« back to GLOBAL TRANSPARENCY PAGE

Italy
transparency obligations overview

Latest update: 29 November 2018 | 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

CODE: 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.
LAW: No later than 15 days after the payment

Authority

CODE: Assobiomedica
LAW: NHS’s local health unit (Aziende Sanitarie Locali – ASL)

Who Must Report

CODE: Members of Assobiomedica
LAW: Medical technology companies are required to report aggregate amounts paid to HCPs employed by the Italian National Health Service (NHS)

Covered Recipients

CODE: Healthcare professionals (HCPs), healthcare organisations (HCOs) and third parties
LAW: Public service employees in Italy

Pharmaceutical Companies

What is reported:

  • Participation in congresses and events (limited to the participation fees, travel and accommodation)
  • Consultancy services
  • Donations and grants
  • Research & development expenses
  • Exclusions: transfers of value regarding over-the-counter (OTC) products, gifts of negligible value, samples, meals and accommodations

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.”

Medical Device Companies

What is reported:

CODE: 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

LAW: All payments to HCPs employed by NHS except in the following cases:

  • Collaborations with journals, encyclopedias or similar publications
  • Economic use of the HCP’s intellectual property
  • Participation in seminars or conferences
  • Whenever only the costs are reimbursed to the HCP
  • When the performance of the services puts the HCP in “leave” from his/her position
  • Assignments pursuant to a role or position in trade unions
  • Training activities and training directed to employees of the public administration as well as scientific research

How to Report

CODE: By means of a specific Transparency Template, which constitutes an integral part of this Code (annex 2).
LAW: Report aggregate amounts paid to HCPs employed by the Italian National Health Service (NHS). The aggregate amounts have to be reported to the relevant NHS’s local health unit (Aziende Sanitarie Locali – ASL)

Resources

CODE: Assobiomedica.it code of ethic february-2018.pdf
LAW: Above information based on Secondary source, see:
MedTech Europe ComplianceHandbook_2017.pdf (under: ‘Italy’)
Refer to:
Legislative Decree 165/2001 of 30th March, Article 53
Law no. 190/2012 of 6 November, Article 1, paragraph 42.
Legislative Decree 156/2001 Article 53, paragraph 6.
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 reflects that 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 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 such cases, your company only needs to disclose the transfers of value on the mentioned due date if your company is a member of that association).
  • “Due date” means the date on which the transfers of value need to be published. For example, the deadline for submitting/sending the complete information to the authority could be before the due date to give HCPs/HCOs the opportunity to check the data that the pharmaceutical companies/medical device companies are going to disclose.
  • The information does not take into consideration:
    • 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)
  • If your company is a member of MedTech/EFPIA (or if the industry association your company belongs to is a member of MedTech/EFPIA), the due dates are as mentioned above for MedTech/EFPIA (end of June), unless a law/regulation specifically states otherwise (e.g., the jurisdiction is suspended/exempted from following MedTech/EFPIA).

Disclaimer:

The information contained in this website is for general information purposes only. The information is provided by MediSpend and, while we endeavor to keep the information up to date and correct, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability with respect to the website or the information, products, services, or related graphics contained on the website for any purpose. Any reliance you place on such information is, therefore, strictly at your own risk.

In no event will MediSpend be liable for any loss or damage including, without limitation, indirect or consequential loss or damage, or any loss or damage whatsoever arising from loss of data or profits arising out of, or in connection with, the use of this website.

Through this website you may be able to link to other websites which are not under the control of MediSpend. We have no control over the nature, content and availability of those sites. The inclusion of any links does not necessarily imply a recommendation or endorse the views expressed within them.

Every effort is made to keep the website up and running smoothly. However, MediSpend takes no responsibility for, and will not be liable for, the website being temporarily unavailable due to technical issues beyond our control.