THE MEDICRIME CONVENTION. Combating Pharmaceutical Crimes through European Criminal Law and Beyond

Transcription

1 THE MEDICRIME CONVENTION Combating Pharmaceutical Crimes through European Criminal Law and Beyond Stefania Negri* ABSTRACT The falsification of medicinal products represents a significant public health threat and has rapidly turned into a global criminal phenomenon. Pharmaceutical crimes are considered an emerging category of transnational organised crime and have progressively become cyber-enabled crimes. The international community has called for a stronger and more effective response, but the international legal framework has long remained substantially inadequate at both European and international levels. Against this background, 1 January 2016 marked a significant milestone in the fight against falsified medicines with the entry into force of the Council of Europe MEDICRIME Convention. The Convention is the first binding European criminal law instrument to oblige States Parties to criminalise the falsification of medical products and similar offences posing serious threats to public health. It represents a landmark tool which will pave the way for harmonised criminal legislation and enhanced international cooperation in criminal matters at pan-european level and beyond. Keywords: falsified/counterfeit medicines; MEDICRIME Convention; pharmaceutical crimes; public health; transnational organised crime * Associate Professor of International Law, Director of the Observatory on Human Rights: Bioethics, Health, Environment, School of Law, University of Salerno, Italy; snegri@unisa.it. 350 Intersentia

2 The MEDICRIME Convention 1. THE FALSIFICATION OF MEDICINAL PRODUCTS: A GLOBAL CRIMINAL PHENOMENON POSING A SERIOUS THREAT TO PUBLIC HEALTH The falsification of medicinal products represents a significant public health threat and has rapidly become a global criminal phenomenon. 1 Falsified medicines raise serious concerns about patient safety because they are not equivalent in quality, safety and efficacy to their genuine counterparts. In fact, they may contain ingredients of low quality or in the wrong doses; they may be deliberately and fraudulently mislabelled with respect to their identity or source; they may have fake packaging, the wrong ingredients, or low levels of the active ingredients. As such, they may result in therapeutic failures, adverse side effects (like allergic reactions, drug resistance, intoxication) and even death. Both patent-protected and generic medicines, as well as the active substances and excipients of which they are made, have increasingly been the object of illegal activities of falsification and counterfeiting. International organisations and pharmaceutical companies report that this crime is on the rise around the globe. Moreover, counterfeiting techniques have become ever more sophisticated, making it harder to identify fake products and more difficult to combat the risk that they may enter into the legal supply chain and engender potentially disastrous effects on public health. The magnitude of the problem and the difficulty to assess its real scale are particularly alarming. Falsified medicines have been reported to occur worldwide and no country can really consider itself immune from the risk that these products may reach patients and consumers. The actual extent varies from country to country and depends on an array of factors, including inadequate legal frameworks and penalties; ineffective controls of manufacturing, import and distribution of medical products; ineffective collaboration among bodies and institutions involved in regulation, control, investigation and prosecution, such as health authorities, police, customs and the judiciary; ineffective collaboration and exchange of information between the public and the private sector; insufficient international cooperation. 2 While very low in developed countries (less than 1% of market value), 3 the incidence of this 1 Since the focus of this article is on the protection of public health, the term falsification is to be preferred to counterfeiting. In fact, while falsified medicines are fake medicines designed to mimic real medicines, counterfeit medicines are, strictly speaking, medicines that do not comply with intellectual property rights or that infringe trademark law. However, both falsification and counterfeiting are illegal and amount to pharmaceutical crimes. 2 See Council of Europe, Counterfeit medicines, Survey report by Jonathan Harper and Bertrand Gellie, Strasbourg, 2006; WHO, Counterfeit medical products, Report by the Secretariat, Doc. A61/16, 7 April WHO, Medicines: spurious/falsely-labelled/falsified/counterfeit (SFFC) medicines, Fact sheet no. 275, May New Journal of European Criminal Law, Vol. 7, Issue 3,

