[Ip-health] MSF Access Campaign publishes analysis of the MPP Licence Agreement with AbbVie for glecaprevir/pibrentasvir (G/P)

leena menghaney leenamenghaney at gmail.com
Mon Mar 11 09:30:49 PDT 2019


 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.
   - Include paediatric and long-acting injectable formulations of G/P in
   the license agreement, with an extended territory covering all low- and
   middle-income countries.
   - Make publicly available disaggregated information of the progress of
   registration of generic medicines produced under the licence, enabling
   easier public monitoring and procurement forecasting.
   - 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 who are excluded from the territory of the
license.

Here is the link to the published document:
https://msfaccess.org/mpp-licence-agreement-abbvie-glecaprevir-pibrentasvir-gp-analysis-and-recommendations

Regards,
Leena Menghaney, MSF Access Campaign
Mobile: 9811365412


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