Public production in Brazil. Presented by Jorge Bermudez, UN High Level Panel on Access to Medicines.

1. Public production in
Brazil
Jorge Bermudez, Fiocruz Brazil
Member of the UNSG HLP on access to medicines
ITPC, Global Summit on IP and access to medicines
Marrakesh, Morocco, 15-17 January 2018

2. Report of the UNSG HLP released on 14
September 2016
• Health technology innovation and access
• Intellectual property laws and access to health
technologies
• New incentives for health technology R&D
• Governance, accountability and transparency
2

3. Some premises for local production
• Local or regional production?
• Political decision and background
• Identifying and enhancing South-South cooperation
• A solid regulatory framework
• Cathegories competence: APIs, chemical synthesis, biotechnology;
verticalization?
3

4. Industrial policy is a top priority on the
public health agenda in Brazil
Public
Health Policy
Industrial
Policy
Health
Industrial
Policy
4

5. Prior national summarized framework
In 1988 Brazil approved the National Constitution – “Health is a right of all and a State duty”
In 1996
- Law 9.313, 13 November 1996 - Guarantees free access to antiretroviral therapy. National
industries currently manufacture ARVs and Brazil is in a strong position to negotiate prices with
patent holders.
In 1999
- Law 9.782, 26 January 1999 - Creates the National Regulatory Agency ANVISA, which decides
the sanitary surveillance policies and regulation.
- Law 9.787, 10 Februrary 1999 - Alters Law nº 6.360, of 23 September 1976, concerning sanitary
surveillance, establishes the generic medicines policy, decides upon the use of generic names in
pharmaceutical products, among other procedures.
- Generic Medicines– The introduction of generic medicines on the brazilian market changes all
the pharmaceutical market share and the pharmaceutical industries approaches.
In 2003 PITCE (Politica Industrial, Tecnologica e de Comercio Exterior) gave rise to industrial
policy on Health

6. Oswaldo Cruz Foundation
1900 – 2018 (what we do)
Research
Education
Innovation and Production
Reference Services
Information and Communication
Planning and Management
History of Science and Health
STAFF: >12,000 / 1000 PhD
BUDGET: > USD 1 billion yearly
RESEARCH: >1,500 projects
PUBLICATIONS: > 1,000 papers per year
TEACHING: >5 thousand students
PRODUCTION:
>130 million doses /vaccines
> 5 million diagnostic kits
> 4 billion medicines

7. PRESENT SITES
Rio de Janeiro
Belo Horizonte
Recife
Salvador
Manaus
Curitiba
Brasília
PLANNED SITES
Campo Grande
Fortaleza
Teresina
Porto Velho
IO CP residência
F ar-Manguinhos
IP E C
C O C
INC QS
E NS P
E P S J V
IC IC T
C E C AL
B io-Manguinhos
RJ
IF F
IP E C
C O C
INC QS
IP E C
C O C
B io-Manguinhos
INC QS
IP E C
C O C
F ar-Manguinhos B io-Manguinhos
INC QS
IP E C
C O C
C E C AL
F ar-Manguinhos B io-Manguinhos
INC QS
IP E C
C O CIC IC T
C E C AL
F ar-Manguinhos B io-Manguinhos
INC QS
IP E C
C O C
E P S J V
IC IC T
C E C AL
F ar-Manguinhos B io-Manguinhos
INC QS
IP E C
C O C
E NS P
E P S J V
IC IC T
C E C AL
F ar-Manguinhos B io-Manguinhos
INC QS
IP E C
C O C
P residência
E NS P
E P S J V
IC IC T
C E C AL
F ar-Manguinhos B io-Manguinhos
INC QS
IP E C
C O C
IO CP residência
E NS P
E P S J V
IC IC T
C E C AL
F ar-Manguinhos B io-Manguinhos
INC QS
IP E C
C O C
IF F
IO CP residência
E nsp
E P S J V
Icict
C ecal
F armanguinhos B iomanguinhos
INC QS
Ipec
C oc
Fiocruz in Brazil
(where we are)

8. South-South Cooperation in health
technology production
Brazil (FIOCRUZ) and Mozambique (SMM)
• Production of antiretroviral and other medicines
• ARV: 226 million pharmaceutical units/year
• Multiproduct: 145 million pharmaceutical units/year
8

9. South-South Cooperation in health technology
production: Unlocking the BRICS proposal on
universal access to TB treatment
IV MEETING OF THE MINISTERS OF HEALTH OF THE BRICS
JOINT COMMUNIQUÉ
The BRICS Health Ministers met in Brasilia on December 5, 2014, at the Fourth Meeting of Ministers of Health of the BRICS.
2. (…).
3. Considering the impact of tuberculosis in the BRICS countries and in many developing countries, the Ministers approved the development of a
cooperation plan, that includes a common approach to:
- universal access to first line anti-tuberculosis medicines for all patients with TB in BRICS countries, as well as in low- and middle- income
countries;
- scientific research and innovations on diagnostics, treatment including drug resistance and service delivery of TB;
- sharing technologies, identifying manufacturing capacities and means of financing;
- to aspire towards a 90-90-90 TB target (90% of vulnerable groups screened, 90% diagnosed and started on treatment with 90% treatment
success);
-and other issues of common interest.
In this context, the Ministers approved the setting up of a working group to develop the operational framework of the aforementioned plan, in
the first half of 2015.
9

10. “The New Face of Innovation” at Fiocruz
IOC, CPqs, PDTIS, Labs
Referência CDTS
Biomanguinhos, Farmanguinhos,
Industry (private or public)CIPBR
Interfaces: collaboration and partnerships

11. Local Production must be framed by
11
• Solid regulatory framework
• Political support
• Governance and sustainability assurance
• Public Health policy on access
• Quality and price, demand and supply chain
• API and final produts architecture
• Overcome barriers (IP, regulatory)

12. Looking backwards and forward
12
• Generic competition in general
• Generic competition with ARVs (lessons learned)
• Challenges for 2nd and 3rd line ARVs
• Medicines for children
• Missing gaps
• New unaffordable products (Hepatitis C, Biotechnology
products, Oncology)

13. Health technology innovation and access:
accelerating the move from neglected
diseases to neglected populations

14. • Neglected diseases – those that primarily affect
populations with little purchasing power, and therefore
offer an insufficient incentive for industry to invest in R&D.
• From neglected diseases to neglected populations,
ensuring that the global R&D system meets the needs of
all, especially of the poorest and most vulnerable
populations.
• These needs are not restricted to neglected diseases, but
must include diseases with global incidence such as
diabetes and cancer; medicines for resource-limited
settings.

15. Bermudez, 2007 Organización
Panamericana de la
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