The United Nations Office on Drugs and Crime

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1 The United Nations Office on Drugs and Crime Agenda 2 Trafficking of Fraudulent Medicines Committee History and Description The United Nations Office on Drugs and Crime (UNODC) was created in 1997 as a union of the United Nations Drug Control Programme and the Centre for International Crime Prevention. It is an international organization that works towards the elimination of international crime, the illicit drug trade, and terrorism. The three fundamentals of UNODC are field-based cooperation, research, and legislative work at all levels of government. UNODC tirelessly works towards providing a safer place for all citizens of all regions of the world. Introduction Fraudulent medicines pose a considerable public health threat as they can fail to cure, may harm and even kill patients. These threats to public health have led the international community to call for a stronger and more coordinated response. Compounding this public health risk is the fact that the supply chain for medicines operates at a global level, and therefore, a concerted effort at the international level is required to effectively detect and combat the introduction of fraudulent medicines along this supply chain. The 20th session of the Commission on Crime Prevention and Criminal Justice (CCPCJ) adopted resolution 20/61 on fraudulent medicines, otherwise referred to as falsified medicines due to concern about the involvement of organized crime in the trafficking in fraudulent medicines. At the same time, resolution 20/6 highlights the potential utility of the United Nations Convention against Transnational Organized Crime (UNTOC) for which UNODC is the guardian, in re-enforcing international cooperation in the fight against trafficking, through, its provisions, inter alia, on mutual legal assistance, extradition and the seizing, freezing and forfeiture of the instrumentalities and proceeds of crime.

2 As with other forms of crime, criminal groups use, to their advantage, gaps in legal and regulatory frameworks, weaknesses in capacity and the lack of resources of regulatory, enforcement and criminal justice officials, as well as difficulties in international cooperation. At the same time, the prospect of the comparatively low risk of detection and prosecution in relation to the potential income make the production and trafficking in fraudulent medicines an attractive commodity to criminal groups, who conduct their activities with little regard to the physical and financial detriment, if not the exploitation, of others. Resolution 20/6 contains nine action points among which paragraph nine requests that UNODC, in cooperation with other United Nations bodies and international organizations, such as the International Narcotics Control Board (INCB), the World Health Organization (WHO), the World Customs Organization (WCO) and the International Criminal Police Organization (ICPO/INTERPOL), as well as relevant regional organizations and mechanisms, national regulatory agencies for medicines and, where appropriate, the private sector, civil society organizations and professional associations, assist Member States in building capacity to disrupt and dismantle the organized criminal networks engaged in all stages of the illicit supply chain, in particular distribution and trafficking, to better utilize the experiences, technical expertise and resources of each organization and to create synergies with interested partners. While focus has been given to the health and regulatory aspect of this problem, it appears that less attention has been given to the issue from a criminal justice perspective. Given its expertise and work to build effective and transparent criminal justice systems and to support states to prevent and combat all forms of organized crime, UNODC can support the fight against the illicit manufacture and trafficking of fraudulent medicines in coordination with other stakeholders. Definition of Key Terms Fraudulent Drugs Currently, an international definition does not exist for the terms fraudulent medicine or fraudulent essential medicine. However, for the purpose of this committee the term fraudulent medicine will mean, a product [that] is sold deceptively. The term fraudulent drug is a drug made by someone rather than the genuine manufacturer. Although they do not have the authority to do so, the people who imitate the authentic drugs often market their fake

3 drugs as the original, authentic ones. Fraudulent drugs are also called as counterfeit drugs. This includes the problem in unauthorized manufacturing, copying or imitating an original product and marketing the copied or illegally made drug as the authorized medicines. Drug Trafficking Drug trafficking is a global illicit trade involving the cultivation, manufacture, distribution and sale of substances which are subject to drug prohibition laws. Drug trafficking is the main goal that has to be tackled and solved through this agenda. The solutions for drug trafficking have to concern all the four concepts: cultivation, manufacture, distribution and sale. Relevant UN Treaties, Resolutions Technical Conference of Experts on the Trafficking in Fraudulent Medicines February 2013 Vienna From 14 to 15 of February, 2013, in Vienna, UNODC held conference on the illicit trafficking of counterfeit medicines which is a form of transnational organized crime that threatens public safety. This conference brought experts from regulatory and law enforcement agencies, regional and international organizations, industry and business associations, civil society and Member States to discuss the illicit production, distribution and trafficking in fraudulent medicine. UNODC Resolution 20/6 Countering fraudulent medicines, in particular their trafficking Encourages nations to strengthen international cooperation by introducing and improving law enforcements on crimes related with fraudulent medicines, exchange information and joint investigations. Requests nations to be in close cooperation with other United Nations departments and international organizations such as the International Narcotics Control Board, the World Health Organization, the World Customs Organization and the International Criminal Police Organization also related regional organizations, national agencies, private sectors, civil society organizations and professional associations to build capacity to demolish the organized crime networks included in illicit supply of fraudulent medicines.

