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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. (traduzione Interpres sas-Giussano)
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