Differential Treatment: Restricted Access to Newer Antiretrovirals

The discovery of antiretroviral (ARV) treatment for people living with HIV (PLHIV) is one of the best success stories of medical research in recent years. It has changed the way in which HIV is viewed -- from that of a death sentence to a chronic illness. However, lifelong treatment requires constant access to newer drug regimens, as an HIV-infected person either develops serious side effects, or the virus becomes resistant to the drugs. While patients in developed countries have treatment options, the same cannot be claimed for those in developing countries. With more than twenty approved antiretroviral drugs, the global HIV drug market is estimated to approach $16 billion by 2016. Yet, not all ARVs, especially newer and more potent treatments, are licensed or available in every country, particularly in the global South. Why is there such a gap in access to treatment between industrialized and developing countries? Why are newer, more potent, less toxic ARVs not available to PLHIV in the global South? How can this growing disconnect between treatment options be altered?
Today there are 33.3 million HIV-infected people worldwide, 95 per cent of whom live in developing countries, and approximately 2.7 million new infections a year. Most of these people will need to be treated if they are to live healthy and productive lives. It is estimated that by 2030, fifty-five million people will need treatment. At the end of 2009, UNAIDS (Joint United Nations Programme on HIV/AIDS) estimated that five out of fourteen million people who needed treatment were on ARVs.1 The treatment options that were available to HIV-infected people accessing ARVs through state-based healthcare systems depended on the cost of medication. These drugs saved lives but came with serious side effects. If a patient was unfortunate enough to experience treatment failure -- often undiagnosed due to expensive testing that was maladaptive for developing countries -- or serious side effects, they were left with few or no alternatives.
The most commonly used treatment in developing countries contains the drug Stavudine (d4T). It causes serious long-term, irreversible side effects and was recommended to be phased out by the 2009 revised HIV treatment guidelines of the World Health Organization. Although Stavudine is no longer used in developed countries, a majority of people in developing countries continue to receive some combination of treatment containing it because of its low cost, thanks to competition among multiple generic drug companies in countries where this drug is unpatented. The next best treatment option containing Tenofovir (TDF) is double the price, costing around $176 per person per year. Yet, even some middle-income countries are unable to access TDF-based regimens due to patent protections, and for them the price increases six-fold, costing around $1,033 per person per year.2
Most countries cannot afford the higher costs of newer treatment options, either for better first-line treatment or, in the case of HIV drug resistance, second-line treatment. Resources for global institutes and programmes, such as the Global Fund for AIDS, Tuberculosis, and Malaria and the United States President's Emergency Plan for AIDS Relief (PEPFAR), which provide most of the funds for treatment through the purchase of generic drugs, are decreasing in real terms. As donors backtrack on HIV funding commitments, even Bill Gates, co-chair of the Bill and Melinda Gates Foundation, speaking at the July 2010 International AIDS Conference in Vienna, noted that we did not have money to treat our way out of this epidemic. Unfortunately, this shift in resources, and the idea that treatment is expensive and will get more expensive as numbers increase, is coming at a time when scientific evidence shows that earlier treatment with newer, improved drugs reduces mortality and hospitalization among HIV patients, and that better adherence prevents them from transmitting the virus.
Rather than asking why newer ARVs are priced out of reach for many that need them, we accept the reality that second-rate drugs available to treat patients in advanced stages of HIV disease are an acceptable option. Patent protections are the reason newer drugs are unavailable to 95 per cent of HIV-infected people living in the global South. The barrier to accessing treatment to newer and more potent ARVs for PLHIV in low- and middle-income countries can be traced back to the signing of TRIPS (Trade-Related Aspects of Intellectual Property Rights) in 1994 that aimed to encompass worldwide intellectual property protections. For the longest time, it was perfectly legal to copy existing molecules, even those developed elsewhere, such as in industrialized countries, enabling many countries to build a local pharmaceutical base offering similar products in the local market at a lower cost. But TRIPS patent protection has limited the competition for newer generic drugs and has impeded access to improved treatment options for HIV-infected persons in developing countries. Most of the newer drugs are protected by patents held by pharmaceutical companies which have exclusive rights to franchise production and distribution to only a few companies and countries. These drugs are unaffordable. At the centre of this war is a very basic concept: the differentiation between the collective good of public health and profit‒seeking by private firms. An example of treatment franchising is Tibotec, an international pharmaceutical company owned by Johnson & Johnson that licensed production of the antiretroviral medicine Rilpivirine to one South African and two Indian manufacturers. However, the company has limited the geographic scope of its license, so that those HIV-infected persons living in middle-income countries will not have access to generic versions of the drug, and will therefore be charged a higher price.3
The epidemiology of HIV varies from country to country and the most at risk populations, including those who use injectable drugs, men who have sex with men, sex workers, migrants, disabled persons, and women -- who already experience stigma and discrimination. What they all have in common is that they rely on state healthcare schemes for testing, treatment, and care services. When costs of inputs go up, such as ARVs, governments ration these services or make cuts. In Africa, drug stock-outs or not enrolling new HIV-infected persons into treatment are evidence of such situations.4
Governments and international institutions should make use of public health safeguards in opposing patent laws and granting exclusive rights to pharmaceutical companies. For newer ARVs to be affordable for all those who are HIV-infected regardless of their location, I have taken recommendations from Médecins Sans Frontières, and added a few personal inputs:

