Submitted by DARCIO ZANGIROLAMI FILHO null (darcio.z@hotmail.com) on 2018-03-26T18:21:29Z No. of bitstreams: 1 TESE ZANGIROLAMI FILHO, DARCIO 26.03.pdf: 1014256 bytes, checksum: b38519b6ca6817296b518a39076e5200 (MD5) / Approved for entry into archive by Alexandra Maria Donadon Lusser Segali null (alexmar@fcav.unesp.br) on 2018-03-27T10:56:11Z (GMT) No. of bitstreams: 1 zangirolamifilho_d_dr_jabo.pdf: 1014256 bytes, checksum: b38519b6ca6817296b518a39076e5200 (MD5) / Made available in DSpace on 2018-03-27T10:56:12Z (GMT). No. of bitstreams: 1 zangirolamifilho_d_dr_jabo.pdf: 1014256 bytes, checksum: b38519b6ca6817296b518a39076e5200 (MD5) Previous issue date: 2018-02-05 / Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) / Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) / As técnicas de fertilização in vitro e transferência de embrião são amplamente utilizadas como multiplicadores genéticos em fêmeas de alto valor zootécnico. Para sua realização é mandatório o uso de anestesia epidural, porém sabe-se que a punção repetida do espaço epidural pode causar alterações inflamatórias e fibrose do canal, aos quais reduzem a eficácia da técnica. Objetivou-se, por meio deste estudo desenvolver uma técnica cirúrgica de implantação de cateter epidural com portal de acesso subcutâneo e avaliar a patência deste dispositivo para a realização de aspiração folicular em vacas, por um período de 510 dias. Para a realização deste estudo foram utilizadas doze vacas, com idade entre 3-5 anos e peso entre 308-518 kg, que foram alocadas em dois grupos, grupo A, animais da raça Nelore e B animais da raça Holandesa. Após contenção em tronco, foi realizada sedação com 0,04 mg/kg de acepromazina 1% associada a 0,01 mg/kg de xilazina 2% pela via intramuscular e bloqueio anestésico local da região sacrococcígea e sacral direita. Procedeu-se uma incisão de pele semicircular de dez centímetros (incisão-I), abrangendo o espaço sacrococcígeo e intercoccígeo. Após divulsão da tela subcutânea, a pele foi rebatida lateralmente. Através de uma agulha de Tuohy (16G) posicionada na articulação sacrococcígea ou intercoccígea, introduziu-se dez centímetros do cateter (17G) em sentido cranial, no canal epidural. Procedeu-se uma segunda incisão (incisão-II), de quatro centímetros, no terço médio da região sacral direita. O cateter epidural foi transposto, da incisão-I para a incisão-II, através do espaço subcutâneo utilizando um guia metálico, para ser conectado ao portal de acesso, o qual foi sepultado no espaço subcutâneo da região sacral (incisão-II). As incisões foram suturadas com pontos simples separados. Após 15 dias da implantação, a patência do cateter e do portal foi comprovada por meio da administração de 3 mL de cloridrato de lidocaína 2%. Decorridos 30 dias, reaplicou-se o anestésico local, através do portal de acesso para se proceder a aspiração folicular transvaginal. Este procedimento foi repetido a cada 30 dias, durante 240 dias (8 ciclos). Na sequência, foi realizado descanso de 9 meses, seguido de nova aspiração folicular aos 510 dias após a implantação. A técnica cirúrgica de implantação do cateter e portal foi de média complexidade de execução. As anestesias foram eficazes para a realização da aspiração folicular durante os oito ciclos propostos. Não foram constatadas quaisquer evidências de rejeição do portal e tampouco obstrução total ou parcial dos cateteres. A ferida cirúrgica para a implantação do cateter epidural e do portal de acesso cicatrizou por primeira intenção em todos os animais. A implantação do portal e do cateter permitiu administrações múltiplas de anestésico local, otimizando a aspiração folicular, cuja patência abrangeu 510 dias desde a implantação. / In vitro fertilization and embryo transfer are often used as genetic multipliers in cows of high zootechnical value. Epidural anesthesia is mandatory preceding these procedures, but repeated puncture of the epidural space may cause inflammation and fibrosis, which reduce the effectiveness of the technique in time. The objective of this study was to describe a surgical technique for implantation of an epidural catheter with subcutaneous access portal, and to evaluate the patency this device during eight follicular aspiration cycles in cows. Twelve cows, aged between 3-5 years, weighting 308-518 kg were used in this study. They were allocated in two groups, (A) Nellore and (B) Holstein. Following physical retrain in a hydraulic stock and sedation with 0.04 mg/kg of acepromazine 1% associated with 0.01 mg/Kg of xylazine 2%, administered intramuscularly, local anesthetic block of the sacrococcygeal and right sacral region was made. Then, a 10-cm semicircular followed by skin incision (I-incision), was performed over the sacrococcygeal space, after divulsion of the subcutaneous tissue. Through a Tuohy needle (16G) positioned within the sacrococcygeal joint, ten centimeters of the catheter (17G) were cranially inserted in the epidural space. A second incision (incision-II), four centimeters long, was made at the middle third of the right sacral region. The epidural catheter