France – In its newest survey, the UFC-Que Choisir tackles drug shortages, denouncing the lack of will of laboratories to resolve this large-scale phenomenon and the lack of responsiveness of the public authorities. [1]. It additionally makes proposals to treatment this example (see field). The response from drug producers was not lengthy in coming. The latter replied, by way of Leem, in a virulent and level by level approach to the arguments of the UFC-Que Choisir, qualifying as “disinformation” the remarks made by the affiliation of shoppers [2]. Less focused, GEMME generics reacted rather more reasonably [3].
Will now we have Augmentin injectable this winter?
It shouldn’t be new to say that, nonetheless marginal in the 2000s, the quantity of drug shortages grew strongly at the begin of this decade and has grown in recent times, Medscape It has additionally been echoed on quite a few events. And the well being disaster of this 12 months has not helped. In a post on Facebook, put on-line on August 7, the Health in Danger collective created by an anesthetist-resuscitator from Henin-Beaumont (62) requested: “Drug shortages in France, supply disruption of protective materials, We will have the Augmentin injectable this winter or not guys? But we are just asking, are all countries concerned? Or just France? “. The National Medicines Agency additionally forecasts 2,400 ruptures for 2020, six occasions greater than in 2016, notes the UFC-Que Choisir [1].
For the shoppers’ affiliation, this example is all the extra alarming as the medication declared in scarcity by the laboratories all share a primordial attribute: “they are drugs of major therapeutic interest (MITM)”. Another level in widespread: “the drugs which are the subject of supply tensions are not recent molecules sold at high prices. On the contrary, the robot portrait of a drug in shortage is that of an old product (75% have been marketed for more than 20 years) and sold inexpensively (3/4 cost less than 25 euros, and even 1/4 less than 4 euros) ”.
Industrialists and public authorities in the sights
In this example of rupture, the Union of shoppers points the finger at two culprits. First, the drug producers who “therefore seem to make the choice to secure the supply of profitable drugs, to the detriment of the oldest, yet still essential to users”. Without forgetting that pharmaceutical corporations have chosen to outsource – with the now well-known determine of 80% of the quantity of energetic substances manufactured outdoors the European Union – but in addition that of just-in-time manufacturing which weakens all the pieces the system in the occasion of important fluctuations in demand.
Another participant in the sights of the UFC-Que Choisir, the public authorities, whose options to the phenomenon of shortages are thought of unsuitable – not addressing the origin of the downside – and incomplete. As for the penalties once they apply – solely two in opposition to laboratories in 2019 – they are certified as anecdotal as the quantities are ridiculously low: € 830 and € 5,807 for the circumstances given as examples.
The Lemma rebels
The drug producers have, of course, not failed to react. Through a virulent press launch entitled “Stop disinformation”, the Leem – which brings collectively many of them – denounces him, untruths in the phrases of the UFC-Que Choisir and needed to reply level by level.
Regarding the quantity of stock-outs and shortages, the Lemma would love to level out that “out of the 1,504 reports identified in 2019”, a couple of third could possibly be resolved by “measures to handle conditions of rigidity between the ANSM and firms (quotas, imports from different nations, and many others.) ”.
Regarding their responsibility for its shortages, producers acknowledge it “in part” however don’t need to take the hat alone by evoking a “mutifactorial phenomenon in which corporations bear a responsibility shared with all actors in the chain. of the drug ”.
Regarding the accusation of favoring revolutionary and costly merchandise at the expense of MITMs, Leem argues that “the corporations which manufacture the oldest merchandise are usually not the similar as these which uncover and manufacture the most historic medication. revolutionary ”.
As for the institution of a precept of increase four-month security shares for all MITMs really useful by the UFC-Que Choisir, Leem considers it “unrealistic on an industrial level given the number of specialties concerned and quality standards associated with the management of these stocks ”and firmly concludes:“ it does not respond to the situation ”, preferring to different proposals.
On the aspect of generics grouped inside GEMME, who additionally needed to categorical themselves, the tone is way much less belligerent, see complete [3]. These different drug producers acknowledge, for his or her half, that the downside of stock-outs is understood and say that they “know that they are, and rightly so, a significant supply of concern for sufferers, particularly these affected. of power pathologies ”.
While admitting “that there is a tension on certain products”, the affiliation of generics considers that in the distinctive context of 2020 the place the demand for sure medication “has multiplied by 202 while production has been stopped on certain sites “,” There was no break noted and the industry was able to continue to supply both the city and the hospital “and is happy. She additionally remembers the proposals she made to enhance France’s provide of important medication.
UFC-Que Choisir asks:
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The obligation for laboratories to represent enough shares to meet the wants of customers of the well being system for all medication of main therapeutic curiosity;
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The strengthening, in regulation and in apply, of sanctions in opposition to laboratories negligent of their administration of provide to the French market;
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That, if relocations had been to be undertaken thanks to public funding, these solely concern medication of main therapeutic curiosity (MITM), and primarily the oldest and affected by recurring shortages;
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The improvement of a public manufacturing of medication, in a position to guarantee the steady manufacture of these deserted by the laboratories.
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