Perspectives on haemophilia access in Brazil?

Abstract

Dear Editor, Although the Brazilian Unified National Health System (SUS) provided relevant advances in public health and universal coverage, the national health care market remains expensive and with a large relative weight of private health expenditure.1 The SUS, which is part of the 1988 National Constitution, acknowledges that health is a fundamental right of the citizen, which must be guaranteed by the State through a set of governmental policies and actions, including community participation (social control). It should be noted that this constitutionally universal and free health system is sustained by a low per capita public investment on health, as well as a low proportional federal expenditure on health (3.4%-6.3% in the last decade), considering the total governmental expenditure, even when compared to some other Latin American countries.1 The purchase of haemophilia clotting factor concentrates (CFCs) is a responsibility of the federal component of the public health sector, and hence any perturbations in this sector’s capacity to fund CFCs will have significant effects on the Brazilian haemophilia community’s access to care. This access has reflected a process of continuous improvement as reviewed over the past years,2, 3 culminating in new contract arrangements which more than doubled the FVIII usage per capita between 2011 and 2012, and extended use of prophylaxis2; recent developments, however, may reflect a more troubled feature. We note that since its considerable increase in 2012, FVIII usage per capita has stabilized and possibly is stagnating (Table 1). This is troubling as the stated commitment to continued prophylaxis should result in demand increasing to levels modelled to approach 7 IU per capita9 and probably higher as therapeutic practice aspires to higher trough levels than the current 1% specified in the 2004 model. Hence, the supply of FVIII in Brazil needs to continue its upward progression, and the introduction of a budget by the Brazilian government which freezes all social spending for 20 years from 2016 poses a severe threat to all health care programmes, possibly including continued progress in haemophilia.10 Concurrently, Brazil’s abandonment of its impressive tender system of acquisition of recombinant FVIII, which assured low prices for concentrate11 in exchange for a monopolistic arrangement with a supplier of this product,12 has developed problems. The austerity imposed by the economic problems has decreased the Brazilian Federal Government’s capacity to continue purchases from the supplier to the levels initially contracted, leading to the threat of litigation.13 The initial agreement included the transfer of the supplier’s recombinant technology to Hemobras, the Brazilian governmental manufacturing facility in charge of the production of haemoderivatives. The original objective of Hemobras was to ensure Brazil’s strategic independence from overseas importation of blood products.14 The progression of this worthy project has been dogged with problems, with little results being visible, after years of investments on building the plant from scratch. In this context, the Brazilian federal government’s recent proposal of a new consortium comprising of partners from another private company and Brazilian public institutions raises more doubts about the future of this project, while it is not clear if the recent outlays announced by the Minister of Health15 are meant to offset the debt to the original provider. Moreover, the consortium raises doubt of the value of investing in a governmental company with similar objectives, instead of putting Hemobras into full operation. What is certain is that Hemobras labelling and packaging of the imported recombinant FVIII, approved by the Brazilian regulatory authority ANVISA does not represent any advancement in this project. While reiterating our anxiety at the uncertainty that these events impose on the continued progress of haemophilia care in Brazil, we point out that imported recombinant FVIII is purchased by some other countries, like Australia, at lower prices due to competitive tendering.16 We suggest that the capacity to leverage advantageous process for the much larger Brazilian market should be further explored by the authorities, in lieu of perusing a policy dogged by controversy. Moreover, it should be considered the reintroduction of the original competitive tender system, if haemophilia care in Brazil is to continue to go forward and prepare for the current age which will, hopefully, lead to a cure. The authors stated that they had no interests which might be perceived as posing a conflict or bias. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.