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Brazil became the first developing country to guarantee free and universal access to HIV/AIDS treatment, with antiretroviral drugs (ARVs) being delivered to nearly 190,000 patients. The analysis of ARV price evolution and market dynamics in Brazil can help anticipate issues soon to afflict other developing countries, as the 2010 revision of the Wor...
Contexts in source publication
Context 1
... Brazilian experience in ART provision and its drawbacks can help anticipate many of the issues soon to afflict other developing countries, as the 2010 revision of the WHO guidelines shifts demand towards more expensive therapies [4,5]; at the same time, current evolution of international legislation and trade agreements on intellectual property rights (IPRs) may reduce availability of generic drugs for HIV care [6][7][8]. As Table 1 shows, the Brazilian Health System provides the decentralized delivery of 20 ARVs and one fixed dose combination (FDC), totaling 33 child and adult formulations. Pharmaceutical patent protection has been enforced in the country since May 1997. ...
Context 2
... patent protection has been enforced in the country since May 1997. Considering the latest available information on patent approvals and pending patent applications in Brazil, from the Brazilian Institute of Intellectual Property patent database, nine of the ARV drugs included in Table 1 are under IPR protection. The patent on Abacavir expired in June 2008. ...
Similar publications
Objectives:
To analyze the cost effectiveness of short-cycle therapy (SCT), where patients take antiretroviral (ARV) drugs 5 consecutive days a week and have 2 days off, as an alternative to continuous ARV therapy for young people infected with human immunodeficiency virus (HIV) and taking efavirenz-based first-line ARV drugs.
Methods:
We conduc...
Despite the success of highly active antiretroviral therapy (HAART) in the management of human immunodeficiency virus (HIV)-1 infection, virological failure due to drug resistance development remains a major challenge. Resistant mutants display reduced drug susceptibilities, but in the absence of drug, they generally have a lower fitness than the w...
Citations
... In the contractual phase, the charge delivery and remuneration of medicines also have higher frequency among the PPP objects investigated in the selected articles, since Brazil is the seventh pharmaceutical market in the world (HOMMA et al., 2013). These articles presented as objective the evaluation of strategies to reduce expenses (MEINERS et al., 2011;CAMPOS;FRANCO, 2017) and greater bargaining in monopoly situations (CHAVES et al., 2017)44, increase transparency in PPP, alignment of different pharmaceutical assistance policies (BEVILACQUA et al., 2011), among others. ...
... The absence of data in places where there are worse SUS quality indicators should be corrected, because it is the data that subsidize decisions that can qualify the said indicators (LANSKY et al., 2007) and information about goods and/or services that are lacking, as well as the time of this lack or absence of health care coverage, are also fundamental for a more efficient, effective and effective planning (MEINERS et al., 2011). ...
... Other difficulties in accessing information were also reported by the authors of the articles that make up this review, such as the possibility that the existing data offer an overview or the construction of an estimate, but make it impossible to produce statements about public contracting in health in Brazil (NUNN et al., 2007;MATOS;POMPEU, 2003), lack of computerization in the recording of data and information (FONSECA; COSTA, 2015), centralization of the management and organization of data by the Ministry of Health because it is the main source of public funding (SILVA; CAETANO, 2018), non-standardization of the data made available in relation to the international market, which makes it impossible to compare the Brazilian public procurement model to other models (MEINERS et al., 2011), among others. ...
Introduction
Investigate the limitations of public procurement information health access in Brazil, from 1990 to 2018, according to Access to Information Law criteria.
Method
Integrative review was carried out on published scientific production in indexed journals, with analysis of the limitations reported in the search for public procurement information health access, considering the criteria provided for in that Law to guarantee access: primacy, integrity, updating, availability and authenticity.
Results
35 articles were included in the review, with a predominance of studies on the external phase of the public health procurement process, complexity of the object of contracting goods and having the federal and municipal spheres as contractor. 64 information sources were identified, the majority being secondary sources, in the format of banks and databases, and 43.75% of these sources reported limitations regarding access to the information obtained.
Conclusion
Public procurement information health access has important limitations in relation to the criterias of Access to Information Law, and has repercussions on the production of scientific knowledge. Information Science can contribute to future studies to qualify the search and retrieval processes for that information.
