Pseudogenerics: emerging battleground in the illegal medicines trade

A new front has opened up in the war against illegal medicines, in the form of products which are manufactured and distributed illegally but are not direct copies of brandname drugs.

Prof. Harald Schweim, who is head of the department for drug regulatory affairs at the Institute for Pharmacy, University of Bonn, told the IQPC Global Pharma Authentication conference in Munich, Germany, recently that enforcement agencies are increasingly encountering products that claim to offer the same benefits of brandname medicines, but do not directly infringe pharmaceutical company trademarks.

If customs find these products, they can generally see that the product contains an active pharmaceutical ingredient, but face a challenge to identify whether it is a legal or an illegal import.

In Germany, for example, that investigation requires the customs official to determine whether the importation is in accordance with Paragraph 73 of the country's drug law, i.e. is there valid approval in Germany.

"This is generally not possible for customs officers in situ at the borders," said Schweim. And because no trademarks are being infringed, it is not possible for the original brand's owner to take action.

Some customs officers are using alternative means to interrupt the trade, for example seizing the goods because of invalid customs declarations, as the shipper rarely specifies in the documentation that the contents is a medicinal product.

Perhaps the best example of this sort of product is Kamagra, sold all over Europe via the Internet and through retail channels as a pseudogeneric containing the same active ingredient as Pfizer's brandname erectile dysfunction drug Viagra (sildenafil).

Kamagra is approved and legal in India, and while some EU states such as Germany allows the public to import it in small quantities for personal use, others take a different view. In the UK for example, it is illegal both to sell and advertise Kamagra as it is an unlicensed drug.

That variation in legal interpretation across the EU adds to an already complex scenario facing enforcement agencies.

While Kamagra is licensed in India, Schweim believes that some counterfeiters are starting to sell pseudogeneric products to exploit this confusion and avoid seizure of shipments at the EU's borders.

Other examples of pseudogenerics include the Tadalies - which contains the same ingredient as Eli Lilly's ED treatment Cialis (tadalafil) - and Womengra, which is promoted as Viagra for women.

Meanwhile, Schweim also believes that a related problem lies in the distribution of falsified dietary supplements, herbal remedies and 'nutraceutical' products which are not regulated under European drug law and are not subject to any form of vigilance system.

Citing figures from Cologne customs, Schweim pointed to the increasing number of cases involving food supplements and herbal preparations, which accounted for around 13 per cent of all the counterfeit seizures by the authority.

The Cologne customs data also reveal some other interesting trends, including an increase in cases involving pharmaceutical precursors, a proportionate reduction in finished medicine doses, and more and more life-saving rather than lifestyle medicines.


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