MedTech Europe
Code of Ethical Business PracticeVersion for Member Companies: March 2017www.medtecheurope.org

Structure of the presentation

Ethics &Compliance

New MedTech
Europe Code

New MedTech
Europe Code

New MedTech
Europe Code

Why
is it
important?

What arethe mainchanges?

What
companies
need to do?

What doesit cover?

www.medtecheurope.org

2

Part 1

WHY ETHICS IS IMPORTANT?

www.medtecheurope.org

1MedTech industry’s special relationship with HCPs

The MedTech industry and
HCPs collaborate closely
throughout several stages ofthe development and use of
medical technologies.

HCPs

MedTechindustry

HCPs actively participate in
the research to develop
new technologies
This close collaboration is
key to develop innovativetechnologies to treat
patients
HCPs are trained on how to
use technologies
The industry liaises
regularly with HCPs to
ensure that thetechnologies are updated
and maintained
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4Industry’s behaviour must respecthigh ethical standards & values

Reducecompliance/bribery risks –unilateral transfer of value
Uphold value andpromote responsible
industry image – Key priority
Harmonisation of requirements
worldwide
Potential prevention of newlaws – stringent self-regulation
Transparency will not end DS
0challenges
by media
and judicial authorities
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5MedTech Europe Code of Ethical Business Practicewww.medtecheurope.org

6Part 2

WHAT ARE THE MAIN CHANGES?

www.medtecheurope.org

1Six biggest changes

Phasing out directsponsorshipTransparency of
educational grants

Common chapter
on general criteria
for events

New chapter on
demonstration
products and samples

Agreeddefinitions

Common independent
enforcement mechanism

www.medtecheurope.org

8Two types of industry support to Third Party Organised Events“Direct sponsorship”“Educational grants”

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 tosupport genuine medical
education.

Such financial support typicallycovers 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.
www.medtecheurope.org

9Phasing out of direct sponsorship2016 2017“Direct sponsorship”

2018“Educational grants”

Stronger rules

www.medtecheurope.org

10How the rules for educational grants will change
Grants will be publicly disclosed, ensuring increased transparencyof 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 whichshould be eligible for the grant but not individual recipients
Companies must have an internal & independent process based on
objective criteria to assess the grant requests

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Transparency: What? When? Where?

Educational Grants to
support Third Party
Organised Events• Support for these Events• Support for HCP Participation

Other Educational Grants
to HCOs• Scholarships & Fellowships• Grants for Public AwarenessCampaigns

2017 data as of 2018
MedTech Europe platform (www.ethicalmedtech.eu)** No double reporting: Exceptions were granted to countries which havepre-existing & equivalent platforms (e.g. Belgium, France)
www.medtecheurope.org

12Chapter on general criteria for all events

Programme

Geographic
Location and
Venue

Transparency

EventsTravelGuestsHospitality

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New Chapter

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Definitions will be aligned in the new Codewww.medtecheurope.org

15

Common enforcement mechanism• Independent MedTech Europe Compliance Panel:

Nancy Russotto(Chair)Arthur Muratyan

David Hornewww.medtecheurope.org

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Part 3

WHAT COMPANIES NEED TO DO?

www.medtecheurope.org

1Timelines for NA & Corporate Members

New Code comes
into force

Transposition of the code bycompanies

2016

End of Direct
Sponsorship

Companies collect data for disclosure+
NAs: 1st report on implementation
strategy & plan

1/1/2017

Transposition at
national level

Companies start disclosing+
NAs to report on progress

1/1/2018

1/1/2020

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Obligations•Transposing the MTE Code (‘regulation or directive style’) by 2020

National
Association•Recommending and promoting the MTE Code as best practice•Engaging local stakeholders to change local practice•Submitting strategies and progress reports including public transparency on the MTE website

MemberCompanies•Transpose the Code by 1/1/2017 & phase out of DS by 1/1/2018•Support National Associations they are member of to support local transposition of the MTE Code

•Provide training on the MTE Code and the normative framework

MedTechEurope• Support to National Associations on the transposition of the MTE Code•Coordinate & support communication to external stakeholders

www.medtecheurope.org

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Part 4NEW CODE OF ETHICS:CONTENT

www.medtecheurope.org

1Who is covered?

Physicians

Procurement
professionals

Hospital

NursesHealthcare
Professional(HCP)

Healthcare
Organisation(HCO)
Technicians

Researchers

Laboratory
Scientists

Grouppurchasingorganisation

Medicalsociety

University

Pharmacy

Laboratory

www.medtecheurope.org

211What is the scope?
MedTech Europe Geographic Area
Countries in the European Economic Area; andCountries where Member Associations are located (e.g. Russia, Turkey, the Mecomed countries)

Interactions
with HCOs& HCPsActivities

IMPORTANT:The Code sets out the minimum standards to Member across MedTech Europe Geographic
Area.
The Code is not intended to supplant or supersede national laws or regulations or
professional codes (including company codes) that may impose more stringent requirements
upon Members.

