Introdução: No âmbito da epidemiologia nos serviços de saúde, este estudo avaliou a adesão ao tratamento medicamentoso de pacientes portadores de hipertensão arterial em uma situação de pleno acesso farmacológico, verificando sua associação com aspectos sócio demográficos, comportamentais e características clínicas. Metodologia: estudo transversal com aplicação de questionário junto a usuários do Programa Remédio em Casa da Secretaria Municipal de Saúde de São Paulo. A variável dependente foi a adesão e as variáveis independentes, as características sociodemográficas, comportamentais e clínicas. Foram calculadas as razões de prevalência e a análise multivariada foi realizada por regressão de Poisson. Principais resultados: portadores de hipertensão arterial com pleno acesso aos medicamentos apresentaram alta adesão terapêutica. Os poucos participantes não aderentes não diferiram dos demais do ponto de vista das características sócio demográficas, comportamentais e clínicas. Conclusão: em situação de adequada assistência, os fatores relacionados aos aspectos individuais perdem influência na determinação da adesão, sendo superados pela oferta efetiva de atenção à saúde e pelo pleno acesso aos medicamentos / Background: This study evaluated the medication adherence of hypertensive patients who had full access to medicines and the association with sociodemographic, behavioral and clinical characteristics. Methods: Cross-sectional study using a questionnaire applied to users of Programa Remédio em Casa [Home Medicine Program], a program of distribution of medicines from the city of São Paulo-Brazil. The dependent variable was adherence and the independent variables were sociodemographic, behavioral and clinical characteristics. Prevalence ratios were calculated and multivariate analyses were performed using Poisson Regression. Results: The study population showed high adherence. The non-adherent participants did not differ from the adherent participants in sociodemographic, behavioral or clinical characteristics. Conclusions: with effective provision of health care and full access to medicine, sociodemographic, behavioral and clinical factors lose influence in the determination of adherence to medicine

Submitted by Renata Lopes (renatasil82@gmail.com) on 2017-03-09T19:24:47Z No. of bitstreams: 1 alinealbuquerquedeoliveira.pdf: 1451212 bytes, checksum: 15ba4b6f2342ac4f8df7a64a03699bef (MD5) / Approved for entry into archive by Adriana Oliveira (adriana.oliveira@ufjf.edu.br) on 2017-03-10T14:34:46Z (GMT) No. of bitstreams: 1 alinealbuquerquedeoliveira.pdf: 1451212 bytes, checksum: 15ba4b6f2342ac4f8df7a64a03699bef (MD5) / Made available in DSpace on 2017-03-10T14:34:46Z (GMT). No. of bitstreams: 1 alinealbuquerquedeoliveira.pdf: 1451212 bytes, checksum: 15ba4b6f2342ac4f8df7a64a03699bef (MD5) Previous issue date: 2016-05-06 / A legitimidade pela garantia do direito universal e integral à saúde tem elevado o número de ações judiciais, inclusive de medicamentos, contra as várias esferas de gestão do Sistema Único de Saúde (SUS). Tais demandas têm causado rupturas na gestão do SUS, criando até mesmo políticas paralelas de gestão, com desvio de recursos públicos para o cumprimento das liminares. Com o intuito de conhecer as características dos autores da ação, das ações judiciais e dos medicamentos solicitados via judicial contra a Secretaria de Estado de Saúde do Estado de Minas Gerais, mais especificamente contra a Superintendência Regional de Saúde de Juiz de Fora (SRS/JF), foi realizado estudo transversal observacional das ações judiciais de medicamentos que desdobraram no período de outubro de 2004 a outubro de 2015. Foram analisados 574 processos