“The unshared revision of the Pharmaceutical Handbook and of law 648 put thousands of jobs in the sector at risk and create dangerous conditions for a serious deregulation of prescriptions and in the dispensing of drugs. With this decree, Europe distances itself and nullifies any possibility of growth of the country and the fight against unemployment”. This is the comment by Maurizio De Cicco, managing director of Roche, vice president of Farmindustria and Chairman of the GEF (European Farmindustria Group), a group that brings together 39 pharmaceutical companies with European capital operating in the Italian market, to the Balduzzi decree, which provides, among other things, for an extraordinary revision of the national pharmaceutical handbook, to exclude from reimbursement drugs no more than interest for the National Health Service, and new rules for the dispensing of off-label drugs. “It is very serious to think of unilaterally reviewing the lists of drugs available to Italian patients only on the basis of economic considerations and without taking into account the prescriptive appropriateness”, explains De Cicco. “If the problem is that the prices of some drugs, already agreed and approved by the Italian Medicines Agency, are judged too onerous, it is within the competence of AIFA to proceed with a renegotiation ".
“If, on the other hand – he continues – we want to radically revise the Handbook, it is necessary to urgently convene a working table to define transparent and shared criteria. Without concertation, the only result that will be achieved will be to deprive doctors and patients of drugs approved by health authorities on the basis of rigorous national and international registration protocols". In addition to concerns for the development of the country, "there are also strong concerns for the risk of a prescriptive deregulation and the dispensing of drugs“. In fact, the draft decree provides for the revision of law 648 on off-label, which regulates the use of drugs off indication, paving the way for the possibility of using medicines for non-approved indications “without side effects or adverse reactions having been studied – explains De Cicco – even in cases in which a drug was already authorized for those indications, but whose price was deemed excessively burdensome for the NHS. Italian patients could therefore be prescribed for mere economic reasons drugs who have not followed the rigorous process of clinical studies necessary for the validation of a drug".
Another point discussed in the provision is that of the so-called "unpackaging" of the drugs, “which would be necessary to administer them for off-label pathologies and which would jeopardize the integrity and safety of the dispensing, exposing patients to potential risks. This procedure would no longer allow companies to hold themselves responsible for the integrity and safety of the dispensed packs, nor to identify a specific responsible party".
