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Cbse.soe.ucsc.eduNo patent, no generic:
Pharmaceutical access and the politics of the copy
Associate Professor University of California at Berkeley Department of Anthropology This essay is forthcoming in Contexts of Invention, edited by Mario Biagioli, Peter Jaszi, and Martha Woodmansee (University of Chicago Press, forthcoming in 2008), and has been published in Portuguese in the journal Sociologias (Brazil): Special issue, Conhecimentos, redes e sociedade, Edição semestral, ano 10, no. 19, Jan-Jun 2008, In the final days of 2001, currency devaluations, the rapid flight of foreign capital, and bank closures paralyzed Argentina. Skyrocketing pharmaceutical prices, medication shortages, and hospital and clinic closures were instrumental in bringing the 2001-2002 economic crisis to a head.1 Following the collapse, among the priority recovery measures established by President Néstor Kirchner's Health Minister, Ginés González García, were two initiatives meant to ensure or at least improve people's ability to acquire medicine, from antibiotics to insulin and beyond. Programa Remediar, established in 2002, distributes free medicines to the poorest Argentines.2 This stop-gap measure was accompanied by a 2002 law promoting the prescription of cheaper, copied drugs over more expensive, dominant brand-name medications. This law, formally entitled the Law of Prescription by Generic Name, was meant to drive medication prices down by requiring that prescriptions contain the generic name of a drug – that is, the name of a molecule, such as enalapril – rather than a specific brand name (such as Merck's brand of enalapril, Renitec™). The goal of this law was to stimulate both a supply of and demand for less expensive medications by prying open the monopoly-like hold that leading brands have maintained on physicians' prescriptions and (thus) on patients' consumption.
Argentina was certainly not alone in pursuing measures of this kind. In 1997, the Mexican government had similarly turned to the generic as the country continued to recover from its own economic crisis and peso devaluation of 1994-5. As in Argentina, the centerpiece of the Mexican measures to combat spiralling medication costs was a prescription decree targeting physicians' common practice of prescribing by brand name.
This move, and associated regulatory shifts, ushered in a new market for generics and paved the way for the emergence and growth of pharmacy chains that traffic exclusively in lower-cost, copied medicines. The effects of have been tangible: beginning in 1999, pharmaceutical prices finally dropped following over four years of precipitous escalation (Hayden 2007).
The idea that generics might come to the rescue in an economic and public health crisis has become an increasingly familiar and important dimension of health politics in Latin America and globally. In the terms used by the World Health Organization, "multisource" or generic drugs are copies marked by two defining features: they are "pharmaceutically equivalent" to the original, and they come into circulation when the original patent has expired or has been modified such that the drug may be manufactured and commercialized by labs other than the original patent-holder (see Homedes and Ugalde 2005: 65). More colloquially, we might say that generics are copied drugs that circulate at the end of the patent.
With the ascendance of intellectual property as a central (if not contested) feature of international trade and pharmaceutical production and distribution globally, and particularly with the rise of global AIDS epidemics, generic drugs have come to prominence as a crucial, often life-saving alternative to expensive, patented medications (see Petryna, Lakoff, and Kleinman 2006; van der Geest and Reynolds Whyte 1988).
Generics configure campaigns for access to medicine in two related ways. First, there is the often spectacular and conflictual matter of "compulsory licensing," a legal instrument now sanctioned by the World Trade Organization's Doha Declaration (2001), in which national governments can, within particular circumstances, circumvent the original patent-holding companies in order to obtain cheaper versions of specific, still-patented drugs. 3 Thailand and Brazil, for example, have issued compulsory licenses on Merck's antiretroviral drug efavirenz in their efforts to combat HIV/AIDS.4 Such moves are not, of course, exercised solely by nations of the global South. In 2001, the U.S. government signaled to Bayer that the company would be asked to "relax" the patent on the antibiotic Cipro (thus, allowing other labs to manufacture and sell it) in the case of a widespread Second, there is the ostensibly more prosaic matter of "off-patent" generics: medicines that are or can be manufactured and commercialized widely (that is, non- exclusively) after the expiry of the original patent. Off-patent generics thus come into circulation at the arbitrarily "natural" death of the patent (the lifespan of a patent in U.S.
law and most multilateral trade agreements is now 20 years), rather than with its hastened demise or relaxation through compulsory licensing. These are, for example, the many ibuprofens one finds vying for shelf-space with Advil in U.S. pharmacies. Efforts to promote the prescription, consumption, and domestic manufacture of off-patent generics intervene in the question of pharmaceutical access by reconfiguring or, to adapt Michel Callon's language (1998), reformatting national pharmaceutical markets in a broad sense.
That is, easing the entry of (legal) copies into the market is meant to stimulate competition and thus reduce medication costs overall. 6 That parenthetical qualification– the generic as legal copy –signals one of my central concerns in this essay. The two initiatives mentioned at the outset, in Mexico and Argentina, are on first glance markedly similar, and fall very much in line with moves to promote off-patent generics as noted above. Yet, the similarities to each other and to received definitions of a politics of the generic are less stable than they may seem. In Mexico, the turn to generics has, in many ways, been framed as we might expect: that is, as a way to counter the dominance of expensive, foreign-made patented drugs. Generics have emerged there as a new and distinctive kind of product, in commercial, regulatory, and legal terms, and domestic generic manufacturers and commercial outlets have vaulted to newfound visibility in the market.
But in Argentina, the generics question is configured differently. The powerful purveyors of dominant brands in question have largely been Argentine drug companies, which have flourished since the mid-twentieth century by making unlicensed copies of drugs patented elsewhere (the U.S. government calls these drugs "pirated"). Indeed, Argentina effectively does not grant or enforce pharmaceutical product patents; as a consequence, generics exist there in name only. (This is not a rhetorical flourish but a technical detail). As we shall see below, their relation to dominant brands might thus better be described as a difference in degree rather than in legal kind. This scenario throws into question a number of assumptions about the definition of the generic and the problem to which it is a solution: the turn to the generic (name) in Argentina takes its force not against foreign-made, patented "original" pharmaceuticals, but in many measures, against domestic copies.
