Gabriela Costa Chaves

Has the implementation of the TRIPS Agreement in Latin America and the Caribbean produced intellectual property legislation that favours public health

OBJECTIVE The World Trade Organizations Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement establishes minimum standards for intellectual property rights, including patent protection for pharmaceuticals; therefore, it may make it difficult for developing countries to gain access to medicines, especially those countries that are the least developed. This study aims to determine whether implementation of the TRIPS Agreement in Latin American and Caribbean countries has generated patent legislation that is sensitive to public health needs. METHODS Legislation in 11 Latin American and Caribbean countries was analysed. The variables considered in the analysis were: the term of patents issued, patentable subject matter, transition periods (that is, time until legislation was enacted), reversal of the burden of proof of patent infringement, exhaustion of rights, compulsory licensing and the early working exception (which allows a country to complete all procedures necessary to register a generic product before the original patent expires). FINDINGS By 2000, all of the countries studied had reformed their legislation to conform to the agreement. Brazil and Argentina used the transition period until 2005 to grant patents in the pharmaceutical industry. All countries, except Panama, made use of the safeguards and flexibilities available through the agreement by including mechanisms for compulsory licensing in their legislation. Argentina; Bolivia, Colombia, Ecuador, Peru and Venezuela (countries that represented the Andean community); the Dominican Republic; and Panama included mechanisms to allow parallel importation. Mexico did not. Brazil only permits parallel importation after a compulsory licence has been issued. The early working exception is included in legislation in Brazil and the Dominican Republic. CONCLUSION The countries in this study did not incorporate all of the mechanisms allowed for by the Agreement and are not adequately using the provisions that enable World Trade Organization (WTO) members to obtain better health for the public, particularly in regard to gaining access to medicines. This situation may deteriorate in future if other agreements establish more restrictive rules for intellectual property rights.

Disponibilidade de medicamentos nas unidades básicas de saúde e fatores relacionados: uma abordagem transversal

RESUMO Este estudo objetivou a caracterizacao da disponibilidade de medicamentos nas unidades basicas de saude (UBS) do Brasil e a identificacao de fatores organizacionais a ela asso ciados, utilizando banco de dados secundarios do Programa Nacional de Melhoria do Acesso e da Qualidade da Atencao Basica. O desfecho relacionado a disponibilidade de medicamentos, expresso de tres diferentes formas, foi explorado em relacao a variaveis explicativas relacionadas a caracteristicas da UBS e a assistencia farmaceutica. Encontrou-se disponibilidade media de 58,5%, que foi tambem baixa em todos os estratos populacionais; houve associacao estatisticamente significativa da variavel desfecho com todas as explicativas. Foi baixa a dis ponibilidade de medicamentos, mostrando-se inversamente associada com a organizacao geral da unidade de saude em geral e da assistencia farmaceutica em particular. PALAVRAS-CHAVE Atencao Primaria a Saude; Assistencia farmaceutica; Avaliacao de medicamentos; Politica nacional de medicamentos; Avaliacao em saude.

Target Product Profile (TPP) for Chagas Disease Point-of-Care Diagnosis and Assessment of Response to Treatment

A first and critical step to address the research and development gap for Chagas disease is to establish a consensus on the desirable product profiles in different conditions of use. To foster and inform the development of these much needed tools, the Pan American Health Organization (PAHO), in collaboration with DNDi, Medecins sans Frontieres (MSF), and the Special Programme for Research and Training in Tropical Diseases (TDR), convened a multidisciplinary group of experts in Rio de Janeiro, Brazil (April 2010), to review the evidence and initiate discussions. The meeting established the basis for the development of target product profiles (TPPs), which are reported in this paper.

