7. a. attaran – draft model law on medicine crime … · web view2007/08/31 · medicine crime is...

Professor Amir AttaranWorking paper for discussion only. Please email comments to the author.

MODEL LAW ON MEDICINE CRIMEDISCUSSION DRAFT

INTRODUCTION

Medicine crime is the dark side of globalization and health. Rising wealth and falling trade barriers mean that more people than ever before are able to afford and access medicines — an overwhelmingly good thing for public health — but this comes at the cost of organized criminals also trafficking falsified, substandard or counterfeit medicines globally, which too often produce tragedies of injury or death. To date, the salutary and criminal effects of the medicine trade are tightly bound to one another as globalization’s yin and yang for public health.

But the relationship need not be as indivisible as that. One can in principle counterbalance existing free trade laws that create opportunities for illicit trafficking, with new criminal laws that make it easier to prosecute the perpetrators, seize their assets, and extradite them to face justice, wherever in the world they may hide. Currently this equilibrium does not exist, because the legal project of opening the doors of globalization has raced too far ahead of the complementary legal project of stationing “guards” at those doors to fight crime.

Thus the solution to medicine crime, which is facilitated by globalization, is ironically more globalization, although of the criminal law kind. Done properly, patients can benefit from cheaper and more accessible medicines from around the globe, with confidence that those medicines are good quality, safe and effective. This is a goal that the public health community, the law enforcement community, and the pharmaceutical industry certainly can agree on, so long as the focus is not diluted and other agendas do not intrude.

This model law on medicine crime represents the first effort of its kind to provide countries with a legislative template to fight medicine crime. It has its origins in a research project funded by Canada’s Social Sciences and Humanities Research Council, with later funding from the UN Office of Drugs and Crime (both are gratefully acknowledged). However, as others have reported, UNODC preferred to develop different model law provisions, which better match European interests and which criminalize all fraudulent misrepresentation or falsification of documents affecting medicines, including intellectual property fraud such as trademark counterfeiting.1

1 Stefano Bonino, “UN draft law against medicine crime is fatally flawed” The Conversation 14 August 2014. Available at http://theconversation.com/un-draft-law-against-medicine-crime-is-fatally-flawed-30281 (accessed 8 November 2014).

Version 1.0 of 10 November 2014

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http://theconversation.com/un-draft-law-against-medicine-crime-is-fatally-flawed-30281


In contrast, this model law is devised with developing countries as the highest priority – because they suffer the most from medicine crime – and specifically excludes trademark counterfeiting and intellectual property violations (see Article 28(2) below). The pure focus is on health, while remaining agnostic on intellectual property violations (because other laws deal with those already).

Before reading this model law, it is important to note three caveats.

First, this model law is not ready for implementation. Model laws are by their nature only approximations of real laws, and much like one-size-fits-all clothing, the fit is never perfect. Therefore, any country wanting to use this model law must expect to do some tailoring, to take into account the local legal and medical traditions, prevailing social, economic and cultural conditions, and any relevant constitutional principles.

Second, this model law does not attempt to create a whole new regime of medicine regulation, because doing so would cause clashes with existing medicine regulatory laws. Instead, the design philosophy has been to write this model law in such a way that it can blend smoothly and coexist with whatever medicine regulatory law that a country already has. For example, the model law deliberately avoids defining a “medicine” because it is assumed that all countries already have a law to define that word, and obviously, it is more elegant for this model’s legal provisions to coexist with existing laws, rather than to clash with them and necessitate their rewriting. Legislative coexistence was also the design philosophy of a group of legal experts working with the World Health Organization (WHO) in 2007, although it is rejected by the Council of Europe’s MEDICRIME Convention.2

Third, and following the coexistence philosophy just mentioned, this model law makes no independent normative judgment about which medicines are “good” or “bad”. Instead, the model law defers to the official quality standards that countries or regions have already chosen, in line with their stage of development. This is the approach favored by the World Health Organization’s Member States, who in 2013 jointly decided that “to prevent and reduce the risk to public health from

2 For example, the WHO’s legal experts chose not to define “medical products”, but similar to this model law, preferred to defer to national sovereignty and utilize that term “as defined in national legislation.” In contrast, the Council of Europe’s MEDICRIME Convention contains a new, stand-alone definition of a “medicinal product”, which counties must adopt if the Convention’s terms are to have their intended legal effect. I think the Council of Europe’s approach is counterproductive, because to implement the MEDICRIME Convention in their national law countries must amend foundational legal terms in their national law for conformity’s sake, with ripple effects throughout their whole medicine regulatory system. See WHO International Medical Products Anti-Counterfeiting Taskforce, “Draft Principles and Elements for National Legislation against Counterfeit Medical Products”, final draft of 31 August 2007.


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substandard, spurious, falsely-labeled, falsified or counterfeit medical products,” it is necessary to ensure that “only medical products meeting the national and/or regional regulatory authority requirements are manufactured, imported, distributed and supplied.”3 No outside judgment is called for in the WHO Member States’ consensus, so none is offered here.

Thus this model law does not contain every aspect of the law that is needed to ensure medicine quality or to combat transnational organized crime, and countries need to have certain foundational laws in place. Unfortunately, not all of them do: WHO estimates that a third of countries have little or no functional medicine regulation. For these countries, this model law has to be taken along with more fundamental legal reform, and technical assistance is available from WHO and UNODC in the medicine regulatory and criminal law spheres, respectively.

The model law that follows is organized in these parts, and among the key features:

Part I contains the statement of purpose and definitions used throughout the model law. There is a key distinction here between merely “substandard” medicines, which are not intentional, and “falsified” medicines, which are substandard by intent. The definitions are broad enough to apply to all sorts of medicine, including compounded medicines, traditional medicines, experimental medicines, and even the ingredients of medicines.

Part II sets out the scope of the model law’s jurisdiction. Included here are some provisions for extraterritorial jurisdiction, jurisdiction over money laundering related to medicine crime, and jurisdiction over offences committed by corporations.

Part III contains the basic criminal offences. These include manufacturing, advertising, selling or otherwise trafficking illegal medicines, as well as the packaging of medicines or paraphernalia used in such crimes. Not all the prohibitions are absolute, and some have exceptions (e.g. administering a substandard medicine where there is medical urgency and no alternative). Aiding, abetting and conspiring in the offences is also criminalized.

Part IV deals with the phenomenon of “internet pharmacies”. It criminalizes the use of internet services to sell medicines without a prescription, and criminalizes internet domain name registrars who maintain an internet address with knowledge that it used for crime. Last, it contains a new innovation that lets the courts seize the electronic payments (e.g. credit card payments) of extraterritorial offenders who refuse to answer an indictment.

3 WHO. Report of the Open-Ended Working Group to Identify the Actions, Activities and Behaviors that Result in Substandard/Spurious/Falsely-labelled/Falsified/Counterfeit Medical Products”. Second meeting of the Member State Mechanism on Substandard/Spurious/Falsely-labelled/Falsified/Counterfeit Medical Products, 12 September 2013, Document A/MSM/2/3.


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Part V sets out principles for criminal sentencing. For example, criminals who target WHO Essential Medicines, which are mainstay treatments for billions of people, or who target anti-infective medicines, where there is a danger of evolving drug resistance, are sentenced more harshly. Where a medicine crime contributes to a patient’s harm or death, that also is sentenced more harshly. Sentences can also be adjusted: downward for persons who assist law enforcement, and upward for repeat offenders.

Part VI contains principles to guide the administration of justice. It rules out using the model law in cases where prosecution is clearly unjust (e.g. scientists using a placebo drug, educators teaching about medicine crime) or outside the realm of health protection (e.g. intellectual property offences like trademark counterfeiting). It also creates a reward system for whistleblowers who report medicine crime, and provides for witness protection where organized criminal groups threaten them or their families. And it provides guidance to the court on how to determine if a medicine crime contributed to a patient’s injury or death.

Part VII provides for other coercive measures, such as the seizure of criminal assets and proceeds of crime, and the destruction of seized goods.

Part VIII contains special measures for international trade. The most important is a power to designate only certain, specially-controlled ports for the importation of medicines, the circumvention of which is a crime. There are also provisions to make transnational medicine crimes extraditable offences.

Part IX contains “safety valve” measures for special cases where it may be necessary to use unregistered and therefore unlawful medicines. These include a transitional mechanism for developing countries that are not yet at the stage of having proper medicine regulation, and an emergency mechanism for disaster situations where a country may need medicines in a hurry (such as a natural disaster, a pandemic, or war).

This model law builds on the previous work of others who are gratefully acknowledged, even if their ideas are not always followed exactly:

The advice of the global representatives of the health professions, including the World Federation of Public Health Associations, the International Pharmacists Federation, and the International Council of Nurses.4

WHO’s 2007 Draft Principles and Elements for National Legislation against Counterfeit Medical Products and the subsequent work of WHO Member States on substandard, spurious, falsely-labeled, falsified or counterfeit medical products.5

4 Attaran A, Barry D, Basheer S, Bate R, Benton D, Chauvin J, et al. How to achieve international action on falsified and substandard medicines. British Medical Journal 2012;345:e7381.5 Ibid.