This small but pointed classificatory matter opens up a thicket of questions about the promise, limits, and specificities of "the generic." Drawing on my research in Argentina and Mexico, this essay addresses, in part, the complex and remarkably different pharmaceutical taxonomies that come to the fore in efforts to bring generics into new economic and regulatory landscapes. This discussion in turn brings to the fore a particular argument about the politics (plural) of the copy. For at stake in the rise and expansion of markets for generic drugs is not simply a David and Goliath relationship between the (cheaper, accessible, democratizing) generic and the (expensive) patented original; also fundamentally gathered into a politics of the generic is the relation between the licit and the illicit copy. This is a point to which international health organizations, pharmaceutical companies, and many national governments are intensely attuned, as multilateral and bilateral trade agreements extending patent rights on drugs into new national contexts have also brought with them restrictive and highly contested redefinitions of what shall count as a legal copy. Yet, this point is often lost in the liberal vocabulary that animates many discussions of pharmaceutical access, in which the template for imagining access ricochets between two possible horizons: if not patented drug (private property), then legal generic (public domain). Among many other iterations of "illicit" copies worldwide, Argentina's domestic copias–neither patented originals nor "generics" – vividly demonstrate the limits of this simple either/or proposition (see also da Costa Marques 2005: 139-140). With this point in mind, I will ask, what are the implications of configuring a political language of access around the terms of intellectual Argentina: Before the generic, there was the copy
Argentina is home to one of Latin America's most powerful domestic pharmaceutical industries, alongside Brazil. While the Brazilian industry has largely been funded by the state (Biehl 2004), 7 "domestic companies" in Argentina are funded by private Argentine capital (Katz and Burachik 1997). Throughout the period of import substitution industrialization (the signature economic strategy of mid twentieth century Latin American nationalist populism and, in Argentina, from the 1930s to the late 1960s), the domestic industry flourished under a set of conditions characterized by a high degree of state protectionism: regulation favoring national companies in the processes of authorizing and launching new products, high import tariffs, and the "weak" protection of international intellectual property standards (Katz and Burachik 1997: 87). Indeed, as a product of the era of import substitution, the Argentine pharmaceutical industry was explicitly and proudly built on the manufacture of copies, precisely in a context in which pharmaceutical patents were not recognized (see Lakoff 204: 195-7). Argentine firms have thus risen to domestic dominance by copying drugs developed elsewhere and marketing them under their own brand names. Domestic labs – the industria copista -- have consistently commanded over 50% of the pharmaceutical market in the country; in 1999, the Argentine laboratory Roemmers was the overall market leader (ahead of U.S., European, Brazilian, and other Argentine companies).8 Argentina's longstanding sanctioned politics of copying has generated accusations of "piracy" from the U.S. government and transnational pharmaceutical firms, particularly since the 1990s, when expanding multilateral trade accords (particularly through the Uruguay Round of the General Agreement on Tariffs and Trade [GATT] in 1988) placed a premium on the protection of intellectual property rights as a trade priority. That is, following the Uruguay Round, signing onto Trade Related Aspects of Intellectual Property (TRIPs) accords became a central condition for developing nations joining the GATT and the World Trade Organization (WTO). Thus, signatory nations must "harmonize" their copyright, trademark, and patent legislation to what are, effectively U.S. standards. To quote former Argentine trade negotiator Carlos Correa, the ascendance of TRIPs has transformed dramatically many developing nations' abilities to exercise what was once a "relative or total freedom to imitate" (Correa 1998: 1).
Following attempts to privatize aspects of the economy during Argentina's military dictatorships (1976-1983), the radical experiments in market liberalization and deregulation initiated by President Carlos Menem in the late 1980s and 1990s indeed seemed poised to put an end to Argentina's practices of copying on several fronts. With Menem's election in 1989, the U.S. thought it had finally found a willing partner in its project to "open" the Argentine economy to foreign investment, competition, and intellectual property protection in a number of arenas, with the large prescription pharmaceutical market—ranked 12th in the world in 1999, with a value of $3 billion U.S.
dollars—serving as a key object of U.S. desire. Consonant with Menem's stated willingness to implement pharmaceutical patents, Argentina signed onto the TRIPs accord of the GATT in 1994 and the legislature subsequently passed a national patent law in 1996 which included pharmaceutical product and process patents. Yet, strong pressure from the powerful domestic industry has kept at bay the implementation of pharmaceutical patents in particular (other domains of patenting have been less controversial). The U.S.-based Pharmaceutical Research and Manufacturer's Association, PhRMA, which has led the charge against what it calls "local pirate firms," has been pointed in its criticism of exceptions written into Argentina's patent law, including, prominently, the right not to grant patents in order to protect "public order" and "morals." These exceptions are understood specifically to signal a longstanding construction of (copied) pharmaceuticals as essential to the Argentine "public good" (see Katz and Burachik 1997: 87-89; Lakoff 2004).
Such wranglings over pharmaceutical patents animated rather vicious trade disputes between the United States and Argentina throughout the 1990s.9 Argentina consistently featured in U.S. State Department and U.S. Trade Representative assessments as Latin America's most egregious pharmaceutical "pirate" (and though a copyright law is also on the books, these complaints were peppered with references to music and film piracy as well). The Clinton Administration levied trade sanctions in 1997 precisely over the pharmaceutical issue. Much has happened in the interim, including the disastrous economic crisis of 2001, largely understood as a direct result of Menem's failed neoliberal "reforms." As matters now stand (in 2007), Argentina technically has a patent law, but effectively does not grant pharmaceutical patents; that is, the law is not enforced for pharmaceuticals.10 This refusal of the pharmaceutical patent does not, however, constitute a blanket rejection of all forms of intellectual property. Brands and trademarks hold an important place in the structure of the domestic drug market. 11 This point is relevant to the fact that one of the key effects of market deregulation in the early 1990s in Argentina was a sharp rise in domestic, "leading brand" drug prices (Lakoff 2004: 196). As Andrew Lakoff notes pointedly, with the removal of state-managed price controls, "domestic firms took advantage of the value structure of the transnational pharmaceutical industry, which is based on patent protection, while at the same time defying such protection" (2004: 196).
