Counterfeit drugs pose major threat to pharmaceuticals - EFCG

13 October 2009 22:35  [Source: ICIS news]

MADRID (ICIS news)--The sale of fake drugs has become more profitable than heroin trafficking, and governments globally must enact clear legislation with strong penalties to combat the problem, a board member of the European Fine Chemicals Group (EFCG) said Tuesday.

Speaking at the CPhI Worldwide pharmaceutical exhibition in Madrid, Spain, Guy Villax, EFCG board member and CEO of Portuguese fine chemical firm Hovione, decried the health threat posed by “falsified” active pharmaceutical ingredients (APIs), which he said comprise 20-30% of the API consumed in  Europe.

Weak regulations and a lack of transparency in the pharmaceutical supply chain has allowed APIs manufactured by completely unregulated Chinese fine chemical companies to enter the market, he said.

New legislation now being considered in Europe as well as the US (Drug Safety Bill, S. 882) would be a major improvement, he said. Villax also pointed to Rx-360, the pharmaceutical consortium for reducing supply chain risk, as a particularly promising development.

In most nations, drug counterfeiting is currently not a crime, Villax said. And where it is, the offense is generally treated as a trademark or patent infringement – as it is in most of the EU and Canada, he said.

“In other words, a counterfeit bottle of EPO [epoetin alpha] that is subpotent is not considered a more serious crime than a fake Christian Dior t-shirt,” he explained. “And I think we should be really worried.”

Only France, Germany and the US have legislation treating counterfeit drugs as a serious crime, in terms of the intent to profit from the patient's trust with a high degree of risk to health, he said.

And even then, “none of these laws address the problem of falsified APIs or falsified excipients,” he said.

Regulated companies in China are marketing APIs produced by unregulated ‘shadow factories’ as their own, he said, surmising that such arrangements “probably explain the high percentage of doubtful origin products that we see in medicines in Europe”.

Villax recalled his first trip to the Canton Fair, a large Chinese trade exhibition, in 1984.

“Already in those days, a company called North Long March Pharmaceutical Company in Szechuan already had received a warning letter from the FDA [the US Food and Drug Administration] for doing precisely this, re-labeling,” he said.

“If you check the books, this company seems to be a repeat offender, but it still happily supplies the rest of the world.”

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By: Clay Boswell
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