While 6.6 million individuals living with HIV/AIDS in low- and middle-income countries are on antiretroviral therapy as of December 2010, there are nine million who need therapy now but are not receiving it, according to AIDS at 30: Nations at the crossroads, a 2011 UNAIDS report. The need can be met. As the report goes on to say: “Between 2001 and 2010, the number of people receiving antiretroviral treatment rose nearly 22-fold, a vivid illustration of the power of international solidarity, innovative approaches and people-centred responses.”
When you consider that many of those 6.6 million in low- and middle-income countries have access to meds only because of the production of low-cost, gold-standard generic versions, it becomes clear that the generic-production solution embraced by countries like Brazil, Thailand, South Africa, and India has worked—but now it needs to work differently.
More than ten years ago, pharmaceutical companies in India, which at the time did not grant patents on medical products, started to produce generic versions of brand-name antiretrovirals at a much lower cost. It was a yearly difference, say, of $10,000 per person versus $300 per person at the time. The market competition that ensued in part caused the brand pharmaceuticals to lower drug prices, as well.
“Antiretroviral treatment using these early medicines can cost less than $70 in some places today,” says Kaitlin Mara, communications manager of the Medicines Patent Pool, a new international initiative launched to address the limits of patent-restricted health options for individuals living with HIV/AIDS. “This dramatic drop in prices is a huge deal—it means that over six million people are getting the chance to live longer, healthier lives thanks to treatment that for the most part would have been completely inaccessible to them ten years ago, so inaccessible as to be unthinkable. So the huge number of people on treatment now really amounts to the world accomplishing what had seemed impossible, and the driver for it happening was competition among generic drug manufacturers in key producing countries where the medicines were not patented.”
Now, however, the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), a mid-nineties agreement that set a minimum standard for the granting of patent rights for countries who are members of the World Trade Organization, has made it easier for patent-holding companies to apply for and get patents in these key generic-producing countries. Many of the new, second-generation antiretrovirals, for example, will be patented in places where many of the medicines produced for the developing world are made.
The challenge we are facing now, Mara explains, is multifactorial: the number of people in need of treatment—and newer, better-tolerated medications— keeps increasing; the development of drug resistance means that individuals will eventually need second- and third-line therapies; new and/or different formulations of meds are not being developed; and the “treatment as prevention” approach, in which, for example, early treatment of uninfected partners in serodiscordant male-female couples has been shown to reduce transmission drastically, depends on widespread access to anti-HIV meds.
Additionally, “[t]he WHO is now also recommending that people in developing countries receive newer, better-tolerated HIV medicines. Newer medicines are often patented in generic-producing countries, and thus significantly more expensive,” says Mara.
“A report by the UK all-parliamentary group on AIDS called this the ‘treatment timebomb.’ The Pool is trying to avert this treatment access crisis by stimulating that generic competition through voluntary licensing.”
Established with the help of UNITAID in 2010 to increase access to gold-standard medications, particularly for those living with HIV/AIDS in low and middle-income countries, the Medicines Patent Pool bridges the gaps between patent holders, generic manufacturers, and patients with a sort of treatment-access management system. Patent holders are invited to share their intellectual property under certain terms and conditions. If an agreement is reached, their patents are licensed to the Pool, which in turn licenses the patents to low-cost generic manufacturers. As a result, the Pool streamlines and makes less expensive the process of patent licensing and new medical research, especially when several different companies hold patents on drugs that need to be combined to simplify treatment programs. Market competition will ensure lowered drug prices and patent holders will receive royalties from the sale of generics.
Though new, the Pool is not empty. The National Institutes of Health licensed its darunavir patent and Gilead Sciences licensed the already established tenofovir and emtricitabine, and the still-in-development cobicistat and elvitegravir, as well as a combination of these products in a single pill known as the “Quad.”
The incentives for joining, according to Mara, are easy to understand: “HIV is an undeniable public health crisis in the developing world and a lot of patent-holding pharmaceutical companies want to be seen as having a hand in improving global health. The Medicines Patent Pool has the support of the United Nations, is in the WHO’s HIV/AIDS Strategy for the next five years, and has been endorsed by the G8 governments—where most of these patent holders are based. The Pool also has support from key civil society organizations and communities of people living with HIV. As such, the Pool is a concrete, visual way for patent-holding companies to contribute to improving global health.”
She continues: “It’s also a collaborative way for patent holders to work with public health advocates. They voluntarily license their patents under certain conditions, they get fair royalties in return, and they avoid the confrontation that is historically prevalent when the need for access to HIV medicines goes unfulfilled.”
A promise of innovation comes from generic production, especially when drug companies or initiatives attend to the needs of patients in resource-limited settings by tailoring drug delivery via meds that do not require refrigeration, formulations for children, and fixed dose combinations, for example. Says Mara: “Our mandate is not only to improve access to existing HIV medicines but also to incentivize the formation of needed new formulations. The Pool aims to incentivize innovation by removing patent barriers that can arise when several different companies own intellectual property needed to make or develop a new formulation.” As part of the Pool’s agreement with Gilead, for example, licensees are permitted to develop and manufacture other combinations that include the four medications that have been licensed.
“It will work by acting as a ‘one-stop shop’ for all the licenses necessary for an entity that wants to do new research and development, such as a generic pharmaceutical company or a product development partnership like the Drugs for Neglected Diseases initiative (DNDi),” says Mara. “In doing so, the Pool will reduce transaction costs, making it much easier for new innovators to enter the market. Where things stand today is…each generic manufacturer is obliged to enter negotiations with the originator patent holding company of every medicine it wishes to license, and where each originator must similarly negotiate with each potential generic or product development partnership.”
Mara says that each negotiation carries with it “risk in terms of cost and uncertainty. The Pool dramatically simplifies the interaction between patent holders, generic producers and potential new innovators [see diagram on previous page]. This will make it much easier for a new innovator interested in working on, for example, a new fixed dose combination or a new formulation designed for children to access the licenses they need to make the medicines that people need.”
The Medicines Patent Pool is currently in negotiations with Boehringer-Ingelheim, Bristol-Myers Squibb, F. Hoffman-La Roche, Sequoia Pharmaceuticals, and Viiv Healthcare (a joint venture of Pfizer and GlaxoSmithKline), as well as the National Institutes of Health. Those who have been invited but have not yet entered negotiations are Abbott, Johnson & Johnson, and Merck. “Negotiations for us means we are discussing the terms and conditions of potential future licenses,” explains Mara. “So, yes, we very much think that other patent holders will soon join and in fact they are already negotiating with us on how they can do so.” Mara says that the newly formed Pool is encouraged that so much progress has been made already.
For more information, access to the complete texts of the licenses and details of the agreements, and updates about the organization’s progress, log on to www.medicinespatentpool.org.