7

An International Code of Practice for
Falsified and Substandard Medicines

Ensuring a safe, reliable drug supply is ultimately a matter for individual countries. To this end, every nation has four main responsibilities: regulating the responsible manufacture of safe and effective medicines; preventing falsified and substandard drugs from entering the market; detecting them when they do; and punishing those who knowingly manufacture and trade them. Executing these responsibilities requires strong national systems for drug regulation, surveillance, and law enforcement. Governments must work with key stakeholders in industry, professional associations, and civil society to protect the drug supply.

However, no country acting alone can protect its citizens from falsified and substandard medicines. The problem, as seen throughout this report, is international, fueled by international trade and telecommunications. Crime and easy money are powerful forces driving the illegitimate medicines business. Its perpetrators gravitate to countries where surveillance, regulation, and law enforcement are the weakest. They take advantage of international manufacturing and trade to produce and sell their products in the global market.

The interconnectedness of modern manufacturing systems makes the “quality and safety of goods … that travel in international commerce” (Gostin and Taylor, 2008, p. 54) a global public health concern. A coherent system of global governance founded on diplomacy and international cooperation can improve product safety and protect health around the world (Gostin and Taylor, 2008). This will require cooperation among countries, among agencies within governments, and among consumers, manufacturers, professional associations, and civil society groups.



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7 An International Code of Practice for Falsified and Substandard Medicines Ensuring a safe, reliable drug supply is ultimately a matter for indi- vidual countries. To this end, every nation has four main responsibilities: regulating the responsible manufacture of safe and effective medicines; pre- venting falsified and substandard drugs from entering the market; detecting them when they do; and punishing those who knowingly manufacture and trade them. Executing these responsibilities requires strong national systems for drug regulation, surveillance, and law enforcement. Governments must work with key stakeholders in industry, professional associations, and civil society to protect the drug supply. However, no country acting alone can protect its citizens from falsified and substandard medicines. The problem, as seen throughout this report, is international, fueled by international trade and telecommunications. Crime and easy money are powerful forces driving the illegitimate medicines busi- ness. Its perpetrators gravitate to countries where surveillance, regulation, and law enforcement are the weakest. They take advantage of international manufacturing and trade to produce and sell their products in the global market. The interconnectedness of modern manufacturing systems makes the “quality and safety of goods . . . that travel in international commerce” (Gostin and Taylor, 2008, p. 54) a global public health concern. A coherent system of global governance founded on diplomacy and international co- operation can improve product safety and protect health around the world (Gostin and Taylor, 2008). This will require cooperation among countries, among agencies within governments, and among consumers, manufactur- ers, professional associations, and civil society groups. 295

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296 COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS This chapter discusses the global governance tools available to fight the public health problem of falsified and substandard drugs. An emphasis on the public health risks of illegitimate drugs is central to framing this problem; protecting drug companies’ proprietary interests is not. In the past, disagreements about the overlap between public health protection and intellectual property guarantees have crippled international discussion on drug safety. Any global governance process will need to focus on public health, a goal all parties can support and come to consensus around. Global governance includes hard law, such as treaties, and soft law, such as resolutions, declarations, memorandums of understanding, and codes of practice (Gostin, 2013). The committee does not believe that the time is ripe for hard-law solutions. If countries or regions wish to negoti- ate a treaty on falsified and substandard drugs, then they should do so, but international soft law may be a more practical short-term solution to the problem. A soft-law solution could encourage international momentum for drug regulation, surveillance, and law enforcement. It would also build trust among stakeholders and pave the way for a future hard-law solution if necessary. Two treaty processes already under way relate to the problem of substandard and falsified medicines. The Council of Europe’s Medicrime Convention (officially, “the Convention on the counterfeiting1 of medical products2 and similar crimes involving threats to public health”) is a multi- lateral treaty intended to prevent the public health threats of illegitimate medicines (Council of Europe, 2011). The convention aims to make crimes of drug adulteration and of the intentional manufacture, supply, or trade in illegitimate medicines or ingredients, and their accessories (Council of Europe, 2011). Other criminal offenses under Medicrime include tamper- ing with the drug pedigree or making false drug documents; putting an unauthorized drug on the market; and intentionally aiding or abetting a criminal in one of the named offenses (Council of Europe, 2011). Med- icrime also gives terms for protecting victims, including victim’s rights to compensation from perpetrators, and for international cooperation in investigation, extradition, and mutual legal assistance (Council of Europe, 2011). By December 2012, 22 countries had signed the convention, but only Ukraine had ratified it (Council of Europe, 2012). Medicrime will not come into force until five countries ratify it, including three Council of Europe members (Council of Europe, 2011). Critics of the convention see in Medicrime an attempt to treat routine 1  The Medicrime Convention defines a counterfeit as a false representation of identity or source (Council of Europe, 2011). 2  The Medicrime Convention defines a medical product as human and veterinary medicines and medical devices (Council of Europe, 2011).

