Pharmaceutical Companies and Medical Device CompaniesWhat is reported:
Companies need to report their collaborations with Danish HCPs (e.g. services between industry and HCPs), except if the interaction is related to Class I products (devices).
The reporting obligation of the company does not include the actual fees paid to the HCP; however, the National Board of Health may request this information at a later stage.
The HCPs have to report the actual fees received. Companies have the obligation to inform the Danish HCPs of their obligation to report/apply for permission.Who must report:
Pharmaceutical and medical device companies, including:
- Companies authorized by the Danish Medicines Act § 7, paragraph 1 (marketing) or a license under § 39 paragraph 1 (business license). Public hospitals and the regional drug organization Amgros are not covered.
- Manufacturers that market medical devices in hazard class IIa, IIb or III, medical devices for in vitro diagnostics or active implantable medical devices, representatives of the manufacturers of this type of product, as well as importers and distributors of this type of product, established in Denmark are covered by the rules.
- Stores established in Denmark, specialized medical equipment suppliers in risk class IIa, IIb or III, medical devices for in vitro diagnostic or active implantable medical devices and representatives of such transactions are covered by the rules. This includes specialized businesses when medical equipment accounts for more than 50 percent of the store’s product range and turnover.
- 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 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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