scholarly journals A Case Study of the Registration of Essential Medicines in the East African Community

Author(s):  
Alexander Karl Green ◽  
Petra Brhlikova ◽  
Moses Ocan ◽  
Allyson Pollock

Abstract Objective: To quantify the essential medicine status of registered medicines in the East African Community (EAC) for antimicrobial medicines and medicines for non-communicable diseases.Methods: The National Drug Registers (NDRs) of Kenya, Tanzania, and Uganda (February 2018) were compared with their respective national Essential Medicine Lists (EMLs) to determine the registration status of essential medicines as an indicator of their availability. The number of registered products was analysed for essential medicines and selected non-essential medicines. Findings: Many essential medicines in the EAC are not registered: Kenya 28% (175/632), Tanzania 50% (400/797), Uganda 40% (266/663). Approximately, only one-third of products on the NDRs are essential medicines: Kenya (29%), Tanzania (36%), and Uganda (42%). 23% to 42% of registered essential medicines only have 1 or 2 products. 42 medicines accounted for over 4100 medical products, half of which were non-essential products. Conclusions: This novel analysis provides insight into how registration of medicines is likely to a be a major barrier to accessing essential medicines. The under registration of essential medicines and the over registration of non-essential medicines demonstrates a mismatch between the market of medicines being produced and registered and the health needs of the East African Community. Joint regional medicine authorisation programs such as the EAC Medicines Registration Harmonization Project have potential to improve access to key medicines if essential medicines are prioritised.

2017 ◽  
Vol 17 (1) ◽  
pp. 145-168 ◽  
Author(s):  
OLUFEMI SOYEJU ◽  
JOSHUA WABWIRE

AbstractOver the years, many developing countries have attempted to make policies utilizing the WTO–TRIPS flexibilities to address the public health needs of their populations. A common strategic trend in these policies has been the tendency to attempt to increase access to medicines through price reduction, achieved by weakening patent protection. This paper, using the policy that has recently been adopted by the East African Community (EAC) member states as a case study, demonstrates the inappropriateness of this strategy. The core argument is that weakening patent protection will hinder further research and invention, which are necessary to ensure the availability of medicines. For developing countries, especially those in Africa, such as the EAC member states, the problem is aggravated by the fact that pharmaceuticals, due to commercial considerations, have already ignored investing in developing medicines for diseases predominant in these countries, hence the need to strengthen rather than weaken, patent protection.


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