3 Stefania Negri phenomenon is much higher in developing countries (up to 30% of the medicines on sale), 4 where drug regulatory systems and legislation are absent or ineffective, 5 smuggling of medicines is rampant, clandestine manufacturing exists, sanctions and enforcement are very weak, and there is high corruption. The globalisation of the pharmaceutical market and the absence of harmonised regulations and controls have also played a crucial role in facilitating the circulation of falsified and counterfeit drugs. Increasing international trade of medicinal products based on global trade arrangements, free trade agreements and deregulation measures sets a scene which multiplies the opportunities for counterfeiters to place fake medicines on the international market. This occurs in particular when countries do not control export medicines to the same standard as those produced for domestic use, or when medicines are traded through free-trade zones or free ports, where control is lax or absent. Also the circulation of medicines through unregulated channels, especially unauthorised Internet pharmacies (e-pharmacies), has facilitated the entry of unsafe products into the distribution channels. Last but not least, of particularly serious concern is the close relationship between drug falsification and counterfeiting and organised crime, including cybercrime. As a matter of fact, trade in fake medicines represents a multi-billion euro business for transnational criminal groups, who are attracted by high profits associated with a low risk of interception and relatively mild penalties (trafficking in fake pharmaceuticals is estimated to be even more profitable and less risky than trafficking in narcotic drugs). Moreover, the illegal market of falsified and counterfeit pharmaceutical products offers a significant additional way through which criminal groups can launder money and finance other illegal activities. Faced with the complex and multifaceted nature of this global criminal problem, its rising trend, and the difficulty to uncover and investigate underworld criminal activities, the international community has called for a stronger and more coordinated response. 6 Several international players have thus become actively involved in combating fake drugs, including the major pharmaceutical companies operating at global level and 4 Amanda Chaves, A Growing Headache: The Prevalence of International Counterfeit Pharmaceutical Trade in Developing African Nations, Suffolk Transnational Law Review, Volume no. 32, Fall 2009 [pages 631 to 654]. 5 According to the WHO, only about 20% of its Member States are known to have well developed drug regulation; about 50% implement drug regulation at varying levels of development and operational capacity and the remaining 30% either have no drug regulation in place or а very limited capacity that hardly functions. 6 Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products, Gillian J. Buckley and Lawrence O. Gostin (eds.), Countering the Problem of Falsified and Substandard Drugs, Washington, 2013, available at catalog/18272/countering-the-problem-of-falsified-and-substandard-drugs. See also Eric Tardif, Medicamentos falsificados: una píldora difícil de tragar y un reto sanitario global, Anuario Español de Derecho Internacional, Volume no. 27, 2011 [pages 591 to 613]; Clotilde Jourdain Fortier, Isabelle Moine-Dupuis (dir.), La contrefaçon des médicaments: les premiers pas d une réaction normative internationale, Dijon, Intersentia

4 The MEDICRIME Convention key international organisations such as the World Health Organization (WHO), leader of global efforts in this field with the crucial support of IMPACT, 7 the United Nations (especially through the UN Office on Drugs and Crime), the World Intellectual Property Organization, the European Union, the Council of Europe, and Interpol (especially through the Pharmaceutical Crime Unit). Each of these organisations has offered over time an important contribution through normative, operational and law enforcement activities, as well as technical support to Member States. 8 However, from a criminal law perspective, it is the entry into force of the Council of Europe MEDICRIME Convention, 9 on 1 January 2016, which marks a significant milestone in the fight against the falsification of medicines and similar crimes posing a serious threat to public health. This article discusses the relevance of the MEDICRIME Convention in the context of the current international legal framework concerning counterfeiting and falsification of medicines, focusing on public health protection through criminal law rather than on intellectual property infringements; compares the Convention to other relevant supranational and international legal instruments to point out its added value in terms of both substance and procedure; and highlights its prominent contribution to the shaping at pan-european level of a new coherent sub-field of European criminal law concerning pharmaceutical crimes. 2. PLACING THE MEDICRIME CONVENTION IN CONTEXT: TWO MAJOR LEGAL ISSUES ARISING IN DRUG COUNTERFEITING AND FALSIFICATION 2.1. THE ABSENCE OF A UNIVERSALLY ACCEPTED DEFINITION OF COUNTERFEIT MEDICINE AND THE INAPPROPRIATE CONFLATION OF PUBLIC HEALTH AND INTELLECTUAL PROPERTY CONCERNS Combating drug falsification and counterfeiting through effective measures of prevention and repression meets a first significant obstacle: the absence of a universally 7 IMPACT is the acronym for International Medical Product Anti-Counterfeiting Task Force. On the role of the WHO and the challenges it has to face, see Gian Luca Burci, Public Health and Counterfeit Medicines : The Role of the World Health Organization, ASIL Insights, Volume no. 17, 11 January See especially the EDQM publications (European Directorate for the Quality of Medicines & Healthcare): Domenico Di Giorgio (ed.), Counterfeit medical products and similar crimes Facts and cases. Practical advice: Case studies, Volume 2, Strasbourg, 2011; Domenico Di Giorgio (ed.), Counterfeit Medical Products & Similar Crimes: Risk communication, Strasbourg, 2011; Bart Wijnberg, Counterfeiting of medical products and similar crimes ( medicrime ): A strategic approach to assist States in protecting the health of their citizens, Strasbourg, Council of Europe, Convention on the counterfeiting of medical products and similar crimes involving threats to public health (MEDICRIME Convention), CETS No. 211, Moscow, 28 October As of 1 August 2016, the Convention has been signed by twenty-six States and ratified by nine (Albania, Armenia, Belgium, France, Hungary, Moldova, Spain, Ukraine, and Guinea). New Journal of European Criminal Law, Vol. 7, Issue 3,

