

For MSF patients who currently cannot be treated satisfactorily with sofosbuvir-based regimens, access to glecaprevir/pibrentasvir (G/P) to form a salvage regimen is essential; however, AbbVie has not yet accepted requests to procure G/P for MSF projects in developing countries, nor provided any information on how to access G/P on ‘compassionate use’ grounds.
Affordable generic versions will take time to develop and are yet to be become available.
With a view to address intellectual property barriers and facilitate the availability of affordable generic versions, the Medicines Patent Pool (MPP) announced a licence agreement with the originator pharmaceutical company AbbVie for glecaprevir/pibrentasvir (G/P) in November 2018.
The MPP-AbbVie licence is publicly available on MPP’s website allowing for a thorough examination of its terms and conditions.
MSF Access Campaign is now sharing its analysis, which describes a number of challenging aspects of the licence with stakeholders and policymakers.
For example, this is the first time a voluntary licence between MPP and a pharmaceutical company has singled out India as a manufacturing-only country. A similar approach has been adopted vis-à-vis China in the licences on Gilead’s tenofovir alafenamide (TAF), ViiV’s DTG, AbbVie’s lopinavir/ritonavir (LPV/r), and BMS’s atazanavir (ATV).
This practice, now endorsed and expanded by the MPP’s voluntary licence agreements, raises ethical questions about harnessing the capacity of developing countries to develop, produce and supply quality medicines while at the same time prohibiting generics companies from responding to considerable unmet medical needs domestically.
While the AbbVie/MPP licence has some positive characteristics, there are multiple shortcomings that can be improved.
We recommend that AbbVie and the MPP revisit the licence and amend relevant clauses to:
We recommend that governments excluded from voluntary licences (1) review the voluntary licence together with patent status of G/P to assess their negative impact on competition and (2) apply TRIPS flexibilities such as a compulsory licence if necessary to reduce prices of HCV treatment in their country.
We recommend that procurers and funders provide sustainable, long-term funding for civil society to challenge patents to improve access to generic HCV treatment in countries with high HCV prevalence who are excluded from the territory of the license.