Treatment and a cure for HIV/AIDS are highly sought after, and as a result, there has been much rancor over who profits from the solutions and who should have access to them. The treatment now commonly prescribed to patients living with HIV/AIDS is a combination of multiple medicines into a single pill, called a fixed-dose combination (FDC). FDCs contain antiretrovirals (ARVs) that fight the virus.
There are many ways to tweak FDCs, including changing the active ingredients, altering the quantity of active ingredients, and/or implementing different processes to manufacture and combine the components. Any of these variables may be subject to a patent, meaning that the person or entity that created the new combination or process would have an exclusive right to commercial use of the idea. With exclusive commercial rights, an inventor does not have any competition, so she may set the price that others must pay to use her idea. This is good because it gives the inventor an incentive to invest in her idea, knowing that she will be able to recover on her investment and even make a profit. The drawback is that the inventor does not have any competition and may set the price so high that people who need the invention will not be able to afford it, which is what happened in 1997 when a revolutionary new treatment for HIV/AIDS hit the market.
Highly active antiretroviral therapy (HAART) was introduced in 1997 , and within four years, the HIV/AIDS death rate had decreased by 84% – that is, the death rate decreased in rich countries where people could afford the new treatment. HAART was so expensive ($10,000 – $15,000 per person per year) that it was almost completely unavailable to people in developing countries. In 2001, there were still fewer than 8,000 people receiving the life-saving treatment in sub-Saharan Africa. This disparity ended when an Indian drug manufacturer ignored patents held by three large pharmaceutical companies and introduced a similarly effective generic FDC for $350 per person per year. This new source of competition caused a dramatic decrease in the cost of treatment worldwide, and people in low-income countries now pay $88 per person per year for basic treatment. While this was a tremendous advancement in the worldwide fight against AIDS, many problems remain.
Much of the medication that is available in developing countries is considered first-line treatment of HIV/AIDS because patients may develop drug resistance and require second-line treatment. Like HAART in the late 1990’s, second-line treatment is so expensive that people in developing countries have almost no access to it. In addition, newer, less toxic first-line treatments are now available in developed countries, but remain too expensive to be widely available to poorer countries. And this time, an Indian drug manufacturer cannot come to the rescue with a drastically cheaper generic version because, as a member of the World Trade Organization (WTO), India is now bound by The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Under TRIPS, WTO members must not infringe upon the intellectual property rights of fellow members. In light of tighter restrictions on intellectual property rights worldwide, how will developing countries gain access to expensive and desperately needed medications to fight HIV/AIDS?
The UNITAID patent pool may be the answer. UNITAID was created by the governments of Brazil, Chile, France, Norway and the United Kingdom in 2006, and its mission is to improve treatment of HIV/AIDS in low-income countries. UNITAID partners with other global health actors to achieve its mission, and derives its funding from taxes on airline tickets in participating countries. The patent pool is a new UNITAID initiative that is intended to increase access to better and more affordable medicines in low-income countries. The way the pool works is that patent holders voluntarily add their issued patents to the pool. Then, other entities can access and use the patents in the pool, but they must pay a royalty back to the patent holder. The UNITAID initiative will limit the availability of products developed and produced as a result of the patent pool by only making them available for marketing in developing countries. To illustrate how the patent pool works, imagine that Elizabeth the researcher wants to combine drugs X, Y, and Z into a single treatment (or FDC), but three different pharmaceutical companies hold the patents for each of these drugs. Elizabeth could go through the bureaucratic and legal hassle of trying to gain permission from each company to use X, Y, and Z, or she could go to the patent pool and obtain licenses to use all three at once. For this reason, patent pools are often described as “one-stop shopping.” The patent pool saves Elizabeth time and money, and it is also benefits patent holders because their ideas can be more easily incorporated into many different products. This arrangement benefits people in need of medication in developing countries because it facilitates the search for new treatments and increases competition, which makes the medication more affordable.
Of course, the prospect of increased competition may deter pharmaceutical companies from participating in the pool, but they stand to at least garner positive publicity for joining. Positive publicity would be no small gain to these companies in light of their global notoriety due to over-priced pharmaceuticals and exorbitant corporate profits. The UNITAID patent pool is voluntary, but if leading drug companies do not find a more effective way of making their medications affordable for people living with HIV/AIDS in developing countries, then WTO members could resort to compulsory licensing under TRIPS. Compulsory licensing occurs when a WTO member deems the price of a medication to be a public health hazard, and offers a license to an entity without the patent holder’s permission so that the other entity can produce a cheaper version of the medication. This loophole could create a scenario similar to what happened with HAART when the Indian company manufactured a generic equivalent and drove down prices. Such an arrangement would be anathema to pharmaceutical companies, so they have an incentive to cooperate with UNITAID and make the patent pool a success. The patent pool has the potential to protect patents, profits, and patients in developing countries all at once. If pharmaceutical companies cooperate, the UNITAID patent pool could offer an appealing compromise for all sides.
* Lauren M. Tozzi is a third-year law student at Wake Forest University School of Law. She holds a Bachelor of Arts in International Relations and Spanish, as well as a minor in Bioethics, from the University of Virginia. Her work experience includes interning at Qorvis Communications (a D.C. public relations firm), serving as a legal assistant at Kirkland & Ellis, LLP, externing for the Honorable Richard A. Paez in the Ninth Circuit Court of Appeals, and serving as the Martin Luther King intern for Legal Aid of North Carolina. Upon graduation in May 2011, Ms. Tozzi hopes to practice law in the Washington, D.C. area.