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The consensus statement of the African Federation of Public Health Associations.6

LegitScript, for its expertise in the domain of internet pharmacy crimes. The United Nations Convention against Transnational Organized Crime

(UNTOC).7

The Council of Europe’s MEDICRIME Convention (not in force at this time).8

Medicine crime has now reached a point of sophistication that makes it exceptionally challenging to prosecute. The criminals have can mimic flawless packaging, can forge or steal security labels, can copy holograms to a level of detail that needs a microscope to detect, and can even fake ingredients so artfully that the fakes pass some forms of analytical testing.9 There is also the problem of licensed pharmaceutical companies, who with gross negligence cut corners and produce medicines that, while appearing legitimate are dangerously compromised.10 Knowing this, many countries, including at least four of the five permanent members of the United Nations Security Council,11 and the major medicine-

6 Communiqué of the workshop on Public Health Policy Development and Advocacy in Africa by the African Federation of Public Health Associations, 25-27 September 2013.7 United Nations, Treaty Series, vol. 2225, No. 39574.8 Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health, Moscow, 28 October 2011. 9 See for example Bate R, Coticelli P, Tren R, Attaran A. Antimalarial Drug Quality in the Most Severely Malarious Parts of Africa – A Six Country Study. PLoS ONE 2007;3:e2132; Newton PN, Green MD, Fernández FM, Day NP, White NJ. Counterfeit anti-infective drugs. The Lancet Infectious Diseases 2006;6:602–13; Ahmad K. Antidepressants are sold as antiretrovirals in DR Congo. The Lancet 2004;363:713; Sow PS, Gueye TSN, Sy E, Touré L, Ba C, Badiane M. Drugs in the parallel market for the treatment of urethral discharge in Dakar: epidemiologic investigation and physicochemical tests. International Journal of Infectious Disease 2002;6:108–12; Hall KA, Newton PN, Green MD, De Veij M, Vandenabeele P, Pizzanelli D, et al. Characterization of counterfeit artesunate antimalarial tablets from southeast Asia. American Journal of Tropical Medicine and Hygiene 2006;75:804–11; Beni S, Limtiaco JFK, Larive CK. Analysis and characterization of heparin impurities. Analytical and Bioanalytical Chemistry 2011;399:527–39.10 For example, a multinational pharmaceutical company, Ranbaxy, fabricated stability and patient trial data for some products. Ranbaxy successfully registered these medicines in many countries using those false data. Ranbaxy was prosecuted in the United States, pleaded guilty to several fraud-related offences, and paid civil and criminal penalties of USD$500 million. See Katherine Eban, “Dirty Medicine” Fortune 15 May 201311 United States (21 USC §331); United Kingdom (Medicines Act 1968, ss. 7, 8 and 45); France (Code pénal, Art 121-3); China (Drug Administration Law, Chapter IX and Art 79).


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manufacturing countries of the United States and India,12 treat both deliberate frauds and grossly negligent acts involving medicines as intentional, and therefore criminal in their laws. Some countries even prosecute medicine crime as an absolute liability offence.13

When lecturing to audiences of experts such as pharmacists, doctors, or nurses, I have often passed around two medicines — one real, the other fake — and asked them which they would take if their own life depended on it. Just as many guess right as wrong. The average expert, to say nothing of the average patient, simply stands no chance against these criminals. It is hoped that this model law serves as a useful and thought-provoking guide toward ending the criminals’ impunity, and ensuring the safety of every patient.

Professor Amir AttaranInstitute of Population HealthFaculty of Law &Faculty of MedicineUniversity of Ottawa, Canada

November 2014

12 United States (21 USC §331); India (Drugs and Cosmetics Act 1940, s. 18). 13 For example, see the doctrine in United States v Park, 421 U.S. 658 (1975), which has been widely applied in US medicine prosecutions.


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PART I – OPENING PROVISIONS

Article 1: Objectives of the Model Law

(1) The objectives of this model law are:

a) to protect the health and safety of humans and animals from criminal activity;

b) to defend the integrity of the medicine supply chain;

c) to complement the prudential regulation of medicines in [insert the name of the State], and;

d) to promote and facilitate national and international cooperation in order to meet these objectives.

(2) This model law shall be interpreted to apply to all crimes arising within its subject matter and the jurisdiction of [insert the name of the State].

Article 2: Definitions and Use of Terms

For the purposes of this model law, the following definitions shall apply:

“Competent authority” means [insert name of the relevant government department] in the case of a medicine for humans and [insert name of the relevant government department] in the case of a medicine for animals;

“Compounded medicine” means a finished pharmaceutical substance created from bulk substances or ingredients for use in humans or animals by a pharmacist or other person authorized to compound medicines under [insert the name of the law governing compound pharmacy];

“Counterfeit medicine” means any medicine that without authorization of the trademark owner bears a trademark that is identical or confusingly similar to a trademark registered in [State or Free Trade Area];

“Domain name” means a text string utilized by the domain name system to resolve an Internet Protocol address;


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“Domain name registrar” means a person, wherever located in the world, who registers the reservation of a domain name to a person, other than a top-level domain name;

“Falsified medicine” means any substandard medicine that is manufactured, produced or otherwise created in accordance with Article 6(1);

“Good manufacturing practices” means the Good Manufacturing Practices of the World Health Organization or the competent authority, as amended from time to time;

“Organized criminal group” shall mean a structured group of [insert number: two or three] or more persons, existing for a period of time and acting in concert with the aim of committing one or more offences to which this model law applies, in order to obtain, directly or indirectly, a financial or other material benefit.

“Packaging material” means all material used to contain or identify a medicine in single or bulk quantity, and without limiting the generality of the foregoing includes a vial, ampoule, syringe, carton, blister pack, label, hologram, security ink or serial number.

“Person” includes both a natural person and a legal person, unless specified otherwise;

“Proceeds of crime” mean any property derived from or obtained, directly or indirectly, through the commission of an offence or unlawful activity, whether such property is located, or the offence is committed, within or outside [insert the name of the State];

“Registered medicine” means any finished, unfinished or investigational pharmaceutical product, ingredient, or formulation of active and inactive ingredients, that is approved for use in humans or animals, in accordance with:

(a) the requirements of [insert the name of all domestic drug registration laws, including for natural health products, traditional medicines and investigational medicines]; or

(b) the order of the competent authority deeming it to be a registered medicine in accordance with the provisions of Part XIII.

“Substandard medicine” means:(a) for a registered medicine, a medicine that is in contravention of

the prescribed specifications of the competent authority, or;(b) for an unregistered or compounded medicine, a medicine that,

excepting any trademark, is misidentified with respect to its identity, source or history;


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and without limiting the generality of the foregoing may include a medicine that is expired, degraded, improperly labeled, contains inappropriate substances, or incorrectly formulated ingredients;

“Supply chain” means the sequential chain of custody through which a medicine passes from a manufacturer to a consumer or user;

“Traffic” means to advertise, broker, deliver, dispense, donate, export, import, offer, sell, transfer or transport an item;

“Unregistered medicine” means any finished or unfinished pharmaceutical product, ingredient, or formulation of active and inactive ingredients, other than a compounded or registered medicine in [State or Free Trade Area], that is represented for use in:

(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical or mental state, or its symptoms, in humans or animals, or

(b) restoring, correcting or modifying organic functions in humans or animals.

COMMENTARY:Arguably the most demanding part of taking legal action against medicine crime is defining wrongful medicines accurately. Previous attempts have been abandoned as too broad or narrow. For example, the member states of the World Health Organization in 2011 decided to abandon WHO’s definition of “counterfeit” medicines because it was overbroad in the sense of potentially criminalizing good quality generic medicines that infringed intellectual property rights. At the same time, the WHO definition was underbroad in that it omitted threats such as falsified medicinal ingredients, or falsified medicines for animals.

To avoid both over- and under-breadth, the mode law uses a more sophisticated nomenclature of several terms, which was devised by a team of lawyers, government officials and health professionals from Africa, Asia, Europe and the Americas.14 Using several unique terms is preferable to using a single term such as “counterfeit” or “spurious” to mean several things. Further, certain words like “counterfeit” already are defined in international instruments like the TRIPS Agreement and the MEDICRIME Convention, but with obvious disagreement on what the term means.15 The terms used in this model avoid these difficulties.

14 Attaran A, Barry D, Basheer S, Bate R, Benton D, Chauvin J, et al. How to achieve international action on falsified and substandard medicines. British Medical Journal 2012;345:e7381.15 The term “counterfeit” is used in Article 51 of the TRIPS Agreement to refer to counterfeit trademarks as an intellectual property offence, but is used in Article 4 of the MEDICRIME Convention to refer to false representations of a medicine’s identity or source.


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The model law deliberately does not define what a “medicine” is, since all countries have laws to define that already and it would be unwise for the model to propound a conflicting definition. Instead, the model simply separates a country’s medicines into one of two categories: (i) “registered medicines”, which are the very large majority of medicines in use, and (ii) “compounded medicines”, which are custom-made products usually made by a licensed pharmacist. All systems of medicine (e.g. Western medicine, Chinese medicine, Ayurveda, homeopathy) utilize both registered and compounded medicines, and national legal systems typically provide for both.16

Both registered and compounded medicines are legal—except when they are “substandard medicines” or “falsified medicines” as defined here.

A “substandard medicine” is simply one that is mislabeled in some material respect or that transgresses the requirements of its registration by the national medicine regulatory agency. Calling a medicine “substandard” implies nothing about intent. A medicine can be substandard because of natural causes like expiration, or because of gross negligence, or because of fraud.

But where a medicine somehow is made to be deliberately substandard, that reflects fraud or other criminal intent, and these are the “falsified medicines”. Note that falsified medicines and substandard medicines might be physically and chemically indistinguishable. To illustrate, consider two medicines which contain the wrong active ingredient: one resulted from a purely accidental error in the factory, while the other resulted from a scheme to cheat and defraud the buyer. In this example, only the latter medicine is “falsified” because of the criminal intent.