iniciais solicitando 929 medicamentos. Houve um predomínio do sexo feminino (63,3%) e residentes no município Juiz de Fora, sede da SRS/JF. Aproximadamente 59% dos autores foram atendidos pela defensoria pública ou por advogado dativo (aquele por ela nomeado) e 88,3% teve como réu exclusivamente o Estado de Minas Gerais. Os medicamentos mais demandados são pertencem ao grupo do Sistema Nervoso Central (26,5%), segundo classificação ATC, sendo os imunossupressores (9,6%), antiepiléticos (7,6%) e agentes trombóticos (6,9%) os subgrupos farmacológicos mais demandados. Os medicamentos mais solicitados foram etanercepte (2,5%), quetiapina e rivaroxabana (2,2%) e oxcarbamazepina (1,9%). Cerca de 11,4% estão presentes na Relação Estadual de Medicamentos para o Programa Farmácia de Minas: atenção primária à saúde e 18,5 % compõem o componente especializado e, conforme verificado em outros estudos, as solicitações são maiores para aqueles não pertencentes às listas oficiais de financiamento público (70,1%). Dos medicamentos solicitados, 77,1% possuem atualmente alternativas terapêuticas no SUS. A utilização do Manual de Indicadores de Avaliação e Monitoramento possibilitou a verificação de semelhanças e diferenças em relação a outros estudos que já o utilizaram ou aqueles que possuem dados semelhantes aos do presente estudo. Acreditamos que as tendências verificadas sirvam de subsídio para a reformulação de políticas públicas, com vistas à ampliação do acesso a medicamentos, preservando a gestão pública e o direito à saúde. / The legitimacy by ensuring universal and integral right to health is the high number of judicial actions, including medicines against various spheres of management of the Unic Health System (SUS). Such demands have caused disruptions in S US management, creating even, parallel management policies, diversion of public funds to meet the injunctions. In order to know the characteristics of the plaintiffs, judicial actions and medicines requested remedy against the State Department of Health of the State of Minas Gerais, more specifically against the Regional Superintendent of Juiz de Fora Health (SRS / JF ), was conducted observational cross-sectional study of lawsuits drugs that deployed from october 2004 to october 2015. 574 initial processes requiring 929 drugs were analyzed. There was a predominance of females (63,3%) and living in the city of Juiz de Fora, headquarters of the SRS / JF. Approximately 59% of authors were attended by the public defender or attorney dative (the one named for her) and 88.3% had the defendant only the state of Minas Gerais. The most demanded drugs are belong to the Central Nervous System group (26,5%), according to ATC classification, immunosuppressants and (9,6%), antiepileptics (7,6%) and thrombotic agents (6,9%) the most demanded pharmacological subgroups. The most requested medications were etanercept (2,5%), quetiapine and rivaroxaban (2,2%) and oxcarbamazepina (1,9%). About 11,4% are present in the State List of Drugs for Mine Pharmacy Program: primary health care and 18,5% make up the specialized component and, as seen in other studies, requests are higher for those not belonging to official lists of public funding (70,.1%). The requested medications, 77,1% currently have therapeutic alternatives in the SUS. The use of the Monitoring and Evaluation Indicators Manual enabled the verification similarities and differences with other studies that have used or those with similar data for the present study. We believe that the trends serve as a subsidy for the reformulation of public policies with a view to expanding access to medicines, preserving the public administration and the right to health.

