Until the Region sanctions the doctor, the caps on expensive drugs are wise and do not compromise prescriptive freedom. Thus the Council of State (judgment 687 of February 11, section III, on the Legal Corner website) rejects Merck Serono's appeal against the 2013 guideline act of the Tuscany Region which aims to limit the prescriptions of biotech drugs. Stone of the scandal is the resolution which, after one hundred prescriptions for growth hormone-based drugs, requires that at least half be for biosimilar drugs and not for branded specialties.
For the administrative judges of appeal, the provision sets a general quantitative objective and gives the doctor the possibility of prescribing a different drug. Furthermore, although "aimed at making the most appropriate use of resources for the same therapeutic result in compliance with state and regional legislation" (i.e. with the criteria dictated by the Medicines Agency and the specific Position paper of 2013), "it does not establish therapeutic equivalence, thus referring to the authorized sources and to the final evaluation of the doctor with reference to the specific cases".
"It is correct that a Region binds doctors to prescribing appropriateness and we family doctors know something about it", comments the Tuscan Sapphi Giustini responsible for the Pharmaceutical Area of the Society of General Medicine Simg. «On the subject of biosimilars, however, it must also be said that the distinction between the use of new molecules and "biological replicas" is linked only to specialist prescriptions. Specialists are now called to respect constraints that GPs are already familiar with.
This has positive and negative consequences; in fact, we GPs for chronic conditions in the area - hypertension, diabetes - now almost only use non-branded drugs and all the appropriateness that was required of us in the past is a bit "out of fashion". Now two thousand colleagues will be co-opted in writing treatment plans like specialists, thanks to the Medicines Agency, but it is a family doctor every twenty, too few.
In reality, the impact of new drugs needs a wider audience, and the family doctor should regain a say in the experimentation and prescription of new molecules».
Mauro Miserendino – Friday, 13 March 2015 – Doctor33
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201410634 | 3 | MERCK-SERONO SPA | CC | 11/02/2015 | 201500687 | 11/02/2015 | CAUTION ORDER | PALANZA ALESSANDRO | LIGNANI PIER GIORGIO | REJECTS |