Gilead Sciences : EFPIA Methodological Note 2024 (gilead sciences efpia methodological note 2024)

Published: 2025-06-02 06:45:05 ET GILD

Published on 06/02/2025 at 06:45

Introduction 2

Definition of Transfers of Value 2

Definition and management of Cross-Border Spend 3

Which Recipients of Transfers of Value are reported by Gilead 3

How Transfers of Value are captured and recorded by Gilead 4

Direct Spend 4

Indirect Spend 4

ToV Dates 4

Treatment of Tax 5

Currency Management 5

How Gilead manages Consent 5

How Gilead avoids reporting duplicate transactions 5

How Gilead checks the accuracy of reports 6

Publication of reports 6

Glossary 7

This methodological note is intended to help readers understand how the Transfers of Value (ToVs) from Gilead Sciences Inc. and its Affiliates (Gilead) to Healthcare Professionals (HCPs) , Healthcare Organisations (HCOs) and Patient Organisations (collectively referred to as Reportable Recipients) within EFPIA countries have been collated and reported. This note covers all EFPIA countries and highlights any differences in specific countries where they may exist.

A glossary has been included at the end of this methodological note containing an alphabetical list of the main terms used within this note and their definitions. The terms in the glossary are always capitalised and appear in bold on first use within this note to aid lookup. The glossary also contains hyperlinks to other terms defined within the glossary to aid understanding.

Gilead began its EFPIA transparency reporting project in 2013 to supplement existing country transparency reporting mechanisms in Denmark, France, Netherlands, Portugal, and UK. This was to ensure that Gilead would be ready to capture all relevant ToVs to Reportable Recipients prospectively throughout 2015 prior to the first EFPIA disclosure in 2016.

To enable Gilead to have assurance that all ToVs to all Reportable Recipients will be reported in the correct format and language(s) for each country, it was decided to automate and standardise data extraction as far as possible and to use a Reporting Engine supplied by a Reporting Engine Provider to produce the reports.

To help with checking and managing the data locally, Gilead has engaged a Transparency & Monitoring Specialist for each Gilead Affiliate who is responsible for ensuring completeness and accuracy of data.

ToVs may arise from the following broad types of activity (there are others):

Advisory Boards - HCPs give Gilead independent advice and contribute with their expertise on particular aspects of Gilead's strategy or the use of Gilead's medicines, where the knowledge cannot be obtained within Gilead. Patient Organisations via their representatives also may give Gilead independent advice and contribute via their personal experiences where the knowledge cannot be obtained within Gilead. Gilead may pay an honorarium to each participant and / or pay their travelling expenses to the place where the meeting is being held.

Meetings - Gilead arranges meetings for HCPs on different topics such as education on a specific therapy area or other scientific events. The knowledge and expertise of HCPs are often needed to help conduct these events. Gilead may arrange meetings focusing on disease awareness. The knowledge and expertise from Patient Organisations is often needed to help conduct these events. Gilead may pay an honorarium and/or travelling expenses to the consultants and Patient Organisation representatives participating in these events.

Individual support - Gilead may support one or more HCPs or members of Patient Organisations to attend a scientific conference or congress which might include paying the HCPs' conference fees and / or their travelling expenses.

HCO Sponsorship - Gilead may Sponsor one or more HCOs who will choose which HCPs to send to a conference. In this case, Gilead does not know which HCPs received the ToVs and will therefore report the ToVs against the relevant HCOs.

Clinical trials - Gilead pays HCOs to participate in clinical trials which are an essential part of ensuring that medicines are effective and have an appropriate safety profile. Gilead may also pay travelling expenses for HCPs involved in clinical trials to travel to meetings with other HCPs involved in the same clinical trials. Clinical trials ToVs are reported within the aggregated figure for research and development activities within each country provided the clinical trials are not Non-Interventional Retrospective. Following the relevant EFPIA guidance, any ToVs for Non-Interventional Retrospective clinical trials are reported at individual level as fees for services and associated travelling expenses.

Market research - small ToVs might be made to HCPs in return for answering questions about Gilead products and / or a therapeutic area. Gilead generally participates in "double blinded" market research where it does not know the identities of the participants. Gilead has therefore not reported any ToVs for these market research activities.

Investigator Sponsored Research - research may be undertaken by individual HCPs and / or HCOs where they would like to investigate a particular aspect of a Gilead medicine. This type of research, where supported by paying a Grant to the relevant HCO, is reported as a ToV under the appropriate heading.

Grants and Donations - Gilead may make grants or donations to HCOs or Patient Organisations to enhance patient care or for the purpose of supporting research or education, with no consequent obligation on the recipient to provide goods or services to the benefit of the donor in return.

Note that food and drink is not reportable under the EFPIA Code.