was transposed from the I-incision to the II-incision through the subcutaneous by using a metallic guide, and promptly connected to the access portal, which was accommodated in the subcutaneous space of the sacral region. Both incisions were sutured with simple interrupted pattern. After 15 days of implantation, the patency of the catheter and portal was confirmed by administration of 3 mL of lidocaine 2%. After 30 days, the local anesthetic was reapplied through the access portal to perform transvaginal follicular aspiration. This procedure was repeated every 30 days for 240 days (8 cycles). Following, 9 months interval a new follicular aspiration was performed on the 510th day following implantation. The surgical technique for the catheter and portal implantation was of medium complexity. Anesthesia was effective for follicular aspiration along the eight cycles. No evidence of portal rejection and total or partial catheter obstruction were noticed. The surgical wounds promptly closed by primary intention. The implantation of the portal and the catheter allowed multiple administrations of local anesthetic optimizing follicular aspiration until the 510th day of implantation. / 2014/11630-8

Made available in DSpace on 2016-12-08T16:24:09Z (GMT). No. of bitstreams: 1 PGCA11MA079.pdf: 1198872 bytes, checksum: 45c625202a482ee64b00347aef9f38a0 (MD5) Previous issue date: 2011-06-30 / The Flemish cattle breed, originarily from the Northeast region of France, was imported to Brazil from Argentina in 1945, being allocated to an experimental Station in Lages, State of Santa Catarina (SC). The Flemish is a double purpose breed very well adapted to the altiplane. Such features contributed to a quick dissemination of this breed in the Southern region of Brazil. However, the introduction of more specialized breeds in the past decades caused a loss of interest in the Flemish breed, resulting in a drastic reduction in the herd size, with only about fifty animals still remaining, all located at the EPAGRI Experimental Station in Lages, SC. The high risk of extinction imposed to this small herd, along with its importance to biodiversity, justifies the need for its preservation. For that, the Ovum Pick Up (OPU)/in vitro embryo production (IVP) and the multiple ovulation and embryo transfer (MOET) procedures are among the available reproductive biotechnologies that could be readily applied for the maintenance and expansion of the breed. However, data regarding the oocyte retrieval efficiency by OPU and embryo yield either by IVP or MOET for Flemish cattle are still lacking. The aim of this study was to compare the efficiency of the in vivo and in vitro embryo production systems for the Flemish breed, using Holstein females as control counterparts. Eight multiparous Flemish females and eight Holstein females were allocated to two subgroups of four animals per breed. Each subgroup was subjected to 10 OPU sessions, at weekly intervals, or two MOET protocols, for two periods of 63 days. After the conclusion of one 63-days long period of OPU and MOET sessions, both procedures were repeated in a second period of 63 days, inverting the subgroups of animals for each procedure. The OPU was performed by ultrasonography for the transvaginal aspiration of &#8805;3 mm follicles. Recovered oocytes were morphologically graded and subjected to IVP procedures, including the in vitro maturation, fertilization and culture steps, up to Day 7 of development. For the MOET subgroups, a standard decreasing FSH dose treatment was used followed by AI, with embryo recovery performed by nonsurgical procedures on Day 7 after AI. Frozen semen from the same Flemish bull was used for the entire experiment. Quantitative data were analyzed using the PROC MIXED or by the Friedman test (SAS), whereas qualitative data were analyzed by the &#967;2 test, and data on the embryonic morphology and kinetics of development by the Kruskal-Wallis test (Minitab), for P<0.05. After 20 OPU sessions per breed, a total of 635 viable oocytes were obtained from Flemish females, with 8.0 ± 0.7 oocytes/animal/section, which was significantly higher than from Holstein cows (543 viable oocytes, 7.3 ± 0.7 oocytes/animal/section). The mean number of blastocysts per IVP procedure (3.9 ± 1.5 vs. 2.1 ± 1.2) and blastocyst rates (11.8% vs. 7.2%) were higher in Flemish than in Holstein females, respectively. After four MOET sessions (total of 32 flushings), Flemish females yielded more viable embryos than Holstein animals (111 vs. 48 viable embryos, with 7.5 ± 1.8 vs. 3.7 ± 1.4 embryos/female, respectively). In conclusion, Flemish females yielded more viable oocytes by OPU and more viable embryos by IVP or MOET than Holstein females. Also, MOET procedures were more efficient than OPU/IVP for the production of embryos, irrespective of the breed. Nevertheless, both reproductive biotechnologies, OPU/IVP and MOET procedures, were efficient as useful tools for the genetic conservation of Flemish cattle / Bovinos da raça Flamenga, originários da França, chegaram ao Brasil em 1945 oriundos da Argentina, sendo