Before they can receive marketing approval, the safety and efficacy of pharmaceutical products must be established. Generating test data to demonstrate this is extremely expensive; consequently, developers of ‘generic’ versions of pharmaceuticals are generally not required replicate these trials and instead may receive marketing approval based on previously submitted test data. However, in many jurisdictions intellectual property rights in submitted test data (often referred to as ‘test data exclusivity rights’) prevent subsequent applicants from gaining approval in this manner for a time-limited period.
During the negotiations which led to the foundation of the WTO, proposals were made for a requirement to provide test data exclusivity in what would become the TRIPS Agreement. These were ultimately rejected; instead, TRIPS Article 39.3 requires that submitted test data be protected against unfair commercial use. This term is not defined, and the meaning of Article 39.3 remains highly contested. Despite this, test data exclusivity has become highly globalised in the post-TRIPS period, and is now a feature of the legal systems of most significant pharmaceutical markets
This thesis seeks to analyse the origins, globalisation and impact of test data exclusivity. Specifically, it examines how test data exclusivity has become so globalised despite its rejection from TRIPS, how test data exclusivity has developed across different jurisdictions, and what some of the practical impacts of test data exclusivity have been. This thesis concludes that Article 39.3 has played an important role in the globalisation of test data exclusivity, that test data exclusivity rights are surprisingly similar across jurisdictions (a similarity which the ambiguity of Article 39.3 may, paradoxically, have contributed to) and that it is likely that these textually similar regulations produce different impacts across jurisdictions due to differing local contexts. Test data exclusivity rights may therefore be poorly adapted to the needs of many jurisdictions.