A proposal for an evaluation model of pharmaceutical services for malaria

Malaria is a serious public health problem in over 90 countries worldwide. In Brazil the disease is prevalent in the Amazon and the control rationale is based on early diagnosis and treatment. Quality pharmaceutical services are considered a key element for control. A proposal for evaluating pharmaceutical services for malaria is presented here. A theoretical outline composed of a logical model and an indicator framework is discussed and strives to establish a basis for assessment and judgment of the way in which these services are actually delivered. The aim is to contribute to the understanding of pharmaceutical services for malaria and other endemic diseases, complying with the directives of the Brazilian National Medicines Policy.

Malária não complicada por Plasmodium vivax e P. falciparum no Brasil: evidências sobre fármacos isolados e associações medicamentosas empregados em esquemas terapêuticos recomendados pelo protocolo terapêutico oficial

Malaria is the most important endemic parasitic disease in the world. Conditions are favorable for transmission of the disease in 60% of Brazils territory. Over 500,000 cases per year are recorded in the country. However, the geographic distribution is uneven, which may explain differences in the efficacy and effectiveness of antimalarial drugs. We conducted an extensive literature review of antimalarial treatment in Brazil from 1980 to 2005 in order to identify evidence that might have been available for the 2001 Edition of the Malaria Treatment Manual, the official Ministry of Health guidelines. Only a few studies, of low methodological quality, were identified by the search. None of the studies would have been capable of generating evidence-based guidelines according to the current classification of levels of pharmacological and clinical evidence. Studies published after 2001 drew on more evidence and are expected to provide the basis for the next edition of the manual, due in 2007. References in the 2001 Edition were outdated, possibly perceived as traditional references in the field, but lacking in specificity for region, population, and/or type of malaria.

Strategies for price reduction of HIV medicines under a monopoly situation in Brazil.

ABSTRACT OBJECTIVE To analyze Government strategies for reducing prices of antiretroviral medicines for HIV in Brazil. METHODS Analysis of Ministry of Health purchases of antiretroviral medicines, from 2005 to 2013. Expenditures and costs of the treatment per year were analyzed and compared to international prices of atazanavir. Price reductions were estimated based on the terms of a voluntary license of patent rights and technology transfer in the Partnership for Productive Development Agreement for atazanavir. RESULTS Atazanavir, a patented medicine, represented a significant share of the expenditures on antiretrovirals purchased from the private sector. Prices in Brazil were higher than international references, and no evidence was found of a relationship between purchase volume and price paid by the Ministry of Health. Concerning the latest strategy to reduce prices, involving local production of the 200 mg capsule, the price reduction was greater than the estimated reduction. As for the 300 mg capsule, the amounts paid in the first two years after the Partnership for Productive Development Agreement were close to the estimated values. Prices in nominal values for both dosage forms remained virtually constant between 2011 (the signature of the Partnership for Productive Development Agreement), 2012 and 2013 (after the establishment of the Partnership). CONCLUSIONS Price reduction of medicines is complex in limited-competition environments. The use of a Partnership for Productive Development Agreement as a strategy to increase the capacity of local production and to reduce prices raises issues regarding its effectiveness in reducing prices and to overcome patent barriers. Investments in research and development that can stimulate technological accumulation should be considered by the Government to strengthen its bargaining power to negotiate medicines prices under a monopoly situation.

Compras públicas de medicamentos para hepatite C no Brasil no período de 2005 a 2015

This paper analyzes the Minister of Healths (MoH) procurement of medicines for hepatitis C from 2005 to 2015. Data sources were the Integrated General Services Administration (SIASG), to estimate annual expenditure for selected medicines of the MoH Clinical Protocols and Therapeutic Guidelines (PCDT) for Hepatitis C. All presentations and strengths recorded on SIASG were included. The unit prices were estimated based on the purchase with the highest volume each year. There was a 159.5 fold increase in expenditure of the selected medicines from 2005 to 2006, because procurement of those medicines became centralized. In 2007 there was 730% increase in spending due to the incorporation of pegainterferons alfa 2a and 2b. In 2012 the purchase of only two new direct-acting antivirals (DAA) accounted for 99% of total annual expenditure. In 2015 the adoption of a new DAA led to an increase of 230% (R

