instrument.

The trade-off between innovation and access is a critical problem in pharmaceutical innovation policy. Without adequate intellectual property protection, knowledge is insufficiently appropriable and the output of innovation is sub-optimal. Patents and sui generis forms of intellectual property are policies utilized by the state to foster innovation, creating temporary monopolies for firms to reward their investments in research and development. This paper explores the topic of pharmaceutical innovation policy by discovering the key legal developments that influence the creation of internationally protected and harmonized minimum standards of IP rights. Equipped with a theoretical understanding of IP as a social contract and knowledge about incentives that the law provides, the status quo system of rewarding pharmaceutical innovation is observed though an analysis of the market for new chemical entities, developing an understanding of the relationship between incentives for innovation and market outcomes. Utilizing an extensive analysis of literature, promising policy options are explored for realigning incentives to better optimize the incremental benefits of pharmaceutical innovation while improving access, including public funding of clinical trials, incorporating value-for-money stipulations into reimbursement and marketing approval decisions, and creating prize-based rewards that delink the market for innovations from the market for pharmaceutical products.

The purpose of my thesis is to analyse and compare trade-related aspects of patent protection in pharmaceuticals in China and India. The first chapter addresses the basic economic and legal models devoted to the impacts of intellectual property rights on the pharmaceutical industry in both developed and developing countries. The second chapter describes the development of patent protection in pharmaceuticals in China and in India. The Chapter Three focuses on a comparison of roles and patent strategies of research oriented and generic pharmaceutical companies on the Chinese and Indian markets. The fourth chapter is devoted to the issue of access to medicines in developing countries with emphasis on the role of China and India. Conclusions are drawn in the closing part which focuses on the summary of current issues.

The East African Community (EAC) states recently adopted a policy on utilising the WTO-TRIPS flexibilities on public health. The policy spells out a number of flexibilities and the minimum standards thereof to be enacted in domestic legislation. This study critically reviews this policy. In doing this, the study notes that the EAC member states, like most developing states, have very low per capita income levels. The people are too poor to afford expensive medicines. At the same time, these countries are faced with peculiar, region-specific diseases, the so-called ‘African diseases.’ Already, these diseases have been neglected by foreign pharmaceuticals reluctant to invest in developing medicines for poor markets. There are no established pharmaceuticals in the EAC states. It is against this background that this research makes an argument against the aforementioned policy. It will be demonstrated that the policy is biased towards ensuring access to medicines through price-reduction, at the expense of patent protection. This approach is inappropriate because: first, given the absence of market incentives to invest in developing medicines for African diseases, the policy will only worsen the already bad situation since it undermines the strongest alternative incentive (patent protection); and second, such a policy will not only discourage foreign pharmaceuticals further but also suppress domestic pharmaceutical activity, which is undoubtedly necessary in view of the growing neglect of African diseases by foreign pharmaceuticals. / Dissertation (LLM)--University of Pretoria, 2014 / gm2015 / Centre for Human Rights / LLM / Unrestricted

Occasionally healthy older adults trip over stationary objects even when seen well in advance. These are known as “inadvertent” trips. The purpose of this study was to determine the prevalence of inadvertent trips in older males and older females under conditions of normal vision with good lighting. We also determined their relationship with unobstructed gait measures and other risk factors associated with falls during everyday activities. Forty-one subjects stepped over an obstacle (height set to 25% of leg length) 100 times. The obstacle was contacted by 15 participants (37%) in a total of 29 trials (0.7% of all trials). Of the 29 obstacle contacts, 52% occurred with lead limb. There was no difference in the frequency of contacts between males and females. Slower stride speed, shorter stride length, and increased gait cycle time variability during unobstructed walking were associated with contacts during the obstacle crossing trials (p <u><</u> 0.041). Inadvertent trips were also associated with the number of prescription medications taken by participants (p = 0.019) and participants’ maximum reported rating-of-fatigue (p = 0.022<u>)</u>. Fatigue was an important factor and 36 subjects (88%) reported an increase in their fatigue across trials highlighting the importance of considering fatigue in all obstacle crossing studies using older adults. We conclude that inadvertent trips are not uncommon in older adults and point to useful future areas of research and risk factors that could be targeted by fall intervention programs

