E-DRUG: MSF's response to ViiV's refusal to license CAB-LA to generics
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Dear e-druggers,
Sharing MSF's response to the announcement from ViiV this week that they will not pursue voluntary licensing for LA-cabotegravir.
Kind regards,
Jessica Burry
HIV/HCV Pharmacist
MSF Access Campaign
Jessica Burry <jessburry@gmail.com>
Geneva, 4 March 2022
Pharmaceutical corporation ViiV has just announced they will not pursue a voluntary licensing deal for long-acting injectable cabotegravir (CAB-LA) to allow generic production and affordable prices for low- and middle-income countries (LMICs). The drug is patented in many countries including India, Brazil and South Africa, and these patent barriers have a chilling effect on the development of low-cost generic formulations.
CAB-LA was approved for the prevention of HIV infection by the USFDA in
December 2021, and ViiV currently charges $3,700 per vial in the US
($22,200 per person per year)
<https://www.aidsmap.com/news/dec-2021/us-approves-injectable-cabotegravir-prep>
Research from the Clinton Health Access Initiative (CHAI) has shown that
generic manufacturers could produce this drug for around $2.60 per vial
(less than $20 per person per year). Although ViiV has publicly said they
would provide CAB-LA for their at-cost price in many LMICs, they have yet
to announce what that price is.
Experience has shown that generic manufacturer prices are frequently
drastically lower than the patented drug - and that generic manufacturers
have the capacity for developing even complicated formulations like
CAB-LA. Even in the case of ViiV's pediatric formulation of the HIV drug
dolutegravir, also sold at their at-cost price in LMICs the generic equivalent costs 22 times less than ViiV's.
<https://www.theglobalfund.org/media/5813/ppm_arvreferencepricing_table_en.pdf>
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Amanda Banda, Infectious Diseases Policy and Advocacy Advisor, MSF Access
Campaign:
'What good is HIV prevention if the people who need it can't afford it?
This drug is the most effective form of HIV prevention for vulnerable and
marginalised communities and yet ViiV is delaying the ability of generic
manufacturers to supply the drug, meaning that many people across low- and
middle-income countries who would benefit from the medicine to prevent HIV
infection won't be able to access it. CAB-LA will need to be available at a
price that is comparable to currently available oral PrEP if country
treatment programs and donors are expected to scale up its use to the
levels needed - and it's hard to imagine that ViiV will make CAB-LA
available at less than $40 USD per year.
'ViiV needs to immediately sign a licensing deal with the Medicines Patent
Pool so that more affordable generics can be produced, and more lives can
be saved.'
Dr. Tom Ellman, Head of MSF's South African Medical Unit:
'We want to urgently make this drug available for people at high risk of
HIV infection in our programs in sub-Saharan Africa - we don't want a
donation with many strings attached from the corporation; it is not the
role of ViiV to control the use of a drug that is approved by the USFDA. We
want ViiV to sell us this drug at an affordable price.'