St Comp Int Dev DOI 10.1007/s12116-015-9183-5

Narrowing the Gaps in Global Disputes: the Case of Counterfeits in Kenya Nitsan Chorev 1

# Springer Science+Business Media New York 2015

Abstract This article investigates the nature and potential trajectories of global disputes. Conventional accounts of global disputes often see them as inherently openended so that actors can always roll back previous defeats; alternatively, pathdependent accounts emphasize the likelihood of those who prevail in early struggles to reproduce their advantaged position. Like path-dependent accounts, I argue that disputes are nested, so that the goals and possible outcomes of new disputes are bounded by the results of earlier disputes—but rather than enlarging the gap between the parties to the dispute by reproducing advantages, nested disputes, on the contrary, lead to the narrowing of positions and to lower stakes. I illustrate this argument by describing two constitutive moments in the debate over intellectual property rights in Kenya: first, the debate around the Industrial Property Act over the exceptions to intellectual property rights; second, the debate around the Anti-Counterfeit Act over whether anti-counterfeit measures should apply to medicines. Keywords Path dependence . Intellectual property rights . Kenya . Counterfeit

Introduction Debates over access to medicines in Kenya around 2008 in some respects resembled debates in South Africa a decade earlier. 1 In both cases, brand-name pharmaceutical companies and health activists were entangled in a bitter legal dispute over the scope of Earlier versions of this paper were introduced in the BAccess to Medicines in the Global South^ workshop at Brown University; BThe Future of Democracy After Neoliberalism: Social Movements in a Globalizing World^ workshop at the University of Tokyo; and BGlobal Diffusion^ workshop at Princeton University. I would like to thank all of the participants for their valuable comments, including Kenneth Shadlen, Peter Evans, Andreas Wimmer, and Takeshi Wada.

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* Nitsan Chorev [email protected] 1

Department of Sociology and Watson Institute for International Studies, Brown University, Providence, RI 02903, USA

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intellectual property rights—in South Africa, the dispute was over the Medicines and Related Substances Control Amendment Act (Medicines Act); in Kenya, it was over the Anti-Counterfeit Act (ACA). In both cases, moreover, the disputed legislation was hardly a local matter but part of a larger, transnational struggle. Some of the rhetoric employed by health activists in Kenya resembled the rhetoric that they have used since their victory in South Africa. And, prominent experts on the politics of intellectual property rights often referred to the Kenyan Anti-Counterfeit Act as a simple reiteration of previous struggles. Susan Sell, for example, explicitly sees it as an attempt by multinational companies (BIP maximalists^) to counter recent drawbacks. Sell writes (2010: 2), Proponents of an IP maximalist agenda increasingly have been rebuffed in recent years. Developing country governments, NGOs, and Access to Knowledge (A2K) advocates have thwarted their efforts to ratchet up standards of intellectual property protection in multilateral intergovernmental forums… A2K advocates challenge the premises behind ever higher and broader intellectual property protection and seek, if not a rolling back of IP rights, at the very least a standstill… Undaunted by recent setbacks at the multilateral level, IP maximalists have launched a major, almost surreptitious, anti-A2K campaign focused on Bcounterfeiting,^ Bpiracy,^ and Benforcement.^ Sell suggests here that the new debates, including debates over counterfeit drugs, are simply new ways (novel venues, new rhetoric) by which to gain (or regain) the same goals as in previous debates. She also implies that this is not impossible, that is, that new debates do allow to Broll back^ previous arrangements. In this paper, I offer an alternative interpretation, which allows us a different view not only of the struggles over intellectual property rights but of transnational struggles more generally. I argue that rather than being a reiteration of previous debates— meaning that the parties are pursuing the same goals as the ones they have fought for in earlier debates and consequently that the stakes remain as high as they were earlier— the debate over counterfeit drugs is a Bnested^ debate. By a nested debate I mean a debate where parties’ claims and what they attempt to achieve is nested in—and therefore constrained by—previous victories and losses. In such a debate, the gap between the two parties’ positions is in fact narrower and the stakes in the debate are correspondingly lower. In the case of intellectual property rights, the original debate was over whether or not intellectual property rights should fall under an international trade regime; later, the fight was over the scope of permissible flexibilities under that regime; and now the fight is over the quality, rather than broader issues of legality, of generic versions of patented drugs. The position in the literature that sees every new debate over intellectual property protection as a novel opportunity to gain new victories or roll back previous defeats reflects a pluralist understanding of the transnational sphere, according to which numerous actors—both state and nonstate—are active in Bgoverning,^ and struggles between camps are resolved based on available material and nonmaterial resources at hand. This account, however, ignores the tendency of struggles to narrow in the move from one fight to the next. An alternative view that may account for the narrowing of the debate is that of path dependence. However, unlike the literature on path

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dependence that emphasizes Bincreasing returns^—and therefore the likelihood of those who prevailed in early struggles to reproduce their advantaged position—I identify this case as one characterized by Bdiminishing returns,^ in which, on the contrary, the path narrows the gap between the two parties by forcing both parties to shift their position closer to the other’s. Importantly, this narrowing of the gap is not the outcome of an emerging consensus but rather the effects of legal and normative struggles that constrain the strategies available in future disputes for both parties. The analysis here is therefore a useful correction both to analyses that assume a relatively pluralistic international realm and to those that predict the gradual prevalence of one party over the other.

Conventional and Alternative Readings of the Post-TRIPS Regime The intellectual property (IP) regime was quite significantly revamped and strengthened in 1994, when states signed the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) under the auspices of the World Trade Organization (WTO). TRIPS obliged WTO member states to put in place laws to improve the protection of patents, including patents of medicines. But, TRIPS also described a number of permissible exceptions (flexibilities) to the protection of patent holders’ rights. The contours of the IP regime—specifically, whether flexibilities could be used to improve access to medicines in developing countries—soon became a site of bitter struggles between brand-name pharmaceutical companies and some national governments on the one hand and health activists and other national governments on the other. Much was at stake, especially with the spread of the AIDS pandemic and the high prices of antiretrovirals (ARVs) that were under patent. These struggles resulted in two texts that confirmed and defined the scope of flexibilities permitted under TRIPS—the Doha Declaration on the TRIPS Agreement and Public Health, which was adopted in November 2001, and the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, which was adopted on August 30, 2003. Many of the debates over access to medicines both before and after the Doha Declaration have taken place not at the international but at the national level (Chorev 2012a, Kapstein and Busby 2013, Shadlen 2009). One of the earlier debates was over South Africa’s Medicines Act, which allowed for a number of flexibilities in an effort to improve access to affordable medicines. Struggles took place also in Brazil and Thailand (Chorev 2012a), as well as Kenya. Kenya followed South Africa and already in 2001 passed the Industrial Property Act (IPA), which contained a number of TRIPS flexibilities. The IPA included not only the more common flexibilities of compulsory licensing and government use but also a broadly defined permission for parallel importation.2 Seven years later, Kenya emerged as a site of conflict for a second time when it became the first African country to pass a 2

Compulsory licensing allows the government, without the consent of the patent holder, to grant a license to a third-party manufacturer to commercialize a patented invention; government use allows the government, without the consent of the patent holder, to make direct use of the patent; parallel importation allows for the purchase of a patented drug from a legitimate third party (Musungu and Oh 2006).

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new Anti-Counterfeit Act. Health activists warned that the ACA contained a definition of counterfeits that threatened the legality of generic drugs and therefore undermined the achievements gained by the Industrial Property Act. Significantly, the introduction of the Anti-Counterfeit Act in Kenya was part of a broader campaign by multinational pharmaceutical companies that has also included legislative initiatives in other countries and multilateral actions, such as the Anti-Counterfeit Trade Agreement (ACTA) and the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). As with numerous other developments in the struggle over the boundaries of the IP regime (Correa 2006, Deere 2008, Drahos 2010), scholars interested in the access to medicines campaign have considered also the shift in attention to counterfeits as Big Pharma’s attempt to nullify or, at minimum, weaken the gains previously achieved by developing countries and health activists. Susan Sell (2010, 2011), in particular, has argued that even after the Doha Declaration, brand-name pharmaceutical companies continued with their efforts to limit the scope of flexibilities and in other ways expand the protection of intellectual property rights. According to Sell’s analysis, as soon as a certain issue or a venue is Bexhausted^ (in the sense that a specific dispute is resolved, whether in favor of Bpatent maximalists^ or Bpatent minimalists^ [Sell 2010]), new issues emerge and new venues are explored in attempt to reverse previous unfavorable outcomes. Indeed, the analytical tool often used to understand the nature and trajectory of IP disputes is that of venue shopping (or forum shifting)—defined as the activities of strategic actors who attempt to locate or shift policy processes to those settings most hospitable to their interests (Sell and Prakash 2004: 154, Chorev 2006, see Baumgartner and Jones 1993, Helfer 2004, Sell 2011). Thinking in terms of venue shopping offers a useful view of the disputes over IP as related rather than independent of each other—new venues (and, consequently, new claims) are pursued when old venues are exhausted. But, this framing maintains two assumptions that we may want to question, that of static logic and pendular outcomes. Static Logic Sell forcefully describes, BEver since the WTO TRIPS negotiations… [proponents of an IP maximalist agenda] have been using every opportunity to increase intellectual property protection and enforcement beyond TRIPS. They have been relentless, focused, and have devoted untold resources to their quest …^ (Sell 2010). According to this description, in the shift from one dispute to the following one there is little change not only in the perceived interests and preferences of the two parties but also in their claims and what they hope to achieve. While moving from one venue to the next, the fight—both the position of the two parties and what is at stake—remains the same. New claims and justifications made by either multinational companies (MNCs) to expand the IP regime or by health advocates to restrict that regime are seen as opportunistic façades that conceal the fact that the dispute over the boundaries of the IP regime has remained the same. This literature reveals little interest in how new claims might have evolved or how the nature of the struggle might have changed across venues or over time. Pendular Outcomes The range of possible outcomes, in turn, is surprisingly broad. As Sell describes the struggles over the IP regime, BThe past 15 years have been marked by ups and downs, victories and defeats both for those who seek to ration access to

