DM 4-12-90

 

MINISTRY OF HEALTH
DECREE 4 December 1990.

Amendments to the ministerial decree of 23 June 1981 governing the activity of scientific information on drugs.

THE MINISTER OF HEALTH

Given the paragraphs 4 and 5 of the art. 31 of the law of 23 December 1978, n. 833, which, among other things, entrust the Ministry of Health with the task of dictating rules for the regulation of the scientific information service on drugs and the activity of scientific informants, as well as of subjecting the scientific information carried out by companies holding authorizations for marketing drugs to control;
Having regard to its decree of 23 June 1981, published in the Official Gazette no. 180 of 7 July 1981, modified and supplemented by ministerial decrees of 23 November 1982 and 26 February 1985, published, respectively, in the Official Gazette no. 333 of 3 December 1982 and n. 61 of 12 March 1985, with which, in implementation of the provisions of the aforementioned art. 31 of the law n. 833 of 1978, rules governing the activity of scientific information on drugs were established;
Having seen, in particular, articles 5 and 3 of the aforementioned ministerial decree, which respectively establish the criteria which scientific congresses and conferences must comply with, as well as the criteria for collecting the data necessary for the fulfillment of the ministerial decree of 20 March 1980, published in the Official Gazette no. 83 of 25 March 1980, and subsequent modifications;
It is deemed necessary to make changes and additions to the discipline contained in the aforementioned art. 5, in order to ensure more adequate controls by the Ministry of Health and to avoid that illicit activities or, in any case, activities that do not comply with the principles contained in the ministerial decree of 23 June 1981 are carried out through congressional initiatives or during them;
Also considered appropriate to limit the carrying out of phase IV clinical trials in hospitals and public institutes:
Decrees:
Article 1.
1. The art. 5 of the ministerial decree of 23 June 1981, published in the Official Gazette no. 180 of 2 July 1981, most recently amended by the ministerial decree of 26 February 1985, published in the Official Gazette no. 61 of 12 March 1985, is replaced by the following:
“Art. 5 - 1. Congresses and scientific conferences organized in Italy and abroad by pharmaceutical companies, or in which they participate with funding, even indirectly, must be devoid of advertising intent, comply with criteria of a strictly technical nature and be oriented towards the development of knowledge in the sectors of pharmaceutical technical chemistry, biochemistry, physiology, pathology and clinics.
2. Companies are required to notify the Ministry of Health – Director General of the Pharmaceutical Service, at least sixty days before the date of the start of the congress, of the following elements:
a) name, company name, tax code and registered office of the company that organizes or finances all or part of the scientific convention or congress;
b) venue and date of the event;
c) addressees of the initiative;
d) object of the theme of the conference;
e) professional, scientific or university qualifications of the speakers;
f) estimate of the expenses referred to in paragraph 3;
g) undertaking, jointly undersigned and authenticated in accordance with the law, with which the legal representative of the company and the organizer of the convention or congress exclude the advertising purposes of the products of the company organizing the convention or congress.
3. The congresses and conventions referred to in paragraph 1 must take place in places equipped with adequate technical-scientific structures and cannot include charges for travel expenses or free hospitality for the participants, with the exception of:
a) for speakers;
b) for qualified sector operators, useful for achieving the aims of the event, when their presence is decisive for the achievement of the aims of the event.
In particular, hospitality expenses must refer to the period of time between the 12 hours preceding the start of the congress and the 12 hours following its conclusion.
4. If within thirty days of the communication referred to in paragraph 2, the Ministry of Health, on the basis of the data acquired, deems the conference non-compliant with the provisions of this article, the pharmaceutical company concerned is required to comply with the instructions consequently issued by the same Ministry.
5. No form of distribution or display of medicinal samples or illustrative material of medicinal products may be carried out within the congress or convention or side by side with it, with the exception of the scientific information technical sheet for which the fulfillment of the provisions of art. 3, first paragraph.
6. Samples of medicines or scientific information material cannot be distributed at trade union or associative congresses.
7. To verify compliance with the provisions of this article, the Ministry of Health avails itself, among other things, of the commission established by art. 7 of the ministerial decree 16 January 1990, n. 79 and the anti-sophistication and health units of the Carabinieri.
8. In the event of ascertained and serious non-compliance with the provisions of this article, the competent offices, without prejudice to the application of art. 10, propose to the single drug advisory commission, set up by art. 3 of the decree-law of 30 October 1987, n. 443, converted, with modifications, by law 29 December 1987. n. 531, the exclusion from the therapeutic handbook of the National Health Service of the medicinal product to which the irregularity refers, also informing the judicial authority of the facts, where the details of the crime referred to in art. 170 of the consolidated text of health laws approved by royal decree 27 July 1934, n.1265, and subsequent modifications and additions».
Article 2.
1. In art. 3 of the aforementioned ministerial decree of 23 June 1981 the following paragraphs are added at the bottom:
«Phase IV clinical trials can only be carried out in public hospitals and institutes. The trial cannot take place if the Ministry of Health, which must be informed at least 30 days before the start of the same, has made known its motivated dissent".
"Trial outside the premises indicated in the previous paragraph is permitted only at the express request of the Ministry itself, in relation to public health needs".
Article 3.
1. This decree enters into force on the ninetieth day following that of its publication in the Official Gazette of the Italian Republic.

Rome, December 4, 1990

The Minister: De Lorenzo