UNITAID Launches Patent Pool for HIV/AIDS Drugs
A "patent pool" that promises to spur innovation and lower costs for state-of-the-art HIV/AIDS treatment took a big step closer to becoming a reality on Tuesday, with a crucial procedural decision that sets up an entity that can negotiate with the makers of key drugs to secure access to their intellectual property.
After months of negotiations, the executive board of UNITAID, the international drug purchasing facility that has spearheaded the push for a drug patent pool, formally approved an agreement to set up a Medicines Patent Pool Foundation and provide it with US$4.4 million in funds for its first year.
"What this means in practical terms," explained Philippe Douste-Blazy, chair of UNITAID's executive board, "is that formal negotiations with the patent holders can now begin. We expect the Patent Pool Foundation to have its first licenses within a year."
Douste-Blazy, a doctor and former French minister for health and foreign affairs, told Intellectual Property Watch that the decision "should save millions of lives of people living with HIV across the developing world."
A patent pool brings together ("pools") multiple patents belonging to different owners, and makes them available to third parties against the payment of a royalty.
UNITAID believes that pooling the patents for key HIV/AIDS drugs would make it simpler, and cheaper, for researchers and drug manufacturers other than the patent-holders to access important intellectual property. This would facilitate competition and hence, lower prices, since several different manufacturers could pay the royalty, and then access the intellectual property in the pool to make drugs for sale in developing countries. The ‘one-stop shop' for intellectual property would also enable innovation, since it would become easier for companies to access the different patents needed to create new fixed-dose combinations, included badly needed ones for children.
UNITAID wants the patent pool to focus initially on HIV/AIDS medicines that are expensive (the newer, ‘second-line' medicines that receive patent protection in India, a major source of low-cost versions of older drugs) or unavailable (formulations that can withstand hot temperatures, as well as those for children). It wants the licence agreements with patent holders to cover both low- and middle-income developing countries - covering only the former might mean a market for generics too small to yield adequate price reductions.
Sources say that the statutes of the Medicines Patent Pool Foundation, which have been filed with the Swiss authorities, include provisions to prevent drugs created via access to the eventual pool from being diverted to developed country markets, where the companies that will be asked to license their patents make much of their money.
The Medicines Patent Pool Foundation will be a Swiss non-profit foundation, independent from UNITAID or its host, the World Health Organization. The reason for creating a separate legal entity, instead of having UNITAID house the patent pool, was that patent-holders might have been reluctant to license drugs to a UN-affiliated body. The UN's various legal privileges and immunities might have made legal recourse difficult if they were unhappy with how their intellectual property was being used.
The three members of the foundation's board that have been confirmed so far are Bernard Pécoul, the head of the Drugs for Neglected Diseases initiative, Charles Clift, a well-known expert on intellectual property and health, and Paulo Teixeira, the former head of Brazil's national AIDS programme.
Ellen ‘t Hoen, a senior adviser on intellectual property and the medicines patent pool with UNITAID, said that there was now a "complete green light" to transfer money to the new foundation, which will start operations in the weeks to come. But the creation of the Medicines Patent Pool Foundation simply allows negotiations to start with pharmaceutical companies such as ViiV and Gilead; it is not the ultimate goal.
"What the world is waiting for is concrete results from the patent pool," she said. "Now the hard work can start."