Rethinking Health Innovation from
the South
WORKSHOP South Africa/ Cape town
December 13 – 15 /2010
Partnership for the productive development (PDP).
The social responsibility of the State in order to ensure the
public health requires:
• strong government intervention in medicine availability policy throughout all
the chain for producing medicines, such as:
•
Producing the chemical Intermediaries, APIs and finished formulations.
This premise and necessity have driven the
Brazilian Government to insert the field of Health
in the Growth Acceleration Program (PAC).
All the Chain for producing medicines
• Laboratory fase
2. Industrial pilot
Gram/ 1 kg product
15/ 20 kg product
All steps should be conducted with GMP and GLP.
Industrial Production
ICT
Technological Unit
Or Manufactures
Objectives of this program:
• Reducing the vulnerability of the social Brazilian
policy on health:
To achieve this objective is important to strengthen the
Industrial and Innovation Complex in Health, associating and
aligning the productive capacity with the pillars of the National
Policy of Health defined in the scope of the SUS (Unified Health
System).
• Increasing the competitiveness of public and
private laboratories in the context of the Industrial
Complex of Health.
To accomplish this objective it is necessary to give to public and
private laboratories conditions by which they are capable for
facing the competition with products available on the
international market.
These conditions may be summarized as follows:
(1) strengthening their capacity in reverse engineering and innovation of
Drugs and Medicines
(2) promoting a robust process of substitution of imported products used
in health prophylaxis and treatment;
(3) giving priority to the substitution of products which involve major
density in knowledge and are essential to meet the health needs of
the Brazilian population
To fulfill these objectives, several governmental decrees
were launched, for example:
• Jointly-Ministries decree No. 128/08
• Ministry of Health decree No. 3031/08
• Presidential Decree No. 5.813/06
• Ministry of Health decree nº 978/08 -This degree was reviewed on May 2010
Agreement for the Development of Medicines
Production.
Partnerships between public laboratories and private producers of
medicines and drugs were implemented in order to achieve the goals of
the Productive Development Policy (PDP) and the following objectives:
•Strengthening public health laboratories and expanding its role in the
market regulation;
•Encouraging local production of high cost and / or major health and
social impacting APIs or medicines;
•Supporting the development of the productive capacity of the national
pharmochemical industry;
•Implementing a representative industry of phytochemicals by taking
advantage of the great Brazilian genetic patrimony.
Current Status
The partnerships had clear rules and are monitored by MoH.
Role of each actor in the process.
•Ministry of Health: Establishes agreements with Public Laboratories ,
for five years, with price reduction of 5% per year, ensuring market to the
manufacturer in this period.
•Public Laboratory:
1) Hire private pharmaceutical company for developing the
pharmaceutical formulation. It should be produced by the public laboratory
within two years.
2) Establishes agreements with a chemical-pharmaceutical laboratory
aiming the local production of the APIs.
•Private Chemical-Pharmaceutical Laboratory
Establishes, if necessary, an agreement with an international producer for
manufacturing APIs.
Local production of API should be in routine after two years.
Monitoring and Evaluating the developing and
manufacturing process.
To accomplish this policy, the Brazilian Government
created a task force comprising:
• External consultants having expertise in the required field.
• Public expert employees from the MoH
• Public expert employees from NDRA (National Drug Regulatory
Agency)
All projects are quarterly evaluated by the group on the ongoing
progress of each Partnership in the Development and Production
Process.
Outcomes:
In 2009-2010, twenty partnership for developing and
producing priority medicines were established. These twenty
partnerships involve 25 products, 9 public laboratories, 17
private industries (10 national laboratories and 7 international
laboratories).
Annual expense with those medicines are around R$ 1,200
billion of Reais, it is equivalent to USD 600 million of dollars
with potential saves of R$ 250 million of Reais, it is equivalent
to USD 125 million of dollars.
Priority projects ongoing:
Product
Public Lab
Taliglucerase
alfa 200UI
Private Lab
Private
pharmochemica
l Lab
Disease
Biomanguinho Pfizer/Proalix
s
Pfizer
Gaucher
Betainterferona
1a
Biomanguinhos
Aché
Ache
multiple
sclerosis
Formoterol+
Budesonida
Farmanguinhos
ChemoLiconsa( Spain)
Nortec
Asthma
Sirolimus
Farmanguinhos
Libbs
Libbs
Imuno
supressor
Tacrolimus
Farmanguinho Libbs
s
Libbs
imunosupress
or
RIPE
Farmanguinhos
????
tuberculostatic
Lupin
Priority projects ongoing:
Product
Public Lab
Private Lab
Private
pharmochemica
l Lab
Disease
Donezepil
Furp/Funed
Cristália
Cristália
Alzheimer
Entecavir
Funed
Microbiologica
Microbiologica
Hepatite B
DIU
Furp
Ingelflex
------
Dispositivo
intrauterino
Octreotida
IVB
Hygea
Hygea
Inhibitor of
growth
hormone
Rivastigmina
IVB
Laborvida
Norte
Alzheimer
Micofenolato de
Mofetil
Lafepe
Roche
Nortec
Rejection in
transplant
Priority projects ongoing:
Product
Public Lab
Private Lab
Private
pharmochemica
l Lab
Disease
Raloxifeno
Public
Laboratory
Blanver
Nortec
osteoporosis
Ziprasidone
Public
Laboratory
Laborvida
NPA/Hetero
schizophrenia
Projects in the NRDA for Register:
Product
Public Lab
Private Lab
Private
pharmochemi
cal Lab
Disease
Quetiapine
Lafepe
Cristália
Cristalia
antipsychotics
Olanzanpine
Lafepe
Cristália
Cristália
antipsychotics
Olanzanpine
Lafepe
Cristália
Cristália
antipsychotics
Tenofovir
Funed
/Lafepe
Balnver/Crist
ália
Cristália
antiretroviral
Projects in negotiation between the partners
Product
Public Lab
Private Lab
Private
pharmoche
micaLab
Disease
Atazanavir
Lafepe and
Farmanguinhos
BMS
Nortec and
Cristalia
Antiretroviral
Raltegravir
Lafepe and
Farmanguinhos
Merck
Nortec and
Cristália
Antiretroviral
Acknowledgment :
Fernanda Macedo email: macedo.rf@gmail.com
Thank you
Eloan Pinheiro email: eloan@infolink.com.br