5 Stefania Negri accepted definition of counterfeit medicines at both national 10 and international levels. 11 In a narrow legal sense, a counterfeit drug is one that breaches intellectual property rights (IPR) protecting a registered trademark, 12 but the ordinary meaning of the term is much broader, including any drug manufactured with the intent to deceive. This lack of a standard definition makes information exchange between countries very difficult and limits the ability to understand the true extent of the public health problem at global level. Moreover, the broad and sometimes ambiguous use of the term counterfeit does not allow a proper distinction between public health concerns and trademark concerns, which in turn hinders the development of appropriate public-health oriented counter-strategies. Actually, in order to avoid confusion with trademark infringements (strictly counterfeits), public health experts strongly recommend that medicines posing a public health concern be categorised as either falsified (misrepresenting the product s identity or source, or both) or substandard (failing to meet national specifications in accepted pharmacopoeia or the manufacturer s dossier). 13 But this recommendation seems particularly difficult to put into practice at both national and international levels. While conceptual differences between domestic laws can be easily understood, it is interesting to note that inconsistencies at the international level are nonetheless quite common. International organisations and the other relevant actors sometimes use a variety of terms such as counterfeit/falsified/fraudulent/illicit/fake as synonyms and to designate the same problem, while in other circumstances they employ them more precisely, either pointing to the element of IPR violations (the true counterfeits ) or to the criminal element of intentional fraud (falsified/fraudulent medicines). For example, both Interpol and Europol refer interchangeably to counterfeit/fake/ illicit drugs as the object of their operations against pharmaceutical crimes to ensure 10 At the national level, a comparative study directed by the WHO shows that domestic legislations either lack any legal definition of counterfeit medicine, or use this term exclusively to describe trademark law or IPR violations. See WHO, Preliminary Draft Survey on National Legislation on Counterfeit Medicines, Working document WHO/ACM/1, 4 May See the exhaustive survey carried out by Buckley and Gostin, supra note 6, on the different definitions of counterfeit, substandard and falsified pharmaceuticals, as reported in Tables 1 1 to 1 3, pages 34 to 47. See also Charles Clift, Combating Counterfeit, Falsified and Substandard Medicines: Defining the Way Forward?, Chatham House Briefing Paper, Centre on Global Health Security, November Buckley and Gostin define a counterfeit medicine a drug that bears an unauthorized representation of a registered trademark on a product identical or similar to one for which the trademark is registered (supra note 6, pages 1 and 313). 13 See Lawrence O. Gostin, Gillian J. Buckley, Patrick W. Kelley, Stemming the Global Trade in Falsified and Substandard Medicines, Journal of the American Medical Association, Issue no. 309, 2013 [pages ]. 354 Intersentia

6 The MEDICRIME Convention the quality of products and to protect public health globally. 14 The European Union adopts the term falsified to mean a false representation of the identity of a medical product (including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients), of its source (including its manufacturer, its country of manufacture, its country of origin or its marketing authorisation holder), or of its history (including the records and documents relating to the distribution channels used), while excluding unintentional quality defects and IPR infringements. 15 Similarly, the UNODC employs the term fraudulent as equivalent to falsified to stress the intentional fraud element with the exclusion of intellectual property issues. 16 Counterfeit has instead been used by the Council of Europe 17 and for more than two decades by the WHO to refer to a medicine which is deliberately and fraudulently mislabelled with respect to identity and/or source, including products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging. 18 In the WHO context, the definition of counterfeit medicines has thus been associated to a broad range of situations, covering both the adulteration of the product with respect to its components (inactive and ineffective preparations containing no active ingredients; medicines containing wrong dosages of active ingredients, or different active ingredients, or contaminated or harmful toxic substances instead of the required active ingredients) and the tampering of its packaging and labelling (including products being initially genuine, that is to say products containing the correct quantities of active ingredients, but whose packaging has been modified in order to declare a higher level of active ingredients, a later expiration date, an incorrect name of manufacturer and/or country 14 Interpol, Pharmaceutical crime. A major threat to public health, Pharmaceutical-crime/Pharmaceutical-crime; see also at international-law-enforcement-action-against-fake-medicines. It is to be noted, however, that Interpol includes in illicit medicines also unlicensed and controlled/banned substances. 15 Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products, Official Journal of the European Union, L 174, 1 July 2011 [pages 74 to 87]. Article 1, para. 1.c, introduces the first definition of falsified medicines in EU law and clearly distinguishes between illegal falsified medicinal products and licit medicine containing unintentional defects of quality attributable to errors of manufacturing or distribution. The definition is released from intellectual property issues in order to focus on public health hazards. 16 UNODC, The Illicit Trafficking of Counterfeit Goods and Transnational Organized Crime, available at 17 MEDICRIME Convention, Article 4. Paragraph 38 of the Explanatory report to the Convention states that Though the terms counterfeit and counterfeiting are also used in a more narrow sense in the field of protection of intellectual property rights, the ad hoc committee decided to use these terms for the purposes of this Convention in the sense in which they are widely understood and used, i.e. corresponding to false and manufacturing a false product and passing it off as genuine. 18 WHO, Counterfeit drugs, Report of a WHO/IFPMA Workshop, 1 3 April 1992, WHO/DMP/ CFD/92, page 1. New Journal of European Criminal Law, Vol. 7, Issue 3,

