Decisions to reform pharmaceutical policy often involve trade-offs between competing social and commercial goals. Canada's Access to Medicines Regime (CAMR), a reform that permits compulsory licensing for the production and export of medicines to developing countries, aimed to reconcile these goals. Since it was passed in 2004, only one order of antiretroviral drugs, enough for 21,000 HIV/AIDS patients in Rwanda for one year, has been exported. Future use of the regime appears unlikely. This research aimed to examine the politics underlying the formation of CAMR. Parliamentary committee hearing transcripts from CAMR's legislative development (2004) and from CAMR's legislative review (2007) were analyzed using a content analysis technique to identify how stakeholders who participated in the debates framed the issues. These findings were subsequently analyzed using a framework of framing, institutions and interests to determine how these three dimensions shaped CAMR's final policy design. In 2004, policy debates were dominated by two themes: intellectual property rights and TRIPS compliance. Promoting human rights and the impact of CAMR on innovation were hardly discussed. With the Departments of Industry Canada and International Trade as the lead institutions, the goals of protecting intellectual property and ensuring good trade relations with the United States appear to have taken priority over encouraging generic competition to achieve drug affordability. The result was a more limited interpretation of patent flexibilities under the WTO Paragraph 6 Decision. The most striking finding is the minimal discussion over the potential barriers developing country beneficiaries might face when attempting to use compulsory licensing, including their reluctance to use TRIPS flexibilities, their desire to pursue technological development and the constraints inherent in the WTO Paragraph 6 Decision. Instead, these issues were raised in 2007, which can be partly accounted for by a greater representation of the interests of potential beneficiary country governments. While the Government attempted to strike a balance between drug affordability and intellectual property protection, it designed CAMR as a last resort measure. Increased input from the developing country beneficiaries and shifting to institutions where the right to health gets prioritized may lead to policies that better achieves affordable drug access.

INTRODUÇÃO:Os medicamentos pertencentes à RENAME têm sua eficácia comprovada são embasados sob critérios técnicos e científicos, e quando prescritos assumem profunda relevância dentro do contexto da saúde pública brasileira, por facilitarem o acesso aos medicamentos.OBJETIVO: Avaliar a associação entre acesso a medicamentos e prescrição segundo a Relação Nacional de Medicamentos Essenciais (RENAME). METODOLOGIA: Foram analisadas cópias de receitas médicas obtidas da pesquisa intitulada Experiência de Acesso da População de Baixa Renda a Medicamentos e Genéricos, Município de São Paulo 2005; para as análises estatísticas, foram utilizados os programas Epi-Info 2000 e OpenEpi. RESULTADOS: A média de medicamentos com receita foi de 2,5 / desvio padrão: 1,5479; o percentual de nenhum acesso e acesso parcial ás prescrições, juntos, foi de 54por cento ; nas Unidades Básicas de Saúde foram realizadas mais da metade das prescrições analisadas; a forma farmacêutica predominante foi comprimidos; cerca de 75por cento dos medicamentos estava presente nas listas de medicamentos essenciais, nacional ou municipal; dos medicamentos prescritos, 78por cento foram obtidos e 41por cento , dos que não estavam prescritos, também foram obtidos. CONCLUSÃO: Do total de medicamentos analisados, 65por cento estavam prescritos segundo a RENAME, e desses, 78por cento , foram obtidos; as Unidades Básicas de Saúde foram responsáveis por fornecer mais da metade das receitas; a quantidade de medicamentos prescritos mostrou-se negativamente correlacionada ao percentual de acesso aos mesmos; as prescrições quando seguem a RENAME têm a chance de acesso entre 4 a 6 vezes maior de se obter os medicamentos / INTRODUCTION: The medicaments belonging to RENAME have their eficiency verified, under technical and cientific criteria and when they are prescribed they become a matter of great concern regarding the Brazilian Publich Health because they facilitate the access to medicaments. OBJECTIVE: Evaluate the association between access to medicaments and prescription according the National List of Essential Medicaments (RENAME). METHODOLOGY : Copies of the medical prescriptions obtained from the research called Experience in Access to medicament and Generic of Low income population, Sao Paulo Municipal Discrict, 2005,and also the Programs Epi-Info 2000 and OpenEpi because of the statistic analysis. RESULTS: The average of medicament with prescription was 2,5 / Standard Deviation: 1.5479, the percentage of no access and partial access together was 54per cent. More than a half of the analysed prescriptions were done at the Health Fundamental Units. Also, among the pharmaceutical kinds, tablets and pills were the dominant ones and around 75per cent of the medicaments were present in the lists of essential medicaments in the country and districs. Among the prescribed medicaments, 78per cent were obtained while 41per cent of the non-prescribed ones were also obtained. CONCLUSION: From a total of the analysed medicaments, 65per cent of them were prescribed observing RENAME, and 78per cent of them were obtained. The Health Fundamental Units were responsible for providing more than a half of the prescriptions. The amount of medicaments involved were negatively correlated to the number of medicaments. The prescriptions that observe RENAME have 4 to 6 times more chances to be successful when it comes to obtaining medicines