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intellectual property and those who seek to expand access^ (Sell 2011: 448). In addition to the participation of nonstate actors, it is this open-ended nature of the possible outcomes—that is, the fact that each party could potentially prevail—that makes these arguments pluralist in nature. Successful strategies, according to these analyses, could wipe out or nullify previous losses (Abbott and Reichman 2007, Correa 2006, Drahos 2007). In some cases, scholars suggest that this has indeed happened. Sell, for example, suggests that, Bextra-multilateral agreements… have eliminated much of the legally permitted flexibility under TRIPS^ (Sell 2011). If the logic is static, so that each dispute repeats the logic of the disputes that preceded it, and if the outcomes are open-ended, then each debate could greatly modify the existing system and the stakes of each individual dispute remain high. The first column in Table 1 offers a schematic view of what, according to a pluralist logic, are the likely outcomes in three consecutive disputes between two parties. It suggests that the parties are not likely to change their position over time and that the results of each dispute are independent of previous gains or failures. My study of the post-TRIPS IP regime questions the presence of a static logic, where each dispute in some ways replicates the goals and possible outcomes of previous disputes and, as a result, has similarly high stakes. I argue, instead, that disputes are nested, so that the goals and possible outcomes of new disputes are bounded by the results of earlier disputes. Let me describe, briefly, the nature of the Bnested^ disputes in the IP regime. In the struggle over the contours of the regime, the first relevant dispute was whether to have intellectual property rights defined as part of an international trade agreement. Once this debate was resolved in favor of multinational companies (they were able to have TRIPS as one of the WTO agreements), in the next rounds of disputes, health activists did not try to invalidate TRIPS but instead win an interpretation of TRIPS that is more favorable to their concerns; in turn, initiatives such as the anti-counterfeit campaign do not try to invalidate the flexibilities won by health activists but only to affect them in the margins. The way that claims are framed is an important indication of the narrowing of the gap between the two parties. Initially, Big Pharma legitimated its position by referring to profit-making as a necessary condition for future innovation; health activists talked about life and about access to medicines as a human right. When defending its anti-counterfeit initiatives, Big Pharma expressed concern with the safety of illegal medicines. Critics find this concern disingenuous (Sell 2010), but they miss the point that using the argument of safety radically narrows what Big Pharma can achieve even if they win the round. Using a claim that should really be a concern of the other side can be effective but it is likely to have inherent limits. The same, of course, applies to health activists as well. Identifying the nested nature of disputes allows for a more dynamic view of transnational disputes, where the gap in the claims made to support the parties’ positions narrows over time. As a result of this centripetal logic of disputes, the range of possible outcomes is also narrower and the stakes become increasingly lower. In turn, if disputes over the IP regime follow a centripetal logic rather than an openended one, we need to question the pluralist understanding of international relations that the literature on venue shopping relies on. Pluralism has gained popularity especially among international relations scholars who describe the emergence of Bglobal governance,^ in which both state and nonstate actors are involved in processes

St Comp Int Dev Table 1 A schematic comparison of three approaches to international disputes Pluralism

Path dependence 1: Increasing returns

Path dependence 2: Diminishing returns

Time 1

X………………………Y 1……………………....10

X………………………Y 1………………………10

X………………………Y 1……………………....10

Result 1

………………….R1….. ……………………8…..

………………….R1….. ……………………8…..

………………….R1….. ……………………8…..

Time 2

X………………………Y 1……………………....10

………X………………Y ………4……………....10

……X……………Y….. ……3……………9..….

Result 2

…R2…………………….. …2………………………..

…………………..R2.…. ……………………9..….

…………R2……………… …………6………………

Time 3

X………………………Y 1……………………....10

………………X………Y ………………7……....10

………X……Y………… ………4……7…………

Result 3

…………………..R3.…. ……………………9..….

……………………….R3 ………………………..10

………………R3..……… ………………7…………

This is a schematic representation of how three approaches to international disputes describe the likely evolution of international disputes over time. X and Y are the two parties to the dispute, and their positions along the 1-to-10 scale measure both their position vis-à-vis the two extreme points (1, 10) and the gap between their respective positions. R is the result of each consecutive dispute and it shows again the position of the result vis-à-vis the two extreme points as well as vis-à-vis the preferences of the two actors X party to the dispute, Y party to the dispute, R1–R3 results of each dispute

of decision-making in a manifestly decentralized way (Rosenau and Czempiel 1992, Cerny 2001). This Bdisaggregation of authority^ signifies the ability of powerful business interests and activist groups—not only states—to shape international debates and determine their outcomes (Rosenau 2007). While some discuss the overwhelming influence of business (Schneiberg and Bartley 2008, Sell 2003), others emphasize the growing involvement of activist groups, including social movements (O’Brien et al. 2000) and transnational advocacy networks (Keck and Sikkink 1998) and they often suggest that NGOs are as likely to win global disputes as businesses are (Sell and Prakash 2004). In line with this pluralist orientation, the literature on venue shopping has a somewhat narrow view of institutions—they only matter as opportunities, which are either still open or already blocked. But, institutions do not function independently of each other and moving to a new venue does not eliminate the influence of previous venues. In this way, I argue, previous disputes, resolutions and negotiations— even if they occurred in a different venue—create a narrower scope of possible strategies. This is, of course, the argument made in the literature on path dependence, according to which, Bwhat has happened at an earlier point in time will affect the possible outcomes of a sequence of events occurring at a later point in time^ (Sewell 1996: 262–263). However, most scholars use path dependence to identify self-reinforcing sequences, including when analyzing intellectual property laws (Thambisetty 2009). Self-reinforcing sequences are characterized by the formation and long-term reproduction of a given institutional pattern (Mahoney 2000, Pierson 2000). Such sequences would predict that the outcome of the original dispute—here, TRIPS—is self-reinforcing, in a way that would likely lead in this case to the continuing advantage of MNCs over health activists also in future disputes. Whereas the literature on venue shopping

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keeps the outcome open-ended, then, the common way of thinking about path dependence would predict Bincreasing returns^ for pharmaceutical companies and the growing disadvantage of health activists. The second column in Table 1 offers a schematic view of what, according to the self-reinforcing logic, are the likely outcomes in three consecutive disputes between two parties. However, there is an alternative path for path dependence processes, namely, reactive rather than self-reinforcing sequences. These sequences too are chains of temporally ordered and causally connected events. But they are reactive, rather than self-reinforcing, because early events trigger subsequent development not by reproducing a given pattern, but by setting in motion a chain of tightly linked reactions and counter-reactions (Mahoney 2000, Abbott 1983). Hence, BWhereas self-reinforcing sequences are characterized by processes of reproduction that reinforce early events, reactive sequences are marked by backlash processes that transform and perhaps reverse early events^ (Mahoney 2000: 526, emphasis in the original). Building on these insights, I suggest that these recurrent backlash processes may create a pattern that, in a mirror image of Bincreasing returns,^ is leading to Bdiminishing returns,^ in the sense that in each sequence, one of the parties wins a victory that is of a lesser consequence than previous victories. Rather than pulling in one direction (reinforcing one option and makes other options less likely, as in the case of increasing returns), reactive sequences may steer a middle course. If self-reinforcing processes happen when the disadvantaged party quickly adapts to the arrangements created by the previous dispute, reactive processes happen when both the disadvantaged and the advantaged parties adapt to the new institutions. Such adaptive behavior functions not as a reproductive mechanism (so that some are able to reproduce their interests at the expense of others) but as forced convergence. The third column in Table 1 offers a schematic view of what, according to the reactive logic, is the likely outcomes in three consecutive disputes between two parties. To summarize, I argue that rather than remaining open-ended, global disputes, such as the one over intellectual property rights, are likely to follow a path in which previous disputes shape the content and outcome of future disputes. While such paths often follow the logic of increasing returns, however, the case of the IP regime allows us to identify an alternative path, that of diminishing returns, in which rather than reproducing previous victories, the sequences create a centripetal logic of narrowed debates and lower stakes. In what follows I offer a detailed description of the debate surrounding the Kenyan AntiCounterfeit Act of 2008. I show how even while moving to a new venue, that of counterfeits, the previous debates over flexibilities—both in Kenya and elsewhere—narrowed the gap between the positions held by the two parties and lowered what was at stake.

