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This page provides access to CISG case law sorted by the category of goods traded. For more details, see further information on CISG practice by goods traded. Toggle navigation CISG-online.
CISG practice by goods traded
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The counterfeit drug market is a nebulous and constantly evolving entity that has become increasingly difficult to define and quantify. Counterfeiting can apply to both branded and generic products. This can include products with bona fide ingredients, but with insufficient or excessive quantities, products with the wrong ingredients, or products with deceptive packaging. Regardless of the definition, drug counterfeiting has become a global problem. In addition to the intellectual property rights that counterfeiters violate, the products they make can place consumers in danger. Legitimate pharmaceuticals must pass vigorous standards and undergo large, randomized trials before being formally approved for the public. Then, all sanctioned medications are manufactured under heavily monitored conditions. Counterfeit medications bypass all these safeguards 2. Despite these potential dangers, the market for counterfeit products has grown astronomically. However, the WHO has since become less definitive in estimating the scope of the problem, as there is an inherent difficulty in quantifying counterfeit products, which have become increasingly sophisticated and difficult to differentiate from genuine medicines. Regardless, it is clear that counterfeit medications have reached an industrial level scale. These numbers do not even account for individual distribution and consumption of illegal pharmaceuticals, not to mention the illegal operations that escape detection. Some sources estimate that the market for counterfeit medications ranges between 75 and billion dollars 5 , 6. The large market for counterfeit medications is not equally distributed in size or class of medications worldwide. It is largest in poor and developing countries, with the size of the market being inversely proportional to the amount of regulation. However, even in these well-regulated countries, the market for counterfeit PDE-5i has grown. Globally, antibiotics comprise the largest class of counterfeit medications, but in Europe, PDE-5i are the most commonly counterfeited medicines 7. In fact, for PDE-5i, the illegal market in industrialized countries approaches the size of that in developing countries. Between and , Two separate analyses in Europe estimated that 0. However, the true scope of illicit PDE-5i use is difficult to estimate. In one study attempting to estimate illicit sildenafil use, concentrations of sildenafil and sildenafil metabolites were measured in sewage treatment centers in the Netherlands. Many factors contribute to the disproportionately large market of counterfeit PDE-5i. First, there are high economic gains to be made. Erectile dysfunction ED is a common problem and increases in incidence as men age As the world population ages, there is a larger potential market forming. With the low cost of base materials and the high cost of pills, the profit margin for creating sildenafil is approximately 2, times that of cocaine. Meanwhile, while the punishment for buying 1 kilo of cocaine would be a minimum of 5 years to a maximum of 40 years in jail, the punishment for buying 1 kilo of sildenafil is typically 3 years With such significant profits to be made at a relatively low risk, there is a tremendous incentive for counterfeiters to tap into the growing market for PDE-5i. Besides the high profit margins, the underlying characteristics of consumers of PDE-5i make it a prime target for counterfeiters. There is an associated embarrassment of the underlying condition of impotence that leads patients to seek alternative means of obtaining PDE-5i Predictive factors for obtaining PDE-5i while avoiding interaction with healthcare professions were embarrassment and the perception that it would be cheaper to get the medicine through alternative means. Furthermore, many users of PDE-5i are recreational users. These statistics speak to the underlying idea that users believe PDE-5i are harmless and that they can be self-prescribed, with no negative consequences. Furthermore, PDE-5i use is a relative luxury. Increasing household income and availability of a sexual partner positively correlate with their legal use These patients with higher socioeconomic statuses having the resources to pay for pharmaceuticals out-of-pocket, combined with the stigma of ED, creates an environment ripe for an illicit market. Internet pharmacies have made it easier for PDE-5i users to bypass the healthcare system, as Many of these pharmacies are based in foreign countries and are poorly regulated. The ease and convenience of purchasing counterfeit PDE-5i products via the Internet have contributed to the growth of the illicit market. While the market for counterfeit pro-erectile medications is partially driven by the cost of prescription drugs, this reality could soon change. As the patents for PDE-5i will be expiring soon, it is conceivable that the cost of these drugs may be reduced significantly. This in turn could lead to a decreased demand for cheaper alternative counterfeit options. These dynamics are already evident with many pharmacies advertising for generic sildenafil 20 mg , used for pulmonary hypertension, at a significantly lower cost. Furthermore, as mentioned earlier, embarrassment with potency issues leads patients to avoid physician visits. PDE-5i have been shown to be safe medications and may ultimately be available over the counter. This strategy could help ease patient concerns and re-invigorate the PDE-5i market. PDE-5i are effective in treating ED of many etiologies, and are currently both the first line and mainstay treatment option. Studies have suggested that PDE-5i are also effective in treating premature ejaculation, decreasing refractory time post-ejaculation, and diminishing lower urinary tract symptoms They are an inhibitor of phosphodiesterase, which is an enzyme in the biochemical cascade of erection initiation. In the normal erection process, vascular endothelium releases nitrous oxide, which activates guanalyl cyclase to convert guanosine triphosphate to cyclic guanosine monophosphate cGMP. There are numerous known side effects of PDE-5i, some of which may be life threatening. As PDE-5i are active in the vasodilation pathway, there is a risk of profound hypotension and syncope with concurrent use of nitrates and alpha-blockers. The use of nitrates is an absolute contra-indication to PDE-5i use and the use of alpha-blockers is a relative contraindication. There is no current pharmacologic antidote to these interactions Many of these side effects occur because there is cross-reaction with other phosphodiesterase types located throughout the body 18 , PDE-5i are metabolized almost