On August 15 I had an op-ed in the Baltimore Sun on the growing dangers of counterfeit drugs (“Pharmaceutical Fakery is Health Care Terrorism”). I pointed out that one of the weakest links in the chain is the European practice of parallel trade.
I believed it then. I believe it now. Here’s a link to my original article:
But I clearly ruffled some feathers Over There. Richard Freudenberg, the Secretary General of the British Association of European Pharmaceutical Distributors, dashed off a very defensive letter that appeared in The Sun on August 25.
(Here’s a link to the letter: http://www.baltimoresun.com/news/opinion/letters/bal-ed.le.25aaug25,0,2130712.story?coll=bal-oped-headlines.)
Among other things, he rants that my “allegations are, at best, unfounded, at worst blatently false.”
But not only does he think I am completely wrong, he proposes that he is completely right. He continues, “In fact, to date, there has not been a single case of counterfeit drugs in Europe which have entered the legitimate supply chain via parallel trade.”
To rebut Mr. Freudenberg, I asked Graham Satchwell, one of the world’s undisputed experts on counterfeit prescription medicines, to address the issue. Here is what Mr. Satchwell had to say — unexpurgated — and he pulls no punches.
RESPONSE BY GRAHAM SATCHWELL TO RICHARD FREUDENBERG:
Over two years ago I published a book on counterfeit medicines and organized crime. Since that time the matter has gained greater attention and one could reasonably believe that the Pharmaceutical Industry, the middle-men and the American public were becoming more aware — as indeed they must if they are to be adequately protected. It was heartening for instance to see the British regulatory authority, the FDA and World Health Organisation and others beef up there anti-counterfeiting efforts.
As part of the global campaign to raise awareness Mr. Peter Pitts wrote an article published in the Baltimore Sun on August 15 (“Pharmaceutical Fakery is Health Care Terrorism”).
So much to the good.
How disappointing then that the leader of the British Association of European Pharmaceutical Distributors has apparently had his head up his harness for the last two years.
In his response to the cautionary article by Peter Pitts, Richard Freudenburg commented, “Peter Pitts incorrectly links the worrisome issue of counterfeit medicines with the perfectly safe and legal practice of parallel distribution of medicines in Europe.”
Mr. F is of course wrong to glue the words perfectly safe to legal in the way he does, for they are certainly not inseparable. After all, prostitution, pot-holing, drunkenness, bungee jumping, and suicide are amongst the many types of behavior that are often legal but dangerous they also certainly are — similarly parallel trade in medicine — legal but not always safe.
Mr. F goes on to contend that, “parallel distributors source and sell products exclusively from EU countries and therefore do not facilitate the entry of products from non-EU countries such as Russia.” If only Mr. Fraudenberg could guarantee that that were always the case. However, if were to do so he would he would be naive, stupid or dishonest.
It seems to be a matter of overwhelming logic that in any given population you will have those who comply with the rules and who usually behave ethically and those who will break the rules because of perceived self interest or negligence. Were it not so then our planet would surely witness a race, tribe or occupation where crime and punishment were unknown.
Nevertheless, unprepared to leave his criticism there, Mr. F continues, and it seemed to me by this stage of reading Mr. F’s critique that he was developing a style, for he again links to distinct notions as if one, “Associating counterfeiting with Europe’s parallel distributors, who have operated successfully and safely for decades, is unjustified and irresponsible.”
“Successfully and safely?” The former means that they have made a lot of money, the latter is provably untrue for there have indeed been occasions on which counterfeit medicines have been found in the distribution chain and in the hands, or from the hands of those holding parallel traders licenses.
Perhaps Mr. F is unaware? Perhaps he shouldn’t be. Perhaps he should do a little research. Perhaps he would do a greater public service to the American public if he were to highlight the extreme weaknesses in the systems within Europe for the movement of pharmaceutical products and the dangers — real and potential — which that threat poses. But hang on, who does he represent? Well he is paid to represent the interests of those very European traders who benefit from parallel trade — strange coincidence you might think.
Mr. F’s slip is really showing when he offers the following, ‘In fact, to date there has not been a single case of counterfeit drugs in Europe which have entered the legitimate supply chain via parallel trade.” How very wrong you are Mr. F, please do some research.
Of course it might be that in Mr. F is only talking about the performance of his membership, which comprises, across Europe, only about 70 companies. Let me remind Mr.F. lest it slipped his memory, there are literally thousands of parallel traders licenses in existence in Europe.
The erstwhile Mr. F assures us “member companies across the EU, adherence to strict Good Distribution Practice guidelines is mandatory.” Yes Mr. F, like speeding restrictions on our roads, politicians declaring all their expenses properly, and little boys washing behind their ears.
Mr. F assures us all, “The idea that the EU’s latest enlargement round has compromised the safety of the European pharmaceutical supply chain also belies reality.” At this stage one might wonder about whose reality we are discussing here, Mr.F’s or the rest of the civilized world? For anyone with any doubt about the increased risk of all sorts of criminality which faces Western Europe from the newest members of the Union, please (a) do a Google search on such criteria as fraud+Eastern Europe, or (b) read what the EU officials or WHO or Interpol have said on the subject, or (c) read the rather detailed report of Dr. Jonathan Harper, or (d) simply ask any reasonably informed law officer.
There can be little doubt that few parallel traders would want to deal in counterfeit medicines, but as Mr. F knows, or should, it is the very act of removing original packaging with anti-counterfeiting features and repackaging those goods in translated items before shuffling them from country to country and dealer to dealer that affords the opportunity for the unscrupulous few to do real harm.
Two years ago I took the opportunity to publicly debate some of these issues, yet Mr. F. seems unaware of the evidence that so clearly undermines his position, surely he cannot have forgotten? If he has, then let me invite Mr. F to publicly debate these issues with me at any venue of his choice. This is a real and specific opportunity for Mr. F to set the record straight and once again here some hard facts.
Want to do it Mr.F?
There was a time when there were many voices in Europe and the USA echoing the sentiments of the bold Mr. F. Most have been embarrassed into silence, it is time for Mr. F to stop insulting the intelligence of consumers.
If any US reader wants to know more about the real situation in Europe then visit my website (PocoSolutions.com) go to articles and see the full text of A Sick Business and other articles.
Thank you, Graham. Well said.
Ringside seats for this debate between Mr. F and Mr. S (when scheduled) will be available at www.drugwonks.com.