Yesterday the Council on Foreign Relations held a conference on the issue of global counterfeiting of both food and drugs. Appropriately, the U.S. Commissioner of the Food & Drug Administration, Peggy Hamburg, was the keynote. And she had some interesting and important things to say.
A few pearls from Peggy:
* The new reality of food and drug regulation is that it’s global. In fact, it should be a topic for conversation at the next meeting of the G20.
* The recent crises in both food and drug safety will only repeat themselves unless regulatory agencies from around the world work in closer and more regular partnership.
* There is a responsibility on the part of the FDA and other more developed regulatory agencies around the world. (MHRA certainly comes to mind.) to help build “regulatory capacity” for those nation’s that want and need assistance. (Nigeria comes to mind.
* Part of a closer working relationship means a more regular and robust sharing of global intelligence on issues of counterfeiting. (And, for that matter – many other things too.)
* And lastly, “We can’t inspect our way out of this problem."
All good things – progressive things -- but, short of a regulatory Marshall Plan, things that will have to rely (at least initially) on personal relationships between senior officials at various regulatory agencies and a focus on what’s best for global public health writ large is convergent with what’s best for any given nation.
It’s not as easy as it sounds.
Beyond the generally difficult nature of international regulatory harmonization (yes friends, it is a lot harder than it looks) is the profoundly difficult issue of domestic economic interests and trade.
For example, every nation (from the United States to Nigeria) is concerned about counterfeit drugs and unsafe food coming across its borders. That’s obvious. But are all nations equally concerned about controlling the export of counterfeit, unsafe, and substandard products to other nations? That’s trade.
Principles aren’t principles, as my father used to say, until they hurt.
Paul Orhii, Director-General of Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), was on the event’s first panel and he shared a chilling story – not of children dying from imported Chinese cough syrup laced with diethylene glycol, but of the Chinese government’s view on where it’s responsibility for quality control begins and ends.
The Chinese, it seems, believe their responsibilities end when a product leaves the borders of the Middle Kingdom.
According to Orhii, when he complained to the SFDA (the Chinese drug regulatory agency) that many of the counterfeit medicines in Nigeria (where, according to the NAFDAC DG, 40% of the drug supply is counterfeit) were coming from China, he was bluntly told that Beijing was not responsible for the quality of medicines in Nigeria – that was his problem.
So much for regulatory fraternity.
And, when it comes to counterfeit medicines there’s the definitional problem – largely driven by (yep) domestic and international trade concerns. You can talk TRIPS all day long, but at the end of the day it’s about money.
If we can’t even agree on the definition of “counterfeit medicines,” how are we ever going to start, methodically and cross-nationally, measuring its size and scope? And while the war of words rages within the Byzantine confines of the WHO, people continue to die and the problem continues to grow.
As a next step, how about a coordinated international effort to measure the infiltration of counterfeit medicines into national drug supplies. After all, if you can’t measure it, then it doesn’t really count.
We cannot continue to combat counterfeit medicines through the power of horrific anecdotes.
“Man is the measure of all things.”
-- Protagoras