Implied here is that the "value structure" of the transnational industry is reliant not just on the patent, but on the value of the recognized brand name. Domestic labs, relying on the latter (the brand name) but rejecting the former (the patent), have not only managed to block the implementation of pharmaceutical patents. They were also instrumental, until González García's post-crisis measures in 2002, in blocking the emergence of a generics market as well. The (absent) patent, the (blocked) generic, and the (dominant) unlicensed copy thus served, until 2002, as the triangulated coordinates of the Argentine prescription Mexico's new generics
In many respects, Argentina's contrast with Mexico could not be more stark.
Mexico's tight economic and political "integration" with the United States has made an Argentina-like stance on pharmaceutical patents nearly impossible to contemplate.
Strong patent, copyright, and trademark legislation was introduced in the early 1990s, as President Carlos Salinas de Gortari's administration paved the way for Mexico's entry into the North American Free Trade Agreement (NAFTA). Moreover, Mexico does not have a domestic pharmaceutical industry with anything like the strength of the Argentine industria copista. There are, in contrast, a number of relatively small generics labs which, from 1950s to the late 1990s, had as their consumers the state-funded public health sector. Following regulatory moves in 1997 to foment a wider market for generics, these labs now have new commercial outlets for their products, in the form of domestic pharmacy chains selling cheaper generic drugs to the wider public (see Hayden 2007). Nonetheless, in the late 1990s and early 2000s, over 90% of the pharmaceutical market in Mexico (in value) was controlled by transnational firms.
Efforts to make generics more widely available there in 1997 and 1998 took shape in a pharmaceutical marketplace essentially divided in two. The largest part of the state's investment in health goes to the state- and employer-funded health insurance and pension program known by its acronym, IMSS, covering those with formal employment. There is a similar program for employees of the state, the military and the nominally state-run oil company; a network of poorly funded hospitals for those without recourse to any of the above; and a new insurance plan, the Seguro Popular, that seeks to enroll this latter category of the "uncovered" in a hybrid form of health coverage drawing on individual contributions and decentralized state funding. With the exception of the Seguro Popular (a relatively new experiment), these state institutions have their own pharmacies, which for the most part distribute unbranded, off-patent generics.
Many people –those who can afford to do so, those who for contested reasons of patronage have been kept out of IMSS, those who do not have access to IMSS because they work in the "informal" sector, or those who feel they cannot take an entire day off of work to wait for an appointment— instead pay for private care, which in turn directs patients to private (not state-run) pharmacies. Until the late 1990s, the majority of drugs prescribed and sold in these corner pharmacies and other commercial outlets were relatively pricey name-brand "originals" or inovadores; generics were simply not available commercially. This situation was identified as a source of increasingly untenable out of pocket costs for the many consumers who, for one reason or another, bought their drugs in commercial pharmacies. The problem became particularly acute in the years between 1995 and 1997, when the public sector pharmacies began experiencing shortages of many of the drugs in their basic pharmacoepia; these patients also turned to private pharmacies. The move to generics in Mexico was thus designed to channel a wider range of cheaper, off-patent generics into regular corner pharmacies and thus, presumably, into consumers' hands.
The travel of the generic out of Mexico's public sector pharmacies and into the public sphere of the marketplace --that is, as a new commercial and regulatory category –has produced a flurry of controversy, public relations and media battles, and contested claims about the site and source of a drug's "quality." Indeed, the generic emerged as a novelty that required some explanation, not to mention promotion. The Secretary of Health and domestic pharmacy chains launched public relations campaigns promoting the idea that a drug can be de-coupled from its (best-known) brand name, and can be re- imagined as one of many possible vehicles for delivering a key substance or active ingredient. The dominance of foreign drug companies such as Roche, Merck, and Schering-Plough has fuelled a fair amount of nationalist marketing on the part of emergent pharmacy chains such as Farmacias Similares (Hayden 2007). For their part, transnational companies and their domestic affiliates have put up a fierce fight in an effort to stem this insurgent tide of cheaper competitors, placing the idea of "quality"(and its ostensible attachment to the recognized name brand) at the center of their efforts to redefine these legal copies as somehow less than licit.
Contested as it may be, this ongoing reconfiguration of the pharmaceutical marketplace in Mexico has been defined around the operative terms of two kinds of intellectual property law that, as in the U.S., function in a closely related manner to convey priority to the original drug: "the brand" is associated with "the patented original," and the legal or licit copy emerges both chronologically and semiotically as a cheaper "second." Here, the generic and its many siblings (interchangeable generics and branded generics) step in as the other(s) to the original, patented, or brand-name drug.
