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Italy
transparency obligations overview

Last reviewed: January 2024 | Important Notes
PHARMACEUTICAL

Report Due Date

Annually, within first six months of the year after the expenses were incurred

Authority

Farmaindustria

Who Must Report

Members of Farmaindustria

Covered Recipients

“Any Healthcare Professional or Organisation that carries out a profession or principle activity or that has the main domicile or legal head office in Europe”
MEDICAL DEVICE

Report Due Date

Data related to transfers of value shall be published annually starting from 1 January 2021, with reference to data regarding the 2020 calendar year.
The Members shall publish the transfers of value made each year within the first six months of the following year.

Authority

Confindustria Dispositivi Medici

Who Must Report

Members of Confindustria Dispositivi Medici

Covered Recipients

Healthcare professionals (HCPs), healthcare organisations (HCOs) and third parties

Pharmaceutical Companies

What is reported:

Transfers of value related to:

  • Events
  • Consultancy services
  • Donations and grants
  • Research & development

How to Report

On the company’s website using the template in Schedule 1 of the Farmaindustria Code. “Each pharmaceutical company shall disclose a note summarizing the methodology used to lay down data with reference to information regarding VAT, currency or possible fiscal aspects connected to the transfers of value in individual or aggregate form.”

Resources

http://www.farmindustria.it
https://www.farmindustria.it/chi-siamo/

Note

Italian Sunshine Act

Italy Chamber Assembly approved the proposed “Italian Sunshine Act” which requires pharmaceutical and medical device companies to publicly disclose all payments to or agreements with HCPs/HCOs. The legislation would supersede the transparency reporting requirements laid out by both the pharma and medical device industry associations.

See: http://www.senato.it/leg/18/BGT/Schede/Ddliter/49379.htm

On August 17, 2023, the Ministry of Health published the draft decree, and related technical regulations, on the “Transparent Healthcare” public register and launched a public consultation to gather comments and contributions from stakeholders, including manufacturers of health products, healthcare professionals and organizations. Consultation period was to remain open until September 17, 2023.

Reporting Payments NHS

There is also a law applicable related to payments to ‘HCPs employed by National Health Service (NHS).Art. 53 of Legislative Decree n. 165/2001 (concerning conflict of interests in public sector) says:

  • That businesses cannot grant paid assignments to public employees without the prior authorization of the administration the employee works for.
  • Authorization must be requested by the company or by the employee.
  • The administration must decide within thirty days of receipt of the request.
  • In case there is a transfer of value: the company must notify the administration of this within 15 days.
  • Within the following 15 days, that administration shall communicate to the Ministry of Public Administration the assignments granted to such employees

Deadline: No later than 15 days after the payment. For more details in English, refer to the following secondary resource: https://hivda.hu/wp-content/uploads/2018/11/ComplianceHandbook_2018_FINAL_20181010.pdf).

Medical Device Companies

What is reported:

The Members, individually for each recipient, shall disclose the amount of transfers of value made over the course of the previous year with reference to:

  • Costs for participation in training, educational and promotional events on company’s products organised by the Members (excluding meals and beverages);
  • Fees for consultancy activities and professional services, including speaking services, set forth in a specific contract between the Member and the professional indicating the type of service rendered, including the related travel and accommodation costs (excluding meals and beverages).

The Members must make public, on an individual basis, the amount of the transfers of value made with each healthcare organisation or other third parties by way of:

  • Financial support of events (e.g. sponsorship of conventions, congresses and scientific meetings, etc.) aimed at meeting a scientific or other educational/training need as described in paragraphs 2.7.1 and 2.7.2 (excluded meals and beverages)
  • Fees for consultancy activities and professional services, including speaking services, under a specific contract between the Member and the healthcare organisation, indicating the type of service rendered, including the related travel and accommodation costs (excluding meals and beverages);
  • Donations in cash or cash equivalents provided to the HCO

The following transfers of value shall also be published in aggregate form:

  • All donations in cash and cash equivalents to third parties, other than the HCO
  • Costs for research and development activities
  • Scholarships

How to Report

By means of a specific Transparency Template, which constitutes an integral part of this Code (annex 2).

Resources

 https://www.confindustriadm.it/codice-etico/

Note

Italian Sunshine Act

Italy Chamber Assembly approved the proposed “Italian Sunshine Act” which requires pharmaceutical and medical device companies to publicly disclose all payments to or agreements with HCPs/HCOs. The legislation would supersede the transparency reporting requirements laid out by both the pharma and medical device industry associations.

See: http://www.senato.it/leg/18/BGT/Schede/Ddliter/49379.htm

On August 17, 2023, the Ministry of Health published the draft decree, and related technical regulations, on the “Transparent Healthcare” public register and launched a public consultation to gather comments and contributions from stakeholders, including manufacturers of health products, healthcare professionals and organizations. Consultation period was to remain open until September 17, 2023.

Reporting Payments NHS

There is also a law applicable related to payments to ‘HCPs employed by National Health Service (NHS).Art. 53 of Legislative Decree n. 165/2001 (concerning conflict of interests in public sector) says:

  • That businesses cannot grant paid assignments to public employees without the prior authorization of the administration the employee works for.
  • Authorization must be requested by the company or by the employee.
  • The administration must decide within thirty days of receipt of the request.
  • In case there is a transfer of value: the company must notify the administration of this within 15 days.
  • Within the following 15 days, that administration shall communicate to the Ministry of Public Administration the assignments granted to such employees

Deadline: No later than 15 days after the payment. For more details in English, refer to the following secondary resource: https://hivda.hu/wp-content/uploads/2018/11/ComplianceHandbook_2018_FINAL_20181010.pdf).

 

Important notes:

  • This information is provided for your convenience and should not be construed as legal advice. The applicability of these requirements to your organization depends on individual circumstances. The information is not exhaustive.
  • Kindly check with your legal department and do not depend solely on the information provided here. Moreover, the rules mentioned could be subject to interpretation of local authorities/courts in the applicable jurisdiction. Lastly, be mindful of the latest update mentioned above. These rules and regulations change frequently, so it is important to determine whether the information provided reflects the most recent changes and is still applicable.
  • Reporting dates are related to the transparency obligation regarding transfers of value by pharmaceutical companies and/or medical device companies (excluding – in most cases – suppliers of in vitro diagnostics) to HCPs and HCOs. These often are based on laws or rules in codes of conduct of industry associations. In case it is based on codes of conduct, your company only needs to disclose the transfers of value on the mentioned due date if your company is a member of the association that follows that code.
  • Including a jurisdiction in the Legislative Watch does not guarantee that jurisdiction is available for reporting via the MediSpend Transparency Reporting Solution.
  • Reporting date normally means the date the transfers of value need to be published. The deadline for e.g. submission/sending the complete information to the authority could be before that date, for example to give HCPs and/or HCOs and/or the authority/association who publishes the information, the possibility to check the data the pharmaceutical companies/medical device companies are going to disclose.
  • The information does not take into consideration (unless explicitly mentioned):
    • Transparency related to clinical trials (unless it concerns transfers of value as mentioned above)
    • Transparency related to patient organizations (unless the patient organization is considered an HCO)


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