7 Stefania Negri of manufacture). But, as it is well known, this definition attracted harsh criticism, even within the United Nations, 19 based on the argument that the pharmaceutical industry had allegedly exerted great pressure on the WHO to conflate IPRs and quality, safety and efficacy issues, with a view to guaranteeing higher levels of IP protection for its own benefit. As a result, the Organisation decided to move away from the use of counterfeit and to opt for the all-encompassing term substandard/ spurious/falsely-labelled/falsified/counterfeit medicines 20 (SSFFC medicines), while awaiting further developments towards a more specifically public health-oriented definition. 21 The decision taken by the WHO and the reported inconsistencies in the use of the term counterfeit are clear evidence of the urgent need to agree on universally accepted and distinct definitions of counterfeit medicines and falsified medicines. 22 This is especially compelling in order to move towards counterstrategies specifically targeted at public health protection and based on a clear distinction between falsification, IPR violations, unintentional violations of quality/ safety requirements, and legitimate generics. Each of these categories is built on separate legal concepts and brings about different legal problems which call for distinct and clear-cut solutions THE INTERRELATIONSHIP BETWEEN PHARMACEUTICAL CRIMES, TRANSNATIONAL ORGANISED CRIME, AND CYBERCRIME According to Interpol, a pharmaceutical crime involves the manufacture, trade and distribution of fake, stolen or illicit medicines and medical devices. It encompasses the counterfeiting and falsification of medical products and their packaging and associated documentation, as well as theft, fraud, illicit diversion, smuggling, 19 See Report of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, Anand Grover, on access to medicines, A/HRC/23/42, 1 May 2013, para The acronym also includes substandard medicines, which are pharmaceutical products that fail to meet either their quality standards and specifications, or both. They may arise due to the application of poor manufacturing practices or due to the storage and distribution of the product under improper conditions, leading to deterioration of its good quality. Substandard medicines can themselves be considered SFFC products when a legitimate manufacturer gets involved in a criminal activity and produces a substandard product intentionally or deliberately. 21 The World Health Assembly decided in 2012 that the newly established Member State Mechanism on SSFFC medical products would employ the term SSFFC medical products until a definition has been endorsed by the governing bodies of WHO and entrusted it with the task of further develop[ing] definitions of substandard/spurious/falsely-labelled/falsified/counterfeit medical products that focus on the protection of public health. See WHO, Resolution WHA65.19, Substandard/spurious/falsely-labelled/falsified/counterfeit medical products, 26 May 2012, annex. 22 This call for clarity and distinction is also strongly voiced in the preamble to the above-mentioned Directive 2011/62/EU, recital Intersentia

8 The MEDICRIME Convention trafficking, the illegal trade of medical products, and the money laundering associated with it. 23 As noted above, organised criminal groups are deeply involved in the manufacture and illegal trade of falsified and counterfeit medical products. These networks operate through complex distribution channels characterised by a high level of organisation, an equally high degree of specialisation, labour exploitation, corruption, and the ability to use any possibility provided by advanced technology. As with other forms of organised crime, criminal groups use to their advantage gaps in legal and regulatory frameworks at domestic level, weaknesses in capacity and controls, the lack of resources of regulatory, enforcement and criminal justice officials, as well as difficulties in international cooperation. 24 Actually, many countries still lack appropriate deterrent laws or have never enacted a special legislation outlawing counterfeiting or the unauthorised manufacturing and supply of medicinal products, or the placing on the market of medical products that are not in compliance with conformity requirements. Moreover, even in jurisdictions where these practices are considered as crimes, it occurs that penalties are too mild as compared to the severity of the offence. To make things worst, the absence, until the adoption of the MEDICRIME Convention, of a dedicated international legal instrument establishing these activities as criminal offences (aggravated when realised within an organised crime context), and providing the basis for efficient international cooperation to combat them, has facilitated the cross-border operation of pharmaceutical criminals and the flourishing of this global phenomenon. In this context, the Internet has been playing a significant role. 25 Organised criminal groups have taken advantage of modern communication strategies, and using the web including the Darknet 26 has proved to be a safe and easy way to advertise and supply their dangerous products directly to patients and consumers. In the framework of the global spread of e-commerce, e-pharmacies have appeared with increasing frequency, business of online medicines has expanded and become more and more lucrative, and the Internet has been employed as a crucially important unregulated channel to offer fake medicines both at the wholesale and at the retail level. 27 In sum, cyberspace has given counterfeiters a global reach, offering them almost unlimited possibilities to exploit an extremely profitable marketplace. As a 23 Interpol, Pharmaceutical crime, supra note See UNODC, Trafficking in fraudulent medicine, at introduction.html. 25 Anita Lavorgna, The online trade in counterfeit pharmaceuticals: New criminal opportunities, trends and challenges, European Journal of Criminology, Volume no. 12, Issue no. 2, 2015 [pages 226 to 241]. 26 Interpol, Pharmaceutical Crime on the Darknet. A study of illicit online marketplaces, available at page According to the WHO, medicines purchased over the Internet have been found to be falsified or counterfeit in over 50% of cases: see WHO, Medicines: spurious/falsely-labelled/ falsified/counterfeit (SFFC) medicines, Fact sheet no. 275, May New Journal of European Criminal Law, Vol. 7, Issue 3,

