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.

Avoiding a Pharmaceutical "Scramble for Africa"

The Indian government is to embark on another generic drugs sales drive in Africa.  The main objective of the aggressive campaign is to persuade African countries not to introduce laws under which (as the Indians see it) some generic drugs will be treated as counterfeit drugs.

Anyone who has travelled widely in Africa will recognise the desperate need for affordable, high quality medicines.  The Indian pharmaceutical industry, with its low cost base and rising quality levels, is well placed to fill that need with good quality, off-patent drugs.  They already have a strong grip on the African pharmaceutical trade, especially in Anglophone countries. China is also waking up to the potential of Africa as an export market for pharmaceuticals.

The problem is that India and China are also major sources of fake medicines.  The European Commission has compiled data from customs seizures, previously reported in the Financial Times, that show India to be the market leader in terms of their share of counterfeit drugs seized in the EU, but I suspect that China is not far behind. The worst fake drugs are shoddy, sub-standard products.  Often made from inert building materials, they may contain toxic impurities and little or no active ingredient.

The grey area is drugs which are copies of someone else's intellectual property.  They may be reasonable quality but are not authorised and therefore could be classed as counterfeit. Africa needs good, cheap medicines but not at any price.  The legitimate Indian generic industry is too often a cover for unscrupulous operators to make quick profits from useless fakes.

The better way forward is for generics to mean just that.  The term should apply to patent-expired products, and makers of generic products should not try to copy the brand attributes (appearance, logo etc) of the original. For their part, multinational drug companies need to do much more to speed up access to their medicines in developing countries.  It is starting to happen but we need more effort.

The great need for medicines means there is room for many pharmaceutical producers in Africa.  However, unless we are careful then the African people will be exploited again in another "land-grab" as competing interests vie to harvest the commercial potential as cheaply as possible.

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.

Fake Drugs in Africa - A Local Perspective

For an African perspective on the fake drug problem, see a very interesting and professional video called "If Symptoms Persist" at http://www.mpedigree.org/home/symptoms.php. This isn't brand new but provides a great local viewpoint (especially the first two-thirds of the 30 minute show) on the counterfeit problem in Ghana and its impact on issues such as malaria and public health. In my experience, the concerns, attitudes and priorities expressed are true of all African states. China is highlighted as the main source of the fake goods.

We need to address the counterfeiting problem now where it hits home hardest (in Africa, Latin America, Southeast Asia) and at its main sources (in China and elsewhere) or it will spread like a virus. Like a new infectious disease, fake drugs have the potential to kill millions unless we take quick action. 

Fake Drugs, Real Lives

Fake drugs have never been so prevalent, but we rarely hear about the true cost in lost and damaged lives. The news media usually fits fake drug stories into other pigeonholes: sex and health for erectile dysfunction drugs, foreign trade for counterfeits from India or China. When we get a personal angle to these stories it is usually from the white world.

The true cost of fake drugs is measured not by bedroom disappointment or boardroom dollars but by lives unlived. These tragedies are occurring mostly in Africa, Asia, and Latin America, away from the Western media spotlight.

Malaria is a mostly-curable disease that disproportionately afflicts the young. Effective drugs exist but are widely counterfeited. How many children in developing countries die needlessly of malaria because the drugs that should save them are fake? No-one knows, but my bet is that if it was American kids that were dying then we would know more about it and something would have been done about it by now.

It's time for a global initiative to stamp out fake drugs. Yes, I know that various pilot programs are under way and data standards are under discussion and the supply chain is complex and blah blah blah. This problem is solvable. We should do it now.

Photo: ephotography from Flickr