[Ip-health] TWN Info: WHO - Member State Mechanism agrees to drop ³counterfeit² term

Sangeeta Shashikant sangeeta at twnetwork.org
Wed Nov 30 02:13:32 PST 2016

Title : TWN Info:  WHO - Member State Mechanism agrees to drop ³counterfeit²
 Date : 2016-11-30


TWN Info Service on IP and Health
30 November 2016
Third World Network
www.twn.my <http://www.twn.my>

WHO:  Member State Mechanism agrees to drop ³counterfeit² term

Geneva, 28 November (TWN): 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 ³counterfeit² 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

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 ³counterfeit² when referring to
quality-compromised medicines.

The MSM agreed that the ³term Œcounterfeit¹ is now usually defined and
associated with the protection of intellectual property rights²,
acknowledging the definition of ³trademark counterfeit goods² 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 ³the prevention and control of
substandard/spurious/falsely-labelled/falsified/counterfeit medical products
and associated activities², ³in order to protect public health and promote
access to affordable, safe, efficacious and quality medical products².

The MSM further agreed that ³[i]n the context of medical products, the term
Œfalsified¹ 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.²

Thus the MSM replaced the term ³counterfeit medical products² with
³falsified medical products² 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 ³spurious² and ³falsely-labelled², and
elaborated definitions for ³substandard² as well as
³unregistered/unlicensed² medical products.

The MSM further agreed to replace the use of
³substandard/spurious/falsely-labelled/falsified/counterfeit medical
products² with ³substandard and falsified medical products², 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 MSM¹s 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 MSM¹s 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 ³counterfeit² may be traced to WHA Resolution 41.16 on
Rational Use of Drugs adopted in 1987.

The use of the term ³counterfeit² 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 WTO¹s 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 world¹s 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 ³counterfeit medicines² 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 WHO¹s 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 ³anti-counterfeit²
heading, using public health as a front.
Subsequently many developing countries objected to IMPACT and to WHO¹s use
of the term ³counterfeit² 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 ³substandard/spurious/falsely-labelled/falsified/counterfeit² would
be utilized as a temporary measure.

In 2012, WHA Resolution 65.19, which set up the MSM, noted in a footnote:
³The Member State mechanism shall use the term
Œsubstandard/spurious/falsely-labelled/falsified/counterfeit medical
products¹ until a definition has been endorsed by the governing bodies of
WHO.² The resolution also specifically mandated the MSM ³[t]o further
develop definitions of
Œsubstandard/spurious/falsely-labelled/falsified/counterfeit medical
products¹ that focus on the protection of public health².

The MSM agreed that the consensus that has now been reached on the
definition is ³meant 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 perspective².

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), UNODC¹s senior expert in
charge of activities on fraudulent medicines stated: ³[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.²

Definitions of falsified, substandard and unregistered/unlicensed medical
products agreed by the MSM
* Falsified medical products: ³Medical products that
deliberately/fraudulently misrepresent their identity, composition or
The MSM goes on to state, with regard to the definition of falsified medical
products: ³Any consideration related to intellectual property rights does
not fall within this definition.

³Such 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.

³ŒIdentity¹ shall refer to the name, labelling or packaging or to documents
that support the authenticity of an authorized medical product.

³ŒComposition¹ shall refer to any ingredient or component of the medical
product in accordance with applicable specifications authorized/recognized
by NRRA [national/regional regulatory authority].

³ŒSource¹ shall refer to the identification, including name and address, of
the marketing authorization holder, manufacturer, importer, exporter,
distributor or retailer, as applicable.

³Medical products should not be considered as falsified solely on the
grounds that they are unauthorized for marketing in any given country.²
*  Substandard medical products: ³Also called Œout of specification¹, these
are authorized medical products that fail to meet either their quality
standards or their specifications, or both.²
A footnote to the definition states: ³When 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 Œfalsified¹.²
* Unregistered/unlicensed medical products: ³Medical 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.²

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