Conference Vetting System
May 2013
Christine SAINVIL
Compliance Officer, EthicalMedTech
Background
Collaboration and partnerships between hospitals, clinicians, nurses and
other HCPs: driver of innovation & patient safety.
Most medical devices and most improvements to medical devices are
developed from ideas generated by healthcare professionals.
Medical devices directives require, in many cases, that companies provide
professional training to HCPs relating to their products.
HCPs must also receive annual professional training (« continuing medical
education ») in order to maintain their licenses to practice – third party
educational conferences provide such training
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Legal Measures Designed to Prevent Corruption
U.S. Foreign Corrupt Practices Act
UK Bribery Act
Existing Laws in Many European Countries
Huge Fines are being assessed against the industry for violations
Prison sentences are being handed down
New « Sunshine » transparency legislation will have an effect on healthcare
professional attitudes
Companies are creating staffs of Compliance Officers
Codes of Conduct are becoming more important
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What is Eucomed?
Eucomed represents the medical technology industry in Europe. Its mission
is to make modern, innovative and reliable medical technology available to
more people
Based in Brussels, Belgium
25 staff
Members:
25 national industry associations
3 associate Members
61 direct corporate members
Over 4,000 local association members
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Code of Ethical Business Practices
The Eucomed Code of Ethical Business Practice is a formal document, which is signed up to yearly
by all members of Eucomed as a condition for membership.
The Code is composed of
1.
Eucomed Guidelines on Interactions with Healthcare Professionals (2008)
⇒ Statement of purpose and values (the spirit of the law vs. the letter of the law)
⇒ Specific rules of conduct
2.
Q&A on the Eucomed Guidelines On Interactions with Healthcare Professionals (updated
regularly)
3.
Eucomed Compliance & Competition Law Guidelines (2012)
⇒ Statement of purpose and values
⇒ Specific rules of conduct
4.
Procedural Framework (2012)
⇒ Implementation of the code, handling of code violations & sanctions
5.
Opinions and advisory interpretations of the Eucomed Compliance Panel (ref. Conference
Vetting System)
A European single system
For the reasons stated above, it is critical that HCP sponsoring by
companies is conducted in the most ethical, consistent and transparent
manner.
To do this, Eucomed has created a centralised decision-making system to
approve Eucomed members’ sponsorships of individual healthcare
professionals to conferences.
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Independent implementation of the code
Nancy Russotto,
European Affairs
Advisor
John Mc Loughlin,
Chair
Attorney
Arthur Muratyan,
Lawyer
Christine Sainvil,
Compliance Officer
Appointment by the Board – 02/03/2010 for three years
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Tasks of the Compliance Panel
Provide guidance on interpretation of the Eucomed Code and dispute resolution principles, i.e.
provide consistency of interpretation of nationally applicable codes with the Eucomed Code
Assist NAs, when required, to set up resolution of complaints system under national codes;
Interact with relevant Eucomed groups to further develop the Eucomed Code and Q&A.
Handle national complaints directly, as a first and last instance decision-maker, in all territories
where there is no complaint handling process which complies with these Eucomed dispute
resolution principles
Oversee the Conference Vetting System (CVS):
Supervise the Compliance Officer
Ensure treatment of requests in full compliance with competition rules
Hear appeals of C.O. decisions
The Conference Vetting System (CVS)
Objective
CVS reviews the compliance of third-party educational
conferences with the Eucomed Code of Ethical Business Practice
(the “Code”) to determine the appropriateness for companies which
are members of Eucomed and members of the national associations
affiliated with Eucomed to sponsor Healthcare Professionals to
participate in such conferences.
Decisions
Conference assessments are binding upon the Eucomed members.
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The Conference Vetting System
Scope
Third party educational conferences in:
European Economic Area + Switzerland + Russia + Turkey.
The Compliance Panel may, exceptionally and at its discretion, extend the scope
to national and/or international conferences.
Eligibility
Eucomed members, including corporate members, national
associations and associate members.
The Compliance Members of the national associations who are not direct corporate
members of Eucomed may only file a submission through their national association.)
