transparency obligations overview

Latest update: 2 October 2019 | Important Notes

Pharmaceutical Companies and Medical Device Companies

What is reported:

  • Product education and training
  • Modest meals in conjunction with product education and training
  • Honoraria, consultant, speaker fees and related out-of-pocket expenses
  • Reasonable travel and lodging necessary for training
  • Demonstration or evaluation units
  • Educational gifts (journal articles, anatomical models, textbooks)
  • Charitable donations
Data points to be disclosed:

  • Company ID
  • Covered recipient ID
  • Covered recipient full name
  • Category payment ID
  • Amount of payment
  • Number of events reflected
  • Disclosure report period
  • License type
  • License number

Covered Recipients

A covered recipient is anyone or any organization that is in a position to decide which prescription drugs and medical devices are:

  • Prescribed and dispensed to patients
  • Purchased for patients, e.g., in a hospital or nursing home
  • Recommended for use by a patient as part of a course of treatment or treatment plan
  • Purchased as a diagnostic tool or therapeutic equipment
  • Covered by an insurance provider for subscribers to or participants in a health plan

A covered recipient could be an individual, such as a:

  • Doctor
  • Dentist
  • Pharmacist
  • Nurse practitioner
  • Audiologist
  • Podiatrist
  • Physical therapist

A covered recipient is also the person or persons who decide what prescription drugs or medical devices an employer will allow as part of that company’s employee health benefit plan. Massachusetts-licensed practitioners are covered recipients, regardless of whether they are actively practicing or where they practice.

A covered recipient could be a facility or program, such as a hospital, nursing home, clinic, hospice program, clinical laboratory, home health agency or pharmacy.

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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