Books

Generics and their Doppelgängers

Jeremy Greene’s Generic describes how off-patent medicines have been legislated and regulated in the United States from the 1960s to the early twenty-first century. Greene’s brilliant book is the first full-length monograph to trace the history of how Americans think about generics, and it is going to be the key reference for many years to come.

Generic deals mostly with the US case, but also opens a window onto how generics circulate in other markets and jurisdictions, especially in the global South. Attempts at understanding generics in a comparative perspective seem to be haunted by Doppelgänger effects: in different times and different places, generics appear to be “the same but not the same” matters of concern. I have never read a book about medicine in the US that produced so many déjà vus with my experiences of medicine in India. Trust and distrust in different manufacturers, legal contestations of what should count as the “same” or “significantly different,” and the political leanings of supporters and detractors of cheaper medications, all look weirdly familiar. Even the notion that “there is no such thing as a ‘generic’ drug” (p. 54), as promoted by US Big Pharma, is an often heard statement of people who market or sell pharmaceuticals in India. Ironically, though, “we don’t sell generics” is repeated by people who sell “generics” (to them, they are “brands”).

Greene wrestles with these strange cases of recurrence as well: “We are constantly repeating our pasts, but what returns is never exactly the same as what came before, only similar” (p. 269). It could be argued that the “we” here is an American “we,” not a global “we.” The ghostly doubles of Greene’s book are the global histories of generics that have, for the most part, not been written yet. Only when these histories are at hand will it be possible to say what is unique about generics in the United States.

For the time being, Greene assumes that the US case is the real thing and not the Doppelgänger of events and processes that happened elsewhere. But that off-patent drugs now make up the largest share of all medicines prescribed is not uniquely US American. Nor is it special that lower-priced drugs are used as a kind of private sector solution to rising health care costs. Nor is it peculiar to the US how Big Pharma came up with a myriad of reasons why generics should be treated like perilous counterfeits.

In the chapter on the “global generic,” Greene suggests that the US inspired the global politics of equitable access: “Generic drugs emerged locally as a solution to problems of cost and access in health care earlier in the United States than in many other places in the world” (p. 243). Even the WHO’s essential drugs list, first introduced in 1977, was “informed by North American debates” (p. 246), and an American, Daniel Azarnoff, is credited with drafting its early guidelines. To be sure, these statements about US uniqueness are qualified and contextualized, especially when Greene highlights that easy juxtapositions of “big” US-based generics companies and “small” global competitors do not hold (p. 259). But if the US were the true innovators of affordable access to drugs the world over needs to be studied in greater detail.

Greene also argues that the US led the development of the TRIPs agreements under the World Trade Organization (which is probably true), and that forcing India to protect product patents allowed the Indian generics industry to flourish (which is probably not true). In my view, the increases of generics exports from India to the US since 1995 cannot be attributed to TRIPs. For example, Dr. Reddy’s Laboratories’ landmark success in breaking into the US market with its version of fluoxetine 40mg in 2001 rested on its ability to play by much older FDA rules, TRIPs had nothing to do with it. And it seems safe to say that TRIPs has not been a growth engine for generics manufacturers, in India or elsewhere. The vicious legal wrangling around Novartis’ Indian patent application for the anti-cancer drug Glivec shows that, if anything, TRIPs is a huge barrier for the global reach of generic manufacturers.

So what is special, or innovative, about US generics? It might be the historical timing of some pieces of legislation. It might be specific assemblages of agencies, industries, and legislators. It might be that prices for patent-protected drugs are even higher in the US than elsewhere, making affordable generics even more alluring. However, none of this means that the US experience paved the way for the rise of the global generic. To me, what makes the global history of generics so intriguing is that the apparent “originals” often come from elsewhere. It was in Tanzania in 1970 that the first essential medicines list was drawn up, for example. Or maybe, when it comes to generics, any questions about a true innovator–of a drug, of a piece of legislation, or of a procurement mechanism—are impossible to answer.

 

Stefan Ecks is Senior Lecturer in Social Anthropology at University of Edinburgh.  He is the author of Eating Drugs: Psychopharmaceutical Pluralism in India (NYU, 2013).


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