Abstract
Since 2010, pharmaceutical organisations have begun to provide drug patents in sub-Saharan Africa through the UN Medicine Patent Pool. This initiative allows any pharmaceutical manufacturer to access these patents and manufacture the drugs, thereby aiming to decrease the associated lead times and costs. The participation of numerous manufacturers, some of whom may not have well-established quality control systems in the market, intensifies the need for effective drug quality monitoring. Research indicates that it is often the case that these ‘niche drug provision systems’ face many challenges with the quality of new-generation drugs and the implementation of effective pharmacovigilance (PV)1 systems for the reporting of adverse drug reactions. The lack of resource efficiency in adverse drug reaction reporting within the sub-Saharan context is also a growing concern.
Highlights
In the contemporary landscape it is evident that there has been a significant shift in health care trends around the world that calls for innovative drug manufacturing, distribution, and surveillance monitoring
The challenges that arise in the manufacturing and distribution systems of drugs whose patents are made available through the medicine patent pool (MPP) were discussed in this article
The challenges related to developing countries, and challenges faced within the HIV/AIDS setting, were considered
Summary
Since 2010, pharmaceutical organisations have begun to provide drug patents in sub-Saharan Africa through the UN Medicine Patent Pool. This initiative allows any pharmaceutical manufacturer to access these patents and manufacture the drugs, thereby aiming to decrease the associated lead times and costs. The lack of resource efficiency in adverse drug reaction reporting within the sub-Saharan context is a growing concern. Sedert 2010 het farmaseutiese organisasies deur middel van die UN Medicine Patent Pool medisyne patente vrygestel vir lae- en middelinkomste lande. Hierdie inisiatief laat toe dat enige farmaseutiese vervaardiger die patente kan gebruik om medisyne te vervaardig; sodoende word die koste en vervaardigingstyd verminder. Die gebrek aan menslike hulpbronne vir die monitering van negatiewe reaksies op die medisyne in hierdie lande is ook ’n groeiende probleem
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