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Ministry of Health's spending on drugs: program trends from 2002 to 2007

Abstracts

OBJECTIVE: To analyze the evolution of the Ministry of Health's spending on drugs. METHODS: The Ministry of Health's total (added) spending on drugs and its (not added) programs' were analyzed between 2002 and 2007. Actions that financed drug acquisition were obtained from the Siga Brasil system and classified according to pharmaceutical service programs. Settled values were identified for each program. For 2006 and 2007, antiretroviral drug acquisitions were analyzed. As regards drugs from the Programa de Dispensação em Caráter Excepcional (Exceptional Circumstance Drug Distribution Program), budget action data were compared to those available in the Sistema Único de Saúde (Unified Health System). Values obtained were deflated by applying the Índice de Preços ao Consumidor Amplo (Broad Consumer Price Index). Exploratory data analysis was subsequently performed. RESULTS: Spending in 2007 was 3.2 times higher than 2002 and drug spending participation in total spending rose from 5.4% in 2002 to 10.7% in 2007. Primary care drug spending increased by 75%, and strategic program spending by 124%. In the case of antiretroviral drugs, the increase was about 6%, but with an increase by 77% from 2005 to 2006, followed by a reduction by 29% from 2006 to 2007. The most significant increase in spending was observed with exceptional circumstance distribution drugs, 252% between 2003 and 2007. CONCLUSIONS: There was significant increase in drug spending between 2002 and 2007, with greater participation of antiretroviral and exceptional circumstance distribution drugs, which are comprised by a large number of patent-protected pharmaceuticals.

Health Spending; Drug Costs; Pharmaceutical Services; Política Nacional de Medicamentos (National Drug Policy); Public Health Policies; Sistema Único de Saúde (Unified Health System); Brazil


OBJETIVO: Analisar a evolução do gasto do Ministério da Saúde com medicamentos. MÉTODOS: O gasto total (agregado) do Ministério da Saúde com medicamentos e de seus programas (desagregado) foram analisados para o período de 2002 a 2007. As ações que financiaram a aquisição de medicamentos foram obtidas no sistema Siga Brasil e classificadas segundo os programas de assistência farmacêutica. Os valores liquidados foram identificados para cada programa. Para 2006 e 2007, foram pesquisadas as aquisições de anti-retrovirais. Em relação aos medicamentos do Programa de Dispensação em Caráter Excepcional, confrontaram-se os dados da ação orçamentária com aqueles disponíveis no Sistema Único de Saúde. Os valores obtidos foram deflacionados aplicando-se o Índice de Preços ao Consumidor Amplo. Foi efetuada análise exploratória dos dados. RESULTADOS: O gasto em 2007 foi 3,2 vezes o de 2002 e a participação do gasto com medicamentos no gasto total aumentou de 5,4% em 2002 para 10,7% em 2007. O gasto com os medicamentos da atenção básica teve aumento de 75% e com medicamentos dos programas estratégicos, de 124%. No caso dos anti-retrovirais o aumento foi de aproximadamente 6%, mas com aumento de 77% de 2005 a 2006, seguida de redução de 29% de 2006 a 2007. O aumento mais expressivo do gasto foi observado com os medicamentos de dispensação em caráter excepcional, 252% de 2003 a 2007. CONCLUSÕES: Houve aumento significativo do gasto com medicamentos entre 2002 e 2007, havendo maior participação nesse gasto dos anti-retrovirais e medicamentos de dispensação excepcional, os quais são constituídos por número expressivo de fármacos protegidos por patentes.

Gastos em Saúde; Custos de Medicamentos; Assistência Farmacêutica; Política Nacional de Medicamentos; Políticas Públicas de Saúde; Sistema Único de Saúde; Brasil