alocados em Lages, no Estado de Santa Catarina. Esta raça é de dupla aptidão e que, devido à perfeita adaptação às condições edafoclimáticas regionais, acabou compondo inúmeros rebanhos na região Sul do Brasil. Porém, a introdução de raças especializadas no decorrer das últimas décadas ocasionou desinteresse pela raça Flamenga, resultando na redução drástica do rebanho, com cerca de cinqüenta animais ainda remanescentes e lotados na EPAGRI de Lages. O risco de extinção imposto a este rebanho e sua importância para a biodiversidade justificam a necessidade de sua preservação. Dentre as biotécnicas reprodutivas que podem ser utilizadas para a expansão desta raça destacam-se a Ovum Pick Up (OPU)/produção in vitro de embriões (PIV) e a produção in vivo de embriões pela múltipla ovulação, inseminação artificial (IA) e transferência de embriões (TE). Informações sobre a eficiência de recuperação de oócitos obtidos por OPU para a PIV ou mesmo de embriões produzidos por TE na raça Flamenga são praticamente inexistentes. O objetivo deste estudo foi comparar as eficiências de produção in vitro vs. in vivo de embriões da raça Flamenga, utilizando-se a raça Holandesa como controle. Oito fêmeas da raça Flamenga e oito da raça Holandesa foram subdivididas em dois subgrupos de quatro animais/raça. Cada subgrupo foi submetido a um bloco de 10 seções de OPU/PIV com intervalo semanal ou a duas seções de TE, em um intervalo de 63 dias. Passado este primeiro período de 63 dias, ambos os procedimentos (OPU/PIV e TE) foram repetidos em um segundo período de 63 dias, invertendo-se os subgrupos de animais para cada procedimento. A OPU foi realizada por ultrassonografia transvaginal para a aspiração de folículos com diâmetro acima de 3 mm. Todos os CCOs foram avaliados morfologicamente e submetidos à PIV, a qual incluiu as etapas de maturação, fecundação e cultivo in vitro até o Dia 7 de desenvolvimento. Para a TE, realizou-se protocolo padrão com doses decrescentes de FSH, seguida de IA, com recuperação de embriões realizados por procedimento não-cirúrgico no dia 7 após a inseminação. Sêmen congelado do mesmo touro da raça Flamenga foi utilizado em todo o experimento. Os dados quantitativos foram analisados pelo PROC MIXED ou pelo teste de Friedman (SAS). Os dados qualitativos foram analisados pelo teste do &#967;2, e analisou-se os dados de morfologia embrionária e cinética de desenvolvimento pelo teste de Kruskal-Wallis (Minitab), para P<0,05. Após 20 seções de OPU/raça, o número total de oócitos viáveis e a média de oócitos/animal/seção na raça Flamenga (n=635 e 8,0 ± 0,7) foram superiores à raça Holandesa (n=543 e 7,3 ± 0,7), respectivamente. O número médio de blastocistos obtidos por rotina de PIV (3,9 ± 1,5 vs. 2,1 ± 1,2) e a taxa de blastocistos pela PIV (11,8% vs. 7,2%) foram maiores para fêmeas da raça Flamenga se comparadas a fêmeas da raça Holandesa, respectivamente. Após quatro seções de TE (32 coletas/recoletas totais), produziram-se 111 embriões viáveis na raça Flamenga, com média de 7,5 ± 1,8 embriões/fêmea, sendo superior à raça Holandesa, a qual obteve um total de 48 estruturas viáveis, com média de 3,7 ± 1,4 embriões viáveis/fêmea. Desta maneira, conclui-se que as fêmeas Flamengas forneceram mais oócitos viáveis por OPU e mais embriões viáveis por PIV ou TE do que fêmeas Holandesas. Além disso, o procedimento de TE apresentou maior eficiência que a OPU/PIV para a produção de embriões, independente da raça. Contudo, ambas as biotécnicas se mostraram eficazes como ferramentas úteis para a conservação genética de animais da raça Flamenga

"Mémoire présenté à la Faculté des études supérieures en vue de l'obtention du grade de Maîtrise en droit (LL.M.) Option droit, Biotechnologies et société" / [À l'origine dans / Was originally part of : CRDP - Droit, biotechnologie et rapport au milieu] / Texte du mémoire également publié dans Lex Electronica ; vol. 10, no 2 (Été/Automne 2005) / Au cours de la dernière décennie, la pharmacogénomique est devenue le mantra révolutionnaire de nombreux chercheurs et de certains porte-paroles de l'industrie. L'intérêt que porteront les compagnies bio-pharmaceutiques du secteur privé à la recherche et au développement de nouveaux médicaments pharmacogénomiques sera déterminé par la facilité à obtenir du financement et les perspectives de retombées économiques. Dans cette perspective, le droit de la propriété intellectuelle (plus spécifiquement le droit des brevets) a toujours été l'instrument de prédilection pour motiver la recherche et le développement des produits pharmaceutiques. Cependant, l'extension de ce droit au domaine de la pharmacogénomique est controversé. Cette étude évalue l'applicabilité du système international des brevets au domaine de la pharmacogénomique. Suite à une analyse comparative du droit et des principaux textes normatifs, applicables aux brevets pharmaceutiques et biotechnologiques, ainsi qu'à une revue de la doctrine, l'étude soutient que le système de brevets reste une solution viable pour encourager la recherche et le développement dans le domaine de la