KEYWORDS:
Information access; Public information; Information sources; Health expenditure; Literature reviews
... In this scenario, the price changes according to the market share of biosimilars; an increase in competition by the addition of new biosimilar in the market usually causes a decrease in prices. A decline in pricing is directly correlated with the market share of generic products (Dylst & Simoens, 2011;Meiners et al., 2011). The fact that originator suppliers strategically set prices to lessen the prospect of compulsory licencing and generic competition is also well recognized. ...
... Originator suppliers set prices strategically to reduce compulsory licensing and generic competition threats. Meiners et al. (2011) 3. ...
The high prices of biotherapeutics remain an area of concern for various national and international agencies working toward developing strategies for monitoring, evaluating, and managing the prices of medicines to promote equitable access. This paper deploys a unique study design to identify emerging themes and determine the elements influencing the price of biotherapeutics specifically biosimilars. This review is based on a bibliometric and qualitative synthesis approach to generate a new line of thinking for future studies. The findings enable knowledge assimilation for policy decisions. The results indicate that while the factors like market share, market competition, and pricing policies are extensively explored by researchers, the factors such as innovation capability, product development costs, and local factors like regulatory ecosystem can be further examined as potential influencers of prices. Further, pricing frameworks and regulations designed for generic drugs cannot be replicated to estimate the prices of biotherapeutics. As a result, policymakers must take the necessary actions to construct innovative pricing frameworks for this class of products that are in conformity with national policies, regulations, market dynamics, and economics. Moreover, studies on incentives and profit margins associated with the last‐mile delivery and accessibility of high‐cost biotherapeutics are essential for their efficient adoption.
... Na fase contratual, a entrega do encargo e a remuneração de medicamentos também têm maior frequência entre os objetos de PCP investigados nos artigos selecionados, visto que o Brasil é o sétimo mercado farmacêutico do mundo (HOMMA et al., 2013). Estes artigos apresentavam como objetivo a avaliação de estratégias para redução de gastos (MEINERS et al., 2011;CAMPOS;FRANCO, 2017) e maior barganha em situações de monopólio (CHAVES et al., 2017), incremento de transparência no PCP, alinhamento de diferentes políticas de assistência farmacêutica (BEVILACQUA et al., 2011), entre outros. ...
... A ausência de dados em locais onde existem piores indicadores de qualidade do SUS deve ser corrigida, porque são os dados que subsidiam decisões que podem qualificar os referidos indicadores (LANSKY et al., 2007) e informações sobre bens e/ou serviços que faltam, bem como o tempo deste desabastecimento ou ausência de cobertura de assistência à saúde, também são fundamentais para um planejamento mais eficiente, efetivo e eficaz (MEINERS et al., 2011). ...
... Outras dificuldades de acesso à informação também foram relatadas pelos autores dos artigos que compõem essa revisão, tais quais as possibilidades dos dados existentes ofertarem uma panorama ou a construção de uma estimativa, mas impossibilitarem produzir afirmações sobre a contratação pública em saúde no Brasil (NUNN et al., 2007;MATOS;POMPEU, 2003), falta de informatização no registro dos dados e informações (FONSECA; COSTA, 2015), centralização da gestão e organização dos dados pelo Ministério da Saúde por este ser a principal fonte de financiamento público (SILVA; CAETANO, 2018), não padronização dos dados disponibilizados em relação ao mercado internacional, que inviabiliza comparações do modelo de contratação pública brasileira a outros modelos (MEINERS et al., 2011), entre outros. ...
Introdução: Investigar as limitações do acesso às informações sobre contratação pública em saúde no Brasil, no período de 1990 a 2018, de acordo com critérios definidos na Lei de Acesso à Informação. Método: Revisão integrativa da produção científica publicada em periódicos indexados no período supramencionado, com análise dos registros de limitações relatados na busca do acesso às informações sobre contratação pública em saúde, considerando os critérios previstos na referida Lei para garantir o acesso de: primariedade, integridade, atualização, disponibilização e autenticidade. Resultados: Foram incluídos 35 artigos na revisão, com predomínio de estudos sobre a fase externa do processo de contratação pública em saúde, complexidade do objeto de contratação de bens e tendo como contratante as esferas federal e municipal. Identificou-se 64 fontes de informação, sendo a maioria fontes secundárias, no formato de bancos e bases de dados, e 43,75% destas fontes apresentaram relato de limitações em relação ao acesso às informações obtidas. Conclusão: O acesso às informações sobre contratação pública em saúde apresenta limitações importantes em relação à Lei de Acesso à Informação, e tem repercussões sobre a produção do conhecimento científico. A Ciência da Informação pode contribuir com estudos futuros para qualificar os processos de busca e recuperação da referida informação.