OBJETIVO: Analizar la evolución del gasto del Ministerio de la Salud de Brasil con medicamentos. MÉTODOS: El gasto total (agregado) del Ministerio de la Salud con medicamentos y de sus programas (desagregado) fue analizado para el período de 2002 a 2007. Las acciones que financiaron la adquisición de medicamentos fueron obtenidas en el sistema Siga Brasil y clasificadas según los programas de asistencia farmacéutica. Los valores liquidados fueron identificados para cada programa. Para 2006 y 2007, fueron pesquisadas las adquisiciones de anti-retrovirales. Con relación a los medicamentos del Programa de Dispensación en Carácter Excepcional, se confrontaron los datos de la acción presupuestaria con aquellos disponibles en el Sistema Único de Salud. Los valores obtenidos fueron deflacionados aplicándose el Índice de Precios al Consumidor Amplio. Fue efectuado el análisis exploratorio de los datos. RESULTADOS: El gasto en 2007 fue 3,2 veces el de 2002 y la participación del gasto con medicamentos en el gasto total aumentó de 5,4% en 2002 a 10,7% en 2007. El gasto con los medicamentos de la atención básica tuvo aumento de 75% y con medicamentos de los programas estratégicos, de 124%. En caso de los anti-retrovirales el aumento fue de aproximadamente 6%, pero con aumento de 77% de 2005 a 2006, seguida de reducción de 29% de 2006 a 2007. El aumento más expresivo del gasto fue observado con los medicamentos de dispensación en carácter excepcional, 252% de 2003 a 2007. CONCLUSIONES: Hubo aumento significativo del gasto con medicamentos entre 2002 y 2007, habiendo mayor participación en ese gasto de los anti-retrovirales y medicamentos de dispensación excepcional, los cuales son constituidos por número expresivo de fármacos protegidos por patentes.

Gastos en Salud; Costos en Drogas; Atención Farmacéutica; Política Nacional de Medicamentos; Políticas Públicas de Salud; Sistema Único de Salud; Brasil


ORIGINAL ARTICLES

Ministry of Health's spending on drugs: program trends from 2002 to 2007

Gasto del Ministerio de la Salud con medicamentos: tendencia de los programas de 2002 a 2007

Fabiola Sulpino Vieira

Ministério da Saúde. Brasília, DF, Brasil

Correspondence Correspondence: Fabiola Sulpino Vieira Ministério da Saúde Esplanada dos Ministérios Bloco G Anexo A Sala 229 A 70058-900 Brasília, DF, Brasil E-mail: fabiolasulpino@uol.com.br

ABSTRACT

OBJECTIVE: To analyze the evolution of the Ministry of Health's spending on drugs.

METHODS: The Ministry of Health's total (aggregate) spending on drugs and its programs' (not aggregate) were analyzed between 2002 and 2007. Actions that financed drug acquisition were obtained from the Siga Brasil system and classified according to pharmaceutical service programs. Settled values were identified for each program. For 2006 and 2007, antiretroviral drug acquisitions were analyzed. As regards drugs from the Programa de Dispensação em Caráter Excepcional (Exceptional Circumstance Drug Distribution Program), budget action data were compared to those available in the Sistema Único de Saúde (Unified Health System). Values obtained were deflated by applying the Índice de Preços ao Consumidor Amplo (Broad Consumer Price Index). Exploratory data analysis was subsequently performed.

RESULTS: Spending in 2007 was 3.2 times higher than 2002 and drug spending participation in total spending rose from 5.4% in 2002 to 10.7% in 2007. Primary care drug spending increased by 75%, and strategic program spending by 124%. In the case of antiretroviral drugs, the increase was about 6%, but with an increase by 77% from 2005 to 2006, followed by a reduction by 29% from 2006 to 2007. The most significant increase in spending was observed with exceptional circumstance distribution drugs, 252% between 2003 and 2007.

CONCLUSIONS: There was significant increase in drug spending between 2002 and 2007, with greater participation of antiretroviral and exceptional circumstance distribution drugs, which are comprised by a large number of patent-protected pharmaceuticals.

Descriptors: Health Spending, trends. Drug Costs. Pharmaceutical Services. Política Nacional de Medicamentos (National Drug Policy). Public Health Policies. Sistema Único de Saúde (Unified Health System). Brazil.

RESUMEN

OBJETIVO: Analizar la evolución del gasto del Ministerio de la Salud de Brasil con medicamentos.

MÉTODOS: El gasto total (agregado) del Ministerio de la Salud con medicamentos y de sus programas (desagregado) fue analizado para el período de 2002 a 2007. Las acciones que financiaron la adquisición de medicamentos fueron obtenidas en el sistema Siga Brasil y clasificadas según los programas de asistencia farmacéutica. Los valores liquidados fueron identificados para cada programa. Para 2006 y 2007, fueron pesquisadas las adquisiciones de anti-retrovirales. Con relación a los medicamentos del Programa de Dispensación en Carácter Excepcional, se confrontaron los datos de la acción presupuestaria con aquellos disponibles en el Sistema Único de Salud. Los valores obtenidos fueron deflacionados aplicándose el Índice de Precios al Consumidor Amplio. Fue efectuado el análisis exploratorio de los datos.

