KNOWLEDGE PORTAL
on innovation and access to medicines
VOLUNTARY LICENSING
v1.0 researched and written by Elise Erickson, edited by Suerie Moon, last updated June 2018
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Abbott, Frederick. 2016. “Excessive Pharmaceutical Prices and Competition Law: Doctrinal Development to Protect Public Health.” UC Irvine Law Review 6 (3): 281."Abstract: Public health budgets and individual patients around the world struggle with high prices for pharmaceutical products. Difficulties are not limited to low income countries. Prices for newly introduced therapies to treat hepatitis C, cancer, joint disease and other medical conditions have entered the stratosphere. In the United States, state pharmaceutical acquisition budgets are at the breaking point -- or have passed it -- and treatment is effectively rationed. Competition/antitrust law has rarely been used to address “excessive pricing” of pharmaceutical products. This is a worldwide phenomenon. In the United States, the federal courts have refused to apply excessive pricing as an antitrust doctrine, either with respect to pharmaceutical products or more generally. Courts in some other countries have been more receptive to considering the doctrine, but application in specific cases has been sporadic, including with respect to pharmaceuticals. This remains a paradox of sorts. Competition law experts acknowledge that one of the principal objectives of competition policy is to protect consumers against the charging of excessive prices. The currently preferred alternative is to address the “structural problems” that allow the charging of excessive prices. That is, “fixing the market” so that the underlying defect by which excessive prices are enabled is remedied. There is a fundamental problem with the “fixing the market” approach when addressing products protected by legislatively authorized market exclusivity mechanisms such as patents and regulatory marketing exclusivity. That is, mechanical aspects of the market are not broken in the conventional antitrust sense. Rather, the market has been designed without adequate control mechanisms or “limiters” that act to constrain exploitive behavior. Political institutions, such as legislatures, that might step in are constrained by political economy (e.g., lobbying), and do not respond as they should. Competition law and policy should develop robust doctrine to address excessive pricing in markets lacking adequate control mechanisms. This article will focus specifically on the pharmaceutical sector because of its unique structure and social importance. This focus is not intended to exclude the possibility that development of excessive pricing doctrine would be useful in other contexts. This article is divided into two parts. The first addresses competition policy and why it is appropriate to develop the doctrine of excessive pricing to address distortions in the pharmaceutical sector. The second addresses the technical aspect of how courts or administrative authorities may determine when prices are excessive, and potential remedies. The policy prescription of this article is twofold: first, the United States should incorporate excessive pricing doctrine in its antitrust arsenal, and; second, other countries should maintain the status quo with respect to multilateral competition rules that allow them flexibility to develop and refine doctrine, including excessive pricing doctrine, that is best suited to their circumstances and interests. Link: https://scholarship.law.uci.edu/ucilr/vol6/iss3/3/
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Heller, Peter S. “The Prospects of Creating ‘Fiscal Space’ for the Health Sector.” Health Policy and Planning 21, no. 2 (March 1, 2006): 75–79. https://doi.org/10.1093/heapol/czj013."Abstract: Not Available Link: https://academic.oup.com/heapol/article/21/2/75/554947
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Lexchin, Joel. 2015. “Drug Pricing in Canada.” In Pharmaceutical Prices in the 21st Century, 25–41. Adis, Cham. https://doi.org/10.1007/978-3-319-12169-7_2."Abstract: Not available Link: https://link.springer.com/chapter/10.1007/978-3-319-12169-7_2
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Love, James. 2012. “Affidavit: Natco Pharma Limited versus Bayer Corporation.” https://www.keionline.org/sites/default/files/aff-jameslove_13Feb2012_as_Filed.pdf."Abstract: Not available Link: https://www.keionline.org/sites/default/files/aff-jameslove_13Feb2012_as_Filed.pdf
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Ottersen, Trygve, Riku Elovainio, David B. Evans, David McCoy, Di Mcintyre, Filip Meheus, Suerie Moon, Gorik Ooms, and John-Arne Røttingen. 2017. “Towards a Coherent Global Framework for Health Financing: Recommendations and Recent Developments.” Health Economics, Policy, and Law 12 (2): 285–96. https://doi.org/10.1017/S1744133116000505."Abstract: The articles in this special issue have demonstrated how unprecedented transitions have come with both challenges and opportunities for health financing. Against the background of these challenges and opportunities, the Working Group on Health Financing at the Chatham House Centre on Global Health Security laid out, in 2014, a set of policy responses encapsulated in 20 recommendations for how to make progress towards a coherent global framework for health financing. These recommendations pertain to domestic financing of national health systems, global public goods for health, external financing for national health systems and the cross-cutting issues of accountability and agreement on a new global framework. Since the Working Group concluded its work, multiple events have reinforced the group’s recommendations. Among these are the agreement on the Addis Ababa Action Agenda, the adoption of the Sustainable Development Goals, the outbreak of Ebola in West Africa and the release of the Panama Papers. These events also represent new stepping stones towards a new global framework. Link: https://www.cambridge.org/core/journals/health-economics-policy-and-law/article/towards-a-coherent-global-framework-for-health-financing-recommendations-and-recent-developments/32B84686FD13D7CB340643D798832095
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Wirtz, Veronika J., Hans V. Hogerzeil, Andrew L. Gray, Maryam Bigdeli, Cornelis P. de Joncheere, Margaret A. Ewen, Martha Gyansa-Lutterodt, et al. 2017. “Essential Medicines for Universal Health Coverage.” The Lancet 389 (10067): 403–76. https://doi.org/10.1016/S0140-6736(16)31599-9."Abstract: Not available Link: https://www.thelancet.com/action/showPdf?pii=S0140-6736%2816%2931599-9
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World Health Organization. n.d. “Essential Medicines.” WHO. http://www.who.int/medicines/services/essmedicines_def/en/.Abstract: Not available Link: http://www.who.int/medicines/services/essmedicines_def/en/
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Xu, Ke, David B Evans, Kei Kawabata, Riadh Zeramdini, Jan Klavus, and Christopher J L Murray. 2003. “Household Catastrophic Health Expenditure: A Multicountry Analysis.” The Lancet 362. http://www.who.int/health_financing/documents/lancet-catastrophic_expenditure.pdf."Abstract: Not available Link: http://www.who.int/health_financing/documents/lancet-catastrophic_expenditure.pdf
INTRODUCTION
The literature on voluntary licensing is thin*, and most of the literature is quite recent (after 2012).
SEARCH TERMS
Voluntary license
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).
→ See also the review on Patent Pools
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.)
→ See also the review on Compulsory Licensing
RESEARCH GAPS
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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
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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
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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)
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Further analysis of access concerns in voluntary licenses, such as implications for middle income countries and for the generics industry
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Analysis of operation and costs of patent pools
CITED PAPERS WITH ABSTRACTS
* 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.
