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transparency obligations overview

Latest update: 14 September 2018 | Important Notes
PHARMACUETICAL

Report Due Date

Annually, within the first six months following each applicable period (calendar year).

Authority

Farmaindustria

Who Must Report

Members of Farmaindustria

Covered Recipients

Healthcare professionals (HCPs) or healthcare organizations (HCOs)
MEDICAL DEVICE

Report Due Date

The first publications were in the first 6 months of 2018, with the data referring to the year 2017.

Authority

FENIN

Who Must Report

Members of FENIN

Covered Recipients

Healthcare organizations (HCOs) or institutions

Pharmaceutical Companies

What is reported:

In addition to the information below, refer to the requirements under the implemented transparency provisions of the European Federation of Pharmaceutical Industries and Associations (EFPIA) Code on disclosure.

Report transfers of value related to donations, events (sponsorships, registration fees, travel, and accommodation) and the provision of services, as well as transfers of value relating to research and development. Reporting requirements exclude the delivery of materials, the delivery of samples, and hospitality (lunches or dinners), as well as transfers of value resulting from commercial transactions in relation to non-prescription medicines.

To the extent legally possible, pharmaceutical companies must publish this information individually, except for transfers of value relating to research and development. In such cases, make public, if applicable, the:

  1. Number of recipients involved
  2. Overall amount attributable to these transfers of value

How to Report

For the disclosure template, see annex II of following: Farmaindustria Code

Resources

Medical Device Companies

What is reported:

  • During the first 6 months of the year, the companies will disclose all grants given to health organizations or institutions, either directly or through professional event organizers.
  • Organizations and/or health Institutions should be identified by their name and tax identification number
  • Companies should disclose in aggregate the amounts paid in euros, for each clearly identifiable recipient, separately and according to the following categories:
    1. Support of educational events organized by third parties
    2. Other training grants, including those applied to courses or training days/grants for public awareness campaigns
  • Companies shall document the methodology used in the preparation of information, including a general summary and specific aspects such as handling value-added tax (VAT) or other fiscal aspects. At Fenin’s request, the companies will facilitate this methodology.
  • The information must be published on MedTech Europe’s website (http://www.ethicalmedtech.eu) and will remain in the database at least 3 years from the date of publication./li>

How to Report

Template can be found on page 38 of this document: Panelfenin.es buenas_practicas documento_23.pdf

Resources

file:///Users/freijntjes/Downloads/Code-of-Practice-for-the-Pharmaceutical-Industry%20(2).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 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).

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