Abstract The purpose of this study is to look at the plant use on the coast of the Bothnian Bay and especially the changes that have taken place in the era of modernization. What changes do we see in the use of grave plants? How did urbanization influence everyday plant use? How did garden culture and food culture influence external contacts? The households surveyed were located on Keskikatu, Tornio, from the end of the 17th century to the beginning of the 19th century. As a reference, to the early modern households, I have studied the use of grave plants of the east coast of the Bothnian Bay. The results are based on the archaeological excavation results of the cemeteries and the inventories under the churches. The burials under the floors of the Tornio, Kempele, Keminmaa and Haukipudas churches have been dated to the 17th to 19th centuries. The results of archaeological excavations at the Iin Hamina and Manamansalo cemeteries indicate the region's medieval graves. The burials from Oulu Cathedral cemetery represent the 17th and 18th centuries, respectively. The gardening of the 18th century is a sign of a modern relationship with nature and, as part of urbanization, a key feature of modernization. The garden culture was visible earlier in the late 17th century and especially in 18th century Tornio and the northernmost parts of Sweden in structures and plans. New architectural currents were also introduced to Tornio in the form of urban plans, and features of classicalism were introduced during the 1700s, but some not until the next century. Ideas largely reached the North thanks to lively trade relations. Even though new commodities - ideas and materials - were wanted, appeared more in desires and plans than in practice. This is reflected in both food culture and garden culture. Foreign plants, medicines or foods were replaced by local plants. The availability of materials defined ownership in Tornio, and the disclosure of one's own ethnic or class identity was not so important in a small community. The manifestations of city identity were a new type of diet and a city garden. The early modern manifestation of nature is a form garden. During the 1700s and 1800s, the town garden grew into a more aesthetic park-like part of the city. In burial ceremonies, different customs and traditions mixed with each other and the origin of the meanings sometimes became obscured. In graves, new plants and artificial decorations were introduced alongside local plants. The 1700s were also central to this change. In the 19th century, burials were associated with indoor flowers and increasingly strong species of origin. There are long traditions in certain graves that follow neither cultural boundaries nor geographical, temporal or religious environments. These include, for example, the use of spruce twigs (Picea abies) and birch bark (Betula). The choice of plants, both in everyday life and in celebrations, began to emphasize individual focus and versatility. Spruce, birch, juniper (Juniperus communis) and raspberry (Rubus idaeus) remained in the life and death of the northern people, as medicines, decorations, food, spices, odours, structures and symbols. / Tiivistelmä Tämän tutkimuksen tarkoituksena on tarkastella kasvienkäyttötapoja Perämeren rannikolla ja erityisesti niiden muutoksia modernisaatioon liittyen. Mitä muutoksia hautakasvien käytössä näkyy? Miten kaupungistuminen vaikutti arjen kasvienkäyttöön? Millä tavalla puutarha- ja ruokakulttuuri saivat vaikutteita ulkoa tulevista kontakteista? Tutkimuksen kohteena olevat kotitaloudet sijaitsivat Keskikadulla, Torniossa, 1600-luvun lopusta 1800-luvun alkuun. Vertailukohteena olen tutkinut kasvien käyttöä Perämeren itärannikon hautauksissa. Tulokset perustuvat hautausmaiden arkeologisiin kaivaustuloksiin sekä kirkkojen alla tehtyihin inventointeihin. Tornion, Kempeleen, Keminmaan ja Haukiputaan kirkkojen lattioiden alle tehdyt haudat on ajoitettu 1600- ja 1800-luvuille. Arkeologisten kaivausten tulokset Iin Haminan ja Manamansalon hautausmailla kertovat alueen keskiaikaisista haudoista. Oulun tuomiokirkon hautauksien tutkimustulokset edustavat vastaavasti 1600–1700-lukuja. 