programas de 2002 a 2007 Ministry of Health ’ s spending on drugs : program trends from 2002 to 2007

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 fi nanciaram a aquisição de medicamentos foram obtidas no sistema Siga Brasil e classifi cadas segundo os programas de assistência farmacêutica. Os valores liquidados foram identifi cados para cada programa. Para 2006 e 2007, foram pesquisadas as aquisições de antiretrovirais. 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 defl acionados aplicando-se o Índice de Preços ao Consumidor Amplo. Foi efetuada análise exploratória dos dados.


INTRODUCTION
In Brazil, the publication of the Política Nacional de Medicamentos (National Drug Policy) in 1998 a 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.a 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. b 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 fi nancial crisis. 3In 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), c little is known about the evolution of spending among the different programs that comprise total spending.Ministerial Decree GM/MS nº 204, from January 29th 2007, c 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 specifi c 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.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.d 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 defi ned 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 identifi ed 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-profi t institutions).
Coherence among the product defi ned in the LOA e for each action, the objective of the program to which it belongs, and the indicators proposed for each program was observed to confi rm whether budget actions actually funded drug acquisition.All data were input on an electronic spreadsheet and the values obtained were defl ated by applying the Índice de Preços ao Consumidor Amplo b (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. 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   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).a The result of this estimate is shown on Figure 2 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.corroborates the increase in drug spending worldwide, especially in the last decade. 1,3The US government estimated that spending on drugs would rise from US$ 184 billion in 2003 to US$ 519 billion in 2013. 5In 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 justifi ed 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. 1ble 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 confi rm 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 specifi c 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 diffi cult 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 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 effi cient management of pharmaceutical services and SUS resources.Grangeiro et al 2 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. 4This emphasizes the importance of effi cient management of pharmaceutical services and, consequently, of information about drug spending as a process component.

Figure 1 .
Figure 1.Percentage of value settled for acquisition of drugs of the National Health Fund.Brazil, 2002-2007.

Figure 2 .
Figure 2. alue with HIV/AIDS drug acquisition settled by the federal government per patient.Brazil, 2002-2007.
. 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).

Table 1 .
Values settled by the National Health Fund, in 2007 R$ (reais), to acquire drugs using the federal budget.Brazil, 2002-2007.

Table 2 .
Participation of spending on antiretroviral drugs in 2006 and 2007 in total spending on antiretroviral drugs acquired by contract and variation in cost and amount acquired.Brazil, 2006 and 2007.
Source: Portal de Compras do Governo Federal website -http://www.comprasnet.gov.br/ a It refers to total spending on antiretroviral drugs acquired by contract.It does not include agreements made with institutions such as public laboratories.

Table 3 .
Resources executed with the Exceptional Circumstance Distribution Drug Program, according to data on outpatient service production of the Unifi ed Health System and federal budget.Brazil, 2002 to 2007.
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.aInaddition,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.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 Table3, 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.