HCP/HCO DISCLOSURE – METHODOLOGICAL NOTE
1. Introduction
Johnson & Johnson Innovative Medicine (J&J IM) is committed to transparency and integrity in its interactions with Healthcare Professionals (HCPs) and Healthcare Organisations (HCOs). These interactions support the advancement of medical science, patient care, and the appropriate use of medicines. In line with the EFPIA Code on Disclosure of Transfers of Value and its transposition into applicable national codes, J&J IM discloses its Transfers of Value (ToVs) made to HCPs and HCOs.
2. Definitions
Recipients
In the context of EFPIA Code on Disclosure of Transfers of Value, this term refers to any HCP or HCO whose primary practice, principal professional address or place of incorporation is in Europe.
Healthcare Professionals (HCPs)
Any natural person who is a member of the medical, dental, pharmacy, or nursing professions, or any other person who may prescribe, purchase, supply, recommend, or administer medicinal products.
Healthcare Organizations (HCOs)
Any legal person or organisation that is a healthcare, medical, or scientific association or organisation through which one or more HCPs provide services.
Note: from the above-mentioned Recipients, we also report inactive accounts, which could include retired or deceased HCPs. Our reporting is based on the last known address of the HCP, by the time the Transfer of Value activity took place.
Kind of Transfers of Value:
- Direct Transfer of Value:
All payments made by the Company directly or indirectly, whether in cash, in kind or otherwise, or any reimbursement, to Recipients such as fees for services, related expenses for Speakers’ and Consultants’ services, grants, donations and sponsorships to HCOs. - Indirect Transfer of Value:
Refers to transfers of value made on behalf of another party, typically involving expenses related to travel, accommodation, or event registration. - Research & Development (R&D) Transfers of Value:
Are Transfers of Value to HCPs or HCOs related to the planning or conduct of (i) non-clinical studies (as defined in OECD Principles on Good Laboratory Practice); (ii) clinical trials (as defined in Directive 2001/20/EC); or (iii) non-interventional studies that are prospective in nature and that involve the collection of patient data from or on behalf of individual, or groups of, HCPs specifically for the study (Section 15.01 of the HCP Code).
3. Disclosure Scope
The disclosure report covers all direct or indirect costs, including R&D costs, related to Prescription-only Medicine and, to the extent applicable, accompanying devices, provided by J&J IM to Recipients.
Excluded Transfers of Value
The following is a non-exclusive list of Transfers of Value that we exclude from our disclosure report:
- Activities incurring Transfer of Value where J&J IM has no visibility of the ultimate beneficiary (e.g., blinded market research).
- Purchases and sales of medicines in the ordinary course of business
- Meals
- Charities and charitable contributions not addressed to HCOs / Patient Organizations
- Transfers of Value by a distributor/sales intermediary NOT made on behalf of/at the direction of a J&J IM Company; those Transfers of Value must be disclosed by the distributor/sales intermediary and not by the J&J IM Company
- Product samples
Transfer of Value Reporting Policy
In general, J&J IM reports Transfer of Value in the calendar year in which the payment was executed or the activity took place.
Direct costs such as fees for service and reimbursements for out-of-pocket costs, donations, grants or sponsorships to HCOs will be included in the calendar year in which we executed the actual payment or reimbursement in our financial systems.
Although our company policies generally prohibit the reimbursement of out-of-pocket expenses, any such expenses paid under exceptional circumstances are disclosed in the calendar year in which they are paid.
Indirect costs such as travel (e.g. flight ticket), accommodation (e.g. hotel room cost) and registration fees will be included in the calendar year during which the activity occurred.
In case of payments through a third party, our payment date to the third party is used as the determining factor to allocate the payment to the related calendar year.
Research & Development (R&D)
In accordance with EFPIA disclosure requirements and the Belgian Sunshine Act of 18 December 2016, all R&D Transfer of Value to HCPs or HCOs are disclosed in aggregate amount per country. This means that no individual reporting is done on the public disclosure.
Non-Monetary Transfers of Value
Benefits in-kind are reported based either on the cost paid by J&J IM or on their current fair market value as calculated based on objective external parameters. The value assigned to each benefit in-kind is stated in the contract with the Recipient.
Partial Attendance, Cancellation, and Reimbursement
Non-recoverable cancellation costs are disclosed in the name of the HCP for whom the costs were incurred.