Though the proliferation of kinds of copies does not map easily onto U.S. or European pharmaceutical taxonomies, the structuring division of prior, patented drug versus copy (or copies) is the same; it is, after all, the division conventionally understood to be embedded in intellectual property law itself. But this opposition is difficult to sustain in Argentina and the seriality of the copy
What is the landscape in which "generics" are meant to intervene in Argentina? As noted above, it is a landscape (already) dominated by copied drugs. Copias are copies in a few senses. First, they are often reverse-engineered from the drugs developed and patented by foreign companies such as Merck, Eli-Lilly, and Schering-Plough. Thus, high profile Argentine companies such as Gador, Roemmers, and Bagó launch products in the domestic market under their own brand names, often even before the originating brand makes its appearance, if it appears at all.12 For example, in several of the top- selling pharmaceutical niches (such as hypertension drugs and certain classes of psychopharmaceuticals), the two or three top-selling drugs are made by Argentine companies, with the "originator" trailing behind (see also Lakoff 2004). Already, then, in terms of both temporality and a predicted period of "market dominance," copias wreak havoc with a conventional notion of the copy's secondary relation to the patented We might usefully think instead in terms of seriality. Theorists of a markedly different realm of intellectual property and industrial production—Anglo-American copyright regimes regarding literature, works of art, and other cultural productions—have made amply clear that certain kinds of products (mass produced cultural works) do not always or fundamentally revolve around their relation to a presumably foundational "original" (Frow 1988; Lury 1993: 43-44). As Celia Lury notes, drawing on Umberto Eco, a notion of seriality (such as in the TV series) can overshadow the straw idea of the copy as a replica of and therefore deviation from an authentic original (Lury 1993: 42- 43). 13 Though we are indeed talking about quite different objects and forms of production, circulation, and consumption, this analytic shift of emphasis to the copy as part of a regime of seriality is intensely germane to the context at hand. Indeed, it points us to feminist and post-structuralist interventions that would have us think about "the original" itself as an iterative copy (Butler 1990).
For in the Argentine pharmaceutical market, all drugs literally have a serial relation to other drugs on the market ; that is, copias join presumably "original" brands (which have no purchase as such) in an often astonishingly large, horizontal field of like products. Consider the best-selling pharmaceutical in Argentina, the hypertension drug, enalapril (the name of the molecule, not a brand name). In 2006, there were thirty brands of enalapril on the market, including Roemmers' Lotrial, Bayer's Baypril, Merck's Renitec, and the Argentine lab Raffo's Enalafel. Each of these products is considered a brand, but none is the brand in the sense that is assumed and enforced in the U.S. or that has been in operation in Mexico since the early 1990s – that is, privileged as the original, patent-holding, brand name drug.
While the effect in some senses is a remarkably level field where the patent is (not) concerned, we might also note that in the midst of all of this likeness, hierarchies do emerge. One of these thirty drugs is likely to stand out from the field as the best-selling or leading brand, la marca líder. How do these two measures of distinction – a patent- centered notion of originality or priority and a trademark-centered notion of the leading brand-- relate to each other? In this context, there is no necessary correlation between them. The U.S.-based pharmaceutical company Merck, Sharp and Dohme was the original developer and patent-holder on enalapril, which it markets as Renitec. In the two years before the expiry of its U.S. patent (in February 2000), Renitec was Merck's second best-selling drug worldwide.14 But in Argentina, the leading brand, for the last twenty- five years – that is, from the time enalapril was patented and marketed in the U.S. and elsewhere--, has been Roemmers' Lotrial (González García 2004).
Everything a copy, everything a brand
This decentering of patent-protected "originality" makes the Argentine pharmaceutical market similar to the many other arenas in which intellectual property rights are an oddity and a threat rather than a naturalized form of social, legal, and technical relations (see Vann 2006). Yet we would do well to note the particular dimensions of this decentering in Argentina. As we have seen, at work is not the wholesale absence of intellectual property but rather a reorientation of the relationships between different forms thereof. As Daniel Maceira described the scenario to me, in Argentina, the brand is "divorced" from the patent (Maceira, interview, 2006), thus flattening out and re-wiring the temporal horizon which, in other contexts, purifies the "original" as distinct from and prior to the copy.
This decoupling of the brand from the patent has a number of important corollaries which, together, help set the stage for a consideration of what a generic drug is – and is not -- in this context. First, in the Argentine market, as my interlocutors noted repeatedly, all drugs are, from the outset, brands. Thus, simultaneously, all are copies, in the sense of being one of many. Todos son de marca; todos son copias. Second, as noted previously, leading Argentine copias are not necessarily cheaper than other brands, including those made and commercialized by foreign companies. For example, as the longstanding leading brand (marca líder), Roemmer's Lotrial ranks with Merck's Renitec among the more expensive brands of enalapril, while Bayer (a German company) and Duncan (from Argentina) are among the labs offering sometimes markedly lower prices for the same presentation.15 Third (and therefore), very much unlike in Mexico, hierachies of value, credibility, and even price are not primarily organized around the axis of the original versus the copy, or even the foreign versus the national. Rather, when I asked pharmacists how they narrow the field of potential products in order to make a recommendation, especially in a well-populated class such as the enalaprils, they routinely made a distinction between the reputable "big labs"—a list in which the domestic and the foreign mix easily (Roemmers, Bagó, Merck, Duncan, Bayer) -- and the "little labs" that "no one has heard of." In the case of enalapril, these were smaller Argentine laboratories and a few Brazilian labs.
Without doubt, the bigger Argentine drug laboratories have had a tremendous hold on "brand recognition" among physicians, pharmacists, and consumers. This hold is achieved through various means, from engaging in the kind of direct-to-physician marketing often associated with transnational labs (Lakoff 2004) to their tight relationship to the obras sociales, the mutual associations that are a major form of social insurance for many people in Argentina. Obras sociales provide medication coverage and health plans for most people with formal employment; these associations contract with particular pharmacy networks and offer 40% discounts on drugs to their members.
For the most part the covered drug in any given category will be the marca líder, which is often a national product. The power of regulating such access should not be underestimated: the obra social for retirees, which is known by its acronym PAMI, alone accounts for almost 50% of the prescription pharmaceutical market in the country (Tobar, interview, May 19, 2006).
