RESEARCH SYNTHESIS: VOLUNTARY LICENSING
v1.0 researched and written by Elise Erickson, edited by Suerie Moon, last updated June 2018
The literature on voluntary licensing is thin*, and most of the literature is quite recent (after 2012).
Synthesis of the literature
Voluntary licensing refers to the practice of IP-holders voluntarily granting licenses to their patents or other IP, and has increasingly been adopted to promote access to lower-cost generic medicines in low and middle-income countries. Voluntary licensing is often contrasted with compulsory licensing, in which a government authority grants a third-party a license to the IP. Voluntary licenses can take many forms, and may be bilateral (between a single licensor and licensee) or multilateral (between multiple licensors and licensees, as through a patent pool).
A few papers and reports map different existing voluntary licenses on medicines (MSF Access Campaign 2017; Amin 2007). A 2016 report from the WHO shows that voluntary licenses have allowed sofosbuvir prices to fall substantially, and discusses what conditions need to be met to allow for a competitive market under a voluntary license agreement (World Health Organization (WHO) 2016).
There is also limited literature that describes the Medicines Patent Pool (MPP), which works to increase access to HIV, hepatitis C and TB treatment in LMICs through voluntary licensing and patent pooling. The mostly descriptive literature dates primarily around 2010 when the initiative was launched (Cox 2012; Childs 2010; Bermudez and ’t Hoen 2010). More recent analyses discuss the benefits and accomplishments of the MPP so far (Perry 2016), and the projected savings from voluntary licenses of ARVs through MPP by 2028 (Juneja et al. 2017). (See further discussion in our review of "Patent pools")
A few papers discuss potential access concerns relevant to voluntary licensing (Beyer 2013, MSF Access Campaign 2017, 2015). The MSF Access Campaign has highlighted access concerns in middle-income countries that were excluded from Gilead’s voluntary license agreements on HIV and hepatitis C medicines (MSF Access Campaign 2017, 2015).
Discussion of voluntary licensing sometimes arises in papers focusing on compulsory licensing, which has attracted far more research attention. For example, some discuss how the threat of a compulsory license may invite a voluntary licensing agreement (Raju 2017), or that pharmaceutical companies will use voluntary licenses to prevent the use of compulsory licenses (or the use of other TRIPS flexibilities), thereby preventing competition in the market. Many of the papers that discuss both types of licensing, however, tend to focus on compulsory rather than voluntary licenses (Beall and Kuhn 2012). (See our review of Compulsory Licensing.)
Mapping of terms and conditions in voluntary licenses, including covered medicines, countries, timeframes for negotiation, period of licenses, provisions for use of TRIPS flexibilities, criteria for licensees, and suppliers in and outside of voluntary licenses
Comparison between bilateral (e.g. patent-holding firm to licensees) and multilateral (e.g. Medicines Patent Pool, patent-holders to 3rd party to licensees) voluntary licenses
Further research on changes in prices and availability of medicines under voluntary license and other policies (e.g. no license, compulsory license, narrower or wider voluntary licenses, tiered pricing, donations)
Further analysis of access concerns in voluntary licenses, such as implications for middle income countries and for the generics industry
Analysis of operation and costs of patent pools
* For the purposes of this review, we have established three categories to describe the state of the literature: thin, considerable, and rich.
- Thin: There are relatively few papers and/or there are not many recent papers and/or there are clear gaps
- Considerable: There are several papers and/or there are a handful of recent papers and/or there are some clear gaps
- Rich: There is a wealth of papers on the topic and/or papers continue to be published that address this issue area and/or there are less obvious gaps
Scope: While many of these issues can touch a variety of sectors, this review focuses on medicines. The term medicines is used to cover the category of health technologies, including drugs, biologics (including vaccines), and diagnostic devices.
Disclaimer: The research syntheses aim to provide a concise, comprehensive overview of the current state of research on a specific topic. They seek to cover the main studies in the academic and grey literature, but are not systematic reviews capturing all published studies on a topic. As with any research synthesis, they also reflect the judgments of the researchers. The length and detail vary by topic. Each synthesis will undergo open peer review, and be updated periodically based on feedback received on important missing studies and/or new research. Selected topics focus on national and international-level policies, while recognizing that other determinants of access operate at sub-national level. Work is ongoing on additional topics. We welcome suggestions on the current syntheses and/or on new topics to cover.