Aids 2008
Drug Pricing Policies and Challenges
Lessons from Brazil
August 7, 2008
Mexico City
Mariangela Simao
National STD/Aids Program
Ministry of Health - Brazil
Cities with at least one aids case.
Brazil, 1990 – 2007
85% of all municipalities
1990-1995
1996-2000
2001-2007
Prevalence (15-49 yrs 2006): 0,61% - 610,000
New cases/year - 32,000
In Brazil
Free and universal access policy - 1996 –
centralized procurement – MoH (only buyer)
- budget 2008 = US$ 640 million
December 2008 - 190.000 people on ART
National guidelines – National Health System
ARV distributed in Brazil - 2008
IP
ITRN e ITRNt
RITONAVIR (1996)*
ZIDOVUDINE (1993)*
SAQUINAVIR (1996)*
ESTAVUDINE (1997)*
INDINAVIR (1997)*
DIDANOSINE (1998)*
NELFINAVIR (1998)**
LAMIVUDINE (1999)*
AMPRENAVIR (2001)
ABACAVIR (2001)
LOPINAVIR/r (2002)
TENOFOVIR (2003)
ATAZANAVIR (2004)
DIDANOSINE EC (2005)
FOSAMPRENAVIR (2007)
DARUNAVIR (2008)
ITRNN
FUSION INHHIBITORS
NEVIRAPINE (2001)*
EFAVIRENZ (1999) ENFUVIRTIDE (2005)
*national production – not protected by patents
**excluded in 2007
“As close as possible” to universal access
94,8% ART “coverage” – universal access
Average costs*
1st line (AZT – 3TC – D4T – DDI – TDF – EFZ – NVP) –
US$ 667 ppy
2nd line (LPV/r – SQV – IDV – ATV – FOS – RTV)
- US$ 2,114 ppy – 25% of all patients
* Excluded costs DRV and T20
Sustainability of free and universal access
is related to fair prices.
What is a fair price?
Most common price determinants
Intellectual property rights – theoretically based on
innovation
What is the real cost of innovation? How much costs the process itself
and how much is used for marketing the new ARV?
How long does it take to pay the costs involved directly in innovation?
“a black box”
IP promotes innovation
Ends up in monopolies – no competition
Hampers access to cheaper generic ARV
Prevalence and level of income alone
or combined are poor criteria for LAC
A fair criteria could go beyond:
an equal cost per patient for all developing countries,
with small differences according to GNP/capita
consider the level of use of that drug in the country
and the treatment coverage
costs incurred by the Governments from their own
budgets, not from grants or donations – sustainability
and commitment
The case of the compulsory licensing of
Efavirenz in Brazil
Compulsory licensing 2007 - Efavirenz
Most used imported ARV – 75,000 patients
Long negotiation process – price stable since
2003 - US$ 1,59/tb
– Thailand – 1,2% prevalence
• 17,000 patients – US$ 0,67/tb
– Dominican Republic – 1.1% prevalence
• 1,500 patients - US$ 0,67/tb
Compulsory licensing - Efavirenz
Annual cost - from US$ 580.00 to US$166.36 ppy
– US$ 0.46 (including royalties and air freight)
Estimated “savings” until 2012 - US$ 237 millions
In 2007 – from US$ 42 millions to US$ 12 millions
National production by 2009
Proportion - Expenditure with ARV, 2006
Proportion - Expenditure with ARV, 2007
*
*2007 – dados preliminares
Other challenges for price negotiation 2009
ATV 150mg + 200mg = US$ 54,7 millions = 22% budget imported ARV
34,000 patients
ATV 200mg – US$ 2.28
Other challenges for price negotiation 2009
TDF = US$ 42 millions = 14,7% budget imported ARV
The case of tenofovir – 2008
1st line ARV – rapid increase - 33,000 patients - agreement
Patent deposited in Brazil in1995 - not granted yet – MoH
declared it of public interest in April 2008
– Brazil – US$ 3.25/tb = US$ 1,186/yr
– Thailand – US$ 1,24/tb = US$ 454/yr
– Gilead Access price - US$ 0,567/tb = US$ 207/yr
CIPLA – not prequalified yet – US$ 0,43/tb = US$ 157/yr
Challenges for all of us
• Expand access to fair prices – review of
present criteria
• Use of the flexibilities provided by the
declaration of the Doha on TRIPS and Public
Health – support from partners and WHO
• WHA 2008 – Global Strategy on Innovation,
Public Health and Intellectual Property – put it
into practice...