A useful analogy to remember the difference between substandard and falsified medicines is found in the law of homicide. In most countries, homicides are divided into different categories such as “murder”, which is intentional, and “manslaughter”, which is not intentional, and of course the penalties for these categories differ by a great deal. The same logic is found here, where the definition of “falsified” is different from “substandard”, so that the all-important distinction of criminal intent (also called mens rea) is always made clear to law enforcers.

Finally, this leaves the “unregistered medicines”, which are all the medicines unknown to the national medicine regulatory agency. Unregistered medicines cover

16 The laws for registered medicines are more developed than for compounded medicine because historically compounded medicine emerged from traditional practice and registered medicines emerged later as industrial goods. The model law strives to treat both equally, but that is only possible if countries update obsolete laws governing compounded medicine, as some have recently done. For example, see the United States Compounding Quality Act, Title I of the Drug Quality and Security Act of 2013.


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everything from products of excellent quality, to quack concoctions that are useless or dangerous. Their provenance is questionable because someone has created, smuggled, stolen or unlawfully diverted the medicine, thereby avoiding the legitimate supply chain and the medicine regulatory agency’s registration and regulation processes. Even where the medicine itself begins as good quality, the act of diverting it can make it unsafe for patients (e.g. the dosage information and safety warnings are written in a foreign language that patients don’t understand).

Finally, there are “counterfeit medicines”. The model law defines this term, but only to carve it out and to exclude counterfeiting from the law’s scope. Counterfeiting is already dealt with in the World Trade Organization’s TRIPS Agreement, and national laws for trademarking, so it does not need extensive coverage here. Since the only goal of the model law is to protect health and safety, the carve-out ensures there is no conflict or prejudice between these bodies of law.

All of the above definitions—substandard, falsified, unregistered and compounded—are broadly written to cover not just finished medicines, but also the ingredients of medicines. Addressing ingredients is necessary because of the fact that criminals have sometimes falsified ingredients but not finished medicines, and that crime has killed persons all the same.17

Finally, it should be noted that all the above definitions apply equally to human and veterinary medicines. Of course, the impact of medicine crime on animals is much less studied than in humans, but the United Nations Food and Agriculture Organization considers it a serious problem.18

17 Walt Bogdanich and Jake Hooker, “From China to Panama, a Trail of Poisoned Medicine” New York Times 6 May 2007.18FAO (2012). Alliance to combat black market in counterfeit veterinary drugs. Available at: http://www.fao.org/news/story/en/item/123165/icode/.


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http://www.fao.org/news/story/en/item/123165/icode/


PART II - JURISDICTION

Article 3: Criminal Jurisdiction

(1) The courts of [insert the name of the State] shall have jurisdiction over the offences in this model law when:

(a) committed [insert wholly or partly] within the territory or territorial waters of [insert the name of State],

(b) committed [insert wholly or partly] on board a vessel or aircraft registered in [insert the name of the State],

(c) committed by a [insert the name of the State] national whose extradition from [insert the name of the State] is refused on the grounds of nationality,

(d) the victim of the crime is a national [or permanent resident] of [insert the name of the State], or

(e) the crime is committed by a national [or permanent resident] of [insert the name of the State].

COMMENTARY:The model law’s jurisdiction provisions are distilled from customary international law and Article 15 of UNTOC, with certain amendments and simplifications. Of particular importance, subsection (d) furnishes jurisdiction to prosecute offences occurring outside of the territory of a state, but targeting persons under its protection (the so-called passive personality principle). Subsection (c) implements the rule of extradite-or-prosecute (aut dedere aut judicare) which because it is customary international law is binding on all states regardless of UNTOC.19

Article 4: Designated Offences of Money Laundering

(1) Notwithstanding any other law, each offence in this model law is deemed a designated offence for the crime of [insert citation to the money laundering law of the State].

(2) Where an offence in this model law is committed in the jurisdiction of another state, the proceeds of which are subsequently knowingly controlled by a person under the jurisdiction of [insert the name of the State], the extraterritorial offence is deemed a designated offence for the crime of [insert citation to the money laundering law of the State].

COMMENTARY:

19 United Nations International Law Commission (2011). Fourth report on the obligation to extradite or prosecute (aut dedere aut judicare). UN Document A/CN.4/648.


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Medicine crime frequently generates financial proceeds that have to be laundered. For states that require particular offences to be designated so as to support a collateral charge of money laundering, this Article prescribes so comprehensively, for all the offences in this model law.

This Article can be deleted for countries that do not designate specific offences as predicate for a money laundering prosecution.

Article 5: Liability of Legal Persons

(1) A legal person may prosecuted for any offence in this model law, regardless of whether a natural person may be or has been prosecuted for the same offence.

(2) Where a legal person is convicted of any offence under this model law, in addition to the penalties prescribed in the offences, the court may impose additional penalties that are proportionate and desirable to protect human and health, including:

(a) the dissolution or winding-up of the legal person;

(b) the prohibition of the legal person for a period of time from specified activities which may endanger human life or health;

(c) the disqualification of the legal person from contracts or procurement in which [insert the name of the State] is a party;

(d) the divestment or improvement of assets used in the commission of the offence;

(e) the prohibition of the legal person reconstituting itself or divesting assets to a different legal person;

(f) the payment of restitution to specified victims of medicine crimes.

COMMENTARY:Natural or legal persons can commit medicine crimes, and this model law applies to both. However, there is no widespread agreement on how – or even if – countries should hold legal persons liable for criminal offences, and international law leaves it up to national legal principles (see for example Article 10 of UNTOC).

It is not for this model law to explore all the various ways in which countries today deal with the criminal liability of legal persons. This Article is offered as one possible solution, but may be deleted if a country has laws for the liability of legal


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persons that are incompatible with or more extensive than the provisions here (e.g. Slovenia, which has a very clear and detailed approach)20.

20 Republic of Slovenia (2005), Liability of Legal Persons for Criminal Offences Act. Available at http://www.wipo.int/edocs/lexdocs/laws/en/si/si033en.pdf.


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http://www.wipo.int/edocs/lexdocs/laws/en/si/si033en.pdf


PART III – GENERAL OFFENCES

Article 6: Criminal Manufacturing of Medicine

(1) A person who falsifies a medicine by fraudulently manufacturing or otherwise creating an intentionally substandard medicine commits an offence punishable by [insert penalty sufficient to take into account the gravity of the offence: see Row 1 of Schedule A].

(2) A person who employs reckless or grossly negligent means in manufacturing or otherwise creating a substandard medicine commits an offence punishable by [insert penalty sufficient to take into account the gravity of the offence: see Row 2 of Schedule A].

(3) In any prosecution under this section, the proof of fraudulent, reckless or grossly negligent intent may be inferred from objective factual circumstances, including but not limited to:

(a) whether the medicine contains ingredients of a grossly incorrect type or quantity;

(b) whether the medicine was created by a licensed manufacturer;(c) whether the medicine is grossly mislabeled or counterfeit, or;(d) whether there is contemporaneous evidence of any other offences of a

fraudulent nature.

Exception – due diligence

(4) For greater certainty, no person shall be convicted of the offence in paragraph (2) if he or she made best efforts to satisfy good manufacturing practices of [the competent authority] [the World Health Organization] at the time of the offence.

COMMENTARY:This Article deals with the two cases where creating a substandard medicine is intentional and therefore criminal: subsection (1) deals with the high crime of falsifying a medicine by fraudulent intent, and subsection (2) deals with the lesser crime of creating a substandard medicine with reckless or grossly negligent intent. While both are criminal, they are punished at different levels to reflect that there is a difference in moral turpitude, per the penalties in Schedule A.

It is important in this Article that the wording go beyond just manufacturing, since some acts that create a falsified medicines are outside the manufacturing process:


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e.g. forging a test result,21 or relabeling a correct but degraded or expired medicine as new.22 Subsection (4) is important to avoid unjust prosecution in cases where a medicine is substandard by accident. Where a person, such as a pharmaceutical company, has made best efforts to comply with the good manufacturing practices prescribed by the drug regulator or the World Health Organization (as appropriate), then that person has no criminal intent, and there is a statutory bar to conviction.

Article 7: Trafficking of Medicine and Supply Chain Security

(1) A person who, having knowledge or negligently disregarding that a medicine is falsified, substandard or unregistered, traffics that medicine or possesses that medicine with the intent to traffic it, commits an offence punishable by:

(a) in the case of a falsified medicine [insert penalty sufficient to take into account the gravity of the offence: see Row 1 of Schedule A],

(b) in the case of a substandard medicine [insert penalty sufficient to take into account the gravity of the offence: see Row 2 of Schedule A], or

(c) in the case of an unregistered medicine [insert penalty sufficient to take into account the gravity of the offence: see Row 3 of Schedule A].

(2) A person authorized by the competent authority to traffic a medicine in [insert the name of the State] who obtains information of a falsified, substandard or unregistered medicine in the supply chain and who fails to notify the competent authority within [insert number of days based on speed of communication in the State] commits an offence punishable by [insert the penalty sufficient to take into account the gravity of the offence].

Exception - recall

(3) No person shall be convicted of the offence in paragraph (1) if:

(a) that person traffics the medicine for the sole purpose of analyzing, destroying, or warning others about it,

21 See the Ranbaxy case, discussed above at footnote 11.22 This was the case with with falsified antiretroviral medicines for HIV/AIDS which criminals inserted into Kenya’s supply chain. The medicines were real, but degraded, and following a WHO investigation it was discovered they were repackaged with a batch number of medicine that had not been supplied to Kenya. See WHO (2011). Falsified lamivudine, zidovudine and nevirapine tablets (Zidolam-N) in Kenya.