RESULTADOS: El gasto en 2007 fue 3,2 veces el de 2002 y la participación del gasto con medicamentos en el gasto total aumentó de 5,4% en 2002 a 10,7% en 2007. El gasto con los medicamentos de la atención básica tuvo aumento de 75% y con medicamentos de los programas estratégicos, de 124%. En caso de los anti-retrovirales el aumento fue de aproximadamente 6%, pero con aumento de 77% de 2005 a 2006, seguida de reducción de 29% de 2006 a 2007. El aumento más expresivo del gasto fue observado con los medicamentos de dispensación en carácter excepcional, 252% de 2003 a 2007.

CONCLUSIONES: Hubo aumento significativo del gasto con medicamentos entre 2002 y 2007, habiendo mayor participación en ese gasto de los anti-retrovirales y medicamentos de dispensación excepcional, los cuales son constituidos por número expresivo de fármacos protegidos por patentes.

Descriptores: Gastos en Salud, tendencias. Costos en Drogas. Atención Farmacéutica. Política Nacional de Medicamentos. Políticas Públicas de Salud. Sistema Único de Salud. Brasil.

INTRODUCTION

In Brazil, the publication of the Política Nacional de Medicamentos (National Drug Policy) in 1998ª a Secretaria de Políticas de Saúde. Política Nacional de Medicamentos. Rev Saude Publica. 2000;34(2):206-9. DOI: 10.1590/S0034-89102000000200018 encouraged the creation of programs aimed at guaranteeing the population's access to drugs.

Offer of essential drugs, included in the Programa de Medicamentos de Dispensação em Caráter Excepcional (Exceptional Circumstance Distribution Drug Program), with an usual high cost per unit known as Alto Custo (High Cost), has increased.b b Ministério da Saúde. Programa Nacional de DST/Aids. Responsabilidade dos estados pela compra e distribuição de medicamentos. Brasília; [s.d.] [cited 2008 Sep 1] Available from: http://www.aids.gov.br/data/Pages/LUMIS69662342PTBRIE.htm

If, on the one hand, drug access is fundamental to guarantee the constitutional right to health, on the other, it has become a reason for concern about the evolution of spending. A study performed in 2007 showed irregular growth in spending on health and drugs at the federal level. For the Ministry of Health, while total spending on health increased by 9.6%, those on drugs increased by 123.9%, between 2002 and 2006.c c Brasil. Decreto nº 6.108, de 04 de maio de 2007. Concede licenciamento compulsório, por interesse público, de patentes referentes ao Efavirenz, para fins de uso público não-comercial. Diário Oficial União. 07 jul 2005 [cited 2008 Sep 1]; Seção 1:54.Available from: http://www.planalto.gov.br/ccivil_03/_Ato2007-2010/2007/Decreto/D6108.htm

Similar situation has occurred in other countries. In the United Kingdom, spending on drugs in primary care grew 10% between 2001 and 2002 and caused a financial crisis.3 In Canada, growth in spending was estimated at 6% in 2006, totaling US$ 25 billion, of which US$ 21.1 billion were on prescription drugs.1

In the case of Brazil, even though there is a good estimate of the total value allocated by the Ministry of Health for drugs in recent years (2002 a 2006),

Ministerial Decree GM/MS nº 204, from January 29th 2007,d d Ministério a Saúe. Meicamentos e ispensação excepcional. Brasília; 2006[cite 2009 Jun 1]. Available from: http://portal.saude.gov.br/portal/arquivos/pdf/texto_excepcionais.pdf. organized and categorized drug acquisition resources in the Bloco de Financiamento da Assistência Farmacêutica (Pharmaceutical Service Funds):

  • Pharmaceutical Service Basic Component - aimed at pharmaceutical service materials and drug acquisition in primary health care and those associated with specific health programs and problems.

  • Pharmaceutical Service Strategic Component - funds pharmaceutical service actions for the following strategic health programs: a) control of endemic diseases, such as tuberculosis, leprosy, malaria, leishmaniasis, Chagas's disease and other endemic diseases with a national or local scope b) AIDS/STD program's ARV drugs; c) blood and blood derivatives; and d) immune-biological vaccines and serums.

  • Exceptional Circumstance Distribution Drug Component - aimed at acquisition and distribution of this type of drugs, in accordance with criteria established by the

    Protocolos Clínicos e Diretrizes Terapêuticas (Therapeutic Directives and Clinical Protocols).