No patent, no generic
Where does the generic fit in this picture? Most pointedly, what room is there for the generic when the brand is unmoored or divorced from the original, and when there is, indeed, no patent? Many people argue that generics do not actually exist –in fact, they cannot exist -- in Argentina. For the physicians, policy-makers, and pharmacists whom I interviewed in 2006, the point is simple. Without patents – the horizon against which the generic is defined-- there is simply no such thing as a generic. Sin patente, no hay genérico. This elegant double refusal draws our attention directly to the defining, and limited, status of the generic drug as a juridical object, often described or assumed to be the "opposite" of, or the outside to, the patented molecule. It thus draws our attention to the specificities of a U.S.-centered perspective on intellectual property, unsettling some easily assumed legal and political vocabularies that place their limits at the organizing axis of private (the patent) and public (the generic). 16 Clearly, the generic is anything but "generic" – generalized, or undifferentiated (see Homedes and Ugalde 2005; see also Hayden 2007). It is a highly specific, legal, technical object, which is defined in its strongest and clearest sense in the context of an enforced patent regime. If the generic requires and assumes the patent, then in Argentina, it is a non sequitor.
However, although "there is no such thing as a generic" in Argentina, there are pharmacies that advertise generic medicines, pharmacists who sell them, and people who consume them, in all senses of the word. What is circulated, then, under the name of the generic? It would be more accurate to say "under the generic name," for the generic does not operate in the Argentine context at the level of ontological or legal thing-ness.
Rather, it operates through signification; that is, through the process of re-naming existing pharmaceuticals. 17 As I was told emphatically by Federico Tobar, the energetic and thoughtful pharmaco-economist who currently directs the Secretary of Health's Programa Remediar, the unique approach of Argentina in this matter is precisely that it did not create a new market for a new thing called generics. Here, the contrast with Mexico surfaces again, and this time the question of copying versus innovation surfaces, playfully, at the level of national policy. Tobar argued, Mexico was a copy. That is, the Mexican policy is a copy of the American policy, right? The only pharmaceutical politics (or policy) that was truly innovative was ours. In what sense? Well, the United States created an additional market, we could say. It created two markets: one market for original drugs under patent protection, and one market for generic medicines. Argentina's innovation was that the law we passed, 24C49, does not produce a market in generics, like what the United States, Mexico, and Brazil did. It only decrees that you must use [prescribe] drugs by their generic name… So, we didn't create a market in generics. What we did, by decree and by force, was turn all medicines into generics (emphasis added). (May 19, 2006) All drugs are copies, all are brands – and, in Tobar's assessment, in one fell swoop, all became "generics" as well. That is, all drugs on the market already have a generic name (the name of the molecule on which the drug is based) and it is this name which now must be prescribed. The 2002 law is thus meant to enable and encourage physicians, pharmacists, and consumers to rename (or we might say retroname) existing products and thus to re-think their relation to each other. This move re-embeds "leading brands" back in a field of similarity and substitutability.18 While mechanisms of "generic-ization" in Mexico and Argentina differ substantially, in many ways their rationales are not radically divergent. Despite its formal, legal impossibility in Argentina, the generic is a concept that does in fact intervene in a way that one might expect, and that falls in line with the intentions signalled by the Secretary of Health, Ginés González García. That is, as with the situation in Mexico, relatively expensive brand name drugs do dominate the Argentine pharmaceutical market, and physicians and consumers alike have been effectively made aware of dominant brands. The project around which the generic (name) is organized in Argentina, as in Mexico, is to enable and encourage consumers to enter a pharmacy and ask for enalapril (the compound) and not Lotrial, the leading brand. This reformulation of the commonplace, formulaic question, "do you have [insert molecule here]…?" is precisely the moment of substitution on which a promise of improved access to "health," at least in the form of pharmaceuticals, is seen to rest.
Yet of course the key difference between Argentina and Mexico on this front is that in the former, many (but not all) of the expensive, dominant brands are also already copies. In my research in Buenos Aires in 2006, I asked a wide range of pharmacists, including those who work in new pharmacy chains that specifically sell generics, to help me understand the difference between a copied brand that sells as a brand, and a copied brand that sells as a generic. In Villa Lugano, a working class neighborhood on the outskirts of Buenos Aires, one pharmacist explained: "well, the thing is, they're all the same – everything on these shelves (all stocked with generics) is a brand. What happens is that if people don't recognize a drug from TV [he gestured towards the television mounted high in the corner of the small storefront], then it must be a generic" (interview, May 31, 2006).
This rule of thumb actually holds in many ways. The pharmacies that exclusively sell generics are selling drugs made by the small labs that "no one has heard of," with very little marketing budget. These drugs sell more cheaply than many of the well- known copias made by the bigger Argentine labs, most of which have a vivid presence on billboards, on advertisements in the subway, on television and radio, and in physicians' offices. In a context in which all medications are brands, and all are copies, it is the combination of price, reputation, and marketing presence that, for now at least, differentiates the brand from the generic. In other words, the concept of the generic in Argentina emerges not out of patent law, but rather, out of marketing.19 Languages of access
I argued above that the Argentine double refusal – no patent, no generic-- draws our attention to the specificities of a U.S. perspective on intellectual property, unsettling a vocabulary both organized and limited by the axis of private property (the patent) and public domain (the generic). It is only within this framework, of course, that we might automatically define a generic as that which is not patented and branded by a Merck or a Wyeth (Maceira pers. comm. May 29, 2006). With Argentina's copias firmly in view, we must note the degree to which this formulation seamlessly naturalizes the generic (and by extension, the public domain) as both residual in relation to the patent and total in relation to all that is left: everything that is not Merck must be a generic. In the context of contested international trade negotiations and reconfigured national regulatory and commercial landscapes, this is not a descriptive statement, but a normative one.