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(b) that person diligently and in good faith attempts to recall the medicine from the supply chain at the earliest opportunity, or

(c) the competent authority decides that recalling the medicine is not warranted.

Exception – lawful international transit

(4) No person shall be convicted of the offences in paragraph (1)(c) in respect of an unregistered medicine that is in the territory of [insert the name of the State] for the sole purpose of securely transiting to a foreign state where it is lawfully registered.

Exception – professional standard of care

(5) No person shall be convicted of the offence in subsection (2) for incorrectly concluding that it is not necessary to notify the competent authority, if that person exercised a professional standard of care and draws that conclusion in good faith.

COMMENTARY:This Article addresses the trafficking and possession of unlawful medicines, and contains offences designed to protect the global supply chain of medicines.

Subsection (1) deals with trafficking and possession of medicines that one knows or ought to know are falsified, substandard or unregistered. Trafficking these unlawful medicines is criminalized, as is possession with the intent to traffic. Importantly, bare possession is not criminalized since many persons could possess unlawful medicines without having any reason to believe it is unlawful (e.g. a patient). The subsection only applies where one knows or is willfully blind to a medicine being unlawful.

Subsection (2) deals with the situation where a person authorized by the competent authority to traffic medicines, such as licensed wholesaler, becomes aware of a falsified, substandard or unregistered medicine in the supply chain. Such persons have a duty to warn the competent authority within a specified number of days, or they face criminal liability. This contributes to supply chain security since all authorized persons in the supply chain must report illegality. However, to avoid injustice, subsection (5) also stipulates no person shall be convicted for a failure to warn, if they exercised a professional standard of care in good faith.

Subsection (3) provides a defence for persons who become aware of an unlawful medicine, and who traffic it in the course of actions that defend the supply chain and public safety (e.g. actions such as analyzing the medicine, destroying it, or recalling it from trade). It would be obviously undesirable to prosecute these persons.


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Subsection (4) provides a defence where persons engage in the secure international transit of an unregistered medicine while en route to another state where the medicine is registered is lawful. This exception is necessary to respect freedom of transit in customary international law and treaties like the Barcelona Convention23, and to avoid legal interpretations that have in the recent past led to World Trade Organization disputes.24

Article 8: Manufacturing and Trafficking False Packaging or Documents

(1) A person who, having knowledge that packaging or documents are specially adapted to be used in association with a falsified medicine, and who manufactures, designs or otherwise creates the packaging or documents, commits an offence punishable by [insert the penalty sufficient to take into account the gravity of the offence].

(2) A person who with knowledge traffics or possesses with intent to traffic, packaging material or documents intended for a falsified medicine commits an offence punishable by [insert the penalty sufficient to take into account the gravity of the offence].

COMMENTARY:This Article criminalizes a suite of intentional acts involving the false packaging or documents that are used in association with falsified medicines. Because falsification often depends on copying the appearance of a medicine, it is desirable to criminalize not only the persons who deal with the medicines, but also the persons involved in the execution of the offence, who will often be members of the same organized criminal group.

Article 9: Paraphernalia of Manufacturing or Trafficking

(1) Any person who, having knowledge that a device, tool, instrument, material, component, chemical, software, algorithm, hologram, security code or other thing is intended or specially adapted for use in trafficking, manufacturing or otherwise creating a falsified, substandard or unregistered medicine, or their packaging or documents, and who:

(a) manufactures or creates,(b) repairs,

23 Barcelona Convention and Statute on Freedom of Transit, 20 April 1921.24 European Union and a Member State — Seizure of Generic Drugs in Transit, Dispute DS408; see also Kumar, Shashank P., Border Enforcement of IP Rights Against in Transit Generic Pharmaceuticals: An Analysis of Character and Consistency (April 15, 2009). Available at SSRN: http://ssrn.com/abstract=1383067


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(c) traffics, or(d) possesses with the intent to traffic

that thing commits an offence punishable by [insert the penalty sufficient to take into account the gravity of the offence].

(2) No person shall be convicted under paragraph (1) if that person in good faith seeks and obtains a believable assurance that the thing in question would be used for lawful purposes only.

COMMENTARY:This Article criminalizes a suite of intentional acts involving paraphernalia, other than false packaging or documents, that are associated with falsified, substandard or unregistered medicines. In particular, this Article captures things which need not be intrinsic to the packaging or documentation, such as fake chemicals or security codes, and which are vital to product integrity and supply chain security. The Article is modeled on provisions in Canadian law that are often useful against second-tier participants in organized criminal group.

Article 10: Prohibited Clinical Use

(1) A licensed health professional who with knowledge administers or otherwise supplies a falsified or substandard medicine to a person under his or her care commits an offence punishable by:

(a) in the case of a falsified medicine [insert the penalty sufficient to take into account the gravity of the offence: see Row 1 of Schedule A], or;

(b) in the case of a substandard medicine [insert the penalty sufficient to take into account the gravity of the offence: see Row 2 of Schedule A].

(2) No person shall be convicted of the offence in paragraph (1) if the equivalent registered medicine was not obtainable in a situation of medical necessity or urgency, and the falsified or substandard medicine was believed to offer a therapeutic benefit.

(3) Where a health professional is convicted of the offence in subsection (1), the prosecutor shall notify [insert the name of the relevant professional licensing body governing that person].

COMMENTARY:This section criminalizes any licensed health professional (e.g. a doctor, nurse, dentist, et cetera) who violates his or her ethical duty by knowingly providing or administering a falsified or substandard (but not unregistered) medicine to a patient. However, the prohibition is not absolute, and subsection (2) creates an


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exception for cases of medical necessity or urgency, as might occur in remote settings where nothing but unlawful are available and the patient’s health is in danger. This is, for example, the case in much of Africa, and it would be unjust to prosecute African health care workers for doing their best in the circumstances.

Subsection (3) provides that a health professional convicted of this offence shall be referred to his or her licensing body. This provision aims to ensure the criminal justice system works together with the health professional licensing in fighting medicine crime. This sort of inter-sectoral cooperation is recommended in CCPCJ Resolution 20/6, which calls on member states to ensure that “no stage” of the supply chain in medicine crimes is neglected. It is also recommended by WHO, which urges member states to “establish legal mechanisms to improve coordination and exchange of information among health, regulatory, police, customs and other enforcement officers/authorities.”25

Article 11: Prohibited International Trade

(1) A person who carries out international trade of a medicine in violation of an administrative order of the competent authority respecting border controls under Article 36 commits an offence punishable by [insert a fine sufficient to take into account the gravity of the offence].

COMMENTARY:This section criminalizes violations of orders that the competent authority makes under Article 36 to regulate the safe traffic of medicines in international trade. The offence is one of absolute liability because the purpose is to secure compliance with the competent authority’s orders at all times.

It is recommended not to stipulate any term of imprisonment for this offence, as imprisonment for absolute liability offences is inherently unjust (per the maxim nulla poena sine culpa). Any persons who are caught knowingly trafficking unlawful medicines can be prosecuted and imprisoned under Article 7.

Article 12: Obstruction in Criminal Proceedings

(1) A person who, in the course of an investigation or prosecution under this model law knowingly uses force or threats of intimidation, or who promises, offers or gives any undue gift, concession or other advantage for the purpose of interfering with:

25 WHO (2007). Draft Principles and Elements for National Legislation against Counterfeit Medical Products, at section 3.18. Available at http://www.who.int/impact/events/PrinciplesElementsforNationalLegislation.pdf.


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(a) the giving of testimony or production of evidence,

(b) the duties of any authorities responsible for human or animal health,

(c) the forensic analysis conducted by a laboratory or its personnel, or

(d) law enforcement, prosecution or judicial authorities in the course of their official duties

commits an offence punishable by [insert the penalty sufficient to take into account the gravity of the offence].

COMMENTARY:This section criminalizes attempts to obstruct or interfere with criminal proceedings under this model law.

Subsection (1) includes a number of offences, some of which are specific to medicine crime, and is an improvement on the standard language used for obstruction of justice in Article 10 the UNODC Model Legislative Provisions against Organized Crime. That standard language is inadequate to prohibit specific acts of obstruction that can exist in the medicine crime context, such as tampering with laboratory tests.

Article 13: Obstruction of Inspectors

(1) A person who, being the registrant of a registered medicine, who knowingly in the course of an investigation:

(a) prevents an inspector of the competent authority from accessing facilities, documents or persons in relation to an investigation, or

(b) declines to provide validated laboratory standards and laboratory protocols for the purpose of analyzing the quality of a medicine

commits an offence punishable by [insert the penalty sufficient to take into account the gravity of the offence].

COMMENTARYThis Article imposes obligations on the lawful registrant of a medicine to assist the competent authority in its investigations. Subsection (1)(a) obligates them to grant access to the competent authority’s inspectors. Subsection (1)(b) obligates them to furnish authentic laboratory standards and protocols for forensic analysis. As a practical matter, analytical laboratories require validated standards and protocols in order to analyze suspicious medicines, and without them it is very challenging to perform an analysis that would be viewed as reliable enough for prosecution. Since reputable pharmaceutical companies regularly provide this kind of cooperation to


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law enforcement, this absolute liability offence is meant solely to ensure that no company withholds cooperation.