... The judicial claim as reasoning for the purchase of medicines by government agencies is a topic discussed in four studies [13,[19][20][21]. These studies addressed the economic impact, the potential effects on the incorporation of new technologies [22,23], and responsibilities of the federative entities in medicines acquisition and distribution. ...
... Grangeiro, Teixeira, Bastos & Teixeira, 2006 ;Meiners, Sagaon-Teyssier, Hasenclever & Moatti, 2011;MSF, 2008 ;Nunn et al., 2007; ...
Si de nombreux travaux ont été consacrés à la politique menée au Brésil dans la lutte contre la pandémie du Sida, très peu en revanche prennent pour objet central ses développements les plus récents qui consistent en l’introduction d’une 3ème ligne d’antirétroviraux pour les patients qui en ont besoin. L’introduction d’une troisième ligne soulève des problèmes complexes et pour parte inédits. Quel mode de sélection des patients, comment les déclarer éligibles ? Quel mode d’administration et de suivi ? Comment l’hôpital s’organise-t-il ? Est-il préparé pour faire face à cette tache inédite ? Est-il toujours en situation de la faire de manière efficace ? Enfin last but not least comment assurer le surcoût de financement que représente l’acquisition de la 3ème ligne dont les prix sur le marché mondial sont prohibitifs et sans rapports avec les prix des antirétroviraux de première et même de seconde ligne. Des politiques locales de production (sous licence) de tels médicaments sont-elles possibles ? À quelles conditions ? Telles sont les questions au centre de cette thèse. Pour tenter d’y réponde, la thèse est organisée en deux parties : la première présente les caractéristiques de l’épidémie et le contexte institutionnel de sa prise en charge ; la deuxième retrace et analyse les conditions de l’introduction d’une 3ème ligne de traitement antirétroviral au Brésil. La pérennité du programme brésilien est confrontée à plusieurs défis. Tout d’abord, (i) l’arrivée de nouveaux patients qui commencent un traitement chaque année. Le traitement offrant une espérance de vie plus longue, (ii) les patients restent inscrits dans le programme plus longtemps. Enfin, pendant cette période, les patients restent plus vulnérables aux mutations virologiques, (iii) ce qui exige un changement de thérapie. L'analyse du cas brésilien montre que la nécessité croissante d'intégrer de nouveaux traitements dans les protocoles nationaux représente une charge très lourde pour le budget du programme de lutte contre le Sida. Ainsi en 2014, l’achat des médicaments de 3ème ligne représentaient-ils 34,88% du coût total d’achat des antirétroviraux. Entre 2010 et 2014, ces médicaments ont eu aussi une forte influence sur la croissance du coût total des antirétroviraux. Aussi pour tenter de surmonter les obstacles qui se dressent dans l’accès aux médicaments contre le VIH, le Brésil s’est-il engagé dans une politique de production nationale à travers le Partenariat de Développement Productif (PDP), et encourage-t-il de plus en plus l’industrie brésilienne à s’engager dans la production d’antirétroviraux. Enfin en se tournant du côté de la demande ce travail donne un aperçu de la situation des patients brésiliens assistés par l’hôpital public. Une étude de cas met en évidence qu’avant de faire face au VIH, les patients doivent surmonter d’autres défis tels que l’instabilité financière et le manque de scolarité qui mène à la méconnaissance de ses droits. Ce cadre ne permet pas de produire les résultats d’observance souhaités : seulement 20,7% des 145 patients ont une bonne observance. Des politiques de soins tournées vers les patients de 2ème et 3ème lignes sont donc indispensables pour éviter et prévenir les changements de thérapies en lien à une observance inadéquate.
... In 1996, Brazil was the first country to guarantee to HIV/AIDS patients the right to receive all of the drugs needed for their treatment free of charge through the public system. 5 A pharmaceutical care model specializing in HIV/AIDS was developed by the Specialized Municipal Assistance Service (SAME) in Sorocaba City, SP, Brazil. This model consists of a pharmaceutical consultation that seeks information regarding medications and provides explanations to patients about their treatment, enhancing co-responsibility and contributing to adherence to therapy. ...
