Pharmaceutical Companies and Medical Device CompaniesNote:
The Ministry informed stakeholders that for the first reporting period, between January and March 2020 (ToVs made in favor of a Receptor from July – Dec 2019), the ToV will not be published. The Ministry mentioned that they will make an official announcement in this respect. However, so far, we were not able to confirm this statement as we did not yet see an official announcement (until 31 May 2019). We will post additional information on our Legislative Watch as we learn more.
What is reported:
Transfers of value (‘ToV’) to people who perform any of the following activities in ‘the national territory’ in the Health Sector:
- Prescribe services, pharmaceutical products, and health technologies
- Work or provide services in a public or private institution in the health sector
- Are responsible for purchasing of pharmaceutical products and health technologies
- Lead or teach courses, programs or professional careers related to topics in the health field, in universities or other types of teaching or research entities
- Work or provide services covering health issues in any communication media
Likewise, the legal persons constituted as follows are considered recipients:
- Organizations of professionals in the health sector
- Societies or associations that are scientific, medical, or trade-union in nature
- Professional associations in the health area
- Educational institutions
- Organizations of patients or caregivers
- Non-governmental organizations, foundations, associations and corporations that participate, directly or indirectly, in providing or receiving health services
- Benefit Plan Administrating Entities -BPAE and health service providers
- Communication media that cover topics related to health
The following ToV:
- Delivery and/or payment for food and beverages
- Payment for travel, including transportation, accommodations, and travel allowances
- Financing for the performance of clinical studies and health research
- Supplying of licenses for the use of software and registration in databases
- Funding for registration, enrollment, or participation in a college or educational program, round table discussion, workshop, meeting, seminar, symposium, conferences, scholarship or other exclusively academic or continuing medical education activities
- Funding for the organization or celebration of conferences, round table discussions, workshops, meetings, seminars, symposia, conferences, events and other exclusively academic or continuing medical training activities
- Funding for publications or subscriptions to books, brochures, magazines, scientific articles, etc.
- Funding of patient programs, including those carried out directly by those required to report
- Delivery of documents or objects that contain printed promotional advertising information
- Delivery of medical samples
- Payment of fees for service provider contracts
- 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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