Event (Participant) Agreement
11 October 2018
We are pleased to confirm your engagement to attend a meeting of the multi-stakeholder initiative “HIV Outcomes” on 27 November in the European Parliament, Brussels. We look forward to a constructive and informed debate on this issue in the interests of all stakeholders.
In accordance with the compliance and ethical policies of the event’s sponsors, Gilead Sciences and ViiV Healthcare, we attach the Principles of Engagement applicable to your participation.
In order to secure the success and well-being of the meeting, all participants are required to abide by these Principles and your agreement to these terms will be confirmed by your attendance. They relate primarily to ethical codes of conduct and industry regulation but also provide for disclosures pursuant to the EFPIA Codes (and/or local codes or legislation reflecting the same principles, such as the ABPI Code of Practice) where applicable, so please read them carefully.
If you have any questions about the event or the Principles of Engagement, please do not hesitate to contact me on +32 (0) 2 613 28 28 (or firstname.lastname@example.org).
Fipra International Limited
Principles of Engagement
Fipra International Limited, of 6 Hay’s Lane, London SE1 2HB, United Kingdom (“Fipra” or “we” or “us”), is pleased to confirm your participation (the “Engagement“) at the meeting (the “Event“) described in the cover letter sponsored by Gilead Sciences Europe Ltd and ViiV Healthcare “the Sponsors”. We look forward to an active debate and to hear your candid and impartial views, opinions and experience.
We set out the principles applicable to the Engagement:
- You will in the course of the Engagement, and Fipra and the Sponsors will in relation to the Event, abide by all applicable laws and ethical codes (including all relevant industry local codes of practice such as the ABPI Code of Practice for the Pharmaceutical Industry), and make any disclosures required under such applicable laws or codes. Fipra and the Sponsors may each collect and process personal information about you in order to comply with disclosure requirements relating to the Engagement (e.g. your name and attendance at the Event, any direct or indirect costs paid or reimbursed to you in relation to the Event (“transfers of value”) and any presentations given). This is specifically required in respect of HCPs, HCOs and patient groups under the EFPIA Disclosure Code (and local codes reflecting the same principles such as the ABPI Code of Practice) and your Engagement signifies your agreement to such required data processing and disclosure. Such disclosure may be made public on the Sponsors’ websites or those of another third party, such as an industry association’s central platform. You are entitled to withdraw this consent at any time, but your Engagement may have to be terminated and Fipra and/or the Sponsors may still continue to include anonymised data about you in disclosures of aggregate statistics required of any applicable code. Subject to any applicable disclosure requirements outlined above, any personal data provided by you will be treated confidentially and we shall ensure that all our personnel who have access to and/or process that data are obliged to keep it confidential and the data shall not be used by us for any purpose other than as outlined in this agreement or as required by law and we shall not transfer such data outside the European Economic Area.
- The Event is intended to be a scientific exchange and no promotional activities in relation to any product shall take place. In the event that your participation involves presentation or handouts, you will provide the same to us on reasonable request in advance to ensure that they are compliant and factually accurate.
- Nothing in this agreement shall create or be deemed to create a partnership or relationship of employer and employee between us. You will be responsible for compliance with any applicable regulations and administrative procedures in tax and social security matters applicable in your country.
- Without prejudice to the disclosure required in clause 1 above, you will not disclose any confidential information, know-how or other proprietary intellectual property of any third party during or after the Event without such party’s consent. It is intended that there should be an open sharing of information, however participants should be mindful not to use this forum to disseminate competitively-sensitive information or for any form of conduct which would cause them to breach any anti-trust or competition legislation.