1700-luvun puutarhaharrastus on merkki uudenlaisesta luontosuhteesta. Kaupungistumisen osana se on modernisaation keskeinen piirre. Puutarhakulttuuri oli aikaisemmassa vaiheessaan 1600-luvun lopulla ja erityisesti 1700-luvulla Torniossa ja pohjoisimmissa osissa Ruotsia näkyvillä rakenteiden ja suunnitelmien kautta. Myös uudet arkkitehtoniset virtaukset tuotiin Tornioon ensin kaupunkisuunnitelmien muodossa ja klassismin piirteet tulivat käyttöön pitkin 1700-lukua; osa vasta seuraavalla vuosisadalla. Ideat saavuttivat pohjoisen suhteellisen nopeasti vilkkaiden kauppasuhteiden ansiosta. Uudet hyödykkeet – ideat ja materiaalit – vaikka haluttuja olivatkin, esiintyivät enemmän toiveina ja suunnitelmina kuin käytäntönä. Tämä näkyy sekä ruokakulttuurissa että puutarhakulttuurissa. Vieraita kasveja, lääkkeitä tai ruokia korvattiin kotoisilla kasveilla. Torniossa materiaalien saatavuus määritteli omistamista, eikä oman etnisen tai luokkaidentiteetin julkituominen ollut pienessä yhteisössä niin tärkeää. Kaupunki-identiteetin ilmentymiä olivat uudenlainen ruokavalio ja kaupunkipuutarha. Varhainen modernin luontosuhteen ilmentymä on muotopuutarha. Kaupunkipuutarha, joka oli ollut tunnusomaista kaupungeissa jo keskiaikana, jalostui 1700- ja 1800-lukujen aikana esteettisemmäksi, puistomaiseksi kaupungin keskeiseksi osaksi myös Torniossa. Hautaamisessa eri tavat ja perinteet sekoittuivat keskenään ja merkitysten alkuperä hämärtyi. Hautakasveissa paikallisten kasvien rinnalle tuli uusia kasveja ja keinotekoisia koristeita. 1700-luku on tässäkin muutoksessa keskeinen. 1800-luvulla hautaamisen yhteyteen tulivat sisäkukat ja yhä vahvemmin alkuperältään vieraat lajit. Tiettyjen hautakasvien kohdalla on nähtävissä pitkiä perinteitä, jotka rikkovat kulttuurirajoja, sekä maantieteellisessä, ajallisessa että uskonnollisessa ympäristössä. Tällaisia ovat esimerkiksi havujen ja tuohen käyttö. Kasvien valinnassa, sekä arjessa että juhlassa, alkoi korostua yksilökeskeisyys ja monipuolisuus, joita vahvisti varallisuus. Kuusi, koivu, kataja ja vadelma - pysyvät pohjoisen väen elämässä ja kuolemassa, niin lääkkeinä, koristeina, ruokana, mausteina ja hajuina kuin rakenteina ja symboleinakin.

L'évaluation des bénéfices et des risques des médicaments joue un rôle central dans la protection de la santé publique. Cependant, et de l’avis général, il apparaît que cette évaluation nécessite d’être revisitée. En 2010, aucun examen n’avait encore été effectué pour déterminer si les méthodes disponibles pouvaient être appliquées à l’évaluation de la balance bénéfice-risque des médicaments dans le cadre réglementaire, et si oui à quel point elles seraient applicable. L’objectif de cette thèse a donc été d’identifier la ou les méthodes pouvant être théoriquement utilisées pour ce type d’évaluation, puis de les confronter à des cas concrets afin d’en déterminer leur applicabilité. Les résultats de l’évaluation des méthodes ont montrés que les méthodes les plus appropriées sont la méthode d’aide à la décision multicritère (MCDA) ainsi que ses variantes. Les résultats de l'application pratique de la méthode MCDA ont indiqué que cette méthode peut être utilisé dans les scénarios communs d'enregistrement en Europe. Cependant il convient de noter que cette méthode ne fournit ni une recette « prête à l'emploi » pour exécuter cette évaluation ni une réponse directe. / The benefit-risk evaluation of new medicines plays a central role in safeguarding public health. Nevertheless, it seems that the benefit-risk evaluation calls for further improvement. In 2010, no review had been performed of how available benefit-risk assessment methods could be applied for a regulatory benefit-risk assessment and how feasible that would be when facing real-life cases. The objective of this thesis has thus been to identify method(s) that could be theoretically used for such an assessment, and then to confront it/them to real-life cases, in order to determine their applicability. The results of the methods evaluation showed that the most suitable methods for a regulatory benefit-risk assessment of medicinal products are the MCDA method and the MCDA based methods. The results of the practical application of the MCDA indicated that the method could be used for medicinal products registered through a common registration scenario in Europe. However it should be noted that this method provides neither a “ready-made” recipe to perform an assessment nor a direct answer.

