The traditional model for drug development has almost exclusively relied on the enterprise and resources of the commercially driven pharmaceutical industry. The return on investment (ROI) for drugs that consume very large development costs result in product development being skewed towards more lucrative markets. ROI also necessitates the zealous protection of intellectual property making it difficult to manufacture generic versions even for countries where the IP owner may either not have a commercial interest or is unwilling to supply at a price is affordable. Attention in recent years has therefore been directed to new models or mechanisms of addressing the needs of impoverished populations. They address issues of access that span several stages of product development and/or availability – starting from the inventive concept through to the various stages of product development and finally addressing products that are already on the market.
This project pursues three distinct lines of enquiry. First it addresses how strategic management, specifically IP, of early stage inventions in academia can be utilised in a manner commensurate with successful delivery of a product to impoverished populations when that product ultimately reaches the market. This is achievable through what is often referred to as “socially responsible licensing” (SRL). This is largely dependant on the successive and overlapping stages of a) advocacy and awareness raising amongst academic policymakers that access needs can be met through responsible policy b) implementation of policy that has social imperatives in addition to other imperatives such as development of local industry and the need for licensing revenue c) the interaction of various stakeholders including scientists and TTOs to define clearly the humanitarian objectives before issuing a licence d) developing best practices in SRL and e) using these best practices in a manner that preserves the incentives for industry to develop the product without unduly hampering future availability. We will develop and build upon existing models so that a comprehensive SRL framework emerges that can be readily relied upon by both policymakers and practitioners. We will also create a focus group amongst an association of licensing and technology practitioners and will make use of existing society memberships to do so. This will help interaction with a diverse group of professionals such as licensing practitioners and legal experts, the parallel objective being further gathering of opinion and informed suggestions on policy and practice of SRL. In addition wide networking with individuals, institutions and other associations concerned with SRL will help in our development goals.
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