Northeastern University Law Review, Vol. 10, No. 2, pp. 226-315 (2018); Northeastern University School of Law Research Paper No. 314-2018.
Abstract: As a result of global AIDS activism, governments’ latent and exercised powers to bypass pharmaceutical monopolies, and halting pharmaceutical industry accommodation, a new form of voluntary licensing has emerged focused on first permitting and then facilitating generic production of certain pharmaceutical products for sale and use in many but not all low- and middle-income countries (LMICs). These so-called “access” licenses are pluralistic in detail and not free of commercial motivations for either originators or generic producers, but they do differ from arms-length, purely commercial licenses that have been broadly used in the industry for decades. Although the first of these access licenses were negotiated bilaterally by innovators at the receiving end of AIDS activism and threats of government action, including the issuance of compulsory or government-use licenses, the leading model of more public-health oriented voluntary licenses can be traced to the formation of the Medicines Patent Pool [MPP] under the financial sponsorship of Unitaid in 2010.
The primary goals of this Article are: (a) to increase understanding of the history and evolution of access licenses and their key terms and conditions, including their impacts on access to medicines in territories included in and excluded from the licenses; (b) to identify and assess best-practice licensing terms for delivering meaningful access to medicines, including the impact of voluntary licensing practices on registration and uptake, and (c) to make policy recommendations on measures that can be taken to improve terms and conditions of access licenses, including those of the MPP.
Despite the achievements of access licenses in increasing generic competition, accelerating access to newer HIV and HCV medicines in many LMICs, and reducing prices and saving money, the exclusion from coverage of significant populations in upper-middle income countries with significant disease burdens, restrained resources, and high levels of inequality, is deeply problematic. Offsetting the wholesale work that access licenses accomplish in creating aggregated markets for accelerated generic competition is concern about industry’s power to bifurcate LMICs to maintain hegemony in the most commercially appealing markets and to weaken political will to oppose unworthy patents and to otherwise overcome monopoly control. As a consequence, the net plus value of voluntary licenses as an access strategy is contested. However, any fair assessment of voluntary licensing strategies must address the complementarity of this strategy with the strengths and weakness of other access strategies, including law reform, use of patent opposition procedures, and grant of compulsory and government use licenses. Although this complementarity is briefly addressed in the conclusion, more work and evidence is needed to identify optimal strategies.
Full paper available at SSRN: https://ssrn.com/abstract=3123108
