Law 5-8-78 n. 484

LAW 5 August 1978, n. 484.
Discipline of scientific information and drug advertising and establishment of the participation of patients in the expenditure for pharmaceutical assistance.
The Chamber of Deputies and the Senate of the Republic have approved;
THE PRESIDENT OF THE REPUBLIC
PROMULATE
the following law:
Article 1.
The Minister of Health, having consulted the Higher Health Council and, starting from its constitution, the National Health Council, approves with his own decree the therapeutic handbook referred to in article 9 of the decree-law of 8 July 1974, n. 264, converted, with amendments, into law 17 August 1974, n. 386, also valid for the assistance provided by mutual-social security institutions until the entry into force of the law establishing the National Health Service, subject to a proposal from a committee composed of:
by the Ministry of Health which presides over it;
by the director general of the pharmaceutical service of the Ministry of Health;
by the director of the Higher Institute of Health;
by the directors of the pharmacology and drug chemistry laboratories of the Higher Institute of Health;
by seven experts designated by the Ministry of Health, chosen from among university professors of pharmacology and clinical medicine and among doctors and pharmacists employed by or affiliated with the structures of the National Health Service and, until the entry into force of the law establishing the aforementioned Service, among doctors and pharmacists employed by public diagnosis and treatment structures or affiliated with pharmaceutical assistance providers under a mutual-social security regime;
by a representative of the Ministry of Industry, Commerce and Crafts;
by two health economics experts designated by the Minister of Health on the proposal of the National Research Council;
by three experts appointed by the regions. They are chosen by the President of the Council of Ministers from among the experts designated, one each from the regions and, as regards the Trentino-Alto Adige region, one from the province of Trento and one from the province of Bolzano.
The functions of secretary of the committee are exercised by an official of the managerial roles of the Ministry of Health.
The committee referred to in the first paragraph is appointed by 30 November 1978 by decree of the President of the Council of Ministers, on the proposal of the Minister of Health, and is renewed every three years.
The therapeutic handbook must comply with the principles of therapeutic efficacy, product cost-effectiveness, simplicity and clarity in the classification of the exclusion of over-the-counter products.
This handbook must include a list of medicines exempt from users' co-payments, identified on the basis of the following criteria:
1) therapeutic efficacy recognized on the basis of controlled scientific data;
2) presence of a single substance, with the exception of exceptions in which properties cannot be attributed to the individual components separately;
3) need for the treatment of socially relevant conditions requiring long-term therapies or for the treatment of clinical emergency situations.
The Minister of Health shall update the therapeutic handbook by 31 December of each year with the procedure referred to in this article.
Article 2.
Starting from the fifteenth day following the entry into force of this law, those who are entitled to pharmaceutical assistance by virtue of compulsory insurance are required to pay
offer a portion of the public sale price of medicines not included in the list of exempt medicines, as well as of the sale price of medicinal galenics, to the following extent:
a) for each package of medicinal product priced up to L. 1,000: L. 200;
b) for each package of medicinal product with a price exceeding L. 1,000 up to L. 3,000: L. 4OO;
c) for each package of medicinal product with a price exceeding L. 3,000: L. 600.
The amounts referred to in the previous paragraph under the direct assistance regime are paid by the assisted persons to the pharmacist upon taking the medicine and are excluded from reimbursement under the indirect assistance regime.
Article 3.
To holders of a social pension, referred to in article 26 of the law of 30 April 1969, n. 153, a lump-sum refund of L. 10,000 of the charge referred to in article 2 of this law is paid.
This repayment is made when the thirteenth month's salary is paid. For the year 1978 the reimbursement amounts to L. 4,000.
Article 4.
The quotas currently envisaged in the therapeutic handbook are abolished and absorbed by the quotas envisaged by article 2.
Article 5.
The participation fees of the assisted in the expenditure envisaged by article 2 of this law must be indicated in print by the manufacturer for each drug on the packaging punches, next to the sale price to the public.
Medicines deposited with industry, for distribution with wholesalers and, for sale, with pharmacies can be hesitated within one hundred and twenty days of the entry into force of this law even without the fulfillment referred to in the first paragraph. During this period, for the transfer to the clients, the pharmacies will indicate on the prescription the participation fee envisaged by article 2. After this period, the indication referred to in the first paragraph of this article must be affixed by the industry, wholesalers and pharmacists using a transparent self-adhesive sticker to be superimposed on the original punch or label. The pharmacy owner is required to display to the public a sign bearing the indication relating to the participation fees of the assisted to the expenditure referred to in Article 2.
The request for payment of the prescriptions sent to the insurers must be made on the basis of the retail price, reduced by the amount of the fees collected.
Article 6.
Any form of propaganda and advertising to the public of medicines subject to the obligation of presentation of a medical prescription and in any case of those contained in the therapeutic handbook approved with the ministerial decree of 19 October 1976, and subsequent amendments and additions, is prohibited.
Until the matter is governed by the law establishing the National Health Service, the Minister of Health determines with his own decree the limits and methods for the publicity and publicity of drugs other than those indicated in the previous paragraph, taking into account the directives on the subject of the European Economic Community and the biennial program for scientific information on drugs referred to in the following art. 7.
Article 7.
The Minister of Health, having consulted the regions and the Higher Health Council, taking into account the Community directives and having evaluated the observations that will arrive from the Higher Institute of Health and from university and research institutes, including those of the pharmaceutical industry, prepares a two-year program