Data exclusivity for biologics – an emerging multilateral standard?

Abstract

Biological medicines, or biologics, revolutionised the treatment of some of the most serious medical conditions. These are highly research-intense pharmaceuticals and their development requires enormous expenditure. Countries with strong innovative pharmaceutical industry have been promoting the protection of undisclosed safety and efficacy data relating to biologics by including data protection provisions in regional and bilateral trade agreements. This is a controversial endeavour that not only has been criticised by commentators, but has also led to serious complications in trade negotiations.

Many countries regulate the protection of clinical data relating to biologics, but it has never been subject to multilateral negotiations. Consequently, while data protection provisions are being routinely included in trade agreements, there is no international consensus on the standard.

This thesis analyses the phenomenon of an emergent IP protection standard, namely data protection for biologics, and its relationship to the multilateral framework. It explores various aspects and consequences of the paucity of an accepted multilateral standard. Throughout the analysis, it draws attention to the mismatch between the underlying IP principles and the prevalent methods of implementation.

The thesis proposes a hypothetical multilateral standard by bringing together all theoretical and practical aspects of the analysis, and, finally, demonstrates the utility and practical consequences of the proposed norm.