Made available in DSpace on 2016-05-02T13:54:42Z (GMT). No. of bitstreams: 1 Dissertacao completa Fabio de Souza Terra.pdf: 1253899 bytes, checksum: 97e2a9b443864eee5e5db5722e7f2770 (MD5) Previous issue date: 2007-03-23 / Coordenacao de Aperfeicoamento de Pessoal de Nïvel Superior / This study evaluated the QL of end-stage renal patients submitted to hemodialysis and their adhesion to daily pharmacologic treatment knowing their life expectancy and the main complications presented during HD It is an epidemiologic descriptive tranversal and quantitative research carried out at a hemodialysis clinic of a university hospital of Alfenas State of Minas Gerais Brazil with the participation of all the 30 dialysis patients in the period of the collection of data A questionnaire was used for the obtainment of data about the participants' characterization adhesion to pharmacologic treatment and life expectation QL was analyzed through the instrument WHOQOL-bref of the World Health Organization The data were tabulated in the statistical program SPSS version 10.0 and analyzed by means of the medium score with application of the following tests Qui-square Coefficient of Correlation of Pearson Test of Wilcoxon Student s t test Cronbach s Alpha Coefficient The results showed that most of the interviewees referred that HD interfered in their professional activities and in leisure and recreation but 53.33% were calm during the permanence in the clinic The most frequent complications were the arterial hypotension vomit and dizziness All the patients take medicines mainly antihypertensives With regard to knowledge of the indication of the medicines 40% of the dialysis patients know all the drugs that they take Thirty patients informed to take the medicines daily but 16.66% have already interrupted the treatment on their own account due to adverse reactions The average scores of QL were General QL 3.26 physical domain 3.10 psychological domain 3.58 social relationships 4.19 and environment 3.54 Therefore the participants of the study classified their QL as being above "neither bad, nor good" while the domain social relationships was evaluated between "good" and "very good" The variables did not interfere in the patients' QL in other words they did not present any correlation with the domains of WHOQOL-bref Through the reproducibility it was verified that the interviewees' QL was stable between the "test" and the "retest" having satisfactory reliability while the internal consistency of WHOQOL-bref was acceptable for the facets and domains indicating a homogeneity in the appraised items The main expectation of the patients' life is receiving a renal transplantation 82.35% are in the waiting list and 47.06% encountered the refusal of their relatives in donating the organ It can be verified that the instrument WHOQOL-bref showed to be effective to evaluate QL of end-stage renal patients submitted to HD thus being a reliable instrument for such a measure Finally dialysis patients will have a better QL when they are informed about their disease and treatment when cared for in a solid supportive system and rehabilitation in order to make them capable to lead an active productive and self-sufficient life / Este estudo avaliou a QV dos nefropatas crônicos submetidos à hemodiálise e sua adesão ao tratamento farmacológico de uso diário conhecer a expectativa de vida dessa população com relação ao futuro e as principais complicações apresentadas durante a HD Trata-se de uma pesquisa epidemiológica descritiva transversal e quantitativa realizada em uma clínica de hemodiálise de um hospital universitário de Alfenas-MG com todos os 30 pacientes submetidos à HD no período da coleta de dados Utilizou-se para a coleta um questionário com dados sobre a caracterização dos participantes adesão ao tratamento farmacológico e expectativa de vida e a QV foi analisada por meio do instrumento WHOQOL-bref da Organização Mundial da Saúde Os dados foram tabulados no programa estatístico SPSS versão 10.0 e analisados por meio do escore médio com aplicação dos seguintes testes Qui-quadrado Coeficiente de Correlação de Pearson Teste de Wilcoxon Teste t de Student Coeficiente Alfa de Cronbach Os resultados mostraram que a maioria dos entrevistados referiram que a HD interferiu em suas atividades profissionais e de lazer e recreação mas 53,33% se sentem tranqüilos durante a permanência na clínica As complicações de maior ocorrência foram a hipotensão arterial vômito e tontura Todos os pacientes fazem uso de medicamentos sendo os antihipertensivos os mais utilizados Quanto ao conhecimento da indicação dos medicamentos 40% dos renais crônicos conhecem todos os fármacos que usam Os 30 pacientes estudados informaram tomar os medicamentos diariamente mas 16,66% já interromperam o uso por conta própria devido a reações adversas Os escores médios referentes à QV foram QV geral 3,26 domínio físico 3,10 psicológico 3,58 relações sociais 4,19 e meio ambiente 3,54 Assim os participantes do estudo classificaram a QV como sendo acima do nem ruim nem boa enquanto o domínio relações sociais foi avaliado entre boa e muito boa As variáveis estudadas não interferiram na QV dos pacientes ou seja elas não apresentaram correlação