Abstract:
Registered in 2001, tenofovir disoproxil fumarate (TDF) has quickly become a mainstay of first line regimens
for the treatment of HIV. Initially only available in developed countries at a cost of US$5 000 per person per year
(ppy), Gilead’s Access Programme (GAP) has extended the use of the product to 2.4 million patients in low and
middle income countries. The programme has two components: distribution of the branded product at reduced
prices and licensing partnerships with generic manufacturers. The licensing partnerships now supply 75% of the
market by volume, at a treatment cost of US$57 ppy (1% of the branded cost). From Gilead’s perspective, GAP
must be considered a huge success. It has enabled the company to maintain high prices in developed countries
whilst reducing its input costs and deflecting criticism of its failure to provide essential medicines for the poor,
hence risking the possibility of compulsory licensing. Over the period 2001 to 2011, TDF in its various forms has
generated for Gilead more than US$31 billion revenue at a gross margin of 80%, equivalent to a gross profit of
US$25 billion. Analysis of the TDF value chain, from preparation of the active pharmaceutical ingredient (API) to
sale of the formulated product, shows that manufacturing margins are highly skewed in favour of the originator,
with the latter’s profit being US$3.2 billion vs. US$4 million for API manufacturers and US$39 million for formulators
(2011). The data argues for a more rational approach to drug pricing including possible regulation in developed
countries and more sustainable margins for the generic producers.