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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

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General Criteria for Events
A common chapter on criteria for all events:

Event
programme

Event locationand venue

GuestsReasonable
hospitality

TravelTransparency(Employer Notification)www.medtecheurope.org

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What are the criteria for Event programme?
•

The Event programme should be:- directly related to the specialty and/or medical practice of the HCPs who will attend the Event, or- sufficiently relevant to justify the attendance of the HCPs
- for Third Party Organised Educational Events: under the sole control and responsibility of thethird party organiser

Organising Events which include
Entertainment

Not appropriate

Supporting Entertainment elements
where part of Third Party Organised
Educational Events

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What is Entertainment?

Does notconstituteentertainment

Entertainment

Incidental, background music
Reasonable hospitality

Examples: dancing or arrangements where live
music is the main attraction, sight-seeing trips,
theatre excursions, sporting events(e.g. skiing, golf or football match) etc.

www.medtecheurope.org

26Entertainment in Third Party Organised Educational Events• Entertainment in Third Party Organised
Educational Events should:- be outside of the educational programme schedule and paid forseparately by the Healthcare Professionals- not dominate or interfere with the overall scientific content of the
programme and must be held during times that do not overlap with ascientific session.
- not be the main attraction of the Third Party Organised Educational Event.

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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 residenceof 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 scientificor business centre, suitable for hosting an Event

Selected time of year
• Selected time of the year outside a touristic season
for the selected geographic locationwww.medtecheurope.org

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Who is competent to assess the General Criteria for Events?
The CVS (Conference Vetting System) reviews
the compliance of Third-Party Organised
Educational Events (educational conferences
and procedure trainings) with the MedTech
Europe Code of Ethical Business Practice.

It issues a binding decision on theappropriateness for Member Companies tofinancially support these events througheducational grants, promotional activity(e.g. booths) or satellite symposia when
they are in scope of the system.
Find out more about the Conference
Vetting system at www.ethicalmedtech.eu.
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29
1What about Guests?
•

Member Companies are not permitted to facilitate or pay for meals, travel,
accommodation or other expenses for Guests of HCPs

Guests of HCPs
Any person who does not have a bona fide
professional interest in the information being shared at an Event

SpousesPartners

FamilyOther
accompanying
peoplewww.medtecheurope.org

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Quiz: Guest of HCPs

Q: A physician asks whether he can bring his wife to a company event organised totrain cardiac surgeons. He sends proof that his wife is running a private dermatology
practice and has been a practicing HCP for 25 years. Can the company allow him tobring his wife along and participate in the training as well as cover her costs foraccommodation and travel?

NOa. Yes, the company can allow him to bring his wife as he has provided theNOb. Yes, the company can allow him to bring his wife to participate in thenecessary documentation that she is an HCP as well.

trainings, if she only participates passively and the cost of her meals is paidby the HCP.

YES

c. No, under the MedTech Europe Code it is not permissible to bring a spouse
who does not have bona fide professional interest in the information being

shared at the event.
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What is required when it comes to hospitality?

•

Meals + accommodations = hospitality•

Any hospitality offered must be:- Subordinate in time
- Focus to the Event purpose- Reasonable

Reasonable
hospitality

Not considered
as reasonable

Appropriate standard for the given location
Complying with the national laws, regulations
and professional codes of conduct

Lodging at top category or luxury hotels

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What does the Code require when it comes to travel?
•

Any reimbursed/paid travel should:- Be reasonable- Be actual- Not cover a period of stay beyond the official duration of the Event

What is appropriate
when it comes toreimbursement of
air travel costs?

Economy or standard class

Appropriate
Business class for flights longer than 5 hours

Not appropriate

Business class for flights shorter than 5 hours
First classwww.medtecheurope.org

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How to determine what needs to be done
under transparency principle?

Are there any applicable laws with regard to the disclosure
or approval requirements associated with financial support of HCPs?

YES
National
disclosure/approvalrequirements apply:
A Member Company to proceedin accordance with therequirementsof the law

NO

Code transparency
requirements apply:
A Member Company
to require Employer Notification
is made prior to the event

www.medtecheurope.org

34Third Party Organised
Educational Event• Third Party Organised Educational Conferences• Third Party Organised Procedure Training

www.medtecheurope.org

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What are Third Party Organised Educational Conferences?

