It seems that with the publication of a World Health Organisation-International Centre for Trade and Development report in December 2011 [1], the long debate on the value of lower income countries manufacturing pharmaceuticals is converging on a conclusion: that local production is a key strategy if sustainable, predictable and equitable access to medicines is to be achieved.
The African Union [2] (AU) Assembly reached this conclusion in Abuja in 2005, when they mandated the African Union Commission to institute the Pharmaceutical Manufacturing Plan for Africa (PMPA). We at COHRED have from the very beginning been in support of this plan and its approach. We think that local production is not only an important piece of the puzzle for achieving equitable access to medicines, but it also brings a clear dual benefit. To elaborate, by supporting local production, local capacity and expertise is also supported, initially through manufacturing, and ultimately through research and innovation. This is a strategic, sustainable approach to development that directly empowers countries. We have worked hard with the New Partnership for Africa’s Development [3](NEPAD) to support the efforts of African countries in this regard, by developing tools and guidance through the Strengthening Pharmaceutical Innovation in Africa [4] project.
In December 2011, we welcomed the opportunity to continue active engagement in this area, when we were invited by the AU to join with African Ministries of Health, NEPAD, the United Nations Industrial Development Organisation [5] (UNIDO), UNAIDS [6] and others at the 4th meeting of the Technical Committee for the Pharmaceutical Manufacturing Plan for Africa: the technical committee working to operationalize the PMPA. This meeting was a critical forum for discussions on concrete details of the PMPA. Items on the agenda included the establishment of timelines, the development of a business plan, and intensive discussion of central policy issues.
It is well known that in recent years there has been a multiplication of philanthropic and public-private initiatives to address issues of access to medicines. This has been given greater focus by the looming deadline of the Millennium Development Goals [7]. Alongside these, there has perhaps been no single greater development towards addressing medicines access than the rise, and rise of India as the ‘pharmacy of the world’. India’s vast capacity to produce and export cheap, safe and effective generic pharmaceuticals has had a spectacular impact [8] on the price and availability of HIV medication in sub-saharan Africa.
The limiting factor of all of these solutions is sustainability. Many of the philanthropic and Public-Private-Partnerships do not support the health research systems and priorities of the countries in which they operate [9]. They tend to have a narrow focus –particularly on deliverables and disease groups. While the support they offer is clearly welcome, the question must be asked: what happens when the donor money disappears? Similarly, reliance on India is not the solution. It is a massive risk for Sub-saharan Africa to rely so heavily on a single country source of generic pharmaceuticals. Particularly when one considers the not yet fully realized impact of India joining the World Trade Organization [10] in 2005. Many commentators think that this, and growing bilateral pressure from developed countries, will ultimately put the brakes on India’s ability [8] to produce the range of pharmaceuticals needed.
African countries must be the architects of Africa’s solutions. Ten years ago, the Economist declared on its cover that the African continent was hopeless [11]. Last December, in a complete volte face, they called it the hopeful continent [12]. Over the last decade, 6 of the 10 fastest growing economies in the world have been African. There are many examples [13] of what is possible when African infrastructure and innovation is encouraged and supported: Insecticide treated bed nets in Tanzania, a low-cost medical incinerator in Uganda, a low-cost diagnostics for schistosoma, andnew uses of mobile technology [14] to monitor counterfeits in Ghana medicine. African countries are clearly poised for success.
The timing is critical – and the signs are that now is the right time for African countries to consider strategies for the local production of medicines. For example, the least developed (LDC) economies in Africa can capitalise on the fact that the global framework for intellectual property related to pharmaceuticals does not apply to them, and will not until 2016, and probably later than that with appropriate negotiation. Last year’s UNCTAD report [15] not only made this point, but also highlighted that the LDCs are well placed to attract FDI and technology transfer to support infant pharmaceutical industries.
A recommendation to pursue local production comes with clear warnings –highlighted by the TCPMPA, COHRED and by the WHO report. Firstly, one size does not fit all. Local production is not for everyone. Some countries will find greater health impact by focusing on better procurement strategies, and improving supply chains. Countries must, using the tools available to them, conduct a thorough, realistic assessment of their capacity, their capability, and their priorities and decide what the best strategies are. Secondly, African countries must continue to pay rigorous attention to achieving globally recognised standards of medicines quality. The last thing Africa needs is new sources of low quality, unsafe medicines. Finally, close attention must be paid to cost. The medicines produced must be affordable for the population they are manufactured to serve – particularly important in contexts where medicines are usually paid for out of pocket. Great care must be taken to achieving needed efficiencies in production and in scale.
Even with these warnings, the overriding message is opportunity. Local production is another way in which African countries can demonstrate not simply self-sufficiency, but also excellence. The South African Government is clearly following this pathway to success, recently establishing theKetlaphela plant in partnership with Pelchem and Lonza [16]. This will be the first plant to manufacture active pharmaceutical ingredients (APIs) in South Africa.
The COHRED Group stands ready to support countries in this regard, both through technical assistance, and through our continuing collaboration with the TCPMPA.
Best wishes,
Carel.
You can also follow Carel on Twitter via @CarelsNews [17] where he tweets in his personal capacity.
