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A debate about the international criminalization of falsification of medicines: responding to Attaran, Bate and Kendall

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Neil Boister and Benn McGrady

In a recent article in Journal of International Criminal Justice, we responded to a proposal by Amir Attaran, Roger Bate and Megan Kendall that a treaty should be negotiated under the auspices of the World Health Organization (WHO). More specifically, we responded to the suggestion that a treaty for the criminalization of falsifying medicines should be negotiated under the auspices of the WHO.

We argued that Attaran, Bate and Kendall had failed to consider questions of institutional choice. Working on the assumption that international legalization is an appropriate response to the problem of falsified medicines, we argued that the ‘WHO is not the only forum in which these issues may be addressed and nor is it clear that negotiations under the auspices of the WHO would be better than negotiating an optional protocol to [the UN Convention on Transnational Organized Crime] UNTOC or pursuing a joint initiative of the WHO and the UN Office on Drugs and Crime (UNODC).’ We stressed that if criminalization through international law is the approach to be adopted, it may be more appropriate to locate negotiations within the pre-existing UN criminal justice framework.

In their comments on our response, Attaran, Bate and Kendall have mischaracterized our arguments on a number of important points and introduced misleading information on others. We consider it appropriate to provide a further brief response in order to address those aspects of the second article that are misleading.

First, Attaran, Bate and Kendall suggest that we are proposing negotiation of an optional protocol to the UNTOC, a proposal the authors characterize as ‘poor’. We did not make any such proposal. The point of our article was simply to say that if criminalization through international law is the favored approach, the UN criminal justice organs based in Vienna  may provide a better forum than WHO. Our article, necessarily limited as it was, said nothing about the merits of international legalization, or criminalization, as means of addressing the public health consequences of falsified medicines.

Second, we did not propose that criminal law should be applied to both the question of deliberate falsification of medicines as well as to substandard medicines. There are a number of complementary approaches required to address falsified and substandard medicines and our suggestion that a criminal law forum might be used for purposes of criminalization says nothing about the merits of other approaches, or even about the merits of criminalization more generally.

Third, the authors suggest that we proposed a UNODC led solution. As was noted above, we have made no such proposal. More disturbing, however, is that Attaran, Bate and Kendall suggest that our putative proposal was not original and that we should have cited or referenced the Government of Argentina, which raised the issue of falsified medicines in an April 2011 meeting of the Commission on Crime Prevention and Criminal Justice.

Our suggestion was not intended to be an original idea and was not presented as such. As we noted in our reply to the initial article, UNTOC ‘already applies to all domestic medicine counterfeiting offences that carry a penalty of four years or more, that are transnational in nature, and which involve an organized criminal group.’ In our response to Attaran, Bate and Kendall we were merely pointing to a well-known, pre-existing and applicable legal regime that the authors failed (inexplicably) to consider in their initial analysis. In this context, it was quite improper for Attaran, Bate and Kendall to attempt to impugn our academic integrity by suggesting that we failed to provide a necessary citation to the Government of Argentina. 

Our point was about engaging with this pre-existing legal framework. We argued that if criminalization under international law is to be pursued, engagement with the UN’s criminal justice framework is desirable. In contrast, Argentina’s point was about utilizing the existing resources of inter-governmental organizations. In paragraph 8 of its draft resolution Argentina proposed to request the UNODC:  

in accordance with its mandate and in close cooperation with other United Nations bodies and international organizations, such as the World Health Organization, the World Customs Organization, the International Criminal Police Organization and the European Police Office, as well as the private sector, regional bodies, civil society organizations, professional associations, private partners and others, to better assist Member States in disrupting and dismantling the organized criminal networks responsible for the production, distribution and sale of and trafficking in fraudulent medicines, to better utilize the experiences, technical expertise and resources of each organization and to create synergies with interested partners, and invites Member States and other donors to provide extrabudgetary contributions for those purposes, in accordance with the rules and procedures of the United Nations.

The common theme between Argentina’s draft resolution and our comments is that we both favor coherence in terms of the efforts of inter-governmental agencies.

Fourth, at no point did we suggest that a protocol to UNTOC should be adopted without international negotiation. Attaran, Bate and Kendall suggest that a new protocol to UNTOC ‘requires nothing more than a decision of the UN General Assembly, which could be passed in a single sitting’, whereas ‘a WHO-led treaty probably would take years of hard negotiations’. The authors argue that this weighs in favor of a WHO-led treaty negotiation because ‘the iterative process of negotiations helps countries refine their interests and objectives, and cements their political will.’

It is a misrepresentation to suggest that in terms of procedure one venue would necessarily provide scope for negotiations whereas another would not. In this respect, the UNTOC protocols were negotiated among states. It is also worth stressing that our response to the original article emphasized that the question of institutional choice is about finding the preferable venue for negotiations. We argued that ‘the WHO is not the only forum in which these issues may be addressed and nor is it clear that negotiations under the auspices of the WHO would be better than negotiating an optional protocol to UNTOC or pursuing a joint initiative of the WHO and the UNODC.’