Let me explain with reference to some of the effects we might identify from recent efforts in Mexico and Argentina to improve pharmaceutical access through a turn to the generic, or at the very least, the generic name. First, in both Mexico and Argentina, the emergence of (something named) generics has resulted in documented decreases in pharmaceutical prices and the broader availability of cheaper medicines (Espicom 1999; González García 2004). "Access," understood specifically and arguably problematically, as an increase in private consumption particularly among the poor, may indeed improve with efforts to bring cheaper, lesser-known drugs into a market dominated by expensive, At the same time, the notion of the generic does not only "open up" access through the enhanced circulation of (some) copies. Its regularization also disciplines and closes down the circulation of (other) copies. This, we might say, can be a second effect of processes of generic-ization. Consider the wide range of terms for copied prescription pharmaceuticals currently operating in Mexico and Argentina: "similar" drugs, interchangeable generics, regular generics, and branded generics in Mexico; and "copias," "genéricos," drugs made by big labs, drugs made by little labs, and drugs made by the state, in Argentina. The arrival of a particular kind of copy called the generic, within such heterogeneous pharmaceutical taxonomies, can have powerful disciplining effects. The argument is particularly pointed in Mexico, where federal health regulators and transnational industry associations have worked together to institute new regulations that will eliminate all kinds of legal (off-patent) copies from the market except the most restrictive category of generic, the "interchangeable generic." This designation signals that a copied drug is not only based on the same active substance as the patented original, but that it has also been subject to relatively costly "bioequivalence" trials on human subjects, to test the rate of absorption of the drug into the bloodstream. Such trials are not required for other categories of generics and copies in Mexico (Hayden 2007). The move to name interchangeable generics as the only legitimate kind of copied drug within a field of legal copies is complex, to say the least. It is made in the name of "quality" – itself a highly charged political as well as public health matter --but, as the directors of several domestic generics labs have noted, it also produces a costly obstacle to the entry of domestic companies into the generics market (see Hayden 2007). In Mexico, the interchangeable generic figures strongly in efforts to subject the unruly world of copied pharmaceuticals to standards and terminology that are, as the business intelligence community likes to say, "internationally compliant." But what of Argentina, in which the generic (name) enters a field of like products in such a way that the kinds of domaining effected in Mexico seem almost irrelevant or at least- for the moment- impossible? This temporal qualifier is important, for the classificatory universe sketched above should not necessarily be expected to remain static for long. Referring to the distinctive feature of current Argentine pharmaceutical patent law, which exists but is not enforced, Federico Tobar told me: "We have a patent law, but we don't give [pharmaceutical] patents. It's brilliant. It's also a bit like spitting into the air; sooner or later it will come down and hit you in the face" (pers. comm. May 19, 2006). Tobar was not alone among my many interlocutors in suggesting that an enforced pharmaceutical patent regime in Argentina is a distinct possibility within the next decade; a bit like the effects of gravity, he suggested, it may well be inevitable.
In this case, we might expect the generic to do and be different things as well.
Consider the current situation in India, whose powerful drug industry has long been a key supplier of cheaper "generics" for Brazil, Thailand, and other nations in the global South as well as the global North (see Sunder Rajan 2006; Shadlen 2007). As in Argentina, the Indian industry was forged in the absence of a pharmaceutical patent regime, and the leading brands have tended to be domestically-made copies (Ecks, pers. comm., January 30, 2007). Yet, on January 1, 2005, India's ten-year period of exemption from TRIPs came to an end and a new pharmaceutical patent law entered into force. Stefan Ecks notes what might be expected in the coming years, as he has observed the simultaneous emergence of a notion of original drugs and consequently of "generics": "the increasing entry of patent-protected ‘originals' for the first time creates the perception of ‘generics' [as a distinctive kind of drug] among Indian patients" (Ecks, pers. comm., 2007; original Indeed, as pharmaceutical patent regimes do come into force (with all due regard for the considerable contestation and heterogeneity thereof) in nations such as India and – possibly --Argentina, we may have to pose a question about corollary forms of expansion. In India, and perhaps in Argentina, the categorically distinctive object called the generic arrives not against the patent, but in a neatly bundled package with it. For the legally sanctioned public domain travels only as far as does intellectual property. It is in this sense that I am interested in both the promises and the limits of a politics of access, equity, and distribution tethered to the language of intellectual property itself. This point is relevant not only to the matter of copied pharmaceuticals, but also to a wide range of arenas of knowledge- and technological production in which alternative strategies for ensuring equity of access and distribution have come to be configured through the idiom of the public domain. I would thus urge a critical awareness of the implications of ever- expanding commitments to "securing" the public domain or "commons." In many progressive political- technical projects in the U.S. and Europe, these idioms have come to stand for the only possible antidotes to the excesses of privatization. But does the legally sanctioned public domain constitute the only idiom or mechanism through which to re-think access, equity, and a politics of copying? This query does not necessarily make the "illicit" copy into the answer to problems of (pharmaceutical) access. This essay is organized, after all, around the fact that the absence of the patent and the prevalence of unlicensed copies in Argentina have not helped "access" in the form of a proliferation of cheaper drugs; it is the high prices of unlicensed copies that prompted Argentina's 2002 generic prescription decree in the first place. Rather, I am concerned with a too-easy reification of the public domain as both the universal and constitutive "outside" or antidote to the patent and to other forms of intellectual property. We have been reminded in other contexts—particularly, in indigenous and postcolonial critiques of renewed interests in bioprospecting and biogenetic collection-- that the public domain is made and not found. If pharmaceutical access is to be configured around the question of what may count as a viable politics of the copy, then it is both analytically and politically important that we not lose sight of this point, and its incitement to analyze the domaining effects of intellectual property and its corrollary, the public domain.
I gratefully acknowledge the thoughtful engagement, comments, and assistance of Andrew Lakoff, Daniel Maceira, Federico Tobar, Horacio Sívori, Carlos Forment, Sylvia Hirsch, Mario Biagioli, Ivan da Costa Marques, Stefan Ecks, Ken Shadlen, and Hélène Abbott, Frederick. 2005. "The WTO Medicines Decision: World Pharmaceutical Tradeand the Protection of Public Health," American Journal of International Law 99: 317-358.
Biehl, Joao. 2006. "Pharmaceutical Governance," in Adriana Petryna, Andrew Lakoff,and Arthur Kleinman, eds. Global Pharmaceuticals: Ethics, Markets, Practices, pp. 206-239. Durham, NC and London: Duke University Press.
-----. 2005. Vita: Life in a Zone of Social Abandonment. Berkeley and Los Angeles:University of California Press.
