The Direct Impact of Counterfeit Drugs on Human Life - Essay Example

1. Identification of purpose The aim of this essay is to present current of pharmaceutical drug counterfeit market and analyse effectiveness ofits regulation. This investigation is important because of the direct impact of counterfeit drugs on human life, which causes the necessity to rule the flow of medicine in a safe way. However, this regulation is constantly facing a conflict between its own efficiency and fairness of social objectivity (Baldwin et al., 2012, p. 31). Thus, setting the extent of counterfeit drug regulation is important through critical synthesis of both optimistic and pessimistic visions on regulation in academic environment. 2. Critical discussion of current literature 2.1. Current state of counterfeit drug regulation In the recent years, both the appearance of incurable diseases and the popularity of fake medication complicate global counterfeit regulation. In particular, the core sense of this activity in the current economic framework of developed North and developing South, which was a crucial and is still not solved problem. In other words, pharmaceutical drug regulation is incorporated in global economy. In this context, huge profits of pharmaceutical companies cause the situation when business structures resist to any strict regulatory practices. In fact, it is reasonable because regulation has always been strong enough to block innovative potential for business by its strict ruling nature (Brooker and Cullum, 2008, p. 5). Consequently, this number of challenges require regulation to concentrate rather on fundamental transformation than on fixing daily mistakes (Brooker and Cullum, 2008, p. 7), as its efficiency is linked to the social satisfaction. Furthermore, the nature of this process is doubtful in case of pharmaceutical counterfeit regulation. In general, the deep contradiction between human life and business profit eliminates the balance within the regulatory practices in the sphere. In this context, certain researchers found severe problems connected with the impact of regulation on society. For instance, Weinstein (2005) mentions that certain technological measures of regulation challenge personal privacy and freedom (p. 31-32). In addition, current regulation of global pharmaceutics usually relies on national governments and legal institutions not ordinary people personally (Burns, 2006). In other words, counterfeit combat is above all a political battle. In this context, the analysis of regulation in this sphere is based on interest group theories (Baldwin et al., 2012, p. 43-49). Thus, issue of making regulation more effective is crucial for the medical sphere in general and counterfeit combat in particular, because it has social consequences and political nature. 2.2. Defining key notions in counterfeit drug industry regulation At the very beginning, the object of counterfeit regulation is blurring. In general, there is no definition of counterfeit drugs, common for all the countries (Kelesidis et al., 2007, p. 215). Moreover, researchers from different countries often confuse counterfeit drugs with substandard (Kelesidis et al., 2007), generic (Deisingh, 2005), and fake drugs (Outterson and Smith, 2006, p. 530-531). In the given context, Mackey and Liang (2011) noticed that misinterpretation of these terms springs from “divergent interests of state actors that often trigger intellectual property consideration versus those of public health” (p. 4571). Hence, it is relevant to state that national interests complicate regulation. In addition, Marucheck et al. (2011) differ ‘counterfeiting’ from ‘contamination’ by the economic component of productive motivation (p. 715). In other words, there exist multiple motives, which lead to lack of clarity in determinations and attitudes. Concerning the internal structure of this term, its range is not limited to a special drug class and “includes counterfeits in therapeutic classes that extend to antimalarials, antibiotics, birth control, cancer, diabetes, erectile dysfunction, heart disease, schizophrenia, and transplantant drugs” (Mickey and Liang, 2011, p. 4572). In general, the scope of this problem is significant; however, the validity of available data can be questioned due to improper geographical choice, sampling methods and author’s institution identification (Outterson and Smith, 2006; Almuzaini et al., 2013). Nevertheless, the extent and consistency of public discussion on the problem if regulation clearly illustrates the severity of it. Unlike the presented misinterpretations of ‘counterfeit’ term, pharmaceuticals do not evoke similar problem. In this context, it is common to define them as “chemical substances used to diagnose, cure, treat or prevent disease or adverse medical conditions” (Marucheck et al., 2011, p. 714). Thus, solely ‘counterfeit’ term is hard to define, even though the other concepts are clear in this sphere. In general, there exist a common