In this context, the present study aimed to analyze the Ministry of Health's evolution of spending on drug programs.

METHODS

Analysis was performed from total (added) spending and its (not added) programs, between 2002 and 2007.

Survey of Federal Budget actions that funded drug acquisition was performed using the Siga Brasil system.e e Vieira FS, Mendes ACR. Evolução dos gastos com medicamentos: crescimento que preocupa. In: VIII Encontro da Associação Brasileira de Economia da Saúde; 2007; São Paulo, BR. São Paulo: PUC/SP; 2007[cited 2008 Sep 1]. Available from: http://www.abresbrasil.org.br/pdf/18.pdf As research universe, the item "Despesa execução" (settled expense) of each year was selected from its corresponding Lei Orçamentária Anual (LOA - Annual Budget Law), such as LOA 2007 - Despesa execução. The universe name, program as code and description, action as code and description, and values settled were defined as research "result objects". The "consultation filter" was the "Fundo Nacional de Saúde" (FNS - National Health Fund) budget unit.

Settled values that were constant on the spreadsheet were added to obtain the total value settled by the FNS for each year. In the case of values settled for drug acquisition, all budget actions were identified on each spreadsheet as code and description, whose name is associated with or suggests the offer of treatment to patients, regardless of the category of resource use (whether direct use or transfer to other federal units, foreign locations or private non-profit institutions).

Coherence among the product defined in the LOAf f Ministério da Saúde. Portaria GM nº 204 de 29 de janeiro de 2007. Regulamenta o fi nanciamento e a transferência dos recursos federais para as ações e os serviços de saúde, na forma de blocos de fi nanciamento, com o respectivo monitoramento e controle. Diário Oficial União. 31 jan 2007[citado 2008 set 2];Seção 1:45. Available from: http://dtr2001.saude.gov.br/sas/PORTARIAS/Port2007/GM/GM-204.htm for each action, the objective of the program to which it belongs, and the indicators proposed for each program was observed to confirm whether budget actions actually funded drug acquisition.

The important and unexpected reduction in the value settled for the budget action of acquisition of HIV/AIDS drugs, between 2006 and 2007, led to the ARV drug acquisition survey, made during these two years, to compare data according to sources. This search was conducted on the Portal de Compras do Governo Federal website,g g Senado Federal. Orçamento da União: Siga Brasil. [cited 2008 set 1 ]Available from: http://www9.senado.gov.br/portal/page/portal/orcamento_senado/SigaBrasil according to the following path: acesso livre> consultas> extratos de contratos> órgão: 36000 - Ministério da Saúde> Uasg: 250005 - Coordenação-Geral de Recursos Logísticos> período> modalidade: 50 - contrato. Each year's contract records were consulted and those related to ARV drug acquisition were copied. These records include data on the contractor, contractual object, value, amount and effective date of contract term. As regards the Exceptional Circumstance Distribution Program drugs, budget action data were compared to those available on the web page of the Departamento de Informática do Sistema Único de Saúdeh h Ministério do Orçamento, Planejamento e Gestão. Lei Orçamentária (LOA). Brasília; 2007[cited 2008 Sep 1]. Available from: http://www.planejamento.gov.br/secretaria.asp?cat=50&sub=215&sec=8 - Datasus (Unified Health System Department of Information Technology), according to the following path: informações de saúde> assistência à saúde> produção ambulatorial> Brasil por região e unidade da federação> tabnet (linha: procedimento após 10/99> coluna: ano de competência> conteúdo: valor aprovado> procedimento após 10/99: seleção apenas dos medicamentos). Data refer to values approved to be transferred to the State Departments of Health as payment for Autorizações de Procedimento de Alta Complexidade (Apac - High Complexity Procedure Authorizations).

All data were input on an electronic spreadsheet and the values obtained were deflated by applying the Índice de Preços ao Consumidor Amploi i Ministério do Planejamento, Orçamento e Gestão. Portal de Compras do Governo Federal: ComprasNet. [cited 2008 Sep 1] Available from: http://www.comprasnet.gov.br (IPCA - Broad Consumer Price Index), thus enabling them to be compared with 2007 values.

RESULTS

Actual growth in drug spending was observed between 2002 and 2007 (Figure 1). Spending in 2007 was 3.2 times higher than in 2002 and participation of drug spending in the Ministry of Health's total spending rose from 5.4% in 2002 to 10.7% in 2007.


