1. 1 Fábio Gomes May 1, 2009 This work was adapted from my social policy master dissertation entitled: “Threats to equity in organ allocation for transplantation: an analysis of Brazilian legal criteria” (2007), advised by Dr. Debora Diniz, (University of Brasilia, Brazil).

2. 2 The Brazilian Unified Health System (SUS) has a broad, complex and productive public transplantation program, which can benefit from informations that sponsor its improvement. Examples of extensive media coverage on the issue of organ transplantation during 2009.

3.  Topics for evaluation of legal documents: - principles of social justice; - principles of access to health actions and services (including specific criteria for organs); - transplantation program structuring; - mechanisms that have influence on organs availability; - sanctions related to breaches of the Transplantation Law; - jurisdictions for transplantation policy regulation; - transplant information transparency.  Equity debate: - John Rawls´ principles of justice and - Amartya Sen´s multidimensional health equity approach. 3

4. Basic access criteria to organs  Federal Constitution, Health Organic Law (nº 8.080 of 1990) and Transplantation Law (nº 9.434 of 1997): - solidarity principle - solidarity principle - equality principle  Executive regulations (federal decree and ordinances from the Ministry of Health): - compassion principle - compassion principle - efficient distribution principle - efficient distribution principle 4

5. Brazilian regulations on transplantation seek equity, but two significant threats were found:  Omission to regulate weights used to apply allocation criteria for most types of organs (available on computer programs but not in regulations);  Breakage of hierarchy between regulations in the establishment of a new allocation criterion based on clinical severity of disease (by means of an ordinance, not considering a principle established by a decree). 5

6.  Context of scarcity and regional inequalities;  Stagnation in productivity observed after 2004 is being reverted! 6

7. 7 Chart 1. Selected organs transplantation absolute frequency recorded by the Brazilian Transplantation Program from 2001 to 2008

8. 8 Chart 2. Selected organs transplantation absolute frequency recorded by the Brazilian Transplantation Program from 2001 to 2008

9. 9 Table. Performance indicators of the Brazilian Transplantation Program – 2006 and 2008 Source: (*) Ministry of Health – Brazil (2009); (**) Council of Europe (for 2006) and Brazilian Registry of Transplantations – ABTO (for 2008). Legend: p.m.p= per million persons. Performance indicators Situation in 2006 Situation in 2008 Number of transplants (*) 15,132 (50% - cornea) 19,125 Cornea transplantation rate (p.m.p) (*) North Region Southeast Region 52.73 9.79 69.83 67.64 16.64 98.36 S olid organs transplantation rate (p.m.p) (*) North Region Southeast Region 22.774.5330.8924.882.7731.86 Persons in waiting list (*) 69,053 (49% - kidney) 68,906 (50% - kidney) Donation rate (p.m.p.) (**) 5.5 (was 7.3 in 2004) 7.2

10.  Greater attention must be taken to the relationship between the transplantation program, the National Unified Health System (SUS) and the Brazilian Welfare State.  More equitable results depend on: improved program management, strategic planning, greater transparency of information, revisions and eventual corrections of normative omissions.  The program cannot act isolated from SUS. 10

11. Files available (both in English and Portuguese) through the following sources: http://health.med.br Email: fabio.gomes@camara.gov.br 11