Historical Archive

A MARKET WITH INCREASINGLY MORE GENERICS


The disappointing measures for the development of the La Finanziaria sector and the permanent controversies on safety, quality and obsolescence.

Aetiche this year, as in 2006, we have heard a lot about generics, often, it must be said, in an inappropriate way. But what we unfortunately have to note once again is that so many words have not been followed by so many concrete facts. We continue to be the champions of all those who have to keep their accounts under control, but concrete measures for the development of the generics market are not being adopted. The measures in the Finance Law We participated with commitment in the table on pharmaceuticals, wanted by the Turkish Minister, to study together the measures necessary for the entire pharmaceutical sector, but none of the proposals made by Assogenerici was then taken into consideration when it came to translating them into norms. The measures introduced with the latest tax decree, on the government of pharmaceutical expenditure, which in the intention of the legislator should guarantee more adequate control of expenditure and offer companies a new price regulation structure, creating a market more favorable to competition and to innovation, are wholly inadequate for achieving the stated objectives and do not guarantee any space for concrete development to companies producing generic drugs. First of all, the total amount of resources dedicated to territorial pharmaceuticals is defined year by year and therefore the opportunity to start a stable multi-year programming is not taken, the methods envisaged for programming then assign too broad a discretion for the Regulator and finally the budget allocation by product portfolio is equivalent to fixing ex-ante the outcomes of the market and the shares due to each company. With a system of this type, market shares will in fact become plastered, not only for the companies already present, but even more for the new companies producing generics that would like to enter the market. Then foreseeing a budget also for generics, with consequent compensation for any overrun is like saying we put a ceiling on the savings that the NHS can achieve during the year! It would have been much more appropriate to start building an institutional framework in which to move the coordination between the State and the Regions on the subject of expenditure governance with reference to real aspects, such as the regulation of supply and demand and the verification of the prescribing practices of doctors . But there is no trace of this in the new regulations, the parliamentary debate on the new system for regulating pharmaceutical expenditure was rather fast and not very thorough, the only clear voice of dissent was raised by the Antitrust, whose reporting to Parliament however, it remained a dead letter. While great interest and numerous positions were raised by the provision, briefly passed through the Finance bill, on the prescription of class C medicines by active ingredient. So much clamor for nothing, I allow myself to say, considering that the provides for the principle of substitutability of the prescribed medicinal product with the cheaper equivalent. Basically you mean that what is written on the prescription, even if it is the name of a brand, can be replaced in the pharmacy, and therefore using the active ingredient instead of the brand on the recipe would not change anything in daily practice. Of course it must also be said that calling a drug by its own name and not with invented names would allow the active substance to be recognized immediately, thus facilitating the task of both the doctor and the pharmacist and if finally the citizen-patient also acquired greater familiarity

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco