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)