Updated: June 11, 2012 (Initial publication: June 4, 2012)

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The European Medicine Agency (Agence européenne du Médicament - EMA) offers since May 31, 2012 a website identifying side effects of drugs allowed on European Union markets, data provided by national regulatory authority and pharmaceutical laboratories.

The European Medicine Agency (Agence européenne du Médicament - EMA) launched on May 31, 2012 a database, available on an Internet site, indicating "suspicious side effects" of drugs allowed on European Union markets. The information comes both of the different authorities of national regulation of drugs and pharmaceutical companies who spontaneously reported these side effects.

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The European Medicine Agency announced Thursday the launch of a website for information on the side effects of the medicine which is placed on European Union markets, for reasons of more "transparency" on the general public.

The idea is that the regulation involves initially the ex-ante of the administrative authorization (national authorisation to be placed on the market as a medicinal product), and then a second time, in a way permanent, by the consumer drug information which, although established on the market, must be used with caution, even with caution.

Such an approach, implemented here, can surprise because it avoid the need of the intermediation of the prescribing doctors and pharmacist, professionals informed and informants, whose function is precisely to warn the consumer of drugs of the side effects of the drugs on the market. If the European Medicines Agency yet chooses to offer directly to the public a database on "suspicious" side effects, that is to say that there are prima facie toxic (although secondary, which justified therefore the authorisation and placing on the market, the mere fact of a drug intersaction), is that on the one hand the European institutions, even in the form of an agency still takes as its model the desintermediated market, where professionals (doctors, pharmacists) are weight.

More pragmatically, self-medication, and its particular dimension that is the mixture by the consumer of prescription drugs in isolation by professionals, justifies that is directly informs the consumer of the side effects. Drug interaction in self-medication to support this type of initiative and the self-medication is a behaviour that is easily associated with the use of the Internet, which justifies the creation of a website as a mode of intervention.

For the moment, referred drugs are those placed on the market on the whole territory of the European Union but later the base will make available information on drugs on exclusively national European Union markets. Moreover, the interest of this initiative is that, contrary to other sectors in which the European Agency is a concentrate of the public authorities, it draws its information on the one hand from the information collected by the national health authorities on the negative side effects of drugs. We are in an assumption of coregulation.


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