Purpose:
To verify the effectiveness of a pharmaceutical care model developed by the
Specialized Municipal Assistance Service in Sorocaba, Brazil, on adherence to
ART among patients infected with HIV.
Methods: A cohort study compared adherence to ART in two groups of patients:
intervention group (patients assisted with pharmaceutical care, n=130) and
non-intervention group (patients attended by the habitual dispensing process,
n=229). Antiretroviral adherence was measured by the number of pharmacy refill
records in a six-month period. The relationship between the use of other drugs
for the treatment of opportunistic infections and the adherence rate in the
intervention group and the correlation between adherence and viral load and CD4
lymphocytes were also assessed.
Results: Higher adherence rates were observed in the
intervention group (p
... Although ARV prices have been decreasing over time [5][6][7] , population treatment-associated expenses are steeper each year, especially in face of new and costly medicines incorporated in treatment guidelines, most of which present very limited competition or none at all 8 . According to Hoen et al. 8 the "policy space to produce or import generic versions (…) is shrinking" in developing countries, due to patent regimen pressures. ...
The provision of ARVs is central to HIV/AIDS programs, because of its impact on the course of the disease and on quality of life. Although first-line treatments costs have declined, treatment-associated expenses are steeper each year. Sustainability is therefore an important variable for the success of treatment programs. A conceptual framework on sustainability of ARV provision was developed, followed by data collection instruments. The pilot study was undertaken in Brazil. Bolivia, Peru and Mozambique, were visited. Key informants were identified and interviewed. Investigation of sustainability related to ARV provision involved implementation and routinization events of provision schemes. Evidence of greater sustainability potential was observed in Peru, where provision is implemented and routinized by the National HIV/AIDS program and expenditures met by the government. In Mozambique, provision is dependent on donations and external aid, but the country displays a great effort to incorporate ARV provision and care in routine healthcare activities. Bolivia, in addition to external dependence on financing and management of drug supply, presents problems regarding implementation and routinization. The conceptual framework was useful in recognizing events that influence sustainable ARV provision in these countries.
... Other factors may also be involved, from lack of the necessary purchaser's power in price negotiations [1,[30][31][32], as befalls many other financially constrained middle-income countries, to inadequate revision and faulty adherence to therapeutic guidelines [1]. ...
The costs of medicines pose a growing burden on healthcare systems worldwide. A comprehensive understanding of current procurement processes provides strong support for the development of effective policies. This study examined Brazilian Federal Government pharmaceutical procurement data provided by the Integrated System for the Administration of General Services (SIASG) database, from 2006 to 2013. Medicine purchases were aggregated by volume and expenditure for each year. Data on expenditure were adjusted for inflation using the Extended National Consumer Price Index (IPCA) for December 31, 2013. Lorenz distribution curves were used to study the cumulative proportion of purchased therapeutic classes. Expenditure variance analysis was performed to determine the impact of each factor, price and/or volume, on total expenditure variation. Annual expenditure on medicines increased 2.72 times, while the purchased volume of drugs increased 1.99 times. A limited number of therapeutic classes dominated expenditure each year. Drugs for infectious diseases drove the increase in expenditures from 2006 to 2009 but were replaced by antineoplastic and immunomodulating agents beginning in 2010. Immunosuppressants (L04), accounted for one third of purchases since 2010, showing the most substantial growth in expenditures during the period (250-fold increase). The overwhelming price-related increase in expenditures caused by these medicines is bound to have a relevant impact on the sustainability of the pharmaceutical supply system. We observed increasing trends in expenditures, especially in specific therapeutic classes. We propose the development and implementation of better medicine procurement systems, and strategies to allow for monitoring of product price, effectiveness, and safety. This must be done with ongoing assessment of pharmaceutical innovations, therapeutic value and budget impact.
... Generics were initially procured from Indian manufacturers (Ranbaxy labs, Aurobindo pharma), and later manufactured locally through by 5 national firms namely, FarManguinhos-Rio, LaFepe-Pernambuco, Globequimica, Cristalia, and Nortec (Lago & Costa, 2009). Nationally produced generics were costlier than imported generics due to research and developments costs, and were reliant on imports of APIs from other countries and increase vulnerability to currency valuation rate increases (Meiners, Sagaon-Teyssier, Hasenclever, Moatti, & Boni, 2011). ...