belief that ‘counterfeit’ category is distinguished from the other ones by the presence of “criminal element” for this type of fake medicine. In terms of actors who are involved in this process, Kelesidis et al. (2007) mention, “Organized crime, corruption, the narcotic trade, the business interests of unscrupulous politicians and unregulated pharmaceutical companies” (p. 215). Correspondingly, Outterson and Smith (2006) bring in the definition of “criminal gangs,” Deisingh (2005) claims on “criminal networks” to produce counterfeit widely, and Mickey and Liang (2011) introduce “globalized crime” as distinguishing marker for counterfeit drugs. Moreover, the very activity of counterfeit dealers resembles illegal narcotic trade, when criminals hide drugs in toys or label them as pet food (Burns, 2006). Although, contemporary researchers start to supplement this notion with medical peculiarities. For instance, Pullirsch et al. (2014) consider microbiological contamination as an exclusive component of counterfeit drugs. Nevetheless, it is only the trend but not a tendency. In general, there exists a common belief that counterfeit production in medical sphere means low quality and substandard medication; thus, its existence is a problem. Therefore, it is common to define ‘counterfeit’ rather in political terms of criminality than through the clear medical explanation of internal fake structure of drug. 2.3. Necessity of regulation in the pharmaceutical sphere In the given circumstances, the lack of mutual understanding in moral, medical and economic terms brings doubt in the very ability of pharmaceutical counterfeit drug regulation to be effective. Hence, does it necessary mean that regulation of medical drugs should solely rely on ‘invisible hand of market’ within capitalistic structure? On the one hand, market interests surely exist within medical sphere. As Outterson and Smith (2006) mention, “drug companies are reluctant to release information that might harm the marketing efforts for their branded products” (p. 527). In other words, it is evident that currently medical companies operate on market rules; consequently, they are highly interested in maintaining their privileged position in global market. Previously, there even existed the belief that emphasis on public health within the World Health Organization will surely damage the freedom of commerce in industrialized world (T’Hoen, 2003, p. 48). On the current stage, pharmaceutical companies had already initiated overt, covert, and forensic (or replication) security measures (Deisingh, 2005, p. 277). These means even enable British media to blame pharmaceutical companies for regulating the sphere in secret manner; however, their efforts had certain effective public results (Cockburn et al., 2005). Thus, it is evident that market forces have instruments to regulate counterfeit problem by themselves. On another hand, current marketing strategy on drug production and sale cannot operate without any regulation. On a global scale, developed countries support a tendency to sale medicine as expensive as possible in order to “pursuit a profit-maximizing strategy, rather than considering what would allow for greater access to the medicine” (Lee, 2010, p. 45). In other words, regulation in market terms encourages certain diseases in favour to interested pharmaceutical companies. In the given circumstances, Li (2012) noticed that “as markets have become more global, business competition has evolved from a firm-versus-firm race to a supply chain-against-supply chain battle and a wrestling match between lawful manufacturers and counterfeiters” (p. 2). In this situation, the improvements in current regulation style are necessary. 2.4. Key factors that complicate public control in counterfeit regulation Since it is evident that pharmaceutical counterfeit regulation cannot work in the framework of capitalist market, the necessity of third parties involvement is evident. Nevertheless, on the modern stage almost no public control over the sphere is applied. If it touches directly everyone, why people cannot influence the situation in pharmaceutics directly? Firstly, institutional regulation is needed due to the high costs of laboratory checking the quality of the drug (Kalesidis et al., 2007, p. 229). Namely, Deisingh (2005) mentions simple chemical approaches, the GPHF mini-lab, chromatography, mass spectrometry, spectoscopies, isotopic characterization, and tensiography (p. 273-277). In addition, some governments have imposed the specific tracking of drug in order to secure pharmaceutical supply chain for this purpose (Marucheck et al., 2011, p. 717). Precisely, radio frequency identification (RFID) has replaced simple bar code scanning in order to track shipment of drugs (Weinstein, 2005, p. 30). The potential of this solution is highly estimated by several authors (Weinstein, 2005; Marucheck et al., 2011). However, these measures raise indicated by Baldwin et al. (2012) issue