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Refund, substitution… The real false on the new rules for generic drugs


Medication. – pixabay

  • This January 1, 2020, the rules surrounding the dispensing of generic drugs have changed.
  • The new system in force is fueling concerns and questions, some of them particularly dreading the “systematic” dispensing of generic drugs.
  • 20 minutes takes stock of the concrete elements induced by this change.

Patients accustomed to favoring original drugs (or princeps) in the credits may have an unpleasant surprise during their first visit of the year
in pharmacy. Because since
January 1st, the rules for dispensing these brand-name medicines, which until now could have been favored over generics thanks to a simple prescription marked “non-substitutable” (NS),
have hardened considerably.

This change raises as many concerns as more or less exact statements around generic drugs, these cheaper “copies” of already existing drugs whose patents have gone into the public domain (which allows their selling price to be reduced thanks to savings in research costs made by laboratories).

20 minutes sorts the true from the false on this new device.

FAKE OFF

Has generic drug delivery really become “routine” since January 1?

Since 1999, pharmacies can substitute a generic drug for that prescribed on the prescription, “provided that this drug is in the same generic group and that the doctor has not excluded this possibility by affixing the handwritten mention” not substitutable “on the prescription”, as recalled by the Health Insurance website.

However, since January 1, 2020, doctors can only add this mention to a prescription if they specify the medical reason behind their decision, which must comply with the very specific criteria set out in the decree of November 12, 2019.

“Concretely, from now on, the generic offer by pharmacists must be systematic but the patient always has the right to take the reference drug [princeps] if he wishes, “nuances Philippe Besset, president of the Federation of Pharmaceutical Unions of France (FSPF).

“With this change, the issuance of generics is strongly encouraged by the government when there are no non-substitutable drugs according to the criteria now in force, which are very strict,” agrees Gilles Bonnefond, president of the Union of community pharmacist unions (USPO).

Thedoes “non-substitutable” relate to from now on only “some exceptions”?

The decree of November 12, 2019 lists the three “medical situations” allowing doctors to use the term “non-substitutable”: MTE, EFG and CIF. A “very reduced” list, according to Gilles Bonnefond and Philippe Besset.

“The MTE [médicaments à marge thérapeutique étroite] concern little medicine, explains Philippe Besset. This is for example the
Levothyrox or medication to avoid rejection after a transplant. The second case, the EFG, is that of generic drugs that would not have a pediatric form [et seraient donc inadaptés pour un enfant]. You have to imagine an original drug available in syrup form but which, in generic terms, would only be in tablet form. Currently, this scenario does not exist, they necessarily have the same shape. So this is a situation that may exist in the future. “

And to conclude: “The case of CIF is the most complex, it concerns proven allergies to excipients with known effects (EEN), according to a list defined by the health authorities, which we are still in the process of establishing but which concerns very few drugs. “

For its part, the National Health Insurance Fund (Cnam) tells us that “in some cases, for certain drugs considered” narrow therapeutic margin “(whose dosages are very finely adjusted), the pharmacist can deliver the drug princeps , even if this mention is not written on the prescription ”.

Does the refusal of a generic drug prevent him from benefiting from third-party payment?

This is what many Internet users think, relaying an article with the worrying title: “From 2020, if you refuse a generic medicine, you will no longer be entitled to third-party payment”.

Gold, inability to benefit third-party payer in case of refusal of generic drugs is nothing new, since it is in force
since 2012.

“The only difference with the situation in effect before January 1, is that patients who refuse them will now be reimbursed on the basis of the price of the generic: the difference will therefore be at their expense,” said Gilles Bonnefond. Whose union – like the FSPF – does not hide its reluctance towards the provisions that came into force at the start of this year: “Knowing that less than 10% of patients do not take generics in France, we are not not in favor of this measure, which will entail costs for patients and take a long time for pharmacists with a low return for the public authorities. “

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