BRAZIL
North
7.60% North-East
28.12%
Center-West
6.85%
South-East 45.62%
• Brazilian Population:
195,000 million
• GDP: 2.09 U$ trillion
• 7th largest economy in the world
• Per Capita
income:
11,769 U$
South 14.8%
BRAZILIAN PUBLIC HEALTH
Unified Health System (SUS)
Universal Access
Free of direct charges
Open to all the Brazilian population
Covers near 70% of Brazilian population
BRAZILIAN CONSTITUTION - 1988
ARTICLE 199 - § 4º
“(...) It is forbidden to sell blood, blood components and plasma
derivatives”
Blood donation is non-remunerated, altruistic and anonymous
30% remaining covered by private health assurances
OPTIONS IF THE ANSWER IS NOT TO FRACTIONATE
• IMPORT 100% OF THE COUNTRY NEEDS
• TOLL FRACTIONATION CONTRACT
• COMBINATION OF THESE TWO OPTIONS
OPTION 1: IMPORTATION ONLY
• Utilization of safe and proved medicines
• Avoid the risks of building and operate a fractionation plant
• Shortages: the worldwide demand can surpass the production
• Affordability : prices can get higher and difficult to afford
• Changes on the worldwide market: Consumption in countries with large populations can increase leading to a disequilibrium between supply and demand
ADVANTAGES RISKS
TOLL FRACTIONATION
• Proved system
• Allows the use of recovered plasma
• Complements and ensures the country supply
• Lower prices, compared to imports
• Free capacity of existing plants
• Contracts not easy to manage
ADVANTAGES RISKS
TO FRACTIONATE
• Technology incorporation
• Improve the country blood system
• Fast pay back
• Avoid plasma wastage
• Lowest cost
• High investment required
• Failure on the tech transfer
• Plasma availability
• Lack of specialized engineering teams
ADVANTAGES
RISKS
BRAZILIAN DECISION
• Toll fractionation
+
• Building a local plant - HEMOBRAS
+
• Import the remaining amount needed to
satisfy country’s demand
HEMOBRAS
• State-owned company, created for fractionating plasma and for producing plasma derivatives
• Started in 2006
• Not-for-profit organization
• Plant capacity: 500,000 liters of plasma/year
HEMOBRAS
• October 2007: LFB selected for transfer
of technology
• Concept and basic design started in
January 2008
• Albumin
• Factor VIII
• Factor IX
• IVIg
• Prothrombin Complex
• von Willebrand factor
HEMOBRÁS – PLASMA DERIVATIVES TO BE PRODUCED
TOLL FRACTIONATION IN BRAZIL: PART II
• 2007: New tender for select one company for toll
fractionation
• LFB wins the tender
• April 2010: Hemobras assumes the contract
• Toll fractionation activities coupled to the tech transfer
activities