Política Nacional de Medicamentos em retrospectiva: um balanço de (quase) 20 anos de implementação

945 million) in MoH spending. The significant increase of MoH expenditure on medicines for hepatitis C from 2005 to 2015 was due to the increase of volumes purchased as well as the incorporation of alfapeginterferon and new DAAs. Ensuring universal access to treatment for hepatitis C will depend on the implementation of strategies that strengthen the MoHs bargaining power in price reduction negotiations with the manufacturers of monopoly medicines.

Farmácia Popular Program: pharmaceutical market analysis of antihypertensive acting on the renin-angiotensin system medicines

Resumo A assistencia farmaceutica (AF) e a formulacao de politicas de medicamentos sao campos de atuacao do Sistema Unico de Saude (SUS). Assim, em 1998, apos um processo participativo, a Politica Nacional de Medicamentos (PNM) foi aprovada e publicada em portaria. A PNM traz em seu cerne, baseadas nos principios e diretrizes do SUS, diretrizes e prioridades para balizar as acoes das tres esferas de Governo no alcance do objetivo essencial da politica. A fim de conduzir o leitor a momentos de reflexao sobre esse periodo de vida da politica, o artigo se propoe a fazer um balanco dos quase 20 anos da PNM, com a discussao de algumas diretrizes especificas a luz de principios do SUS. Nao se pretendeu exaurir todas as atividades do periodo, mas aproximar se daquelas que se destacaram por apontar avancos e dilemas, com potenciais riscos de retrocessos. Vislumbrou-se esforcos de implementacao de uma agenda ambiciosa para a AF, que tentou lidar com desafios de enfrentamento do mercado farmaceutico, da operacionalizacao da AF dentro do SUS. Apesar dos principios do SUS serem reconhecidos nas diferentes iniciativas, identifica-se tambem que a operacionalizacao traz uma serie de contradicoes e riscos que podem comprometer alguns desses principios.Pharmaceutical services and the formulation of a medicines policy are SUS areas ensured by the organic health care law 8,080/90. Thus, after a widely participative process, involving stakeholders, the National Medicines Policy (NMP) was approved in 1998 by Ordinance 3,916.The NMP presents directives and priorities, aligned with organic health care law, which should guide the federal, states and municipals entities actions to achieve the policy goals. Considering almost 20 years of the NMP, this paper took stock discussed some of the directives in light of the SUS principles. It was not the objective to provide an exhaustive review of all the activities performed during this period. The authors tried to get close to those that have brought advances and dilemmas, with potential risk of regression. Efforts to implement an ambitious agenda applied to pharmaceutical services were identified. This agenda tried to deal with different challenges like the dynamics of the pharmaceutical market and the operation of pharmaceutical services to guarantee the supply of medicines aligned with principles and directives of SUS.

Assistência Farmacêutica nos 30 anos do SUS na perspectiva da integralidade

This paper aims to analyse changes in the retail pharmaceutical market following policy changes in the Farmácia Popular Program (FP), a medicines subsidy program in Brazil. The retrospective longitudinal analyses focus on therapeutic class of agents acting on the renin-angiotensin system. Data obtained from QuintilesIMS (formerly IMS Health) included private retail pharmacy sales volume (pharmaceutical units) and sales values from 2002 to 2013. Analyses evaluated changes in market share following key FP policy changes. The therapeutic class was selected due to its relevance to hypertension treatment. Market share was analysed by therapeutic sub-classes and by individual company. Losartan as a single product accounted for the highest market share among angiotensin II antagonists. National companies had higher sales volume during the study period, while multinational companies had higher sales value. Changes in pharmaceutical market share coincided with the inclusion of specific products in the list of medicines covered by FP and with increases in or exemption from patient copayment.