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Collins C Ajibo and Ndubisi A Nwafor

The emergence of market and data exclusivity standards for new pharmaceuticals and biologics in such mega trade agreements as the TPPA, CETA and perhaps the TTIPA, will destabilize the inherent flexibilities relied upon for the maintenance of public health. The TPPA is particularly notable for provisions on data exclusivity for biologics, with the CETA subtly incorporating the same, effectively delaying the early entry of follow-on biosimilars despite the difficulties involved in recreation. Although exclusivity is required in recognition of the tremendous efforts involved in originating data as well as the value of the data, a trade-off is necessitated, especially for the poorer countries such as the Sub-Saharan African (SSA) countries. Consequently, the SSA countries’ efforts to safeguard future public health imperatives may have to be guided by the following. Firstly, market and data exclusivity provisions in future agreement should be consistent with and not distortive of public health flexibilities. Secondly, there should be monitoring, data collection, and impact assessment of market and data exclusivity provisions on access to medicines before a conclusion of future agreements. Thirdly, an investor-state dispute settlement (ISDS) provision should not be emasculative of public health imperatives. Fourthly, focus should be centred on capacity building that fosters skill reservoirs necessary for the development of pharmaceutical manufacturing capacities.