com os domínios do WHOQOL-bref Por meio da reprodutibilidade verificou-se que a QV dos entrevistados foi estável entre o teste e o reteste tendo uma confiabilidade satisfatória enquanto a consistência interna do WHOQOL-bref foi aceitável para as facetas e domínios indicando uma homogeneidade nos itens avaliados A principal expectativa de vida dos pacientes é a realização do transplante renal sendo que 82,35% estão na lista de espera e 47,06% se depararam com a recusa dos familiares em doar o órgão Pode-se verificar que o instrumento WHOQOL-bref mostrou-se eficaz para avaliar a QV de renais crônicos submetidos à HD sendo confiável para essa medida Por fim o paciente submetido à HD terá uma melhor QV quando ele for informado acerca de sua doença e tratamento quando existir um sólido sistema de suporte e reabilitação e ser capaz de levar uma vida ativa produtiva e autosuficiente

The object of this master´s thesis is to analyse economic situation in the company Lékárna s. r. o. by used methods. The external and internal structure is gradually analyzed. Furter, Kralick´s Quick Test is performed. The result of the thesis is the identification of suggestions and recommendations for improvement of the state.

"Zimbabwe and South Africa are facing an HIV/AIDS epidemic of such proportions that the populations of these countries will markedly decline in the next ten years despite the existence of effective drugs to treat the symptoms of AIDS and dramatically lower the communicability of the virus. These drugs are under patent protection by companies in the developed world and the patents raise the prices above the level of affordability for HIV infected persons in South Africa and Zimbabwe. Zimbabwe has declared a national emergency on HIV/AIDS, apparently in conformance with TRIPS and has issued compulsory licenses to a local company that has started to manufacture and sell cheap anti-retroviral drugs. South Africa has not declared a national emergency and has not invoked the TRIPS flexibilities or utilized flexibilities inherent in its own legislation. However, while thousands of people die every week in the two countries, neither government has yet provided an effective HIV/AIDS policy. Extensive litigation and public pressure in South Africa has led the government to announce a policy of supplying free HIV drugs in public hospitals while the Zimbabwean government has announced the provision of the same drugs, also in public hospitals, apparently utilising the state of emergency. The TRIPS agreement under which the two governments undertook to protect international patents allows compulsory licensing under certain circumstances (not limited to a national emergency) and the Doha Declaration on TRIPS and Public Health, and subsequent agreements by the Ministerial Council of the WTO allow the manufacture and, in limited circumstances, the parallel importation of generic drugs. These provisions provide a theoretical mechanism for poor countries to ensure their citizens' rights of access to health (care). The research is aimed at identifying the extent of the effectiveness of the legal norms created by Articles 20 and 31 of TRIPS, the Doha Declaration and subsequent Council of Ministers' decisions, which together ostensibly provide a framework to allow provision of generic drugs. It is further aimed at investigating how the state of emergency in Zimbabwe has been utilised to provide cheap generic drugs to Zimbabweans and whether this would be an option for South Africa. A comparison of the legal provisions governing the provision of drugs in the two countries will also be undertaken to examine the extent to which international and national constitutional and legal provisions may be utilised to give effect to the right to health." -- Introduction. / Thesis (LLM (Human Rights and Democratisation in Africa)) -- University of Pretoria, 2004. / Prepared under the supervision of Dr. Enid Hill at the American University in Cairo. / http://www.chr.up.ac.za/academic_pro/llm1/dissertations.html / Centre for Human Rights / LLM

Объектами исследования служили лекарственные препараты активированного угля, аскорбиновой кислоты, инсулина, ацетилцистеина и подсластителя, в основе которого лежит шестиатомный спирт – сорбитол. Целью работы является разработка методик определения микропримесей тяжелых металлов в готовых фармацевтических препаратах методом атомной абсорбции. В литературном обзоре рассмотрены вопросы влияния микропримесей тяжелых металлов на стабильность лекарственного средства и степень его лечебного воздействия на организм человека. Показано, что контроль содержания тяжелых металлов является важной задачей фармацевтического анализа. Анализ литературных источников позволяет заключить, что атомно-абсорбционная спектрометрия является наиболее распространенным методом, используемым в фармакопейном анализе для определения тяжелых металлов. В ходе экспериментальной части были апробированы методики определения микропримесей тяжелых металлов в субстанциях и готовых лекарственных препаратах, представленных в Государственной Фармакопее Российской Федерации ; внесены корректировки в процедуру анализа с учетом особенностей состава присутствующих добавок в лекарственных