ACTA - Risks of Third-Party Enforcement for Access to Medicines
Originally published in American University International Law Review, v.26, p.579 (2011).
In its current near-final draft form, the Anti-Counterfeiting Trade Agreement [ACTA] being negotiated plurilaterally—and largely secretly—by a self-selected group of countries proposes to allow preliminary and final injunctive relief against third parties (third-party enforcement) to prevent infringement of intellectual property rights and/or to prevent infringing goods from entering into the channels of commerce. There is lingering uncertainty whether the relevant civil enforcement section will apply to the entire range of intellectual property rights or whether patents will be excluded. If patents are excluded, the dangers in ACTA would be reduced but not eliminated—new globalized forms of third-party enforcement would still pose unprecedented risks to the lawful trade of generic medicines. Extending third-party liability and imposing interlocutory and/or permanent injunctions against (1) innocent active pharmaceutical ingredient suppliers whose materials are used in the manufacture of patent infringing medicines or in mislabeled products without their knowledge, (2) transporters who use international channels of trade through countries where the “patent manufacturing fiction” or “trademark confusion” claims might apply, and (3) other actors in the global procurement and supply of medicines, could interfere with the goals of robust generic competition and access to medicine. Under the risk of preliminary and permanent injunctions, and contempt of court sanctions for violating such injunctions, API suppliers would predictably shy away from selling base ingredients to generic producers, entities like the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) and the U.S. PEPFAR Supply Chain Management System (SCMS) could be deterred from funding the purchase of generic medicines, and shippers might refuse to transport finished generic medicines through ordinary transshipment routes involving ACTA signatories. Health activists must collaborate globally to eliminate or at the very least reduce these risks.
26 Am. U. Int'l L. Rev. 579 (2011)