4 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, This convention is about extensive efforts on drug trafficking which includes attempts on solving money laundering and others. It provides for international cooperation such as extradition of drug traffickers and look over the trade of medicines. Also this convention led to resolution 1998/8 of 25 May 1988 of the Economic and Social Council on the basis of resolutions 39/141 of 14 December 1984 and 42/111 of 7 December 1987 of the General Assembly. The text of the Final Act was published in E/CONF.82/14. United Nations Convention against Transnational Organized Crime, New York, 15 November Resolution A/RES/55/25 of 15 November 2000 at the fifty-fifth session of the General Assembly of the United Nations was adopted in this convention. Decision 2013/246 (ECOSOC) This Decision is to improve the governance and financial situation of the United Nations Office on Drugs and Crime. Resolution 22/2 (CCPJ, 2013) This Resolution did the same work as the Decision 2013/246 from above. Resolution 22/5 (CCPJ, 2013) This resolution is to promote international cooperation for the analysis of trends in transnational organized crime. Resolution 22/6 (CCPJ, 2013) This resolution is for strengthening the international cooperation and capacity to combat the transnational organized crime at sea. A/RES/67/186 (GA) This is to strengthen the resolutions and reform the criminal justice institutions, particularly in the areas related to transnational organized crime and drug trafficking.

5 Resolution 2011/34 (ECOSOC) This resolution is to support the United Nations Office on Drugs and Crime. Resolution 2011/35 (ECOSOC) This resolution is to promote international cooperation in the prevention, investigation, prosecution and punishment of economic fraud and identity-related crime. Decision 2011/258 (ECOSOC) This decision is to improve the governance and financial situation of the United Nations Office on Drugs and Crime. Decision 2011/259 (ECOSOC) This decision is for joint meetings of the reconvened sessions of the Commission on Narcotic Drugs and the Commission on Crime Prevention and Criminal Justice. Resolution 20/2 (CCPJ) This resolution is for implementation of the budget for the biennium for the United Nations Crime Prevention and Criminal Justice Fund Resolution 20/6 (CCPJ) This resolution is for countering fraudulent medicines, especially in its trafficking. Resolution 20/8 (CCPJ) This resolution is for the budget for the biennium for the United Nations Crime Prevention and Criminal Justice Fund. The Problem There is an astounding difference in fraudulent medicine prevalence between more developed countries (MDCs) and developing countries. In MDCs, the prevalence rate of fraudulent medicine is at approximately 1%. This small figure can be attributed to more advanced and efficient border security, as well as less corrupt governments and government officials, and overall pharmaceutical processing by various countries. In contrast, the rate of prevalence

6 increases by ten times in some developing countries reaching a 10% prevalence rate. This figure then triples again in some parts of Asia, Latin America, and Africa, where fraudulent medicine comprises approximately 30% of the pharmaceutical market. The trend seems to exist: the less developed a country is considered, the more likely it is that said country has an increased prevalence of fraudulent medicine within its borders. More specifically, throughout the continent of Africa a multitude of problems continue to exist due to fraudulent medicine, a closer look at this region helps to explain the traumatic impact tampered pharmaceuticals can have on a population. To further understand the reason that the Africa continent has one of the highest prevalence s of fraudulent medicine in the world, it is important to understand where these falsified drugs are manufactured. The two most involved countries in the conception of fraudulent medicine are India and China. Not only are these countries growing on the international scale, but also their pharmaceutical industries are currently experiencing high growth rates, only leading to the production of more dangerous medicines. The increased rate of production is only furthered due to the ease at which a person can falsify individual pills. The UNODC recognizes that often times all it takes is accessibility to a laser printer in order to add falsified marking to medicines in order to make them appear safe. Additionally, many companies in South Asia make a ludicrous amount of by producing falsified drugs and sending them to developing countries. The transport of the drugs is facilitated through containerized shipments, rather than through the air. Transportation via containers and free trade zones decreases the likelihood of closer inspection by border control and other entities. Once in an African country s borders, detection is highly unlikely and distribution often undetectable According to the UNODC, the three most obvious signs of fraudulent medicine are: falsified packaging, no active ingredient, active ingredients other than the ones specified in the packaging. Simple, yet effective methods of testing exist to detect illegal and even harmful forms of deceptive medicines. It must be the job of the creating country and the job of the receiving country to ensure that medicines are safe and legally created. For example, recent reports have showed a strengthening of communication and information sharing between Chinese pharmaceutical companies and African governments. However, not all countries play by the rules, and often times shipments slip through the cracks unnoticed. However, some technologies have been introduced to Africa in order to detect bad shipments. A new innovate on called TruScan helps border patrol agencies as well as government officials scan shipments to determine if they have a good chemical composition, meaning