-----. 2004. "The Activist State: Global Pharmaceuticals, AIDS, and Citizenship inBrazil." Social Text 22 (3):105-132 Butler, Judith. 1990. Gender Trouble: Feminism and the Subversion of Identity. Londonand New York: Routledge.
Callon, Michel. 1998. "Introduction," in The Laws of the Markets, edited byMichel Callon, pp. 244-276. Oxford: The Sociological Review.
da Costa Marques, Ivan. 2005. Cloning Computers: From Rights of Possessionto Rights of Creation. Science as Culture 14 (2): 139-160.
Espicom Business Intelligence, Limited. 2003. Report on Mexico. WorldPharmaceutical Markets Series, April 11.
González García , Ginés. 2004. "Presentactión de la Política Nacional de Medicamentosen la República del Perú." 29 March. Available athttp://www.msal.gov.ar/htm/site/discursos_des.asp?ID=39. Last accessed 15 May 2007.
Greenslit, Nathan. 2002. Pharmaceutical Branding: Identity, Individuality, andIllness. Molecular Interventions 2:342-345.
Hayden, Cori. 2007. "A generic solution? Pharmaceuticals and the politics of the similarin Mexico." Current Anthropology 48 (4): 475- 495.
Homedes, Núria and Antonio Ugalde. 2005. "Multisource drug policies in LatinAmerica: survey of 10 countries," Bulletin of the World Health Organization 83(1): 64-70.
Katz, Jorge and Gustavo Burachik. 2007. "La industria farmacéutica y farmoquímicaargentina en los años 90," pp. 81- 123. In Jorge Katz, ed. Apertura Económica yDesregulación en el Mercado de Medicamentos. Buenos Aires: CEPAL/IDRC, AlianzaEditorial.
Lakoff, Andrew. 2005. Pharmaceutical Reason: Knowledge and Value in GlobalPsychiatry. Cambridge, UK: Cambridge University Press.
-----. 2004. "The Private Life of Numbers: Audit firms and the Government of Expertisein Post-Welfare Argentina ," in Stephen Collier and Aihwa Ong, eds. GlobalAssemblages: Governmentality, Technology, Ethics. New York: Blackwell, pp. 194-213.
Lury, Celia. 2004. Brands: The Logos of the Global Economy. London and New York:Routledge.
Petryna, Adriana, Andrew Lakoff, and Arthur Kleinman, eds. 2006. GlobalPharmaceuticals: Ethics, Markets, Practices. Durham, NC and London: DukeUniversity Press.
Shadlen, Kenneth. 2007. "The Political Economy of AIDS Treatment: IntellectualProperty and the Transformation of Generic Supply." International Studies Quarterly 51:559-581.
Strathern, Marilyn. 1980. "No Nature, No Culture: The Hagen Case." In Nature, Culture,and Gender, Carol MacCormack and Marilyn Strathern, eds., pp.174-222.
Cambridge: Cambridge University Press.
Sunder Rajan, Kaushik. 2006. Biocapital: The Constitution of Postgenomic Life.
Durham, NC: Duke University Press.
Tobar, Federico. 2004. "Políticas para promoción del acceso a medicamentos: El caso delPrograma Remediar de Argentina." Technical Paper 002/2004 presented to theInteramerican Development Bank, Washington, DC, January.
van der Geest, Sjaak and Susan Reynolds Whyte, eds. 1988. The Context of medicines indeveloping countries : studies in pharmaceutical anthropology. Amsterdam: HetSpinhuis Publishers.
Vann, Elizabeth. 2006. "The Limits of Authenticity in Vietnamese Consumer Markets."American Anthropologist 108(2): 286-296.
1 The relationship between the roiling crisis and medication shortages is not astraightforward one; it is not just that prices skyrocketed and therefore people could notafford them, though this certainly happened. Argentine human rights organizations and other chroniclers of the crisis have also documented acts of financial speculation andhording by the droguerías, the powerful distribution committees which act asintermediaries between laboratories and pharmacies. The accusation is that thedroguerías fueled shortages by not releasing drugs to pharmacies unless each previousdelivery was paid off in full. Given the devaluation(s), such payments becameincreasingly impossible for many pharmacies, leaving these commercial outlets withoutinventory. In particular, shortages of insulin led well-organized diabetes advocacy andpatient groups to force the government to declare a medical emergency. I am grateful toSylvia Brunoldi of the Liga Argentina de Protección al Diabético for her perspective onthese questions (interview, May 22, 2006).
2 In this program, the government buys medicines at low cost from transnational firms.
These medicines are distributed for free (and in packaging that does not display acommercial name), through Primary Care Centers (CAPs) that are located throughout thecountry (Tobar 2004).
3 The Doha Declaration is formally entitled the Declaration on the TRIPS Agreement andPublic Health (Nov. 14, 2001), Doc. WT/MIN(01)/DEC/2 (Nov. 20, 2001). For a helpfuloverview, see Abbott 2005.
4 See the press release posted on the website of the organization Knowledge EcologyInternational,http://www.keionline.org/index.php?option=com_content&task=view&id=46&Itemid=1,last accessed May 15, 2007.
5 For an excellent discussion and links to resources see the website of the Washington,D.C.-based organization, Center for the Project on Technology,http://www.cptech.org/ip/health/cl/cipro/.
6 There has been precisely such a reconfiguration in the United States following the 1984Hatch-Waxman Act, which removed some of the previously existing barriers to generics'entry into the market once a drug patent expired.
7 It should be noted that in Brazil, state financing of the biomedical and pharmaceuticalsectors has been accompanied, since 1996, by what Joao Biehl calls a dynamic relation totransnational firms, who have remained highly involved in the Brazilian market forantiretrovirals (Biehl 2004, 2005, 2006).
8 As Andrew Lakoff notes, the Argentine pharmaceutical market is, in this sense, "apeculiar one": Argentina joins the United States, Germany, Switzerland, and Japan in alist of "the only countries whose domestic producers have a greater market share thanforeign ones" (2004: 196).