The Pharmaceutical Services are an integral part of the health system and it has in the drug a essential ingredient in the actions in the promotion, protection and recovery of health. Increased access of population to the health system have required changes in the distribution and financing of drugs in order to increase coverage and minimize costs. The present study aimed to evaluate the relationship between the Brazilian governmental financing and assurance the population's access to Drugs, Essential of the Component of Primary Pharmaceutical Care in the city of Aracaju. This is an observational descriptive study of an exploratory nature, the case study type, evaluating the period between the years 2008 and 2012. Work begins rescuing briefly the history of Pharmaceutical Services in the Brazilian Health System and its funding mechanisms in the process of decentralization of health. Proceeds to the analysis of semi -structured interviews conducted by the Pharmaceutical Care`s Municipal Manager, Management Annual Reports of the municipality , reports prepared by Municipal Pharmaceutical Assistance Management and of the deposits made to the account of the Fund allocated to the Municipal Health Component Basic pharmaceutical services and discusses the results. After evaluating the results, it was found that, for the study period, there was sufficient resources to serve all municipal demand for medication of this component, however, it could be seen that there was discontinuity in the supply and consequently, access to these drugs. It is therefore concluded that there was no relationship between sufficiency and ensuring access to Drugs,Essential in the city of Aracaju during the survey period. / A Assistência Farmacêutica é parte integrante do sistema de saúde e tem no medicamento, o insumo essencial em ações voltadas à promoção, proteção e recuperação da saúde. A ampliação do acesso da população ao sistema de saúde exigiu mudanças na distribuição e no financiamento de medicamentos, de maneira a aumentar a cobertura e minimizar os custos. O presente estudo se propôs a avaliar a relação entre o financiamento tripartite da Assistência Farmacêutica Básica e a garantia ao acesso da população aos medicamentos do Componente Básico da Assistência Farmacêutica no município de Aracaju. Tratase de um estudo observacional descritivo, de cunho exploratório, do tipo Estudo de Caso, avaliando o período compreendido entre os anos de 2008 e 2012. Iniciase o trabalho com um breve resgate da história da Assistência Farmacêutica no Brasil, seus mecanismos de financiamento e o processo de descentralização da saúde. Procede-se à análise das entrevistas semi-estruturadas realizadas junto ao gestor Municipal de Assistência Farmacêutica, dos Relatórios Anuais de Gestão do município, dos relatórios elaborados pela coordenação Municipal de Assistência Farmacêutica e dos depósitos realizados na conta do Fundo Municipal de Saúde destinada ao Componente Básico da Assistência Farmacêutica e discutem-se os resultados encontrados. Após avaliação dos resultados, verificou-se que, para o período da pesquisa, existiu suficiência de recursos para atender toda a demanda municipal por medicamentos desse componente, entretanto, pôde-se perceber que, houve descontinuidade no abastecimento e, consequentemente, no acesso a esses medicamentos. Concluise assim, que não existiu relação entre suficiência financeira e garantia de acesso a medicamentos do Componente Básico da Assistência Farmacêutica no município de Aracaju durante o período da pesquisa.

Pharmaceutical advertising involves the advertising of medicines, medical devices, and healthcare services. A review of available international literature indicates the belief that pharmaceutical advertisements negatively affect healthcare decisions made by consumers. Very little research has been conducted to determine how consumers in South Africa (SA) are affected by pharmaceutical advertisements. This study aimed to determine how consumers in the Nelson Mandela Metropole (NMM) perceive pharmaceutical advertisements. More specific objectives included the investigation of legislation in SA employed in pharmaceutical advertisements, the interpretation and misinterpretation of the advertisements, and the identification of problematic areas in this form of advertising. South African legislation applied to pharmaceutical advertisements was investigated by means of a literature review. A qualitative research design was also used to achieve the aim and objectives. This included a focus group consisting of six randomly selected participants in the NMM. A consumer survey, consisting of a 100 consumers obtained from 10 randomly selected community pharmacies within the NMM, supported the findings of the qualitative techniques. The themes identified in the focus group were incorporated into a questionnaire used in the consumer survey. Three randomly selected pharmaceutical advertisements were also decoded to interpret the components employed in each. The results determined that pharmaceutical advertising is a marketing tool that incorporates various emotional and psychological techniques to persuade consumers. It was also evident that consumers can misinterpret pharmaceutical advertisements. Various legal and ethical problems were identified in pharmaceutical advertisements. These results showed that pharmaceutical advertisements have the possibility of negatively affecting consumers’ healthcare decisions and warrants further investigation.

