Q: Whether company’s HQ may hold an overseas meeting on the previous day of an international congress and at the same venue, inviting the overseas meeting participants under the contractual arrangements
A: We understand that a company’s HQ considers having investigators meeting or consultation meetings at the same country where an international congress is held. HCPs who participate in the international congress will be invited to these meetings in their investigators and/or consultants capacities (collectively, “consultants,” hereinafter the same will apply) under the relevant contractual arrangements.
In this case, the relevant medical study and/or consulting arrangements should be executed between HQ and respective HCP, and therefore, HQ has contractual obligations to pay service fees (including reasonable out-of pocket expenses, such as lodging and meals) for their services. As such, we believe that such payments may not be prohibited under the Notification, as far as HQ is able to support the existence of bona fide study and/or consulting arrangements. For this purpose, regulatory authorities (i.e., KFTC and/or MIHWAF) may review the following factors:
Selection
§ Decisions regarding the selection or retention of HCPs as consultants should be made based on defined criteria such as general medical expertise and reputation, or knowledge and experience regarding a particular therapeutic area;
§ The criteria for selecting consultants are directly related to the identified purpose and the persons responsible for selecting the consultants have the expertise necessary to evaluate whether the particular HCPs meet those criteria;
§ Companies should continue to ensure that consultant arrangements are neither inducements nor rewards for prescribing or recommending a particular medicine or course of treatment;
Documentation
§ A written contract specifies the nature of the consulting services to be provided and the basis for payment of those services;
§ A legitimate need for the consulting services has been clearly identified in advance of requesting the services and entering into arrangements with the prospective consultants;
§ The retaining company maintains records concerning and makes appropriate use of the services provided by consultants;
Compensation
§ It is appropriate for consultants who provide advisory services to be offered reasonable compensation for those services and reimbursement for reasonable travel, lodging, and meal expenses incurred as part of providing those services;
§ Any compensation or reimbursement made in conjunction with a consulting arrangement should be reasonable and based on fair market value;
§ While modest meals or receptions may be appropriate during company sponsored meetings with healthcare professional commercial consultants, companies should not provide recreational or entertainment events in conjunction with these meetings;
§ It is not appropriate to pay honoraria or travel or lodging expenses to non-faculty and non-consultant healthcare professional attendees at company-sponsored meetings, including attendees who participate in interactive sessions;
Number and Venue
§ The number of HCPs retained is not greater than the number reasonably necessary to achieve the identified purpose; and
§ The venue and circumstances of any meeting with consultants are conducive to the consulting services and activities related to the services are the primary focus of the meeting; specifically, resorts are not appropriate.