7 they detect if shipments are adequately labelled. Furthermore, now consumers are being given the power to make more informed decisions when purchasing pharmaceuticals as well. Certain pharmaceutical companies have begun to include scratch off codes on their medicinal products. Consumers can scratch off a label to discover a code and then send a free text message with the code to the pharmaceutical company; instantly, the company is able to verify if the drug that was purchased is real or not. Simple individual empowerment techniques like this allow citizens to protect themselves against the dangerous fraudulent medicine trade, rather than relying on governmental action that is not always consistent. Africa s Challenge According to the World Health Organization, approximately 100,000 deaths a year occur in Africa due to fraudulent medicine. These deaths can be attributed to multiple complications that arise in falsified medicines. Additionally, medications that are tampered with aids in increasing the amount of antibiotic resistant strains of various diseases that may arise; thus, only growing the threat of already-rampant viruses in Africa. The aforementioned problems are attributed to the fraudulent medicines that reach their destinations. So why can t these problems be stopped by increased border security on an individual country level? The problem is that many African countries do not have strong enough regulation efforts to stop the spread of these illegal, and highly dangerous medicines; additionally, most African countries have extremely open borders that allow easy access for a variety of trade types. Without a concerted effort by the region, individual country action is likely to be minimal at best. Effective legislation has yet to be passed to properly prosecute those creating and spreading fraudulent medicines. On top of this, trained personnel are severely lacking in the areas that need it most. Without properly trained officials, the task of ending the illegal pharmaceutical trade becomes somewhat impossible. Moreover, in many African States, political volatility has led to poor drug purchasing practices by healthcare administration, and lack of proper training, inadequate work force, and corruption are common among African health care sites. Lack of both medicine legislation and prosecution enforcement in the continent encourages criminals to produce fake drugs as well. Even a week supply of medication can stimulate the fraudulent medicine trade, as shortages cause people to buy fake substitutes.

8 Likewise, poverty drives the purchase of counterfeit medications. As stated above, medicines sold in licensed pharmacies are often too expensive for many; a WHO study determined that duties, taxes, mark-ups, distribution costs, and dispensing fees are often high, regularly constituting between 30% to 40% of retail prices, but occasionally up to 80% or more of the total. Therefore, African consumers support open drug markets, because their products are simply reduced. Also, illiteracy is a significant problem, as the uneducated have slightor no information on the efficacy of genuine and fake medications. Consequently, delegates must strive to develop solutions that focus on remedying the causes and foundations of the fraudulent medicine trade. Delegates, too, can look to Rwanda as an example for possible solutions, as no fraudulent tuberculosis medications have been found within the nation. The Rwandan government purchases high-risk drugs directly from World Health Organization-certified manufacturers, and a large proportion of health care workers are adequately trained to spot and report fake drugs through governmental and non-governmental organization (NGO) support. Furthermore, a unit of customs officials and health regulators examines drugs coming into the nation at the border, informing the police, who then inform Interpol, if something is awry. The Rwandan approach, simply stated, is complete and all-inclusive. Another viable solution that has been utilized in West Africa to counter such an illicit trade is the use of SMS-protected drugs. MPedigree Network and Sproxil, global leaders in the fight against counterfeiting in the health sector, have designed systems that allow legitimate drug manufactures to label their packages with an encrypted code. Consumers and patients can take off the label and text the code under the label free of charge. The manufacturer will then send an instant response to the consumer, notifying him or her whether the medication is genuine. Innovative solutions such as SMS-protected drugs are often times effective and should be explored within committee. All in all, counterfeiting is a criminal act, and it is imperative that all African nations, in addition to drug exporting nations, take measures to deter fraudulent medicines. Only then will such a devastating trade come to an end.