Conference Organisers (COs), including Medical Societies (MS).
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The Conference Vetting System (CVS)
The system operates independently of Eucomed to ensure objectivity in
conference assessments.
Separate website & visual identity: www.ethicalmedtech.eu
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Caveats
We do not:
Verify the accuracy of information provided;
Review of the scientific content of the programme;
Take into account national and local laws, regulations or professional or
company codes that may impose more stringent requirements upon
Eucomed members, members of national associations, Healthcare
Professionals and/or conference organisers.
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Scientific Programme
Conference programme must:
Present a detailled schedule
Be available in advance
Be relevant for the HCPs
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SCIENTIFIC PROGRAMME
Provision
Source
The schedule of the scientific conference programme – The detailed programme should present a clear
schedule with no gaps during the conference scientific sessions (i.e., a minimum of 6 hours for full
conference day/ 3 hours for a half day), the faculty for each session must be identified, the session
topics must be serious medical subjects.
Eucomed Compliance Panel Advisory
Interpretation of the Eucomed Code
N°2010-001 point 1.6
The availability of the programme in advance – The programme should be available at least 90 days
prior to the events and contain sufficient information to enable an evaluation of the scientific value of
the sessions and permit companies to notify each sponsored HCP's hospital administration, superior or
locally designated competent authority.
Eucomed Compliance Panel Advisory
Interpretation of the Eucomed Code
N°2010-001 point 1.6
The relevance of the programme – The programme content should directly relate to specialty and/or
medical practice of the HCP who will attend the conference or have a sufficiently reasonable
relationship to justify the attendance of the HCPs. Minor components of the agenda content relating to
non-scientific topics, such as leadership skills, practice management, and speaking and presentation
skills are acceptable.
Eucomed Compliance Panel Advisory
Interpretation of the Eucomed Code
N°2010-001 point 1.6
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Geographic Location & Conference Venue
Location
Venue: Seasonal resorts, golf resorts,
cruise ships and spas not allowed
Time of the year
Ease of access
Central location giving the country of
origin of delegates.
Local HCP exception
Pre-clearance for Geographic Location
and Venue
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Geographic Location
Provision
Source
The geographic location – The geographic location should be in or near a city or town which is
a recognised scientific or business centre, suitable for hosting a conference, which is conducive
to the exchange of ideas and the transmission of knowledge.
Eucomed Code - Q&A on the Eucomed
Guidelines On Interactions with Healthcare
Professionals – Sept. 2012 (v8); Q&A 6 – On
appropriateness of a geographic location
The time of the year – The selected time of year must not be associated with a peak touristic
season (for example, a ski resort in the winter, an island beach resort in the summer or any
other geographic location renowned primarily as a seasonal vacation or holiday destination)
unless attended only by “local” Healthcare Professionals who live or work in the specific
geographic location in question or its immediate surrounding vicinity.
Eucomed Code - Q&A on the Eucomed
Guidelines On Interactions with Healthcare
Professionals – Sept. 2012 (v8); Q&A 6 – On
appropriateness of a geographic location
The central location – Taking into account the place of origin of HCP delegates, the geographic
location must be centrally located. If the HCP delegates are primarily from one country, the
geographic location of the conference should be in that country. If the participants are from
multiple countries, then a country affording ease of access for participants should be chosen.
The country selected should be the residence of at least some of the Healthcare participants of
the meeting.
Eucomed Code - Q&A on the Eucomed
Guidelines On Interactions with Healthcare
Professionals – Sept. 2012 (v8); Q&A 6 – On
appropriateness of a geographic location
The ease of access – The geographic location should have ease of access for the attendees (for
example, close proximity to airports, train stations, highways and have good ground
transportation infrastructure).
Eucomed Code - Q&A on the Eucomed
Guidelines On Interactions with Healthcare
Professionals – Sept. 2012 (v8); Q&A 6 – On
appropriateness of a geographic location
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Conference Venue Facility
Provision
Source
The Conference Venue – The conference venue should be a business or commercial centre with
providing conference facilities conductive to the exchange of scientific and medical
information and the transmission of knowledge. It should not be the main attraction of the
conference. The image of the location among the public, media and authorities cannot be
perceived as purely luxury, touristic/holiday and/or entertainment venue.
