The European debate about combating counterfeit medicines is generating a lot of heat in Brussels as it comes to a head. In March the European Parliament is starting to tackle the detail of the European Commission’s proposal to stop falsified products getting into the legal supply chain – about the same time as officials from the EU member countries are nearing some sort of view on the technicalities.
It’s no surprise that things are getting hot. The complex debate cuts across many distinct vested interests. Manufacturers of the brands that suffer most from counterfeiting are backing expensive validation devices and systems to protect their products. Pharmacists are arguing for a large slice of the action if they are to become the final gatekeepers in validation systems. Wholesalers are pointing out that traceability could be necessary all along the supply chain if it is to be really effective – and they do not want to left to bear the costs of that. Generic manufacturers are trying to avoid getting sucked into any expensive system. And parallel importers are warning that the branded manufacturers are exaggerating the risks and are imposing complex and costly solutions as a way of squeezing parallel trade out of Europe.
Now that the discussion is focusing on specific controls rather than broad generalizations about what a bad thing counterfeiting is, each interest group is becoming more energetic in defending its own corner.
One of the most imaginative approaches to the current wave of political lobbying going on in Brussels is an advertising campaign featuring a picture of the Mona Lisa. In the must-read media for the EU’s political class – such as EUObserver or European Voice - the famous face appears in two different frames, side-by-side, one of silver gilt, the other of wood.
“Nice picture. New frame. No problem”, reads the headline.
The text then goes on to assert: “A Da Vinci in a different frame vibrates with the same artistry. Yet some people claim that the identical products in different boxes are not the same. Don’t believe them. Parallel trade in pharmaceuticals is subject to the same regulatory environment and continues to serve as a significant lever for cost reduction”.
The advertisement has been placed by the German Association of Parallel Pharmaceutical Distrributors, VAD. It’s a neat riposte to similar visual campaigns run by brandname manufacturers, featuring parachutes, the brakes on high-speed trains and aqualungs, and stressing the need for pack integrity.
But it doesn’t quite convince. Like all metaphors, this one works only up to a point. The essence of a picture is its surface. If you can see that, you can see all you need to see. Not quite the same as a medicine. A different pack can conceal a quite different product. And even if you can see the product through the pack, it’s essence is not what can be seen, but what the product does.
So with no disrespect to Da Vinci (whose pictures are far more attractive than aqualungs or disc brakes), this campaign misses the target by a mile.
validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes
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