MedTech Companies to Disclose Transfers of Value Under Italian Industry Code

Background

CDM is the Italian trade association representing the medical technology industries, including medical devices, in vitro diagnostics and digital health.

Based on the Code of Ethics of CDM (CDM Code), member companies are expected to comply with a variety of requirements, including CDM preventive assessments, restrictions on direct transfers of value to HCPs and — as of next year — far-reaching disclosure obligations.

Article 4 of the CDM Code now requires member companies annually to document and publish on their websites all direct and indirect transfers of value made to HCPs, HCOs and other third parties.

Relevant transfers of value include payments relating to HCPs’ participation in training, educational activities and promotional events organized by member companies; consultancy activities and professional services provided by HCPs, HCOs or third parties; support provided to HCO-organized or third party-organized events, such as congresses and scientific meetings; donations to HCOs or other third parties; research and development activities; and scholarships.

Member companies will have to publish data regarding those transfers of value on an annual basis, beginning January 1, 2021 (for 2020 transfers of value), and they must ensure that such data remains in the public domain for at least three years.

Italy-Specific Disclosures

 The CDM Code imposes on member companies disclosure requirements that go beyond those established by MedTech Europe throughout Europe (in the MedTech Code).

First, the MedTech Code requires member companies to disclose only educational grants paid to support third party-organized events and other educational grants to HCOs, such as scholarships, fellowships or grants for public awareness campaigns. The CDM Code covers additional significant transfers of value such as: costs relating to the participation of HCPs in company-organized training, educational and promotional events; fees for consultancy activities and professional services paid to HCPs; and donations to HCOs and other third parties.

Second, the MedTech Code requires member companies to disclose only transfers of value made to HCOs and other third parties. The CDM Code disclosure provisions target also transfers of value to individual HCPs, such as those made in relation to company-organized events and consultancy activities.

Third, the MedTech Code requires disclosure to be made on an aggregate basis (that is, a cumulative amount for each identifiable and separate recipient). The CDM Code requires member companies to make disclosures on an individual basis (that is, transfers of value by category, for each identifiable and separate recipient) in the majority of cases, restricting disclosure on an aggregate basis to instances where HCPs have not given consent to the processing of their personal data, donations to third parties other than HCOs, transfers of value relating to research and development activities, and scholarships. As a result, data disclosed under the CDM Code will be more detailed than data required to be disclosed under the MedTech Code.

Next Steps

In preparation for the 2021 publication, companies subject to the CDM Code should start tracking and recording the relevant transfers of value as soon as possible (see Transparency Template in the CDM Code). In addition, to ensure that appropriate procedural safeguards are in place, such companies should include transparency clauses in their agreements with HCPs (for example, regarding their participation in company-organized events and consultancy activities) to obtain their consent to the processing of personal data.

Finally, it is worth noting that, besides the disclosure requirements, the following CDM Code requirements will become effective in 2020: patient associations will be considered HCOs, events will not be allowed to take place in tourist destinations during the relevant tourist seasons (some exceptions apply), and member companies will be prohibited from providing hospitality to HCPs in top-class or luxury hotels.