“E 4 Ethics”: EFPIA Offers Pre-Assessment of Educational Events Regarding Adherence To HCP Code

 

The focal point of the EFPIA HCP Code provisions on scientific or educational meetings and conferences is “appropriateness.” This loose standard is fleshed out some in Section 10, outlined in detail below, as well as individual EFPIA member codes. EFPIA has also developed a website in which they pre-assess events for compliance. This resource, available here, lists upcoming events arranged by name, organizer, specilaty, date, and country, and provides a pre-assessment and recommendation along several categories. 

EFPIA’s pre-assessment for events generally outlines several factors, including the schedule and structure of the event, the location/venue, and whether the sponsor provides any hospitality. For the most part, the pre-assessment states for each category that “[i]t is recommended to check the rules prevailing under applicable national codes.” For example, under one event, EFPIA’s pre-assessment simply states the following:

For others, EFPIA is critical of certain aspects of the intended program. For example, the pre-assessment may focus on the fact that events have an “entertainment” or “leisure” focus. EFPIA may also state that hospitality must not extend beyond the completion an event. Several notifications also stress that the particular event’s website lacks sufficient details to determine whether the program will be compliant with the EFPIA HCP Code. 

 

EFPIA’s HCP Code Provisions on Education Events

As stated above, much of the EFPIA HCP Code provisions on scientific or educational meetings and conferences rely on an “appropriateness” standard. Such events must be held in an “appropriate” venue, conducive to the main purpose of the event, and may only offer “appropriate” hospitality that otherwise complies with the provisions of other applicable codes. (Section 10.01). 

Scientific Program Schedule

• An event program should show that the event has a genuine scientific purpose. The program posted on the website of the event will be used for reference for the pre-assessment.
  

Hospitality

• Hospitality extended in connection with events shall be limited to travel, meals, accommodation, and genuine registration fees and must not extend beyond the officail durantion of the event. 
• Meals to HCPs must not exceed the monetary threshold set by the relevant Member Association in its national code.
• Hospitality may only be extended to persons who qualify as participants in their own right, and not to accompanying persons. 
• Hospitality must be “reasonable” in level and strictly limited to the main purpose of the event. As a general rule, the hospitality provided must not exceed what healthcare professional recipients would normally be prepared to pay for themselves.
• Hospitality must not include sponsoring or organizing entertainment (e.g., sporting or leisure) events. Companies should avoid using venues that are “renowned” for their entertainment facilities or are “extravagant.” EFPIA indicates that member associations must provide guidance on the meaning of “reasonable,” “appropriate,” “renowned,” and “extravagant” venues.”

International Events: 

• International events are only allowed if the venue makes logistical sense due to the majority of invitees being located there or due to the location of the relevant resource or expertise that is the object or subject matter of the event. 
• Promotional information on exhibit stands or distributed to participants at international events may refer to products or uses which are not registered in the country where the event takes place, or which are registered under different conditions, so long as (i) any such promotional material is accompanied by a statement indicating countries in which the product is registered and makes clear that the product or use is not registered locally, and (ii) any such promotional material (indications, warnings etc.) authorized in countries where the medicinal product is registered must indicate that registration conditions differ internationally.

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Country-by-Country Index of Educational Events an Ethical Evaluation 

EFPIA Worksheet outlining what issues they are looking for