Despite the adoption of the Doha Declaration on the TRIPS Agreement and Public Health in 2001, which unequivocally affirmed WTO members’ rights to use compulsory licences and other TRIPS flexibilities to access medicines, thirteen years on, developing countries and least developed countries are still grappling with access to medicines issues and a high disease burden. Despite some well researched and eloquent arguments to the contrary, it is a trite fact that patents remain an impediment to access to medicines by encouraging monopoly prices. The WTO TRIPS Agreement gives members room to legislate in a manner that is sympathetic to access to affordable medicines by providing for exceptions to patentability and the use of patents without the authorisation of the patent holder (TRIPS flexibilities). This study focuses on access to medicines under the TRIPS Agreement from a SADC comparative perspective by interrogating the extent of the domestication of TRIPS provisions promoting access to medicines in the SADC region with specific reference to Botswana, South Africa and Zimbabwe. After establishing that all SADC members, including Seychelles which is yet to be a WTO member have intellectual property (IP) laws in their statute books, this study confirms that while most of the IP provisions may be used to override patents, they are currently not being used by SADC members due to non-IP reasons such as lack of knowledge and political will. The study also engages in comparative discussions of topical occurrences in the context of access to medicines litigation in India, Thailand and Kenya and extracts useful thematic lessons for the SADC region. The study’s overall approach is to extract useful lessons for regional access to medicines from the good experiences of SADC members and other developing country jurisdictions in the context of a south-south bias. The study draws conclusions and recommendations which if implemented will in all likelihood lead to improved access to medicines for SADC citizens, while at the same time respecting the sanctity of patent rights. The study recommends the adoption of a rights-based approach, which will ultimately elevate patient rights over patent rights and urges the region to consider using its LDCs status to issue compulsory licences in the context of TRIPS Article 31 bis while exploring the possibility of local pharmaceutical manufacturing to produce generics, inspired by the experiences of Zimbabwe and current goings on in Mozambique and the use of pooled procurement for the region. The study embraces the rewards theory of patents which should be used to spur innovation and research into diseases of the poor in the SADC region. Civil society activity in the region is also identified as a potential vehicle to drive the move towards access to affordable medicines for all in the SADC region. / Mercantile Law / LL.D.

Cette thèse se propose d’étudier les déterminants des prix des médicaments innovants de l’oncologie, en s’interrogeant à la fois sur le rôle des caractéristiques propres à chaque produit, en particulier sa valeur thérapeutique ajoutée, et sur l’influence d’éléments structurels, notamment les modalités des politiques de fixation des prix appliqués par les Etats.Une revue de la littérature nous permet tout d’abord de spécifier les modalités de fixation des prix ainsi que les nouveaux instruments mis en place par les décideurs pour réguler leur montant. Nous montrons que la détermination des prix des traitements innovants passe par l’évaluation de la valeur ajoutée et donc la mise en place de politiques d’évaluation de type Health Technology Assessment (HTA). Toutefois, nous mettons en lumière que les politiques de prix se réfèrent à des doctrines différentes tant dans les démarches évaluatives que dans la fixation des prix. Dès lors, nous proposons un cadre théorique de détermination des prix qui permet de prendre en compte ces différences. En complément, la constitution d’une base de données incluant les caractéristiques des anticancéreux et leurs prix fixés dans huit pays de l’OCDE, nous permet d’entreprendre différentes analyses statistiques.A partir des études empiriques, nous examinons dans un premier temps la relation entre les prix et le caractère innovant des anticancéreux. Nous commençons pour cela par nous intéresser à l’accès au marché de ces produits dans les pays retenus avant d’examiner les disparités de prix entres les pays.Si l’on constate qu’une majorité des médicaments de notre échantillon étaient bien disponibles dans ces pays, il apparaît néanmoins des différences en matière réglementaire, notamment concernant l’octroi du statut de médicament orphelin ou encore en matière de délais d’enregistrement. Une étude comparative plus fine des évaluations faites par le NICE et la HAS confirme l’existence de divergences sur les décisions et/ou recommandations de prise en charge malgré une appréciation similaire de la valeur ajoutée. Enfin lorsqu’on procède à la comparaison des prix, on constate un écart de prix considérable selon les modalités de fixation des prix appliqués par les Etats.Ce dernier constat nous conduit ensuite à rechercher des éléments d’explication à partir d’une approche économétrique permettant de mesurer l’effet de la valeur ajoutée, définie par la survie incrémentale, sur le prix des anticancéreux. De façon complémentaire, nous montrons que cette influence se manifeste même lorsque l’estimation de cette valeur ajoutée reste incertaine au regard du niveau de preuve obtenu.De façon complémentaire, les analyses économétriques confirment que les écarts de prix entre pays reflètent les différences internationales sur