AIDS & Essential Medicines: Obstacles to treatment

Fact: In 2009, only 37% of all individuals in need of anti-retroviral (ARVs) drugs in sub-Saharan Africa received them.  The proportion of HIV-infected children receiving treatment was 26%.²

The Global Burden of HIV and AIDS

According to the WHO, in 2009, an estimated 1.8 million people died of AIDS.  With over 33.4 million individuals already infected with HIV and an additional 2.6 having contracted HIV that same year, the global burden of HIV/AIDS continues to worsen, according to the 2010 UNAIDS Global report [4].

Without treatment, HIV infections eventually become acquired immunodeficiency syndrome (AIDS).  People living with HIV/AIDS (PLWHA) have weakened immune systems and suffer previously rare fungal, bacterial, and viral infections.  A health crisis in its own right, HIV/AIDS is made all the more tragic by the fact that much of the suffering, and many deaths and new infections are preventable through the use of currently available pharmaceutical agents. Thus the HIV/AIDS pandemic represents not only a public health crisis but a humanitarian and human rights disaster as well.

Impeded Access to Essential HIV/AIDS Drugs

While antiretroviral (ARV) drugs cannot cure HIV and hence must be taken for life, they are capable of drastically reducing the longterm affects of HIV. In 2001, The UN Declaration of Commitment on HIV/AIDS [3] asserts that every HIV positive woman, man, and child deserves the right to treatment so that they may lead long, healthy, and productive lives. However, this right to treatment remains out of reach for many, particularly in low- and middle-income countries.

As Stephen Marks points out in Access to Essential Medicines as a Component of the Right to Health [2] in Health: A Human Rights Perspective [1], there are many obstacles to making essential medicines available in poor countries: affordable prices; government commitment and policy; adequate, sustainable, and equitable public sector financing; generic substitution; consumer information; efficient distribution; control of taxes; and careful selection and monitoring.  These structural gaps are addressed by the WHO Medicines Strategy, but have proven to be nearly intractable in many low-income countries, with some notable and inspiring exceptions.

ARV therapy typically requires a combination of three or more medications and must occasionally be changed due to side effects or the development of drug resistance. While first line ARV therapy has been brought down in price from $10,000 per patient per year in 2000, to $70 per patient per year today, second-line therapies necessary to reduce drug toxicity and to combat drug resistance remain too expensive for much of the world. In 2009, only 37% of all individuals in need of ARVs in sub-Saharan Africa were receiving them, and only 26% of HIV infected children are being treated.

See http://www.who.int/hiv/pub/2010progressreport/ch4_en.pdf [5] [6] (PDF)

Some countries have attempted to overcome the obstacle of unaffordable prices by negotiating lower prices or substituting patented drugs with ones obtained through their own production or parallel importation. The pharmaceutical industry challenges the idea that patents cause a lack of access (in part, because not all of the 319 products on the WHO Model List of Essential Medicines [9] are patentable).  Nevertheless, patents to protect investment in research and development drive the high price of certain drugs, notably ARVs.

The Medicines Patent Pool

Patent issues are derived in large part from the desire of pharmaceutical companies to protect their intellectual property rights in order to ensure they receive a return on their research and development investments.   One solution, initiated after years of negotiation by the international organization UNITAID [8], is an international patent pool. [7]

According to Médecins Sans Frontières [10] (MSF or Doctors Without Borders, a humanitarian-aid NGO), “A patent pool for medicines has the potential to increase access to patented medicines for people living with HIV in the developing world, by creating a structure for patent holders to share their HIV drug patents and receive royalties in return. Drug companies can then access these patents to produce more affordable versions of the patented medicines. Companies are financially rewarded, and patients benefit from access to more affordable medicines.”

Pharmaceutical companies would be able to license their ARV patents to the pool, allowing generic manufacturers to produce these patented ARVs in return for a royalty fee payment  to the company that designed the ARV. Additionally, researchers would be able to access the patent pool in order to create new formulations of ARVs appropriate for children.  New fixed-dose combinations, pills that contain more than one ARV, could also be created to give patients effective treatment combinations with simpler regimens.

The Medicines Patent Pool was established in 2010 and the National Institutes of Health has licensed its patent for the ARV darunavir.  However, this alone will not reduce the price of this life-saving medication or allow for further research, as other patents on this drug are held by the pharmaceutical company Tibotec. In the end, the Pool will only be as useful as the drugs that are licensed to it.