pharmacogénomique. Cependant, certains ajustements sont nécessaires pour empêcher que des brevets trop larges, ayant des fondements juridiques douteux, ne soient octroyés sur des nouveaux tests de diagnostic pharmacogénomiques et sur des nouveaux outils de diagnostic pharmacogénomiques, ce qui serait néfaste à la recherche et limiterait l'accès aux soins de santé. Plusieurs stratégies sont proposées pour promouvoir un système de brevets applicable au domaine des biotechnologies qui, tout en donnant la motivation nécessaire aux inventeurs et à l'industrie, protégerait nos valeurs humaines fondamentales. / In the last decade, pharmacogenomics has become the "revolution" mantra for numerous researchers and industry representatives. The research interest of the industry for pharmacogenomics will be determined by financing possibilities and prospective economic benefits. In this perspective, the intellectual property system (more specifically patents), has always been the privileged tool to motivate research and development of pharmaceutical products. However, its application to pharmacogenomics is controversial. This study evaluates the applicability of the international patent system to the area of pharmacogenomics. A comparative review and analysis of international laws and guidelines applicable to biotechnology and pharmaceutical patents as well as a review of the literature was carried out. Our study found that the patent system remains a viable solution to promote research and development of pharmacogenomics. However, some adjustments are needed to ensure that overbroad patent having a weak legal basis are not granted on both new pharmacogenomic research tools and diagnostic tests since this could be detrimental to research and limit access to healthcare. Strategies are suggested to promote a patent system, applicable to the field of biotechnology, that will give the necessary incentive to inventors and industry while protecting our fundamental human values.

<p>What is the political role of risk? What is its role in the power structures of today’s societies? And how can understanding its role lead to a better understanding of political change? This research is inspired by the students of late modernity who argue that the way we are dealing with risk is nowadays structuring culture, society and politics. According to these conceptions of late modernity, risk and political change are closely intertwined through the idea of reflexivity, a process of self-confrontation of a society with its own rules and institutions. This study builds on this theorization of risk and aims to discover why France and Canada, even though they were facing similar technological challenges, were progressively taken along different paths when it comes to regulating GMOs. This study has found that major differences in risk related discourse and in the strategies adopted to manage social risks are factors in explaining different policy outcomes. In addition, it shows that differences in institutional risks management also contribute to the explanation. The comparison of the French and Canadian cases has indeed revealed that, if risks can create significant pressures in favour of institutional and political change, governments may in turn possess the necessary leverage to prevent reflexivity. This comparative analysis exposed that this capacity to manage institutional risk by controlling discourse and preventing reflexivity is related to the characteristics of such core democratic institutions as the parliament, the public administration, the press, and civil society.</p> / Doctor of Philosophy (PhD)

Le diagnostic de prédisposition génétique du cancer du sein et de l’ovaire est détenu par la firme de biotechnologie Myriad Genetics depuis 1996, sous la forme d’un brevet, qui lui octroie une licence d’exploitation internationale, infirmant le droit d’analyse moléculaire aux autres laboratoires. Ce monopole, lui permet de statuer sur un prix excessivement plus élevé qu’en milieu public et d’astreindre en justice, les laboratoires contrevenants. Depuis 2001, le Québec est la seule province qui se soumet (en partie) au brevet, en faisant appel à la compagnie pour le séquençage complet. À travers cette recherche, j’analyse les politiques de brevetage génétique, dans sa construction juridique de la propriété intellectuelle et dans les significations culturelles des biotechnologies. Je m’appuie sur un cadre analytique des théories de propriété et sur la recherche en biomédical. Je procède également à l’analyse du discours des médecins et conseillers généticiens au Québec, à travers des entrevues conduites dans des centres hospitaliers de la région de Montréal et de Sherbrooke. Cette étude qualitative identifie comment les conseillers et médecins généticiens conçoivent le rôle des brevets dans les dépistages et diagnostics du cancer et comment les brevets génétiques expriment une culture médicale. Je cherche à déterminer comment sont perçus par des professionnels de santé les brevets génétiques en analysant et en comparant les variations entre limites idéologiques