PARIS, Jan 30 (APM) - France's health minister has said substitution in favour of a biosimilar would only be possible for patients who have a pharmaceutical file (DP).
Marisol Touraine spoke on Thursday to open a debate at the National Assembly by the parliamentary office for the evaluation of scientific and technical choices (OPECST) on the theme of biosimilars.
The social security funding law (LFSS) for 2014 includes, essentially in Article 47, two measures relating to biosimilars.
On the one hand, France’s drugs regulator ANSM is due to set up a reference list specifying, where necessary, the reference biological drugs and the biosimilars that can be substituted in place of the former.
On the other, the pharmacist can substitute a biosimilar in place of a reference biological drug but only on treatment initiation and provided the prescriber does not object, and where the latter and the patient are aware of these facts and provided the drug actually dispensed is recorded on the prescription.
Article 47 requires the publication of an application decree. Touraine said the text was in the “last stage of consultation” and promised it would be published “shortly”. She added that other regulatory measures might be passed later, covering both public health and economic aspects.
She pointed out that a working group on issues relating to the application of Article 47 had been formed within the framework of the health and medical technology industry strategic industry committee (CSF), although she did not mention the fact of the suspension of this work for several months owing to the absence of the pharma executives.
The minister reported that the pharma executives spoke in favour of an obligation for patients to have a DP and for the pharmacist and doctor involved to (have) access to information on the biologicals covering the whole treatment period (access is currently four months only).
She excluded the possibility of making the DP compulsory, particularly in light of the position on this point of the board that enforces data protection legislation (CNIL), although she said dispensing a biosimilar within the framework of substitution on treatment initiation could be conditional on having a DP.
She supported a request for access, within the DP, to patient information relating to the entire treatment duration, to make sure the same biosimilar will consistently be dispensed to the patient.
Responding to a request expressed during an opening address by the chair of the National Assembly social affairs commission, Catherine Lemorton (Socialist Party, Haute-Garonne), she acknowledged that dispensing a biosimilar should be effected “in the confidence of all the health professionals involved in caring for the patient”.
Touraine also expressed her desire to strongly encourage “prescribers, and particularly hospital prescribers” to select biosimilars in their prescriptions.
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