« back to GLOBAL TRANSPARENCY PAGE

Europe
transparency obligations overview

Last reviewed: January 2024 | Important Notes
PHARMACUETICAL
MEDICAL DEVICE
PHARMACEUTICAL (GENERIC)

Pharmaceutical Companies

For EFPIA report see: https://www.efpia.eu/media/676436/efpia-code-report-2021.pdf

What is reported:

Transfers of value related to:

  • Donations and grants
  • Contribution to costs related to events
  • Fees for service and consultancy
  • Research and development

(See details in art. 23 of the EFPIA Code.)

EFPIA members also need to publish details of financial support and significant non-financial support to patient organisations.

(See details in art. 24 of the EFPIA Code.)

Medical Device Companies

What is Reported:

Subject to the terms of the ‘Disclosure Guidelines’ of the MedTech Europe Code of Ethical Business Practice (the ‘Code’, see: Resources), each Member Company shall document and disclose all payments related to Educational Grants (as described in Chapter 4, section 3 of the Code) that it makes to a healthcare organization based or registered in Europe, without limitation of value.

Member Companies shall disclose an aggregate amount related to any of the categories set forth below:

  • Educational Grants to support Third Party Organized Events (including Support for HCP Participation at Third Party Organized Educational Events) and,

  • Other Educational Grants to Healthcare Organizations (including Scholarships, Fellowships and/or Grants for Public Awareness Campaigns).

Pharmaceutical Companies (Generic)

What is Reported:

“Companies must publish disclosure data relationg to the following transfers of value (whether directly or indirectly funded) made to healthcare professionals, healthcare organisations or parent organisations:

  • Fee for service (excluding associated expenses) except fees paid in connection with research & development activities or anonymous market research;
  • Registration fees to amend a third party congress/conference;
  • Travel and accommodation provided to delegates to amend a meeting – including third party meetings, company organised meetings and site visits;
  • Grants and donations, both financial and in-kind, to organisations that are part of the healthcare community;
  • Sponsorship of healthcare organisations’ and parent organisations’ activities and events.”

(See 7.2.1 of the Code. For more details, refer to (the rest of) chapter 7.)

 

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)


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.