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arznei-telegramm 2013; 44: 54

 


Sanofi - Fined for disinformation campaign against clopidogrel generics: It can be assumed that, in principle, generics are accepted nowadays as an established sector of the pharmaceutical industry's range of products. However, when a patent expires, the makers of the original product occasionally find it difficult to come to terms with the jostling of the competition. And then they can quite possibly try to put stones in the path of their competitors with dubious tricks. The French Competition Authority (Autorité de la concurrence) has just imposed a fine on Sanofi of €40.6 million. In 2008, the company tried to make use of its dominant market position to thwart the marketing of generic versions of their strong-selling thrombocyte aggregation inhibitor PLAVIX (clopidogrel). Thus, Sanofi led doctors and pharmacists to believe that substitution of the original drug with a generic from another supplier implied a liability risk (Scrip, May 24, 2013: 18). Sanofi and their co-marketer Bristol-Myers Squibb (ISCOVER) have systematically spread disinformation in Germany, too; for example with widespread dissemination of letters to doctors and pharmacists, in which the legitimacy of the authorisation of the generics was brought into doubt. The efficacy and safety of the products were called into question for instance because these use a different salt of clopidogrel. Under pharmaceutical legislation, however, several different salts are regarded to be "one and the same active substance", unless their properties, according to scientific data, differ widely in terms of safety and efficacy, which in the case of clopidogrel does not apply (a-t 2008; 39: 91-2). In newsletters, opinion leaders actually advised "strongly" against substitution with "the medication clopidogrel besilate" (what they meant by this were the generics from Hexal and ratiopharm) (MÜNZEL, T.: Letter to doctors dated December 11, 2008). Disinformation spread by companies has a frighteningly long half-life. Consequently, years after patent expiry, the substitution of clopidogrel preparations is still being called into question (a-t 2012; 43: 30). And also, the senseless claim resurfaces again and again, that the bioavailability of the generic as against the original preparation can differ, in general, as much as 45% (a-t 2013; 44: 44-5). In comparison with the fines levied in the USA, which can reach billion dollar figures (a-t 2010; 41: 116), the amount of €40.6 million in France seems very low. But this figure is at least a signal to, at long last, act against such questionable marketing strategies, -Red.



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