Eucomed Code - Q&A on the Eucomed
Guidelines On Interactions with Healthcare
Professionals – Sept. 2012 (v8); Q&A 11 –
On appropriateness of luxury hotels as
Conference Venue
The fact that a top category or luxury hotel downgrades itself to a lower category hotel in
order to attract a conference or an event does not change the analysis. Perception of what is
considered as an appropriate location by the industry, the public and government authorities
overrides price considerations.
Eucomed Code - Q&A on the Eucomed
Guidelines On Interactions with Healthcare
Professionals – Sept. 2012 (v8); Q&A 10 –
On appropriateness of a Hotel as
Conference Venue
Cruise ships, golf clubs or health spas and venues renowned for their entertainment facilities
are not appropriate venues and should not be used.
Eucomed Code - Q&A on the Eucomed
Guidelines On Interactions with Healthcare
Professionals – Sept. 2012 (v8); Q&A 13 –
On appropriateness of a Conference Venue
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Hospitality & Accommodation
Not excessive or could be
considered « entertainment »
Reasonableness of hospitality
Separate additional charge
included for spouses, partners,
family & guests
Duration
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Hospitality & Accommodation
Provision
Source
The reasonableness of hospitality – Any hospitality should be reasonable in value, subordinate in
time and focus to the educational purpose of the training and in compliance with the regulations
of the country where the Healthcare Professional is licensed to practice.
Eucomed Code of Ethical Business
Practice – Sept. 2008; Section II –
member-sponsored product training and
education
The term ‘hospitality’ includes meals and accommodation. It is important that members
differentiate between ‘hospitality’ which is permitted and ‘entertainment’ which is not.
‘Entertainment’ includes, but is not limited to, dancing or arrangements where live music is the
main attraction, sight-seeing trips, theatre excursions, sporting events and other leisure
arrangements.
Eucomed Code - Q&A on the Eucomed
Guidelines
On
Interactions
with
Healthcare Professionals – Sept. 2012
(v8); Q&A 14 – On the meaning of
hospitality
The hospitality offered to spouses, partners, family and/or guests subject to a separate charge –
Eucomed members are not permitted to facilitate or pay for accommodation for spouses/guests of
sponsored HCPs. Any hospitality offered to them must be the subject of a separate charge which
may not be paid for or reimbursed by Eucomed members.
Eucomed Code of Ethical Business
Practice – Sept. 2008; Section II –
member-sponsored product training and
education
The appropriateness of accommodation – If a top category or luxury hotel is chosen by an
independent third-party as the venue of their scientific conference, the following should be
considered: Provided that the conference is a bona fide independent, educational or scientific
event and the above-mentioned considerations carefully appraised, members can sponsor
healthcare professionals to attend the conference (i.e. registration fees and reasonable travel) but
cannot pay for or reimburse accommodation for healthcare professionals at such top category or
luxury hotels, unless there are exceptional extenuating circumstances which can be adequately
documented. Exceptional extenuating circumstances would be generally limited to healthcare
professional health and security risks prevailing in the chosen location.
Eucomed Code - Q&A on the Eucomed
Guidelines
On
Interactions
with
Healthcare Professionals – Sept. 2012
(v8); Q&A 11 – On the appropriateness of
luxury hotels as conference venue
The accommodation to be limited to the duration of the conference – Accommodation and/or other
services provided to HCP delegates should not cover a period of stay beyond the official duration
of the conference.
Eucomed Code - Q&A on the Eucomed
Guidelines On Interactions with
Healthcare Professionals – Sept. 2012
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(v8); Q&A 25
Spouse & Guests
Provision
Source
Spouses, partners, family and/or guests' packages may not be paid for
by Eucomed members – It is not appropriate for Guests of a
Healthcare Professional to attend either member-sponsored product
training courses or scientific, educational or training sessions which
take place during third party conferences (unless the individual
qualifies as a participant in their own right), nor is it appropriate in
the interest of maintaining the scientific exchange for Guests to
participate in related hospitality events during such trainings or
conferences (for example, lunches and coffee breaks) even when the
Healthcare Professional pays for the Guest’s expenses.
