Dr. Stefano Bonino of Durham University has just published an interesting and worrying article about the state of legal progress in the fight against poor quality medicine. The United Nations Office on Drugs and Crime (UNODC) has taken a significant interest in helping emerging nations work out how to combat the scourge of falsified and substandard medicines. UNODCs draft model laws were written by renowned expert (and contributor to this site), Professor Amir Attaran. I edited the draft at the request of UNODC, as did other experts. I was however, not invited to attend the session deliberating the draft held in Vienna from 9-11 July. It is fortunate that Dr. Bonino did attend, because UNODC is repeating a mistake made by another UN body, the World Health Organization (WHO).
The WHO is largely failing in its mission to combat poor quality medications because of the intransigence of influential member states such as India and, to a lesser extent, Brazil. As is well known to reviewers of our work on this site, India spends far more effort promoting its drug exports than in ensuring that the quality of those exports are fit for use. Any criticism of Indian drugs is assumed to be done at the behest of Western interests.
While its allegations are generally wrong, bellicose nationalism, or misdirected, some members of the health community have bought into the notion of conspiracy. It doesn’t help that many in the drugs industry are fixated on intellectual property enforcement, when drug quality issues (whether breaching IP or not), are the main health concern. WHO’s early efforts against inferior medicines were heavily funded by the drugs industry, and even though its IMPACT initiative didn’t really do much wrong, it was shot down by India and some health advocates as being too Eurocentric and cozy with western pharma. WHO restarted its efforts more multilaterally, but once again India has slowed progress.
Now, UNODC, a leaner more nimble organization than WHO, has stepped up to help poorer nations draft laws to outlaw criminal actions that lead to inferior medicines. Because of the WHO’s history, it was vital that UNODC made its efforts as geographically inclusive as possible. But according to Professor Bonino, at the consultation in July only one African and no Latin Americans nor Asians were present (and no one from US FDA or any other branch of US Government was there either). It is not too late to increase consultation at future meetings and go back to the original drafts of Professor Attaran.
But if UNODC does not do this, I foresee its efforts going the same way as WHO. Asian pharma interests will lobby their governments to fight any concerted efforts to prevent inferior medicines from being exported, and they will rightly claim that like in early WHO efforts they were not properly consulted.
With so many people being harmed by both criminally made falsified medicines and negligently made substandard medicines it is vital that progress is made and quickly.