Counterfeits in Kenya What is a Counterfeit? A counterfeit drug is a product that intends to look like a specified drug (say, Advil®) and as if it is manufactured by a specific company (for example, Pfizer) even though it is not manufactured by that company. Importantly, generic versions (copies) of

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Ibuprofen that do not pretend to be the brand name Advil® and independently of any disputes on whether these products violate Pfizer’s patent rights are not counterfeits. While most seem to agree on what is and what is not a counterfeit medicine (even if some health activists prefer not to apply the term Bcounterfeit^ to medicines at all), there is a bitter dispute over how to formally define a counterfeit so that the definition does not also include copies of medicines that are not counterfeit. Indeed, it is difficult to define a counterfeit medicine exactly because the term is borrowed from the legal field of trademarks which makes it potentially inappropriate for pharmaceutical commodities where copies (that is, generic versions of brand-name drugs) can be legal. Trademarks can last indefinitely—in the case of Levi’s Jeans, for example, a copy would be a counterfeit as long as Levi’s is registered as a trademark. But, this logic does not apply to patents, which do expire, so once the patent on Ibuprofen has expired, others were allowed to make a copy of Advil® (even if they are not allowed to use the trademark of the innovator company). Counterfeit Drugs: How Much of a Problem? At the World Health Organization (WHO), concern with counterfeit medicines was first raised at the WHO Conference of Experts on Rational Drug Use in Nairobi, Kenya, in 1985. At the time, Bcounterfeit^ was one of a number of categories used to describe instances of inappropriate drugs, including falsely labeled, spurious, and substandard (WHO 1997).3 Nowadays, however, concerns—including in the popular media—have been focusing only on the issue of counterfeit drugs. The New York Times and the Washington Post, among other media outlets, have recently published numerous op-eds warning against fake drugs both in developing and developed countries. One piece written by Amir Attaran, from the University of Ottawa, and Roger Bate, a resident scholar at the American Enterprise Institute, begins with the warning: BThe world’s medicine supply is under attack. From Pakistan… to the United States… regulators are finding their defenses overwhelmed by shoddy drug companies and organized criminal groups that make fake drugs containing no active ingredients^ (Attaran and Bate 2012). The New York Times editorial board found the topic significant enough to write a piece on Bthe problem of fake and useless drugs.^ While stating that, BNo one knows precisely how much fraudulent or substandard medicine is sold around the world,^ the editorial suggests that, Bthe fragmentary data are alarming. In poor countries, half of the medicines used to treat some deadly diseases have been found to be fakes that had little or no active ingredient; worse yet, some contained toxic substances^ (Editorial 2012). These pieces reflect a new interest with the issue of counterfeit drugs both at the international and domestic levels, much of it based on the notion that this is not only an illegal commercial activity but a serious public health issue. These warnings, however, rely on particularly suggestive data. Reports readily circulate truly frightening numbers, especially in developing countries, but no one 3 Products are falsely labeled if they provide wrong information on the label with regard to the content, date of manufacture, place of manufacture, or date of expiry; products are spurious drugs if contrary to the label they contain no active ingredient or a wrong active ingredient or an insufficient amount of active ingredient; substandard drugs are low-quality drugs caused by poor manufacturing practices, poor transportation techniques or poor storage facilities.

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knows the actual prevalence of counterfeit drugs in various markets. By 2005, publications could assert that, BIt has been estimated that up to 15 % of all sold drugs are fake, and in parts of Africa and Asia this figure exceeds 50 %^ (Cockburn et al. 2005). But, based on what evidence? The authors of this particular piece support their assertion by offering seven references. The first reference is an unpublished presentation by the lead author of the piece. The second is a short BBC News piece on Bglobal rise in use of fake drugs.^ The third and fourth are dated reports from the WHO. The first WHO report, from 1992, states BThere is inadequate information about the scale of pharmaceutical counterfeiting. The Counterfeiting Intelligence Bureau estimates that 5 % of all world trade in 1991 was counterfeit…. Estimates from a wide spectrum of countries range from 0 to over 60 % in sectors of the market that are inadequately controlled^ (WHO 1992, emphasis added). The second report, from 1998, offers no data (WHO 1998). The fifth reference is an editorial, written by one of the other co-authors of the piece, which relies on damning but anecdotal evidence. Finally, the sixth and seventh ones talk only about Southeast Asia. Reports on specific countries do not fare much better. In regard to Kenya, reports, including the WHO website, regularly mention that 30 % of the medicines in the country are counterfeit. 4 Newspaper reports rely on industry sources to suggest that, B20 to 30% of the medicines entering Kenya… are either counterfeit or illegally imported^ (Kimani 2004, Tai 2011). Many of these reports rely on declarations provided by the Kenyan National Quality Control Laboratories (NQCL) or the Kenya Association of Pharmaceutical Industry (KAPI) with no evidence or reference to actual studies. Bate (2008), for example, mentions that Balmost 30 % of drugs in Kenya were counterfeit.^ This is based on a report from 2006 by IMPACT that, in turn, refers to BA random survey by the… NQCL and the Pharmacy and Poisons Board.^ This survey is not publicly available but another study that is based on NQCL data suggests that these are laboratory rather than packaging tests (Chepkwony et al. 2007). Estimates that rely on primary research are also unreliable, however, for a number of reasons. One reason is that it is quite difficult (and therefore also expensive) to credibly identify counterfeit drugs. As a result, many studies are Bpoorly designed and executed^ (Amin and Kokwaro 2007). Medicines have to be collected in a representative and nonbiased manner from pharmacies across the country. Two types of tests are then required. One is a laboratory test for determining the quality of the drug (including the presence of active pharmaceutical ingredients). But, even an adequately performed lab test cannot identify counterfeits. The problem is that while counterfeit drugs are likely to be of poor quality, it is hardly the case that all poor-quality drugs are counterfeit. Perfectly legal drugs could still be poorly manufactured or they could get Bspoiled^ over time, because they expired or were stored in inappropriate conditions. Legal drugs could also be later falsely mislabeled, which makes them illegal but not a counterfeit. Hence, to determine that a drug is a counterfeit there is a need for a second test—packaging analysis that identifies mislabeling with regard to the drug’s identity (Nayyar et al. 2012). Most empirical studies, however, conduct the first test but not the second one. As a result, these studies conflate substandard with counterfeit drugs (Amin and Kokwaro 2007, Shakoor et al. 1997). This means that poor manufacturing,

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http://www.who.int/medicines/services/counterfeit/impact/ImpactF_S/en/index1.html.

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distribution, and storage practices Bcount^ as if they were deliberate attempts to defraud (Amin and Kokwaro 2007), which greatly inflates the numbers of counterfeits.5 A second reason why the numbers are likely to be inflated is that many of the reports study anti-malarial drugs. However, anti-malarials are the drugs most likely to be counterfeit—because they are fast-moving, self-prescribed, and because many patients in developing countries choose anti-malarials based on price. Hence, it is impossible to learn from anti-malarials about the prevalence of counterfeits more generally (in the Appendix, I list studies attempting to identify counterfeits in Kenya and the reasons why the numbers in each study are likely to be inflated; for analyses with similar conclusions, see Nayyar et al. (2012), Amin and Kokwaro (2007); see also Outterson and Smith (2006)). Interestingly, the most recent WHO studies find a particularly low prevalence of substandard anti-malarial drugs in Kenya (WHO 2010a, WHO 2011). In turn, officials of the Kenyan Pharmacy and Poisons Board (PPB) insist that counterfeit drugs enter Kenya Bin suitcases, not containers,^ and these small batches are not likely to have much effect on the market.6 Indeed, only two cases of Bfake^ drugs attracted attention in Kenya in recent years. One, in 2007, was a case of counterfeit of cotexin, an antimalarial drug manufactured by a Chinese company, Beijing Holley-Cotec.7 The second was a case of falsely labeled anti-retroviral drugs. This was a particularly alarming case because the falsified drugs came from a reputable pharmaceutical company in India, Hetero, and sold to Médecins Sans Frontières (MSF). But, these were not counterfeit drugs. Rather, the drugs were produced by Hetero and a third-party later illegally changed the expiration date of the drugs.8 Hence, while counterfeit drugs should raise public health concerns (Amon 2008), given the questionable data, the great emphasis nowadays on counterfeit drugs is curious. One explanation to this recent interest in counterfeits, as critics have pointed out, is that warnings about counterfeits may serve as a convenient tool against generic competitors. In particular, critics have warned that initiatives to address counterfeit drugs might have a hidden agenda to attack legitimate trade in generics. Health activists were particularly alarmed when shipments of legitimate drug products from India to Nigeria, including ARVs, were seized at European ports on charges of counterfeiting and patent infringements (TWN 2009, MSF 2010). Also, in Kenya, the anti-counterfeit campaign was seen by health activists and others as Ba new frontier of conflict^ over intellectual property rights. 9 Wilberforce O. Wanyanga, a private consultant in pharmaceutical quality systems, who has had many years of experience in the private pharmaceutical sector in Kenya and who is known both in Kenya and among UN agencies for his extensive knowledge of the pharmaceutical sector in the country, saw it as the most recent in a chain of strategies by multinational companies to fight generic companies. According to Mr. Wanyanga, first they said that generic drugs were 5 Differentiating between counterfeits and substandard drugs is essential because the legal means required to prevent substandard drugs from reaching the market are very different from the means recommended against counterfeits. 6 Interview by the author with Ahmed Mohamed (PPB), May 29, 2012. 7 Interview by the author with Beijing-Holley Cotec in Kenya, May 25, 2012; interview by the author with Omaera, May 22, 2012 8 Interview by the author with Christa Cepuch (HAI & MSF), Kenya, May 24, 2012. 9 Interview by the author with Gichinga Ndirangu (HAI), Kenya, June 7, 2012.