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INTERNATIONAL CODE OF PRACTICE 297 quality control errors as crimes (Attaran and Bate, 2010). And, though Susanne Keitel, the director of the European Directorate for the Quality of Medicines, explained to the committee in March that the Medicrime Con- vention does not cover infringement of intellectual property rights, some see hostility to generics companies in the treaty (Attaran and Bate, 2010). This impression is fueled by the recent memory of European Union (EU) customs officials seizing as counterfeit generic drug shipments produced in India and bound for Africa or Latin America (EUbusiness, 2010; Reuters, 2011). The Anti-Counterfeiting Trade Agreement (ACTA) is the other treaty relevant to falsified medicines. ACTA sets international standards for in- tellectual property protection and creates a regime outside of the World Trade Organization (WTO) and the World Intellectual Property Organiza- tion (WIPO) to protect intellectual property (Ilias, 2012). Eight countries3 signed ACTA in October 2011, but Japan is the only country that has for- mally ratified the treaty (MOFA of Japan, 2012; USTR, 2011). ACTA will come into force only when six countries ratify it (USTR, 2011). As Chapter 1 explains, this report is not concerned with intellectual property rights. The committee believes that the real or perceived mixing of public health and intellectual property concerns only holds back action on the problem of falsified and substandard drugs. THE ROLE OF THE WHO Protecting public health is the goal of the proposed code of practice on falsified and substandard drugs. Therefore, the World Health Organization (WHO) is the natural home for the negotiation, development, and adoption of the code. Article 2 of the WHO Constitution authorizes the organization, “to act as the directing and coordinating authority on international health work.”4 To this end, the WHO Constitution also grants extensive norma- tive powers to World Health Assembly (WHA), the governing body of the WHO. The WHA’s jobs include determining the organization’s policies and budget, appointing the Director-General, directing the Executive Board on areas for study or action, inviting other organizations to participate in WHO activities, and maintaining agreements with the United Nations.5 The assembly also has the authority to recommend actions to members and 3  Australia, Canada, Japan, Morocco, New Zealand, Singapore, South Korea, and the United States have signed ACTA (USTR, 2011). 4  World Health Organization, Basic Documents, Constitution of the World Health Organi- zation, 45th ed., Supplement, October 2006. Chapter II, Article 2(a). 5  World Health Organization, Basic Documents, Constitution of the World Health Orga- nization, 45th ed., Supplement, October 2006. Chapter V, Article 18(a), (c), (d), (f), (h), (j).

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298 COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS Key Findings and Conclusions •  he political climate is not conducive to a hardlaw, such as a multilat- T eral treaty, against falsified and substandard drugs. •  code of practice is a soft-law solution that would give member A states clear, consistent guidelines and benchmarks for their work against falsified and substandard drugs. •  he WHO should lead in the development of a code of practice on fal- T sified and substandard drugs, in consultation with the World Customs Organization (WCO), the United Nations Office on Drugs and Crime (UNODC), and other stakeholders. to require members to give yearly reports on action taken to comply with recommendations.6 This report makes clear that substandard and falsified medicines are an international problem. There is a precedent for the WHO establish- ing international codes on problems of global public health consequence. Concern about the marketing of infant formula to new mothers led to the 1981 WHO and Unicef International Code of Marketing of Breast-Milk Substitutes (WHO, 1981). In 2010, the WHO responded to the problem of international health worker migration with The Global Code of Practice on the International Recruitment of Health Personnel (WHO, 2010). The codes were possible because of WHO leadership and an open, consultative, deliberation process. The committee believes that a similar process, led by the WHO, will be essential to international action against illegitimate drugs. The WHO is also the international leader in the current discussion about substandard and falsified drugs. In November 2012, WHO mem- ber states met in Argentina as part of a new effort to collaborate on illegitimate medical products (WHO, 2012b). In her opening remarks, Director-General Margaret Chan reiterated the organization’s commitment to working against harmful products in the drug supply and promoting the availability of good-quality medicines around the world (Chan, 2012). Engaging Stakeholders In developing the proposed code of practice, the WHO should engage all major stakeholders; the inclusion of scientific experts and civil society 6  World Health Organization, Basic Documents, Constitution of the World Health Organi- zation, 45th ed., Supplement, October 2006. Chapter V, Article 20, Article 23.