9 Stefania Negri result, pharmaceutical crimes have progressively become what Interpol defines as cyber-enabled crimes. 28 Organised criminal networks have created various types of illegal online pharmacies that can be basically distinguished into rogue and fake e-pharmacies. 29 Rogue e-pharmacies are those that do not adhere to accepted standards of medicine and/or pharmacy practice, including standards of safety, and those that engage in fraudulent and deceptive business practices. Fake e-pharmacies are instead used by cybercriminals not to sell medicines, but as baits to defraud online buyers, as in the case of identity theft and credit card cloning. Both types of deceptive e-pharmacies are often efficiently promoted by spam messages, a very powerful instrument which has become one of the favourite tools used by organised groups to advertise their illegal products. Spamming reaches a huge number of addressees all over the world and is even tailored to meet the needs of specific geographical regions, but people who are attracted by the easy availability of cheaper, stigmatised or unauthorised drugs are largely unaware of the risks of buying them online. 30 This extremely dangerous situation calls for a strong response and makes enhanced awareness-raising, information and prevention campaigns, especially directed to the most vulnerable groups of patients and consumers, highly desirable. Despite the global reach of the phenomenon, only at European level has a harmonised regulation been imposed by Directive 2011/62/UE on falsified medical products, 31 which is particularly important because it represents the first EU legislative measure aimed at preventing the introduction of falsified medicinal products into the chain of legal procurement by making the distribution circuit more secure, particularly on the Internet. To achieve this objective, the Directive introduces tougher rules with new harmonised, pan-european measures, including an obligatory authenticity feature on the outer packaging of the medicines; 32 stricter controls on and inspections 28 Interpol makes a distinction between high-tech cybercrime (i.e. sophisticated attacks against computer hardware and software) and cyber-enabled crime (i.e. traditional crimes evolving in line with the opportunities presented online and therefore becoming more widespread and damaging): see at 29 UNICRI, Project SAVEmed, Counterfeit Medicines Sold through the Internet, available at www. unicri.it/topics/counterfeiting/medicines/savemed/unicri_deliverabled7_2_080513_2406.pdf. 30 It would be very important to identify the categories of patients-consumers most exposed to falsified medicines (mainly people suffering from diseases considered as taboos, such as problems affecting the psychological or sexual sphere), to assess the reasons driving them to purchase from e-pharmacies (e.g. anonymity, cheap prices, the need for specific drugs such as antidepressants, anorectics, illegal doping substances), and evaluate economic-related factors. Such a comprehensive socio-economic approach would help to better understand the overall complexity of the phenomenon and to devise specifically targeted counter-measures. 31 Directive 2011/62/EU, supra note 15. See Graham Smith, James A. Smith and David A. Brindley, The Falsified Medicines Directive: How to secure your supply chain, Journal of Generic Medicines, Volume no. 11, Issue no. 3 4, 2015 [pages 169 to 172]. 32 See also Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use, Official Journal of the European Union, L 32, 9 February 2016 [pages 1 to 27]. 358 Intersentia

10 The MEDICRIME Convention of producers of active pharmaceutical ingredients in order to ensure compliance with good manufacturing practice; strengthened record-keeping requirements for wholesale distributors; and, most interesting of all, the first common regulation of e-pharmacies. 33 In practice, the Directive introduces a common logo for websites of legally-operating online pharmacies/retailers. This logo has to be clearly displayed on every page of the website offering the medicinal products and must be recognisable throughout the Union, while enabling the identification of the Member State where the online pharmacy/retailer is established. The verification of the authenticity of the common logo is done via a hyperlink between the website of the person authorised or entitled to supply medicinal products at a distance and the website hosting the national list; 34 these hyperlinks must be fixed and reciprocal, permanent and secured. The logo can be trusted only if a purchaser, after clicking, is redirected to the entry of that pharmacy on the list of legally operating on-line pharmacies and retailers registered in that Member State on the national authority web-page. The introduction of this common logo represents an important preventive measure to guarantee that patients and consumers only buy from legally-operating pharmacies or retailers and it provides an interesting model which could be usefully exported and applied as a global pattern of e-pharmacies regulation. 3. THE MEDICRIME CONVENTION: COMBATING PHARMACEUTICAL CRIMES THROUGH EUROPEAN CRIMINAL LAW The Council of Europe has long been involved in finding adequate responses to the serious problems posed by the falsification of medical products and other threats to public health. Besides the several decisions and recommendations adopted by the Committee of Ministers and the Parliamentary Assembly, 35 the Organisation has mainly acted through the European Directorate for the Quality of Medicines and Healthcare, a leading organisation that protects public health by enabling the 33 Article 1, point 20, of Directive 2011/62/EU introducing a new Title VIIA on the Sale at a distance to the public. 34 See Commission Implementing Regulation (EU) No 699/2014 of 24 June 2014 on the design of the common logo to identify persons offering medicinal products for sale at a distance to the public and the technical, electronic and cryptographic requirements for verification of its authenticity, Official Journal of the European Union, L 184, 25 June 2014 [pages 5 to 7]. 35 See Resolution ResAP(2001)2 of the Committee of Ministers concerning the pharmacist s role in the framework of health security, of 21 March 2001; PACE Recommendation 1673 (2004) on counterfeiting: problems and solutions, of 7 September 2004; PACE Recommendation 1793 (2007) on the need for a Council of Europe convention on the suppression of counterfeiting and trafficking in counterfeit goods, of 20 April 2007; PACE Recommendation 1794 (2007) on the quality of medicines in Europe, of 20 April 2007; Resolution ResAP(2007)2 on good practices for distributing medicine via mail order which protect patient safety and the quality of the delivered medicine, of 5 September New Journal of European Criminal Law, Vol. 7, Issue 3,