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contaminated. When that failed, they said generic drugs were substandard. And when that failed, they found counterfeits.10 Such statements echo the sentiment according to which the fight over counterfeit drugs is simply a reiteration of previous fights, just with a different language. In what follows, I offer an alternative interpretation. I argue that while the Anti-Counterfeit Act should indeed be seen as a new site of struggle, in the move from debating flexibilities in the Industrial Property Act, 2001, to debating the Anti-Counterfeit Act, 2008, the gap in the claims made by the two parties is decidedly narrower and the stakes in the struggle are clearly lower. In what follows, I analyze the transition from one to the other to show the narrowing of the gap and how it came about. The Industrial Property Act, 2001 In the path-depending narrative regarding the IP regime, the TRIPS agreement—which obliged WTO member states to put in place laws to improve the protection of patents but also described a number of permissible exceptions to the protection of patent holders’ rights—is the critical juncture that to a great extent determines the trajectory of the subsequent path (Mahoney 2000). All future disputes over IP regimes use TRIPS as the point of reference. In early disputes, in particular, where the interpretation of fundamental TRIPS provisions were debated, much was at stake. This is why the South African Medicines Act was so forcefully fought against, including in court, by multinational pharmaceutical companies, and so vehemently defended by AIDS activists across the globe. As the first public confrontation between the two positions—the protection of intellectual property rights on the one hand and the concern with access to medicines on the other—the South African case promised to have a major impact on the future use of TRIPS provisions, including compulsory licensing and parallel importing (Chorev 2012a). The high stakes were reflected in the large gap in the positions of the two parties—even though TRIPS was the starting point in the dispute, the parties held very different interpretations of TRIPS; while MNCs relied on their alleged legal rights, health activists relied on public outrage outside the courtroom; and the parties justified their respective positions by emphasizing very different values—with MNCs highlighting the importance of profits for innovation while NGOs referring to the right for life (and thereby gaining the higher moral ground). In short, while the dispute was already framed within TRIPS, the gap between the parties was still wide and the stakes—the likely availability of generics—clearly high. Like South Africa, Kenya was required to replace its Industrial Property Act, from 1989, and bring the country into alignment with TRIPS. By the time the Industrial Property bill was drafted and discussed in the Kenyan Parliament, the debate over the Medicines Act in South Africa had already been making waves around the world and civil society organizations in Kenya Bwere fully aware of flexibilities.^11 Indeed, while government officials in Kenya were encouraged by the World Intellectual Property Organization (WIPO) to draft a relatively restrictive bill, legal experts from the US organized consultations with Kenyan civil society on effective use of flexibilities.12 10

Interview by the author with Wilberforce O. Wanyanga, Kenya, May 29, 2012. Interview by the author with Peter Munyi (HAI), Kenya, June 21, 2012. 12 Interview by the author with Gichinga Ndirangu (HAI), Kenya, June 7, 2012. 11

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The initial draft of the bill did not take full advantage of flexibilities and a battle was spearheaded by the Kenya Coalition for Access to Essential Medicines (KCAEM), a loose coalition of institutions and individuals, including Médecins sans Frontières (MSF), Health Action International (HAI), and many local associations and networks (Lewis-Lettington and Munyi 2004, Sihanya 2005). Although one of the largest local pharmaceutical companies, Cosmos Industries, lobbied the government to allow compulsory licensing (Sihanya 2005), most local drug manufacturers, while supporting flexibilities, chose not to be actively involved. 13 Still, Mr. Wanyanga, the unofficial spokesperson of the local pharmaceutical industry, did talk in support of flexibilities and his involvement allowed civil society to claim the support of local manufacturers.14 Multinational pharmaceutical companies, which supported a narrow interpretation of TRIPS, were not public in their lobbying and their position was primarily voiced through local law firms and the diplomatic representatives of key developed countries. Still, both the Kenya Association of Pharmaceutical Industries (KAPI), which mostly represents multinational pharmaceutical companies, and the British pharmaceutical group GlaxoSmithKline (GSK) did make their preferences clear.15 To support their position against multinational companies, civil society organizations lobbied Parliament members and mobilized the public. Initially, parliament members were divided, although uncharacteristically not along party lines. 16 But, civil society was ultimately able to convince members of the Parliament committee responsible for the bill to support their position. 17 It helped that media reports disclosed that Parliament members had been invited for a fully paid retreat, including allowances, in the coastal town of Mombasa by big pharmaceutical companies. 18 Activists could now assert that MPs are Bunder pressure from pharmaceutical companies ready to use subtle but notvery transparent ways of pushing their case^ and imply that any MP supporting a narrow interpretation of TRIPS was doing it for the wrong reasons (Sihanya 2005). MPs did not only have to cancel the retreat but deny their support of Big Pharma as well. For public mobilization, the coalition in Kenya drew much inspiration from South Africa. 19 The coalition organized mass demonstrations and press conferences where activists used a by-then familiar contrast between life and profit to press their cause. In one press conference, for example, they Bcalled on MPs to ensure that public health takes precedence over private financial interests^ (MSF 2001a). Around 2.5 million adults in Kenya were living with HIV at the time and less than 2000 people were undergoing treatment. An MSF press release was titled, BEvery Day Parliament Delays Passing IP Bill, 700 More Die of AIDS in Kenya^ (MSF 2001b). To make drugs affordable, activists argued, the Industrial Property Act should make the purchase of

13

Interview by the author with Wilberforce O. Wanyanga, Kenya, May 29, 2012. Ibid. 15 Ibid. 16 Interview by the author with Gichinga Ndirangu (HAI), Kenya, June 7, 2012; interview by the author with Wilberforce O. Wanyanga, Kenya, May 29, 2012. 17 Interview by the author with Gichinga Ndirangu (HAI), Kenya, June 7, 2012. 18 Interview by the author with Wilberforce O. Wanyanga, May 29, 2012, Siringi 2001a. 19 Interview by the author with Gichinga Ndirangu (HAI), Kenya, June 7, 2012. 14

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generic drug legal by making Bfull use of WTO/TRIPS-related safeguards like parallel importing and compulsory licensing^ (MSF 2001a). In addition to arguing that life was a fundamental human right (Siringi 2001a), activists also presented companies’ insistence on profits as particularly petty given how small the Kenyan drugs market was. MSF announced, BMultinational pharmaceutical companies are among the most profitable industries in the world. Africa makes up just over 1 % of the global pharmaceutical market, and Kenya but a minute fraction of that^ (MSF 2001a). The fact that in response to these criticisms the drugs industry slashed some of its prices in Kenya did nothing to pacify the critics (Siringi 2001a). The demonstrations organized by KCAEM were unprecedented because of the high level of public support but also because it was the first time in Kenya, according to HAI, that demonstrations were not about supporting a party, but supporting a law. Partly as a result, these demonstrations got media attention and helped shape the law.20 Civil society’s influence on the IPA was evidenced as some of the text included in the bill was originally formulated by MSF.21 The final draft incorporated the majority of recognized TRIPS-compatible access to medicines safeguards, including the issuance of compulsory licenses, rights of government use, and a particularly expansive interpretation of the principle of international exhaustion of intellectual property rights (parallel importation) (Lewis-Lettington and Munyi 2004). With some exaggeration, a scholar suggested that, Bit was perhaps with the enactment of IPA 2001 that the battle for affordable medicines was won in Kenya^ (Mey 2010: 410). The bill passed into law in June 2001 and came into force in May 2002. But, the debate over the wording of the law continued. In a number of occasions after the IPA passed, amendments were introduced that would have weakened some of the Act’s most progressive provisions, including Section 80 that protects compulsory licensing and Section 58(2) that allows for parallel importation (Lewis-Lettington and Munyi 2004). Parallel importation was the main target. According to Section 58(2), The rights under the patent shall not extend to acts in respect to articles which have been put on the market in Kenya or in any other country or imported into Kenya. In fact, the section had been a site of legal manipulation even before the Act was passed. Initially, the Section had a comma (,) rather than a full stop (.) after Binto Kenya^ and, following the comma, the qualification, Bby the owner of the patent or with his express consent.^ This qualification had been removed before the Act passed. Without the qualification, the provision was understood to mean that if a product that is protected by patent in Kenya is put on the market in any other country, it could be imported into Kenya from that country without the permission of the patent holder. Still, Section 58(2) together with Rule 37 of the Industrial Property Regulations, 2002, made clear that the drug has to be legitimately put in the other country and it needs to be registered in Kenya. 20

Ibid. Interview by the author with Christa Cepuch (HAI & MSF), Kenya, May 24, 2012; interview by the author with David Njuguna (KIPI), Kenya, May 24, 2012. 21

