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On Indian/Brazilian interactions for the production and availability of generic ARVs (1997 - )

On Indian/Brazilian interactions for the production and availability of generic ARVs (1997 - ). Maurice Cassier, CNRS, Marilena Correa, IMS Rio, 4-5 april 2011. MARKET FOR PRODUCTS AND EXCHANGE OF TECHNICAL KNOWLEDGE.

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On Indian/Brazilian interactions for the production and availability of generic ARVs (1997 - )

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  1. On Indian/Brazilian interactions for the production and availability of generic ARVs (1997 - ) Maurice Cassier, CNRS, Marilena Correa, IMS Rio, 4-5 april 2011

  2. MARKET FOR PRODUCTS AND EXCHANGE OF TECHNICAL KNOWLEDGE • The brazilian programme for universal distribution of HIV/aids treatment and the programme for local production of generics ARVs have opened a large market for the active principle of medicines • This products market involved technological exchanges between customers and suppliers in the two countries (technical documentation, procedure to qualify suppliers, visits to industrial sites, etc) • There is thus a space in which technical data and knowledge circulate between Brazil and India • The recent closure of the space for copying medicines in theses two countries has brought Brazilian and indian activists together in legal action against certain patents

  3. Brazilian laboratories’missions to prepare reverse engineering and local production of ARVs • In order to prepare the programme of local production of generic ARVs, the Brazilian federal laboratory Far Manguinhos sent one of its senior chemists to visit the indian laboratories engaged in copying and producing of ARVs ; he produced two technical reports which inform the FM industrial programme • In march 2004, seniors members of the federal laboratory undertook an important mission in India to visit generics laboratories ; they visits several laboratories and collected samples of raw materials that were sent to Brazil through diplomatical channels • The private sector laboratories also sent missions to Indian Laboratories to choose their suppliers ; they participated in symposium with other generics producers

  4. Raw material supplies for R&D work, via diplomatic bag or the market • Circulation of raw material of patented medicines between India and Brazil for the reverse engineering in brazilian laboratories • This circulation justified the legal action taken by Merck in 2004 against the FM Laboratory : Merck accused FM of having put a call for tenders to acquire a patented raw material on the market • Raw material can also circulate via non commercial channels, for the purpose of avoiding legal action

  5. Trading technical knowledge between brazilian government laboratories and indian API suppliers • At FM, the analytical centre tests imported raw material : it identifies the process used to synthesize it, detects the problems of stability and quality of the raw material and send this information back to the indian producers • In the early 2000, brazilian chemists were able to transfer solutions to purify the raw material for Indinavir • Brazilian chemists transferred nabck to their suppliers a large nb of analyses and knowledge on theses molecules : « we become their consultants » (manager of the FM’s analytical centre, 2003) • This circulation of kowledge and expertise between brazilian and indian generics producers serves to improve the available knowledge on theses molecules whoses references were unpublished

  6. Technical cooperation netween brazilian and indian laboratories about Efavirenz in 2009- • Since 2009, brazilian laboratories have undertaken to produce a generic Efavirenz locally ; however, the brazilian laboratories that produce the API have to buy a key intermediate from the indian laboratories • Given the difficulties encountered in the formulation of the final medicine, the FM federal laboratory has engaged in knowledge exchange with the indian supplier • For efavirenz we observe a near integration of knowledge between the public laboratory that produces the final medicine, the brazilian private laboratory that supplies the intermediate

  7. Cooperation in the field of Intellectual Property and opposition procedures • In june 2008, joint opposition filed by the brazilian HIV/association ABIA and by the indian Association SAHARA against Gilead patent on Tenofovir : brazilian patients wanted to ensuire that that brazilian laboratories agains Tenofovir would be able to import indian raw material : this joint legal action illustrates the convergence of patients and indian and brazilian generics producers to defend a public space for medicines • Seminaire organized in november 2008 by FarManguinhos, ABIA and indian NGO tu put forward praticla guidelines for opposing medicine patents

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