- We do not wish to interfere, or put you in a conflict of interest position, with your employment or other obligations to third parties. However, as a healthcare professional, representative of a healthcare organisation, patient group or as a Government Official (as defined in the International Anti-Bribery and Anti-Corruption Principles in Appendix 1) we require you to disclose your participation at the Event to your employer and/or association and/or other third party organisation to which you belong or by whom you are engaged. We attach International Anti-Bribery and Anti-Corruption Principles at Appendix 1. Compliance with the principles in Appendix 1 is contemplated by the Sponsors and is a condition of your Engagement. Furthermore, you represent and warrant that you: i) have the full power and right to enter into this agreement; and ii) will not offer, pay or authorise the offer/payment of any money or the giving of anything of value or do any other thing in order to exert improper influence on any healthcare professional, representative of a healthcare organisation or other Government Official. In addition, as a healthcare professional, representative of a healthcare organisation and/or Government Official yourself, you undertake to us that you have not accepted, and will not accept, any payment or thing that might improperly influence you in that capacity. If you breach this clause 5, we shall, be entitled to end this agreement immediately.
- No expenses or other costs relating to your participation at the Event will be reimbursed to you without the express advance agreement of Fipra. You acknowledge that any such reimbursement may only be carried out strictly in accordance with Fipra’s policies and those of the Event’s Sponsors and will provide all necessary and requested detail to enable compliance with those policies.
- If you have concerns about the legitimacy or the way the Event is established or run, please report these to Fipra.
- These Principles of Engagement and the agreement between us shall be governed by and construed in accordance with the laws of Belgium and each party irrevocably submits to the exclusive jurisdiction of the Belgian courts for all purposes connected with it.
Appendix 1: International Anti-Bribery and Anti-Corruption Principles (and Disclosure Requirements)
Gilead Sciences and ViiV Healthcare (“the Sponsors”) have longstanding corporate policies that prohibit the provision of any payment or benefit to any person or entity in order improperly to influence a government official or to gain an unfair business advantage.
The Sponsors are committed to working with integrity, and acting ethically and legally in accordance with all applicable laws and regulations, including (but not limited to) anti-bribery and anti-corruption laws.
The Sponsors expect the same commitment from the consultants, agents, representatives or other companies and individuals working with them (“Business Associates”), and all those involved in work concerning the Sponsors.
Bribery of Government Officials
Most countries have laws that forbid the making, offering or promising any payment or anything of value (directly or indirectly) to a government official when the payment is intended to influence an official act or decision to award or retain business. For the purpose of these Principles, “Government Official” is interpreted broadly and includes: (i) any person elected or appointed to public office (e.g., a member of a ministry of health); (ii) any employee or person acting for or on behalf of a Government office, agency, or enterprise which is performing a public legislative, executive or administrative function (including public activities in any form) whether private, or partially or fully Government-owned; (iii) any political party, candidate for public office, officer, employee, or person acting for or on behalf of a political party or candidate for public office; or (iv) an employee or person acting for or on behalf of a public international organization (e.g., the United Nations) and “Government” includes all levels and subdivisions of government (i.e., local, regional, or national and administrative, legislative, or executive).
Specifically, the U.S. Foreign Corrupt Practices Act of 1977 (the “FCPA”) prohibits the making, promising, or authorizing the making of a payment or providing anything of value to a non-U.S. Government Official to improperly or corruptly induce that official to make any governmental act or decision to assist a company in obtaining or retaining business, or to otherwise obtain an improper advantage. The FCPA also prohibits a company or person from using another company or individual to engage in any of the foregoing activities. As U.S. companies, the Sponsors must comply with the FCPA and could be held liable as a result of acts committed anywhere in the world by a Business Associate.
Because the definition is so broad, it is likely that Business Associates will interact with a Government Official in the ordinary course of their business on behalf of the Sponsors. For example, doctors employed by government-owned hospitals would be considered Government Officials.
Similar provisions are included in the UK Bribery Act 2010, and in other European jurisdictions (as the same may be amended from time to time) and compliance with all applicable laws by you is a condition of this agreement.