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Less than a month after the Act came into force, in June 2002, an amendment to the IPA was included in the Statute Law (Miscellaneous Amendments) Act, 2002. The amendment said, B58.2 Delete the full stop at the end thereof and add the words ‘by the owner of the patent or with his express consent.’^ Critics of the amendment warned that restoring the qualification essentially blocked the possibility for parallel importation. The amendment passed—but it passed late at night when most MPs were absent, and at a time that key health activists were out of the country. The amendment also violated the Parliamentary rule according to which amendments could only be introduced 6 months after an Act enters into force. In an unprecedented move, the amendment was reversed in August 2002 (Lewis-Lettington and Munyi 2004). This somewhat dramatic chain of events reminds us that the Bpublic face^ of legal disputes—the demonstrations, press releases, newspaper interviews, even challenges in court—may set the tone, but since the devil is often in the detail, public gains could be undermined, or in other cases enhanced, through the actual legislative process. Indeed, in this particular case, activists’ eventual victory had effects on the ground that might have gone beyond activists’ own preferences. Drawing on a loose interpretation of Section 58(2), parallel importation became a tool for importing cheap drugs by members of the Kenya Pharmaceutical Distributors’ Association (KPDA), who proudly refer to themselves as Bparallel importers.^ KPDA members are mostly Kikuyu—in a sector mostly dominated by Asian-Kenyans—so the activity also has a consciously ethnic-political dimension. Others, however, consider KPDA’s practices to be Billegal parallel import.^22 One of the challenges is that there are no regulations to support the procedural requirements for parallel importation, such as special licenses for importers and specific identification of the imported drugs, which means that there are no formal channels in place that Bparallel importers^ could use. Supporters argue that parallel importation has improved access to medicines in Kenya and forced GSK, Pfizer, and Roche to lower their prices. 23 For critics, it highlights the dangers of the Industrial Property Act. Already in 2001, some warned that the influx of generics, likely to occur because of the flexibilities permitted under the Act, would lead to an influx of poor-quality drugs (Sihanya 2005). The Lancet reported of a Kenyan business manager for the multinational pharmaceutical company Boehringer Ingelheim who said that, BOur main fear is that patients might be exposed to medicines that are not of good quality, thus creating resistance to the treatment.^ Others warned not of substandard drugs but counterfeits. According to The Lancet, BGlaxo spokesperson… fears that it may be easier for people to bring in all kinds of counterfeit products^ (Siringi 2001b). Parallel importation, in particular, made it easier to sell drugs not through the formal channels that are more tightly supervised by the original manufacturers and their distributors. Parallel importation, therefore, enabled counterfeits. A local importer of brand-name drugs in Kenya asserted that many of the drugs that arrive through Billegal parallel import^ are fake 24; and a local employee of the multinational pharmaceutical company Bayer warned that, Bparallel import allows for counterfeit^ and Bcounterfeits come as parallel import.^25 22 Interview by the author with Rakesh Vinayak (Surgipharm), Kenya, May 21, 2012; interview by the author with Anastasia Nyalita (Bayer), Kenya, May 23, 2012. 23 Interview by the author with Kamamia Wa Murichu (KPDA), Kenya, June 5, 2012; interview by the author with Ravi Menon (Jubilant), Kenya, June 11, 2012. 24 Interview by the author with Rakesh Vinayak (Surgipharm), Kenya, May 21, 2012. 25 Interview by the author with Anastasia Nyalita (Bayer), Kenya, May 23, 2012.

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In short, also in Kenya, the debate following TRIPS had particularly high stakes since it was to determine the scope of permissible exceptions, with direct impact on access to generic medicines in the country. Drawing on human rights discourse and, more specifically, on legislatures’ responsibility to their community, health activists were able to defend a relatively progressive Industrial Property Act. It is notable that already at this stage even the most vivid critics took TRIPS not as a target to challenge but to manipulate. There was no question that Kenya would follow TRIPS, the only debate was how much should Kenya take advantage of what was consistent with TRIPS. The conflict, of course, did not stop there. One way to criticize the Industrial Property Act in general and parallel importation in particular was by warning against an influx of counterfeit drugs into the country. Hence, MNCs created a new Bvenue,^ by calling for a strict anti-counterfeit law. But, this new venue was nested in the previous debates—and could therefore only manipulate at the margins, rather than challenge, the Industrial Property Act. The Anti-Counterfeit Act, 2008 Just as the Industrial Property Act passed in Kenya in response to international processes, also the Anti-Counterfeit Act, which became law in 2008, was part of a larger wave of initiatives to address counterfeit products. The issue of Bbad^ drugs emerged as a concern at the international level already in the early 1980s, with WHO Member States reporting cases of counterfeit, spurious, substandard, and falsified medicines. The first international meeting that focused specifically on counterfeit drugs was jointly organized in 1992 by the WHO and the International Federation of Pharmaceutical Manufacturers Associations (IFPMA), which represents large multinational pharmaceutical companies and their national and regional associations. In that meeting, a formal definition of counterfeit drugs was proposed: A counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging. This was later inaccurately referred to as the B1992 WHO definition^ even though the definition was never formally adopted by the World Health Assembly. In response to later resolutions, the WHO established in 2006 the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). Critics saw IMPACT as a covert campaign to introduce provisions that go beyond the TRIPS agreement and limit the supply of generic medicines (Kermani 2012). One of the main frustrations that fed the criticisms was the uneven representation at IMPACT, including almost only international organizations, such as Interpol, the World Customs Organizations, and WIPO, and representatives of Big Pharma or their governments. In the third General Meeting held in 2008, IMPACT members developed a more comprehensive definition of counterfeit medicines (WHO 2010b). The definition clarified the terms ‘identity’ and ‘source.’ It also explicitly described a number of instances that should not be confused with counterfeiting, including violations or

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disputes concerning patents, and substandard batches of or noncompliance with good manufacturing practices/good distribution practices in legitimate medical products. It made clear that medical products (whether generic or branded) that are not authorized for marketing in a given country but authorized elsewhere are not considered counterfeit. But, like the original definition, it was criticized for combining IP and health issues under the same rubric—of Bcounterfeit^—in a way that could be abused by those Bmotivated to achieve a strong IP enforcement agenda.^26 The definition was again not endorsed by the World Health Assembly. More ambitiously than unbinding definitions, multinational companies and other advocates of strong anti-counterfeit measures (not only for medicines), pressed countries, including Kenya, to pass anti-counterfeit laws. The stakes in Kenya seemed particularly high partly because of the relatively broad flexibilities Kenya’s Industrial Property Act allowed and because Kenya’s law was likely to influence the laws in neighboring countries. Like similar initiatives, the Anti-Counterfeit Bill in Kenya, which was first published in 2007 (Kimani 2008), was not centrally about pharmaceutical products. Kenya has a flourishing market of counterfeits, including batteries, pens, cosmetics, foods, and juices and the forces lobbying for the bill were therefore extensive. According to health activists, BIndustry was influential. KAM [Kenya Association of Manufacturers] talked strongly against counterfeits.^ 27 Multinational companies also had the support of the US embassy and of some Kenyan government agencies. BKRA [Kenya Revenue Authority] challenged the government to tighten [the law], because [counterfeit goods, which are often smuggled, impose] threat to taxes. KBS [Kenya Bureau of Standards] also. When KRA talks, MPs take notice!^28 Brand-name pharmaceutical companies, especially GSK, supported the stricter measures, and lobbied for measures relating to the importation of counterfeit medicines (AFP 2008). In turn, health activists warned that the Bill was a Bpush to counter the Industrial Property Act of 2002,^ particularly the provisions allowing for compulsory licensing and parallel import.29 Activists argued that failing in other ways, brand-name pharmaceutical companies now tried to block generics by manipulating the fight against counterfeits. There were a number of issues in the bill that worried health activists, including, for example, excessive authority granted to the KRA.30 Their main concern, however, was the scope of the definition. When health activists first encountered a draft of the Bill, Section 2 defined counterfeiting quite broadly and with no explicit reference to pharmaceuticals. According to activists, the broad category of what falls under a counterfeit according to that definition could easily include Blegally manufactured generic medicines of approved quality^ (MSF 2008). Health activists were concerned that, BThe Bill in its current form confuses [intellectual property rights and quality control issues] to such an extent that ‘interested parties’ may take advantage and misinterpret generic medicines as counterfeits.^ 31 More specifically, they warned that, BThe Bill contravenes… the 26

http://www.twnside.org.sg/title2/intellectual_property/info.service/2009/twn.ipr.info.090101.htm Interview by the author with Gichinga Ndirangu (HAI), Kenya, June 7, 2012. 28 Ibid. 29 Interview by the author with Wariara Mugo (MSF), Kenya, May 23, 2012. 30 Message from Christa Cepuch and Peter Munyi (HAI) to [IP-Health] available at http://lists.essential.org/ pipermail/ip-health/2009-January/013355.html 31 Message from Christa Cepuch (HAI) to [IP-Health] available at http://lists.essential.org/pipermail/ip-health/ 2008-September/013036.html 27

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Industrial Property Act, 2001, including Sections 54(2) on early working exception, 58(2) providing for parallel importation, and 80 on government use.^32 Emphasizing what’s potentially at stake, they added, BThese sections have played an important role in the struggle to increase access to essential medicines in Kenya.^33 One solution was to insist on the uniqueness of pharmaceutical products. Activists therefore claimed that, BMedicines are essential and lifesaving and should be distinguished from non-essential goods such as DVDs, batteries, pens, etc.^ 34 Legislators seemed to agree—and when the Bill was debated in the Parliament committee, another subsection was added to Section 2, which defined counterfeit medicines. Initially, many were happy to take credit for the introduction of Section 2(d). Third World Network (TWN) and other NGOs initially claimed that it was NGOs that convinced Parliament to add that section (TWN 2009). According to others, however, the wording was rather proposed by the government, on behalf of NGOs. More curiously, some in the pharmaceutical industry and the government suggested in interviews that it was KAM and KAPI that lobbied for Section 2(d). 35 According to this version, even pharmaceutical companies found the scope of the definition too extensive and lobbied for the use of the WHO definition instead.36 Indeed, some at the Pharmacy and Poisons Board criticized Section 2(d) exactly because it echoed the WHO definition and blamed MNCs for putting that definition in the text. 37 While it is hard to tell based on the evidence who was behind the Section, given NGOs’ later challenge of the Section it seems likely that while supporting in principle a specific definition for pharmaceutical products, they were not influential in drafting it. It is also possible they had proposed a definition that they later regretted. According to Section 2(d), counterfeiting is, the deliberate and fraudulent mislabeling of medicine with respect to identity or source, whether or not such products have correct ingredients, wrong ingredients, have sufficient active ingredients or have fake packaging; Below Section (d), the following statement was added: Provided that nothing in this paragraph shall derogate from the existing provisions under the Industrial Property Act. Initially, civil society organizations saw Section 2(d) and the paragraph below it to be a genuine attempt Bto protect access to medicines.^ 38 So, while identifying some Bproblems with this definition,^ TWN still found the Section, Bsomewhat of a victory for health groups particularly since it clearly safeguards, at least in the context of 32

