[Third World Network, Link] The World Health Organization (WHO) Member State Mechanism (MSM) on substandard/spurious/falsely-labelled /falsified/counterfeit medical products (SSFFC) has agreed to recommend to the World Health Assembly (WHA) to drop the term “counterfeit” to refer to quality-compromised medical products. This decision was taken by the MSM in the context of refining the SSFFC definitions utilized by WHO, during its fifth meeting here on 23-25 November.
This historic agreement follows years of often-intense dispute among WHO member states as to the appropriate terminologies that should be utilized to refer to unsafe medical products circulated by unscrupulous actors.
The recommendation, when endorsed by the WHA, will put an end to nearly 30 years of practice in WHO of using the term “counterfeit” when referring to quality-compromised medicines.
The MSM agreed that the “term ‘counterfeit’ is now usually defined and associated with the protection of intellectual property rights”, acknowledging the definition of “trademark counterfeit goods” included in the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
Intellectual property (IP) considerations are expressly outside the mandate of the MSM, which has as its main objective “the prevention and control of substandard/spurious/falsely-labelled/falsified/counterfeit medical products and associated activities”, “in order to protect public health and promote access to affordable, safe, efficacious and quality medical products”.
The MSM further agreed that “[i]n the context of medical products, the term ‘falsified’ appears to adequately include all the various types of deliberate misrepresentation of a medical product in such a way which enables the specific exclusion of intellectual property rights.”
Thus the MSM replaced the term “counterfeit medical products” with “falsified medical products” to refer to quality-compromised medical products due to deliberate or fraudulent misrepresentations. The scope of the new definition of falsified medical products excludes IP considerations.
The MSM also agreed to drop the terms “spurious” and “falsely-labelled”, and elaborated definitions for “substandard” as well as “unregistered/unlicensed” medical products.
The MSM further agreed to replace the use of “substandard/spurious/falsely-labelled/falsified/counterfeit medical products” with “substandard and falsified medical products”, as the term to be used in its name and in all future documentation on the subject of medical products of this type.
(The exact text of the definitions is reproduced below.)
The MSM’s decision follows the recommendations of an informal technical working group on draft working definitions of SSFFC medical products, which met on 22 November in Geneva. This group was established by the fourth meeting of the MSM to refine the working definitions of SSFFC medical products, based on those currently used by the WHO global surveillance and monitoring system.
The MSM’s outcomes will be forwarded to the WHA for its endorsement.
The MSM decision marks a significant turning point in the history of WHO, whose use of the term “counterfeit” may be traced to WHA Resolution 41.16 on Rational Use of Drugs adopted in 1987.
The use of the term “counterfeit” to refer to quality-compromised medical products has, however, resulted in conflation of IP matters with issues concerning the quality of medical products, as the same term is legally defined in the WTO’s TRIPS Agreement as referring to a specific type of trademark infringement.
This conflation has perpetuated confusion and enabled multinational pharmaceutical corporations to advance their anti-counterfeiting IP enforcement initiatives under the guise of public health protection. Proponents of the IP enforcement agenda also roped in a number of international organizations such as INTERPOL, the World Customs Organization (WCO) and the UN Office on Drugs and Crime (UNODC) to undertake IP-related anti-counterfeiting initiatives under the pretext of addressing public health concerns. For instance, in 2013 INTERPOL received 4.5 million euros from 29 of the world’s largest pharmaceutical companies (proponents of IP enforcement) to carry out anti-counterfeit operations.
The conflation further resulted in unwarranted actions such as seizures of quality generic medicines. For instance, in 2008 and 2009 Dutch customs authorities seized 17 shipments of quality generic medicines in transit as part of an anti-counterfeit initiative.
It is also common for statistics on “counterfeit medicines” to combine data on IP infringements with cases of medicines distributed by unscrupulous actors. As a result, statistics concerning circulation of compromised medicines are inflated, exaggerated and unreliable.
In 2008 many member states questioned WHO’s anti-counterfeit activities, especially in the context of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). Organizations driving the IMPACT initiative included multinational pharmaceutical companies that are advocates of strong IP enforcement measures under the “anti-counterfeit” heading, using public health as a front.
Subsequently many developing countries objected to IMPACT and to WHO’s use of the term “counterfeit” when referring to compromised medical products.
However, no agreement could be reached among WHO member states on the appropriate terminology that should be utilized. As such, the 2010 World Health Assembly agreed that, pending agreement on appropriate terminology, the term “substandard/spurious/falsely-labelled/falsified/counterfeit” would be utilized as a temporary measure.
In 2012, WHA Resolution 65.19, which set up the MSM, noted in a footnote: “The Member State mechanism shall use the term ‘substandard/spurious/falsely-labelled/falsified/counterfeit medical products’ until a definition has been endorsed by the governing bodies of WHO.” The resolution also specifically mandated the MSM “[t]o further develop definitions of ‘substandard/spurious/falsely-labelled/falsified/counterfeit medical products’ that focus on the protection of public health”.
The MSM agreed that the consensus that has now been reached on the definition is “meant to start the process of simplifying the current terminology in use by the WHO global surveillance and monitoring system and the Member State mechanism from a public health perspective”.
The MSM agreement may also influence other international organizations, in their work programmes, to begin delinking IP issues from matters concerning quality of medicines.
For instance, in 2015 UNODC suspended its work programme on fraudulent medicines. In an email dated 12 June 2015 to the embassies of Brazil, Russia, India, China and South Africa (BRICS), UNODC’s senior expert in charge of activities on fraudulent medicines stated: “[W]e have come to appreciate that there is no established definition of fraudulent medicine under the World Health Organization framework of the Member State Mechanism on spurious, falsely labelled, falsified and counterfeit medicines (SSFFC) and the resulting lack of a common understanding may impede the ability of the expert group and UNODC to make tangible and useful progress. Therefore, UNODC has taken the decision to suspend the related work until a definition of fraudulent medicine is agreed upon by the WHO.”
Definitions of falsified, substandard and unregistered/unlicensed medical products agreed by the MSM
- Falsified medical products: “Medical products that deliberately/fraudulently misrepresent their identity, composition or source.”
The MSM goes on to state, with regard to the definition of falsified medical products: “Any consideration related to intellectual property rights does not fall within this definition.
“Such deliberate/fraudulent misrepresentation refers to any substitution, adulteration, and reproduction of an authorized medical product or the manufacture of a medical product that is not an authorized product.
“‘Identity’ shall refer to the name, labelling or packaging or to documents that support the authenticity of an authorized medical product.
“‘Composition’ shall refer to any ingredient or component of the medical product in accordance with applicable specifications authorized/recognized by NRRA [national/regional regulatory authority].
“‘Source’ shall refer to the identification, including name and address, of the marketing authorization holder, manufacturer, importer, exporter, distributor or retailer, as applicable.
“Medical products should not be considered as falsified solely on the grounds that they are unauthorized for marketing in any given country.”
- Substandard medical products: “Also called ‘out of specification’, these are authorized medical products that fail to meet either their quality standards or their specifications, or both.”
A footnote to the definition states: “When the authorized manufacturer deliberately fails to meet these quality standards or specifications due to misrepresentation of identity, composition, or source, then the medical product should be considered ‘falsified’.”
- Unregistered/unlicensed medical products: “Medical products that have not undergone evaluation and/or approval by the NRRA for the market in which they are marketed/distributed or used, subject to permitted conditions under national or regional regulation and use.”