Talk given by Dr G de Oliveira, ANVISA representative, at the 10th International Conference of Drug Regulatory Authorities (ICDRA) in HK, China, June 2002

1. BRAZILIAN PROGRAM OF SELF-
SUFFICIENCY IN BLOOD PRODUCTS
Dr. Granville Garcia de Oliveira
Manager
New Drugs, Research and Clinical Trials
ANVISA - Brazilian National Agency of
Sanitary Surveillance
Office of Blood, other Tissues and OrgansOffice of Blood, other Tissues and Organs
Plasma Fractionation AbroadPlasma Fractionation Abroad

2. FEDERAL CONSTITUTION
Article 199. Health care is open to private initiative
§ 4.º The law shall set down the conditions and requirements to enable the
removal of organs, tissues and human substances for the purposes of
transplants, research and treatment, as well as collection, processing and
transfusion of blood and blood products, of which any type of
commercialization is hereby prohibited.

3.  Article 8. The National Policy of Blood, Components and Blood Products shall
be aimed at ensuring the self-sufficiency of the Country in this sector and at
harmonizing public actions at all government levels, and shall be implemented,
within the scope of the Unified Health System, by the National System of Blood,
Components and Blood Products - SINASAN, made up of:
Law10.205 of 21/03/2001
“Lei Betinho”

4. NATIONAL PROGRAM OF BLOOD PRODUCTS
2000
 National Factories ~ 8.5% of albumin consumed in the
country;
 Temporary fractionating of surplus plasma from
therapeutic use.

5. NEED FOR BLOOD PRODUCTS
X
POPULATION
Recommended - WHO
Estimated consumption in
Brazil - 170 th. inh.
Consumption in Brazil
2000
IG ALB IG ALB IG ALB
20
kg/th/inh/year
100
kg/th/inh/year
3.400
kg/year
17.000
kg/year
550
kg/year
10.000
kg/year

6. ESTIMATED PLASMA SURPLUS/YEAR
PUBLIC SECTOR
COLLECTIONS 100% 1.827.000 TOTAL BAGS
Processing rate 100% 1.827.937 Plasma bags
91.397
General losses - 5%
1.736.540
Plasma bags
169.660
Serologic waste - 9,77
1.566.880
Plasma bags
313.376
Plasma transfusion - 20%
1.253.504
Plasma bags
1 bag ~ 200 ml of plasma
1.253.504 bags ~ 250.000 liters plasma/year.

7. EXPECTED PRODUCTION OF BLOOD PRODUCTS IN BRAZIL
AVERAGE OUTPUT Per liter 200.000 Liters
EXPECTED STATUS IN
RELATION TO
CURRENT
CONSUMPTION
ALBUMIN 24 g 4.800.000 g 1/2 domestic consumption
IMMUNOGLOBULIN 3 g 600.000 g Self-sufficiency
Factor VIII 150 IU 30.000.000 IU 1/5 domestic consumption
Factor IX 250 IU 50.000.000 IU Self-sufficiency
* May reach 400.000L/year with improvement of plasma quality and the
National Program of Voluntary Blood Donation

8. Tool used to collect data:
Questionnaire on Plasma production sent to
Hemotherapy Services by GGSTO/ANVISA -
July/2000
Questionnaires sent : 486
Questionnaires answered: 232 = 47,73%
METHODOLOGY USED FOR SELECTION OF PLASMA TO BE
FRACTIONATED

9. All the plasma:
1- Was selected from Hemotherapy Services, whose information
provided in the questionnaire matched the sanitary inspection reports
issued by the National Program of Inspection of Hemotherapy Units-
PNIUH;
2- Was tested individually, with non-reagent result, for all the serologic
markers required in legislation;
3- Allows tracing of the units;
CLASSIFICATION OF PLASMA ACCORDING TO QUALITY OF
PROCESS:
METHODOLOGY USED FOR SELECTION OF PLASMA TO BE
FRACTIONATED

10. 4- Comes from Hemotherapy Services that carry out internal quality
control in the serology laboratory;
5 - Was frozen for up to 8 hours, after blood collection;
6 - Is stored at -30ºC to -18ºC;
7- Is stored in equipment with temperature stability and control, in
compliance with technical standards.
METHODOLOGY USED FOR SELECTION OF PLASMA TO BE
FRACTIONATED
CLASSIFICATION OF PLASMA ACCORDING TO QUALITY OF
PROCESS:

11. For production of factors, Services with monthly
volume of available plasma of over 100 liters/month
were selected
For production of albumin in the National Centers,
Services with monthly volume of available plasma of up
to 100 liters/month were selected
Initially, Hemotherapy Services with a minimum of 10
collections/day were selected
73
Hemotherapy
Services
70
Unidades
38
Hemoth. Serv.
35
Hemoth. Serv.
13.417 L/month
1.980 L/month
15.397 L/month
METHODOLOGY USED FOR SELECTION OF PLASMA TO BE
FRACTIONATED

12. MONTHLY VOLUME OF AVAILABLE PLASMA PER REGION
North Region
1.218 Northeast Region
2.499
Center-West
2.175
Southeast
Region
6.817
South
Region
708 13.417 Liters/Month
161.004 Liters/Year

13. NUMBER OF HEMOTHERAPY SERVICES SELECTED FOR THE BID
PER FEDERATE UNIT
Number Hemoth. Services
TOTAL: 34 Hemotherapy Services

14. 1 - Minimum size of plasma batches:
5.000 liters of plasma (approximately 25
thousand bags);
2 - Per State;
3 - Regionalization:
North, Northeast, Center-West, Southeast
and South Regions;
PROPOSALS TO FORM PLASMA BATCHES FORPROPOSALS TO FORM PLASMA BATCHES FOR
FRACTIONATION ABROADFRACTIONATION ABROAD

15. 1) Public consultation and hearings;
2) Publication of Announcement – December
2000;
3) Technique x price;
4) Two stages – qualification and proposals.
INTERNATIONAL INVITATION TO BIDINTERNATIONAL INVITATION TO BID
20002000

16. 5) Small batches X Number of participating
companies;
6) Companies with products with and without
registration in Brazil;
7) Plasma in batches =>5.000 L;
8) Certification of plasma collection services.
INTERNATIONAL INVITATION TO BIDINTERNATIONAL INVITATION TO BID
20002000

17. 1) 2 were qualified;
2) Proposals: prices > x difficulty
3) Only 2 companies;
output < x time and
temperature of the plasma
RESULTRESULT
20012001

18. 1) Explanations;
2) New proposals;
3) Final decision = improvement of quality of blood
transfusions and plasma for future factories;
4) Approval of the result of the invitation to bid;
5) Signing of the contract with the companies in
December 2001.
NEGOTIATIONNEGOTIATION
20012001

19. 2002
CONTRACT SCHEDULE
1) Monthly withdrawal of plasma by the
companies delivering the services provided for
in the contract;
2) Final products expected to begin returning to
Brazil in:
 June/2002.