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INTERNATIONAL CODE OF PRACTICE 299 groups is essential. The WHO Essential Medicines division can bring great technical depth to the discussion, especially the public health aspects of the problem. Because the problem has legal dimensions, it will also be crucial to include experts in law enforcement, criminal justice, and customs. In order to assure the proper range of expertise in the drafting of the proposed code of practice, the committee recommends that the WHO work with the UNODC and the WCO. The UNODC helps member states fight organized crime, trafficking, corruption, and terrorism (UNODC, 2012a). Its previous work has de- scribed the trade in illegitimate medicines as the business of terrorist orga- nizations and criminal cartels (UNODC, 2009, 2011, 2012b). The agency’s 2012-2015 strategy emphasizes that responding to transnational, organized crime is a priority, and it highlights their work against new kinds of drug trafficking (UN, 2012). Contributing to the law enforcement and criminal justice sections of an international code on falsified and substandard medi- cines would draw on the agency’s strengths and complement the goals set out in its 3-year strategy. The WCO, the only international organization dedicated to policing flows of goods into and out of countries, is the other stakeholder orga- nization that should contribute to the proposed code. The WCO works on supply chain security and on the harmonization of simplified customs procedures (WCO, 2012a). National customs offices are under pressure to facilitate international trade and to monitor the safety of products enter- ing the country; they have a unique understanding of the circumstances through which illegitimate medicines enter commerce. The inclusion of the WCO in the development of an international code on falsified and substandard drugs could help ensure the code’s validity to stakeholders in customs. The committee recognizes that some stakeholders might object to the inclusion of the WCO in this process, given the organization’s professed commitment to protecting intellectual property rights (WCO, 2012b). Monitoring the trade in illegitimate medicines and enforcing laws against them depend on customs bureaus, however. Failing to include them in the development of the code would risk its being unacceptable or impractical for customs officers, one of the main groups that would need to adhere to it. While some stakeholders might not approve of the WCO, the committee sees no value in excluding them from the discussion. Global governance for health increasingly requires health organiza- tions such as the WHO to work with other international agencies. There is precedent for the WHO’s forming partnerships in the development of a code of practice. The WHO and Unicef collaborated on the International Code of Marketing of Breast-Milk Substitutes, and, since its release in 1981, 84 countries have enacted legislation implementing all or many of

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300 COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS its provisions (Unicef, 2012; WHO, 1981). Unicef continues to work with legislators and lawyers to implement maternity protection laws in more countries (Unicef, 2012). Given the clear relationship between maternal and child health and Unicef’s mission, it was only appropriate for the WHO to engage this organization. Similarly, a partnership with the UNODC and WCO would benefit the development and implementation of the proposed code of practice. Recommendation 7-1: The World Health Assembly, in partnership with the United Nations Office on Drugs and Crime and the World Customs Organization, and in consultation with major stakeholders, should institute an inclusive, transparent process for developing a code of practice on the global problem of falsified and substandard medicines. The code should include guidelines on surveillance, regulation, and law enforcement, empowering states and the international community to prevent and respond to drug quality problems. CONTENT OF THE CODE The code will not be credible unless it is developed through a fair and inclusive process; such processes take time. At a minimum, however, the committee recommends that the process give some attention to interna- tional surveillance, drug regulation, and law enforcement as main areas in which to give guidance. International Surveillance As Chapter 3 explains, surveillance for substandard and falsified drugs is uncoordinated, largely voluntary, and highly variable. The modern drug Key Findings and Conclusions •  he international surveillance component of the code of practice T should provide guidelines on how to develop a surveillance system for falsified and substandard drugs and how to link it to routine pharmacovigilance. •  he code should recommend guidelines, minimum standards, and T benchmarks for medicines regulation. •  he code of practice should provide guidance on how to investigate T and punish pharmaceutical crimes, suggest standard minimum pun- ishments for different crimes, and establish common definitions for various criminal acts.

