from Leadership Medica n. 1/2001

In the 2001 Financial Act a new concept appears with respect to medicine prescription, whereby the concept of “prescriptive interchangeability” which used to enable the chemist to simply replace the medicine prescribed by National Health doctors is replaced by the rule that obliges the patient to pay for the price difference between generic medicines and specialities. Many doctors are faced for the first time with a new regulating aspect of the provision that has created in Italy this new category of so-called generic medicines. Their generic nature is given by the fact that, since these products are no longer covered by a patent, the related complementary protective certificate having expired, they may be manufactured by any other pharmaceutical firm, provided the new product is bio-equivalent to the medicinal speciality which has already been authorised, it has the same composition in quality and quantity as regards active principles, and it has the same pharmaceutical form and the same therapeutic indications. Of course, the production of generic medicines cannot take place automatically, but it requires a number of ministerial authorisations, which are in turn subject to scientific documentation. The fact remains that the procedures adopted for the production and quality control of generic medicines must comply with all existing manufacturing principles and regulations, and thus offer the same guarantees provided by the corresponding speciality. So far, the significance of the generic medicine market in Italy has been modest. However, the expected development of this market sector has increased significantly with the new regulation related to the payment of a price difference by National Health patients. At this stage it is quite obvious that, apart from the name, these pharmaceutical products are by no means generic, but are regular pharmaceutical specialities which competition is regaled with in order to produce the lowest possible prices. All we need to establish is a system whereby it may be possible to guarantee that, in implementing the new regulation, no authorising partiality exists to favour some firm established for the purpose and at the same time ensure full compliance of the product with the speciality replaced. But above all I feel that the new regulation for medicine reimbursement by the National Health Service may lead to a race of all pharmaceutical firms for a new era of medicine prices, with the fixing of a ceiling price for all products. Irrespective of the fact that a firm may have had to apply a higher price to recover research expenses for a new molecule, once the protection period granted by the patent has expired, there is no reason why that firm should not manufacture the product at a lower price, having acquired specific competence for the related production process and already having available all the necessary equipment. Indeed, it is quite obvious that a new firm will in any case have to face definitely higher production costs than the patent holder, as it will have to equip itself entirely in order to manufacture the product; so I do not see how it can quote a price which is over 20% lower. I am quite sure that, after all, everything will end in a price reshuffle, which, to be quite honest, will be to everybody’s advantage.

Amedeo Pavone

(traduzione Interpres sas-Giussano)