Afro Leo is pleased to publish this response to the post "Why Africa needs to develop its drug manufacturing capabilities?" and request from Wilbert Bannenberg.
Dear AFRO-IP readers
Excellent article, indeed!
We have to differentiate the local/regional production of the existing and “old” ARVs and other essential medicines that can also be made very competitively by Indian companies, and the production of “new” generics of products patented after 1 January 2005, which India can no longer easily make and export as generics.
For the pre-2005 patented medicines, generics are easily and affordably available from Indian sources and have no IP barriers thanks to the South African court case of 2001. Unfortunately many African companies have tried to produce the same ARVs for their own markets, and are competing with each other and the lower priced Indian exporters. This has resulted in production mainly for the domestic market, sometimes at prices higher than Indian companies can offer. Development partners are therefore not very eager to support national production in isolation.
For the post-2005 patented medicines, India will not easily make generics for export to Africa. They have the technology to make generics, but are restricted by TRIPS to do so, unless the Government issues compulsory licenses (which recently were issued for a few cancer drugs. Maybe 49% of their production can be exported under TRIPS CL rules to Africa?)
For the LDCs in Africa this poses a unique opportunity to develop the “new” generics in good quality GMP plants in their countries. Uganda, Tanzania, Mozambique have such potential. But these companies/countries will need support from the other countries and institutions in their region. At the regional level they will also need to plan the financing, tech transfer, development and market shaping for these new generics. And the raw materials will also need to be procured (maybe as not patented half-fabricates from India?). If Africa can make a plan, then TRIPS art31.bis allows economic blocks with a majority of LDCs to be treated as one territory. Luckily SADC, EAC and COMESA all have a majority of LDCs, and can thus make regional production plans for the new generics.
Our SARPAM project is currently supporting SADC member states with maximizing the flexibilities in their national IP/patent laws. We have covered so far Botswana, Malawi, Zambia and Zimbabwe. We are ready to support 4 more SADC member states in 2014. We are planning a regional meeting of SADC member states in September 2014 to discuss this issue of regional production of “new” generics. We are open to collaborate with interested AFRO-IP readers on this.
With kind regards
You can follow William Bannenberg on the Twitter handle @essentialdrugs
Friday, 7 March 2014
More on African drug maufacturing capabilities - SARPAM request for collaboration