Pharmaceutical Companies (Generic Companies)What is reported:
Transfers of Value to Patient Organizations:
- Support: financial and in-kind support
- Fee for services: contracted services per Patient Organization, including a description of the nature of the Transfer of Value (educational summer camp, disease awareness world day, development of information brochures for an awareness campaign, etc.) and the amount provided
Transfers of Value to Healthcare Professionals:
- Fees for services and consultancy: aggregated honoraria (excluding expenses such as meals and drinks, travel and accommodation) paid by a Company to a Healthcare Professional in exchange for the provision of services, such as serving as an expert on an advisory board, speaking at a company-organized educational event, participating in a focus group, etc.
Note: Fees paid in connection with research & development activities or market research, are excluded from the scope of disclosure.
- Meetings, educational support and site visits: Medicines for Europe member companies have two options for disclosure and may decide (for themselves and for their affiliates) which option to adopt for disclosure in this category:
Total number (but not actual monetary value) of events, for which an individual Healthcare Professional has received support (which may include payment of registration fees, travel and/or hotel costs).
Support shall be disclosed per individual Healthcare Professional in the following categories and sub-categories:
- Sponsorship for attending a third party organized congress, where the company pays for registration fees, travel or accommodation. Indicate whether each event is local/domestic, within Europe or outside of Europe.
- Site visits
- Company organized meetings for which a Healthcare Professional receives company funded hotel accommodation and/or airplane travel
Aggregate total amount of support provided to Healthcare Professionals per individual conference or meeting as follows:
- Sponsorship for attending a third party organized congress:
- name of congress,
- aggregated amount spent for the congress, including the
- number of Healthcare Professionals financially supported to attend.
- Site visits: aggregated amount spent, including the number of Healthcare Professionals financially supported to attend
- Company organized meeting: aggregated amount spent, including the number of Healthcare Professionals financially supported to attend
- Transfers of Value to Healthcare Organizations:
- Fees for services and consultancy: aggregated honoraria (excluding expenses such as meals and drinks, travel and accommodation) paid by a Company to a Healthcare Organization in exchange for the provision of services, such as serving as an expert on an advisory board, speaking at a company-organized educational event, participating in a focus group, etc. Fees paid in connection with research & development activities or market research, are excluded from the scope of this disclosure.
- Grants and donations: aggregated monetary amounts and a brief description of the nature of the grant or donation (e.g. research grant, equipment donation, product donation, etc.)
- 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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