However, if the company itself is a suspect in a criminal investigation, in some legal systems, subsection (1)(b) might not be appropriate because of the right of the accused against self-incrimination.

Article 14: Aiding, Abetting, Organizing, Directing or Conspiring

(1) A person who intentionally organizes, directs, aids, abets, facilitates, counsels or procures the commission of an offence under this model law commits an offence punishable by:

(a) in the case of organizing or directing [insert penalty appropriate for taking a leading role in an offence]

(b) in the case of aiding, abetting, facilitating, counseling or procuring [insert penalty appropriate for taking a supporting role in an offence].

(2) A person who agrees with one or more other persons to commit an offence under this model law, with the expectation of a direct or indirect benefit, commits an offence of conspiracy punishable by [insert penalty sufficient to take into account the gravity of the offence].

COMMENTARY:This Article addresses various acts of furthering (whether by aiding, abetting, organizing, or directing) or conspiring with others in relation to an offence under this model law. Acts that further the offence are dealt with in subsection (1), while bare conspiracy without furtherance of the offence is dealt with in subsection (2).

Article 15: Participation in an Organized Criminal Group

(1) A person who intentionally participates in the criminal activities of an organized criminal group, knowing both the aim and general activity of the organized criminal group, or knowing its intention to commit an offence under this model law, commits a separate offence punishable by [insert penalty sufficient to take into account the gravity of the offence].

COMMENTARY:This Article, which supplements Article 14, aims to criminalize participation in an organized criminal group where that group intends to commit an offence under this model law.


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Countries have a decision to make under this Article about the minimum size of an organized criminal group. The definition of an “organized criminal group” in Part I suggests making this number either two or three. Three is the number recommended by Article 2(a) of UNTOC, but it is also consistent with that treaty to drop the threshold to only two persons, which would then allow this offence to be used in prosecuting just a buyer and seller of unlawful medicine (which is useful, but to some possibly excessive and unjust). As this Article is loosely modeled on Article 7 the UNODC Model Legislative Provisions against Organized Crime, please see that document for a more extensive discussion of the offence.


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PART IV – INTERNET DISTANCE SELLING

Article 16: No Prejudice

(1) A prosecution of a person under this Part for an offence involving Internet distance selling is without prejudice to the possible prosecution of that person for any other offence under Part III or under the laws of [insert the name of the State].

COMMENTARY:This Article ensures that a person prosecuted for illegal Internet distance selling of a medicine can also be prosecuted for other offences where the evidence exists. For example, a person might be prosecuted under Article 19(2) for selling a medicine on the Internet without a prescription, and concomitantly prosecuted under Article 5 for trafficking an unlawful medicine.

Article 17: Prohibited Internet Trade

(1) A person located anywhere in the world who knowingly, by means of the Internet or any Internet-based service, advertises to a person in [insert the name of the State] a falsified, substandard or unregistered medicine, commits an offence punishable by [insert penalty sufficient to take into account the gravity of the offence].

COMMENTARY:This Article prohibits the use of the Internet, including any services that run on the Internet such as e-mail or social media, for advertising unlawful medicines.

Article 18: Prohibited Domain Name Uses

(1) A domain name registrar located anywhere in the world who registers a domain name and who knowingly allows it to be used for an illegal purpose under this model law commits an offence punishable by [insert penalty sufficient to take into account the gravity of the offence].

(2) An owner of a domain name who knowingly allows it to be used for an illegal purpose under this model law commits an offence punishable by [insert penalty sufficient to take into account the gravity of the offence].

COMMENTARY:This Article is intended to impose criminal liability on Internet domain name registrars and domain name owners who knowingly violate their agreements with the Internet Corporation for Assigned Names and Numbers (ICANN) or similar overseers of the domain name system and Internet space.


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Currently, ICANN makes it a requirement for domain name registrars to take reasonable and prompt steps to prevent domain names being abused for criminal purpose. As Article 3.18 of ICANN’s Registrar Accreditation Agreement reads:

3.18.1 Registrar shall maintain an abuse contact to receive reports of abuse involving Registered Names sponsored by Registrar, including reports of Illegal Activity. Registrar shall publish an email address to receive such reports on the home page of Registrar's website (or in another standardized place that may be designated by ICANN from time to time). Registrar shall take reasonable and prompt steps to investigate and respond appropriately to any reports of abuse.26

ICANN also makes it a requirement for domain name owners not to use that property for illegal purposes. As Article 2 of ICANN’s Uniform Domain Name Dispute Resolution Policy reads:

2. Your Representations. By applying to register a domain name, or by asking us to maintain or renew a domain name registration, you hereby represent and warrant to us that … (c) you are not registering the domain name for an unlawful purpose; and (d) you will not knowingly use the domain name in violation of any applicable laws or regulations. It is your responsibility to determine whether your domain name registration infringes or violates someone else's rights.

Regrettably, ICANN lacks an enforcement mechanism to deal with domain name registrars and owners who knowingly breach these obligations. Therefore, this Article imposes criminal liability, to redress ICANN’s omission. Doing so is consistent with WHO recommendations to “establish liability for internet service providers who facilitate” aspects of medicine crime.27

Article 19: Due Diligence of Internet Distance Seller

(1) A person located anywhere in the world who communicates by Internet to advertise a medicine to another person in [insert the name of the State] shall ensure that the communication includes:

(a) the name and address of the person advertising or selling the medicine;(b) the name and address of a natural person authorized to receive legal

process, and;

26 ICANN Registrar Accreditation Agreement (2013). Available at: https://www.icann.org/en/system/files/files/approved-with-specs-27jun13-en.pdf. 27 See WHO, footnote 25, at section 3.4.


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https://www.icann.org/en/system/files/files/approved-with-specs-27jun13-en.pdf


(c) the registered business name, address and valid license number of the dispensing pharmacy, if different from the person advertising or selling the medicine.

(2) A person located anywhere in the world who communicates by Internet to sell a medicine to another person in [insert the name of the State] shall require the buyer to produce a prescription of a clinical practitioner legally authorized to prescribe in [insert the name of the State], if that medicine is one that requires a prescription to be dispensed in [insert the name of the State].

(3) A person who knowingly or negligently violates subsections (1) or (2) commits an offence punishable by [insert the penalty sufficient to take into account the gravity of the offence: see Row 4 of Schedule A].

COMMENTARY:This Article articulates a series of legal duties for Internet distance sellers who advertise or sell medicine. Specifically, an Internet distance seller must disclose the true name and address of the pharmacy or other business doing the distance selling, and must require the buyer of a medicine to produce a valid prescription. This is consistent with WHO’s recommendation that internet pharmacies “that offer for sale and/or provide medical products should be submitted to the same requirements as [other] operators of the distribution chain or [medicine] retailers.”28 Any breach of these duties is a criminal offence under subsection (3).

To avoid jurisdictional overreach, this Article is limited to Internet distance sellers who advertise or sell medicines to persons in the state where this criminal prohibition is in force.29

Article 20: Due Diligence of Domain Name Registrars

(1) A domain name registrar, located anywhere in the world, who registers an Internet domain name that is used to advertise or sell a medicine to a person in [insert the name of the State] shall:

(a) ensure that the registrant and administrative contact information in the WHOIS record includes that of the domain name owner and is not anonymized; and

28 See WHO, footnote 25, at section 3.48.29 Foreign internet pharmacies not wishing to be subject to this Article can take simple measures to make their services unavailable to persons in that state (e.g. by asking the user where they are from).


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(b) upon becoming aware or being notified by any person that that domain name is being used to advertise or sell medicines contrary to this model law, suspend and lock that internet domain name within ten days.

(2) A person who knowingly or negligently violates subsection (1) commits an offence and is liable on conviction to [insert the penalty sufficient to take into account the gravity of the offence: see Row 4 of Schedule A].

COMMENTARY:This Article articulates a series of legal duties for domain name registrars who register a name used by Internet distance sellers. Domain name registrars must ensure that the contact information of their registrants is kept up to date in the WHOIS database, and must suspend and lock any Internet domain name that is being used for activities that violate this model law within ten days of becoming aware of a breach. Any breach of these duties gives rise to criminal liability under subsection (2). This is consistent with WHO recommendations “establish liability for internet service providers who facilitate” aspects of medicine crime.30

Article 21: Seizure of Payments

(1) Where the court has found a person guilty of

(a) an offence under Articles 19 or 20, for which the payment of a financial penalty is in arrears, or

(b) any offence in [insert the name of the State] resulting from that person’s failure to appear and answer charges under Articles 19 or 20,

the court may order that any financial penalty for which the person is liable be collected by seizing any revenues due to that person by a merchant bank, credit card processor, reseller of credit card processing services, or other payment provider in [insert the name of the State].

(2) Where necessary to prevent the flight of assets, an order under subsection (1) may be executed ex parte and without notice to the affected person.

(3) This Article is without prejudice to any other lawful means of collecting payment in [insert the name of the State].

COMMENTARY:This Article is intended to solve the difficulty of enforcing criminal fines imposed against foreign-based Internet distance sellers and domain name registrars. Since the internet is global, often these entities will not have assets in the jurisdiction.

30 See WHO, footnote 25, at section 3.4.


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However, because all such services depend on global online payment networks (VISA, Mastercard, AmEx, et cetera) and obtain revenue from many countries where payment service providers are found, this section allows the authorities to attach or garnish that revenue stream, which can be done ex parte and without notice to the convicted person if necessary to prevent asset flight. Other methods of collection already established in the country may also be used.


