New Transparency Obligations For Medical Device Companies In Italy

On 1 January 2021, important transparency obligations provided for in the Code of Ethics of Confindustria Dispositivi Medici (the Italian medical device industry association) (the Code) will become applicable. These obligations require medical device companies to disclose all transfers of value made to healthcare professionals (HCPs), healthcare organizations (HCOs), and other third parties as of 1 January 2020. Starting from this month, therefore, medical device companies that are members of Confindustria Dispositivi Medici should keep track of relevant transfers of value in order to ensure smooth compliance with these new obligations.

What to disclose

In a nutshell, Article 4 of the Code imposes the public disclosure of all direct or indirect transfers of value made to HCPs, HCOs, and other third parties each year, within the first six months of the following year. Such provisions strengthen the disclosure obligations included in the MedTech Code and also apply with respect to "third parties", defined as those subjects that organize or manage any scientific, logistical or organizational aspects of medical events.

In particular, the publication obligation concerns the following transfers of value made to HCPs, HCOs or third parties:

costs related to the sponsorship and participation to training, educational or promotional events (excluding meals and beverages); fees for consultancy activities and professional services; donations; costs for research and development activities; scholarships. Transfers of value related to promotional materials, meals, beverages and product samples are excluded from the publication obligation.

How to disclose

To comply with such transparency obligations, medical device companies are required to disclose specific information on their website and maintain it in the public domain for at least three years. Moreover, companies must retain the documentation supporting the published data for a period of at least five years and make it available upon request of the HCP/HCO/third party.

Relevant data must be published in the recipient's country of domicile. For companies that form part of a broader corporate group, the publication obligation extends to the parent company as well as other companies within the same group, subject to the relevant national codes and regulations.

Publication of the information must follow the specific template included in the Code and be compliant with applicable...