Expanding Global Therapeutic Arsenal through African Indigenous Medical Knowledge

抄録

African Indigenous Medical Knowledge (AIMK) refers to indigenous medical knowledge held by African Traditional Health Practitioners (ATHPs) regarding plants, animals, minerals which can be used to treat and manage diseases, serve as prophylactics as well as improve the quality of life. Virtually all the indices for quality of life are worse in Africa compared to other regions. On the other hand, Africa and the Indian Ocean islands are endowed with rich biodiversity. Infact some of the biodiversity is found only in Africa and the Indian Ocean Islands. Furthermore, ATHPs have valuable recipes which can be scientifically evaluated for safety and efficacy, standardised for quaity and subjected to randomised control clinical trials. Medical products which satisfy the safety and efficacy requirements based on both pre-clinical and clinical data can then be developed into new therapeutic agents that can significantly impact positively on public health. However there are prevailing barriers which limit the progression of AIMK to commercially viable therapeutic products. Examples include low partnership between biomedical scientists and ATHPs, poor research infrastructure, lack of financial resources, insufficient manufacturing capacity, ignorance on intellectual property rights, lack of political will to embrace and implement technical tools by the World Health Organization. Furthermore, there is lack of fair, equitable and benefit sharing arrangements between the biomedical scientists and ATHPs. There is also the need for more champions who can lead in the journey from AIMK to therapeutic products. This paper will highlight a case study regarding how the barriers were overcome in the research and development of Niprisan for the clinical management of sickle cell disorder based on AIMK. Based on the AIMK of a Nigerian THP, the National Institute for Pharmaceutical Research and Development, Abuja, Nigeria developed Niprisan. The milestones achieved include regulatory approval of Niprisan and its registration by the national drug regulatory agency, securing USA-based commercial partner for commercial manufacturing and global marketing. Furthermore, Niprisan was subjected to double-blind, placebo controlled randomized clinical trials. In addition , Niprisan was granted orphan drug status by both USA FDA and the European Medicine Evaluation Agency. Niprisan was also granted USA patent.

　

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