Date: 12 July 2011
Source: Health GAP

Gilead`s access moves `disappointing` say activists Countries left behind by Gilead should break patent monopolies by issuing compulsory licenses without delay

Health GAP applauded progress by the Medicines Patent Pool in securing licenses for key AIDS medicines today, but expressed disappointment with the terms and conditions of the licenses, issued for five Gilead products: tenofovir, emtricitabine, and two medicines still in clinical development: cobicistat and elvitegravir (as well as a pill
combining all four medicines). The problematic terms and conditions include the following:

` Although Gilead has agreed to expand the number of territories covered by the licenses slightly, and has included three important products still under clinical development, Gilead has insisted on maintaining its monopoly control over products in many middle-income countries where there is a significant burden of untreated HIV as well as HIV positive people on treatment in urgent need of affordable new medicines as they develop resistance to old medicines.

`In addition to the harmful geographic exclusions, it is extremely problematic that Gilead has restricted licensees to generic companies from India only, as this excludes important generic manufacturers from Asia, Africa, and Latin America.

`Gilead has also maintained excessive and unreasonable control over the market for the Active Pharmaceutical Ingredients (APIs) needed to make the licensed medicines, insisting that APIs be sourced from Gilead itself or from other Indian licensees.

Activists had hoped that the Medicines Patent Pool could have held firm on inclusion of all middle-income countries and of licensees from everywhere in the world`the terms included in the first licensing agreements with the Patent Pool, announced ten months ago by the National Institutes of Health (NIH).

Fortunately, the Medicines Patent Pool extracted some improvements over existing voluntary licenses by Gilead, including the provision that licensees maintain the ability to fulfill compulsory and government use licenses for these products in countries excluded by Gilead.

Activists urged excluded countries such as Thailand, Brazil, and others to take action, including through issuing compulsory licenses where needed, to ensure that low cost generic versions of Gilead medicines will be available even as Gilead attempts to unreasonably exclude them.

Health GAP also called for scaled-up global action against companies that have refused to license their medicines at all. Although there are many important products awaiting inclusion, the refusal of Johnson & Johnson/Tibotec and Merck to license their medicines creates an unconscionable roadblock to desperately needed co-formulated regimens.

Activists applauded the dedication of leaders at the Medicines Patent Pool in seeking greater access. But the Patent Pool, having negotiated an open license from NIH and now a partial license from the first participating pharmaceutical company, is demonstrating the inherent limitations of voluntary measures to address the needs for affordable medicines. Big Pharma will still seek to gain favorable publicity while maintaining its patent monopolies in key markets`many of which are essential to scaling up access and to developing a robust generic
market to achieve lower prices for new medicines. Governments throughout the world will need to step in to ensure that people`s lives, not profit, govern decisions about production and distribution of essential drugs.

Keywords: Health GAP / Patent Pool / Gilead