Fifth, Attaran, Bate and Kendall accuse us of overlooking what they characterize as the undeniable failure of UNTOC protocols in the recent past. Again, this mischaracterizes our response. Our point is that in considering questions of institutional choice, the legal framework created by UNTOC must be considered. We did not purport to undertake a detailed analysis of institutional choice, but merely to highlight important legal structures neglected by the authors. It is also misleading to suggest that the UNTOC protocols have been an undeniable failure in recent years. The authors present only the relatively low participation of states in the firearms protocol as evidence to this effect. This is hardly a serious way in which to analyze the successes and failures of international legal instruments.

Finally, it is grossly misleading to suggest that ‘the evidence shows that a WHO-led treaty is the better option’ for purposes of raising foreign aid money. Attaran, Bate and Kendall suggest that development assistance for tobacco control rose to $240 million annually following the WHO Framework Convention on Tobacco Control (FCTC) and that this outstrips the Crime Prevention and Criminal Justice Fund, which raised on average $50 million to be shared across three protocols. The authors neglect to mention that the $240 million figure includes contributions from all sources, including foundations, whereas the Crime Prevention and Criminal Justice Fund is a dedicated fund set up to receive contributions from states. The authors also neglect to mention that the current budget of the WHO FCTC is under-funded by the Parties (states) and dependent on additional contributions that do no form part of the ordinary voluntary assessed contributions. Even if the figures were comparable, it would not necessarily follow that a WHO-led approach would be capable of raising more funds.


In conclusion, in our response to Attaran, Bate and Kendall we sought to highlight the need for a deeper examination of institutional choice before international legalization to address falsified medicines. We did not seek to prescribe a solution to the problem. On the contrary, there are prior questions concerning the merits of legalization and criminalization that have not yet been examined in sufficient depth. The need to examine these questions, as well as questions of institutional choice, has only been highlighted by recent discussion of WHO reform and the need for WHO to focus its activities in areas of its core competence.

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  • Professor Amir Attaran says:

    Dear Benn,
    Professor Amir Attaran answering you here. Your blog accuses me and my coauthors of being “grossly misleading” in responding to your July 2011 letter in the Journal of International Criminal Justice. Your letter, just so everyone follows, was responding to our original research paper in that same journal, which proposed a new treaty on counterfeit medicines (since renamed “falsified medicines” by popular demand at WHO).
    Gosh. I wish you would have picked up the phone to have a friendly word before accusing us of “grossly misleading”. If we made a mistake – and I don’t think we did – we are honest people and we would have fixed it. Hurling epithets at us on your blog is unnecessary.
    But there are also many statements of yours, Benn, that I find puzzling. Take for instance what you call your first and most fundamental point. In your blog you write, “First, Attaran, Bate and Kendall suggest that we [Benn McGrady and friend] are proposing negotiation of an optional protocol to the UNTOC, a proposal the authors characterize as ‘poor’. We did not make any such proposal.”
    No such proposal for negotiating an UNTOC protocol, Benn? Well, here is what you wrote in your July 2011 letter in JICJ: “The UNTOC provides a platform, which can potentially be reached more comprehensively and more directly by the negotiation of a medicine counterfeiting protocol.” That sure sounds like a proposal to me. And in case anyone missed it, you repeated the point: “UNTOC might also be an appropriate venue in which to initiate these negotiations.”
    You know, Benn, I am always happy to debate a fellow, but a hide-and-seek debate conducted on your blog is off-putting and peculiar as a method to advance your scholarly message (so I won’t be writing on your blog again). Much more importantly, I am delighted to find allies in you and Professor Boister, who share our belief that there needs to be international law against falsified medicines. That is impressive common ground, but if you continue to feel there is something which must be debated, then may I politely suggest to invite us to a moderated debate at your institution, Georgetown University, on an agreed date and with a sizeable audience in the room from across Washington, and certainly I or one of my coauthors will be glad to explain why we believe in the article we published, which is the first-ever detailed outline for a global treaty to fight falsified medicines ever to appear in the legal literature. In fact we’re proud of it.
    Warm regards,
    Amir Attaran
    Canada Research Chair
    Faculty of Law, Faculty of Medicine, and Institute of Population Health
    University of Ottawa

  • Benn McGrady says:

    Dear Amir,
    In hindsight, I should have have sent you a copy of the blog post. That was an oversight on my part and I admit the mistake. There was no intention to have a ‘hide and seek’ debate. We merely wanted to clarify our position. We wrote to an editor of the journal, who indicated that the convention was not to permit us a further reply despite the fact that we felt our arguments were mischaracterized in your response. Picking up the phone was not really an option given that your response was already in print.
    The quote you take from our initial letter is taken out of context. I will leave it to readers to go through the links on the initial blog. We advocate use of criminal law forums for international criminalization, without commenting on the merits of negotiating a new instrument. That may seem an overly nuanced position, but in my view, there is more work to be done before the merits of treaty negotiations in either forum are established. I intend to do some more work on that issue in the near future and will be sure to give you a heads up.
    Yours sincerely,

  • The views reflected in this expert column are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.

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