Distribution of total spending on drugs in pharmaceutical service programs or actions defined in the federal budget is shown on Table 1. On this Table, spending on drugs for exclusive hospital use is not included, as they are funded with resources from the Autorizações de Internação Hospitalar (AIH - Hospital Admission Authorizations), nor are those aimed at offering antineoplastic chemotherapeutic drugs, funded with resources from the Autorizações de Procedimentos de Alta Complexidade em Oncologia (Apac-Onco - High-Complexity Oncology Procedure Authorizations).

In the period analyzed, spending on primary care drugs increased by 75%, and that on strategic program drugs, by 124%. In the case of STD/AIDS drugs, the increase was about 6%. However, the situation of spending on such drugs was peculiar: an increase of 77% between 2005 and 2006, and a subsequent decrease of 29% between 2006 and 2007.

The most substantial increase in spending was observed with exceptional circumstance distribution drugs. In this case, based on the federal budget, it was not possible to distinguish this from the remaining expenses in 2002. By analyzing the series from 2003 to 2007, the rise in spending was 252%.

The increase in the federal budget value settled for the action that funds acquisition of drugs for people with STD/AIDS was 44% between 2002 and 2007, and 3.7% between 2006 and 2007. To analyze the reduction occurred in these two last years, spending on the STD/AIDS Program treatment per patient was estimated, assuming these drugs were used in the same year they were acquired. The number of patients in treatment was obtained from the Programa Nacional de DST/Aids (National STD/AIDS Program).j j Ministério da Saúde. Departamento de Informática do SUS. [cited 2008 Sep 1] Available from: http://w3.datasus.gov.br/datasus/datasus.php The result of this estimate is shown on Figure 2. Relevant reduction (33%) in the patient's mean spending was observed between 2002 and 2003, reaching a plateau that continued until 2005, when there was an increase of 67% between 2005 and 2006, with a subsequent reduction of about 32% in 2007. During this period, average annual spending on treatment per patient was R$ 4,302.00 (2007 reais or constant reais). In addition, as regards STD/AIDS treatment drugs, data on ARV drug acquisition by contract were collected on the Portal de Compras do Governo Federal website (ComprasNet), between 2006 and 2007. Values collected do not include acquisition of drugs from the agreement category, which is performed when the government acquires drugs from public pharmaceutical laboratories, for example. In 2006, R$ 745.8 million (2007 reais) were spent, and in 2007, R$ 452.2 million. There was a reduction of 39% in the value spent on ARV acquisition by contract (R$ 293.6 million).


The following drugs were purchased in 2006, rather than 2007, totaling about R$ 317.5 million (2007 reais) in spending, in that year, thus representing 43% of total spending on ARV drugs acquired by contract: amprenavir 150 mg capsule, atazanavir 150 mg capsule, didanosine 400 mg capsule, efavirenz 200 mg capsule, efavirenz 600 mg pill, and ritonavir 80 mg/ml oral solution.

On the other hand, in 2007, R$ 30.3 million were spent on the following drugs that had not been acquired in 2006 (about 7% of annual total spending on ARV drug acquisition by contract): darunavir 300 mg pill, fosamprenavir 700 mg pill and lopinavir/ritonavir 80/20 mg/ml oral solution.

As regards drugs acquired by contract in 2006 and 2007, R$ 428.4 million (2007 reais) and R$ 421.9 million were spent, respectively. Table 2 shows the share of spending on each antiretroviral drug in each year's total spending on this group of drugs.

Moreover, Table 2 shows that the majority of these drugs (79%, or 11 of the 14 ARV drugs) had their prices substantially reduced between 2006 and 2007. There was also reduction in the amount acquired for 50% of them.

In terms of exceptional circumstance distribution drugs, for which a significant increase in budget spending was found between 2003 and 2007 (252%), comparison with the values approved by the Ministry of Health for procedures paid to the State Departments of Health revealed differences between the two sources (federal budget and Datasus), as shown on Table 3.

From 2003 to 2005, Datasus values were higher than those settled in the specific budget action that funds acquisition of these drugs, subsequently reversing in 2006 and 2007.

DISCUSSION

There is a relationship between federal budget actions and specific pharmaceutical service programs, aimed at guaranteeing the population's successful access to drugs, enabling the estimation of spending on drugs for specific programs. Traditional pharmaceutical service programs are present in each component of the Pharmaceutical Service Funds. Budget actions were developed based on these programs.