Anti-Bribery and Anti-Corruption Principles Governing Interactions with Governments and Government Officials
Business Associates must, and shall ensure that those involved with work concerning the Sponsors must, communicate and abide by the following principles with regard to their interactions with Governments and Government Officials. The Sponsors each have a sponsor contact (“Sponsor Contact”). If a Business Associate does not know who that Sponsor Contact is, they should request details from Fipra:
- Business Associates may not directly or indirectly make, promise, or authorize the making of a corrupt payment or provide anything of value to any Government Official to induce that Government Official to make any governmental act or decision to help the Sponsors obtain or retain business. Business Associates must never make a payment, or offer any item or benefit, to a Government Official regardless of value, as an improper inducement for such Government Official to approve, reimburse, prescribe, or purchase the Sponsors’ products, to influence the outcome of a clinical trial, or otherwise improperly to benefit the Sponsors’ business activities.
- Business Associates need to understand whether local laws, regulations, or operating procedures (including requirements imposed by Government entities such as Government-owned hospitals or research institutions) impose any limits, restrictions, or disclosure requirements on compensation, financial support, donations, or gifts that may be provided to Government Officials. Business Associates must take into account and comply with any applicable restrictions in conducting their Sponsors-related activities. If a Business Associate is uncertain as to the meaning or applicability of any identified limits, restrictions, or disclosure requirements with respect to interactions with Government Officials, they should consult with the Sponsor Contact before undertaking their activities.
- Business Associates, and those involved with work concerning the Sponsors, are not permitted to offer facilitation payments. A “facilitation payment” is a nominal, unofficial payment to a Government Official for the purpose of securing or expediting the performance of a routine, non-discretionary governmental action. Examples of facilitation payments include payments to expedite the processing of licenses, permits or visas for which all paperwork is in order. In the event that a Business Associate, or someone acting on their behalf in connection with work for the Sponsors, receives or becomes aware of a request or demand for such a facilitation payment or bribe, the Business Associate shall report such request or demand promptly to his or her Sponsors Contact before taking any further action.
Bribery and corruption can also occur in non-Government, business to business relationships. Most countries have laws which prohibit offering, promising, giving, requesting, receiving, accepting, or agreeing to accept money or anything of value in exchange for an improper business advantage. Examples of prohibited conduct could include, but are not limited to, the provision of inappropriate gifts or hospitality, kickbacks, or investment opportunities offered improperly to induce the purchase of goods or services. Sponsors’ colleagues are not permitted to offer, give, solicit or accept bribes, and we expect the Business Associates, and those involved in work concerning the Sponsors, to abide by the same principles.
Anti-Bribery and Anti-Corruption Principles Governing Interactions with Private Parties and Sponsors Colleagues
Business Associates must, and shall ensure that those acting on their behalf in connection with work for the Sponsors must, communicate and abide by the following principles with regard to their interactions with private parties and Sponsor colleagues:
- Business Associates may not directly or indirectly make, promise, or authorize the making of a corrupt payment or provide anything of value to any person to induce that person to provide an unlawful business advantage for the Sponsors.
- Business Associates may not directly or indirectly, solicit, agree to accept, or receive a payment or anything of value as an improper inducement in connection with their business activities performed for the Sponsors.
- Sponsor colleagues are not permitted to receive gifts, services, perks, entertainment, or other items of more than token or nominal monetary value from Business Associates, and those involved in work concerning the Sponsors. Moreover, gifts of nominal value are only permitted if they are received on an infrequent basis and only at appropriate occasions.
Reporting Suspected or Actual Violations
Business Associates, and those involved in work concerning the Sponsors, are expected promptly to raise concerns related to potential violations of these International Anti-Bribery and Anti-Corruption Principles or applicable laws and regulations. Such reports should be made to Business Associate’s Sponsor Contact.
Business Associates, and those involved in work concerning the Sponsors, understand and agree that Fipra and the Sponsors may, and in some circumstances will, be required to document and publicly disclose the name of the recipient and any direct or indirect transfer of value (including any contribution to costs relating to the Event). Such disclosure is a specific requirement of the EFPIA Disclosure Code (and local codes of practice implementing the same rules), which applies to HCPs, HCOs and patient groups. If a Business Associate has any concerns over any element of required data processing or disclosure, they should deal immediately with their Sponsor Contact.