les choix de politique de prix. En effet, nous montrons que les prix les plus élevés sont relevés dans les pays exerçant une politique de prix libres. A l’inverse, les prix les plus bas sont retrouvés dans les pays pratiquant une évaluation économique. Et l’on retrouve à un niveau intermédiaire les pays ayant recours à la négociation et au référencement international. / This PhD thesis focused on the regulation and the determinants of innovative drugs prices in oncology. First, with a literature review we provided a comprehensive description examining the pricing mechanisms of innovative drugs in OECD countries. This approach shows us that most of the countries determine their prices according the assessment of the added value of the pharmaceutical product, and use HTA policies in their decisions making. Based on that conclusions and regarding the differences observed between the policies’ countries we assumed a framework to describe the pricing mechanism.In addition, we developed an original database which contains the anticancer drugs characteristics and their prices in 8 OECD countries. From empirical studies, we examined the relationship between the prices and the drugs characteristics. Before assessing prices disparities between the selected countries, we focused on the market approval of these medicines in each country. Nevertheless, even if most of the products were available in all studied countries, we observed differences between their regulations notably concerning the orphan status designation as well as for the time to market authorization.Thereafter, we achieved a comparative study to assess the discordance between the NICE and HAS. This analysis shows that despite a similar estimation of the added value, there is divergences between these HTA bodies in term of decisions making. Then, when we investigated the trends in prices across the selected countries, the level of pricing disparities observed, in most cases, seems to reflect the differences in pricing regulations.Finally, in order to highlight the determinants of these disparities between countries with respect to anticancer drug prices, we used the econometric approaches, we assessed both the effects on the prices of the added value (the incremental survival) and the pharmaceutical policy: It appears that the incremental survival impacts on the prices, independently of its uncertainties and its level of evidence provided in the clinical trials. In addition, the analysis confirms that the prices disparities reflect the pricing policy applied. Indeed, the countries using a free pricing policy have the highest-level prices, followed by the countries using the pricing negotiation and external reference pricing. Lastly, the countries using economic evaluation have the lowest prices.

Despite the adoption of the Doha Declaration on the TRIPS Agreement and Public Health in 2001, which unequivocally affirmed WTO members’ rights to use compulsory licences and other TRIPS flexibilities to access medicines, thirteen years on, developing countries and least developed countries are still grappling with access to medicines issues and a high disease burden. Despite some well researched and eloquent arguments to the contrary, it is a trite fact that patents remain an impediment to access to medicines by encouraging monopoly prices. The WTO TRIPS Agreement gives members room to legislate in a manner that is sympathetic to access to affordable medicines by providing for exceptions to patentability and the use of patents without the authorisation of the patent holder (TRIPS flexibilities). This study focuses on access to medicines under the TRIPS Agreement from a SADC comparative perspective by interrogating the extent of the domestication of TRIPS provisions promoting access to medicines in the SADC region with specific reference to Botswana, South Africa and Zimbabwe. After establishing that all SADC members, including Seychelles which is yet to be a WTO member have intellectual property (IP) laws in their statute books, this study confirms that while most of the IP provisions may be used to override patents, they are currently not being used by SADC members due to non-IP reasons such as lack of knowledge and political will. The study also engages in comparative discussions of topical occurrences in the context of access to medicines litigation in India, Thailand and Kenya and extracts useful thematic lessons for the SADC region. The study’s overall approach is to extract useful lessons for regional access to medicines from the good experiences of SADC members and other developing country jurisdictions in the context of a south-south bias. The study draws conclusions and recommendations which if implemented will in all likelihood lead to improved access to medicines for SADC citizens, while at the same time respecting the sanctity of patent rights. The study recommends the adoption of a rights-based approach, which will ultimately elevate patient rights over patent rights and urges the region to consider using its LDCs status to issue compulsory licences in the context of TRIPS Article 31 bis while exploring the possibility of local pharmaceutical manufacturing to produce generics, inspired by the experiences of Zimbabwe and current goings on in Mozambique and the use of pooled procurement for the region. The study embraces the rewards theory of patents which should be used to spur innovation and research into diseases of the poor in the SADC region. Civil society activity in the region is also identified as a potential vehicle to drive the move towards access to affordable medicines for all in the SADC region. / Mercantile Law / LL.D.