All posts by Sabrina Kunselman

Defining Efficacy: The Pharmaceutical Industry and Access to Treatment

During the 1990s and 2000s, HIV/AIDS activism made huge strides in reducing antiretroviral treatment (ART) prices and making HIV treatment more globally accessible. Through extensive human rights campaigns, activism efforts, and support from a host of governmental and supranational bodies, expensive drugs that were once deemed not cost-effective to provide in developing nations were made available to many of the world’s poor suffering from HIV/AIDS. The authors of Reimagining Global Health note that “The lowest available annual per-patient price of the most common first-line HAART regimen in the developing world fell from $10,000-$15,000 in the late 1990s to $300 in 2002 to $87 in 2007” (Farmer et al., 2013). For many infected with HIV, these improvements meant that HIV/AIDS would no longer be a death-sentence, but could be managed as a life-long chronic illness.

Much of this price-drop was attributed to the increased production of generic forms of brand-name treatments. Through partnerships with governments of developing countries and adapted business models, generic drug manufacturers were able to sell generic antiretrovirals at set—and comparatively low—price points (Farmer et al., 2013). This new wave of generic antiretroviral drug production was spurred in part by the passage of the South Africa’s Medicines Act of 1997. This act gave the government the right to allow compulsory licensing of brand-name drugs in the case of a public health emergency, meaning that patented antiretrovirals could be made by generic drug manufactures without permission of the patent-holder. Although 39 pharmaceutical companies filed lawsuits against the act in South African courts, political and social support for the Medicines Act caused them to withdraw their complaint three years later. Indeed, later that same year the World Trade Organization recognized that South Africa had not violated trade agreements concerning intellectual property rights, further solidifying the precedent that public health matters could override intellectual property rights (Farmer et al., 2013).

While the HIV/AIDS movement for access to ART is a truly remarkable example of harnessing social and political forces to make life-saving pharmaceuticals available in resource poor settings, it stands as the exception to the rule. Indeed, as Nicholas King describes in his article “Security, Disease, Commerce: Ideologies of Postcolonial Global Health,” pharmaceutical companies continue to have little incentive in developing effective and affordable treatments targeted at populations of developing nations. Not only is the Western pharmaceutical industry ill-designed to cheaply produce and sell important medicines to developing nations, but these same manufacturers whose product is inaccessible in poor settings continue to fight against the production of cheaper generic alternatives in non-Western countries—despite the public health importance of the medicines and the low-purchasing power of developing nations.

The battle surrounding patent protection is far from over. Recent trade negotiations concerning the Trans-Pacific Partnership—a trade agreement that would link nations including the United States, Japan, Australia, Canada and Chile, among others—are rife with controversy over the issue of pharmaceutical patenting. Many countries in the partnership want the United States to reduce their patent protection from the current 12 years to allow generics to enter the market sooner, while members of United States Congress have asserted they will not support the deal without a strong intellectual property rights component (Weisman, 2015).

Incidentally, the timing of these trade negotiations coincided with another controversial case involving the pharmaceutical industry. In September, the American pharmaceutical company Turing Pharmaceuticals made headlines when they purchased the rights to the drug Daraprim—a drug developed 62 years ago that treats toxoplasmosis—and increased the price from $13.50 a pill to $750 a pill (Pollack, 2015). The increase in price was not due to increased manufacturing costs of the drug, but due to the desire for an increased profit margin on part of Turing Pharmaceuticals. Unfortunately, this case is not isolated, but only one of many in a series of similarly inexplicable price-hikes enacted by drug companies.

How did the precedent set by the successful price reduction in HAART due to generic manufacturing during the early 2000s fail to translate to other life-saving medications? Aside from cases of “public health emergencies,” the pharmaceutical industry has near complete control over the production and pricing of many crucial medicines. Advocates of the pharmaceutical industry argue that a system based on profit-motive supports industry innovation and the production of better, more effective drugs. And yet, how effective can a medicine really be when it is out of reach of those who it would help the most? The efficacy of a medicine should not be measured simply by its biomedical utility, but also by its accessibility. If a pharmaceutical treatment is not available to a population for social reasons, it cannot be available to treat or cure on a biological level—bringing into question how exactly pharmaceutical companies should approach creating “effective” medicines.

 

 

Sources:

Farmer, A. Kleinman, J. Kim and M. Basilico, eds. 2013. Reimagining Global Health: An Introduction. Berkeley: University of California Press.

King, N. 2002. Security, Disease, Commerce: Ideologies of Postcolonial Global Health. Social Studies of Science 32(5-6): 763-789.

Weisman, J. (2015, July 30). Patent Protection for Drugs Puts Pressure on U.S. in Trade Talks. New York Times. Retrieved October 20, 2015, from http://www.nytimes.com/2015/07/31/business/international/pacific-trade-deal-drugs-patent-protection.html

Pollack, A. (2015, September 20). Drug Goes From $13.50 a Tablet to $750, Overnight. New York Times. Retrieved October 20, 2015, from http://www.nytimes.com/2015/09/21/business/a-huge-overnight-increase-in-a-drugs-price-raises-protests.html

 

Discussion Questions:

  • How much control should the pharmaceutical industry have on setting prices for life-saving treatments? If their control should be limited, which governing body should have the power to decide pharmaceutical pricing?
  • How likely is it that another massive activist movement, such as the movement for access to ART for HIV/AIDS treatment, will be able to drastically change the accessibility and affordability of important medicines?
  • Turing Pharmaceuticals argued that their price increase of Daraprim was justified because the drug is not commonly used anymore, and the increased profits generated from this price-hike will allow the company to expand research and development into other more effective drugs to treat toxoplasmosis. Do you agree with this justification? Why or why not?