Lingering Challenges of EU Border Measures: Focusing on Generic Drugs in Transit and Legal Issues to Be Reviewed

Abstract

A demand for IP protection and enforcement has been consistent even after the introduction of the TRIPS Agreement, which laid down minimum requirements of IP protection, due to continuous technological advancement and the corresponding growth of counterfeit products. Among them, border measures have been conducted mostly by developed countries as one of the most effective means of IP enforcement to protect the interests of right holders against potential IPR infringement. This type of enforcement has emerged as a hot issue especially in some cases relating to the unjustifiable seizure of goods by EU Member States while in transit. This was most problematic in a case where Dutch customs authorities seized and suspended the release of generic drugs in transit en route from India to South America. Much research has been conducted on the illegitimacy of the seizure along with serious complaints made by India and Brazil questioning the compatibility of EU Regulation, on which the customs action was based, with international treaties. Many of the arguments are valid, but some controversial issues need to be reframed and reinterpreted in order to correctly point out the problems in the issues, and reflect them for amendment of the relevant legislation and future consideration. The issues that require reinterpretation are 1) the interpretation of Article 51 and 52 of the TRIPS Agreement, 2) the understanding of legitimate trade in Article 41 of the TRIPS Agreement, and 3) the role of the Doha Declaration in the seizure case. Together with amendment of the Regulation, for the confronted problem, a few changes to the current system, such as reforming the verification system of trades in generic medicine and changing the work distribution of the customs office, may also be required. Furthermore, developing countries also need to be prepared for future conflict over seizure problems.