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INTERNATIONAL CODE OF PRACTICE 301 supply chain involves many countries; therefore, drug surveillance should be a coordinated, global effort. International surveillance is necessary to de- fine the magnitude of the problem and to identify priority areas for action. The sections of the code that discuss surveillance should give guidance on how to set up routine drug quality surveillance and how to make stra- tegic choices about which drugs to monitor in the most vulnerable regions. Once routine surveillance systems are running, data gleaned from them will inform some of these choices in an iterative process. It may be necessary to use active surveillance methods for some high-risk drugs and passive surveillance for others. The code might also recommend how to choose and manage key sentinel surveillance sites. The guidelines should also explain how to tie monitoring for falsified and substandard drugs to routine phar- macovigilance and how to link surveillance with response. Drug surveillance also requires laboratories for quality testing. There are not sufficient drug-quality laboratories in most low- and middle-income countries to support the regulatory agencies’ routine needs (IOM, 2012). And, as Chapter 6 explains, these assays are expensive; running even mini- mal tests could quickly bankrupt a small county’s annual drug testing bud- get. The code should suggest ways to accommodate the added burden that surveillance will place on drug quality laboratories. There may be room for universities to take on more testing or for donors to fund dedicated, regional drug surveillance laboratories. The use of minilabs and hand-held detection technologies could also alleviate the added strain surveillance testing will place on drug quality laboratories. Building surveillance also requires building a workforce dedicated to data analysis and the prompt dissemination of public alerts when necessary. Therefore, using surveillance data effectively requires a strong medicines regulatory system. Guidelines on surveillance for falsified and substan- dard drugs will depend on commensurate guidelines for the regulation of medicines. Medicines Regulation The proposed code of practice should give guidelines on the quality, safety, and efficacy of medicines that all countries can work toward. The code could suggest national minimum standards for licensing of importers, distributors, and wholesalers and guidelines on retail and dispensing of medicines. The WHO has already collected most of this information; the Medicines Regulatory Package will be a useful reference on how to organize regulatory authorities and monitor their performance (WHO, 2011). The code should direct countries to enact comprehensive medicines legislation that provides for all the drug regulatory functions, including the licensing of manufacturers and distributors, the issuing of market au-

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302 COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS thorization, the inspection and surveillance of the drug distribution chain, and the monitoring of medicines on the market (Rägo and Santoso, 2008). The code should also give guidance on harmonization and mutual rec- ognition. Having consistent requirements eases the regulatory burden on industry. Especially in small countries, harmonization allows regulators to make efficient use of their limited labor. The code might recommend oppor- tunities for regulatory agencies in small countries to base their decisions on internationally accepted criteria. The regulatory agencies of Canada, New Zealand, Singapore, and Switzerland, for example, make more efficient use of their staff by accepting new chemical entity data from larger regulatory agencies (ICDRA, 2010; Jessamine, 2010). The code might support the work the Pharmaceutical Inspection Co- operation Scheme has begun. The Pharmaceutical Inspection Convention and the Pharmaceutical Co-operation Scheme, known jointly as PIC/S, work to advance mutual confidence, training, and information exchange among 43 participating regulatory agencies (PIC/S, 2012b, 2013). PIC/S trains inspectors from around the world in pharmaceutical inspections; its trainings and publications promote harmonized understanding of good distribution and manufacturing practices (PIC/S, 2012c,d). Efficient staffing of the regulatory authority depends on sustainable financing. The code could suggest methods for governments to ensure sustainable financing for their regulatory authorities. Most regulatory au- thorities run off public money or market authorization fees; many face an additional dilemma in soliciting user fees from the pharmaceutical industry (Abdul-Rahman, 1996). The code might address this problem and give guidelines on an appropriate financial relationship between the pharmaceu- tical industry and the drugs regulatory authority. A frank public discussion of this question might have an added benefit of encouraging investment in regulatory systems in developing countries. This includes investing in the training and credentialing of the professional workforce needed to run a regulatory system. The code of practice could also lead to the development of accepted good regulatory practices, and tools regulators can use to benchmark their performance. The WHO is the ideal organization to lead the development of good regulatory practices because of its technical depth and experience in medicines regulation. The WHO has convening power to bring regula- tory agencies together; its International Conference of Drug Regulatory Authorities brings regulators together to discuss common challenges and opportunities for collaboration (WHO, 2012a). The development of good regulatory practices could also draw on the work that the International Conference on Harmonisation and the forum for Asia-Pacific Economic Cooperation have done to the same end (Lourenco, 2008; Uyama, 2011).