Eucomed Code of Ethical Business Practice – Sept. 2008; Section II –
member-sponsored product training and education
Eucomed Code - Q&A on the Eucomed Guidelines On Interactions with
Healthcare Professionals – Sept. 2012 (v8); Q&A 16, Q&A 17, Q&A 26
and Q&A 33
Third party conferences which offer extra-curricular
programmes/activities beyond the scientific, educational or training
sessions for Guests of Healthcare Professionals (such as touristic
activities and hospitality) do not disqualify the conference from
support by Eucomed members provided that such an extra-curricular
programme/activity (including attendance of the conference dinner or
a cocktail reception) is subject to a separate charge which must not
be paid for, or reimbursed by, a Eucomed member.
Where imposed under national or local laws and regulations, such as
in Saudi Arabia or any other such country, members may make an
exception to the above and agree that a male Guest of a female
Healthcare Professional may be admitted to member-related activity
or scientific, educational or training sessions which take place during
third party conferences.
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Social Programme
Entertainment
Not allowed, except for modest and incidental gatherings such as an
opening cocktail and /or conference dinner which must be open to all
HCP delegates
Does not dominate or interfere with scientific aspect of the programme.
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Social Programme
Provision
Source
The social program - Members must not pay for the expenses which
relate to the purely social or cultural aspects of the conference.
Modest and incidental gatherings such as the welcome cocktail are
appropriate and members may cover these expenses. Where the
registration fee includes an element of entertainment members must
request that these elements are separated in the registration fee and
subsequently not pay for this element. If the conference organiser is
unable to separate the entertainment costs from the registration fee,
members should assess the image that may be projected to the public
and reconsider supporting the conference. For the avoidance of
doubt, the conference dinner may be supported if it is expected that
all delegates to the conference would normally attend and provided
the dinner is otherwise in line with the requirements of the guidelines.
Eucomed Code - Q&A on the Eucomed Guidelines On Interactions with
Healthcare Professionals – Sept. 2012 (v8); Q&A 19
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Communication Support
Communication / registration support
Inappropriate design of the
advertising support
Unauthorized activities advertised
Combined registration fee which
includes spouses, guests,
partners, family
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Communication Support
Provision
Source
The program advertising - Advertising support (brochures, website and
other materials) should highlight the scientific nature of the
programme content. They should not overly emphasize the
geographic location and should not make excessive or inappropriate
references to or contain images of entertainment, sporting events or
other non-scientific activities.
Eucomed Compliance Panel Advisory Interpretation of the Eucomed
Code
N°2010-001 point 1.6
The registration fee - The registration fee should cover only the
scientific program and authorized activities and hospitality.
Eucomed Code - Q&A on the Eucomed Guidelines On Interactions with
Healthcare Professionals – Sept. 2012 (v8); Q&A 11, Q&A 19
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CVS in numbers (Oct 2012 – Apr 2013)
263 Conferences submitted
113 Compliant
11 Non Compliant
Double Entry
Not Assessed 8%
Intl
6%
Compliant
43%
2 Correction notice
20 Double entries
117 Not assessed
62 Insufficient information
40 within the 90 days
15 International/National Conferences
Submitter profile
5 National Associations
Not Assessed Info
23%
Not Assessed
>90
15%
Correction
Notice
1%
NonNon-Compliant
4%
8 Medical Societies
18 Corporate Members
22 Professional Congress Organisers
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New submission procedures
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www.ethicalmedtech.eu
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Thank you
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Eucomed Compliance Officer
Christine SAINVIL
Tel: + 32 (0) 498 76 36 03
E-mail: christine.sainvil@ethicalmedtech.eu
URL: www.ethicalmedtech.eu
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