Showing posts with label NAFDAC. Show all posts
Showing posts with label NAFDAC. Show all posts

Monday, 15 March 2010

Africa Needs Anti-Counterfeiting Laws, However Imperfect

The vested interests and one-sided reporting that I mentioned in my last post are muddying the waters as various East African countries try to draft laws to control the rampant counterfeiting that blights the lives of their people.  The Ugandan attempts at law-making in this area have today been branded as "threatening access to medicines", for example. The fact that the Ugandan lawyers' efforts are supported by some EU funding is given as evidence of dark commercial motives.

The issues in counterfeiting are not simple, and there are huge grey areas. The provision of good quality drugs at a price that the average African can afford is an objective that we should all share.  The first problem comes when those drugs are unauthorised copies of patented medicines developed by another entity. The justification propagated by some generic producers who specialise in supplying Africa is that they are merely trying to help the poor people by providing these drugs. No they're not. They are spotting a way to make excellent profit from someone else's R&D investment by selling cheaper copies without a licence.

The second problem is that "access to medicines" is used as a cover for those who wish to keep open some of the very useful informal distribution channels that allow them to rack up even better profits by mixing in fake drugs with "genuine" (in the sense of containing at least some active ingredient) consignments.

I am not an apologist for the pharmaceutical industry or the EU. I don't deny that western nations and international drug companies could and should do more to equalize access to health around the globe. However, I have travelled in East Africa and spoken to some of the desperate government officials trying to stem the tide of shoddy fake products (from inadequate malaria pills to ineffective brake pads) that kill their citizens every day. We should provide them with every assistance in their task.  It is far easier to err on the side of strict legislation and then ease restrictions where necessary than to try to tighten up soft laws post-hoc.

Friday, 26 February 2010

Le Plus Ca Change...

...Le plus c'est la meme chose.  Today is the last day of the Florida anti-counterfeiting conference.  It has been well organised and attended by a good mix of interesting and senior people with a lot to say about counterfeit medicines. There have been new developments in tactical approaches to anti-counterfeiting which will make a difference in the detection of fake drugs. But, strategically-speaking, I feel as if I've seen this deja vu somewhere before.  In recent years things have not moved on at the pace that the increasing risk to patient safety warrants.

There are some noble exceptions.  Nigeria, for example, is doing great work.  Dr Paul Orhii, Director General of their drug regulator NAFDAC , gave a good insight into how his country is tackling the counterfeit threat using hand-held devices to differentiate real from fake drugs in the field.

The real quantum leap in approach will only come when a global, or at least multi-regional, approach is decided upon, authorised, funded and rolled out.  At the moment we are still in the realm of individual, relatively small pilot studies which show the potential of Technology X in a controlled environment.  We need to take a deep breath and implement a drug verification system on a wide scale, exposing it to the real world threats of criminal attack and realising that it may not be perfect first time.  Only by road-testing and refining such systems can we start to make a real difference.  The current drug traceability projects, though laudable, are the equivalent of learning to drive on a private road.  We know how to work the car, but we need to get used to traffic on the highway before we can go very far.