French Anti Gift Law: for Meetings and Events

French Anti Gift Law: for Meetings and Events

Date: Thursday 19th May 2022

Expert: Laurent Clerc, Head of Compliance Clardian 

The market leader in software dedicated to compliance and regulatory process optimization. Clardian offers health industries various SaaS solutions to comply with the regulations and standards of today and tomorrow.  

 

Kindly supported by MedCommsNetworking.com

This global initiative facilitates networking and dialogue amongst individuals working in and around the pharmaceutical industry and MedComms, focusing on specialist medical education, medical communications and medical publishing activities.

 

 

Moderator Mark Handforth 3Sixty Event Consulting 

 “In this webinar we attempted to simplify and apply the French Anti Gift Law to meetings and event. If you are working as industry or a 3rd party with healthcare professionals whom gain “advantages” specifically financially this webinar is for you – we hope you enjoy it.”

 

 

 

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Part 1 of the webinar: The French Anti Gift Law for Meetings and Events

The French Anti Gift Law as it is applied to meetings and the approval of costs related to the financial relationships between (French) Healthcare professionals and industry.

Laurent explains the scope of the law, process and timelines, to whom it applies and what information is required to make a submission


  • What are the (financial in/out of scope) “Advantages”: 9mins 15sec
  • Application website URL’s: 14mins 28sec
  • Financial thresholds: 18mins 57sec

Part 2 of the webinar: The French Anti Gift Law for Meetings and Events

MEETING SCENARIOS

In this section we concentrate on 3 specific scenarios and explain how the law applies;

 

  • French HCP’s attending a meeting
  • A company booking an exhibit booth at a French medical meeting
  • Payment of honoraria for a French KOL to speak at a meeting / webinar

Part 3 of the webinar: The French Anti Gift Law for Meetings and Events

In this section we tidy up burning questions and clarifications including;

Q&A and WEBINAR SUMMARY 

  • How to handle approval submissions when you cannot forecast the financial “advantages”
  • The role of 3rd parties in making submission
  • Checking submission status
  • Educational grants

Industry bodies issue guidance on virtual and hybrid meetings by medical societies

Industry bodies issue guidance on virtual and hybrid meetings by medical societies

IFPMA, EFPIA and PhRMA have updated their joint guidance for virtual medical society meetings

The guidance, focused on medical society virtual / hybrid meetings can be seen here in more detail with a Q&A document here.

3Sixty thoughts: 

More very welcome guidance upgraded since the 2020 issue now including Hybrid meetings which are expected, by industry and societies, to be the dominant form of “congress” moving forward.

What caught our eye?

1. The new (ish) IFPMA ethos was reinforced in the document. Why do we think this is important? Well, the Ethos outlines a code based not solely on rules but one framed in; integrity, values and principles. The result? more subjective decision making o identify is something the right thing to do! If your organisation has not already defined how this impacts the part you play in the creation and planning of meetings and ensured your teams are ready then you’re behind the game … 

2.  Guidance is applied to international meetings, defined as medical associations/societies involving HCPs from multiple countries. National meetings are not “in-scope” we tend to use the Congress Vetting System (CVS) criteria when determining what is a national and international medical society meeting.

3. The code (international, regional or national) still applies even if they were written with in-person meetings in mind. Note sections on an events educational value, medicine promotion, certification (see ABPI clause 8 to see how the UK handles this), destination and venue selection in the case of in-person formats as a few examples of how to still apply the code. Reminder, every meeting supported by industry must include a written rationale outlining the reason industry is supporting a meeting in the rush to plan the tactic this can be overlooked.

4. The route to apply the right code and label to a meeting has been strengthened, reminding industry not to rely on medical societies / congresses to determine the applicable code to a meeting but to take that into their own hands.  This is another reason why there should be a stronger link during planning between medical societies, industry and PCO’s pooling knowledge and communicating as a collective how the code applies to meetings.

 

 

MedTech Europe and EFPIA merge medical society congress vetting / assessment platforms

MedTech Europe and EFPIA merge medical society congress vetting / assessment platforms

MedTech Europe and EFPIA merge medical society congress vetting / assessment platforms

events  One of the significant features of healthcare and life science regulation is the need of those business partners, not directly guided by the code, to recognise that the code in a collateral way may impact them.

One such example is the vetting or assessment of independent Medical Society congress activities using metrics derived from the code.

 

Back story

For a number of years congresses have been vetted or assessed if you prefer, via independent solutions and platforms by both European trade / industry / regulatory bodies.

 Medical devices – MedTech Europe, Platform: CVS

Healthcare and life sciences (pharma) – EFPIA, Platform: e4ethics

Criteria differed between both organisations with some common threads.

 

What’s different?

Since 01 January 2022

The MedTech Europe (cvs) and EFPIA (e4ethics) platforms have now merged to be focus applications through the MedTech Europe platform.

MedTech Europe Application Website

So, what does this mean in more tangible terms?

  • Both platforms operate independently from EFPIA and MedTech Europe, via a common Compliance team, to ensure objectivity and independence in conference assessments.
  • e4ethics is aligned with the CVS criteria and approach, including the online proactive submissions by companies or congress organisers (Professional Congress Organisers as well as scientific societies).
  • The submission procedure and appeal process is identical for both systems.

The type of Events qualifying for review will remain different

  • For Events assessed under e4ethics, only those that qualify as major international Events taking place in the countries within the scope of the EFPIA Code, (Europe) will be reviewed. Events in which Healthcare Professionals coming from more than 5 countries may take part and which are expected to attract a significant number of participants (at least 500), will be considered (that means meetings outside Europe too) .

 On the other hand, within the CVS, international Events need to be reviewed when they are taking place within the MedTech Europe geographical scope. This includes:

    • Events attended by delegates coming from at least two countries of MedTech Europe geographical scope; and
    • Events taking place outside the MedTech Europe geographic area, attended by delegates who are HCPs registered and practicing in the MedTech geographical area.

 How do I learn more about the vetting / assessment solutions?

Information on MedTech Europe, CVS approach: Link

Information on EFPA, e4ethics approach: Link

 

Note: the comments within this bog post are those of 3Sity Event Consulting – we recommend viewing the links provided before using this information to execute any business decisions.  

 

 

 

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