The US National Institutes of Health (NIH) has become the first patent holder to join the recently created Medicines Patent Pool, but unless other patent holders follow suit, the NIH's move will not increase access to HIV treatment.
By licensing the life-prolonging antiretroviral (ARV), darunavir, to the patent pool, the NIH has made the technology to produce it available for the benefit of low- and middle-income countries. However, this does not mean generic versions of the drug can now be manufactured and sold in these countries as additional patents on darunavir are still held by the pharmaceutical company Tibotec, part of Johnson & Johnson.
"The licence is an important first step that shows the US is committed to bringing down the cost of ARVs, but pharmaceutical companies must move forward quickly and share their licences using the same positive terms of license as the NIH," Asia Russell of the US-based Health Global Access Project (Health GAP) told IRIN/PlusNews.
Darunavir is a protease inhibitor usually used for patients who have developed resistance to older drugs. It is recommended for use in combination with another ARV, but the cost of darunavir alone for one patient for one year is US$1,095, according to the medical NGO, Médecins Sans Frontières; in comparison, generic first-line combinations cost as little as $90 per patient per year.
The Medicines Patent Pool - established in July by UNITAID, an international health financing agency - aims to create a common space for patent-holders to license their technology for use by generic manufacturers in exchange for royalties. Proponents of the pool argue that not only does it have the potential to reduce the price of existing ARVs, but it could also stimulate the development of urgently needed new medicines and formulations such as paediatric ARVs and fixed-dose combinations.
"The US is one of the main financers of the development of AIDS drugs, and is also home to most of the pharmaceutical companies we are hoping to collaborate with," Ellen 't Hoen, head of the medicines patent pool, told IRIN/PlusNews. "So this is a very significant step; if this patent pool succeeds, the positive benefits - especially to sub-Saharan Africa - will be enormous."
She noted that as ARV regimens were combinations of different drugs with patents owned by multiple players, it was of the utmost importance that other patent-holders joined the pool. "We are in talks with the holders of the additional patents on darunavir to share their patents under agreeable terms," she said.
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UNITAID has held talks with several drug developers, including Tibotec, Gilead and Merck, all of whom have shown "considerable interest".
"Our task is to get these drugs to as wide a geographical scope as possible, and ideally that means patent holders should be willing to provide licences for use by low- and middle-income countries, as defined by the World Bank," 't Hoen added.
According to Health GAP's Russell, the sharing of intellectual property urgently needs to be combined with increased funding to scale-up HIV treatment to all those who need it.
"Sixty-four percent of people who need ARVs still have no access, and increased HIV funding is necessary to provide for them," she said, adding that the USA needed to build on its commitment to the patent pool by meeting its commitments to adequately fund the US president's Emergency Plan for AIDS Relief, PEPFAR, and the Global Fund to fight AIDS, Tuberculosis and Malaria.