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Revision of MedTech Europe’s
Code of Ethical Business Practice Why the industry recommended reforming how they support
medical education
Roeland van Aelst, Chair of the MedTech Europe Compliance Network
SAMED, 27 August 2015
www.medtecheurope.org
What is MedTech Europe?
• MedTech Europe is an alliance of European medical technology industry
associations
• Currently has two members:
- EDMA
- Eucomed
• The alliance founded in October 2012
• One common CEO and management team for all three entities
• In the future, the objective is to have one single legal entity
MedTech Europe 2015 priorities
Priority 1
Rationale for the revision of the EDMA & Eucomed
Codes of Ethics
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Two codes creates confusion; there is a need to have clear
rules
An updated code needs to reflect how society evolved
Current codes drafted 2007/2008 are dated and include
inconsistencies and contradictions
What topics are covered by the revision? • The code revision is very broad and reviewed all aspects covered in the old
codes and included new topics, where compliance risks were identified.
- For example:
- Gifts,
- Company-organised events, including product training and sales & promotion meetings,
- Third-party organised events, including congresses
- Consultancy agreements,
- Royalties,
- Etc.
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Key area of the revision: Industry support of medical education
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Medical education
is an obligation for
Healthcare
Professionals
(HCPs) to ensure
their practice is up-
to-date and can
contribute to the
otpimal care of
patients.
Ensure uptake of existing innovation and research, and foster new innovation
Train HCPs in new techniques and promote disease awareness
Promote independent exchanges and networking amongst peers
Support HCPs to share best practices and build & improve skills in specific disease & treatment areas
Objectives of industry support to medical education:
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Medical &
professional
education
Procedure
training
Product
training
Promotional Others
Disease
education
Surgical
techniques
(skills)
Booth,
satellite
events
E-learning
Therapy
focused
education
Sales
meetings
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Third-party driven,
industry “enablers”, e.g.
products, knowledge,
financial support, etc.)
Industry driven &
responsibility/obligation Shared
Procedure linked to product
training
Industry support to medical education is extensive
N.B.: Any of these activities could happen in the
framework of a congress but not necessarily
The new code will amend rules around congresses
Industry support of
3rd parties-organised events (e.g. congresses)
Direct sponsorship
I.e. individual HCP’s costs of travel, lodging and registration fee to attend a congress are covered by a company
Educational grants
Types, e.g. grant for support of congress
organisation, grant for support of HCP
participation
Other types of financial support
E.g. Sponsorship packages, booths, other promotional
activities
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What is meant by this? Definitions
www.medtecheurope.org
Companies select individual HCPs
and financially support their
participation to 3rd party-organised
conferences.
Companies provide educational grants to
hospitals, medical societies and other
third parties to support genuine
medical education.
“Direct sponsorship”
Such financial support typically
covers some or all of the travel,
lodging and registration costs of the
HCP.
These include educational grants
provided to support HCP participation to
third-party organised event. HCPs are
selected by the receiver of the grant.
“Educational grants”
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1. Relationship between industry-HCPs under increasing
scrutiny by regulators, press and the general public
2. Public opinion questions whether
medical judgement is unbiased
3. Increasing amount of court cases cost
industry hundreds millions of Euros
4. Many countries have either restricted or
banned direct sponsorship altogether
Emerging trends require industry to re-asses its
approach to medical education support
More and more countries are limiting direct sponsorship
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Prohibition or DS
restrictions
Prior approval
requirements
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0
Safeguard integrity and industry
reputation
Reduce compliance risk
Uphold value and promote
responsible industry image
Industry’s behaviour must respect high ethical
standards & values
Transparency + was recommended as the best option
for the European MedTech industry
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There is a deep and strong
relationship between HCPs
and the industry, and the
Transparency+ option would
protect both from undue criticism.
Transparency+ 1.Companies will no longer be able to pay registration fees,
travel and hospitality expenses directly to individual HCPs
for their participation in educational conferences organised
by third-parties. Direct sponsorship will thus be phased
out.
2.As regards educational grants, companies commit to more
stringent rules, to prevent abuse, when providing
educational grants to hospitals, medical societies and/or
third-parties and will have to disclose these grants publicly.
3. The MedTech industry will continue to be able to organise
its own events and trainings for HCPs, according to
stringent rules included in the new code.
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Grants will be publicly disclosed, ensuring increased transparency
of the funds allocated to medical education
Conferences will still need to comply with specific requirements
and with the Conference Vetting System
Grants can only be provided to legal entities but never individuals
and will require a written contract & other related documentation
Companies will be able to define the type of recipients which
should be eligible for the grant but not individual recipients
Companies must have an internal & independent process based on
objective criteria to assess and provide the grant requests
How educational grants will change
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At third-party organised conferences (main program): Companies
may not directly support an HCP, neither as a delegate, nor as a
speaker.
At company-organised events in the frame of third-party organised
conferences (e.g. satellite symposia): Companies may directly
support speakers (i.e. their consultants) but not delegates.
At third-party organised procedure/hands-on trainings: Companies
may support delegates but not speakers, the latter being
independent.
At company-organised product /procedure trainings: Companies
may directly support an HCP either as a delegate and/or as a
speaker.
How will the phase out of direct sponsorship work
Benefits of the new system
• The potential to influence HCP's independent medical
judgment is reduced, as is the risk of conflict of
interest.
• We are proposing a critical step to shield industry from
criticism and safeguarding its image and reputation.
• We ensure continued support to independent medical
education.
• A good industry reputation strengthens our position,
when dealing with European decision-makers and
other stakeholders on other key industry matters.
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NEXT STEPS
Part 5
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Governance: Approval process
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The right thing to do for our industry
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