luni, 8 iulie 2013

A sort of a (failed?) social experiment



It is full of limitations and it has an experimental character, but in my view this is the most interesting part of the new French rules on advertising for pharmaceuticals in France: 

Experimentally and for a period not exceeding two years, information by door-to-door activities or canvassing for the healthcare products mentioned in article L. 5311-1 of the Public health code, with the exception of medicinal products of hospital use and those for which the prescription is initiated in the hospital or not, as well as the products referred to by article L. 5211-1 of the same code, carried out in healthcare institutions may only take place before several healthcare professionals, under conditions defined by an agreement concluded between each healthcare institution and the employer of that person, whose details are defined by a decision of the minister having the health in charge, after the opinion of the High Authority of Health [Haute Autorité de santé, HAS]” (art. 30 of the Law of 29 December 2011) [my imperfect translation from French].

During the Mediator scandal (as it were, as this scandal does not seem to be over yet) the so-called „medical visits” (visite médicales), the equivalent of the American pharmaceutical „detailing visits”, were incriminated in France as promoting the off-label use of the unfortunate drug product and vociferously criticized. Some of the most vocal critics even proposed that such “medical visits” should be altogether prohibited. In a country capable to engender the French revolution with both its bloody madness and progressive ideals, and (probably) still the most statist European nation, I would not have been surprised to see such a rule coming to life there. I must confess that I am still dreaming to see such a complete prohibition on the main pharmaceutical promotional practice, as this would change this market from a rather ethically dubious one (I am speaking based mainly on the realities I see around in my country), to something similar to the sport competitions where doping is prohibited for all. (Of course, in theory doping is also prohibited on the pharma market - there are codes of ethics, self-regulation, strict compliance policies within companies etc, but in practice things are still far from being perfect; I know a compliance director who preferred to resign rather than continue on that position in one of the biggest pharmaceuticals multinationals). But my pleasure of seeing implemented such an embargo on medical visits has not been satisfied. What the French authorities managed to approve – among more compulsory transparency measures defining what has been termed a “sunshine act à la française - was the above rule, with its experimental character and its limited field of application (only a rather narrow class of medicines were affected by this provision, but its horizon was to be extended in the near or middle future). 

Before January 2013, the government had to present to the Parliament a report on this social experiment, based on an assessment to be conducted by HAS (with the intention of extending it). But the Constitutional Council of France stroke an article of the bill of law on financing the healthcare assurance organizing the collective medical visit (collective detailing) on a permanent basis, as being contrary to the constitution (essentially the rationale was that the placing this article in such a law was rather unjustified, being only very indirectly related to the remit of the act). It seems that no official report has been made available to the public on the outcomes of this experiment, which is rather regrettable. The companies were preparing themselves for a change in their promotional strategies, while some commentators rushed to suggest that the medical rep profession was on the verge of its death (it seems that between 2004 and 2011 the number of reps has diminished with about 25% in France[1]), when it rather vanished in thin air. It seems that currently the concept has been abandoned (a pity!), although it might still float in a kind of political limbo.




[1] Eurostaf. L’avenir de la visite médicale : vers une disparition de la profession. Eurostaf – Communiqué de presse, Septembre 2012.

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