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Cases of drug shortage have become more and more frequent over the past decade. FRANCK FIFE / AFP

The France Parkinson association, which helps patients with this chronic neurological disease, Monday alerted the government on the stockouts of a drug, the Sinemet, used by 45,000 patients in France. This shortage could last until March and it could also affect generics of substitution.

The France Parkinson association, whose mission is to promote research and support daily patients suffering from this chronic neurological disease, launched Monday a petition addressed to the French government to warn about the shortage of major drugs in this area. pathology.

The American MSD laboratory (Merck, Sharp and Dohme) announced at the end of August a prolonged stock-outs of certain dosages of Sinemet, a tablet used by 45,000 patients (out of 200,000) with Parkinson's in France, whose first marketing date back to 1967. The stock-out is expected until next March, due to the closure of the US plant producing this drug for compliance, a total of seven months of uncertainty for patients.

According to the National Agency for the Safety of Medicines (ANSM), which publishes on its website a document for patients, it is " the longest break that we have had for Parkinson's ". " We are alerting the public authorities to the acute risk of these disruptions to the health of people already severely affected by the disease. We ask that these unacceptable situations stop , "writes the association France Parkinson in his petition. ANSM has proposed alternatives on 19 September, but generic replacement drugs require dose adjustments and they can induce imbalances in patients accustomed to Sinemet.

Risks also on generics

" We were only told that some doses of the Sinemet were broken at the end of August and the Sinemet is currently out of stock, " confirms the spokesperson of the France Parkinson association, Florence Delamoye. " The ANSM ," she continues, " has in fact immediately warned the professionals and has directed them to either the generic that exists or to another specialty. But the problem , she notes, is that this situation creates a domino effect : the generic drug - which is not dimensioned in terms of production - is also found in tension, even in rupture .

Florence Delamoye said the ANSM has announced a resupply it qualifies as " unexpected " for the next few weeks, but it will by no means be sufficient to hold until March, date announced for a return to normal production of Sinemet. " This March date is the last straw that broke the camel's back ! She admits. " I find it incredible that on pathologies as important and serious, we are affected by these phenomena of out of stock and over such long periods ! ".

Beyond the Sinemet, shortages of drugs and vaccines are recurrent in France, as noted in a Senate report from 2 October. Among some 30 proposals, the authors of this report recommend creating a public program for the production and distribution of essential medicines and grouping vaccine purchases at European level. With regard to the industrialists, it proposes on the one hand financial aid for the pharmaceutical companies which would undertake to manufacture in France certain active substances considered essential; and on the other hand, the publication of sanctions for failures in the implementation of their shortage management plans.

Ten times more shortages in ten years

" We have asked and obtained an appointment with the director of the ANSM during November, but for now, the Ministry of Health has not yet proposed a date, " said for her part the spokesperson of France Parkinson. We hope, however, that the Senate report is the gateway to action at national and European level because France is not the only country affected, "she adds.

Even if it specifies that it is not for the moment in the objectives of France Parkinson, Florence Delamoye does not exclude to organize in the future a collective action on the legal field to make things progress, recourse which could be Join other health associations because Parkinson's is far from the only one facing this type of shortage.

The Senate report has identified 530 drug shortages in France in 2017, ten times more than ten years ago. " We are part of a collective called France Assos Health in which we share information and sharing also political. It's a place of possible dialogue, "she concludes.

(With AFP)