5.5% Contribution for Promotional Expenses, the Guide

Companies that produce or market medical devices in Italy must declare to the Ministry of Health the expenses incurred for promotional activities and provide for the payment of a contribution equal to 5.5% of these expenses.

The promotional activities to be declared are those aimed at healthcare professionals: doctors, healthcare company managers, and pharmacists.

The declaration and payment must be made by April 30th of each year.
The declaration must be submitted even if the amount to be paid is zero.

Expenses to be Declared for the Contribution Calculation

Promotional materials and gadgets in general, including printed materials, digital, software and similar. Costs incurred for the insertion and dissemination of promotional messages in magazines intended for healthcare professionals should also be considered. As well as scientific publications and journals that medical device companies purchase from publishers and deliver through representatives or send to healthcare professionals.

Free product samples, excluding specimens mandatorily provided during participation in public tenders, those given free of charge in execution of a contractual obligation or provided for conducting experiments or clinical investigations.

Congresses, conferences, meetings, gatherings, guided company visits. Expenses for travel, accommodation, and meals for invited healthcare professionals, expenses for organizing agencies and companies, setting up exhibition stands, distributed materials, and speaker fees should also be considered.

Payment of personnel, internal or external, engaged in activities related to the promotion of scientific information, whose weight must be weighted in relation to the number of work hours specifically dedicated to promotional activities.
To be considered as follows:

• Employees: gross economic and social security treatment and additional charges directly originating from the promotion of the medical device (for example, out-of-office travel expenses, including meals and accommodation).
• Personnel under work contracts or non-subordinate arrangements subject to VAT: total amount invoiced by the contractor during the year, always in proportion to the promotional activity of the device.

Other expenses, technological tools such as cell phones, computers, other consumer electronics products and other equipment assigned to scientific representatives and intended to be used for promotional purposes, as long as they are not connected to their employment relationship.

How to Make the Declaration and Payment of 5.5% of Promotional Expenses

The Ministry of Health provides a template for the declaration. The communication must be made on the company’s letterhead, signed by the legal representative, attaching a copy of the declarant’s identification document.
We can handle the preparation of the declaration directly and provide support to calculate the contribution in the correct manner with respect to the expenses actually incurred. You can find our contacts here.

The 5.5% contribution of expenses incurred for promotional activities of medical devices must be paid to the postal account no. 92824879 in the name of the Provincial Treasury of Viterbo or via bank transfer, IBAN: IT58Y0760114500000092824879.

Indicating in the payment description the following: “Contribution referred to in letter d) of the single article of law 266/2005 to be charged to chapter 2582 art. 27”.

The declaration must be sent via certified email (PEC) to the address: dgfdm@postacert.sanita.it

Penalties and Surcharges

As stated on the dedicated page of the Ministry of Health website, manufacturers and distributors must pay the 5.5% contribution for promotional expenses by April 30th. For each month of delay, the calculated contribution is increased by 5%.

In case of ascertained non-payment within the reference year, penalties from €7,500 to €45,000 are provided, in addition to the recovery of the amount due, increased by late payment interest and 5% for each month of delay.