of regulatory expertise; in their own words, “one problem with this test is that it may be difficult for the public to assess [decisions or policies]” (p. 29). In general, it decreases the quality of regulation as the whole but is a necessary measure in current situation. Secondly, insecure supply chain is the root of counterfeit problems (Outterson and Smith, 2006, p. 535). Precisely, global extent of this problem introduces various actors into the manufacturing process (Marucheck et al., 2011, p. 716). As Li (2012) determined this phenomenon, “counterfeiting is a byproduct of the growing global dynamic markets and supply chain” (p. 1). In addition, the key roles of secondary distributors and limited access to technological innovations in complicating counterfeit problem are evident (Marucheck et al., 2011, p. 717-718). In this context, counterfeit drugs appear within the legal shipping or are simply repackaged, and it is hard to recognize and distinguish them (Nelson et al., 2006, p. 1070). In other words, the technological ability to copy an authentic drug in an identical manner makes counterfeit problem even harder to solve (Marucheck et al., 2011, p. 721). Hence, the complications in counterfeit determination are supplement by the problems in its proper identification without technical equipment. Finally, the price factor emerges in the product delivered to customer. On the global scale, it is evident that regulation in its current level of development hardly cope with fact that counterfeit drugs effectively satisfy high demand on cheap drugs in both developing and developed countries. Concerning the developing countries, the situation is severe due to the extent of counterfeit usage (Cockburn et al., 2005) and widely popular and incurable or hardly cured diseases for the last decade (like HIV/AIDS, repriratory infections, and malaria) (T’Hoen, 2003, p. 40). In the developed countries, 12.8 million consumers in Europe suspect they face counterfeits in their daily treatment practice (Jackson et al., 2012, p. 241). In general, it is evident that high prices refer to the notion of monopoly, when “the market ‘fails’ because competition is deficient” (Baldwin et al., 2012, p. 16). Thus, is the very appearance of counterfeit drug a grassroots response to the failure of market self-regulation? The literature does not have an answer to this question, and simply analyzes the way society can react on this problem. In general, due to the high complexity of counterfeit sale effects, customers do not want to regulate the sphere since the information they obtain is too complicated for them (Brooker and Cullum, 2008, p. 6). Moreover, the very nature of medical products makes counterfeit crime hardly recognizable for customers (Nelson et al., 2006, p. 1069). Consequently, public tends to delegate regulation issue to certain institutions. In some cases, it even supports extension of drug sale due to the cheapness of counterfeit and considers it as an alternative medical option. 2.5. Current stage of counterfeit drug regulation As for the global context, literature widely discusses the implementation of supported by numerous countries “Anti-Counterfeiting Trade Agreement” (ACTA) (Shaw, 2008; Lee, 2010). Precisely, this document imposes “new, striker legal and enforcement standards to the trade in informational goods” (Shaw, 2008, p. 1). In this context, it discusses medicine counterfeiting in terms of intellectual property. Furthermore, the enforcement of Trade Related Aspects of Intellectual Property (TRIPS) Agreement within World Trade Organization (WTO) determines current emphasize on intellectual rights (Lee, 2010, p. 44). Nevertheless, the unresolved state of counterfeit drug popularity illustrates that current work of international organizations and multilateral agreements is not effective enough to combat counterfeit drugs. In the given circumstances, the appearance of Internet complicates the work of institutions. In general, it is evident that anti-piracy regulation either fails to eliminate the problem or contradicts the interest of both illegal suppliers and customers (BBC, 2012). In this context, the Web deepens current problems with counterfeit regulation, since “it is difficult to identify anonymous Internet sites and track down counterfeit product” (Nelson et al., 2006, p. 1071). Moreover, it is easier and Nevertheless, global pharmaceutical environment does not reflect this belief, since WTO is blamed for having “a negative effect on local manufacturing capacity and [enforcement of its rules] will remove a source of generic, innovative, quality drugs on which developing countries depend” (T’Hien, 2003, p. 42). In other words, current counterfeit activity is the result of improper regulation; since sales in Web have entered the market, its inability to clarify the situation only deepened. In the context of MHRA activity, this agency also constantly faces a challenging attitude from developing countries, which do not