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transparency obligations overview

Latest update: 29 November 2018 | Important Notes
PHARMACEUTICAL

Report Due Date

Within 6 months after the end of the relevant reporting period

Authority

AIFP

Who Must Report

Members of AIFP

Covered Recipients

Healthcare professionals (HCPs) & 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

Who Must Report

Members of MedTech

Covered Recipients

Healthcare organizations

Pharmaceutical Companies

What is reported:

  1. For transfers of value to an HCO, any amount related to any of the categories set forth below:

    • Donations and grants
    • Contribution to costs related to events
    • Fees for service and consultancy
  2. For transfers of value to an HCP:
    • Contribution to costs related to events, such as:
      1. Registration fees
      2. Travel and accommodations
    • Fees for service and consultancy

How to Report

  • Aggregate Disclosure: For transfers of value where certain information, which can be otherwise reasonably allocated to one of the categories set forth above, cannot be disclosed on an individual basis for legal reasons, a Member Company shall disclose the amounts attributable to such transfers of value in each reporting period on an aggregate basis. Such aggregate disclosure shall identify, for each category, both:
    1. the number of recipients covered by such disclosure, on an absolute basis and as a percentage of all recipients
    2. the aggregate amount attributable to transfers of value to such recipients.
  • Non-Duplication: Where a transfer of value required to be disclosed is made to an individual HCP indirectly via an HCO, such transfer of value shall only be required to be disclosed once. To the extent possible, such disclosure shall be made on an individual HCP named basis.
  • Research and Development Transfers of Value: Each Member Company shall disclose research and development transfers of value in each reporting period on an aggregate basis. Costs related to events that are clearly related to activities covered in this section can be included in the aggregate amount under the “Research and Development Transfers of Value” category.
  • Methodology: Each Member Company shall publish a note summarising the methodologies it used to prepare the disclosures and identifying the transfers of value for each category. The note, including a general summary and/or country-specific considerations, shall describe the recognition methodologies applied and should include the treatment of multi-year contracts, value-added tax (VAT) and other tax aspects, currency aspects and other issues related to the timing and amount of transfers of value for purposes of this Code, as applicable.

Template:

http://www.efpia-e4ethics.eu/usd/e4ethics.nsf/_/AD436DEE9801348BC125806E003BB6B2/%24File/FARMA_129365.pdf

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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