The Ministry of Health's significant increase (222%) in total spending on drugs, between 2002 and 2007, corroborates the increase in drug spending worldwide, especially in the last decade.1,3 The US government estimated that spending on drugs would rise from US$ 184 billion in 2003 to US$ 519 billion in 2013.5 In the case of Brazil, the growth rate between 2002 and 2006 (annual average of 33.6%) was higher than that between 2006 and 2007 (4.4%). This situation could be explained by the fact that only after the Política Nacional de Medicamentos (National Drug Policy) was published in 1998, were programs aimed to guarantee the population's access to drugs either created or expanded. Thus, subsequent years are certainly characterized by rapid growth in resource allocation for the purpose of supplying demand for drugs. As regards the 4.4% growth between 2006 and 2007, it is necessary to wait for the coming years to observe whether this slowing down of growth will continue or not.

The share of spending on drugs in the Ministry of Health's total spending shows the importance that this expense component has assumed throughout the years analyzed. The small reduction observed in 2006 and 2007 is justified by the fact that total resources allocated by the Ministry of Health increased more than the growth in drug spending in 2007, when compared to the previous year.

Even though the share in total spending has decreased, increase in drug spending is a world trend and some factors have already been pointed out to explain this pattern.1

Table 1 shows that the major contribution to the increase in total spending on drugs in the period analyzed resulted from exceptional circumstance distribution drugs (an increase of 252% between 2003 and 2007). In addition, data confirm the discrepancy between resources allocated for primary health care drugs and those allocated for medium- and high-complexity health care drugs. In 2007, for example, R$ 319.9 million were allocated in transfers for states and cities to acquire primary care drugs and R$ 2,7 billion in STD/AIDS drugs and those of exceptional circumstance distribution. Even if the Ministry of Health's strategic program drugs (tuberculosis, leprosy, and human insulin) were included in the amount for primary care, the ratio between spending on STD/AIDS and exceptional circumstance distribution drugs and spending on pharmaceutical services in strategic and primary care would be 2.6 reais to 1 real.

However, the scope of these programs needs to be considered. STD/AIDS and exceptional circumstance distribution drugs serve specific groups of patients (those with HIV/AIDS and those with chronic and usually rare diseases), while pharmaceutical service drugs in strategic and primary care are aimed at more important diseases from an epidemiological point of view and, consequently, the population as a whole. Major differences between drugs used in these two subgroups of programs make it difficult to compare and make conclusions about a possible emphasis on medium- and high-complexity care, to the detriment of primary care. One of them is that an important portion of STD/AIDS and exceptional circumstance distribution drugs are protected by patents, thus causing the cost of these products to be higher.

Studies on factors in the recent trend in ARV drug cost in Brazil showed that those which had been patented (11 of the 18 drugs included in the treatment consensus in 2007, for example) contributed to 60% to 70% of the total cost with ARV drugs between 2001 and 2003, and 80% between 2004 and 2005.6

In the present study, values settled for the budget action of ARV drug acquisition showed a reduction in spending between 2002 and 2005, with a subsequent increase of 77% between 2005 and 2006. Nunn et al6 found that the annual cost per patient decreased between 2001 and 2003, whereas it more than doubled in 2005. For the present study, this spending decreased between 2002 and 2005, and only in 2006 was there an increase of 67% (Figure 2). The divergence between these two studies could be explained by the year of curve inflexion, resulting from different data sources. The authors6 previously mentioned used data on ARV drug spending from the Programa Nacional de DST/Aids (National STD/AIDS Program) until 2005 (which could have some inaccuracy), while the present study used data from the federal budget, which agree with data on ARV drug spending, updated on the Program's web page.k k Instituto de Pesquisas Econômicas Aplicadas. Índice de Preços ao Consumidor Amplo. [cited 2008 Sep 1] Available from: http://www.ipeadata.gov.br/ipeaweb.dll/ipeadata?SessionID=1785468061&Tick=1243899309968&VAR_FUNCAO=Ser_MUso%28%29&Mod=M.

Even though it was not possible to identify all the Ministry of Health's ARV drug acquisitions, their greater amount in terms of resources (performed by contract with private companies) was dealt with. Acquisitions made by public pharmaceutical laboratories, producers of generic ARV drugs, were not included, because consultation of the Ministry of Health's agreement database has not been available for open access until now.

Based on this analysis, as there was greater reduction (39%) in the total value of contracts to purchase ARV drugs than in the total value settled for budget actions (29%), between 2006 and 2007, drugs acquired by contract began to contribute less to the program's total spending in 2007.

