The international harmonization of pharmaceutical standards is promoted both at the normative and institutional level. Guidelines, principles, recommendations and texts of similar legal nature are adopted by technical expert bodies to avoid repetitive tests, reduce risks for human and animal health and cut expenditures for private and public stakeholders. Legitimate reasons, including biological, scientific and climatological factors, may also run against harmonization. There is no international treaty laying down mandatory requirements in this area, but the World Trade Organization Agreement on Technical Barriers to Trade plays a decisive role to determine whether national regulations conform with international standards. From the institutional point of view, international initiatives to ensure medicines’ quality had historically been promoted by World Health Organization expert bodies. However, the International Council for Harmonization may have replaced the World Health Organization. The quality of the standards adopted by this public-private partnership is beyond doubt, but ethics, competition and openness-related concerns have been raised. More broadly, the efficiency and dynamism of the International Council for Harmonization invites to reflect about global health governance adjusted to the twenty-first century challenges and opportunities.
This chapter analyses the advantages and challenges of having technical judges in patent litigation. The inclusion of technical judges is intended to enhance quality in patent adjudication and raises institutional and systemic questions. Technical judges of the Unified Patent Court will have equal legal standing to legal judges and will be involved in the adjudication process from beginning to end. Therefore, in addition to developing an excellent knowledge of the rules of procedure, they must acquire a sound understanding of fair trial principles and the interface between patent law and the broader legal order.
Bilateral, regional, plurilateral and multilateral treaties regulating intellectual property create their own dispute settlement mechanisms. They devote, however, little attention to the fact that similar institutions may have been set up under other treaties dealing with the same subject matter. The lack of regulation of jurisdictional interaction and doubts concerning the relationship between international enforcement-related bodies characterize contemporaneous international intellectual property law. The proliferation of preferential trade agreements regulating intellectual property increases the chances of jurisdictional overlaps and inconsistent jurisprudence. This chapter introduces jurisdictional pluralism and associated risks, presents the most commonly found principles on forum selection, as well as consecutive and parallel litigation, and makes recommendations to preserve coherence within international intellectual property law. Notably, it proposes two standard clauses to be introduced in the dispute settlement chapters of new and existing trade agreements, both clauses recognizing the precedence of the World Trade Organization dispute settlement system.
Xavier Seuba and Elena Dan
Two key policy documents depict and organise the activities of the European Union aimed at ensuring the enforcement of intellectual property rights in third countries: the 2004 and 2014 so-called strategies for the enforcement of intellectual property rights in third countries. This chapter introduces the content of both documents and assesses the main changes produced between 2004 and 2014. It holds that the changes introduced in the 2014 Strategy represent a good assessment of the past decade and the interests at stake, particularly those of a social nature. However, the European Union activity does not seem to be fully coherent with what is announced in the 2014 Strategy. This finding mainly results from the analysis of the preferential trade agreements concluded by the European Union between 2014 and 2017, but also from the economic estimates, methodologies and background described in the 2014 Strategy.