MSF Access Campaign analysis of the MPP Licence Agreement with AbbVie for glecaprevir/pibrentasvir (G/P)

Glecaprevir (GLE) and pibrentasvir (PIB) are medicinal compounds approved for the treatment of chronic HCV in adults. GLE and PIB were first approved by the US Food and Drug Administration as a fixed-dose combination in 2017.

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:

• Provide greater clarification on sublicensees’ freedom to operate when patent applications remain pending in countries excluded from the licence territory.
• Expand the licence territory to include – at a minimum – “manufacturing-only” countries like India and additional middle-income countries with high HCV prevalence, including China.
• Extend the territory of the license agreement to cover all low- and middle-income countries so that adult and paediatric patients in these countries can benefit from G/P formulations.
• Make publicly available disaggregated information of the progress of registration of generic medicines produced under the licence, enabling easier public monitoring and procurement forecasting.
• Ensure that sublicensees who develop long-acting injectables can market the formulation in all low- and middle-income countries.

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.