Essential Medicines and the Complexity of Implementing Nationally Based Compulsory Licensing: On the Need for a Regional System of Compulsory Licensing in Sub-Saharan Africa

摘要

The global enforcement of pharmaceutical patents under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement makes essential medicines very expensive for least developed countries (LDCs), limiting supply for the majority of patients in sub-Saharan Africa (SSA). Nevertheless, essential medicines are a component of the human right to health, according to art. 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). The experience of developing countries outside SSA shows that the successful exploitation of the TRIPS flexibilities, in particular compulsory licensing, constitutes a potential means of obtaining affordable medicines. The aim of this article is to examine the feasibility of a regional system for compulsory licensing in order to manufacture and distribute essential medicines in SSA. The hypothesis of this article is that compulsory licensing by SSA countries will not provide a suitable means of procuring essential medicines in view of their individual economic and political constraints. This hypothesis is premised on the inability of LDCs in SSA to obtain compulsory licences for the procurement of affordable medicines and to distribute them according to need. While the article identifies legal, institutional and, particularly, political pressures as major obstacles to the implementation of the WTO Paragraph 6 Programme, it proposes a regional system for compulsory licensing that is arguably compliant with TRIPS, in order to overcome the complexity in compulsory licensing. Consistent with the hypothesis, the article recommends a regional arrangement for a pharmaceutical compounding programme as a pooled manufacturing scheme to distribute essential medicines within SSA.