Reduction observed in the value allocated in these acquisitions could be almost completely explained by performing stock control in 2006, as only one (didanosine 400mg) of the ARV drugs, which had not been purchased in 2007, is manufactured domestically.k k Instituto de Pesquisas Econômicas Aplicadas. Índice de Preços ao Consumidor Amplo. [cited 2008 Sep 1] Available from: http://www.ipeadata.gov.br/ipeaweb.dll/ipeadata?SessionID=1785468061&Tick=1243899309968&VAR_FUNCAO=Ser_MUso%28%29&Mod=M. The remaining drugs are protected by patents, even though efavirenz, which became subject to compulsory licensing in May 2007, is one of them, thus enabling acquisition of this generic drug internationally.l l Ministério da Saúde. Programa Nacional de DST/Aids. MONITORaids. Gasto com aquisição de medicamentos ARV. [cited 2008 Sep 2]. Available from: http://sistemas.aids.gov.br/monitoraids2/docs/n%20pacientes%20em%20TARV.pdf. In addition, there was no change in therapeutic consensus in this year and, as a result, none of these drugs stopped being/ began to be less used.

Reduction in prices of ARV drugs acquired both in 2006 and 2007 was observed, according to Table 2, even though such reduction was not enough to justify the magnitude of global reduction in spending. If the following are considered - difference in spending on ARV drugs between 2006 and 2007 of R$ 293.6 million (2007 reais); value of drugs purchased in 2006, rather than in 2007, of R$ 317.5 million; and spending on drugs, which had not been purchased in 2006, of R$ 30.3 million in 2007 - then, the difference between "spending not performed" (317.5 million) in 2007 and "added spending" (30.3 million) in the same year equaled R$ 287.2 million and, consequently, only R$ 6.4 million of the R$ 293.6 million difference observed can be attributed to changes in prices and amounts of ARV drugs acquired in two years. Thus, performing stock control in 2006 for use in 2007 is an important factor to explain this situation.

As regards exceptional circumstance distribution drugs, the fact that budget values settled between 2003 and 2005 were lower than the values in procedures approved reveals that resources from other budget actions, especially those for drug acquisition, were used to perform payments to State Departments of Health, which was fully achieved in 2002, when there was no specific budget action to fund the program (Table 3). In 2006 and 2007, this relationship reversed and this can be justified by the acquisition of the following drugs by the Ministry of Health, in a centralized manner: imiglucerase 200 UI, epoetin alfa 2,000 and 4,000 UI, human immune-globulin 5 g, interferon alfa-2b 3,000,000, 5,000,000 and 10,000,000 UI.m m Ministério da Saúde. Programa Nacional de DST/Aids. Monitoraids. Número de pacientes em terapia ARV. Brasil, 1999 a 2007. [cited 2008 Sep 1] Available from: http://sistemas.aids.gov.br/monitoraids2/docs/n%20pacientes%20em%20TARV.pdf In this way, it is possible to observe that these four pharmaceuticals were responsible for 28% of the program's total spending.

Differences observed on Table 3, especially between 2003 and 2005, despite their not compromising the general spending analysis, show the limitation of working with budget data. There is always the possibility that resources from other actions, in addition to the main program funding source, may have been used. However, this situation does not invalidate the data and analysis presented, once this is the best way to approach the Ministry of Health's drug spending, based on open access data sources.

The present study does not intend to defend indiscriminate restriction on drug spending. Even though there are no data on the number of people with drug access, values allocated indicate an important increase in the last years, which is relevant for primary care, as long as the resources are adequately used. Information on spending is an essential measure for efficient management of pharmaceutical services and SUS resources. Grangeiro et al2 predicted investment in other areas would be compromised, if current rates of ARV drug spending and gross domestic product growth were maintained.

In conclusion, despite the government's having saved about half of the spending on ARV drug acquisition by negotiation,6 its role is as important as those of prescribers and patients. The increase in drug spending may be more associated with the number of drugs prescribed for certain age groups/sex and drug type in different therapeutic classes than with the population's demographic changes.4 This emphasizes the importance of efficient management of pharmaceutical services and, consequently, of information about drug spending as a process component.