Ibid. Ibid. 34 Ibid. 35 Interview by the author with William M. K. Mwatu (GSK), Kenya, May 28, 2012; Interview by the author with Ahmed Mohamed (PPB), May 29, 2012. 36 Interview by the author with William M. K. Mwatu (GSK), Kenya, May 28, 2012. 37 Interview by the author with Ahmed Mohamed (PPB), May 29, 2012. 38 Message from Christa Cepuch and Peter Munyi (HAI) to [IP-Health] available at http://lists.essential.org/ pipermail/ip-health/2009-January/013355.html 33

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medicines, the exceptions and limitations as well as other flexibilities in the Kenyan Industrial Property Act^ (TWN 2009). This perception quickly changed, however, in part due to the confiscation of legal generic drugs by European authorities. According to one of the activists, it was then that Bthe weirdness of the language [was made] real^ and they began to suspect that the wording in the ACA could Bequate IP with counterfeit.^39 Civil society organizations concluded therefore that, B[Section] 2(d)… is still vague and has not sufficiently excluded the application of the Act to legally manufactured generic drugs^ (MSF 2010). There were additional concerns. For example, the Section applied only to medicines and not other pharmaceutical products such as diagnostics. 40 In addition, since the definition closely drew from the definition worked out in the workshop organized by WHO and IFPMA in 1992, it suffered from the same flaws that the original definition was criticized for, including the vagueness of the terms Bidentity^ and Bsource^ (TWN 2009). An MSF report forcefully warned, the risk remains that legally manufactured generic medicines of approved quality… may be erroneously interpreted as counterfeit goods in this Act and thereby effectively prohibiting the importation and manufacturing of generic drugs and medicines—such as some of the very ones imported by MSF to treat people living with HIV/AIDS in Kenya (MSF 2010) Some government agencies also criticized the Anti-Counterfeit Act. In June 2010, the Ministry of Medical Services and the Ministry of Public Health published a Sessional Paper on National Pharmaceutical Policy, called BReforming the pharmaceutical sector to ensure equitable access to Essential Medicines and essential health technologies for all Kenyans^ (MMS & MPH 2010). Notably, the paper begins its discussion on the Anti-Counterfeit Act by reminding readers that, BKenya is a member of the WTO and therefore signatory to the TRIPS Agreement.^ It adds, BParagraph 6 of this Agreement recognizes the right of countries to use the full flexibilities in the agreement to protect public health and promote access to medicines for all.^ Hence, the paper uses TRIPS as a way to legitimate—rather than undermine—the concern with access to medicines. Moving from the international to the national realm, the paper continues: BThe Industrial Property Act of 2001… incorporates all the TRIPS flexibilities.^ It then asserts that the Anti-Counterfeit Act is not compatible with existing obligations. However, the [Anti-Counterfeit] Act gives a broad definition and interpretation of counterfeit medicines; and provides investigative and prosecutorial mechanisms that could interfere with the importation and distribution of generic medicines, thereby impeding access to life-saving medicines. The document argued that the legislation put Bgenuine generics at risk of being cast as ‘fake’ or counterfeit.^ And it called on the Government to BAmend the Anti39

Interview by the author with Christa Cepuch (HAI & MSF), Kenya, May 24, 2012. Message from Christa Cepuch and Peter Munyi (HAI) to [IP-Health] available at http://lists.essential.org/ pipermail/ip-health/2009-January/013355.html; MSF 2010. 40

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Counterfeit Act to provide for a definition of counterfeit medicines that is in line with internationally agreed definitions; and to ensure that the [relevant government agency] has the requisite power to identify and take action on counterfeit medicines in a manner that does not to impede access to medicines^ (MMS & MPH 2010). In addition to health activists and some government officials, also Indian drug companies were upset by the Anti-Counterfeit Bill, since they believed that, BThe new legislation is mainly aimed at stopping cheap generic drugs coming from India^ (Unnikrishnan 2010). In support of their position, the Indian government held diplomatic consultations with African representatives stressing on the need to distinguish between counterfeit and spurious drugs, and it launched a major diplomatic exercise in Africa by asking the Indian ambassadors to take up the issue with the Ministers of Health and Trade as well as opinion leaders of each country (Pharma Focus House 2009). In spite of the support from some in the government and others, civil society organizations found it difficult to defend their position. Particularly, they found it difficult to create a popular outrage that would mobilize the public and force change. There were a number of factors that made mobilization difficult, including the fact that following the victorious mobilization over improved access to ARVs, health activism in Kenya lost much of its original energy.41 But, the main difficulty was the fact that Big Pharma successfully monopolized the concern with Bsafety^ and thereby captured the moral high ground. Health activists, in contrast, were seen as Bpro-counterfeits.^ This was a surprising turn of events. In the dispute over flexibilities, it was civil society organizations that represented Blife,^ while MNCs countered with the less evocative Binnovation.^ In a number of subsequent disputes, MNCs have tried to manipulate the concern with Bsafety^ to question the legitimacy of generic drugs but they failed— mostly thanks to the ability of Indian generic companies to get quality approval from the WHO and the US Food and Drug Administration. With the debate over counterfeits, MNCs again tried to be the first to capture the concern with life through safety and this time they were successful. According to health activists, the forces behind the AntiCounterfeit Act employed relentless propaganda about counterfeits in the country, Bfreaking everyone out.^ 42 According to the revised claims of multinational pharmaceutical companies, they supported generic drugs and were merely concerned about counterfeit ones. The GSK director of production communications said, for example (quoted in Wadham 2009), Clearly generics have a role to play in improving affordability of medicines to some of the world’s poorest countries and peoples… But the main challenge is less now about the price of medicines but getting products of appropriate quality to the people who need them. We support the importation of generics… so long as they are legal and quality standards are adhered to. According to GSK, then, generics were fine (even if the comment implicitly questioned their quality). But, counterfeit drugs were unsafe and, if one were genuinely 41 Interview by the author with Christa Cepuch (HAI & MSF), Kenya, May 24, 2012; interview by the author with Wilberforce O. Wanyanga, Kenya, May 29, 2012. 42 Interview by the author with Christa Cepuch (HAI & MSF), Kenya, May 24, 2012.

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concerned with the wellbeing of patients, one would surely support measures against counterfeiting. KAM and KAPI similarly insisted on their support of generics, and asserted that there was nothing in the law that prevented generics and that they would not abuse the law—they had no intention to block the import of generic drugs.43 This safety argument in regard to counterfeits resonated and NGOs as a result lost public support.44 Worse, NGOs found themselves having to assure the public that their criticisms did not mean that they favored counterfeits. One journalist, for example, asked the activists, BSo are you for counterfeits?^ NGOs were not in favor of counterfeit drugs but they found it difficult to explain the difference between their position and a positive favoring of counterfeits.45 One of the reasons it was difficult to Bfight against anti-counterfeit^ was that it was a particularly arcane dispute, and unlike the industry’s position, it was difficult to translate the NGOs’ position into a neat, accessible message. Even the activists themselves found it confusing to analytically distinguish counterfeit, substandard and generic drugs.46 As a result, it was difficult for them to insist on the need to differentiate between counterfeit and substandard drugs—especially as they had no reliable data to support their claim that most poor-quality drugs here not counterfeit. In addition, even to argue that the problem was not counterfeit but substandard drugs did not seem a strong enough reason to oppose initiatives against counterfeit drugs if one could not explain the threat of these initiatives to legal generic drugs. It also did not help that while warning that pharmaceutical companies could use the Anti-Counterfeit Act as a weapon to clamp down on generic drugs, NGOs had no evidence of such tactics being used in Kenya. Finally, even in regard to their legal position, NGOs were on the defensive since Section 2(d), as proponents of the Section repeatedly mentioned, was based on what these proponents referred to as the BWHO definition.^ 47 As mentioned above, this was an informal, and controversial, definition that was never adopted by WHO member states. Still, civil society organizations could not criticize the WHO definition too heavily partly because earlier on MSF itself referred approvingly to that definition (MSF 2008). Indeed, activists’ reliance on a definition they were earlier criticizing suggests that not only the institutionalization of TRIPS but other arrangements as well are behind the diminishing gap that I find in the positions of the two parties. A narrowing of the gap in the positions of the two parties is also revealed in the convergence of strategies. Because civil society organizations lost the public debate over the ACA they decided—not unlike Big Pharma back in South Africa—to challenge the law in court.48 This was a risky strategy as the outcomes were anything but certain, for a number of reasons. First, the coalition was disjointed and not very well organized. In addition, there was a disagreement between those who wanted to kill the ACA completely and those who just wanted to amend it. Both goals were in any case difficult to achieve. Amending was challenging partly because their lawyers could not agree on an alternative language. Nevertheless, in 2009, three HIV/AIDS patients petitioned Kenya’s High Court to declare that the Anti-Counterfeit Act was unconstitutional because it could deny them 43

Interview by the author with Moses Mwangi (KAPI), Kenya, May 18, 2012; interview by the author with William M. K. Mwatu (GSK), Kenya, May 28, 2012. 44 Interview by the author with Christa Cepuch (HAI & MSF), Kenya, May 24, 2012. 45 Ibid. 46 Ibid. 47 Interview by the author with Moses Mwangi (KAPI), Kenya, May 18, 2012. 48 Interview by the author with Peter Munyi (HAI), Kenya, June 21, 2012.