et limites pratiques. / The biotechnology company Myriad Genetics owns the diagnosis of genetic predisposition of breast and ovarian cancer since 1996. The patent, which grants an international license, reverses the right of molecular analysis by other laboratories. This monopoly allows the company to apply an excessively higher price than public laboratories and pursue the offenders in justice. However, since 2001, Quebec is the only province to respect (in part) the patent, using the company for the complete sequencing. This research analyzes the gene patent politics in its legal structure of intellectual property and the cultural meanings of biotechnology. I rely on an analytical framework of theories of property and biomedical research. I also proceeded to the discourse analysis of physicians and genetic counsellors in Quebec through interviews conducted in hospitals in the region of Montreal and Sherbrooke. This qualitative study identifies how doctors and genetic counsellors analysis the role of patents in the screening and diagnosis of cancer and how genetic patents express a medical culture. The study aims to explore how gene patents are perceived in analyzing and comparing the variations between ideological limits and practical limits.

Le thème de ce mémoire de Maîtrise en droit est « La dignité humaine: limite à la brevetabilité du corps humain». Dans ce travail, nous avons tenté d'apporter une contribution à un débat des plus importants de ce début du 21 e siècle. Deux parties composent ce mémoire. La première partie vise à présenter la thématique de la brevetabilité du corps humain. Elle fait l'analyse non seulement des normes juridiques interdisant la brevetabilité du corps humain, mais aussi elle se penche sur le corps humain comme source d'inventions brevetables. Dans la première sous-section, notre analyse porte sur l'étude des documents normatifs d'intérêt international, régional et national. Le modèle et les normes de la Communauté européenne ont largement retenu notre attention alors que le cas des États-Unis, du Canada et surtout de la France nous servait de guide de réflexion pour mieux comprendre l'état du droit au Canada. Par une argumentation serrée nous avons conclu cette partie en affirmant que le corps humain n'est pas brevetable. La prohibition de la brevetabilité du corps humain s'impose comme universelle. La dignité humaine a constitué un élément déterminant de cette prohibition. Ce qui nous a permis, dans la deuxième sous-section de considérer le brevetage de l'ADN. Après avoir présenté les trois critères juridiques de la brevetabilité, à savoir la nouveauté, l'utilité et l'inventivité, nous avons appliqué ces critères à l'ADN. Il s'est avéré que c'est à bon droit que la plupart des pays accordent le brevet sur l'ADN. Mais cet état de droit pose des problèmes sur le plan des valeurs éthiques. Il a notamment comme conséquence de relativiser la dignité humaine. Ces dernières considérations éthiques nous ont conduits à étendre à l'ADN les critères juridiques de la brevetabilité vus dans la première partie. Pour nous prononcer adéquatement sur ce sujet combien délicat, il a fallu considérer la question de la brevetabilité de l'ADN chez les vivants, depuis l'affaire Chakrabarty en 1980, aux États-Unis, en passant par la Directive européenne de 1998, l'affaire Harvard College au Canada jusqu'à Myriad Genetics Inc. En droit, la brevetabilité de l'ADN ne fait plus de doute. Mais elle continue de soulever des « gènes» sur le plan éthique. L'inquiétude que suscite la pente glissante nous a amenés, dans la deuxième partie, à nous pencher sur la brevetabilité dans son rapport avec la dignité humaine. La première sous-section se voulait une analyse permettant de montrer que la dignité humaine est une valeur absolue et inconditionnelle. Si nous considérons cette valeur comme absolue, il devient impossible de breveter le corps humain dans son ensemble. Par contre, en brevetant l'ADN humain, nos institutions se trouvent à relativiser la dignité humaine. C'est ce que la deuxième sous-section tendait à montrer. Soulignons que cette deuxième sous-section a été conçue également comme une conclusion. Elle s'articule autour notamment de la dignité humaine comme principe de précaution. / "Patentability of the Human Body and of DNA through a comparative, ethical and legal study" is at the heart of a crucial debate of our time regarding the effect of biotechnology on human nature. Hereby, we have attempted to bring a contribution to the debate. In the first part of our work, we developed the concept and the legal criterion of patentability. We then presented a comparative study based on normative documents from international, regional and national sources. Based on the norms defined by the European community, as well as documents from the US, Canada and France, it is clear that the human body is not patentable. In fact, this prohibition appears to be widely recognized. At the core of such a prohibition lies the concept of human dignity, a concept that we proceed to analyze both legally and ethically. It follows