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Austria
transparency obligations overview

Latest update: 29 November 2018 | Important Notes
PHARMACEUTICAL

Report Due Date

Yearly, within 6 months after the end of the calendar year

Authority

Pharmig

Who Must Report

Pharmig

Covered Recipients

Healthcare professionals (HCPs) and healthcare organizations (HCOs)
MEDICAL DEVICE

Report Due Date

Yearly, within 6 months of the end of the relevant reporting period. Reporting period means a full calendar year (starting on 1 January and ending 31 December)

Authority

MedTech (Austromed)

Who Must Report

Members of MedTech and members of industry associations that are members of MedTech

Covered Recipients

Healthcare organizations

Pharmaceutical Companies

What is reported:

Transfers of value in connection with:

  • Research and development
  • Donations and subsidies
  • Events
  • Services rendered and consulting provided, including expenses incurred

Individual disclosure is required, except in the case of research and development, where aggregate disclosure is sufficient.

The information to be disclosed is to be broken down as follows:

  1. Transfers of value granted to individual healthcare professionals:

    • Transfers of value granted in connection with events:
      1. Admission and attendance fees
      2. Travel costs and costs for overnight accommodation
    • Fees for services rendered and consulting provided, distinguishing between the payment of fees and reimbursement of expenses
  2. Transfers of value granted to individual institutions:

    • Financial or material donations as well as subsidies
    • Transfers of value granted in connection with events:
      1. Admission and attendance fees
      2. Support of institutions or third parties appointed by such institutions for implementing the event
      3. Travel costs and costs for overnight accommodation
    • Fees for services rendered and consulting provided, distinguishing between the payment of fees and reimbursement of expenses. If transfers of value under Article 9.4A have been allocated indirectly to healthcare professionals via an institution, only one disclosure shall be made.

      Disclosure shall be made in aggregate form without stating the names of the individual healthcare professionals and/or institutions if the relevant ToV relate to research and development. This includes also the reimbursement of expenses for attendance at events in connection with research and development activities.

How to Report

The information shall be disclosed in German or English on a publicly accessible website for which the pharmaceutical companies are responsible. The information shall be disclosed for a duration of at least 3 years starting from the date when it was first disclosed, unless a shorter duration is mandatory for legal reasons.

Template: See page 35 of link mentioned in resources at “ORDINANCE 2/2014 ADOPTED BY THE BOARD OF PHARMIG ON ARTICLE 9 OF THE PHARMIG CODE OF CONDUCT (TRANSPARENCY)”

Medical Device Companies

If applicable (e.g. if your company is a member of MedTech or an industry association that is a member of MedTech): kindly refer to ‘Europe – Medical Device Companies’ for the summary in line with the MedTech Europe Code of Ethical Business Practice.

What is reported:

If not already obliged by local laws/regulations, companies need to make public the aggregate spend regarding educational grants on a yearly basis.

How to Report

An example of the template can be found in annex II of the following source:
MedTech_Europe_Code_of_Ethics.pdf
Disclosures shall be made on the EthicalMedTech website (ethicalmedtech.org) unless the Member Company is already bound by national laws, regulations or professional codes as regulated in Section 1.2 Applicability of these Disclosure Guidelines.

Resources

MedTech Code:
MedTech_Europe_Code_of_Ethics.pdf
Link to MedTech Code currently published on MedTech website:
http://www.medtecheurope.org/legal-and- compliance/code
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 such cases, your company only needs to disclose the transfers of value on the mentioned due date if your company is a member of that association).
  • “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 to give HCPs/HCOs the opportunity to check the data that the pharmaceutical companies/medical device companies are going to disclose.
  • The information does not take into consideration:
    • 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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