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access to generic medicines and in that way violate their right to life (Wadham 2009). The petition asked the court to declare, Bthat Sections 2, 32 and 34 of the AntiCounterfeit Act… contravene constitutional rights as enshrined in… the Constitution of the Republic of Kenya.^ Once the Kenyan new Constitution was promulgated, the original petition was revised to include the Constitutional right to health. The case then became not only about counterfeits but, more ambitiously, a Btest of the strength of the right to health under the new constitution^ (Neondo 2012). A brochure prepared by KELIN explained the legal case in lay terms, in the following way: We are suing the Government of Kenya in the High Court because we believe Anti-Counterfeit Act, 2008, threatens our health and life which are Human Rights guaranteed under the Constitution of Kenya. Various efforts were made last year to improve the draft Bill before it was enacted. However, the new language introduced in the Act is still very confusing and does not assure us that access to medicines is protected. When the seizures of generic medicines started happening in Europe, we realized the same thing could happen here because similar language in the Kenyan Act would allow this to happen. This threatens our health and our Human Right to life. So we decided to take bold action this year to ensure that the issue of generic medicines is clarified. Health activists justified their case by referring to the right to life, the way they did also in South Africa. This time, like the report prepared by MMS and MPH, they also relied on a favorable interpretation of the TRIPS agreement. The coalition behind the three individuals who petitioned the High Court included KELIN, HAI, and MSF among others. The respondent was the Attorney General (AG), and the government’s position was supported by KAPI, but also by local drug manufacturers and the influential Pharmaceutical Society of Kenya (PSK). The AG’s position was that the claims were unfounded because the Anti-Counterfeit Act explicitly said that the provisions of the IP Act had to be taken into account. The AG also reminded the Court that one of the objectives of the ACA was to stop importation of counterfeit goods that would be harmful to the public.49 The claims reveal the relatively narrow gap between the two positions. Formally, the defenders of the ACA claimed that it would have minimal impact on the IPA; but even a maximalist interpretation of how Section 2(d) could be abused suggested that it would affect IPA only in the margins. Three years after the petition was originally filed, High Court Judge Mumbi Ngugi ruled that the language of the Anti-Counterfeit Act was vague and ordered the Attorney General and the Minister of Trade to amend the law and take it back to Parliament. As reported by KELIN, BPatent holders will therefore not be able to use the act to legitimately block the import of generic medicines, as was feared by the petitioners.^50 The judge also made a much broader declaration according to which intellectual property rights should not override the right to life, right to health and right to human dignity outlined in the Constitution. Since this was the first constitutional case based on the right 49

Interview by the author with Peter Hime (Kaplan & Stratton law firm), Kenya, June 18, 2012. KELIN website (http://kelinkenya.org/2012/04/judgment-on-generic-medicines-kenya%E2%80%99s-firstvictory-on-the-right-to-health/) 50

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to health in Kenya, these statements were particularly significant. Still, there was something defensive in the otherwise celebratory response of the petitioners. Speaking about the victory, KELIN’s Coordinator Allan Maleche said: BTo make it clear, we are not supporting counterfeit and substandard medicines, but generics—legitimate exact copies of original brand name medicines.^51 Health activists admitted to be surprised by the ruling. BWe couldn’t believe it.^ 52 Those who opposed the petition, in turn, called the case Bextraordinary.^ They found the 48 pages of ruling Bvoluminous^ and the broader implications Balarming.^ A lawyer who had in the past represented brand-name pharmaceutical companies in Kenya told me, BWhen for the sake of so-called constitutional rights a country can put aside intellectual property rights—then, what’s the point of registering [a patent]?^53 At the time of writing this paper, the Act has not yet been amended but it is likely that the court’s decision was able to weaken the use of anti-counterfeit initiatives to undermine access to medicines, in particular, through parallel importation. The court decision declared, BSection 58(2) of the Industrial Property Act, 2001, as read with Rule 37 of the Industrial Property Regulations, 2002, allowed the parallel importation of generic drugs. It is on the basis of this legislation that availability and access to antiretroviral drugs has increased and greatly enhanced the life and health of persons such as the petitioners who have been living with HIV/AIDS.^ The court decision was meant to keep it that way.

Discussion The debates over parallel import and counterfeits in Kenya are among many across the world in which health activists and brand-name pharmaceutical companies have been in conflict over the scope of flexibilities and other issues that could impact the balance between intellectual property rights and access to affordable medicines. These debates will no doubt continue. Yet, the experience of Kenya suggests a pattern that is quite different from the one often depicted. As I discussed in the introduction, the ongoing struggle over the IP regime is often described as if it has a static logic (new disputes have the same goals as previous ones) with pendular outcomes (new outcomes can reverse old outcomes) (Sell 2010, Helfer 2004, Drahos 2007). An alternative interpretation is that of increasing returns, where arrangements on behalf of one party reproduces the advantages of that party and therefore the likelihood of that party to prevail in subsequent disputes. Instead, I suggest that these struggles follow a centripetal logic, so that new outcomes are limited by the boundaries of previous outcomes in a way that does not reproduce the advantages of one party but, due to backlash and other reactive responses, pushes the claims of both parties closer to each other. BHistory matters^ so parties find it hard to ignore or reverse existing legal or institutional arrangements. New strategies do not bypass previous ones; they build on them. Once arguments are won, parties cannot normally start the fight all over again but have to fight within the new boundaries. And this is not unique to the IP regime—many global conflicts are not permanently open-ended; and ongoing disputes are not an indication of such open51

Ibid. Interview by the author with Christa Cepuch (HAI & MSF), Kenya, May 24, 2012. 53 Interview by the author with Peter Hime (Kaplan & Stratton law firm), Kenya, June 18, 2012. 52

St Comp Int Dev

endedness but, on the contrary, the mechanisms that lead to eventual institutionalization. The foundational dispute was about whether or not to introduce an agreement on intellectual property rights as one of the agreements to be negotiated under the auspices of the World Trade Organization. Given the relative open-endedness of that particular moment, the stakes were extremely high. If not for TRIPS, countries would arguably have maintained much looser intellectual property laws than they have today.54 Once TRIPS was drafted and then signed, the scope of the dispute—the question of permissible flexibilities—narrowed accordingly. The stakes, clearly, were still high, for the dispute was to determine the conditions under which generic versions of patented drugs could be available. Still, the disputes over flexibilities were already Bnested^—even earlier on disputes did not attempt to roll back intellectual property protection standards (that is, reverse TRIPS) but only to expand the use of flexibilities already embedded within TRIPS (Helfer 2004, Shadlen 2004). In the case of counterfeits, in turn, the stakes were even lower. The dispute was again a Bnested^ one, simply over the extent to which anti-counterfeit laws did or did not threaten existing flexibilities. Even critics of the Kenyan anti-counterfeit law mostly saw it as a form of harassment rather than as a tool that could effectively block generics. The concern was over vague provisions that could potentially be interpreted in a way that could possibly be abused to block generic drugs. Hence, both for MNCs and for NGOs, victories were limited within the scope already created by the previous disputes. Indeed, while in principle the two parties have been fighting the same fight over and over—the protection of intellectual property rights versus access to medicines—the claims they have been using in each individual dispute have changed. Brand-name pharmaceutical companies moved from the protection of intellectual property rights to warnings against anti-counterfeit drugs; health activists moved from expanding flexibilities to Bgenerics are not counterfeit.^ This lowering of stakes is reflected in a convergence across two dimensions, normative and strategic. The normative dimension: how do the parties justify their position? The discourse used by each party has changed quite radically over time. In the dispute over flexibilities, brand-name pharmaceutical companies attempted to legitimate their position by referring to the importance of innovation—intellectual property protection, they argued, is essential for motivating investment in research that allows the availability of drugs in the first place. NGOs, in turn, talked about patients’ right to life. In the contest between innovation and life, life prevailed (Sell and Prakash 2004) and NGOs gained the higher moral ground which they were able to exploit in pushing for flexibilities. In the dispute over counterfeits, Big Pharma expressed concern with patients’ safety. As I mentioned above, they had not been able to use the issue of safety to undermine the legitimacy of generic drugs in previous attempts, but counterfeit drugs are likely to be unsafe, which may explain why this time the message successfully resonated. NGOs continued to refer to right to life—and, less evocatively perhaps, right to health—but their attempt to discount the concern with counterfeit drugs backfired. This time, it was pharmaceutical companies who gained the higher moral ground. What is noticeable here is less the 54 However, we should be mindful of the fact that while multinational pharmaceutical companies were heavily involved in lobbying for TRIPS (Sell 2003), health activists’ mobilization against TRIPS started in earnest only with the development of effective anti-AIDS medications, after TRIPS had already been signed.