9 `Case Study Kenya According to the Pharmacy and Poisons Board of Kenya (PPBK), counterfeit drugs are substandard drugs that are fraudulently labeled or include wrong ingredients, whereas fake drugs have no active ingredients. xxx The proliferation of counterfeit and substandard pharmaceuticals has definitely become an increasing issue in Kenya, as the country has lost over $117 million in tax revenues to the trade.xxxi In fact, as of 2012, thirty percent (30%) of all medications sold within the nation have been deemed fraudulent or fake. In one of Kenya s largest counterfeiting incidents (2008), Kenyan officials found a shipment of Panadol Extra tablets, painkillers produced by GlaxoSmithKline pharmaceuticals, amounting to 62,000 USD. Upon examination by the Kenya Medical Research Institute, all tablets were discovered to contain only chalk no active ingredients of any kind were found. Such occurrences have led to public doubt in Kenyan health care systems, deterring patients from seeking necessary treatments for their condition. Additionally, Kenya lacks stringent penalties for those involved in the fake medicine trade, consequently encouraging criminals to resume trade after indictment. Counterfeit drug charges only warrant a fine of $2,340, but Kenya Medical Practitioners, Pharmacists, and Dentists Union Chairman Victor Ng ani stated, Attempted murder charges should be levied against [people who sell fake drugs], and much of Kenya shares his opinion. Thus, delegates should look into the effectiveness of stricter penalties in comparison to more lax ones and implement the punishments that will work best to thwart fake medicines. To counter counterfeit drugs, in April of 2013, Kenya developed an Internet-based, transparent reporting system, known as the Kenya Pharmacovigilance Electronic Reporting System (PV-ERS), in which both patients and pharmaceutical companies describe the quality medicines they have received so as to monitor the quality of drugs sold and relocate their source. Simple to understand forms, which ask patients to describe the color, packaging, and effectiveness of specific drugs, are also available at all health centers in the nation. Within the past year, roughly 200 reports from the public have resulted, aiding in the arrestment of culprits, the confiscation of fake and/or substandard medicines, and the closing of small markets. The PPBK also investigates pharmacies, with the most recent occurring in September 2014; searches in Nairobi led to seizure of counterfeit drugs amounting to560,000

10 USD. As a whole, the simple solutions Kenya has implemented seem to be effective but rather short-term. Short-term and long-term solutions, along with common and unique responses, are needed to successfully end the counterfeit drug trade in all of Africa. Conclusion Criminals groups around the world take advantage of the lack of framework and laws countries have to combat this crime. Fraudulent medicine appears the most in parts Asia, Africa and Latin America as up to 30% of medicine is thought to be fraudulent. The CCPCJ site says this crime is high because, the prospect of the comparatively low risks of detection and prosecution in relation to the potential income make the production and trafficking in fraudulent medicines an attractive commodity to criminal groups. So far, work on this issue has focused on the health and regulatory aspect of this problem rather than the issue of criminal justice. There was a conference in Vienna in February 2013 where the UNODC discussed the production, distribution and trafficking of fake drugs by organized crime networks. The CCPCJ would give their expertise to build a criminal justice system, which could effectively combat this issue while at the same time support nations to prevent this form of organized crime. The part of fraudulent medicine that the CCPCJ committee will be tackling is the trade of the fabricated medicine, as this would allow the countries in the CCPCJ to work together in order to monitor and discuss strategies to limit and/or stop the production and trade altogether. According to fox news, From Cameroon to Ivory Coast, Kenya to the DR Congo, traders in counterfeit drugs does a thriving business with the utmost cynicism and sometimes at the cost of human lives. This problem exists in both developed and developing countries and is truly a global problem that needs global cooperation in order to stop this issue. Questions As high medicine cost drives the fraudulent medicine industry, how will countries stop the demand of fraudulent medicine? How will developing countries deal with the economic impact of fraudulent medicine? How will the UNODC deal with these criminals?

11 How will your country prevent fraudulent medicine from entering or leaving its borders? Will there be punishments for countries that do not monitor medicine production and transportation? What will happen if countries cannot do so? Does your country have any form of legislation on counterfeit drugs, and has it taken action against the illicit trade? Besides the use of SMS-protected drugs and reporting systems, what additional measures have African nations already taken to counteract fraudulent drugs? Have they been effective or ineffective? What steps can be taken to make the counterfeit drug trade in Africa less profitable? As seen in Kenya, lenient punishments lead to the proliferation of the counterfeit drug trade. Are stringent punishments necessary, and how can any form of indictment be constantly enforced within African nations? What consequences should suppliers of counterfeit medications (i.e. corporations based in Southeast Asia) face, and how will such consequences deter the production of fake drugs? How can education be utilized as an instrument to counter counterfeit drugs? Research Links erfeitmedicine/ s-temperature df