• Third Party Organised Educational Conference:- A genuine, independent, educational, scientific, or policy-making conference
organised to promote scientific knowledge, medical advancement and/or thedelivery of effective healthcare- Consistent with relevant guidelines established by professional societies ororganisations for such educational meetings

Examples:•Conferences organised by national, regional, or
specialty medical associations/societies•

Hospitals•

Professional Conference Organisers (PCOs)•

Patients organisations or accredited continuing
medical education providers

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What are Third Party Organised Procedure Trainings?

• Third Party Organised Procedure Training:- Primarily intended to provide HCPs with information and training on the safeand effective performance of one or more clinical procedures in circumstanceswhere the information and training concern:- Specific therapeutic, diagnostic or rehabilitative procedures, namely clinical courses ofaction, methods or techniques (rather than the use of medical technologies); and- Practical demonstrations and/or training for HCPs, where the majority of the training
programme is delivered in a clinical environment.

- For the avoidance of doubt, proctorship and preceptorship are not considered
to constitute Third Party Organised Procedure Training

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What are the requirements for support under the Code?

Requirements

Third Party Organised Third Party Organised
Educational Conference Procedure Training

Compliance with generalcriteria for Events(Chapter 1)?

YES

YES

CVS approval?

YES*

YES

Until 31/12/2017:
Is direct sponsorship of HCPs
allowed?

YES

YES

As of 01/01/2018:
Is direct sponsorship of HCPs
allowed?

NO

YES*CVS approval will be required for the following types of funding starting inJanuary 2018: Educational Grants, promotional activity (e.g. booths) andsatellite symposia.

www.medtecheurope.org

38Company Events• Product and Procedure Training and Education Events• Sales, Promotional and Other Business Meetingwww.medtecheurope.org

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What is Product and Procedure Training and Education Event?

• Product and Procedure Training and Education Event:- Primarily intended to provide HCPs with genuine education, including
information and/or training on:- Safe and effective use of medical technologies, therapies and/or related

services, and/or- Safe and effective performance of clinical procedures, and/or- Related disease areas- In all cases the information and/or training directly concern a Member
Company’s medical technologies, therapies and/or related services.

www.medtecheurope.org

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What is Sales, Promotional and Other Business Meeting?

• Sales, Promotional and Other Business Meeting:- Has the objective to effect the sale and/or promotion of a
Members Company's medical technologies and/or related
services, including meetings to discuss product features, benefits
and use and/or commercial terms of supply.

www.medtecheurope.org

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What does the Code require when it comes to Company Events?

Requirements

Product and Procedure
Training and Education
EventsSales, Promotional andOther Business Meetings

Compliance with general criteria
for Events (Chapter 1)?

YES

YES

CVS approval?

NO

NO

YES

NO
for travel & accommodation (unlessdemonstrations of non-portableequipment are necessary)

Is direct sponsorship of HCPs
allowed ?

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Grants and Charitable Donations• Charitable Donations• Educational Grants• Research Grants

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What are main requirements for Grants and Donations?
Requirements

Charitable Donations

Educational Grants

Research Grants

Can be provided toindividual HCPs?

NO

NO

NO

Can be provided to
HCOs?

NO (unless it is a charitableorganisation/other non-profit
entity; or for non-profit hospitals incase of demonstrated Financial
Hardship under certain conditions)

YES

YES

An independent
decisionmaking/review
process implementedbythe company?

YES

YES

YES

Provided on “restrictedbasis” (i.e. control overthe final use of funds)?

NO (except to ensure that thefunds are applied forcharitable/philanthropic purposes)

YES

YES

Written agreement
and otherdocumentation?

YES

YES

YES

Financial support
publicly disclosed?

NO

YES

NO
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What are types of Educational Grants?

Support for Third Party Organised
Educational Events:• Support for HCPs participation• Support for event

Scholarships and fellowships

Can only beprovided to
HCOs

Grants for public awareness campaigns

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What are the requirements for Educational Grants?
Support for Third Party
Organised Educational
EventsScholarships &
fellowships

Grants for publicawareness campaigns

Financial support
publicly disclosed?

YES

YES

YES

Can be provided toindividual HCPs?

NO

NO

NO

Written agreement andother documentation?

YES

YES

YES

An independent
decisionmaking/review process
implemented by thecompany?

YES

YES

YES

Provided on“restricted” basis?

YES

YES

YES

Compliance withgeneral criteria for
Events (Chapter 1)?

YES

N/A

N/A

CVS approval?

