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Finland
transparency obligations overview

Latest update: 14 September 2018 | Important Notes
PHARMACUETICAL

Report Due Date

Within six months from the end of the reporting period.

Authority

Pharma Industry Finland (PIF)

Who Must Report

PIF members

Covered Recipients

Healthcare professionals (HCPs) and healthcare organizations (HCOs) that have their place of business in Europe.
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:

Economic benefits targeted at healthcare organisations or professionals (persons entitled to prescribe or dispense medicines) who have their principal place of business, work address or registered domicile in Europe. Economic benefit refers to all direct or indirect transfers of economic value either in cash, in benefits in kind ,or other forms of benefit:

  1. Sums allocated to healthcare organisations:
    • Donations and grants
    • Contributions to the costs of events
    • Service and consultation fees
  2. Sums allocated to healthcare professionals
    • Contributions to the costs of events
    • Service and consultation fees

The following is reported: The name of the recipients and their places of work, as well as the value and form of the benefit or fee. For data security reasons, the publication of data on individuals requires the consent of the person in question. If such consent is not obtained, the data is disclosed without the name of the person involved.

How to Report

The publication should be done in Finnish language on the company’s website, following PIF’s template (see page 5 of: Pharma Industry Finland Code of Ethics Q&A). The company must provide a brief presentation of the methods used in the publication and identification of each category.

Note

“Section 91c (1112/2010) Holders of marketing authorisation or registration and other parties engaging in the marketing of medicinal products must keep available for public review an up-to-date list of all direct and indirect financial and comparable support which they have given to associations in the fields of medicine and health care and to patient organisations.” (See: https://www.fimea.fi/documents/160140/765540/18580_Laakelaki_englanniksi_paivitetty_5_2011.pdf – note: Unofficial translation; Amendments up to 1340/2010 included)
The transparency obligation regarding patient organizations is also included in the PIF Code. “IV CODE FOR THE CO-OPERATION BETWEEN THE PHARMACEUTICAL INDUSTRY AND PATIENT ORGANISATIONS 46 § Transparency. The pharmaceutical company must ensure that the support provided by it will be disclosed in an appropriate manner in connection with the sponsored activities.” See: http://www.pif.fi/sites/default/files/attachments/lt_code_of_ethics_2017_netti_final_id_128083_0.pdf )

Medical Device Companies

Saileb (the industry association for medical device companies) refers to the MedTech Code. Therefore, refer to the overview below, which summarizes the rules of the MedTech Code. See:
https://www.sailab.fi/tietoa-ja-tyokaluja/suositukset/code-of-business-practice/

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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