The EU’s industry commissioner says trade in counterfeit medicines in the Union has exceeded its worst fears, according to German daily Die Welt. “The number of counterfeit medicines arriving in Europe … is constantly growing. The European Commission is extremely worried,” the commissioner, Gunter Verheugen, said yesterday. 34 million tablets have been seized in 2 months from various custom points, he said.
Verheugen did not name names. But an AFP report based on Verheugen’s interview to the German daily pointed out that a July EU report had identified India as a large source of many of the fake pharmaceuticals seized in 2008.
That is embarassing, even shocking. If it is true.
But the EU’s definition of counterfeit is elastic. It stretches to include generics of products currently under patent protection in the EU – even if they are in transit to other countries. It is this expansive definition that has led to seizures of Indian drug shipments at EU custom points, and the tarring of India a as a significant source of counterfeits, says D G Shah, secretary-general of the Indian Pharmaceutical Alliance. In recent months, tens of drug shipments from well-known Indian companies such as Dr Reddy’s, Macleods, and Cipla that were merely passing through EU ports on their way to countries in Latin America have been seized, in response to complaints from patent-holding companies such as Sanofi-Aventis, and Novartis. These drugs were however not under patent in the buyer countries.
Given that India is a huge exporter of generic drugs to those countries, and that transit via Europe is a preferred route, then is it any surprise that India is such a large source of ‘counterfeits’?
New Delhi has so far been ineffective in preventing these seizures. It has belatedly reacted by taking the EU to dispute settlement in the WTO. But that’s clearly the beginning rather than the end of the issue as Verheugen’s latest interview – probably intended to keep the issue alive – indicates.
Apothecurry 
But according to the EU’s customs report (for 2008), only 6% of seizures were for patent-infringement.
So the vast majority are fakes, and over half the total came from India.
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I just double-checked in response to your comment. First of all, I think it would be rather hasty to conclude from the EU report that whatever was seized was in fact either patent-infringeing or trademark-infringeing. I quote from the report, “More than 93% of all articles were intercepted on the suspicion of a trademark infringement (itals mine) and 6% on the suspicion of a patent infringement.” Suspicion does not mean proof.
I also believe that there is something inherently wrong in talking about ‘counterfeits’, ‘pirated’, ‘trademark-infringeing’ and ‘fakes’ all in one breath using patient safety as the context. They mean different things and should be treated as such.
I also would like to clarify that by no means am I suggesting that there are no fake drug manufacturers in India. I just don’t think the current allegations are based on clear, and transparent information exchange between India and the EU. At least not as yet. To the best of my knowledge, the Indian government still does not have a complete list of all the seizures mentioned in the 2008 EU report and why they were detained. Perhaps that would be a good place to start.
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Hi Gauri, thanks for your thoughtful response.
We can start with a point of agreement – the EU’s report could be clearer with regards to some of the details of seizures, and this debate would be considerably aided by authorities (in Europe and India) being more open with information. The Indian government’s recent claims about low levels of ‘spurious’ drugs, which they leaked to the press but without supporting data being made available, are another example of unhelpful, biased obfuscation.
However, from what we know it does seem like the vast majority of seized drugs in the EU are not intercepted for patent-infringement. Cited cases this year total “tens”, while we know that millions of pills were seized in 2008 for reasons other than patent-infringement.
I completely agree that we should be clear with terminology, and it would be nice if the EU distinguished between patent-infringement and TM-infringement; but from what we can tell it is not true that patent-infringement rules are significantly increasing the figures on the proportion of Indian counterfeits, so we should not jump to this conclusion.
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Julian, your point on the Indian government’s leaking of data selectively is very valid. A good number of Indian bureaucrats need lessons in transparency – not just in the matter of drugs, but a lot of other issues as well. This is something that the blog has pointed out in a different context and I am glad you have brought it up here.
However, on the matter of India as a source of counterfeits I am going to reserve judgement on whether it is or isn’t until I see the data.
On another note, thanks for sharing your very relevant views and information on this blog!
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