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PART V – AGGRAVATION AND MITIGATION

Article 22: General Principles

(1) In any sentencing proceeding under this model law, a person convicted of an offence is entitled to a just outcome, and the court shall consider the guidance of this Part in determining penalties accordingly.

(2) Subject to the other provisions of this Part and any existing principles of criminal sentencing in [insert the name of the State], and without limiting the evidence or arguments that may be weighed by the court, the court shall consider the following general principles in the exercise of its penal discretion:

(a) whether the convicted person voluntarily disclosed his or her own violation to the authorities in a timely and cooperative manner;

(b) whether the convicted person has previously been convicted of a crime involving medicine or a crime involving fraud;

(c) whether the convicted person breached the duty of care or abused the confidence placed in him or her as a health professional, medicine manufacturer or supplier;

(d) whether the convicted person attempted to commit offenses systematically or on a large scale, including by use of the Internet;

(e) whether the victims of the offence include vulnerable persons, such as children, the elderly, or persons with disease, or;

(f) whether the offence in question concerns a potentially life-saving medicine.

COMMENTARY:This Article provides some general principles of aggravation and mitigation for courts to consider in medicine crime prosecutions. None of the principles are mandatory to apply, although the court shall consider them. The intent is to provide predictability for the accused and guidance the court, and this is especially valuable because most lawyers and judges have seen few or possibly no medicine crime cases in their career.

Article 23: Injury or Death Caused to an Individual or a Population

(1) Notwithstanding any other provision of law, where an offence under this model law is carried out with knowledge and causes mental or physical harm or death:

(g) individually to a natural person or animal, the court may at sentencing multiply the penalties in Schedule A up to [insert a multiplier], or


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(h) broadly in a population of natural persons or animals, located anywhere in the world, the court may at sentencing multiply the penalties in Schedule A by up to [insert a multiplier, larger than in subsection (a)].

(2) It shall not be a defence to the imposition of an aggravated sentence under this Article that:

(a) the accused did not intend to cause harm or death, or

(b) harm or death might have been avoided, if the victim had received medical care superior to the care actually provided.

COMMENTARY:This Article provides that for certain offences in the model law, the court may raise the prescribed criminal penalties by a fixed multiplier (or percent) if a victim is harmed or killed. The victim may be a natural person or animal (recall that the model law applies to both human and veterinary medicines). This aggravated sentence is only available for the offences in Schedule A, which are the “core” offences most closely related to patient safety (specifically, manufacturing, trafficking or clinical use of an unlawful medicine).

Since the treatment of criminal intent (mens rea) in aggravated sentencing often causes confusion, subsection (2)(a) clarifies that the necessary intent to impose an aggravated sentence is that of the medicine crime itself, and not the intent to harm or kill the victim (if it were otherwise, then this Article would not be merely for aggravated sentencing, but would prescribe a whole new criminal offence). Further, subsection (2)(b) stipulates that it shall not be a defence to an aggravated sentence that the victim would not have suffered, or would have suffered less, if he or she had received better medical care than that which was actually administered. Some jurisdictions have abandoned this defence in case law, but to avoid doubt it is expressly eliminated.31

Article 24: Crimes Involving Essential Medicines

(1) Notwithstanding any other provision of law, where an offence under this model law involves a medicine included in the essential medicine list of [insert the name of the State] or the World Health Organization Model Lists of Essential Medicines at the time of the offence, the court may at sentencing multiply the penalties in Schedule A up to [insert a multiplier].

COMMENTARY:

31 For example, in England, see R. v. Smith [1959] 2 QB 35 (A.C.).


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This Article recognizes the fact that not all medicines are equal, and some are more important than others. For certain crimes involving the most essential medicines, it provides for aggravated sentencing.

Since the 1970s, WHO has devised lists of “essential medicines”, which are the highest priority medicines required in ordinary clinical conditions, and many countries have followed suit with essential medicine lists of their own. No health system can function without the essential medicines. Currently, the WHO list includes basic antibiotics, analgesics, contraceptives, medicines for AIDS, tuberculosis and malaria, medicines for safe childbirth, medicines for hypertension and diabetes, anesthesia for surgeries, et cetera. Further, the vast majority of essential medicines are unpatented generic products, meaning that they are among the most affordable treatments available.

Protecting these mainstays of the health system from organized crime is obviously a very high priority, yet particularly in poor countries, where the reliance on essential medicines is highest and law enforcement capacities are weakest, organized criminals could reap enormous returns by targeting these medicines. By treating offences involving the essential medicines as more serious and deserving of aggravated sentencing, it is hoped that the model law deters criminals from targeting the essential medicines and worsening existing health inequities, particularly in poor countries.

Article 25: Crimes Involving Anti-Infective Medicines

(1) Notwithstanding any other provision of law, where an offence under this model law involves a medicine to treat or prevent infectious disease, which is substandard such that it may naturally select drug resistant microbes, the court may at sentencing multiply the penalties in Schedule A up to [insert a multiplier].

(2) It shall not be a requirement for the imposition of an aggravated sentence to prove that the medicine involved in the offence selected drug resistant microbes, and the opinion of a qualified expert in infectious disease that it may do so shall be admissible.

COMMENTARY:This Article recognizes the special characteristics of anti-infective medicines. For certain crimes involving the most essential medicines, it provides for aggravated sentencing.

Medically, the anti-infective medicines are the most vulnerable medicines in the pharmacy. When an anti-infective medicine is incorrectly formulated, not only does it endanger the life or health of the patient, but it also threatens the entire population because it contributes to the evolution of drug-resistant microbes. In


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time, drug resistance causes even the proper medicine to stop working. WHO considers drug resistance a top priority in its work on health security, and writes:

“Antimicrobial resistance (AMR) threatens the effective prevention and treatment of an ever-increasing range of infections caused by bacteria, parasites, viruses and fungi. An increasing number of governments around the world are devoting efforts to a problem so serious that it threatens the achievements of modern medicine. A post-antibiotic era – in which common infections and minor injuries can kill – far from being an apocalyptic fantasy, is instead a very real possibility for the 21st Century.”32

This Article is intended to give support to WHO’s objectives, by ensuring that medicine crimes involving anti-infective medicines are, consistent with the proportionality principle, given aggravated sentencing commensurate with the wider harm that drug resistance does to society.

Because the evolution of drug resistance is a probabilistic outcome and not a deterministic one, paragraph (2) provides that the evidence of a qualified expert is admissible in establishing legal proof.

Article 26: Aggravated Sentences Cumulative

(1) Where an offence under this model law satisfies two or more criteria for an aggravated sentence under this Part, the court may at sentencing apply the multipliers of those criteria cumulatively.

COMMENTARY:This Article provides that the principles of aggravated sentencing in the model law may be applied cumulatively, and not just singly.

For example, if a person was convicted of selling (i.e. trafficking) a falsified antimalarial medicine under Article 7, depending on the circumstances the person could be sentenced with up to three layers of aggravated sentencing operating together: (i) Article 23, if the falsified antimalarial caused death to the victim; (ii) Article 24, if the authentic antimalarial is found on an essential medicine list, and; (iii) Article 25, because antimalarial medicines are anti-infective medicines. It would be up to the prosecutor to demonstrate that any or all of these layers of aggravated sentencing applies.

32 WHO (2014). Antimicrobial Resistance: Global Report on Surveillance.


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PART VI – ADMINISTRATION OF JUSTICE

Article 27: No Prejudice

(1) A prosecution of a person under this model law is without prejudice to the possible prosecution of that person for any other offence under the laws of [insert the name of the State];

COMMENTARY:This Article ensures that a person prosecuted under the model law can also be prosecuted for other offences. For example, a person might be prosecuted for obstructing criminal proceedings under Article 12, and be prosecuted under some other law available in the state for perjury.

Article 28: No Prosecution

(1) No person shall be prosecuted for any offence under this model law in respect of any quantity of medicines, packaging or documents that objectively and in good faith corresponds to a requirement of:

(a) the medical treatment of that person or his or her family members by blood, marriage or civil union recognized in [insert the name of the State];

(b) scientific, clinical, criminological or other research [insert the name of the State], including research using placebo medicines;

(c) service to the public, including education, training, and journalism; or

(d) forensic or law enforcement purposes.

(2) No person shall be prosecuted for any offence under this model law solely by reason that a medicine is counterfeit, generic or violates the intellectual property laws of [insert the name of the State].

COMMENTARY:This Article bars prosecution in cases where it would be unjust.

Subsection (1)(a) deals with persons in medical care or their families, who may possess small quantities of illegal medicines. Pursuing this as a crime would make inefficient use of law enforcement resources, and would open the door to pointless or inhumane prosecutions: e.g. the traveller who mixed two types of pills in a single bottle for convenience, thus rendering one of them incorrectly labeled and, technically speaking, “falsified”.


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Subsections (1)(b) through (1)(d) deal with the legitimate needs of researchers, educators, journalists and law enforcers (including private detectives), all of whom might need to possess illegal medicines. For example, medical researchers and pharmaceutical companies doing clinical trials need to possess and use placebo medicines, which technically are “falsified” because they are inactive but intentionally made to look like the real medicine to fool the patient. Educators working on campaigns to stop medicine crime also need to possess some unlawful medicines for didactic purposes.

