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Poland
transparency obligations overview

Latest update: 29 November 2018 | Important Notes
PHARMACEUTICAL

Report Due Date

Annually, within 6 months of the end of the year

Authority

INFAMRA

Who Must Report

Members of INFARMA

Covered Recipients

Healthcare professionals (HCPs) or 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:

Transfers of value to healthcare professionals:

  1. Transfers of value to healthcare professionals:

    • Expenses incurred in relation to the events:
      1. Registration fees
      2. Travel and accommodation
    • Compensation for any services provided by a HCP:
      1. Remuneration
      2. Additional expenses reimbursed or incurred
    • Transfers of value relating to research and development
    • Expenses other than those from the aforementioned categories
  2. Article 9 Transfers of Value to Healthcare organisations:

    • Donations
    • Expenses incurred in relation to the events:
      1. Registration fees
      2. Travel and accommodation
      3. Value of sponsorship agreements concluded with Healthcare organisations or third parties (including providers of commercial services) to organise an event
    • Compensation for any services provided by Healthcare organisations:
      1. Remuneration
      2. Additional expenses reimbursed or incurred
    • Transfers of value relating to research and development
    • Expenses other than those from the aforementioned categories

How to Report

A disclosure consists in the publication of the standardised template in the form set out in Appendix 1 to the Transparency Code (“Standardised Template”), filled out in Polish, on the website of a signatory of the Transparency Code. At the end of the standardised template, signatories of the Transparency Code describe in detail their methodology, in particular the method of assigning transfers of value to beneficiaries, the treatment of multi-year contracts, tax issues, currency issues and any other issues relating to dates and amounts. The transfers of value shall be disclosed in Polish zlotys (PLN). The standardised template shall include total transfers of Value to Beneficiaries from the signatory of the Transparency Code and from companies of the signatory’s capital group.

Requirements for individual disclosure:

  1. In principle, transfers of value shall be disclosed by assigning to each identifiable beneficiary an amount corresponding to the transfer of value made to that recipient in the relevant reporting period.
  2. Transfers of value made to a beneficiary shall be disclosed under the categories set out above.

Requirements for aggregate disclosure:

  1. If, due to the applicable provisions of law, information about transfers of value received by a beneficiary cannot be disclosed on an individual basis, a signatory of the Transparency Code shall disclose the amounts corresponding to all transfers of value made to that recipient in the relevant reporting period.
  2. For each transfer of value category, the aggregate disclosure shall specify both:
    • the number of beneficiaries concerned, expressed in figures and as a percentage of all recipients who received transfers of value from a signatory of the Transparency Code in the relevant reporting period
    • the total amount corresponding to the transfers of value made to those recipients
  3. Transfers of value relating to research and development shall be disclosed by a signatory of the Transparency Code by disclosing a single amount: the sum of all transfers of value under that category made to all recipients in the relevant reporting period.

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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