Based on a legislative provision approved by the outgoing Government in an electioneering climate, as from 1 January 2001 charges on pharmaceutical prescriptions have been abolished.

Yet the same measure established a public expenditure safeguard notion which in fact, whilst eliminating prescription charges, sneakingly introduced the concept that patients should pay for the price difference between the medicinal speciality supplied and the generic drug or in any case the corresponding speciality sold at the lowest price. However, for merely electoral reasons, the Amato Government deemed it convenient to arrange for the enactment of these measures to take place on two different dates, so as to convey the feeling that the provision was exclusively aimed at eliminating prescription charges as from 1 aJanuary 2001, whereas the starting date for the so-called “reference reimbursement” was scheduled, already at the time, for 31 July 2001, that is for a post-electoral date. Though with a deferment, the Ministry of Health has therefore had to enforce the Law, by enacting two decrees relating to the two aspects of the same health-care expenditure problem. The first Decree, already in force as from 1 September 2001, relates to an aspect that is limited to generic drugs, which we have already dealt with in depth in issue no. 1/2001 of Leadership Medica and Chemist, and it prescribes that for the drugs included in the NHS list, having a higher price than that of the reference generic drug, citizens will have to pay at the chemist’s, upon purchasing the product, the difference between the reference reimbursement of the generic drug and the actual price of the “branded drug”; for this price difference to be paid by the citizens no exemptions are provided for. On the other hand, the second Law by Decree (no. 347 of 18 September 2001) will become applicable as from 1 November 2001 and authorises the chemist to physically replace the drugs which are “not protected by a patent” with the drug having the lowest price among those made available within the ordinary regional distribution cycle. Should the doctor indicate in the prescription that the drug is not replaceable, the price difference between the two drugs will be born by the citizen, and in this case again the law provides for no type of exemption. The generic nature of drugs, ratified by the 1996 Financial Act, and reworded in Law no. 425 of 8 August 1996, simply consists of the fact that, being no longer protected by a patent, and having the time limit provided for by the related complementary protective certificate also been expired, the drug may be manufactured by any other pharmaceutical company, as long as it proves bioequivalent to the already authorised medicinal speciality, that it has the same active principle composition in terms of quality and quantity, that it is produced in the same pharmaceutical form and that it provides for the same therapeutic indications. Of course production of a generic drug cannot be undertaken by whoever wishes to, but requires a whole set of ministerial authorisations, which are subject to the production of scientific documentation certifying bioequivalence with the medicinal speciality whose patent has expired, the same manufacturing process and the same type of manufacturing laboratory, the same administration route and, above all, a reduction in price by at least 20% compared to the originating speciality. It is in any case understood that the procedures adopted for the production and quality control of generic drugs must comply with all principles and standards of Good Manufacturing Practice, therefore offering the same quality guarantees granted by the corresponding medicinal speciality. These new regulations in the field of drug production and sale have already resulted in an increase in the number of generic drugs, since certain companies have launched into producing this type of drugs, in competition with the patent holders of the corresponding medicinal speciality for which they had previously funded research or paid royalties. At this stage, it is quite clear that, apart from the name, these drugs are by no means generic, but are actual pharmaceutical specialities with which the competition has been regaled in order to obtain the best prices. We shall only have to try and find a system whereby it can be guaranteed that, in the actual implementation of the new regulations, no authorisation partiality is allowed to favour any of these companies founded for the purpose and, at the same time, that there is full correspondence between the product and the replaced speciality. But, more than anything else, the new NHS drug reimbursement discipline has led all pharmaceutical companies into a race for a new era in drug pricing, with a tendency to fix a lower ceiling price for all articles. Indeed, as from 1 September 2001, Novartis has reduced the price for its own medicinal speciality “Mesulid” so that it no longer involves the need for a replacement, in that the new price corresponds to that of the generic drug. Other companies that in the past owned a patent for a drug are about to do the same, having by now recovered their research and launch costs and therefore being in a position to safely reduce their profit margins. Indeed, it is quite obvious that any other company will have to face definitely higher production costs than those born today by the patent holder, since it will have to start from scratch in equipping itself to manufacture the product with the same manufacturing processes and the same substances. At the end of the day, all we are achieving is a price reshuffle, as we had already forecasted in the article we published in January, and this, as a matter of fact, is in everybody’s interest.