Experts call for global treaty on drug quality

Published on November 16, 2012 at 5:15 PM · No Comments

By Sarah Guy, medwireNews Reporter

Professionals from the world of health, including health charities, legal and medical academia, and former or current government health officials, have called for the creation of an internationally binding treaty to tackle illegitimate drugs.

The treaty should legally define types of illegitimate medications, define new public health crimes in international law, mandate government cooperation, create an intergovernmental forum to protect the legitimate medicines trade, and include administrative provisions to give financial and technical assistance to regulatory authorities worldwide, say the authors.

"The lack of a treaty means there is generally no agreement on which medicines are wrongful or criminal; no requirement for police to cooperate across borders in carrying out international investigations; and no requirement for prosecutors to share evidence or to respond to extradition requests to bring perpetrators to justice," write Amir Attaran (University of Ottawa, Ontario, Canada) and colleagues in the BMJ.

The World Health Organization (WHO) estimates that between 1% and 10% of medicines in developed and developing countries, respectively, may be "counterfeit," while in 2009, the Pharmaceutical Security Institute detected approximately five incidents of illegitimate medicines of all kinds per day, in over 110 countries.

One example of a falsified medicine currently being combated globally is a product named as the chemotherapeutic drug bevacizumab, but which is thought to contain starch and acetone instead of the active ingredient.

Attaran and co-authors believe the most fundamental reason for current and past inaction against illegitimate medicine is a failure to recognize shared goals, with difficulties also arising from conflict about pharmaceutical pricing or intellectual property laws.

How to define illegitimate medicine is a particular hindrance, suggests the team. The recent decision by WHO to group "substandard/spurious/falsely-labeled/falsified/counterfeit" medicines gives a "mistaken impression" that "they are all deficient in the same way, when actually there are many possible deficiencies, each requiring different solutions."

Not using the term "counterfeit", for example - a private economic wrong, separate from the public health wrong of poor medicine quality - is one recommendation for the treaty.

The authors contend that "substandard" would appropriately cover all medicines that, for unintentional reasons, do not meet the legally required quality specifications of a country's regulators, while "falsified" medicines, although still violating regulators' quality specifications, covers deliberate, criminal intent.

"A binding international law on drug quality - that is, a treaty - is needed to complement the existing trade treaties and put public health on an equal plane," conclude Attaran and co-authors.

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