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Poland
transparency obligations overview
PHARMACEUTICAL
MEDICAL DEVICE
Pharmaceutical Companies
What is reported:Transfers of value related to:
- Donations
- Events
- Fees for service
- Research and development
Medical Device Companies
If your company is a member of MedTech Europe, disclosure should be done in line with the Disclosure Guidelines of the MedTech Europe Code of Ethical Business Practice (see part 2).
The information included in this overview is based on the Disclosure Guidelines of the MedTech Code.
Polmed, Technomed and MedTech Polska are members of MedTech (see: https://www.medtecheurope.org/about-us/members/). Polmed and MedTech Polska mentioned to MedTech Europe that they will use Transparent MedTech for disclosure.
According to the MedTech Europe Code, National Associations shall transpose their Code at the national level by 1 January 2020 (however, implementation could be done later).
For more (up to date) information and/or the latest version of the national code, kindly refer to the websites of the national associations:
https://polmed.org.pl/ (“POLMED adopted a new Code of Ethical Business Practices, which is an implementation of the MedTech Europe Code of Ethical Business Practice into Polish”)
https://ipddl.pl/ (MedTech Polska refers to MedTech Europe Code on their website: https://ipddl.pl/ipddl/kodeks-etyki. They also included a Polish version of the MedTech Europe Code.)
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.
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 provided reflects the 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 – in most cases – 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 case it is based on codes of conduct, your company only needs to disclose the transfers of value on the mentioned due date if your company is a member of the association that follows that code.
- Including a jurisdiction in the Legislative Watch does not guarantee that jurisdiction is available for reporting via the MediSpend Transparency Reporting Solution.
- Reporting date normally means the date the transfers of value need to be published. The deadline for e.g. submission/sending the complete information to the authority could be before that date, for example to give HCPs and/or HCOs and/or the authority/association who publishes the information, the possibility to check the data the pharmaceutical companies/medical device companies are going to disclose.
- The information does not take into consideration (unless explicitly mentioned):
- 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)
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