Wednesday 5 March 2014

Afro Leo

Why Africa needs to develop its drug manufacturing capability

This is the abstract in the latest WHO bulletin of Olasupo Ayodeji Owoeye's piece calling for Africa to urgently develop local drug manufacturing capability. Do you agree?

"Africa has the highest disease burden in the world and continues to depend on pharmaceutical imports to meet public health needs. As Asian manufacturers of generic medicines begin to operate under a more protectionist intellectual property regime, their ability to manufacture medicines at prices that are affordable to poorer countries is becoming more circumscribed. The Doha Declaration on the TRIPS Agreement and Public Health gives member states of the World Trade Organization (WTO) the right to adopt legislation permitting the use of patented material without authorization by the patent holder, a provision known as “compulsory licensing”. For African countries to take full advantage of compulsory licensing they must develop substantial local manufacturing capacity. Because building manufacturing capacity in each African country is daunting and almost illusory, an African free trade area should be developed to serve as a platform not only for the free movement of goods made pursuant to compulsory licences, but also for an economic or financial collaboration towards the development of strong pharmaceutical manufacturing capacity in the continent. Most countries in Africa are in the United Nations list of least developed countries, and this allows them, under WTO law, to refuse to grant patents for pharmaceuticals until 2021. Thus, there is a compelling need for African countries to collaborate to build strong pharmaceutical manufacturing capacity in the continent now, while the current flexibilities in international intellectual property law offer considerable benefits."

You can read the full article here. Comments welcome.

Afro Leo

Afro Leo

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6 March 2014 at 16:59 delete


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

Wilbert Bannenberg
Wilbert Bannenberg, pharmaceutical systems consultant, SARPAM
Coordinator “Trade, TRIPS and access to medicines” project
**24 March 2014 in Johannesburg; 25-26 March in Maseru; 27-28 March in Maputo**; South Africa mobile +27 72 4762697; Netherlands mob +31-6-20873123
Skype/Blackberry: wilbertb1; SARPAM Joburg office tel +27-11-8806993;