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reversal of fortunes but the fact that this reversal was made possible by pharmaceutical companies capturing a concern—that of patients’ safety—that is of concern to health activists as well. In other words, one of the reasons that pharmaceutical companies were at least initially successful in their anti-counterfeit campaign was that they monopolized an issue that resonated and the issue resonated because it was, in fact, compatible with what health activists were concerned with all along. 55 The path-dependent argument regarding Breactive sequences^ is illustrated quite well here, as new arguments are shaped by previous arguments (of both parties), in a way that narrows the gap between the positions taken by the two parties as they respond to and at times try to coopt the normative foundations of the other side. The strategic dimension: what means used to pursue the claims? The strategies used by the parties, like the normative foundations, have come to resemble each other. From early on, both MNCs and health activists have readily used legal procedures to advance their respective causes. However, in the dispute over flexibilities, it was MNCs that were more likely to use the legal system, while activists relied on public outrage to defeat them. When MNCs took the South African government to court, health activists prevailed not thanks to legal arguments but because outside the courtroom public outrage forced Big Pharma to withdraw the case. In the counterfeit case, in contrast, it was NGOs that decided to go to court. As I argued earlier, this decision was partly because they have lost the public debate—which can be explained, in turn, by their inability to create public outrage. But, it was not only that health activists used the legal option. What suggests an increasing convergence in the IP regime is the fact that in South Africa MNCs sued the South African government for violating TRIPS, and in Kenya it was NGOs who sued the government for violating TRIPS.56 The narrowing of the gap in the parties’ position is exactly reflected in the fact that a document that was at the heart of the dispute earlier on was now interpreted in a similar way by the two camps. In short, the ongoing debate between multinational pharmaceutical companies and health activists has changed from one dispute to the next, with both sides modifying their own position as well as their criticism of the other. The institutionalization of the regime through legal and other means meant that what each party could legitimately claim has been increasingly constrained and what each party could possibly win has become increasingly trivial. As a result, the gap between the two positions narrowed over time and neither one of the parties could hope to make big strides. Importantly, reactive sequences are not unique to the IP regime. Existing resolutions influence—and narrow the scope—of future debates in other regimes as well. This is of course the case when debates take place within the same international organization, so debates under the auspices of the WTO, for example, take on a path that locks in future debates in that organization. But it is also the case across international organizations or other venues. It is this argument in particular that questions the analytical significance 55 Of course, there are ways by which parties can capture but then distort otherwise laudable goals. One could argue therefore that the warnings against counterfeit drugs—just like the warnings against generic drugs earlier on—were nothing but a façade. Still, pretending to be concerned with safety does have the outcome, even if unintended, of improving quality standards of drugs. 56 The petitioners Bsubmitted that Article 51 of [TRIPS] limits the use of the term ‘counterfeiting’ to counterfeit trademark goods; that the TRIPS Agreement forms part of Kenyan law in line with the provisions of Article 2 of the Constitution of Kenya; that the term ‘counterfeit’ as used in the Act goes beyond its internationally accepted legal meaning.^

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of venue shopping. Even within a vague legal framework and with no formal relations between venues, debates under the auspices of the WTO took a path that constrained also debates in, say, the WHO or Kenya (Chorev 2012b). It is for this reason that the various anti-counterfeit initiatives could have undermined previous resolutions only in the margin. Importantly, such marginal Bcorrections^ could turn path-breaking. For example, anti-abortion activists in the USA have accumulated enough victories that undermine Roe vs. Wade to a point that they might have reached a path-breaking moment. But, while there are some cases in which there is a way to ignore existing paths, it is normally difficult to bypass them altogether. Also in the case of the IP regime, we are likely to see a process of Bstabilization,^ even if we should not entirely discount the possibility of another critical juncture down the road.

Appendix Studies on counterfeit and substandard drugs in Kenya Report

Argument

Counterfeit?

Kibwage and A report on the quality of SP products Ngugi on the Kenyan market revealed that 2000 one batch out of 26 analyzed failed in the assay for API [3.8 %] while 23 out of 33 batches failed in the dissolution test [70 %].

Discuss quality control, rather than counterfeit. Only anti-malarial drugs.

Thoithi et al. 2002

Overall failure rate of 21.1 %. Anti-malarial drugs had a failure rate of 27.7 %. In Kenya, CQ syrup had 25 % content of active ingredients failure rates; CQ tablets had 42.8 % content failure rates and 28.6 % dissolution failure rates. SP tablets had no content failure but 91.7 % dissolution failure rate.

Discuss quality control, rather than counterfeit.

Orwa et al. 2004

Out of 63 samples, which were obtained directly from local manufacturers and were analyzed for chemical content, six (10 %) samples did not meet pharmacopoeia specification for chemical content.

Examined quality of locally manufactured medicines. Not about counterfeit, since the drugs were obtained directly from the factories.

Amin et al. 2005

Of 116 SP and AQ samples analyzed, 47 (40.5 %) did not meet the US Pharmacopoeia (USP) specifications for content and/or dissolution. Approximately 45.3 % of SP and 33 %

Packaging not tested so cannot say anything about counterfeit (also Nayyar et al. 2012). Nevertheless, in the conclusion it is asserted that, BThere is a need to strengthen postmarketing surveillance systems to protect patients from being treated

WHO 2003

BThe data presented in this report indicate that there is a significant problem of substandard antimalarial drug products circulating in the markets of the participating countries.^ While no direct refer ence to counterfeits in the body of report, the Bbackground^ section talks explicitly about counterfeits (BThe problem of counterfeit drugs is well recognized within the African region^). Only anti-malarial drugs.

St Comp Int Dev (continued) Report

Argument of AQ samples were found to be substandard.

Counterfeit? with sub-standard and counterfeit anti-malarial drugs in Kenya.^ Only anti-malarial drugs.

Atemnkeng Of 24 samples randomly taken from et al. 2007 pharmacies in Nairobi, Kenya and Bukavu, DR Congo, 9 failed European pharmacopeial requirements for active ingredients. Two samples had slight overdoses, while seven were underdosed (38 % failure, 29 % underdosed) Registration was tested. All drugs in Kenya were registered. Three tablets were identified as fake, since the Belgian company named on the pack did not exist. Two of the three products from the fake company conformed to the content requirements. All packaging was examined before and after chemical analysis, and there was no physical evidence that the medicines were counterfeit.

Difficult to differentiate between the different countries. In spite of the findings, the article consistently talks about, BThe problem of counterfeit or poor quality antimalarials.^ In the conclusion, it is asserted that, BCounterfeit or substandard artemisinin-derivative drugs are being sold in parts of Africa. ^ The conclusion does acknowledge, however, the Bambiguity surrounding the terms counterfeit and sub-standard drugs. Two of the three products from the fake company conformed to the content requirements. Several of the registered drugs were underdosed.^ Only anti-malarial drugs.

WHO 2007

In spite of the findings, the report mentions, BThe problem of sub-standard and counterfeit medicines in developing countries is well documented.^ Only examined ARVs (least likely to be counterfeit) and only in relatively reputable sites (least likely to hold counterfeits).

Seven countries of sub-Saharan Africa. BNone of the anti-retrovirals sampled had any critical quality deficiencies which would pose a serious risk to patients.^

Chepkwony The National Quality Control et al., 2007 Laboratory for Drugs and Medical Devices (NQCL) in Kenya reported a failure rate of 42 % out of 229 anti-malarial samples analyzed between 2002 and 2005. SP products accounted for 39 % of the failure rate.

Discuss quality control, rather than counterfeit. Only anti-malarial drugs.

MoH, WHO & HAI 2007

42.6 % of the products were registered by the Pharmacy and Poisons Board, 42.2 % were not registered and the registration status of 15.2 % of the products could not be established. Of the unregistered products found in the market, the majority were from Kenya and India. Overall, 7 of the 43 batches tested failed analysis, a failure rate of 16 %.

Discuss quality control, rather than counterfeit. Many of the drugs not registered have not failed the analysis. The report mentions counterfeits as an issue even though the study cannot identify counterfeits.

Bate et al. 2008

A range of anti-malarial drugs were procured from private pharmacies in urban and periurban areas in the major cities of six African countries. Measure active pharmaceutical ingredient content

Discuss substandard, rather than counterfeit. Only anti-malarial drugs.

St Comp Int Dev (continued) Report

Argument

Counterfeit?

against internationally acceptable standards. 35 % of all samples were substandard. Thoithi et al. 2008

The Kenyan Drug Analysis and Research Unit reported overall rate of failure of 6.1 %; the failure rate among anti-malarial drugs was 27 %. Most of the drugs reported as failing were SP products, with the major contributing factor being dissolution.

Discuss quality, rather than counterfeit. Analyzed drug samples sent to the Unit— so no systematic sampling. Most of the samples submitted were pre-registration drugs.

WHO 2010a

Reports on two studies. 1. A study of the quality of anti-malarial products in selected African countries (QAMSA). World Health Organization, 2010 (draft report). Find 4 % failure rate. 2. Report on the post market surveillance of first line anti-tubercular medicines in Kenya. Pharmacy and Poisons Board, Ministry of Medical Services and Division of Leprosy, Tuberculosis and Lung Disease, Ministry of Public Health & Sanitation, Government of Kenya. (Draft report). Find 8.3 % failure rate.

Survey quality, not counterfeit.

Newton et al. Survey of anti-malarial drugs in 11 African 2011 countries. Collected drugs of suspicious quality. Tests included packaging.

WHO 2011

Even though conclude that, BThese data do not allow estimation of the frequency of poor quality antimalarials in Africa,^ constantly refer to Bcounterfeit and substandard.^

Six countries of sub-Saharan Africa. Two Packaging not tested so cannot say hundred sixty-seven samples were tested anything about counterfeit. and 28.5 % of them failed to comply with One of the goals was, Bestimate the specifications. When focusing only on ex proportion of counterfeit ACT and treme deviations from specifications, which SP products.^ But, BData collected are likely to be associated with health im within the survey were insufficient plications, the failure rate reached 11.6 %. for further investigation In Kenya, the quality of anti-malarials seems to of counterfeiting.^ be reasonably under control. Forty-four Only anti-malarial drugs. samples from 29 batches were selected for laboratory testing. Only two ACT samples tested failed and all SP samples were found to be compliant.

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