The scourge of counterfeit medicines

The fight against counterfeit or illicit medicines has become an international cause since the early 2000s, mobilizing the World Health Organization and the World Customs Organization. Poignant figures and news items are regularly put forward to justify this inclusion on the international agenda: one in 10 medicines in circulation in developing countries is said to be illicit, and customs intercepted 550 million doses of counterfeit medicines in 2013; these medicines are also said to be the cause of many deaths, the most striking example being the 2,500 deaths in Niger in 1995 after the injection of a fake vaccine (pp. 7-10). In this context, the organization since the 2000s of an international fight against this scourge of “pharmaceutical impostures” appears not only perfectly justified, but even somewhat late. How can we explain then that NGOgovernments or activist movements have spoken out against this fight? Based on two ethnographic fields in Kenya and India and on the analysis of the press and reports published by the World Health Organization, Mathieu Quet’s book highlights the controversies surrounding these “pharmaceutical impostures”, which mix public health and economic interests, securing the quality of medicines and controlling their global circulation.

Fifty Shades of Pharmaceutical Deception

The first major contribution of this book is to return, in line with work in sociology and economic history, to the mixed issues of public health and trade raised by the qualification of medicines. “Substandard, Spurious, Falsified, Falsely Labelled, Counterfeit”: this juxtaposition of adjectives which gave its name to a working group created in 2010 by the World Health Organization, underlines the semantic ambiguities in the qualification of pharmaceutical imposture (p. 44). While ” sub-standard “, ” spurious ” And ” falsified “describe quality defects, or even obvious deceptions, endangering the health of those who consume them,” falsely labeled ” And ” counterfeit ” describe violations of information transparency, trademark and patent law that primarily harm the economic interests of manufacturers. However, the simple juxtaposition of these adjectives in the same designation (and therefore in the missions of the working group thus named) puts all these drugs on the same level, disqualified as so many forms of pharmaceutical imposture and all having to be withdrawn from the market.

The common characteristic of drugs considered illicit is that they have not been controlled as such by the competent regulatory system in the territory and are sold without respecting national or international pharmaceutical standards” (p. 16).

The central objective of the book is to trace the process by which manufacturers have managed to assert to international organizations and States (particularly in the South) a vision and practice of “pharmaceutical safety” that does not distinguish among these “pharmaceutical impostures” those that represent a danger to public health (fake medicines) and those that represent a danger to economic interests (counterfeit medicines and generic medicines). From the 1990s and more extensively in the 2000s, drug manufacturers have thus created working groups within theWHO with the aim of promoting a very broad definition of illicit drugs and a policy of “pharmaceutical safety” that indiscriminately punishes all these infractions. These groups have launched studies of morbidity and mortality linked to the consumption of these drugs, but also estimates of the market share of these copies. They have also developed and made available to customs officers technologies intended to distinguish “real” from “fake” drugs and which are based on a database provided by the major pharmaceutical companies (and therefore incomplete). Thanks to this work of framing and instrumenting “pharmaceutical safety”, manufacturers have managed to include the fight against all “pharmaceutical impostures” on the agenda of theWHObut also many States, making public health an argument to protect economic interests.

The worlds of medicine

By tracking these “pharmaceutical impostures” from Kenya to India,WTO to theWHOMathieu Quet also delivers a stimulating reflection on pharmaceutical globalization. This globalization concerns first and foremost the markets: if Western countries (and particularly the United States) constitute the bulk of the global turnover in terms of medicines and are home to almost all of the Big Pharma (large pharmaceutical companies), the bulk of the production of active ingredients is now provided by emerging countries, particularly India (the “pharmacy of the third world”), China, Brazil and, for the African continent, Kenya. These countries have also developed significant generic drug industries, initially aimed at their local populations and increasingly geared towards export. In fact, “pharmaceutical globalization is reflected in the coexistence of heterogeneous market segments, between the multinationals of the richest countries, the powerful and internationalized Indian generic industry, or the national or even regional influence of countries such as Kenya” (p. 78).

