Pharmaceutical CompaniesWhat 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:
- Number of recipients involved
- Overall amount attributable to these transfers of value
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:
- Support of educational events organized by third parties
- 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>
- 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 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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