Marseille 2007
Marseille 2007
Abstract book
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Abstract #437  -  Overcoming TRIPS Constraints on Generic ARV Manufacturing: New policies adopted by the Brazilian Public Laboratories
Session:
  19.8: Universal Access to care (Parallel) on Monday @ 14.00-16.00 in HC Chaired by Shirin Heidari, Jean-Paul Moatti
Authors:
  Presenting Author:   Ms Cristina d Almeida - Universit Paris 13 Nord, France, Metropolitan
 
  Additional Authors:  Dr Benjamin Coriat, Dr Fabienne Orsi,  
Aim:
The Project consists of a study case held in the official pharmaceutical laboratory of the Brazilian Ministry of Health Farmanguinhos. The Study will focus the new policy developed by the Laboratory, as to overcome the multiple constraints to the local manufacturing of generic versions of ARV. This new policy is based on 2 complementary directions : (i) the implementation of new legal mechanisms, allowing the local procurement for active principles; and (ii) the strengthening of technological cooperation partnerships between Farmanguinhos and local entities that perform pharmaceutical research, development and production.
 
Method / Issue:
Through the compilation of bibliographic references and onsite interviews, the article will be structured in 2 axes. The first axe regards the legal hindrances posed by the national public procurement regulation and the possible mechanisms to promote the competitivity of the local manufacturers at tender processes. The new policy is based on a new model of service contract on pharmaceutical manufacturing, founded on service and product differentiation, therefore, introducing a technical component to the local procurement procedure, which, otherwise was simply based upon the best price offer. Moreover, being a matter of service contracting, Farmanguinhos might no longer be limited to the tender proceedings, therefore possessing more room for manuvre in identifying its API suppliers. The second axe relates to the cooperation partnerships being presently established by Farmanguinhos, alongside the private pharmochemical manufacturers, public universities and research institutions. By conjugating the research and technological development capacities locally available, these partnerships might provide the development, manufacturing and innovation of fixed-dose combinations and ARV formulations.
 
Results / Comments:
The article will describe the new momentum presently faced by the Brazilian public laboratories, as well as the new strategies addressed to the overcoming of TRIPS constraints, especially those imposed after 2005. In such, it will expose the sucessful experiences and the obstacles derived from such strategies and its potential social impacts in the access to treatment scale-up. Finally it is expected that the experiences asserted therein might contribute to improve the Aids response of other southern countries, both from price and efficacy standpoints.
 
Discussion:
The compliance of developing countries to the TRIPS Agreement has considerably limited the entrance of new generic drugs in the market, therefore posing a potential challenge to the sustainability of the access to HIV/AIDS treatment, especially in the southern countries. Such limitations are soundly reflected in Brazil, wherein the successful experiences in the 90s concerning the local manufacturing of generic ARVs are now challenged by the constraints that are now in place, especially, concerning the local manufacturing of active pharmaceutical ingredients (APIs). According to the World Trade Organization (WTO) regulation, only by means of international tenders can these ingredients be procured. In such conditions, the Indian and Chinese companies became almost exclusive suppliers of APIs to the Brazilian STD/AIDS Program, to the detriment of the national companies. Moreover, this situation might result in drastic consequences for the sustainability of the local AIDS response, since both countries are bound to the TRIPS limitations imposed since 2005, which might considerably restrain their exportations of APIs. In this context, a new wave is about to be developed amongst certain southern countries that possess pharmaceutical manufacturing capacity.
 
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