... While LDCs have been afforded repeated extensions on transition period for pharmaceuticals until 2033, MICs who did not use the full transitory period to adapt local legislation have experienced deleterious effects on local pharmaceutical capability. Estimates suggest that Brazil spent between USD 420-519 million on 5 ARVs alone due to its patent revalidation system (Meiners et al., 2011). Approximately 340 other medications were granted pipeline protection in Brazil on implementation of TRIPS. ...
Following the Doha ministerial declaration on Public health in 2001, there has been more frequent use of compulsory licenses (CL) to procure HIV medications, and increasingly, non-essential medicines such as oncologic agents, anti-inflammatory agents, and prophylactic drugs for heart disease. Approaches taken by countries include an official government-use policy to compulsory license drugs, use of CLs as a threat, an emergency use for pandemic preparedness, and anti-competitive tool to promote parallel trade. Each case has unique motivators and reveals context specific outcomes.
While use of compulsory licenses is controversial, countries have traditionally used them in case of exceptionally expensive medicines (Cancer drugs, and 2nd line ARV medication), often after failed negotiations (Brazil, Thailand, and Taiwan). The TRIPS Article 31 framework allows significant liberty in issue and use of compulsory licenses, but requires further clarifications of certain provisions to clarify ambiguities passed down from the Paris convention of 1885. Some further policy clarifications are also prudent given the evolving nature of the patent landscape, and current global discussion on impending need for change to the innovation framework has been
motivated by conflicting goals between Human rights and Inventors rights.
... Existing literature on ARV price determinants does not reflect the global market because analyses are conducted using either transactional data at the regional level [10,12]; data provided by a reduced number of funding sources [8] or data from the old GPRM at the medicine level (old GPRM reporting not comparable prices in terms of the international commercial terms) [11]. Separate estimations better fit the data and are one of the main contributions of this article. ...
... Price discrimination across regions could be reflecting a generic firm oligopoly that progressively drives the worldwide supply, maximizing profits by segmenting markets according to consumers' willingness to pay [10]. This would not be so striking if we take into account the findings of Meiners et al. [12], who suggested that the Brazilian generic segment is not as competitive as it was thought. Transaction costs could be a second explanation for the generic price patterns across geographic regions, indicating the different payment capabilities of countries: payment delays could imply additional credit costs [14,15]. ...
... a As suggested by the polynomial regression technique, exponents were introduced until the estimated coefficients were not significant. prices confirm the hypotheses of Lucchini et al. [10] and Meiners et al. [12] that monopsony (the presence of a single purchaser in a market) is able to compensate for monopoly power only when alternative suppliers are available. ...
Introduction:
This study aims to provide a landscape of the global antiretroviral (ARV) market by analyzing the transactional data on donor-funded ARV procurement between 2003 and 2015, and the ARV price determinants.
Design:
The data were obtained from the Global Price Reporting Mechanism (GPRM) managed by the AIDS Medicines and Diagnostics Service of the WHO, and it consists of information that covers approximately 80% of the total donor-funded adult ARV transactions procurement.
Methods:
ExWorks prices and procured quantities were standardized according to the guidelines in terms of yearly doses. Descriptive statistics on quantities and prices show the main trends of the ARV market. Ordinary least squares estimation was carried out for the whole sample, then stratified according to the type of supplier (originator and generic) and controlled for time and geographical fixed-effects. Given that analyses were carried out on a public dataset on ARV transactional prices from the GPRM, ethics are respected and consent was not necessary.
Results:
Originator medicines are on average the least expensive in the sub-Saharan Africa region, where at the same time, generic medicines are on average the most expensive. By contrast, originator medicines are the most expensive in Europe and Central Asia, and generic medicines are the least expensive. In fact, the data suggest mixed strategies by ARV suppliers to exploit opportunities for profit maximization and to adapt to the specific conditions of market competition in each region. Our results also suggest that the expiration of patents is not sufficient to boost additional developments in generic competition (at least in the ARV market) and that formal or informal agreements between generic firms may de facto slow down or even reverse long-term trends towards price decreases.
Conclusions:
Our findings provide an improved understanding of the ARV market that can help countries strengthen policy measures to increase their bargaining power in price negotiations and the use of TRIPS flexibilities, with a special emphasis on negotiations with generic manufacturers.
