In a strongly-worded opinion column for The Indian Express on the Ranbaxy fraud published last week, Amir Attaran of the University of Ottawa rightly calls on the Indian government to do more to ensure that drugs produced in India are safe and effective.
But Attaran is wrong is when he uses references to the fraud and to India’s shortcomings in drug safety improvement as a rhetorical device to delegitimize arguments that the Indian government has advanced to oppose global anti-counterfeit initiatives.
Rather than addressing these arguments, Attaran slams the Indian government’s position as “foiling global efforts to improve medicine quality,” and accuses it of “cynical diplomacy” meant to “shelter India’s pharmaceutical industry from outside scrutiny.”
Linking patents and drug safety
Global efforts to improve medicine quality, such as the WHO International Medical Product Anti-Counterfeit Taskforce (IMPACT), the Anti-Counterfeiting Trade Agreement (ACTA) and, most recently, the Interpol Pharmaceutical Crime Programme, have been couched in the language of ‘anti-counterfeiting’ efforts.
India has opposed this anti-counterfeiting frame because it creates a narrative that defines stronger protection of intellectual property (IP) rights as an appropriate means to protect consumers from unsafe medicines. Moreover, it focuses on criminal law to enforce IP rights and, thereby, allegedly improve consumer protection.
Attaran alleges that “in foreign eyes, India’s government is not a partner in the global fight against substandard and falsified medicines, but the main problem.”
But it is not just the Indian government but also several others notably from Asia and South America, and also the European Parliament, that have raised concerns against the framing of policies to improve medicines quality in terms of anti-counterfeiting. The concerns relate to the effectiveness of such an approach and to its potentially negative effects on the trade in generic medicines of assured quality.
The link between drug safety, IP rights and criminal law enforcement is created through the ambiguous use of the term ‘counterfeit’. The term is used to denote medicines that contain the wrong composition of ingredients; fake drugs produced by criminal organizations; medicines that violate a specific category of IP rights, namely trademarks; and it is used to refer to the infringement of intellectual property rights (IPR) in general, including patents. So by using the term ‘counterfeit’ medicines, the debate links concerns about drug safety with concerns about IP infringement.
Moreover, in international IP law the term counterfeit has a specific meaning that creates a focus on criminal law as means of enforcement.
In general, IP rights are private rights. This means that it is up to the owner of such rights to enforce them through the judicial system of civil law. Disputes about IP rights are usually commercial disputes between two or more legally recognized organizations. They are therefore considered best served through civil law.
There is one exception, however. When trademark rights are willfully violated at a commercial scale it is assumed that a criminal organization is involved. Hence, criminal law enforcement and penalties apply.
By using the term counterfeit, the debate not only conflates the issues of drug safety and IP infringement but it also conflates different types of IP. The latter creates a focus on criminal law as means of enforcement.
Why are policies that aim to enhance drug safety through stronger IP protection and its enforcement through criminal law problematic? There are at least three reasons.
One, it is not the most effective approach to strengthening drug safety. Many drugs that endanger the lives of patients because they are potentially unsafe do not violate any IP rights. They contain insufficient or even dangerous ingredients but their packaging does not even try to imitate a trademark; neither do they infringe any patents. Those products cannot be reached through strengthening IP enforcement. They can only be taken off the market through improved drug regulation and supply chains.
Two, addressing drug safety problems though IP policies and especially criminal law shifts the costs of enforcing private commercial rights to the public, i.e. the taxpayer. Moreover, it takes political attention and scarce resources away from issues that cannot be addressed through civil law, such as strengthening the drug regulatory system for instance.
Three, the anti-counterfeiting frame of the debate undermines people’s trust in generic medicines. Insinuating that there is a link between the IP status of a drug and its quality may well reinforce ideas that many patients already hold about generic drugs being second-rate medicines. In light of ever increasing healthcare costs, this is a trend that governments can ill-afford.
Whatever the exact motifs of the Indian government to oppose global anti-counterfeiting initiatives may be, some of the arguments it has put forward are important and should inform the debate.
Dr Anne Roemer-Mahler is a Lecturer in International Relations at the University of Sussex (UK) and a Research Fellow at the Sussex Centre for Global Health Policy. She holds a PhD in Development Studies from the University of Oxford where she worked on the role of Indian pharmaceutical companies in shaping the global IP regime. Currently, Anne works on the role of pharmaceutical companies from emerging markets in public-private partnerships to develop and procure medicines for tuberculosis.
Pic courtesy Dr Roemer-Mahler
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