9 See the excellent, extensive timeline of this dispute posted on the website of theWashington, D.C.-based Center for the Project on Technology:http://www.cptech.org/ip/health/c/argentina/argentinatimeline.html10 There was a flurry of activity in 2000 in which 82 patents were granted, out of a marketthat contains thousands of products.
11 Though not always to the degree that foreign companies would like. One mightconsider here the etiqueta (label) shops in Buenos Aires selling labels and tags withnames and logos ranging from those of neighborhood community groups to Wrangler andother transnational brands.
12 Consider Lipitor, the brand name of Pfizer's blockbuster chloresterol-lowering drugatorvastatin, which is still under patent (but as we know through the distinctive mediumof spam, something called "generic Lipitor" is widely available online. Pfizer is pursuinglegal action against those internet merchants). In Argentina there are three atorvastinproducts on the market, two made by Argentine laboratories (Northia and BioquímicoArgentina) and the third by the Brazilian lab Richet. Pfizer itself does not directly marketLipitor or atorvastin in Argentina.
13 Even here, though, theoretical discussions tend to require a theory of novelty ororiginality that can be located within the copy. In the context of the serial TV show, forexample, or the detective novel, seriality allows a space for novelty or variation withinthe form of the formulaic copy itself (see Lury 1993: 42-43).
14 Current Patents Gazette February 18, 2000, available athttp://220.127.116.11/search?q=cache:fP26dmwyBv8J:scientific.thomson.com/ts/media/cdjournals/gazettenews/2000/CPG_News_0007.pdf+enalapril+patent&hl=en&gl=us&ct=clnk&cd=2.
15 As of May 2007, sample list prices for a package of 30 pills at 10mg each were asfollows: Merck's Renitec, $26.89 (Argentine pesos); Roemmers' Lotrial, 19.79; Bayer'sBaypril, 17.42, and Duncan's Enaldun, 14.81. http://www.alfabeta.net.
16 It also, not incidentally, recalls anthropologist Marilyn Strathern's pointed doublerefusal,"no nature, no culture"(Strathern 1980), on which I draw with some poetic licensehere. Strathern's essay by that title drew on work in Melanesia to argue against easyrecourse to familiar, and linked chains of oppositions (public/private, male/female,nature/culture) in ethnographic analysis. Needless to say, "Argentina" and "Melanesia"serve as placeholders for different kinds of difference vis-a-vis Anglo-Americantechnical, legal, and epistemological norms and forms. But as noted in the text, thedouble refusal does analogous work here.
17 Lakoff articulates the point well in his discussion of the Argentine pharmaceuticalmarket in the late 1990s, when he notes that "… key developments were taking place interms of crafting brand-consumer relationships rather than at the level of making newthings" (Lakoff 2004: 196). His reference was to the production of copied drugs ratherthan "new" or "innovative" drugs (and the importance of the branding relationship to theformer) but the same could be said of the emergence of a move towards "generics."18 We might note that this is a kind of branding or marketing in reverse , in which"interchangeability" and similarity become, themselves, marks of distinction. This is apoint worthy of elaboration; space constraints prevent me from doing so here.
19 See Nathan Greenslit (2002) for an inverse account of the degree to which marketingtechniques are, in the U.S., being used to justify extending patents on essentially the"same" molecules whose patents are on the verge of expiration.
Anthony N. Lawrence, III Tony Lawrence was born in Pascagoula, Mississippi on April 3, 1965. He is the son of Anthony & Darla Lawrence of Pascagoula. He graduated from Our Lady of Victories High School in 1983. He attended The University of Southern Mississippi, receiving a Bachelor of Science Degree in History and Political Science in 1987. He attended The University of Mississippi School of Law, receiving his Juris Doctor Degree in 1990. He was admitted to the practice of law that year. He also is admitted to practice law in all courts in the State of Alabama. Mr. Lawrence began his practice in a general litigation firm and tried civil lawsuits in both Mississippi and Alabama. He served as Assistant District Attorney from 1996 to 1999 in the Nineteenth Circuit Court District and as a Special Prosecutor in other Circuit Court Districts in the State of Mississippi. He joined the law firm of Colingo, Williams, Heidelberg, Steinberger, & McElhaney on September 20, 1999, and practiced primarily in the area of medical malpractice defense. Mr. Lawrence was elected District Attorney for Jackson, George, and Greene Counties in November 2003 and is presently serving in that position, having been reelected in 2007 and 2011. Mr. Lawrence is a member of the Mississippi Bar, Alabama Bar, Jackson County Bar, the National District Attorneys Association, the Mississippi Prosecutors Association and the Association of Government Attorneys in Capital Litigation. He has served as Special Judge in the Jackson County Youth Court. Mr. Lawrence has served as Vice-President, President-Elect and President of the Mississippi Prosecutor's Association and on the Board of Directors for 7 years. He was appointed by Governor Haley Barbour to serve on the Children's Justice Act Task Force. Mr. Lawrence has been an Adjunct Instructor of Criminal Investigations at the Mississippi Gulf Coast Community College – Jackson County Campus and the University of Southern Mississippi at the Long Beach campus. Mr. Lawrence was appointed by Governor Phil Bryant to the Judicial Appointment Governor Advisory Committee and the Governor's Teen Pregnancy Task Force. He has served as President of the Singing River Soccer Club, and was a founding officer in the Mississippi Coast Futbol Club. He has coached youth sports for approximately 27 years and served as coach for the Resurrection High School Varsity Girls Soccer Team for 8 years and as head coach for Resurrection Varsity Boys Soccer Team for 5 years. He coached Resurrection High School Mock Trial Team for over 15 years and volunteers as a Guest Lecturer in area schools. He is married to Anita Lawrence, the former Anita Williamson, and they have two children, Taylor age 23, and Bay age 19. They attend Our Lady of Victories Catholic Church.