REFERENCES

Received: 09/03/2008

Revised: 12/10/2008

Approved: 01/25/2009

  • 1. Kondro W. Drug spending tops $25 billion. CMAJ. 2007;176(13):1816. DOI: 10.1503/cmaj.070680
  • 2. Grangeiro A, Teixeira L, Bastos FI, Teixeira P. Sustentabilidade da política de acesso a medicamentos anti-retrovirais no Brasil. Rev Saude Publica. 2006;40(Supl):60-9. DOI: 10.1590/S0034-89102006000800009
  • 3. Macdonald S. Increased drug spending is creating funding crisis, report says. BMJ. 2003;326(7391):677. DOI: 10.1136/bmj.326.7391.677
  • 4. Morgan SG. Implications of expenditures on care. Prescription drug expenditures and population demographics. Health Serv Res. 2006;41(2):411-28.
  • 5. Moynihan R. Drug spending in North America rose by 11% in 2003. BMJ. 2004;328(7442):727. DOI: 10.1136/bmj.328.7442.727
  • 6. Nunn AS, Fonseca EM, Bastos FI, Gruskin S, Salomon JA. Evolution of antiretroviral drug costs in Brazil in the context of free and universal access to AIDS treatment. PLoS Med. 2007;4(11):e305. DOI: 10.1371/journal.pmed.0040305
  • d
    d Ministério a Saúe. Meicamentos e ispensação excepcional. Brasília; 2006[cite 2009 Jun 1]. Available from: http://portal.saude.gov.br/portal/arquivos/pdf/texto_excepcionais.pdf. little is known about the evolution of spending among the different programs that comprise total spending.
  • Correspondence:
    Fabiola Sulpino Vieira
    Ministério da Saúde
    Esplanada dos Ministérios Bloco G
    Anexo A Sala 229 A
    70058-900 Brasília, DF, Brasil
    E-mail:
  • a
    Secretaria de Políticas de Saúde. Política Nacional de Medicamentos.
    Rev Saude Publica. 2000;34(2):206-9. DOI: 10.1590/S0034-89102000000200018
  • b
    Ministério da Saúde. Programa Nacional de DST/Aids. Responsabilidade dos estados pela compra e distribuição de medicamentos. Brasília; [s.d.] [cited 2008 Sep 1] Available from:
  • c
    Brasil. Decreto nº 6.108, de 04 de maio de 2007. Concede licenciamento compulsório, por interesse público, de patentes referentes ao Efavirenz, para fins de uso público não-comercial. Diário Oficial União. 07 jul 2005 [cited 2008 Sep 1]; Seção 1:54.Available from:
  • d
    Ministério a Saúe. Meicamentos e ispensação excepcional. Brasília; 2006[cite 2009 Jun 1]. Available from:
  • e
    Vieira FS, Mendes ACR. Evolução dos gastos com medicamentos: crescimento que preocupa. In: VIII Encontro da Associação Brasileira de Economia da Saúde; 2007; São Paulo, BR. São Paulo: PUC/SP; 2007[cited 2008 Sep 1]. Available from:
  • f
    Ministério da Saúde. Portaria GM nº 204 de 29 de janeiro de 2007. Regulamenta o fi nanciamento e a transferência dos recursos federais para as ações e os serviços de saúde, na forma de blocos de fi nanciamento, com o respectivo monitoramento e controle.
    Diário Oficial União. 31 jan 2007[citado 2008 set 2];Seção 1:45. Available from:
  • g
    Senado Federal. Orçamento da União: Siga Brasil. [cited 2008 set 1 ]Available from:
  • h
    Ministério do Orçamento, Planejamento e Gestão. Lei Orçamentária (LOA). Brasília; 2007[cited 2008 Sep 1]. Available from:
  • i
    Ministério do Planejamento, Orçamento e Gestão. Portal de Compras do Governo Federal: ComprasNet. [cited 2008 Sep 1] Available from:
  • j
    Ministério da Saúde. Departamento de Informática do SUS. [cited 2008 Sep 1] Available from:
  • k
    Instituto de Pesquisas Econômicas Aplicadas. Índice de Preços ao Consumidor Amplo. [cited 2008 Sep 1] Available from:
  • l
    Ministério da Saúde. Programa Nacional de DST/Aids. MONITORaids. Gasto com aquisição de medicamentos ARV. [cited 2008 Sep 2]. Available from:
  • m
    Ministério da Saúde. Programa Nacional de DST/Aids. Monitoraids. Número de pacientes em terapia ARV. Brasil, 1999 a 2007. [cited 2008 Sep 1] Available from:
  • Publication Dates

    • Publication in this collection
      19 June 2009
    • Date of issue
      Aug 2009

    History

    • Accepted
      25 Jan 2009
    • Received
      03 Sept 2008
    • Reviewed
      10 Dec 2008
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