De Gaulle et le peuple français : une relation nouvelle se noue, se renoue, lorsque, le 29 mai 1958, la vie politique française bascule. Ce jour-là, devant l’incapacité de la classe politique à trouver une solution au conflit ensanglantant l’Algérie depuis la Toussaint 1954, le président de la République, René Coty, fait appel à un « homme providentiel », un militaire illustre qui, aux yeux des Français, a déjà sauvé le pays, le hissant du rang de vaincu en 1940 à celui de victorieux cinq années plus tard.Le général de Gaulle, hostile au régime des partis qui divisent le pays, se veut l’incarnation du peuple rassemblé. Dernier président du Conseil de la Quatrième République, il transforme les institutions politiques. A une République parlementaire succède une République qui reconnaît la fonction primordiale du chef de l’Etat, fonction renforcée par son élection au suffrage universel direct après la réforme constitutionnelle de 1962. À la République des partis, Charles de Gaulle substitue une « République des citoyens » dans laquelle prime l’expression de la souveraineté populaire.Souveraineté populaire, responsabilité politique pleine et entière des citoyens rassemblés au sein d’une nation qui regroupe toutes les classes sociales, toutes les sensibilités et se mettant elle-même au service de l’homme et du monde… Ces idées vont être mises en pratique, en mots, en images dans les villes et les villages de France, au cours des vingt-six voyages présidentiels de Charles de Gaulle en France métropolitaine. Les déplacements en province sont alors un élément clef, essentiel, de la « République des citoyens » voulue par le Général.La relation établie entre le chef de l’Etat et le peuple français présent aux cérémonies officielles organisées lors des déplacements présidentiels repose sur un échange : légitimité accordée au président de la République par la présence populaire ; sollicitation des citoyens par le chef de l’exécutif afin d’obtenir informations et réflexions relatives aux décisions à prendre nationalement et localement. Fondé sur cet échange avec le peuple régulièrement renouvelé sur les places des villes et des hameaux, sur les changements constitutionnels instituant le peuple comme ultime souverain, sur le recours fréquent à la procédure référendaire, le gaullisme au pouvoir sert une République portée à son accomplissement. / De Gaulle and the French people : their relationship was profoundly renewed when, on May 29, 1958, French political life toppled over. That day, President of the Republic René Coty – faced with a political class that proved incapable of finding a solution to the bloody Algerian conflict, raging since November 1954 – called upon a "providential man", an illustrious soldier who, in the eyes of the French, had already saved the country : France had been vanquished in 1940, but it was victorious five years later.Hostile to the partisan system that divided the country, General de Gaulle wanted to represent the assembled people. The last President of the Council of the Fourth Republic thus deeply transformed political institutions : the parliamentary Republic turned into a Republic that recognized the primary function of the Head of State. This function was reinforced by the constitutional reform of 1962 and its introduction of direct universal suffrage: under Charles de Gaulle, the partisan Republic was replaced by a "Republic of the citizens", in which the expression of popular sovereignty prevailed.Popular sovereignty in a nation that brings all social classes, all leanings together and is itself at the service of Man and of the world : these concepts were put into practice, words, images in the towns and villages of France, in the course of twenty-six presidential trips to the provinces in metropolitan France. They were key to the "Republic of the citizens" wanted by the General.The relationship between the Head of State and the people who came to these official ceremonies was based on an exchange: the popular presence granted the President of the Republic legitimacy – the head of the executive in turn solicited citizens to obtain information and thoughts on measures that needed to be taken, locally and nationally. Gaullism – based on these regular exchanges in town and hamlet squares, on the constitutional changes instituting the people as the ultimate sovereign and on the frequent use of referendums – served a Republic brought to its fulfillment.