Some ToVs to Reportable Recipients are made by a Gilead Affiliate, or on behalf of a Gilead Affiliate, that is not the "home country" (country of principal practice) of the Reportable Recipient receiving the ToVs. For example, Gilead UK might make ToVs to a German HCP, or an events agency working for Gilead's European Head Office might make ToVs to several HCPs from different countries. This is called Cross-Border Spend.

Any ToVs made by, or on behalf of, any Gilead Affiliates to Reportable Recipients within EFPIA countries, including Cross-Border Spend, are captured as described under "How Transfers of Value are captured and recorded by Gilead".

Gilead has flagged all Reportable Recipients as defined under the EFPIA Code within its internal systems to aid extraction of relevant ToVs. The Reportable Recipients are defined in the Glossary.

Where HCPs have set up separate legal entities through which to deliver their services, Gilead discloses the transfer of value under the names of the HCPs themselves wherever clearly identifiable; otherwise, the transfer of value is disclosed under the name of the legal entity, being treated as an HCO.

Where Gilead has made a transfer of value to a department within an HCO, that transfer of value is disclosed under the name of the HCO, not the department.

In all EFPIA reporting countries, the local reporting template used is in the local language(s) and includes any additional fields required by particular countries such as a specific unique identifier for HCPs and / or HCOs.

Professional Congress Organisers (PCO) are not reportable recipients. Transfers of Values made to PCOs are disclosed under the end recipients (HCOs or HCPs) if they are clearly identifiable and the exact values transferred to them are made available by the PCOs.

Gilead makes some ToVs directly to Reportable Recipients; these transfers are referred to as Direct Spend. Direct Spend typically covers items such as fees for services and associated travelling expenses, plus any non-monetary ToVs made to HCPs via Gilead employee out-of-pocket expenses.

Gilead has modified its Enterprise Resource Planning (ERP) system and employee expense reimbursement system to extract all Direct Spend to any Reportable Recipient into a standardised format. These data are uploaded into an internal database where they are checked and stored temporarily before being transferred to the Reporting Engine.

ToVs made to Reportable Recipients by Third Party Vendors on behalf of Gilead are called Indirect Spend. Indirect Spend typically covers travel and accommodation at meetings and conferences and may also include honoraria payments.

Gilead uses a template Excel spreadsheet to enable Third Party Vendors to capture ToVs to Reportable Recipients. The template Excel spreadsheet provides data in the same standardised format, which are then treated in the same way as for Direct Spend as described above.

The date recorded against each ToV determines the ToV reporting period. The ToV date recorded by Gilead is the payment date except for the following instances:

Air / Rail Travel: The ToV date is the departure date of the respective trip.

Travel Transfers: The ToV date is the date the transfer was provided; and

Accommodation: The ToV date is the latest date on which the accommodation was provided (i.e. the last day of the hotel stay).

Some payments were made in 2024 for activities that occurred in 2023, and these are reported as ToVs in the 2024 report. Equally, some payments were made, and will be reported, in 2024 that relate to activities that occur in 2025.

Where the country implementation of the EFPIA Code permits companies to choose whether to report ToVs inclusive or exclusive of taxes, Gilead has chosen to report inclusive of taxes.

Three EFPIA reporting countries, Austria, Greece and Italy, have mandated that ToVs are reported exclusive of taxes. Gilead has complied with that mandate.

Each ToV is transferred to the Reporting Engine in its original currency. The Reporting Engine has the capability to convert the ToV into any currency enabled within the system. This permits Gilead to publish the required local report in local currency, albeit some ToVs may have been made in a currency other than the local currency.

The Reporting Engine Provider maintains exchange rates within the Reporting Engine using rates obtained from a well-known, reputable provider.

As required by local Data Privacy legislation Gilead has sought Consent from Reportable Recipients for individual disclosure of their ToVs in the EFPIA Report. Such Consent has been obtained either on an engagement-by-engagement basis, or by reporting period, based on Gilead Affiliate business processes.

Gilead does not permit "cherry-picking": either all ToVs made to a Reportable Recipient in a reporting

period are disclosed individually, or they are disclosed in aggregate.

Gilead has put in place several steps to ensure that ToVs are reported only once. The key step is that the Gilead Affiliate that makes the ToV is responsible for capturing the ToV.

Where Gilead works with other pharmaceutical companies, each company reports the ToVs relating to the activities that they organised. For jointly organised events, the companies agree in advance which ToVs will be reported by each company. This mechanism avoids duplicate reporting for joint activities.

Transparency & Monitoring Specialists are responsible for reviewing Reportable Recipient ToVs in the Reporting Engine and taking reasonable steps to identify and resolve any potential duplicates.

As a minimum, Reportable Recipients who Consent to individual disclosure are pre-notified of the ToVs Gilead intends to disclose in their name, and therefore have the opportunity to identify any duplications or other errors.

Disclaimer

Gilead Sciences Inc. published this content on June 02, 2025, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on June 02, 2025 at 10:44 UTC.