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INTERNATIONAL CODE OF PRACTICE 303 Law Enforcement Guidelines for surveillance and drug regulation will be central to a code of practice on substandard and falsified drugs. This report makes clear, however, that the problem cannot be solved without input from law enforcement, a broad category that includes disparate agencies with limited budgets and competing priorities. The nature of pharmaceutical crimes and the constraints on law en- forcement agencies pose challenges to prosecuting and punishing offenders. The illegitimate drug business is a global industry that mirrors legitimate business in many ways: it sources materials from around the world and bases manufacturing in countries with the cheapest labor and most favor- able regulatory regimes. Criminals and unscrupulous manufacturers use the internet to identify suppliers and customers. They may also sell drugs over the internet, on the black market, or even through legitimate distribu- tion channels. Thorough investigation and successful prosecution of those responsible is difficult and expensive because of clandestine manufacturing and distribution networks. Pharmaceutical crime covers a spectrum of low-risk, high-reward of- fenses. Many countries have not enacted laws making these acts crimes or set out terms for international cooperation on investigations (Attaran et al., 2011). The code of practice on falsified and substandard medicines could give guidelines on how to investigate and punish the illegitimate medicines trade, as well as standard minimum punishments for different crimes. The code could also establish common definitions for different criminal acts such as the manufacture of an illegitimate drug, the unauthorized reuse of packaging, tampering with any documents or receipts necessary to recreate the chain of custody, and knowingly selling or distributing an illegitimate product. A code of practice would build momentum for international coop- eration on the investigation of pharmaceutical crimes. The national police agencies’ authority stops at the border. Investigating transnational crimes sometimes requires mutual legal assistance treaties (Attaran et al., 2011; Palmer, 2012). Pharmaceutical crimes are particularly time-consuming and expensive to investigate. They put novel demands on the detectives and prosecutors who are expected to work on homicides and other violent crimes. The code of practice could suggest guidelines for police agencies on how to balance priorities. It could also give political cover to police agen- cies looking to direct more staff time to investigating crimes against the drug supply. The code would also establish guidelines for both choosing the venue to prosecute and the terms for extradition. Chapter 4 describes how police and customs officers may channel their work against falsified drugs in brief, intense campaigns and not in sus-

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304 COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS tained, coordinated action. The law enforcement guidelines in the proposed code of practice could explain how to integrate action against falsified drugs into daily police work. They would also allow police and prosecutors to make these crimes a priority. At a minimum, the code should establish definitions for different crimes involving the medicine supply, establish minimum penalties for these crimes, recommend protocols for international cooperation on investigations and extradition, and clarify the role of customs and border police in investigat- ing medicines trafficking. These actions could go a long way in increasing awareness of the gravity of pharmaceutical crime. Compliance by States and Stakeholders A code of practice is a voluntary agreement. Countries have no for- mal, legal obligation to conform. A code of practice can do much to raise awareness and promote harmonized actions among countries. Some recent commentary has suggested that the WHO should exercise more leadership on global health problems (Sridhar and Gostin, 2011). The organization is uniquely poised to convene stakeholders and issue a soft law for address- ing this problem. An open and transparent convening process will lay the groundwork for future compliance with the code. The WHO can also give incentives for compliance and encourage co- operation among nations. Countries that adopt the code should be able to report on their progress and share strategies for overcoming obstacles. The WHO Director-General could then report to the WHA on implementa- tion and potential barriers to compliance. Nongovernmental organizations could also have a useful role in monitoring compliance with the code, per- haps issuing reports on which countries and stakeholder groups make good on their promises (Gostin, 2013). One likely barrier to action is limited capacity for drug regulation, law enforcement, and surveillance in low- and middle-income countries. The code might suggest incentives, such as funding and technical assistance for implementation, as well guidance on how law enforcement agencies can work together across jurisdictions. Costs are another important barrier to widespread adaption of the code. The PIC/S funds its activities through membership fees (PIC/S, 2012a). At- tendance at conferences and trainings is extra (PIC/S, 2012a). The expense can be a barrier for regulators from poor countries. Furthermore, tracking countries’ progress to meeting the code and planning member state activi- ties will take staff time and administrative effort. It may be necessary to establish a WHO secretariat dedicated to the code of practice on falsified and substandard drugs. In this case, the WHA should direct the necessary

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