Uppsatsen handlar om att granska vilka regler och vad som gäller angående tvångslicens av läkemedel. Detta är ett väldigt aktuellt ämne med tanke på den diskussionen som pågår rörande förslaget om att slopa patenträtten för att bekämpa covid-19 eftersom tvångslicens inte anses vara tillräckligt som åtgärd. Den reglering som finns om tvångslicens hittas i en internationell överenskommelse som kallas för TRIPS-avtalet och som ska fungera som en internationell standard för hur länder ska utforma de regler som finns på det immaterialrättsliga området. I TRIPS-avtalet regleras vissa undantag till den ensamrätten som patent innebär. I artikel 31 regleras just tvångslicenser. För att kunna erhålla en tvångslicens ställs ett antal krav. Till exempel måste det ansökande landet på ett rimligt sätt ha försökt träffa avtal om licens, men inte nått framgång inom en skälig tid. Det finns undantag för när detta inte är nödvändigt, till exempel vid en nationell krissituation. Tvångslicenser får enbart användas för det syftet och den tidsperiod som det har beviljats för. Patenthavaren ska även erhålla en skälig ersättning för licensen. Ursprungligen var tvångslicens endast tillåtet för användning inom landet, men inte för export. Detta har dock ändrats genom Doha-deklarationen och gav möjligheten genom dess implementeringsbeslut till att exportera läkemedel som framställts från tvångslicens. I samband med ändringen förtydligades också att TRIPS-avtalet ska tolkas så att det inte står i vägen för ländernas förmåga att skydda dess invånare och deras hälsa. Avtalet ska även tolkas för att främja tillgången på läkemedel för allmänheten.  TRIPS-avtalet och dess bestämmelse om tvångslicens i artikel 31 är ju en internationell överenskommelse och fungerar därför som en slags minimistandard för medlemsländerna. För att bestämmelsen ska gälla måste den införas i medlemsländernas lagstiftning. I uppsatsen tas det upp hur olika länder har inkorporerat bestämmelsen om tvångslicens. Eftersom TRIPS-avtalet är en internationell standard ser ländernas lagstiftning något olika ut. I uppsatsen tas även tidigare fall på området upp. Det som tas upp är några av de ungefär 20 fall där tvångslicens faktiskt tidigare har använts. I de flesta fallen handlar det om medicin för HIV/AIDS. De länder som har använt sig av förfarandet är bland annat Thailand, Malaysia och Indien. Brasilien har också använt sig av förfarandet som ett medel i förhandlingar med läkemedelsföretag, men inte fullfört processen eftersom parterna kunde nå en lösning ändå. Rwanda och Kanada har också använt tvångslicens för att exportera läkemedel enligt implementeringsbeslutet.  Det finns ett antal fall då tvångslicens har använts, men det har inte använts i så stor utsträckning och inte i en sådan situation som covid-19. Vissa parter menar därmed att tvångslicens inte kan och inte är anpassat för att användas i den situationen som vi befinner oss i nu. De anser därmed att den enda lösningen för att producera tillräckligt med vaccin mot covid-19 är att tillfälligt slopa patenträtten. Med anledning av den diskussionen som pågår kommer uppsatsen att mynna ut i en analys där följande frågor besvaras. Vad krävs egentligen för att tvångslicensiering ska kunna användas? Kan det tillämpas för covid-vaccin? Kan tvångslicens användas vid pandemier eller är den enda lösningen vid sådana situationer att slopa patenträtten helt? Är systemet för tvångslicensiering tillräckligt bra och effektivt för att användas?

It was the purpose of this study to determine the effect of study trips and subsequent discussion on the vocabulary of kindergarten pupils from three social groups in Madora County. Seventy-nine pupils, selected from three classrooms in three rural school districts, were classified as middle-class Anglo-American, lower-class Anglo-American, and lower-class Mexican-American. Two of the three classes were designated as experimental and one as the control class. The instructional design, twelve study trips (one each week) and ensuing discussions, encourage pupils to use new words and develop and expand the meanings of words. The major source of data was the Watts Vocabulary Test for Young Children administered prior to and following the experimental instruction. To provide a basis for interpreting the vocabulary data, the language skills of the pupils were rated by their teachers. Nineteen pupils, selected as high, average, and low verbal responders, were observed in the classroom to determine the effect of the instruction on their verbal behavior. Data also were collected, by the use of observation techniques, to find the extent the instructional plan was implemented and its effect on the verbal behavior of all pupils. An analysis of variance technique was applied to the means obtained on the Watts test to determine the statistical relationship of the experimental and control groups and of the social-class groups. Significant differences, at the .05 level, were located by using post hoc tests. The t test was used to find differences between means. A correlation technique was used to compare vocabulary scores and the language ratings. Language ratings and social-class placements were compared with the quartile distribution of scores for the nineteen pupils selected for more intensive observation. The conclusions from the study include the following: (1) the vocabularies of the pupils in each of the social groups in the experimental classes were effectively stimulated by the instruction; (2) the instruction was most effective for the middle-class pupils, and the least effective for the lower-class Mexican-American pupils; (3) in the distribution of language ratings and vocabulary scores the Mexican-American pupils usually placed low, middle-class Anglo pupils high, and lower-class Anglo pupils in the middle. The findings suggest the needs for further research to: (1) validate the instructional plan by replicating the study in the same school districts; (2) evaluate the effect of the instruction on vocabulary skill after an interval of two years; (3) measure the results of similar curricula administered to the same pupils for at least three years; (4) determine the gain in English vocabulary when the discussions include the use of the native language of the Mexican-American pupils; (5) evaluate the effects of the plan when used with younger pupils.

No description available.