In the last year, a number of public health organizations — including the HIV Medicines Alliance, UNAIDS, Clinton Health Access Initiative, UNITAID and the Medicines Patent Pool — have taken steps to enter the voluntary licensing space. In our latest report, “Voluntary Licensing: Optimizing Global Efforts and Measuring Impact”, we comment on the efforts taken by these global health institutions and offer suggestions to ensure that licenses are pursued in a strategic, access-maximizing manner. We note that the stakes are particularly high when it comes to creating normative standards, as pharmaceutical companies are unlikely to agree to terms more generous than those endorsed by these agencies, which are seen as representing the entire HIV community.
In examining our collective commitment to universal access, we note that accepting access to affordable ARVs for some while endorsing the exclusion of others is an abdication of our collective responsibility to the global patient community. We acknowledge that concessions may be necessary to move a specific negotiation forward; however, to endorse a framework of exclusion is a breach of our community’s mandate to promote universal access.
In our report, we highlight that existing originator access programs already cover on average 75% (and at best, 90%) of people needing antiretroviral therapy. We argue that the true value-add of global health institutions is to close this gap, and to advocate for coverage of the middle-income countries that are being systematically left behind, particularly for second-line ARVs which are often priced out of reach. These countries account for one fourth of total patients needing ART, or roughly 3.5 million people. The HIV epidemic in these countries is often concentrated in vulnerable communities plagued by stigma and discrimination and ignored by governments.
It is these communities that struggle the most to access treatment and need the intervention of public health institutions to make access a reality.
For this reason we propose recommendations for the Medicines Patent Pool, who aims to act as the lead negotiator for all future ARV licenses. We also offer a new measurement tool applicable to all public health organizations working in the licensing arena, which can assess licenses facilitated or endorsed by these institutions. This “Voluntary License Scorecard” offers a set of indicators for both structuring license terms and standards and monitoring their impact on an ongoing basis. The indicators are categorized as follows:
- Global Patient Coverage (measured as compared to the status quo, and as compared to the goal of 100% universal access)
- Financial Impact (including tracking actual purchase volumes and prices on an ongoing basis)
- Market Impact (assesses the extent to which the licenses foster a healthy and competitive marketplace)
- TRIPS flexibilities (the impact of the license on the use of safeguards in national law, examination, opposition, compulsory licensing)
The Voluntary License Scorecard is available within our 4 page report here.