that the idea of patenting a human body violates human dignity as well as the integrity and freedom of the person. However, the same cannot be said about the patentability of the DNA. By applying the legal .criteria prevalent to patentability of "human parts," as they appear in Sections 1 and 4 of our thesis, and after considering the debate raised by Chakrabarty in the US, the European Directive of 1998, the Harvard College case in Canada and that of Myriad Genetics, one sees that patentability of the DNA is accepted legally in spite of its ambivalent statutes and the ethical issues. There is no conclusion as this matter is an ongoing subject of public and individual concern. To avoid sliding down a road leading to the patentability of the human body as a whole, one searches for safeguards, such as the "plastic" concept of human dignity.

Depuis les années quatre-vingt-dix Cuba développe et commercialise des vaccins et méthodes en biotechnologies médicales dont certains sont des premières mondiales. L'île est alors encore considérée comme un pays en voie de développement et est la cible d’un embargo imposé par les États-Unis depuis plus de trente ans. Or les biotechnologies sont une science aussi coûteuse en matériel qu'en ressources humaines très spécialisées et elles sont de ce fait réservées aux pays de la sphère scientifique centrale. Ces réussites suggèrent la mise en place d'un potentiel scientifique et technique réel autant qu'elles peuvent constituer un artéfact dans un secteur moins développé ou moins pérenne qu'il n'y paraît. Quel est le vrai visage des biotechnologies cubaines au milieu des années deux-mille ? C'est à cette question que tente de répondre cette étude. Elle consiste dans un premier temps à retracer les paramètres du développement des institutions de recherche en biotechnologies dans un contexte qui connaît peu de répit depuis l'avènement de la Révolution : indicateurs socio-économiques bas, embargo, planification socialiste, isolement géopolitique, crises économiques mondiales, dissolution du bloc soviétique... Elle se poursuit avec une analyse bibliométrique permettant de donner un visage quantitatif des réalisations cubaines dans le domaine : au-delà des réalisations mises de l'avant, dans quelles revues et dans quels domaines les chercheurs cubains en biotechnologie publient-ils ? Avec quels pays collaborent-ils et par quels pays sont-ils cités ? Quelle est leur place dans le monde ? Nous exploiterons l'ensemble de ces indicateurs et de ces éléments historiques pour conclure, au tournant des années deux-mille, à l'existence d'un potentiel scientifique et technique développé mais d'une science aux ressources maigres constamment tenue de rapporter un certain capital économique aussi bien que politique. En cohérence avec la dialectique socialiste propre à l'île, les sciences cubaines, depuis 1959, ne constituent jamais une fin en soi mais restent un moyen politique et social. En 2006 elles le sont encore. Malgré leurs réalisations elles touchent aux limites de la planification et réclament leur indépendance face au politique afin d'exploiter pleinement leur potentiel, bien réel. / Since the 1990s, Cuba has developed and marketed vaccines and medical biotechnology methods of which some have been the first in the world. At that time, the island was considered a developing country and had been the target of an embargo imposed by the United States for more than thirty years, as it still is now. Yet biotechnology is a costly science both in terms of material resources and in terms of highly specialized human resources, and for this reason it is usually exclusive to the world’s leading scientific countries. These successes in Cuba thus suggest the creation of a real scientific and technical potential in country, as much as they constitute an artifact in a sector that is less developed or less established than might seem to be the case. What is the true face of Cuban biotechnologies at the turn of the millennium? This is the question that this study seeks to answer. The study first retraces the parameters of the development of Cuban research institutions in biotechnology in the context of the difficult circumstances that the country has experienced since the Revolution: low socio-economic indicators, the American embargo, socialist planning, geopolitical isolation, world economic crises, and the dissolution of the Soviet bloc. The study then presents a bibliometric analysis, which offers a quantitative vision of Cuban achievements in biotechnology. In which periodicals and in which domains have Cuban researchers in biotechnology published their results? To which countries do the researchers who have collaborated with them or cited them belong? What is their place in the world? We will use these indicators and historical elements to conclude that a developed scientific and technical potential exists in Cuba at the turn of the millennium but that the Cuban sciences remain relatively poor in resources and remain constantly pressured to yield political as well as economic capital. In accordance with the socialist dialectic proper to the island, the Cuban sciences since 1959 have never constituted an end in themselves but have been a means to achieve political and social goals. This remains the case in 2006. Despite their achievements, they remain subject to the limits of socialist planning. They require independence from political concerns in order to fully exploit their potential, which is very real