11 Stefania Negri development, supporting the implementation, and monitoring the application of quality standards for safe medicines and their safe use. 36 The need to strengthen the legal framework in this field and to protect the fundamental rights to life and to health, prompted the Committee of Ministers to set up in 2007 a Group of Specialists on Counterfeit Pharmaceutical Products, entrusting it with the task of drafting an international binding instrument. Following the adoption of a draft convention by the Group, negotiations were launched in the ad hoc Committee on Counterfeiting of Medical Products and Similar Crimes Involving Threats to Public Health with the participation of all member States and observers of the Council of Europe. The Committee made a series of amendments to the draft convention, notably with regard to the provisions on substantive criminal law, and at its last meeting approved a text which was further finalised by the European Committee on Crime Problems and finally adopted by the Committee of Ministers on 8 December 2010 as the Convention on Counterfeiting of Medical Products and Similar Crimes Involving Threats to Public Health (MEDICRIME Convention). The MEDICRIME Convention represents the first international treaty against falsified medical products with a clear focus on the protection of public health. 37 The term counterfeit is in fact synonymous with falsified as used in EU law, referring to a false representation as regards identity and/or source of the product, 38 while the broad definition of medical products covers both medicinal products and medical devices (including medicines for human and veterinary use, active substances, excipients, medical devices with their components and accessories, and medication used in clinical trials). The Convention is applicable to such medical products irrespective of their status under intellectual property law, meaning that it also covers generic medicines and that the protection of IPRs does not fall within its scope. 39 Following the pattern common to the Council of Europe criminal law conventions, the MEDICRIME Convention contains both substantive and procedural criminal law provisions, provisions concerning the protection of victims and testimonies, measures of prevention and a follow-up mechanism. The core provisions of the treaty are those imposing on States Parties the obligation to criminalise a number of offences that amount to pharmaceutical crimes when 36 The EDQM s standards are recognised as a scientific benchmark worldwide. The European Pharmacopoeia, which defines requirements for the qualitative and quantitative composition of medicines, the tests to be carried out on medicines and on substances and materials used in their production, is legally binding in the member States of the European Pharmacopoeia Convention and the European Union. 37 For a brief general overview of the Convention s contents, see Susanne Keitel, The MEDICRIME Convention: criminalizing the falsification of medicines and similar crimes, Generics and Biosimilars Initiative Journal, Volume no. 1, Issue no. 3 4, 2012 [pages 138 to 141]. 38 This definition corresponds in substance to Article 1, para. 1.c of Directive 2011/ In this respect, see the critical comments made by Roger Bate and Amir Attaran, A counterfeit drug treaty: great idea, wrong implementation, The Lancet, Volume no. 376, 30 October 2010 [pages 1446 to 1448]. 360 Intersentia

12 The MEDICRIME Convention committed intentionally. Article 5 refers to the intentional manufacturing of counterfeit medical products, active substances, excipients, parts, materials and accessories; paragraph 2 adds that the provision also applies to adulterated excipients and parts, with adulteration to be understood as making a product poorer in quality by injuriously adding or substituting another undeclared substance. Article 6 refers to the intentional supplying and offering to supply falsified products, including the acts of trafficking, brokering, procuring, selling or offering for free, promoting (also through advertising), keeping in stock, importing and exporting such products, their active substances, excipients, parts, materials and accessories. Article 7 refers to the intentional falsification of documents with the aim of deceiving the person reading or looking at the document into believing that the medical product, active substance, excipient, part, material or accessory, which the document accompanies, is legitimate and lawful; falsification covers both the making of a false document from scratch, and the unlawful amendment or change of a document with regard to its content and/or its appearance. Article 8 refers to other similar crimes threatening public health, such as the intentional unauthorised manufacturing or supplying of medicinal products (for example the placing on the black market of medicinal products for hormonal treatment produced both legally and without authorisation as means of doping for sports persons and others) and the placing on the market of medical devices which do not comply with conformity requirements. In this case, the offence refers not to the production and circulation of falsified products but rather to the legitimate manufacture of a medical product which is then diverted through the black market for a wholly illegal purpose and gain by criminals. Paragraph 2 also targets the intentional abuse of original documents for criminal purposes related to the conducts set out in paragraph 1 of article 8, e.g. to cover up the fact that a medicine has been manufactured without authorisation by pairing the unauthorised product with original documents intended for another authorised medicinal product. The Convention requires the Parties to establish their jurisdiction over these offences according to the principles of the territoriality of criminal law, of active or nationality criminal jurisdiction and of passive or victim criminal jurisdiction (art. 10), which implies that these offences do not amount to international crimes in strict legal terms. In substance, the criminal law provisions of the Convention aim to respond to the need for criminalisation of those illicit conducts that are considered to be inherently dangerous to public health 40 through European criminal law and harmonised criminal legislation at pan-european level. The obligation to take the necessary legislative and other measures to establish them as offences under domestic law aims to fill existing gaps in the national legislation of those countries where criminal and 40 It is interesting to note that these provisions are applicable also in cases where only a potential threat to public health has been detected, and no actual physical or psychological damages to victims have materialised: see Explanatory report, para. 42. New Journal of European Criminal Law, Vol. 7, Issue 3,