препаратах; правильность полученных результатов определения микропримесей тяжелых металлов в образцах активированного угля методом ААС оценена путем сравнения с независимым методом инверсионной вольтамперометрии. / The objects of the study were activated charcoal, ascorbic acid, insulin, acetylcysteine and a sweetener, which is based on six-atom alcohol – sorbitol. The aim of the work is to develop methods for the determination of trace amounts of heavy metals in finished pharmaceutical preparations by atomic absorption. In a literature review, the issues of the influence of trace metals of heavy metals on the stability of the drug and the degree of its therapeutic effect on the human body are considered. It is shown that control of the content of heavy metals is an important task of pharmaceutical analysis. An analysis of literary sources allows us to conclude that atomic absorption spectrometry is the most common method used in pharmacopoeia analysis to determine heavy metals. During the experimental part, methods were tested for determining microimpurities of heavy metals in substances and finished medicinal products presented in the State Pharmacopoeia of the Russian Federation; adjustments were made to the analysis procedure taking into account the characteristics of the composition of the additives present in the drugs; the correctness of the results of determination of microimpurities of heavy metals in activated carbon samples by the AAS method was evaluated by comparison with the independent method of inversion voltammetry.

In 2001 the Declaration on the TRIPS Agreement and Public Health (‘Doha Declaration’), affirmed the right of member states of the World Trade Organisation (‘WTO’) to interpret and implement the TRIPS Agreement as supportive of the protection of public health and, in particular, access to medicines. While initially well-received, consternation soon arose over the interpretation of a specific paragraph in the Doha Declaration dealing with compulsory licensing. After a further two years of deliberation, the WTO Decision on the Interpretation of Paragraph 6 (‘Paragraph-6 Decision’) was announced in August 2003 specifying when countries can import drugs produced elsewhere under compulsory licence. With one third of the world's population is still denied access to essential medicines - a figure which rises to over 50 per cent in Asia and Africa - the problems facing the public health community are two-fold. The first is the capacity of developing countries (‘DCs’) actually to use the flexibilities afforded under the TRIPS Agreement, the Doha Declaration, and the Paragraph- 6 Decision amid stark inequalities in health resources and the world trading system as a whole. These include provisions for compulsory licensing, parallel importation, and addressing imbalances in research and development (‘R&D’). The pending ratification of the Paragraph-6 Decision, from an interim solution to a permanent amendment, is accompanied by considerable uncertainty: will the protections be accessible under the system currently proposed? The second problem concerns the undermining of the above hard-won flexibilities by provisions adopted under various bilateral and regional trade agreements. Known as ‘TRIPS-plus’- or ‘WTO-plus’- measures, the level of intellectual property rights (‘IPRs’) rights protection being negotiated and even adopted under other trade agreements are more restrictive as regards public health protection. These two sources of concern have led to an increase in rather than a lessening of tensions between the public health and trade policy communities. The thesis opens with a brief analysis of the interplay between patents and medicines. This includes an overview of the human rights framework and the right of access to medicines as a manifestation of human rights. The historical development of the TRIPS Agreement, its legitimacy, and the effect of the introduction of patents for pharmaceuticals are critically analysed. The terms of the Doha Declaration as it relates to public health, the Paragraph-6 Decision and its system, the December 2005 Amendment, and the progress made to date on the public health protections available under the TRIPS Agreement are reviewed and discussed in detail. The thesis describes how, despite these important clarifications, concerns as to the capacity of DCs to implement specific measures persist. This thesis further addresses the development of compulsory licensing in India and South Africa, and the legal framework for compulsory licensing in these countries. The role of competition law and constraints faced by DCs in implementing the flexibilities offered by the TRIPS Agreement and Doha Declaration are considered before turning to the threat posed by TRIPS-plus measures and calls for their critical reassessment. The thesis considers the role of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG), the WHO Commission on IPRs, Innovation and Public Health (CIPIH), Patent Pools, and international and multilateral donors in access to medicines. The thesis concludes by reviewing potential ways forward to ensure that access to medicines by the poor living in DCs is secured in all trade agreements. / Mercantile Law / LL.D.

