The EU’s Biopolitical Governance of Advanced Therapy Medicinal Products

This paper focuses on the specific example of the newly operational Regulation on Advanced Therapy Medicinal Products to explore the potential for biopolitics, an arena in which biocitizens can demand and contest the exercise of EU power over life. The paper shows how the discourses producing, organizing and orchestrating citizen participation in the EU’s governance of advanced therapies from above figure a ‘deficit model’ of citizens in need of education inter alia through their membership of patients’ associations who have membership of the Committee on Advanced Therapies established by the Regulation. Biocitizens are shown to be incorporated to service the EU’s legitimacy needs. The paper then warns against assuming biocitizens’ (self-) reflexivity ensures they do not reiterate and reinforce their construction within the ‘deficit model’ by unwittingly deploying the terms of their subjection. After which the paper highlights some elements that provide a rhetorical and operational opening for participation, and which therefore can be used by biocitizens to reconstruct their engagement with EU governance from below, the wider governance of advanced therapies, as well as in their self-governance.

Intellectual Property and the EU’s Deep Trade Agenda

The EU is considered to be one of the main proponents of what has been called the deep trade agenda—that is, the push for further trade liberalization with an emphasis on the removal of domestic non-tariff regulatory measures affecting trade, as opposed to the traditional focus on the removal of trade barriers at borders. As negotiations on the Doha Development Round have stalled, the EU has attempted to achieve these aims by entering into comprehensive free trade agreements (FTAs) that are not only limited exclusively to tariffs but also extend to non-tariff barriers, including services, intellectual property rights (IPRs), competition, and investment. These FTAs place great emphasis on regulatory convergence as a means to secure greater market openings. The paper examines the EU's current external trade policy in the area of IP, particularly its attempts to promote its own regulatory model for the protection of IP rights through trade agreements. By looking at the IP enforcement provisions of such agreements, the article also examines how the divisive issues that are currently hindering the progress of negotiations at WTO level, including the demands from developing countries to maintain a degree of autonomy in the area of IP regulation as well as the need to balance IP protection with human rights protection, are being dealt with in recent EU FTAs.