13 Stefania Negri administrative liability for the manufacturing, distributing and selling of falsified products is not yet covered. In line with this scope, the Convention also contains a very important provision on corporate liability (art. 11). This aims to make commercial companies, associations and similar legal entities ( legal persons ) liable for the pharmaceutical crimes performed, on their behalf and for their benefit, by anyone in a leading position acting within their powers, as well as for the offences committed by any employee or agent of the entity whenever anyone in a leading position has failed to supervise (i.e. has not taken appropriate and reasonable steps to prevent employees or agents from engaging in criminal activities on the entity s behalf). As far as punishment is concerned, the Parties are required to lay down sanctions which are effective, proportionate and dissuasive, such as prison sentences that can give rise to extradition, in case of individual liability, and criminal, administrative, civil or monetary sanctions, in case of corporate liability, including other measures like exclusion from entitlement to public benefits or aid, temporary or permanent disqualification from the practice of commercial activities, placing under judicial supervision, or a judicial winding-up order. The Convention also provides for measures such as the seizure, confiscation and destruction of medical products, active substances, excipients, parts, materials and accessories, as well as goods, documents and other instrumentalities used to commit the offences or to facilitate their commission. It also envisages that proceeds of the offences, or property whose value corresponds to such proceeds, may be seized or confiscated (art. 12). It is noteworthy that the aggravating circumstances to be taken into consideration in determining the sanctions to be imposed include the circumstances that the offences of supplying and offering to supply were committed having resort to means of large scale distribution, such as information systems, including the Internet and that the offence was committed in the framework of a criminal organisation (art. 13, d)-e)). These provisions are particularly meaningful in light of the considerations developed above with regard to the evident links between pharmaceutical crimes, organised crime and cybercrime. As far as the relevant procedural provisions are concerned, the Convention designs a legal framework for national and international cooperation across the different sectors of the public administration involved in combating pharmaceutical crimes, namely the competent health, police and customs authorities at both national and international levels. It requires the Parties to adopt appropriate legislative and other measures guaranteeing crime prevention, the effective prosecution of crime through measures of cooperation in investigation and prosecution, and the protection of victims (including their right to stand in criminal investigations and proceedings) and witnesses. Moreover, in order to facilitate international cooperation in criminal matters, the Convention authorises a Party that makes mutual assistance in criminal matters or extradition conditional on the existence of a treaty to consider the Convention as the 362 Intersentia

14 The MEDICRIME Convention legal basis for judicial cooperation with a Party with which it has not concluded such a treaty (art. 21.3). This provision is of particular interest because it removes all technical/ legal impediments to the surrender of criminals to requesting States that have title to exercise their jurisdiction over the pharmaceutical crimes concerned. Obviously, the Parties must in any case act in accordance with the relevant provisions of their domestic law which may provide for conditions or grounds for refusal, as well as with their obligations under international law, including international human rights law. 41 Last but not least, the Convention provides for the establishment of a monitoring mechanism based on a multisectoral and multidisciplinary approach, centred on the work of a Committee of the Parties. The Committee is responsible for follow-up tasks related to the implementation of the Convention, including the identification of any problems and the effects of any declarations made under the Convention; it is meant to play a general advisory role making specific recommendations to the Parties, and also to serve as a clearing house with the aim of facilitating the exchange of information on significant legal, policy or technological developments in relation to the application of the provisions of the Convention. In sum, and despite the criticism addressed to its wording, 42 the Convention represents an important step forward in the criminalisation and repression of pharmaceutical crimes at pan-european level and beyond, having also the potential to meet the need for a global convention until the WHO possibly takes a similar initiative INTEGRATION BETWEEN THE MEDICRIME CONVENTION AND OTHER INTERNATIONAL LEGAL INSTRUMENTS AS KEY FACTOR IN THE FIGHT AGAINST PHARMACEUTICAL CRIMES AT PAN-EUROPEAN LEVEL AND BEYOND One of the major purposes of the MEDICRIME Convention is to promote national and international cooperation in order to guarantee a more effective and coordinated response to the public health threats posed by falsified medical products. The idea that 41 See Explanatory report, para See Bate and Attaran, supra note The need for a global convention to be drafted under the auspices of the WHO is especially voiced by Amir Attaran, Roger Bate, and Megan Kendall, Why and How to Make an International Crime of Medicine Counterfeiting, Journal of International Criminal Justice, Volume no. 9, Issue no. 2, 2011 [pages 325 to 354], and Roger Bate, Phake: The Deadly World of Falsified and Substandard Medicines, Lanham, 2012, pages 358 and following. A joint WHO-UNODC initiative is instead preferred by Neil Boister and Benn McGrady, Why and How to Make a Treaty Crime of Medicine Counterfeiting. A Reply to Attaran, Bate and Kendall, Journal of International Criminal Justice, Volume no. 9, Issue no. 4, 2011 [pages 947 to 951]. New Journal of European Criminal Law, Vol. 7, Issue 3,

