Maria Auxiliadora Oliveira

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.

Avaliação da assistência farmacêutica às pessoas vivendo com HIV/AIDS no Município do Rio de Janeiro

This study evaluates access by people living with HIV/AIDS to pharmaceutical care provided by public health care facilities in the city of Rio de Janeiro, Brazil, focusing on availability, accessibility, and accommodation. The evaluation was conducted using the implementation analysis approach, assessing the process of producing intervention outcomes, considering its relationship to the organizational context. A case study was performed in 11 public health facilities selected according to: different health program areas; diverse levels of complexity; and more than 100 HIV/AIDS patients registered. The degree of implementation (89%) was considered acceptable. Problems with human resources skills and lack of a quality program were identified. Some limitations of the indicators are discussed. Finally, the study highlights the importance of this kind of evaluation as a methodology for continuous monitoring of quality in pharmaceutical care.

Talidomida no Brasil: vigilância com responsabilidade compartilhada?

This paper discusses issues related to the regulation and rational use of thalidomide in Brazil, by means of a historical approach comprising three different stages. The first part is a historical review of the controversial drug since it was first synthesized, then marketed and subsequently banned during the 1950s and 60s, until the present, when an apparently irreversible process of rehabilitating the drug is under way. Brazilian experience with the use of thalidomide is described, emphasizing legal, political, and institutional work led by two social movements, the Brazilian Association of People with Thalidomide Syndrome (ABPST) and the Movement for Reintegration of People with Hansens Disease (Morhan). The article describes the results and analyzes an active search of new cases in what is a second generation of thalidomide syndrome in Brazil. Finally, based on clinical and scientific evidence of thalidomides therapeutic efficacy, the growth of social movements struggling both for and against authorization of the drug, and a restrictive regulation proposed by the Ministry of Health, the article discusses the implementation of policies for the regulation and rational use of thalidomide in Brazil.

Crescimento, diarréia e aleitamento materno: o caso da Vila do João

A prospective study on children under six months old living in an urban area on the periphery of Rio de Janeiro was carried out to examine the possible effect of diarrhea in differentiating the monthly growth rate in weight and height, according to type of nursing. The results seem to indicate that infants show a delay in growth of weight and height as a result of greater incidence and prevalence of diarrhea. It was also shown that human breast milk has a protective effect, reducing weight loss from episodes of diarrhea. The study concludes that the promotion of breastfeeding, together with the control of diarrheal diseases, can provide immediate benefits in improving the nutritional status of the infant population.

Access to medicines in Latin America and the Caribbean (LAC): a scoping study

Objective To assess scientific publication and map research gaps on access to medicines (ATM) in Latin American and the Caribbean low-income and middle-income countries (LMIC). Design Scoping review. Two independent reviewers assessed studies for inclusion and extracted data from each study. Information sources Search strategies were developed and the following databases were searched: MEDLINE, ISI, SCOPUS and Lilacs, from 2000 to 2010. Eligibility criteria Research articles and reviews published in English, Spanish and Portuguese were included. Studies including only high-income countries were excluded, as well as those carried out in very limited settings and discussion papers. Results The 77 articles retained were categorised through consensus among the research team according to the level of the health system addressed, ATM domain and research issues covered. Publications on ATM have increased over time during the study period (r 0.93, p=0.00; R2 0.85). The top five countries covered were Brazil (68.8%), Mexico (15.6%), Colombia (11.7%), Argentina (10.4%) and Peru (10.4%). ‘Health services delivery’ and ‘patients, household and communities’ were the health system levels most frequently covered. The ATM domains ‘leadership and governance’, ‘sustainable financing, affordability and price of medicines’, ‘medicines selection and use’ and ‘availability of medicines’ were the top four explored. There are research gaps in important areas such as ‘human resources for health’, ‘global policies and human rights’, ‘production of medicines’ and ‘traditional medicine’. Conclusions The upward trend on scientific publication reflects a growing research capacity in the region, which is concentrated on research teams in selected countries. The gaps on research capacity could be overcome through research collaboration among countries. It is important to strengthen these collaborations, assuring that interests and needs from the LMIC are addressed and local capacity building is promoted.

Logic models from an evaluability assessment of pharmaceutical services for people living with HIV/AIDS

Brazil was the first developing country to provide people living with HIV/AIDS (PLWA) with comprehensive, universal, free access to antiretroviral medicines (ARV). Pharmaceutical services are considered a strategic action that has the goal of providing access to rational use of quality medicines while also promoting user satisfaction. User satisfaction is a complex concept, and evaluation models for pharmaceutical services for PLWA were not found in the literature. Therefore, an evaluation approach to help assess this issue had to be developed. This article seeks to describe a theoretical evaluation model of user satisfaction with the dispensing of ARV, developed as part of an Evaluability Assessment (EA). It presents a brief review of the EA and user satisfaction and describes the development of models created during the EA. The lessons learned in the process are presented as a conclusion.O Brasil foi o primeiro pais em desenvolvimento a fornecer medicamentos antiretrovirais (ARV) de forma integral, universal e gratuita as pessoas vivendo com HIV/Aids (PVHA). A Assistencia Farmaceutica e considerada uma acao estrategica e busca prover acesso a medicamentos de qualidade, com uso racional, promovendo a satisfacao dos usuarios. Satisfacao do usua-rio e um conceito complexo e modelos para avaliarem servicos farmaceuticos para PVHA nao sao encontrados na literatura. Este artigo objetiva descrever o desenvolvimento de tres modelos criados em um Estudo de Avaliabilidade (EA). E apresentada uma breve revisao dos conceitos de EA e de Satisfacao do Usuario. As licoes apreendidas no processo sao apresentadas como conclusao.

Medicamentos essenciais e processo de seleção em práticas de gestão da Assistência Farmacêutica em estados e municípios brasileiros

The selection of medicines is a skilled process that produces an essential medicines list (EML) and substantiates rational management of pharmaceutical services. This paper presents the selection of essential medicines in Brazilian states and municipalities. It discusses the perception of pharmaceutical services managers regarding the concept of essential medicines and strategies adopted for their implementation, in addition to investigating how the National Essential Medicines List was adopted and is supporting local pharmaceutical services actions. A nationwide study was carried out adopting a qualitative methodological approach in health. State and municipal managers from the five Brazilian regions were interviewed. The findings point to weaknesses in local selection procedures and in the use of the National Essential Medicines List (Rename). Barriers such as lack of formalization of pharmaceutical services at regional levels, difficulties in drafting and maintaining a pharmacy and therapeutics committee and the acritical incorporation of drugs on the EML were identified. States and municipalities have distortions that exclude the EML form the concept of essential medicines.

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

Sustainability of ARV provision in developing countries: challenging a framework based on program history

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.