title: What strategies to boost production of affordable fixed-dose anti-retroviral drug combinations for children in the developing world?
abstract: BACKGROUND
  No more than 8% of HIV positive children needing treatment in low- and middle-income countries have access to antiretroviral drugs (ARVs). Children presently account for about 4% of all treated patients, while for equitable access they should make up at least 13%.
  
  
  OBJECTIVE
  This study explores key issues, implications and interaction dynamics to boost production of easy-to-use and affordable fixed-dose combination (FDC) ARVs for children in the developing world. Potentials for equitable solutions are examined including priority steps and actions, appropriate treatment options and reliable forecasting methods for paediatric ARVs, as well as combination incentives to generic companies against market unattractiveness and enforced intellectual property (IP) rights. Moreover, implementation strategies to enhance the development and production of affordable ARV paediatric formulations and appropriate supply systems to ensure availability are investigated.
  
  
  RESULTS
  The current market for FDC paediatric ARVs is already substantial and will only grow with improved and scaled up diagnosis and monitoring of children. This provides an argument for immediate increase of production and development of FDC ARVs for children. These formulations must be low cost and included in the list of Essential Medicines to avoid children continuing to lag behind in access to treatment. Access-oriented, long-term drug policy strategies with the ability to pass muster of governments, the UN system, as well as generic and research-based enterprises are needed to let children gain expanded and sustained access to FDC ARVs. Under the requirements listed above, IP-bound Voluntary License (VL) flexibilities do appear, if coupled with substantial combination incentives to generic firms, as a fitting tool into the needs. Policies must consider enhancing human resource capacity in the area of caregivers and social and health workers aiming to spread correct information and awareness on effectiveness and rationale of FDC ARVs for children. Policies should urge that paediatric ARV treatment programmes entwine with extant interventions on prevention of mother-to-child transmission, as well as with HIV treatment initiatives focused on mothers and household members. Policies, again, should consider centralising functions and pooling resources to help overcome drug supply barriers. WHO's brokering role in VL-based agreements between wealthy and developing country industries, as well as its technical guidance in setting international standards should not be waived while looking for sustained access to optimised ARV treatments for children. Strategies discussed in this paper, while taking unavoidability of marketing and profit rules into account, look closely into the trade and drug policy directions of China and India according to frontier crossing implications of their IP management trends as well as their multi-faceted penetration strategies of both the wealthy and under-served markets the world over.
authors.affiliation: Infectious Disease Division, Pistoia Hospital, Pistoia, Italy. d.dionisio@usl3.toscana.it
authors.forename: Daniele
authors.initials: D
authors.lastname: Dionisio
authors.forename: Robert
authors.initials: R
authors.lastname: Gass
authors.forename: Peter
authors.initials: P
authors.lastname: McDermott
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Racalbuto
authors.forename: Marina
authors.initials: M
authors.lastname: Madeo
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Braghieri
authors.forename: Siobhan
authors.initials: S
authors.lastname: Crowley
authors.forename: Eloan Dos Santos
authors.initials: Edos S
authors.lastname: Pinheiro
authors.forename: Peter
authors.initials: P
authors.lastname: Graaff
authors.forename: Ashwin
authors.initials: A
authors.lastname: Vasan
authors.forename: Achara
authors.initials: A
authors.lastname: Eksaengsri
authors.forename: Helene
authors.initials: H
authors.lastname: Moller
authors.forename: Arun Kumar
authors.initials: AK
authors.lastname: Khanna
authors.forename: Krisana
authors.initials: K
authors.lastname: Kraisintu
authors.forename: Sandeep
authors.initials: S
authors.lastname: Juneja
authors.forename: Stavros
authors.initials: S
authors.lastname: Nicolaou
authors.forename: Aloka
authors.initials: A
authors.lastname: Sengupta
authors.forename: Francesco
authors.initials: F
authors.lastname: Esperti
authors.forename: Daniela
authors.initials: D
authors.lastname: Messeri
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy* / Q000191:economics; D044966:Anti-Retroviral Agents / Q000191:economics / Q000600:supply & distribution* / Q000627:therapeutic use; D002626:Chemistry, Pharmaceutical / Q000191:economics*; D002648:Child; D002669:Child Welfare; D002675:Child, Preschool; D003906:Developing Countries; D004338:Drug Combinations; D016527:Drug Costs; D004345:Drug Industry; D016568:Drugs, Generic; D005002:Ethiopia; D006297:Health Services Accessibility; D006801:Humans; D018973:Intellectual Property; D040541:Marketing; D011480:Protease Inhibitors / Q000191:economics / Q000600:supply & distribution*; D011640:Public Policy; D018894:Reverse Transcriptase Inhibitors / Q000191:economics / Q000600:supply & distribution*; D014454:Uganda
chemical_list: D044966:Anti-Retroviral Agents; D004338:Drug Combinations; D016568:Drugs, Generic; D011480:Protease Inhibitors; D018894:Reverse Transcriptase Inhibitors