Cette thèse montre les enjeux et les controverses liés au développement de la thérapie génique au Royaume-Uni. Adoptant une approche d'analyse des politiques publiques, elle décrit la mise sur agenda de la technique, pour des raisons thérapeutiques et économiques et en réponse à des questions éthiques et à un risque sanitaire. Le processus de réglementation adopté, sous la forme d'un réseau d'organismes de contrôle est décrit, avec les normes qu'il impose. Les éléments ayant favorisé sa mise en Œuvre et son développement sont présentés, ainsi que le rôle d'un ensemble d'acteurs publics et privés : initiatives gouvernementales, administrations décentralisées, agences de développement régional, entreprises pharmaceutiques et de biotechnologie, associations caritatives, académies scientifiques et médicales, hommes politiques et personnalités influentes. Les relations entre les différents acteurs sont mises en évidence ainsi que leur influence sur les décisions politiques. Une évaluation des effets des mesures gouvernementales et un bilan du développement de la thérapie génique dresse un état quantitatif et qualitatif des essais réalisés et analyse leurs répercussions sur l'opinion publique, à travers l'étude des médias et des sondages d'opinion. L'analyse, en 1990 et en 1995, des points de vue des acteurs concernés, qu'ils soient scientifiques, religieux ou membres de groupes d'intérêt, montre une évolution des mentalités. Mais si la thérapie génique somatique à des fins thérapeutiques est maintenant bien acceptée, son utilisation pour améliorer les caractéristiques de l'être humain, ainsi que la thérapie génique germinale et l'eugénisme restent des sujets controversés.

Le thème de ce mémoire de Maîtrise en droit est « La dignité humaine: limite à la brevetabilité du corps humain». Dans ce travail, nous avons tenté d'apporter une contribution à un débat des plus importants de ce début du 21 e siècle. Deux parties composent ce mémoire. La première partie vise à présenter la thématique de la brevetabilité du corps humain. Elle fait l'analyse non seulement des normes juridiques interdisant la brevetabilité du corps humain, mais aussi elle se penche sur le corps humain comme source d'inventions brevetables. Dans la première sous-section, notre analyse porte sur l'étude des documents normatifs d'intérêt international, régional et national. Le modèle et les normes de la Communauté européenne ont largement retenu notre attention alors que le cas des États-Unis, du Canada et surtout de la France nous servait de guide de réflexion pour mieux comprendre l'état du droit au Canada. Par une argumentation serrée nous avons conclu cette partie en affirmant que le corps humain n'est pas brevetable. La prohibition de la brevetabilité du corps humain s'impose comme universelle. La dignité humaine a constitué un élément déterminant de cette prohibition. Ce qui nous a permis, dans la deuxième sous-section de considérer le brevetage de l'ADN. Après avoir présenté les trois critères juridiques de la brevetabilité, à savoir la nouveauté, l'utilité et l'inventivité, nous avons appliqué ces critères à l'ADN. Il s'est avéré que c'est à bon droit que la plupart des pays accordent le brevet sur l'ADN. Mais cet état de droit pose des problèmes sur le plan des valeurs éthiques. Il a notamment comme conséquence de relativiser la dignité humaine. Ces dernières considérations éthiques nous ont conduits à étendre à l'ADN les critères juridiques de la brevetabilité vus dans la première partie. Pour nous prononcer adéquatement sur ce sujet combien délicat, il a fallu considérer la question de la brevetabilité de l'ADN chez les vivants, depuis l'affaire Chakrabarty en 1980, aux États-Unis, en passant par la Directive européenne de 1998, l'affaire Harvard College au Canada jusqu'à Myriad Genetics Inc. En droit, la brevetabilité de l'ADN ne fait plus de doute. Mais elle continue de soulever des « gènes» sur le plan éthique. L'inquiétude que suscite la pente glissante nous a amenés, dans la deuxième partie, à nous pencher sur la brevetabilité dans son rapport avec la dignité humaine. La première sous-section se voulait une analyse permettant de montrer que la dignité humaine est une valeur absolue et inconditionnelle. Si nous considérons cette valeur comme absolue, il devient impossible de breveter le corps humain dans son ensemble. Par contre, en brevetant l'ADN humain, nos institutions se trouvent à relativiser la dignité humaine. C'est ce que la deuxième sous-section tendait à montrer. Soulignons que cette deuxième sous-section a été conçue également comme une conclusion. Elle s'articule autour notamment de la dignité humaine comme principe de