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;
- costs for research and development activities;
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 provisions on the protection of personal data.
Medical device companies must obtain HCPs' explicit consent in order to disclose their data on an individual basis. A facsimile of the form for the acquisition of the HCPs' consent is available on Confindustria Dispositivi Medici website. If a HCP denies such consent, the publication may take place on an aggregate basis. Companies must retain, for a period of at least three years, specific documentation showing that the HCP has given consent to the publication of her/his data.
Who must disclose
The transparency obligations in the Code only apply directly to the members of Confindustria Dispositivi Medici and other companies within the same group. However, the Code is considered best practice for all medical device undertakings operating in Italy.
Recommendations for medical device companies operating in Italy
The new transparency obligations will apply as from January 2021, with respect to transfers of value made during year 2020. Therefore, starting from the current month, medical device companies should:
- put in place procedures to keep track of all relevant transfers of value made in 2020, and to gather all relevant documentation. Such documentation must be kept for at least five years and made available upon the concerned party's request;
- include in the contracts with HCPs a request of consent for the publication of relevant data on an individual basis, and keep the related documentation for at least three years.
Finally, as specified by Confindustria Dispositivi Medici in its guidance on the interpretation of the Code, the transparency obligations provided for therein do not exempt member companies from complying with the MedTech transparency obligations. Companies should thus ensure compliance with both Confindustria Dispositivi Medici and MedTech requirements.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.