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Estonia
transparency obligations overview

Latest update: 29 November 2018 | Important Notes
PHARMACUETICAL

Report Due Date

Law: 1 February, annually
Code: Yearly, six months after the end of financial year.

Authority

Law: State Agency of Medicines
Code: APME

Who Must Report

Law: The holder of a marketing authorisation for a medicinal product
Code: Members of APME

Covered Recipients

Law: Pharmacists, assistant pharmacists, persons qualified to prescribe medicinal products and their associations
Code: Healthcare professionals (HCPs), pharmacists and healthcare organizations (HCOs)
MEDICAL DEVICE

Report Due Date

Annually, not later than 6 months after the end of the relevant reporting period. Each reporting period covers full calendar year, starting on 1 January and ending 31 December.

Authority

MedTech

Who Must Report

Members of MedTech

Covered Recipients

Healthcare organizations

Pharmaceutical Companies

What is reported:

Law: By 1 February each year, the holder of a marketing authorisation for a medicinal product must submit to the State Agency of Medicines a report concerning support awarded the previous year under subsections 86 (2: gifts) and (5: support a medical or pharmaceutical event organised by a research institution or professional organisation) of the Medicinal Products Act to pharmacists, assistant pharmacists, persons qualified to prescribe medicinal products and their associations for the purpose of participation in or organisation of medical or pharmaceutical events, and on the meetings and patient information events organised, samples distributed and discounts made based on subsection (6) of the same section. A report on advertising of medicinal products submitted by a marketing authorisation holder is public information.

Code: Payments made either directly or indirectly to healthcare professionals, pharmacists or healthcare organizations during a calendar year shall be disclosed six months after the end of financial year on the APME member companies’ website according to the APME ethical code Appendix C methodology and Table C1 Data disclosure form.

Payments referred to in the previous sentence (hereinafter referred to as “payments”) paid to healthcare professionals, pharmacists, healthcare organizations or to third parties on their behalf (for example, to service providers such as accommodation establishments), including:

  • Registration fees for events (e.g. conferences)
  • Travel and accommodation expenses for events
  • Service or consultancy fees
  • Studies or development related fees
  • Payments to healthcare organizations:
    1. Donations
    2. Grants

How to Report

Law: The minister responsible for the field will establish the standard form of and procedure for submitting the report specified in subsection (6) of this section

Code: On APME member companies’ website according to the APME ethical code Appendix C methodology and Table C1 Data disclosure form. The disclosure of the data shall be made at APME member companies website in Estonian and, if needed, in English no later than 1 June after the end of the relevant reporting year.
Research and development transfers of value shall be disclosed on an aggregate basis and all other payments are disclosed in personalized way.

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:
MedTechEurope_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:
MedTechEurope_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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