October 22, 2020

Advertising condoms: No need to request prior authorization from the Ministry of Health

The rules on advertising condoms are expected to change in the next few days. On October 6, Vice-Minister of Health Pierpaolo Sileni signed a decree allowing condoms to be advertised without prior authorization from the Ministry of Health. The decree has not been published in the Official Journal (Gazzetta Ufficiale) yet and will become applicable 15 days after publication.

Condoms are considered medical devices and, as such, the related advertising to the public must be duly authorized by the Ministry of Health pursuant to Article 21 of Legislative Decree No. 46 of February 24, 1997. From a practical standpoint, the authorization process may be very long. Indeed, for each advertisement, the company manufacturing condoms (or the company that places condoms on the market) must apply for authorization by submitting an application with information concerning the company itself, the advertised product, and the type of advertising and its means of dissemination (TV, social networks, billboards, etc.). In addition, a fee must be paid. The Ministry of Health has 45 days to evaluate the application and decide whether or not to authorize the advertising, with the option to request changes. If changes are requested, the company can either accept the proposed changes or reformulate the proposal: this makes the timeline for the procedure even longer. If the Ministry does not reply for 45 days, the advertising is considered tacitly approved (silenzio-assenso).

In light of this complex mechanism, in late January two members of Parliament sought to have these regulations revised, with the aim of improving and facilitating communication and information about the use of condoms. The logic was that citizens should be informed as best as possible in matters of sexuality using an aware and guided approach, as doing so protects citizens’ health. Bearing in mind that aim, on October 6 the Vice-Minister of Health signed a decree regarding condom advertising that has not yet been published in the Official Journal (Gazzetta Ufficiale). According to available information, the main provisions of the decree are as follows:

  • Condom advertising does not require the authorization of the Ministry of Health;
  • Even though authorization is no longer mandatory, manufacturers and distributors of condoms will continue to have the opportunity – if they wish – to apply for authorization in connection with the advertising;
  • If condom advertising presents information that may pose a risk to consumers’ health, the Ministry of Health is entitled to order (i) that advertising cease immediately, and (ii) publication at the offender’s expense of a statement rectifying and clarifying the information.

The decree will become applicable 15 days after its publication in the Official Journal (Gazzetta Ufficiale).

[1] The content of this article is based on the information available on October 22, 2020.

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