What happened?

Since June 2022, the Médecins Sans Frontières (MSF) and ViiV healthcare-the sole supplier of long acting cabotegravir anti-retroviral, have been in contract negotiations aimed at increasing access to the medicine by vulnerable groups in low- and middle-income countries.

MSF has now raised concerns over ViiV Healthcare’s introduction of new clauses in the agreement that would essentially increase supply chain risk around the commodity and limit accessibility by low-resourced regions including Africa.

Context

Born out of a partnership between GSK, Pfizer and later Shionogi, ViiV healthcare, for more than a decade now has focused its efforts around HIV medicines and research. And prime in its efforts is an injectable long-acting pre-exposure prophylaxis (PrEP) anti-retroviral medicine Cabotegravir.

Cabotegravir is expected to ramp up the fight against spread of HIV particularly in Africa where the disease burden is disproportionate to global figures. Being an injectable form of PrEP administered twice between 4 weeks and once 8-weekly thereafter, it is expected to be a crucial factor in stamping on stigma and improving adherence.

Particularly, in a region with more than 25 million people living with HIV (PLHIV) it is expected that use of cabotegravir can result in a 79% relative reduction in HIV risk compared to the oral PrEP.

This medicine is the first long-acting HIV prevention medicine and in July 2022, the WHO recommended its inclusion by countries as part of their comprehensive approach to HIV prevention.

MSF claim that they have held lengthy discussions with ViiV healthcare since June 2022 and their position is that the new terms introduced in the negotiations in May 2023 will only serve to delay access to the crucial medicine.

MSF, whose key mandate is to provide medical assistance to people affected by exclusion from healthcare is seeking withdrawal of the confidentiality clauses and terms amended to ensure security and timely availability of cabotegravir.

What was said?

In an open letter to the top brass at ViiV Healthcare, Dr. Sidney Wong, an executive co-director at MSF highlighted 4 main contentious clauses:

• ViiV Healthcare to maintain right of refusal of purchase orders with no valid reason
• ViiV increases time of approval of a purchase order from 5-45 days
• Introduction of a termination of convenience clause with a 90-day notice.
• Addition of a confidentiality clause specifically on pricing

 

What’s more

MSF has called for openness on manufacturing capacity and supplies allocation:

“We call on ViiV once again to commit to transparency around manufacturing capacity and supply allocation to countries with relatively higher rates of HIV infection and therefore need for better PrEP as compared to those countries with financially more lucrative markets.”

Dr. Sidney Wong, Exexutive Co-Director, MSF

In its part ViiV Healthcare has stated that its still working closely on contract negotiations with MSF to enable access to Cabotegravir as quickly as possible and reiterated its commitment  to serving its partners.

Notably

In July 2022, ViiV Healthcare and Medicines Patent Pool announced the signing of a new voluntary licensing agreement for patents relating to long-acting cabotegravir to enable access to 90 countries. Through this agreement three generic manufacturers; Aurobindo, Cipla and Mylan will have the opportunity to manufacture, develop and supply generic versions of the drug.

MSF also raised concerns over this agreement due to several issues including that: the geographical scope of the license is limited and does not even match that of the licenses for dolutegravir (2014 and 2020), the other anti-retroviral licensed by ViiV to MPP. Further, it excludes 47 out of 54 upper middle-income countries (UMICs).