précaution. / "Patentability of the Human Body and of DNA through a comparative, ethical and legal study" is at the heart of a crucial debate of our time regarding the effect of biotechnology on human nature. Hereby, we have attempted to bring a contribution to the debate. In the first part of our work, we developed the concept and the legal criterion of patentability. We then presented a comparative study based on normative documents from international, regional and national sources. Based on the norms defined by the European community, as well as documents from the US, Canada and France, it is clear that the human body is not patentable. In fact, this prohibition appears to be widely recognized. At the core of such a prohibition lies the concept of human dignity, a concept that we proceed to analyze both legally and ethically. It follows that the idea of patenting a human body violates human dignity as well as the integrity and freedom of the person. However, the same cannot be said about the patentability of the DNA. By applying the legal .criteria prevalent to patentability of "human parts," as they appear in Sections 1 and 4 of our thesis, and after considering the debate raised by Chakrabarty in the US, the European Directive of 1998, the Harvard College case in Canada and that of Myriad Genetics, one sees that patentability of the DNA is accepted legally in spite of its ambivalent statutes and the ethical issues. There is no conclusion as this matter is an ongoing subject of public and individual concern. To avoid sliding down a road leading to the patentability of the human body as a whole, one searches for safeguards, such as the "plastic" concept of human dignity.

Le développement fulgurant noté dans le domaine des biotechnologies peut être attribué, sinon essentiellement du moins partiellement, à l’utilisation des ressources génétiques (RG) et des savoirs traditionnels (ST) acquis sur ces ressources. Ces ressources et ces savoirs sont, notamment, utilisés dans le cadre d’inventions biotechnologiques qui peuvent s’avérer concluantes et faire l’objet de demande de protection par brevet. Ce développement ne s’est tout de même pas réalisé sans heurts majeurs, il l’a été au prix de tumultueuses oppositions. En effet, la découverte progressive de la valeur commerciale et scientifique de telles ressources et de tels savoirs a fait naître des intérêts et attisé des rivalités qui ont fini par opposer fournisseurs et utilisateurs de ces matériels. Force est de constater que parmi leurs divergences, celle qui se rapporte au partage des avantages fait l’objet de discussions des plus âpres qui soient dans le domaine. Une solution qui a été, aussi, envisagée a porté sur les régimes d’accès et de partage des avantages. Ce partage des avantages, les pays fournisseurs espèrent le réaliser par le biais de l’obligation de divulguer l’origine des RG et des ST dans les demandes de brevets. L’application d’une telle exigence connaît des limites en ce sens qu’elle est d’application territoriale. C’est sur la base d’un tel constat que les pays fournisseurs envisagent d’en faire une obligation reconnue et applicable à un niveau international. Dans le cadre de cette étude, nous essaierons de démontrer que l’obligation de divulguer l’origine des RG et des ST dans les demandes de brevets, telle qu’elle est actuellement appliquée, ne constitue pas un moyen pertinent qui permettrait d’en arriver à un partage juste et équitable des avantages. / The rapid development in the field of biotechnology can be attributed to a large degree to the innovative use of genetic resources (GR), a significant portion of which were based on traditional knowledge (TK). The biotechnological inventions resulting from these resources and knowledge are, for the most part, subject to patent protection. This legal protection is designed to allow creators of innovative inventions the possibility to recoup their investment by limiting the use of the resulting creation by people other than the inventor and his assignees. Indeed, the gradual recognition of the scientific and commercial value of such resources and associated knowledge has raised interest and fuelled rivalries that eventually led to conflict over the use and trade of such products between user and producing States. A possible solution to resolve this conflict is the use of access and benefit-sharing agreements. One requirement proposed by producing States is an obligation to disclose the origin of GR and TK in patent applications. However, since the issues in this area, generally, exceed the national sphere, producing countries are attempting to make this requirement recognized at an international level. Accordingly the most effective and efficient means of doing so would be via the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) in the World Trade Organization WTO. In this thesis, we will demonstrate that the obligation to disclose the origin of GR and TK in patent applications does not constitute an appropriate means that would lead to a fair and equitable sharing of benefits arising out of their use.