The proposed bill requires that conventional medical practitioners should adhere to the regulations set by the Kenya Medical Research Institute (KEMRI) failure to which a fine not exceeding 3million will be issued or a three-year imprisonment according to the bill.
The bill, which was presented to the national assembly by Seme MP, James Nyikal, seeks to formalize and regulate indigenous remedies and community-based healing. Moreover, the bill also empowers KEMRI to evaluate quality, safety and efficacy of all traditional and alternative medicine across the country. Remedies deemed unsafe, ineffective or unsanitary could be removed from the market while those meeting scientific standards would require certification before public use.
Under the proposed law, practices such as adulterating herbal medicine with pharmaceutical drugs and making unsubstantiated health claims would be criminal ofense. The bill also visualizes a restrictive formation where unapproved healers risk being pushed out of the market if their remedies do not pass formal evaluation.
Significance of the bill.
This moves by the government, aims to create pathways for scientific validation, commercialisation and innovation in the public sector. It is also a step towards modernizing the heath sector and a way to shield the public from unsafe or fraudulent treatments.
The move is in line with global trends where indigenous knowledge is being leveraged systematically for pharmaceutical development as diseases evolve. Firms across the world are exploring wider possibilities in affordable and accessible herbal remedies that could produce less side effects.
The bills downfall.
The proposed framework does not give details on benefit sharing arrangements if community remedies lead to commercially viable drugs. Critics of similar policies elsewhere in Africa have warned of biopiracy, where state or private actors profit from traditional knowledge without returning value to its original custodian.
Ownership of all inventions developed by KEMRI`s employers and associates will be granted to the institution as per the proposed bill, while also mandating creation of national biobanks to collect, store, and manage human tissues, blood and genetic materials. KEMRI would handle patent applications under the industrial property act, retain the right to commercialize resulting innovations and distribute financial benefits according to its internal policies.
The bill was presented following a discord over a homegrown anti venom, between KEMRI and the innovators. Researchers from Machakos alleged in a senate petition that their rights were blocked by a state researcher demanding illegal payments and pursued rival projects after they disclosed the formula for a conventional, non-animal plasma treatment.
This conflict shows that while consolidating research, regulation and intellectual property in a single firm may guarantee coherence, it is highly probable to suppress innovations, demoralize native knowledge sharing and it may fabricate a conflict of interests where the regulator is also the competitor.
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