Return to the past on the prescription for active ingredients introduced by the spending review. And a crackdown on substitutability in pharmacies. From the package of amendments to the Balduzzi decree finalized on Saturday by the health councilors, two proposals emerge that could please doctors. The document of the Regions, in fact, asks for a new article of four paragraphs (numbered 14bis) to be inserted in the decree which in fact makes a clean sweep of the innovations introduced only a month ago by the law on the spending review on the prescription of equivalents. With the amendment, in essence, the doctor should go back to writing the drug in full, with the trade name (in the case of branded) or that of the manufacturing company (in the case of pure generic).
But the amendment of the Regions seems to meet the wishes of the prescribers also with regard to substitutability. In fact, the article reconfirms the obligation for the pharmacist to offer the patient the cheapest product in the event that the prescription indicates a drug with a price higher than the reimbursement price; however, when there are no price differences, the medicine to be dispensed can only be the one chosen by the doctor and any "improper substitution by the pharmacist entails the official charge of the medicine delivered".
September 4, 2012 – DoctorNews
Drug regulations: thumbs down from Big Pharma
Big Pharma against the Balduzzi decree. After Farmindustria's protests against the rule that provides for the indication of the active ingredient in the recipe and the one on the revision of the pharmaceutical handbook and of the law 648 contained in the mini-health reform of the Ministry, pharmaceutical companies join the chorus of nos. "While we are talking about measures for growth, those who invest in this sector can only draw a great signal of uncertainty, if not a clear invitation to get out of it or to reduce one's industrial presence". The criticism is advanced by Luc Debruyne, General manager of the multinational GlaxoSmithKline, who adds: «The one under study is a measure that penalizes the pharmaceutical sector, on which the 40% of the reduction of the National Health Fund already weighs. Despite the willingness shown, it is strange that our sector is not involved in the discussion given that the measures for growth and sustainability require collegial analysis and conception which can hardly be the result of the study, albeit rigorous, of a single social part". «The unshared revision of the Pharmaceutical Handbook and of law 648 put thousands of jobs in the sector at risk and create dangerous premises for a serious deregulation in the prescribing and dispensing of medicines. With this decree, Europe distances itself and any possibility of growth for the country and the fight against unemployment is nullified» is the comment by Maurizio de Cicco, managing director of Roche. «It is very serious to think of reviewing them unilaterally and without any comparison