exclusively by the cytochrome P system in the liver, specifically Cytochrome PA. Concurrent use of CYP 3A inhibitors or inducers can significantly alter the concentration of serum PDE-5i changing the side-effect profile, effectiveness of the medication, or severity of drug interactions Examples of commonly prescribed medications that have interactions with PDE-5i are included in Table 1. Before PDE-5i are prescribed, patients must be evaluated for potential drug interactions and warned of the absolute contra-indications. There is also an indirect risk of missing potential medical conditions in patients that bypass the healthcare system to purchase illicit PDE-5i. It has been well documented that ED is associated with significant medical comorbidities including cardiovascular disease, diabetes, metabolic syndrome, hypertension, and hyperlipidemia The Second Princeton Consensus on sexual dysfunction and cardiac risk stated that all men with ED, even in the absence of manifesting cardiac symptoms should be regarded as having potential risks for cardiovascular disease Currently, evidence suggests that ED is not only correlated with cardiovascular disease due to shared medical comorbidities, but is, in fact, an independent risk factor for cardiovascular disease. Thus, all men with vasculogenic ED should undergo cardiac risk stratification and risk factor management Furthermore, The most detrimental problem with counterfeit PDE-5i is that the content is unregulated. In , United Kingdom authorities seized 2, samples of counterfeit Viagra and forwarded them to Pfizer laboratories for analysis. Similar results were found in an analysis of counterfeit ED drugs sold in Italy, Austria, and Canada These problems are magnified in developing countries with less regulation. Quantities of active ingredients are also highly variable, as seen in Table 2. The effects of widely variable amounts of active ingredient range from low efficacy at a minimum to severe side effects and negative drug interactions at the worst. As stated, counterfeit PDE-5i rarely are packaged with the appropriate warning labels. In addition, counterfeit PDE-5i often contain contaminants. These are used either as bulking agents to lower production costs or to imitate the appearance and physical qualities of the genuine product. In those samples seized in the United Kingdom, Italy, and Indonesia, there were contaminants such as gypsum, non-purified talc, amphetamine, commercial grade paints, paracetamol, and metronidazole 27 , 28 , These non-pharmaceutical ingredients can have toxicities of their own. Non-declared pharmaceuticals can have drug interactions and side effects such as gastrointestinal symptoms and nausea when combining metronidazole and alcohol. Counterfeiters do not declare these ingredients or warnings of possible deleterious interactions on their packaging. Furthermore, the manufacturing conditions of counterfeiters cannot match the sterile processing conditions of legitimate pharmaceuticals. These results are not surprising, when considering the strict regulations and inspections that legitimate pharmaceutical producers must pass, compared with the unsterile conditions in which counterfeiters may work. Many laboratories of counterfeiters are exposed to the open air and use unsterile water that would not be safe for drinking. Contamination with either adulterants or bacteria poses risks to consumers of counterfeit PDE-5i. Unlike pharmaceuticals requiring prescriptions, there is little Food and Drug Administration FDA regulation of health supplements. In a well-known example, non-diabetic patients were hospitalized with hypoglycemia in Singapore. Seven patients fell into a comatose state, and four subsequently died. The common link between these patients was the use of an ED supplement that contained glyburide a sulfonylurea used to treat diabetes , as well as illicit PDE-5i In one study, the ingredients of 58 products available for the treatment of ED without a prescription were analyzed. Several contained higher-than-approved amounts of PDE-5i, and others contained PDE-5i analogs that are not approved for use. One even contained phentolamine, an alpha-blocker, with which concurrent use with PDE-5i is contraindicated. Packaging and labeling were inadequate, and only 14 samples warned against concomitant nitrate use, a potentially fatal drug interaction Recently, in January of , the FDA announced warnings against 40 products marketed as dietary supplements that contained undeclared PDE-5i 33 Table 3. However, by doing so, many of these patients are unknowingly subjecting themselves to significant health dangers. Strategies to limit counterfeiting should be multi-faceted and target prescribing healthcare professionals, pharmaceutical companies, regulatory authorities, and patients. As such, in , the WHO created a global coalition of stakeholders called International Medical Products Anti-Counterfeiting Taskforce IMPACT , which aims to build coordinated networks across and between countries in order to halt the production, trading, and selling of fake medicines around the globe Similarly, PDE-5i manufacturers have started working with regulatory and law enforcement authorities, as well as providing distinctive packaging using holographic security foil, 2D barcodes, and radio frequency identification RFID tags. Similarly, the FDA has launched significant public education campaigns through magazine public service announcements, education leaflets, news articles, a consumer website www. Counterfeit PDE-5i pose many—possibly serious—risks to patients. Counterfeit PDE-5i have become a worldwide problem that comprises a large percentage of PDE-5i use in both developing and well-developed countries. Patients embarrassed by their condition or seeking less expensive alternatives to legitimate pharmaceuticals have fueled the market, and the growth of Internet pharmaceuticals have made counterfeit pharmaceuticals easy to obtain. However, ED is a medical condition that needs to be treated as such. By bypassing the legitimate healthcare system, users of counterfeit PDE-5i bypass screening for concurrent medical comorbidities, as well as proper education and warnings of PDE-5i use. Furthermore, counterfeit PDE-5i often contain improper dosing and contaminants that may place patients at direct risk. Physicians who treat ED should warn patients against purchasing PDE-5i via alternative means, especially the Internet. The use of dietary supplements for treatment of ED should be screened for and given due precautions. Conflicts of Interest: Dr. WJ Hellstrom has been an advisor or consultant to Pfizer. The other authors have no conflicts of interest to declare. Table 1 Common medications and dietary supplements with interactions with phosphodiesterase-5 inhibitors PDE-5i Full table. Figure 1 Microbial growth analysis of phosphodiesterase-5 inhibitors PDE-5i products Transl Androl Urol ;6 1
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