Outline Counterfeit Medicines Discussions in WHO Role of other IGOs Conclusions
PART ICounterfeit Medicines: Conflated Perceptions andData
Counterfeit Medicines What is a counterfeit medicine? What is the extent of the problem of counterfeiting of medicines? How to address the real problem?
Perceptions about counterfeitmedicines IP infringing medicine Medicines infringing trademarks Fake medicines with wrong, contaminated, or inadequate ingredients, manufactured to intentionally defraud consumers (The Bad Counterfeits) Medicines containing chalk powder, corn starch, etc. Legitimate medicines which do not meet QSE standards Improper manufacturing, poor transportation or storage
Extent of the Problem – Conflation ofData To what extent are « Bad » counterfeit medicines being proliferated? What is the extent of the problem of substandard medicines? Data is anecdotal and unverifiable, using counterfeit medicines as an umbrella term conflating « bad » counterfeit medicines with substandard and possibly IP infringing medicines WHO studies reveal substandard medicines are the biggest problem
WHO Findings in SelectedCountries In Myanmar and Viet Nam prevalence of substandard drugs is a greater problem than counterfeit http://apps.who.int/medicinedocs/pdf/s2276e/s2276e.pdf In Cameroon, Chad and Madagascar – 17.8 % antibiotics were substandard, 7.6% were fraudulent Lao PDR – Substandard:22%; counterfeit;1%
Counterfeit Medicine – AnUmbrella Term Very few studies have examined what is the appropriate definition of « counterfeit medicine » Some studies point to a conflation of several distinct issues like substandard, false labelling, TM infringement Caudron JM, Ford N, Henkens M, Macé C, Kiddle-Monroe R, Pinel J. (2008). Substandard medicines in resource-poor settings: a problem that can no longer be ignored. Tropical Medicine and International Health,13(8): 1062- 72 Outterson K, Smith R. (2006). Counterfeit drugs: the good, the bad and the ugly. Albany Law Journal of Science and Technology, 16(3): 525–43 Generic medicines that may infringe patents are often classified as counterfeit medicines (Outterson and Smith, 2006)
Examples of conflation OECD (2008) on economic impact of counterfeiting and piracy Patent rights are infringed … by the counterfeiters … to produce the active ingredients, excipients, or finished products UN Interregional Crime and Justice Research Institute (UNICRI, 2007) Counterfeiting – illegal reproduction or imitation of products, resulting from the violation of any type of intellectual property rights
The Proposed Definitions ofCounterfeit 1992 WHO-IFPMA Workshop, Rome: A counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredient or with fake packaging IMPACT 2008: The term counterfeit medical product describes a product with a false representation of its identity and/or source. This applies to the product, its container or other packaging or labelling information. Counterfeiting should not be confused with patent infringement.
TRIPS Definition “counterfeit trademark goods” shall mean any goods, including packaging, bearing without authorization a trademark which is identical to the trademark validly registered in respect of such goods, or which cannot be distinguished in its essential aspects from such a trademark, and which thereby infringes the rights of the owner of the trademark in question under the law of the country of importation
TRIPS All TM infringement is not counterfeiting Near identical copying of registered TM for similar or identical products can constitute counterfeiting Criminal sanction only for wilful counterfeiting on a commercial scale Border measures – right holder has to apply, situations of import
Minutes of 1992 WHO-IFPMARome Conference WHO-IFPMA, Rome 1992 – Counterfeiting is an international problem which needs to be addressed by implementation of international laws. A sound legal framework is provided by the proposed anti- counterfeiting provisions in the draft GATT-TRIPS Agreement … which is based on effective international trademark protection and supported by enforcement and sanctions and penalties (including imprisonment).
TRIPS Plus TRIPS plus IP Enforcement trends (WCO, INTERPOL, WIPO, ACTA, UPU, Global Congress Against Counterfeiting) Coincides with IMPACT G8 Declaration (Heiligendam) welcomes IMPACT as An IP enforcement initiative Health and Safety linked to Anti-counterfeiting agenda
Linking IP to Health and Safety IMPACT Concept Paper (Combating Counterfeit Drugs: A Concept Paper for Effective International Cooperation): - need to begin the process of shifting the policy perspective on counterfeit goods to an understanding that counterfeits are not only an intellectual property legal problem, but also a very real public health problem - Efforts to protect public health from injury associated with counterfeit goods can complement and augment strategies to protect intellectual property rights
Solutions? Opposite Approaches From a public health perspective, the focus should be on detection and removal of poor quality medicines, not on whether they are counterfeit or not (Caudron et al. 2008) IMPACT (2007) – Counterfeit medicines need to be addressed through IP protection and enforcement, pharmaceutical products and medical devices regulation and control, and criminal law
Chronology 1985 WHO Conference of Experts on the Rational Use of Drugs in Nairobi: Term « Counterfeit medicine » referred to for the first time 1988 WHA Res. 41.16 on the Rational Use of Drugs mandates the WHO to initiate programs for prevention and detection of export, import and smuggling of falsely labelled, spurious, counterfeited or substandard pharmaceutical preparations. 1992 WHO-IFPMA workshop, Rome – definition of counterfeit medicines 1994 WHA Res. – 47.13 and 52.19 2006 – Rome Conference of WHO-IFPMA-AIFA, IMPACT established 2008 – 61st WHA Report on Counterfeit Medical Products and draft resolution based on IMPACT recommendations 2009 – 124th EB Secretariat asked to prepare a revised report and an information document on IMPACT 2010 – 63rd WHA decision to establish a Working Group on SSFFC, excluding IP considerations 2011 – 64th WHA establishes new Member State Mechanism on SSFFC 2012 – First Meeting of MSM on SSFFC recommends establishment of an open ended working group to identify actions, activities and behaviors that lead to SSFFC
Workplan of MSM Working Group Strengthening and capacity building of regulatory authorities and quality control laboratories Identify activities, actions and behaviors that result in SSFFC Strengthening capacities to ensure the integrity of the supply chain Other issues – affordability of medicines, price regulation, local production, use of INNs in prescriptions
WIPO WIPO Global Congress for Combating Counterfeting and Piracy publications on counterfeit medicines roundtable on technical assistance on counterfeit medicines, technical assistance on IP enforcement which also addresses health and safety issues
WCO Co-organizers of Global Congress on Combating Counterfeiting and Piracy Technical assistance to customs authorities on seizures of « counterfeit medicines »
Interpol 2008 resolution on counterfeit medical products 2010 resolution on counterfeit medical products and pharmaceutical crime Combating counterfeit medical products and pharmaceutical crime a law enforcement priority Several resolutions on IP violations Several national and regional trainings with law enforcement agencies on IP crime Co-organizer of the Global Congress on Combating Counterfeiting and Piracy
UNODC Commission on Crime Prevention and Criminal Justice 2011, Resolution 20/6 on fraudulent medicines invites UNODC to provide technical assistance and capacity building to Member States to disrupt and dismantle organized criminal networks involved in distribution and trafficking of fraudulent medicines
The WHO MSM process has adopted the appropriate approach of understanding the root causes behind SSFFC and identify the real nature and extent of the problem WHO should provide guidance to Member States in addressing these issues Strengthening drug regulatory capacities will be absoutely essential to meaningfully address the problem of QSE Excessive and disproportionate focus on IP enforcement and criminal sanctions may not address the larger aspects of the problem of QSE nd can be detrimental It will be important for other organizations and entities to ensure that discourses on counterfeit medicines do not add to the conflation