J&J Innovative Medicine Disclosure Methodology

What payment recognition rules do we use?

• Fees for service and reimbursements for Out-of-pocket costs, Donations, Grants Sponsorships to HCOs and financial support to Patient Organisations (POs) will be included in the calendar year in which we executed the actual payment or reimbursement in our financial systems.
  
• Transfers of value related to 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.

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. We will publish a quarterly amendment in case of significant changes to the initial publication.

How do we report TOV related to multi-year contracts?
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.

Are VAT and/or Withholding Tax included?
All payments (e.g. fees for service, Donations, Grants, Sponsorships and other financial support), are reported exclusive of VAT. They include Withholding Tax (when applicable), regardless of whether it is paid directly to the authorities or not.

All TOVs from services or products (e.g. flight ticket, hotel room, …) are reported gross, so inclusive of VAT (and tips) when applicable.

The disclosure reported TOV amounts should not be used for any VAT/Tax reporting purposes. If fiscal reports are required, the company provides them directly to the HCPs/HCOs & POs.

How are different currencies handled?
All values reported are in local currency, i.e. the currency of the country in which disclosure is made.

For TOVs that were originally made in non-local currency, a conversion to local currency is made and exchange rate details can be provided on a case by case basis.

Are TOVs made by non-EFPIA based J&J companies reported?
TOVs to any HCP/HCO/PO 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 company organized and/or made the TOV.

What is reported in case of partial meeting attendance/cancellation?
Only costs related to the partial participation are reported. Costs of cancellation prior the event are not reported as they do not constitute a value transfer to its recipients.

What about related expenses agreed in the fee for service or consultancy contract?
In case an HCP/HCO/PO performs a service or provides consultancy, the related cost of travel, accommodation arrangements provided and any reimbursement of Out-of-pocket expenses as per the contract terms, are reported in the designated EFPIA report section (i.e. “Related expenses agreed in the fee for service or consultancy contract, including travel & accommodation relevant to the contract”).

What is reported in case the TOV is made to/through a third party?
In case an HCP is contracted and paid through an HCO (Health Care Organization) that the HCP is part of, we will disclose the TOV (Service Fee) on the HCO that received the TOV. Any person related expenses, like travel & accommodation, will be reported on the HCP unless otherwise stated in the contract.

What is included in the aggregate disclosure section of the EFPIA reporting template?
The HCP’s aggregate section of the Disclosure reporting template contains the total value per cost type that was transferred to HCPs that have chosen not to be disclosed individually.

According to individual privacy rights, consent to individual disclosure can be withdrawn by HCPs, in which case disclosure is made on an aggregate basis. We apply Consent or withdrawal of consent per HPC for all TOVs for a given year.

What address do we show in the EFPIA report?
We will display the most recent HCP/HCO/PO address that we have in our database at the time of the reporting.

Activities handled through distributors/sales intermediaries
TOVs by a distributor/sales intermediary NOT made on behalf of/at the direction of a J&J Company will be disclosed by the distributor/sales intermediary and not by the J&J Company.

R&D TOV reporting
We report by country and as one annual total amount, all the R&D TOVs to HCPs/HCOs. This means that, aligned with the EFPIA disclosure requirements, no individualized reporting for R&D TOVs is done on the public disclosure.

R&D TOVs are TOVs 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).

Disclaimer
We rely on a combination of automated systems, standardized processes, and manual data entry from internal and external resources 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. 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 TOVs disclosed as per EFPIA requirements and on this site, are only used to meet the EFPIA reporting requirements. The costs are not to be used as backup for any TAX Authority Reporting, or any other reporting similar to this.

CP-459038
September 2024