recognize European standards and have a huge consumer base in UK (Deisingh, 2005, p. 72). In particular, United Kingdom feels the growing of counterfeit problem as well as the whole world due to the fact that it plays a role of “transit point and an end-user market” (Jackson et al., 2012, p. 242). In other words, even highly protected and regulated countries suffer from counterfeit drugs being affected by global situation. In this context, the issue of World Health Organization’s ineffectiveness emerges, since it does not provide any comprehensive approach through involving multiple stakeholders and transparent methods of working (Sridhar and Gostin, 2011, p. E1). In British case, it is evident that current international situation complicates the activity of national regulatory institutions. 2.6. Effectiveness of current counterfeit drug regulation In general, the analysis of counterfeit regulation demonstrates that it is rather a developing than a solved problem. In this context, U.S. and E.U. agencies even confuse the definitions of concepts they should regulate (Outterson and Smith, 2006, p. 530). In addition, current WHO activity is not active enough to regulate counterfeit crimes (Sridhar and Gostin, 2011, p. E2). Although, such a comprehensive vision will enable appropriate facing the counterfeit problem. For instance, Lee (2010) highlights compulsory license as one of the ways to introduce competition and reduce high prices in the sphere (p. 46). In this context, even within well-established TRIPS there exists sharp inequality between developed and developing countries (Lee, 2010, p. 44). As for the current situation, USA and European countries tend to force other countries to behave in a beneficial manner for their interests (Lee, 2010, p. 48). In addition, it is almost impossible to regulate Internet sales on current stage (Mickey and Liang, 2011, p. 4575). In the current debate, Brooker and Cullum (2008) stand for improving the quality of regulation regardless to its quantity. Nevertheless, this method cannot be a universal measure in the circumstances, when developing countries have no political will to combat counterfeit (Nelson et al., 2006, p. 1071). In this case, the statement made more than ten years ago that “in most tropical countries… the only check on the authenticity of the tablets will be the patient or relative buying the medicine” (Green, 2002, p. 801) is still up-to-date. Another necessary measure is to guarantee transparent regulatory activity (Baldwin et al., 2012, p. 29); in other words, “to extent the ‘behind the scenes’ fight against fakes to a public collaborative approach with a legal responsibility to report suspected counterfeits to drug regulatory authorities” (Cockburn et al., 2005). Therefore, only the core transformations can improve the regulation. 3. Conclusions and recommendations In fact, it is evident that on its current stage regulation in pharmaceutical industry is incapable to cope with the key problems in the sphere. In fact, the very nature of pharmaceutical regulation emphasizes on human rights to obtain safe and qualitative cure. Nevertheless, it operates in the framework of market rationale in contrast to social responsibility. Hence, problems appear on all levels of regulatory practice: from the definition of ‘counterfeit’ notion to the manner in which it operates globally. In addition, the current situation of counterfeit drug regulation reveals its political nature. For instance, there exists a common belief that criminal element is the key element of counterfeit production and distribution, even though there exist attempts to define this notion in scientific terms. In addition, current disproportion of counterfeit drugs between North and South turn this problem to political filed. In other words, there is an unequal bargaining power, since developed pharmaceutical corporations have more opportunities and resources to produce authentic drugs than those from the developing countries. In order to sum up, lack of information in the relations between corporations and customers is the core reason of regulation failure in the sphere. Consequently, ordinary people are incapable to defend their right to have safe medication personally. In general, this finding reflects the idea that public awareness is crucial for effective regulation, since both market forces and political institutions cannot comprehend each individual need. As a result, encouragement of public sector can increase the effectiveness of counterfeit drug regulation in each country in particular and in the world in general. References: Almuzaini, T., Choonara, I., and Sammons, H. (2013) Substandard and counterfeit medicine: a systematic review of the literature. British Medical Journal Open, vol. 3, is. 8, pp. 1-7. Available at: < http://bmjopen.bmj.com/content/3/8/e002923.full.pdf+html> [Accessed 2 March 2015]. Baldwin, R., Cave, M. and Lodge, M. (2012). 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