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transparency obligations overview

Latest update: 15 November 2019 | Important Notes
PHARMACEUTICAL
MEDICAL DEVICE

Pharmaceutical Companies

What is reported:

Transfers of value related to:

  • Events
  • Consultancy services
  • Donations and grants
  • Research & development

Medical Device Companies

What is reported:

CODE: The Members, individually for each recipient, shall disclose the amount of transfers of value made over the course of the previous year with reference to:

  • Costs for participation in training, educational and promotional events on company’s products organised by the Members (excluding meals and beverages);
  • Fees for consultancy activities and professional services, including speaking services, set forth in a specific contract between the Member and the professional indicating the type of service rendered, including the related travel and accommodation costs (excluding meals and beverages).

The Members must make public, on an individual basis, the amount of the transfers of value made with each healthcare organisation or other third parties by way of:

  • Financial support of events (e.g. sponsorship of conventions, congresses and scientific meetings, etc.) aimed at meeting a scientific or other educational/training need as described in paragraphs 2.7.1 and 2.7.2 (excluded meals and beverages)
  • Fees for consultancy activities and professional services, including speaking services, under a specific contract between the Member and the healthcare organisation, indicating the type of service rendered, including the related travel and accommodation costs (excluding meals and beverages);
  • Donations in cash or cash equivalents provided to the HCO

The following transfers of value shall also be published in aggregate form:

  • All donations in cash and cash equivalents to third parties, other than the HCO
  • Costs for research and development activities
  • Scholarships

LAW: All payments to HCPs employed by NHS except in the following cases:

  • Collaborations with journals, encyclopedias or similar publications
  • Economic use of the HCP’s intellectual property
  • Participation in seminars or conferences
  • Whenever only the costs are reimbursed to the HCP
  • When the performance of the services puts the HCP in “leave” from his/her position
  • Assignments pursuant to a role or position in trade unions
  • Training activities and training directed to employees of the public administration as well as scientific research

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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