Subsection (2) deals with the cases of counterfeit and generic medicines. Generic medicines per se are not unlawful if they are of good quality, although some efforts against medicine crime have erroneously targeted them.33 Counterfeit medicines are unlawful in the trademark infringement sense—but trademark crimes are outside the scope of this model law. This exclusion is consistent with the wishes of countries expressed both at WHO and UNODC.34

Article 29: Suspicion of Threat to Human or Animal Health

(1) Where in the course of any criminal investigation, an official of [insert the name of the State] suspects that a medicine may be falsified, substandard, unregistered or counterfeit, or any combination thereof, that official shall immediately:

(a) notify the competent authority of that potential threat to human or animal health, and

(b) cooperate with the competent authority for the medicine to be analyzed by an official laboratory and recalled if necessary.

COMMENTARY:This Article promotes inter-sectoral cooperation between the law enforcers and the health protection authorities of a country. It places a duty on criminal investigators

33 European Union and a Member State — Seizure of Generic Drugs in Transit, Dispute DS408; see also Kumar, Shashank P., Border Enforcement of IP Rights Against in Transit Generic Pharmaceuticals: An Analysis of Character and Consistency (April 15, 2009). Available at SSRN: http://ssrn.com/abstract=1383067.34 The exclusion of counterfeit medicines from the WHO mandate on SSFFC medicines is well known. Less widely known is that UNODC’s Commission on Crime Prevention and Criminal Justice did the same thing in the negotiation of Resolution 20/6 of 2011. Specifically, the CCPCJ rejected the first draft resolution advanced by Argentina which targeted “misbranded” medicines, and in the final version agreed by consensus, it restricted UNODC’s mandate to medicines “whose contents are inert, are less than, more than or different from what is indicated, or have expired”.


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to inform the competent authority when they suspect a medicine is unlawful, so that corrective action such as a recall can be taken. While it seems obvious that this kind of inter-sectoral cooperation should exist, often it does not, and so instances of medicine crime that police, customs or other law enforcement authorities detect are never reported to the health ministry for action. This Article serves as a gentle reminder that such cooperation should exist.

Article 30: Official Laboratories

(1) The competent authority may by order designate certain laboratories, whether or not located in [insert the name of the State], for the purpose of conducting analyses in criminal investigations under this model law.

(2) Notwithstanding any other provision of law, the findings of a laboratory designated under paragraph (1) shall be admissible evidence in any legal proceeding without proof as to the qualifications of the laboratory or the analyst, but the accused may challenge the reliability of the findings.

COMMENTARY:To prosecute medicine crime, a country needs dependable forensic laboratories, yet many countries (especially developing ones) have not addressed this requirement. This Article allows the competent authority to designate a number of laboratories, whether domestic or foreign, to carry out analyses. Subsection (2) deems the analyses conducted by designated laboratories to be admissible in court, but preserves the right of the accused to challenge the reliability of the analytical findings.

Article 31: Principles of Evidence and Proof

Principle – Inferred Harm to Person or Animal

(1) Where a natural person or animal receives medical treatment with a falsified or substandard medicine for a medical condition, and an expected medical benefit is not achieved, the court may without direct evidence infer from the opinion of a qualified expert in the relevant medical specialty that that the person or animal was harmed by that medicine.

Principle – Reverse Onus for Possession Offences

(2) Subject to any other defences available in the law of [insert the name of the State], where a person is prosecuted under this model law for an offence of possession of a prohibited thing, that person bears the onus of demonstrating that possession was intended for reasons other than trafficking that thing.


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COMMENTARY:This Article stipulates two rules of evidence that, because they could prove controversial in a prosecution, are clarified explicitly.

Subsection (1) deals with the situation of patients (human or animal) who receive a substandard or falsified medicine in the course of treatment and who do not have the expected medical response. When such a patient’s health fails to improve, or deteriorates, often it is hard to attribute that causally to the medicine. For example, if a heart patient takes a falsified blood thinner and dies of a fatal heart attack, is that death caused by the medicine? Direct proof in such cases is obviously impossible, but under the rule of evidence in paragraph (1), it is permitted to draw an inference based on the evidence of a qualified medical expert.

Subsection (2) is a reverse onus provision, which requires a person possessing a prohibited thing to demonstrate that possession was for a legitimate reason. Therefore, there is a rebuttable presumption that a person possessing a prohibited thing does so unlawfully. The person may also rely on other legal defences, such as those in Article 28.

Article 32: Confidential Informants (Whistleblowers)

(1) Where a natural person, having subjective knowledge of a criminal offence committed under this model law, confidentially informs the competent authority or any other law enforcement authority in [insert the name of the State], the authority shall not disclose the name of identity of that informant without written permission.

(2) Where a confidential informant freely elects to participate as a witness in a criminal proceeding, and his or her evidence:

(a) is provided truthfully and without inducement; (b) is of substantial assistance to a prosecution; and(c) is of a nature which objectively could not be discovered otherwise

the court may, upon sentencing of the accused, award [insert percent] of any monetary penalty to that informant.

COMMENTARY:This Article encourages the cooperation of witnesses, by giving them a financial incentive to make disclosures to law enforcement (so-called “blowing the whistle”).

The two largest medicine-manufacturing countries rely on whistleblower rewards to detect fraud. In the United States, the whistleblower reward law is limited to


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frauds on the federal government, and has been used for medicines.35 In India, the drug regulator administers a special whistleblower reward scheme, which together with India’s general whistleblower reward law addresses wrongdoing in both private institutions and in government offices.36

Subsection (2) stipulates the conditions under which a whistleblower may receive a court-ordered reward. Subsection (1) provides that whistleblowers are entitled to the confidentiality and witness protection measures available in the state. It should be recalled that many organized criminal groups are violent, and there will be cases where such protection is of the utmost importance to the whistleblower.

Article 33: Victim and Witness Protection

(1) At all times before, during and after an investigation or prosecution, the competent authority, any law enforcement authority, and the court shall take all appropriate measures to ensure that a witness or victim of an offence to whom this model law applies, and his or her family, are provided adequate protection from intimidation, retaliation, or any other threat to safety.

(2) Without prejudice to any other witness or victim protection program of [insert the name of the State], the measures to be taken under paragraph (1) to protect a person may include:

(a) providing a new legal identity to that person and his or her family; (b) sealing law enforcement and judicial records;(c) closing court hearings;(d) suppressing the identity of the person in legal proceedings; and(e) any other measures that are considered necessary.

COMMENTARY:This Article attempts to preempt the dangers faced by victims and witnesses who give evidence to criminal investigations or prosecutions of medicine crime. Protection is likely to be needed where the witnesses are disclosing the actions of organized criminal groups, who may be violent. Subsection (2) prescribes some actions that the court may take to protect such persons, without prejudice to any other options that might exist in national law. The aim is to provide victims and

35 In the United States, see the False Claims Act 31 U.S.C. §§3729–3733, also known as the “Lincoln Law”. Recently this law was used against Ranbaxy, discussed above at footnote 11.36 Ministry of Health & Family Welfare, Reward Scheme for whistleblowers in the fight against the menace of spurious or fake drugs, cosmetics and medical devices, available at http://www.cdsco.nic.in/writereaddata/Whistle%20Blower%20Scheme.pdf (accessed 28 October 2014). See also Whistle Blowers Protection Act, 2011, No. 1 of 2014.


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http://www.cdsco.nic.in/writereaddata/Whistle%20Blower%20Scheme.pdf


witnesses with the broadest possible range of measures to induce their testimony while protecting them and their families.


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PART VII – ADDITIONAL COERCIVE MEASURES

Article 34: Confiscation and Forfeiture

(1) Where a person is convicted for a manufacturing or trafficking offence, an offence of aiding, abetting, organizing, directing or conspiring in a manufacturing or trafficking offence, or participating in an organized criminal group having the aim or intention to commit a manufacturing or trafficking offence, the court may, if satisfied on balance of probabilities that any property is proceeds of that offence, order the confiscation and forfeiture of property:

(a) forming the subject of the offence, including income and other benefits obtained therefrom, and;

(b) that has directly or indirectly become part of the assets of the person convicted, from the date of the earliest of the acts forming the basis of his conviction;

(2) Where the evidence does not establish to the satisfaction of the court under that property is the proceeds of crime described in paragraph (1), but the court is satisfied beyond a reasonable doubt that the property is proceeds of another crime, the court may order the confiscation and forfeiture under paragraph (1) of that property.

(3) An order may be issued under this Article in respect of property located outside [insert the name of the State].

Fine Instead of Forfeiture

(4) If a court is satisfied that an order of confiscation and forfeiture under this Article should be made in respect of any property, but that the property or any part of or interest in the property cannot be made subject to an order, the court may instead order the person convicted of the offence to pay a fine in an amount equal to the value of the property or the part of or interest in the property. In particular, a court may order that person to pay a fine if the property or any part of or interest in the property:

(a) cannot, on the exercise of due diligence, be located;

(b) has been transferred to a third party;

(c) is located outside [insert the name of the State];

(d) has been substantially diminished in value or rendered worthless; or


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(e) has been commingled with other property that cannot be divided without difficulty.

Imprisonment in Default of Payment of Fine

(5) Where a court orders a person convicted of the offence to pay a fine pursuant to subsection (4), the court shall impose, in default of payment of that fine, a term of imprisonment, to be served consecutively to any other term of imprisonment for which that person is liable:

(a) not exceeding [insert short duration], where the amount of the fine does not exceed [insert low amount],

(b) not exceeding [insert middle duration], where the amount of the fine does not exceed [insert middle amount],

(c) not exceeding [insert long duration], where the amount of the fine does not exceed [insert high amount].

No Prejudice to Other Confiscation and Forfeiture Law

(6) This Article is without prejudice to any other law of confiscation or forfeiture in [insert the name of the State].

