transparency obligations overview

Latest update: 11 October 2019 | Important Notes

Pharmaceutical Companies and Medical Device Companies

What is reported:

  • Samples (separate disclosure template)
  • Device loaners (allowed for up to 120 days)
  • Clinical and research payments
  • Compensation for bona fide services
  • Sponsorship and fellowship payments
  • Educational materials
  • Demo/evaluation units
  • Coupons, vouchers and discount cards
  • Charitable contributions

Data points to be disclosed:

  • Manufacturer’s name
  • Recipient’s name
  • License number of recipient
  • Date of expenditure
  • Value of expenditure
  • Nature of expenditure
  • Purpose of expenditure
  • Product type and name

Covered Recipients

Vermont healthcare providers (HCPs), including healthcare professionals; academic institutions located in or providing services in Vermont; non-profit hospital foundations located in or providing services in Vermont; professional, educational, and patient organizations representing or serving health care providers or consumers located in or providing services in Vermont; and members of the Green Mountain Care Board

  • A Vermont “healthcare provider” (HCP) is a health care professional, a hospital, nursing home, pharmacist, health benefit plan administrator, or any other person authorized to dispense or purchase for distribution prescribed products in Vermont. A hospital foundation that is organized as a nonprofit entity separate from a hospital is not an HCP.
  • A “healthcare professional” is any of the following:
    1. A person who regularly practices in Vermont and is authorized by law to prescribe or recommend prescribed products (such as a licensed clinical social worker or a licensed psychologist), and is licensed or otherwise lawfully providing health care in Vermont
    2. A partnership or corporation made up of persons described in 1 above
    3. An officer, employee, agent or contractor of a person described in 1 above, or a partnership or corporation made up of such persons, who is acting in the course and scope of employment providing healthcare to individuals, including nursing and front-office staff
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 reflects that 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.
  • “Due date” means the date on which the transfers of value need to be published. For example, the deadline for submitting/sending the complete information to the authority could be before the due date e.g. to give HCPs/HCOs the opportunity to check the data 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)
  • If your company is a member of MedTech/EFPIA (or if the industry association your company belongs to is a member of MedTech/EFPIA), the due dates are as mentioned above for MedTech/EFPIA (end of June), unless a law/regulation specifically states otherwise (e.g., the jurisdiction is suspended/exempted from following MedTech/EFPIA).

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