What is reported:
Law: The value of advertising and marketing expenses and non-monetary benefits provided directly or indirectly to HCPs in the following categories:
- Marketing and drug promotion expenditure
- Clinical trials, non-interventional studies and post-marketing safety studies
- Market research
- Lectures and consultancy
- Registration fees, travel, accommodation and meals
- Gifts and donations
Disclosures must be made at the individual level and include:
- Name and address of the recipient
- Value of the expenditure/benefit
Code: Transfers of value related to:
- Donations and grants
- Contribution to costs related to professional events
- Registration fees
- Sponsorship agreements with healthcare organisations or third parties appointed by HCOs to manage a professional event
- Travel and accommodation
- Fees for services and consultancy
Member companies shall disclose research-and-development transfers of value in each reporting period on an aggregate basis.
Medical Device Companies
What is reported:
Aggregate spend regarding educational grants, including donor name, device name and total amount for the past calendar year
- 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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