Cross-Border Activities
Transfers of Value to any HCP/HCO of a country that is in scope of the EFPIA disclosure code will be reported in their country of residence, regardless of which J&J IM company organized and/or made the Transfer of Value.
Voluntary Disclosure Not applicable (N/A).
4. Specific Considerations
Country unique identifier
For each Recipient J&J IM will report the country unique identifier that is available in its Customer Relationship Management System (CRM), if applicable and required following local country’s disclosure rules and regulations.
Self-incorporated HCP
In accordance with the Belgian Sunshine Act of 18 December 2016 and the Royal Decree of 14 June 2017, all transfers of value are disclosed under the name of the individually identified HCP, even if the HCP was contracted and/or paid through an HCO.
If an HCO contracts a third party (Professional Congress Organizer or PCO) to organize a scientific meeting on its behalf, the transfer of value is reported under the HCO, regardless of whether payment was made to the HCO or the PCO.
Multi-year agreements
For contracts that span across multiple years, typically a split payment approach is used. This means that the total value is transferred in multiple, separate payments over time. Each of these separate payments will be included in the calendar year in which we executed the actual payment or reimbursement in our financial systems.
Country-Specific Features
Not applicable (N/A).
Quality Controls
J&J IM conducts regular data quality reviews and reconciliation procedures to maintain high data standards and facilitate continuous process improvement.
Disclaimer: Although we strive for efficient and fast processing, it might occur that payment information becomes available only after the date of publishing. We expect this to be exceptional and will monitor actual occurrences. In the event of significant changes compared to the original publication, we will publish an amendment within a reasonable period of time.
5. Data Protection Legal Basis
In accordance with the Belgian Sunshine Act of 18 December 2016 and the Royal Decree of 14 June 2017, all recipients of transfers of value will be uniquely identified by means of a specific identification code:
- The Crossroads Bank for Enterprises (CBE) number, which identifies Healthcare Organizations (HCOs) and Patient Organizations.
- The INAMI/RIZIV number, which identifies Healthcare Professionals who have a single INAMI/RIZIV number.
- The National Register Number, which identifies Healthcare Professionals who do not have an INAMI/RIZIV number or who have multiple INAMI/RIZIV numbers.
6. Form of Disclosure
Date of publication
Transfers of Value are published annually in accordance with EFPIA and national code timelines and made available via the appropriate disclosure platform.
Disclosure Platform We inform you that the privacy policy on the external site may be different from the jnj.innovativemedicine.com website. We inform you that the privacy policy on the external site may be different from the jnj.innovativemedicine.com website.
The statutory transparency obligation requires J&J Innovative Medicine (J&J IM) to document and disclose annually all transfers of value provided directly or indirectly to Healthcare Professionals (HCPs), Healthcare Organizations (HCOs), or Patient Organizations on the betransparent.be
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Grants and benefits provided in the context of Research & Development (R&D) activities (as defined in Chapter 2) are also disclosed on this platform. However, these are reported on a non-individualized, aggregated basis, without revealing the identity of the recipient.
The published data remain publicly available in the transparency register for a period of three years, after which they are removed.
In addition, J&J IM maintains an internal record of all transfers of value, which can be consulted via the J&J Transparency website.
Language of Disclosure
Disclosure is done in the local language.
7. Disclosure of Financial Data
In accordance with the Belgian Sunshine Act of 18 December 2016 and the Royal Decree of 14 June 2017, all payments are reported excluding VAT.
The published amounts relating to transfers of value may not be used for VAT or other tax reporting purposes. If a tax certificate is required, the company will provide it directly to the relevant HCPs or HCOs.
All reported values are disclosed in the national currency, i.e., the currency of the country in which the information is published.
Transfers of value for which the original payment was made in a currency other than the national currency are converted into the national currency. Information regarding the exchange rate used may be provided on a case-by-case basis.
8. Additional Information
We rely on a combination of automated systems, standardized processes, and manual data entry from internal and external sources to record relevant data and finally report it. The information reported in this submission reflects our good faith and best efforts to comply with the requirements of the EFPIA Disclosure Code and the Belgian Sunshine Act. Should we, despite our best efforts to ensure accurate reporting, fail to include complete and correct information in our submission, we will appropriately investigate and address in case of erroneous information.
The disclosed transfers of value published on this website in accordance with the requirements of the EFPIA Disclosure Code and the Sunshine Act may only be used to satisfy the applicable legal publication requirements. The reported amounts must not be used as supporting documentation for tax filings or any submissions to tax authorities or similar purposes.