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Europe
transparency obligations overview

Latest update: 9 August 2019 | Important Notes
PHARMACUETICAL
MEDICAL DEVICE

Pharmaceutical Companies

Note:

Recently, EFPIA consolidated its three EFPIA Codes (HCP – PO – Disclosure) into one simplified Code. The new Code is available here: link. “Member Associations are asked to transpose the revised Code provisions by 30 June 2020 and must implement it by no later than 31 December 2020.”

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

Meals are not included.

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).

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)


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