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IMSTA Annual Conference
From Ethics to Innovation
what
s happening in Medtech
Dublin 22 March 2017
Filip Moriau
www.medtecheurope.org
INTRODUCTION TO THE CODE OF ETHICS
www.medtecheurope.org
2
WHAT ARE THE MAIN CHANGES?
3
Six biggest changes
1. Phasing out direct sponsorship
2. Transparency of educational grants
3. Common chapter on general criteria for events
4. New chapter on demonstration products and samples
5. Agreed definitions
6. Common independent enforcement mechanism
www.medtecheurope.org
Sponsorship Changes / Educational Grants
5
Grants will be publicly disclosed
Conferences will still need to comply with specific requirements
Grants can only be provided to legal entities never individuals and
will require a written contract
Companies can define the recipients type not individual recipients
Companies use intern. & indep. process with objective criteria
1
2
3
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5 www.medtecheurope.org
Chapter on general criteria for all events
www.medtecheurope.org
Events
Programme
Geographic Location and
Venue
Guests
Hospitality
Travel
Transparency
Five principles
Image & Perception
No luxury hotels, luxurious dinners etc.
Transparency Informing institution/superior of any
interaction
Equivalence Setting the fee for service on strict
FMV methodology
Separation Decision-making is not primarily
sales-driven
Documentation Signing the contract & documenting
expenses
www.medtecheurope.org
7
What are the criteria for appropriate Event location & venue?
• Perceived image:
- Must not be perceived as luxury, or tourist/holiday-oriented, or that of an Entertainment venue
• Centrality:
- Centrally located when regard is given to the place of residence of the majority of invited participants
• Ease of access:
- In close proximity to an airport and / or train station / ground transportation infrastructure
• Recognised scientific or business centre:
- Near a city or town which is a recognised scientific or business centre, suitable for hosting an Event
• Selected time of year:
- Selected time of the year outside a touristic season for the selected geographic location
www.medtecheurope.org
Who is covered?
www.medtecheurope.org
Healthcare Professional
(HCP)
Physicians
Nurses
Technicians
Laboratory Scientists
Researchers
Procurement professionals
Healthcare Organisation
(HCO)
Hospital
Group purchasing
organisation
University
Laboratory
Pharmacy
Medical society
What are the requirements for support under the Code?
Requirements Third Party Organised
Educational Conference
Third Party Organised
Procedure Training
Compliance with general
criteria for Events (Chapter
1)?
YES YES
CVS approval? YES* YES
Until 31/12/2017:
Is direct sponsorship of HCPs
allowed?
YES YES
As of 01/12/2018:
Is direct sponsorship of HCPs
allowed?
NO YES
www.medtecheurope.org
*CVS approval is required for different types of funding including
educational grants, promotional activity (e.g. booths), satellite
symposia
Two types of industry support to Third Party Organised
Events
www.medtecheurope.org
Companies select individual HCPs
and financially support their
participation to Third Party
Organised Events.
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”
11
Phasing out of direct sponsorship
www.medtecheurope.org
“Educational grants” “Direct sponsorship”
Stronger rules
2016 2017 2018
Transparency: Where?
• www.ethicalmedtech.com
www.medtecheurope.org
ETHICS TO INNOVATION
14
MedTech industry’s special relationship with HCPs
15
HCPs are trained on how to
use technologies
The industry liaises
regularly with HCPs to
ensure that the
technologies are updated
and maintained
HCPs actively participate in
the research to develop
new technologies
This close collaboration is
key to develop innovative
technologies to treat
patients
MedTech
industry HCPs
The MedTech industry and
HCPs collaborate closely
throughout several stages of
the development and use of
medical technologies.
www.medtecheurope.org
Strategy, Not Technology Drives Innovation
10,000
Iphone Game
400,000
Space Shuttle
6,700,000
Chrome
14,000,000
Boeing 787
40,000
Windows 7 OS
300,000,000
Connected Car
2015
Our new environment
Global Fluid Technological
Innovation Engine
Our Focus in the Digital Age
Create Value
Big Data Stake
holders
Agility
Innovation
Disruption
Talent
Ethics
Leadership
The Focus of Medtech is changing
Medtech Core Tasks
Technology Support Models
Ethical Business Practice
Outside In Innovation
