[Ip-health] Suspension of UNODC work program on model law on fraudulent medicines

[Mirza Alas]

*TWN Info Service on Intellectual Property Issues (Oct15/04) 1 October 2015
Third World Network*

*Suspension of UNODC work program on model law on fraudulent medicines*


http://www.twn.my/title2/intellectual_property/info.service/2015/ip151004.htm


Geneva, 1 October (K M Gopakumar) – The United Nations Office on Drugs and
Crime (UNODC) has suspended its work on the development of a model law on
fraudulent medicines.

The development of such a model law had created controversy due to the
hidden intellectual property (IP) enforcement agenda in the name of
protecting quality and safety of medicines.

In an email dated 12June 2015 to embassies of Brazil, Russia, India, China
and South Africa (BRICS) UNODC’s senior expert in charge of activities on
fraudulent medicines stated: “ … we have come to appreciate that there is
no established definition of fraudulent medicine under the World Health
Organisation 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 ”.

[WHO established the Member State Mechanism on SSFFC medical products
through a World Health Assembly resolution after the objections from
developing countries including Brazil, India, Iran, Pakistan and Egypt
against a WHO partnership on counterfeit medicines known as the
International Medical Product Anti Counterfeit Taskforce (IMPACT). IMPACT
was an initiative by the pharmaceutical transnational corporations along
with developed country Member States to push to enhance IP enforcement
standards by conflating IP enforcement with quality of medicines.  The
IMPACT Secretariat was moved out of WHO due to objections from developing
country Member States.]

The main concern related to the UNODC model law is the definition of
fraudulent medicine, which gives ample room for the conflation of quality
of medicine with IP.  According to the draft law ‘fraudulent medical
product’ means any medical product with a false representation of:

(1) its identity, including its packaging and labelling, its name or its
composition as regards any of the ingredients including excipients and the
strength of those ingredients;

(2) its source, including its manufacturer, its country of manufacturing,
its country of origin or its marketing authorisation holder; or

(3) its history, including the records and documents relating to the
distribution channels used.

The false representation of identity including packaging and label as per
the definition can clearly bring trademark infringement within the scope of
fraudulent medicine.  Similarly some experts are also worried that the
false representation of identity and history can even include patent
infringements.

Further concerns had also been raised on the process of the model law
development and the involvement of NGOs with close links to industry.
(See *Fraudulent
medicines model law promotes pharma interest
<http://www.twn.my/title2/intellectual_property/info.service/2014/ip141201.htm>*
dated 8 December 2014.)

The BRICS countries in a letter to the UNODC Secretariat dated 10December
2014 questioned the process and sought the following clarifications:

·             On what basis was the selection of the countries/NGOs/experts
participating in  the above meeting made by the UNODC?

·              In our understanding, the resolution 20/6 on Fraudulent
Medicines adopted by the CCPCJ (Commission on Crime Prevention and Criminal
Justice) in 2011 does not provide a mandate to UNODC to start expert level
consultations to develop a model law   on fraudulent medicine. Under which
mandate has this process been initiated?

·             What is the source of funding of the said informal expert
group meeting?

The letter also asked UNODC “to reconsider further actions towards
developing a model law on fraudulent medicine, pending consultation with
Member States”.

In response to the letter from the BRICS UNODC said: “As reported in
CTOC/COP/2014/11, entitled Provision of technical assistance to States in
the implementation of the United Nations Convention against Transnational
Organized Crime and the Protocols thereto, UNODC has commenced the
development of model legislative provisions to combat fraudulent medicines
posing threats to public health, in line with the Organized Crime
Convention. The model legislative provisions will be accompanied by a
commentary and include various drafting options, which will be applicable
to all legal systems and adaptable to the needs of each State. The model
legislative provisions will be utilized by UNODC as technical assistance
tools to provide advisory services and assistance to countries”.

However, it became very clear that there was no explicit mandate from the
Member States to develop a model law on fraudulent medicines. In the
absence of such a mandate UNODC justified its decision as part of its
technical assistance program and ignored the norm-setting effect of a model
law. Further UNODC asserted that since there is a mandate for technical
assistance there is no need to obtain the approval of the Member States for
the model law.

In its email responding to the BRICS UNODC reiterates the same position: “
… in accordance with standard UNODC practice for tool development and as
noted in our previous communications, technical subject matter experts, in
their individual capacity, have been approached from different regions.
Once, the drafting process resumes, we would be pleased to invite experts
from your countries, in their individual capacity, to participate in any
future meetings.”

UNODC’s selective selection of experts who hold the view of the
pharmaceutical industry has come under public scrutiny.  On the experts,
Stefano Bonino, Research Associate at the School of Applied Social Science,
Durham University (UK) remarks: “The French government has also previously
directly funded UNODC’s fight against fraudulent medicines. It is excellent
that France cares to support UNODC’s work in this effort, but given that a
good number of the experts involved in the consultation were French
(working for UNODC, Council of Europe and INTERPOL) and/or representing
French interests, including Sanofi, we need to be careful about how much
influence this one player has and whether the entire world is willing to
follow suit.” (See:
https://theconversation.com/un-draft-law-against-medicine-crime-is-fatally-flawed-30281
)

(Sanofi is a major pharmaceutical company.)

However, in their earlier response UNODC did not disclose the source of
funding and simply stated: “Funding for this activity comes from the
regular budget of the United Nations, and voluntary contributions”.

In its initial response to the BRICS letter of December 2014 on the scope
of the model law UNODC stated that, “The focus of the provisions is on
crime prevention and criminal justice in the intentional manufacturing of
and trafficking in fraudulent medicine.  The model legislative provisions
have no relation to intellectual property rights and do not apply to
unintentional quality defects. Rather, the focus of the provisions is on
criminal behaviour and intentional manufacturing of and trafficking in
fraudulent medicines”.

Observers of the debate say that the decision to suspend the work on the
model law clearly shows the admission of mistake by the UNODC Secretariat
in pursuing a donor-driven IP enforcement agenda.+