[Ip-health] WHO: Expert working group on SSFFC definitions established

Mirza Alas mirzalas at gmail.com
Fri Nov 27 09:05:08 PST 2015

*Title :* TWN Info (IP/Health): WHO: Expert working group on SSFFC
definitions established
*Date :* 26 November 2015


TWN Info Service (Intellectual Property / Biodiversity and TK)
26 November 2015
Third World Network

*WHO:  Expert working group on SSFFC definitions established*

Geneva, 23 November (K M Gopakumar) – The World Health Organization’s work
on substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC)
medical products has taken a step forward.

The WHO Member State Mechanism (MSM) established a working group on working
definitions in a decision taken at its 4th meeting held on 19-20 November
at the WHO Headquarters in Geneva.

The primary objective of the expert working group is to refine the working
definitions used by the WHO for the surveillance and monitoring of SSFFC
medical products. Even though the working definitions do not use the term
“counterfeit” the definition of falsified medicines could include medical
products infringing intellectual property rights.

According to the MSM meeting report, the working group of experts will be
from national and regional regulatory agencies and they will work on
refining the working definitions. The modalities of the working group and
budget implications, along with an update on the existing working
definitions, would be submitted to the MSM Steering Committee by the WHO
Secretariat at its meeting in March 2016.

The report of the MSM Steering Committee held on 26September 2015 did not
explicitly recommend the establishment of the working group. The report
stated: “It was proposed that the Steering Committee recommend to the
Member State Mechanism that technical experts be identified to work with
the Secretariat to review the comments received on working definitions used
in the SMP (surveillance and monitoring project) and make recommendations
for consideration”.

Third World Network (TWN) learned that even though the decision to
establish the working group was taken in the morning of 20 November the
ambassador of Monaco questioned the decision during the drafting at the MSM
meeting. The report of the meeting captures the decisions and conclusion of
the meeting. During the drafting of the report the ambassador said that
there was no decision to establish the working group and the decision was
to request the Secretariat to submit modalities of the working group and
budget estimation by March 2016 and it is for the Steering Committee to
take further decisions in this regard.

This was contested by many Member States who pointed out that there was a
decision to establish the working group. One developing country delegate
told TWN that the ambassador of Monaco was not present in the morning of
20November when the MSM meeting took the decision on establishment of the
working group. The ambassador justified her position stating that even
though she was absent she has notes of the meeting from her colleague.  The
drafting of the report took more than 3 hours.

WHO’s working definition on falsified medical product states: “A visually
imitated medical product and/or its packaging purporting to be licensed by
a national medicines regulatory authority (NMRA)”. The term ‘visual
imitation’ is too vague and can include trademark infringement.

Many working definitions currently used by WHO’s surveillance and
monitoring mechanism goes beyond substandard, spurious, falsely labeled or
falsified medical products. Apart form falsified medical products WHO also
uses the following working definitions to capture data on SSFFC medical
products. These terms are: suspected falsified medical product, substandard
medical product, suspected substandard medical product, intentionally
manufactured substandard medical product, diverted medical product, stolen
medico product and unlicensed edictal product. This can result in
projecting inflated data on SSFFC medical products (

This expert working group is also expected to provide clarifications on
different terms used to identify quality-compromised medicines. Currently
different international and national agencies are using different
terminologies to refer to medicines with compromised quality.  WHO uses the
terms substandard, spurious, falsely labeled, falsified, and counterfeit.
While INTERPOL uses ‘counterfeit’ the World Customs Organization uses the
term ‘illegal medicine’. The UN Office on Drugs and Crime (UNODC) prefers
‘fraudulent medicine’ and the Global Fund to Fight against TB and Malaria
uses the term ‘fake medicine’. There is no existing legal definition for
any of the terms used by these international organizations.

The absence of legal definitions has provided a favorable condition for
pharmaceutical transnational corporations (TNCs) and their developed
country partners to conflate quality issues of medicines with intellectual
property (IP) enforcement. By linking IP enforcement with quality issues
TNCS and developed countries are aiming at placing Drug Regulatory Agencies
(DRA) as a gatekeeper of IP protection and to enforce IP using public money.

The working group on definitions is supposed to offer a long-standing
solution to the description of medical products with compromised quality.
Recently UNODC suspended its work on developing a model law on fraudulent
medicines until a definition of fraudulent medicine is agreed upon by the
WHO (see http://www.twn.my/title2/health.info/2015/hi151003.htm).