15 Stefania Negri international cooperation is key to this crucial objective is especially reflected in the preamble to the Convention, which recalls all the relevant legal instruments and programmes adopted by the Council of Europe, the WHO and the European Union. Along these lines, article 26 refers to the duty of the Parties to cooperate with each other, in accordance with the provisions of this Convention and in pursuance of relevant applicable international and regional instruments and arrangements agreed on the basis of uniform or reciprocal legislation and their domestic law and in pursuance of the relevant applicable international, regional and bilateral treaties on extradition and mutual legal assistance in criminal matters concerning the offences established in accordance with [the] Convention. These provisions are of special significance in view of the importance that integration between the MEDICRIME Convention and other legal instruments may hold for the continuing success of the fight against falsified medicines. Among such relevant international and regional instruments, a prominent role is played by the above-mentioned Falsified Medicines Directive (Directive 2011/62/EU), the EU Framework Decision on the European Arrest Warrant, 44 the United Nations Palermo Convention against Transnational Organised Crime, 45 and to a lesser extent the Council of Europe Cybercrime Convention. 46 As far as the Falsified Medicines Directive is concerned, it is to be noted that it was adopted pursuant to articles 114 and 168, para. 4.c) of the Treaty on the Functioning of the EU and not pursuant to article 83, concerning the approximation of criminal laws. Therefore it is not meant to impose on Member States an obligation to typify pharmaceutical crimes in their domestic legislation, although it calls for the imposition of effective penalties for acts involving falsified medicinal products taking into account the threat to public health posed by those products (recital 27) and requires Member States to lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and to take all necessary measures to ensure that those penalties are implemented (art. 118a). According to the Directive, such rules should address, inter alia, the manufacturing, distribution, brokering, import and export of falsified medicinal products, as well as the sale of falsified medicinal products at a distance to the public by means of information society services; non-compliance with the provisions laid down in the Directive on 44 Council Framework Decision of 13 June 2002 on the European arrest warrant and the surrender procedures between Member States (2002/584/JHA), Official Journal of the European Union, L 190, 18 July 2002 [pages 1 to 20]. 45 United Nations Convention against Transnational Organized Crime, adopted by General Assembly resolution 55/25 of 15 November 2000, entered into force on 29 September To date the Parties to the Palermo Convention are Council of Europe, Convention on Cybercrime, CETS No. 185, Budapest, 23 November 2001, entered into force on 1 July Notwithstanding its playing a minor role in this field, the Cybercrime Convention is equally relevant as some aspects of its provisions could be appropriate for pharmaceutical crimes committed through illegal e-pharmacies, and most of all for its provisions on international cooperation and mutual assistance. 364 Intersentia

16 The MEDICRIME Convention manufacturing, distribution, import and export of active substances; and noncompliance with the provisions laid down in the Directive on the use of excipients. The Directive also adds that the relevant penalties must be effective, proportionate and dissuasive (a typical formula used also by the MEDICRIME Convention), and must not be milder than those applicable to infringements of national law of similar nature and importance. By way of comparison, it is interesting to note that the Directive targets a variety of acts that do not differ considerably from the illegal conducts that the Parties to the MEDICRIME Convention are requested to criminalise. Nonetheless, it is evident that the application of the MEDICRIME Convention by EU Member States will strongly support the implementation of Directive 2011/62 and strengthen its effectiveness from the criminal law perspective, while filling the gap of a missing EU legislative measure of harmonisation of domestic criminal legislation in this field. On the other hand, the implementation of the Convention by non-eu countries will remedy the possible absence of a strict regulation of the pharmaceutical sector, including pharmacovigilance, comparable to that adopted in EU law. As for international cooperation in countering pharmaceutical crimes, it is clear that their transnational dimension calls for intense collaboration between police and judicial authorities, with a special focus on investigation and prosecution of the activities carried out by criminal organisations operating across national borders. 47 In this respect, two legal instruments are especially relevant for cooperation purposes at European and global levels. The first is the EU Framework Decision on the European Arrest Warrant, which provides that a number of offences may give rise to surrender pursuant to a European Arrest Warrant without verification of the double criminality of the act, provided that they are punishable in the issuing Member State by a custodial sentence or a detention order for a maximum period of at least three years (art. 2.2). Pharmaceutical crimes fall under the scope of this provision because they match in substance some of the relevant offences listed therein, namely participation in a criminal organisation, fraud, counterfeiting and piracy of products, and computer-related crime. Falsified and counterfeit medical products are indeed the output of fraudulent and pirate activities which, as said before, are mainly managed by criminal networks also operating on the Internet through illegal e-pharmacies. Within the European Union, the issuing, by the judicial authorities of the State having jurisdiction on such pharmaceutical crimes, of a European Arrest Warrant pursuant to art. 2.2 of the Decision facilitates the surrender of the requested suspects by another EU Member and makes the implementation of both Directive 2011/62 and the MEDICRIME Convention more effective. 47 Most relevant are the annual operations carried out by Interpol, known as Pangea, the latest being Pangea VIII, the largest ever Internet-based operation focusing on the illicit sale of medicines and medical devices via the Internet, with the participation of 115 countries and 236 agencies from police, customs and health regulatory authorities. See at Pharmaceutical-crime/Operations/Operation-Pangea. New Journal of European Criminal Law, Vol. 7, Issue 3,