Info Service on Health Issues (Oct15/03)
Suspension of UNODC work program on model law on fraudulent medicines
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 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.+