In 2001 the Declaration on the TRIPS Agreement and Public Health (‘Doha Declaration’), affirmed the right of member states of the World Trade Organisation (‘WTO’) to interpret and implement the TRIPS Agreement as supportive of the protection of public health and, in particular, access to medicines. While initially well-received, consternation soon arose over the interpretation of a specific paragraph in the Doha Declaration dealing with compulsory licensing. After a further two years of deliberation, the WTO Decision on the Interpretation of Paragraph 6 (‘Paragraph-6 Decision’) was announced in August 2003 specifying when countries can import drugs produced elsewhere under compulsory licence. With one third of the world's population is still denied access to essential medicines - a figure which rises to over 50 per cent in Asia and Africa - the problems facing the public health community are two-fold. The first is the capacity of developing countries (‘DCs’) actually to use the flexibilities afforded under the TRIPS Agreement, the Doha Declaration, and the Paragraph- 6 Decision amid stark inequalities in health resources and the world trading system as a whole. These include provisions for compulsory licensing, parallel importation, and addressing imbalances in research and development (‘R&D’). The pending ratification of the Paragraph-6 Decision, from an interim solution to a permanent amendment, is accompanied by considerable uncertainty: will the protections be accessible under the system currently proposed? The second problem concerns the undermining of the above hard-won flexibilities by provisions adopted under various bilateral and regional trade agreements. Known as ‘TRIPS-plus’- or ‘WTO-plus’- measures, the level of intellectual property rights (‘IPRs’) rights protection being negotiated and even adopted under other trade agreements are more restrictive as regards public health protection. These two sources of concern have led to an increase in rather than a lessening of tensions between the public health and trade policy communities. The thesis opens with a brief analysis of the interplay between patents and medicines. This includes an overview of the human rights framework and the right of access to medicines as a manifestation of human rights. The historical development of the TRIPS Agreement, its legitimacy, and the effect of the introduction of patents for pharmaceuticals are critically analysed. The terms of the Doha Declaration as it relates to public health, the Paragraph-6 Decision and its system, the December 2005 Amendment, and the progress made to date on the public health protections available under the TRIPS Agreement are reviewed and discussed in detail. The thesis describes how, despite these important clarifications, concerns as to the capacity of DCs to implement specific measures persist. This thesis further addresses the development of compulsory licensing in India and South Africa, and the legal framework for compulsory licensing in these countries. The role of competition law and constraints faced by DCs in implementing the flexibilities offered by the TRIPS Agreement and Doha Declaration are considered before turning to the threat posed by TRIPS-plus measures and calls for their critical reassessment. The thesis considers the role of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG), the WHO Commission on IPRs, Innovation and Public Health (CIPIH), Patent Pools, and international and multilateral donors in access to medicines. The thesis concludes by reviewing potential ways forward to ensure that access to medicines by the poor living in DCs is secured in all trade agreements. / Mercantile Law / LL.D.