COMMENTARY:This Article provides an extensive scheme for confiscation and forfeiture of property associated with medicine crime. It is modeled broadly on provisions in Canadian criminal law, which apply in both the common law and civil law (Quebec) systems of that country.37

Subsection (1) targets forfeiture of property in manufacturing or trafficking offences, including participating in a organized criminal group or aiding, abetting, organizing, directing or conspiring in the same. Under subsection (2), the court must be persuaded that the property in question is the fruit of crime. Subsection (3) allows the court to order the forfeiture of extraterritorial property.

However, forfeiture is not always practical, particularly where organized criminals seek to hide assets or make them judgment-proof. Therefore, subsection (4) allows the court to order a fine in lieu of the forfeiture of property if necessary, and subsection (5) allows for imprisonment in default of a fine so ordered.

Subsection (6) provides that this forfeiture scheme coexists with and is without prejudice to any other law of confiscation or forfeiture that a state possesses.

37 See Criminal Code, R.S.C., 1985, c. C-46, Part XII.2, which with the forfeiture of proceeds of crime in Canada, and particularly s. 462.37 thereof.


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Article 35: Destruction of Goods

(1) Upon the conviction of a person for an offence under this model law and the conclusion of all related investigations or prosecutions in which they may be required as evidence for the prosecution or defence, any forfeited articles of the crime, including falsified, substandard, unregistered and counterfeit medicines, packaging or documents, and paraphernalia of manufacturing or trafficking, may be destroyed.

COMMENTARY:This Article addresses the destruction of unlawful medicines, packaging, documents and paraphernalia that are seized by law enforcement. Subsection (1) authorizes such destruction, but requires that the accused first be convicted of an offence, and that all related investigations or prosecutions in which those goods might be used as evidence are concluded, to avoid the problem of spoliation of evidence.


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PART VII – INTERNATIONAL MEASURES

Article 36: Border Controls in International Trade

(1) [The competent authority] may by order designate specific procedures for medicines that are imported or transiting in international trade, including but not limited to:

(a) the designation of a limited number of ports of entry for imported medicines;

(b) procedures for the receipt of pre-shipment information, before any drug consignment arrives;

(c) the requirement to obtain an import license under [insert name of relevant import control law];

(d) the inspection of medicines at ports of entry or in transit, including bonded warehouses and free zones;

COMMENTARY:This Article authorizes the competent authority to designate specific supply chains for imported medicines. By limiting the number of ports at which medicines enter the country, and having specific entry procedures for medicines, it become easier to discern illegally trafficked medicines that have circumvent the same.

While measures of this kind are common in developed countries, there is evidence that developing countries can benefit. For example, Nigeria has experienced a sharp reduction in medicine crime by applying guidelines for the clearance of imported medicines.38

Article 37: Extradition

(1) The offences referred to in this Act shall be deemed to be included as extraditable crimes in any extradition treaty that has been or may hereafter be concluded by [insert the name of the State] and any foreign state.

(2) Where [insert the name of the State] and any foreign state do not make extradition conditional on the existence of a treaty or reciprocity, the offences referred to in this Act shall be deemed extraditable crimes as between them.

38 National Agency for Food and Drug Administration and Control, Ports Inspection Directorate, Guidelines for Clearance of Imported Drugs (Human and Veterinary) and Related Products in Nigeria. Document NAFDAC/PID/001/00.


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COMMENTARY:This Article is included to ensure that the medicine crimes herein are treated as extradition crimes. The two subsections here are borrowed with only small changes from the League of Nations International Convention for the Suppression of Counterfeiting Currency (1929).39 The intent is to provide a safeguard, so that countries that omit not update their extraditable offences to include medicine crimes are nonetheless able to enter into extradition agreements. In other words, this is a “backup” provision only, that can be safely deleted if a country keeps its list of extraditable offences comprehensive and current.

This model law does not include comprehensive extradition language, on the assumption that most countries have an extradition framework in place already. For those that do not, additional guidance can be found in the UNODC Model Law on Extradition (2004).

39 International Convention for the Suppression of Counterfeiting Currency and Protocol. Signed at Geneva, April 20, 1929 [1931] LNTSer 45; 112 LNTS 371.


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PART VIII – REGULATORY RECOGNITION ORDERS

Article 38: Transitional Regulatory Recognition Orders

(1) Where urgent for the preservation of human or animal health, the competent authority may by order deem an unregistered medicine to be a registered medicine for the purpose of this model law provided that:

(a) an importer or manufacturer of the medicine applies for such an order, and;

(b) the medicine is:(i) registered by the medicine regulatory authority of a foreign

State that is a member of the International Conference on Harmonization, or

(ii) prequalified by the World Health Organization.

(2) The competent authority shall not issue any order under this section unless the importer has filed an application and paid the prescribed fee.

(3) The competent authority shall publish notice of any order under this section in [the State’s official register] specifying:

(a) the medicine to which the order applies;(b) the medicine regulatory authority of the foreign state upon which

the order is based;(c) a likeness of the medicine and its packaging;(d) the duration of the order;(e) the name and contact information of the applicant.

(4) An order under this section shall not be valid for longer than two years, but may be renewed in accordance with subsection (1).

COMMENTARY:According to WHO, about 30% of countries have little or no functioning medicine regulatory authority, which of course means that all the medicines in those countries are unregistered.40 Since it is obviously unrealistic and unjust to criminalize every medicine in those countries, this Article aims to provide an interim solution for developing countries in that position, by creating a new “regulatory recognition order” to serve as a stepping-stone toward a medicine regulatory authority.

40 Countries wanting to build their medicine regulatory capacities are suggested to contact WHO and the World Bank for assistance. At this writing, both are engaged in providing technical and financial assistance to regions of countries (West Africa and East Africa) on this subject.


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Subsection (1) allows the competent authority to deem an unregistered medicine to be registered, where the manufacturer or importer applies, and where that medicine is either prequalified by WHO, or registered in a foreign country whose medicine regulatory authority demonstrates performance at an advanced level by belonging to the International Conference on Harmonization (ICH).41 WHO itself has proposed using these surrogates for true registration.42

Subsection (2) provides that the competent authority shall not issue a regulatory recognition order except where a proper application is filed and the application fee is paid. This is done so as to avoid opportunities for corruption.

Subsection (3) provides for the transparency of regulatory recognition orders, so that pharmacists and law enforcement authorities are aware of it and can act accordingly.

Subsection (4) stipulates that a regulatory recognition order shall not last longer than two years. This is needed to ensure that such orders remain a transitional mechanism for the interim only, and do not become a permanent one that usurps the development of a proper medicine regulatory system.

Article 39: Emergency Regulatory Recognition Orders

(1) Where a declaration of emergency is made under [insert the name of the law governing national emergencies], the competent authority may by order deem that any medicine or category of medicines that are registered or otherwise approved as an experimental medicine in a foreign state or states are immediately registered for the purposes of this model law.

(2) As soon as practicable, having regard to the emergency, the competent authority shall publish notice of any order under this section in [the State’s official register] specifying:

(a) the medicine or category of medicines to which the order applies;(b) the medicine regulatory authority of the foreign state or states

upon which the order is based;(c) the duration of the order;(d) the declaration of emergency on which the order is based.

41 The ICH members currently are the European Medicines Agency (EU), Japanese National Institute of Health Sciences (Japan), and the Food and Drug Administration (USA). 42 WHO. The Impact of Implementation of ICH Guidelines in non-ICH Countries: Regulatory Support Series No. 9 (2002).


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(3) Notwithstanding any other law, medicines imported into [insert the name of the State] pursuant to an order under this section shall not be charged customs duty.

(4) An order made under this section shall expire on the date provided in the order, or at the termination of the declaration of emergency, whichever is sooner.

COMMENTARY:This Article provides for “emergency orders” in cases of national emergency, as a variant on the “regulatory recognition orders” described in the previous Article (please see that commentary).

The intent of this section is to deal with the urgent need for medicine that often arises following epidemic emergencies (e.g. an Ebola or influenza outbreak) or natural disasters (e.g. earthquakes, typhoons). For example, in the 2013-2014 Ebola virus outbreak in West Africa, this Article would permit the expeditious, lawful importation of experimental treatments and vaccines that would otherwise be criminalized by this model law. Likewise, this Article allows the international humanitarian relief community, to import unregistered medicines in the critical hours and days after a disaster, without those medicines being detained at customs.

Under subsection (1), emergency orders are triggered by the declaration of a national emergency, they may take effect “immediately”, and may apply to a category of several medicines rather than just a single medicine. Under subsection (2), transparency is required, but not immediately due to the more pressing concerns in an emergency. Under subsection (3), customs duties are waived for medicines under an emergency order, so as to avoid both delays in customs formalities and opportunities for corruption. Under subsection (4), emergency orders automatically terminate at the end of the declared emergency.


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SCHEDULE 1 – PENALTIES

ROW OFFENCES (intent) FINE IMPRISONMENT1 - Manufacturing falsified medicine (with fraudulent intent)

- Trafficking falsified medicine (with knowledge or negligent intent)- Administering falsified medicine to patient (with knowledge)

[highest] [highest]

2 - Manufacturing substandard medicines (with grossly negligent or reckless intent)- Trafficking substandard medicines (with knowledge or negligent intent)- Administering substandard medicine to patient (with knowledge)

[middle] [middle]

3 - Trafficking unregistered medicines (with knowledge or negligent intent) [lowest] [lowest]4 - Internet distance sellers and domain name registrars – breach of legal duties (with knowledge

or negligent intent)[open] [open]


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