Public health, and not intellectual property or trade issues, should be the prime consideration in defining and combating counterfeit and substandard medicines, according to an article published in open-access journal PLoS Medicine.
The authors, led by Paul Newton of the Centre for Tropical Medicine at Oxford University, suggest that the World Health Organization (WHO) should also take a more prominent role in improving the world's medicine quality and supply.
"Attempts to improve medicine quality have been hampered by confusion and controversy over definitions," they write. "For counterfeit (or falsified) medicines, this has arisen from perceived differences between public health and intellectual property approaches to the problem."
Disagreements over the definition of counterfeit and substandard medicines has contributed to a near-paralysis of the WHO's ability to take a lead in the fight against counterfeit medicines, and particularly its involvement with the multi-stakeholder International Medical Products Anti-Counterfeiting Taskforce (IMPACT).
Faced with allegations of pandering to an IP agenda laid out by the pharmaceutical industry which was threatening access to medicines in the developing world, the WHO set up an intergovernmental working group to try to work out its own role in the fight against counterfeits, which because of the definition controversy are now lumped into a category referred to as 'substandard/spurious/falsely-labelled/falsified/counterfeit' (SSFFC) medical products.
A few weeks ago, a draft resolution by the working group effectively concluded that the WHO should take a backseat on the issue, with the lead taken by a yet-to-be-formed "mechanism" for international collaboration among World Health Assembly member states.
While the WHA "should be an ideal setting in which to thrash out solutions to the problem of poor quality medicines in the developing world," the wrangling is causing delays in developing an organised response to the problem and "is not in the best interest of global public health", note the authors.
Newton et al support three possible interventions to help deal with the problem of poor quality medicines, including the drawing up of public health-oriented definitions for counterfeit and substandard medicinal products. In fact, they argue that the definitions currently proposed by the WHO are fit-for-purpose as they specifically do not invoke IP issues.
Secondly, the organisations with potential conflicts of interest should issue unambiguous statements "eschewing the use of IP law to counter generic medicine," citing the recent statement to this effect by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA).
The authors would also like to see international treaty on medicine quality, drafted under the auspices of the WHO, which could be refined incrementally "to facilitate transnational jurisdiction over widespread, systematic counterfeiting as a crime against humanity."
The treaty could also include "positive legal powers and a financial mechanism to facilitate good quality manufacturing and access to affordable high quality medicines to reduce the frequency of substandard medicines."
The article can be read online here.