Voluntary Licensing Agreement

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Voluntary licensing has enabled 18 generic drug manufacturers to develop and import a cheaper version of the drug in many countries, although the product is still patented. Each generic drug manufacturer sets its own price, which varies from country to country. The agreements allow distribution in the following countries: if rights holding companies do not exclusively grant voluntary licenses for patented drugs, they allow other manufacturers to develop generic versions of these drugs. This helps to promote competition, support supply, improve affordability and improve accessibility. Edwards added that we still need “increased and sustainable funding for HIV from both donors and governments in countries most affected by HIV/AIDS. In the field of research and development, we will continue to need improved therapies, with lower costs and better tolerance. When licensing, we want more middle-income countries to be included in the agreed licensing conditions. During the consultation, it was also agreed that mechanisms should be put in place to inform countries whether or not they are included in voluntary licences and that patent holders are responsible for ensuring real access that goes beyond the creation of a voluntary licence. The literature on voluntary licensing is thin, and most of the literature is fairly recent (after 2012). The debate over voluntary licensing is sometimes found in documents that focus on compulsory licensing, which has attracted much more attention in research. Some discuss, for example, how the threat of a compulsory licence can lead to a voluntary licensing agreement (Raju 2017) or whether pharmaceutical companies use voluntary licenses to prevent the use of compulsory licenses (or other entertainment flexibilities) and thus prevent competition in the market. However, many of the titles that discuss both types of licences focus on mandatory licences rather than voluntary licences (Beall and Kuhn 2012). (See our review of the mandatory license.) Voluntary licensing refers to the practice of IP licensees who voluntarily license their patents or other intellectual and legal advice, and has been increasingly adopted to promote access to cheaper generic drugs in low- and middle-income countries.

Voluntary licences often face licensing, in which a public authority licenses a third party for the IP address. Voluntary licenses can take many forms and can be bilateral (between a single licensee and a taker) or multilateral (between multiple donors and licensees, such as through a patent pool). Licensed products are intended for the treatment of HIV/AIDS or hepatitis C and have a high level of public health. In many cases, licensed products appear on both WHO EML and are considered first-line treatments: emtricitabine, sofosbuvir, leedpasvir and velpatasvir. Licenses for HIV/AIDS products are accepted through the Pharmaceutical Patent Pool (MPP), while Gilead has agreed to license hepatitis C products, the first company to do so directly with generic drug manufacturers.