  • A country and/or countries within an economic trading bloc must have the right to design flexible patent laws for essential life-saving medicines and export or import, as needed.
  • In the case where essential drugs are patented, a country where these are unaffordable can issue compulsory licenses without suffering repercussions from big pharmaceutical companies.
  • Pharmaceutical companies must be encouraged to participate in the new UNITAID Medical Patent Pool (MPP).5 The MPP allows patent holders to make licenses available through the Pool and for those who take the licenses to pay royalties on their sales. In this way, generic versions of patented ARVs will be available in developing countries, and generic drug manufacturing companies can make and sell fixed dose combination drugs and develop paediatric formulations.

The fight for the right to health and access to medicines has been uphill against those in society who view these medicines as an opportunity for profitmaking. What is required is a rationalized approach: we need to determine an acceptable and affordable price for the research and development investment made by the investor. AIDS activism has been an engine for change in how we view the right to life and, by proxy, the right to health. This next battle for new and improved access to ARVs will not be easy -- prices for newer drugs will not come down as they did for the first generation of treatment options. HIV activists will need to mobilize and to make use of public health safeguards and international human rights law in protecting their access to essential life-saving drugs. At the UN General Assembly High Level Meeting on AIDS, scheduled for 8-10 June 2011, international institutions with their strategies of zeros6 need to come out boldly in favour of communities affected by the HIV epidemic and the right to access the new ARVs. In matters of life and death, there should be no differential treatment.
Notes 1 UNAIDS (2010), Global Report 2010, Chapter 4, "HIV Treatment." Geneva, UNAIDS. 2 MSF (2010), Access to Essential Medicines. Untangling the Web of Antiretroviral Price Reductions. 13th Edition. 3 The Pharma Letter available at: http://www.thepharmaletter.com/file/101692/jj-unit-tibotec-signs-multiple-deals-with-generic-drugmakers-for-access-to-new-hiv-treatment-rilpivirine-pre-pre-approval.html/. Also see MSF press release available at: http://www.msfaccess.org/media-room/press-releases/press-release-detail/index.html%3ftx_ttnews%5Btt_news%5D=1667&cHash=dec96f3170/. 4 MSF (2010), "The Ten Consequences of AIDS Treatment Delayed, Deferred or Denied." MSF. 5 UNITAID is an international facility for the purchase of drugs for HIV/AIDS, malaria and tuberculosis. Founded in 2006, it provides a strategic market intervention that aims to decrease the price of medicines for priority diseases and increase the supply of drugs and diagnostics. http://www.unitaid.eu/en/. In 2008, UNITAID set up the MPP to increase access to newer antiretroviral medicines for HIV/AIDS. Now a separate entity, MPP negotiates with patent holders to share their intellectual property with the Pool, and then licenses it to other producers to facilitate the production of affordable generic medicines well-adapted for use in resource poor settings. 6 UNAIDS has developed a new HIV strategy for 2011-15, "Getting to Zero," which calls for zero new infections, zero AIDS-related deaths, and zero discrimination by 2015. WHO and UNAIDS are also focusing on Treatment 2.0 a new treatment/prevention paradigm optimizing treatment approaches, i.e., simpler, safer, and more resilient regimens using new and existing drugs as well as simplified laboratory tools. For more on these strategies visit http://www.unaids.org/.