One of the objectives of the MSM established under the World Health
Assembly resolution (WHA 65.19) is to further develop definitions of
“substandard/ spurious/falsely-labelled/falsified/counterfeit medical
products” that focus on the protection of public health”.

Even though WHA 41. 16 refers to spurious, counterfeit, falsely labelled
and sub-standard medical products WHO does not have a definition approved
by its governing bodies. Until 2010 WHO used a working definition used in a
WHO-IFPMA joint workshop in april 1992 on counterfeit medicines to refer to
counterfeit medicines (IFPMA is the International Federation of
Pharmaceutical Manufacturers & Associations).This was not approved by any
WHO expert group or governing body.

The WHO-IFPMA definition on counterfeit medicine states: “A counterfeit
medicine is one which is deliberately and fraudulently mislabelled 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*”.*

The word counterfeit has a specific meaning in the context of intellectual
property. Therefore this definition creates confusion and implicitly
includes intellectual property rights.

The definition does not explain the word identity. From a pubic health
perspective identity of drugs means the international non-proprietary name
(INN) of a drug. In the absence of an explanation it can also mean the
trademark or trade name of the drug. Thus this definition encompasses
intellectual property elements. As a result, a drug consisting of a correct
active ingredient but having a close similarity with another trademark or
trade name can be termed as a ‘counterfeit’ drug.

The 1992 WHO-IFPMA workshop viewed the issue of counterfeit as an
intellectual property issue. The workshop report recommends:
“Counterfeiting is an international problem which needs to be addressed by
the implementation of international laws. A sound legal framework is
provided by the proposed anti-counterfeiting provisions in the draft
GATT–TRIPS agreement (General Agreement on Tariffs and Trade-Aspects of
Intellectual Property Rights including Trade in counterfeit Goods), which
is based on effective international trademark protection supported by
effective enforceable sanctions and penalties (including imprisonment).
(See page 14 of the workshop report:

(The pharmaceutical industry succeeded in getting the United States, the
European Commission and Japan to push for the inclusion of an intellectual
property agreement in the Uruguay Round of trade negotiations. What ended
up as the TRIPS Agreement originated as a draft from industry.)

The International Medical ProductsAnti-Counterfeiting Taskforce (IMPACT)
initiative, which WHO is part of, proposed another definition.  IMPACT
defines ‘counterfeit medical product’ in the following way: “*A medical
product is counterfeit when there is a false representation in relation to
its identity, history or source. This applies to the product, its container
or other packaging or labelling information. Counterfeiting can apply to
both branded and generic products. Counterfeits may include products with
correct ingredients/components, with wrong ingredients/components, without
active ingredients, with incorrect amounts of active ingredients, or with
fake packaging”.*

The IMPACT definition expands the scope of counterfeit by including false
representation with regard to identity, source and history, to the product,
its container or other packaging or labelling information.The definition
does not give any explanation on these terms. These terms clearly target
the issues related to intellectual property protection. For instance, a
medical product becomes counterfeit irrespective of correct information
with regard to source and identity if the product or packet carries the
same colour schemes of another medical product. A product may even be
classified as counterfeit when the shape of the product is similar to a
competing product. This is important especially in the light of the
broadening scope of trademark into non-traditional areas like taste, shape,
colour, touch and feel, smell etc.

There was another incident which clearly brought out the IP enforcement
agenda behind WHO’s programme on counterfeit medical products.  The
Secretariat circulated a draft resolution at the 124th meeting of the WHO
Executive Board (EB) in December 2008. The draft resolution in its preamble
stated that “*Recognizing that disputes about, or violations of
intellectual property rights are not to be confused with counterfeiting*”. (

The next day the Secretariat brought out a corrigendum which stated:
“Please note that the sixth preambular paragraph of the draft resolution
addressed to the Health Assembly should read as follows: Recognizing that
disputes about, or violations of, patents are not to be confused with
counterfeiting” (
http://apps.who.int/gb/ebwha/pdf_files/EB124/B124_14Corr1-en.pdf). Thus the
corrigendum makes it clear that trademark infringements would be treated
counterfeit medicines and that these compromise the quality, safety and
efficacy of medicines.

Since the Secretariat is in charge of developing the modalities for the
consideration of the Steering Committee, the scope of the newly established
working group would be clear only after the meeting of the Steering

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