This globalization of markets has been both the cause and the consequence of a globalization of regulation through the rules issued by theWTO and theWHOmaking these institutions central arenas of confrontation between industrialists and the states that host them. Finally, globalization has also affected social movements with the formation of international networks of activists specializing in patent law who attempt to counter Big Pharma’s strategies in terms of intellectual property by sharing information, organizing various demonstrations (such as those organized in Vienna, Brussels or Delhi in 2010 against drug seizures) or setting up awareness-raising actions (such as in Nairobi where Health Action International organized a meeting with the presence of Indian activists and lawyers) (pp. 41-47). These networks, which were formed to counter the claims of pharmaceutical companies in terms of patents, have had more difficulty in taking up the fight against “fake drugs”, because they did not immediately perceive the threat that this fight posed to generic drugs and access to health.

The originality of this work is to move away from the classic North/South opposition to focus on “globalization from the South” as it is seen in relations between India and Kenya. These relations, which date back to Antiquity, were strengthened by the British Empire and continued after Kenya’s independence. The Indian population or population of Indian origin, estimated at 100,000 people and recognized in 2017 as the “44^e Kenyan tribe”, occupies an important place in the Kenyan pharmaceutical industry where they play an intermediary role with the Indian industry. But these relations between India and Kenya are not without their problems, as they mix cooperation and competition: thus Kenyan producers and distributors do not only face competition from Big Pharma Western countries that highlight the superior quality of their original drugs; they must also deal with parallel imports of Indian generic drugs sold at competitive prices and with a reputedly higher quality level. In this context, the denunciation of “pharmaceutical impostures” and the implementation of a “pharmaceutical safety” policy constitute a major challenge for “disciplining competition” (Stanziani, 2013), by favoring industrial players who have invested in traceability systems for their products.

A policy of flows

In the last part of the book, Mathieu Quet links the two previous reflections around what he calls the “pharmaceutical logistics regime” and its flaws. “A logistics regime is not only a system for organizing circulations (of goods or people); it corresponds to a political regime by being the bearer of a conception of the distribution of powers, of the constitution of the public and of political subjects, of justice and of the common good” (p. 162). The agreements of theWTO on intellectual property rights and the fight against illicit medicines (whether substandard or counterfeit) have thus established a watertight barrier between medicines that have the right to circulate and those that must be withdrawn from circulation, between legitimate circulation flows that must be organized and “pirate” flows that must be stopped, and finally between wealthy populations who must be inundated with medicines (sometimes by “inventing diseases” to increase demand, cf. Angell, 2005 and Blech, 2008) and poor populations who will be deprived of them due to their lack of connection to legitimate flows. This current global pharmaceutical logistics regime is for the author only a form of neo-colonialism whose “domination does not arise from territorial control, the exploitation of the resources of a dominated nation or a cultural hegemony (but rather) from an arrangement of regulations, standards, transport techniques, facilities offered by export zones” (p. 184).

In his last chapter, however, Mathieu Quet somewhat undermines this perfection of the pharmaceutical logistics regime, by mentioning three types of disputes over flows. First, there is “flow branching” when “entrepreneurs” use their links with distributors, doctors or pharmacists to divert part of the legal drugs to the black market for drugs (pp. 189-196). Then there is “flow diversion”, when Australian or American consumers who have been unable to access their treatments for Hepatitis C (the famous sofosbuvir or Sovaldi®) in their country, because their prices are too high or because they are banned by the health authorities, organize buying clubs and rely on their contacts in countries where the treatment is available at a lower cost, to import it under the counter (see the film Dallas Buyers Club for similar practices concerning triple therapies) (pp. 196-201). Finally, protest can take the form of a “flow disruption,” when pharmacists and patients organize to sell and “self-consume” drugs (such as tuberculosis treatments) outside of recommended and authorized uses (pp. 202-206). It is precisely these different types of protest that policies to combat illicit drugs attempt to curb, if not annihilate. While “these flow diversions” constitute only a tiny fraction of the volumes of drugs circulating in the world, they nonetheless remain alternatives (and threats) to the pharmaceutical logistics regime put in place in the 1990s and 2000s.