Ed.: We report under the law that instituted the generic and then the equivalent. We have therefore reported the data on drug patents and the classification between branded drugs, generic drugs and copy drugs. Finally we reported the evaluation of the Italian Society of Pharmacology and the controversial issue of tolerance of difference of 20% between the brand and generic drug.
Law 28 December 1995, n. 549 (Official Gazette no. 302 of 29 December 1995 – Ord. Supplement).
Subject: Public finance rationalization measures.
Article 3
129. With effect from 1 April 1996, drugs based on the same active ingredient for which the same route of administration is envisaged and which have the same pharmaceutical form, placed in classes a) and b) pursuant to art. 8, paragraph 10, of the law of 24 December 1993, n. 537, are paid by the National Health Service limited to the lowest price among those of drugs that have the characteristics referred to in this paragraph. For the purposes of applying this paragraph, the prices of the drugs are related to the dosage unit, taking into account any differences in the concentration of the active ingredient. The doctor who prescribes a drug having a higher price than that identified pursuant to this paragraph is required to inform the patient of the availability of a drug based on the same active ingredient fully paid for by the National Health Service. Within thirty days from the date of entry into force of this law, the Single Drug Commission defines the list of drugs for the purpose of applying the provisions referred to in this paragraph. Within thirty days from the date of entry into force of this law, the Single Drug Commission shall identify the drugs necessary for the treatment of particular pathologies as well as the definition of the pathologies themselves. These drugs are placed in classes a) and b) pursuant to art. 8, paragraph 10, of the law of 24 December 1993, n. 537, and a discount of no less than 50 percent of the retail price established by art. 9, fifth paragraph, of the decree-law of 8 July 1974, n. 264, converted, with modifications, by law 17 August 1974, n. 386, calculated according to the provisions of paragraph 128.
130. The Minister of Health can authorise, upon request, the placing on the market as generics of all medicines whose formulation is not protected by patent o from the complementary protection certificate referred to in the law of 19 October 1991, n. 349, and to Regulation (EEC) n. 176
