transparency obligations overview

Latest update: 18 December 2018 | Important Notes

Pharmaceutical Companies

What is reported:

Transfers of value in connection with:

  • Donations and grants
  • Contribution to costs related to events
  • Fees for service and Consultancy

Medical Device Companies

Both the Irish Medtech Association and IMSTA are member of MedTech Europe:

  • The Irish Medtech Association has transposed and adopted the MedTech Europe Code as its new Code, which entered into force on the 1st January 2018.

  • The most recent IMSTA Code is an exact transposition of the MTE Code.

What is reported:

Educational Grants shall be disclosed on an aggregate basis. Each Affiliate of a Member Company shall disclose, for each clearly identifiable and separate recipient, the amounts paid as Educational Grants to such recipient in each Reporting Period which can be reasonably allocated to one of the categories set out below.

Such amounts will be aggregated on a category-by-category basis, but itemised disclosure shall be made available upon request by the Member Company, as deemed necessary, to (i) the relevant recipient, and/or (ii) the relevant authorities.

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

  1. Educational Grants to support Third Party Organised Events (including Support for HCP Participation at Third Party Organised Educational Events) and,

  2. Other Educational Grants to Healthcare Organisations (including Scholarship, Fellowships and/or Grants for Public Awareness Campaigns).

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 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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