YES

N/A

N/A

Requirements

www.medtecheurope.org

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Arrangements with Consultants•

Member Companies may engage HCPs to provide
bona fide consulting and other services, e.g.:- Research- Participation on advisory boards- Presentations at Company Events and product development•

Member Companies may pay HCPs reasonable
remuneration for performing these services- The Code is applicable also to those cases where a consultant HCP
declines a fee for provision of their services

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What are the requirements for consulting arrangements?

Writtenagreement anddocumentationof the services

Decisionmaking/review
process Plan

Legitimate
business need
Selection
criteria directly
related to theidentified
business need

Consulting
arrangements

Employernotification

Adequate
number of
consultants

Principle ofseparation
Fair Market
value

Meetings with
consultants:
general criteria
for events

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Quiz: Written agreement

Q: An employee of a in vitro diagnostics company wants to engage an HCP toprovide specific consulting services. The employee's superior told him that a
written contract is required for such services.

Which rules apply as far as

contracts for consulting services are concerned?

NOa.

Consulting services may only be provided on the basis of a written contract thatprecisely describes the services (nature, time, benefit for the company, etc.),
whereastheremunerationmaybeagreeduponorally.

YESb.

A written agreement must be in place before the services are rendered. Suchagreement should describe, in detail, the nature of the services to be provided
and the basis for payment of these services.

NOc.

A written contract is needed only for multiple consulting services, whereas anagreement by telephone or e-mail is fully sufficient for a single service, inparticular when the services is for free.
www.medtecheurope.org

49Research•

Member Company-Initiated Research•

Member Company-Post Market Product Evaluation•

Third Party-Initiated Research

Falls under Chapter 4:
Grants & Charitable Donations

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What does the Code requirefor Member Company-Initiated Research?

Legitimate business need for data, e.g.
• Medical needs, e.g. patient safety• Research and development• Scientific purposes, e.g. performance indicators• Regulatory, e.g. post-market surveillance, vigilance, safety• Reimbursement and health economic, e.g. clinical and cost-effectiveness data

Documentation of any arrangements to procure research-related services:• Written agreement referencing written research protocol• Written Schedule of work
• Required consents, approvals and authorisations

Compliance with applicable Good Clinical Practice guidelines, if relevant
Appropriate clinical trial transparency:• Appropriate disclosure of information about company’s clinical trials,
e.g. in external public registries

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What does the Code require forMember Company-Post Market Product Evaluation?

Legitimate business need to obtain evaluation/feedback from HCPs
and HCOs in relation to the evaluation products

Evaluation products may be provided on a no charge basis in returnfor the requested user feedback

Documented in a written protocol or questionnaire forming
part of the contract

Provision of evaluation products must not improperly induce
and/or encourage HCPs/HCOs to purchase, lease, recommend etc.
companies’ products or services

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Royalties
A Member Company and an HCP may enter into royalty arrangement where the HCP is
expected to make or has made a novel, significant, or innovative contribution to, forexample, the development of a product, technology, process, or method, such that the HCP
would be considered to be the sole or joint owner of such intellectual property underapplicable laws and regulations

Appropriate royalty
arrangements

A written agreement on royalty arrangements providing
appropriate and reasonable remuneration in accordancewith applicable laws and regulations

Not appropriate royalty
arrangements

Royalties paid are conditioned on a requirement that the
HCP recommends products or services of the company

www.medtecheurope.org

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Educational Items and Gifts

Member Companies may only provide educational items and/or gifts, if these are:Compliant withapplicable local
requirements

Provided on
exceptional
basis

Related to the
HCP’s practice, or
benefit patients, orserve a genuine
educational
function

Inexpensive
Exception: if greater
value, then can only
be provided to an
HCO

Not given in
the form of
cash orcash
equivalents

Not provided
in responseto requests
made byHCPs
Not intended to improperly
reward, incentivise and/or
encourage HCPs topurchase, lease,
recommend, prescribe,
use, supply or procure
the Member Company’s
products or services
www.medtecheurope.org

How to determine if the gift is appropriate under the new code?

www.medtecheurope.org

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Are there any gifts that are never appropriate?

Food, alcohol and items which areprimarily for use in the home or car

Never allowed

Gifts to mark significant life events e.g.
marriage, birth or birthday
Cash or cash equivalence

www.medtecheurope.org

56

Quiz: Gifts

Q: An employee of a medical device company has been working with an HCP for
several years. It is early December and Christmas is coming. Furthermore, the HCP
celebrates the 25th anniversary of her practice in January. The company employee
wonders what kind of gift he can give the HCP and for what occasion.

NOa.

The employee can give a bottle of wine to the HCP for the 25th anniversary ofher practice, but not for the occasion of Christmas, as this is a general holiday.

NOb.

The employee can give a calendar or diary for the 25th anniversary of herpractice and clinical items such as wipes, nail brushes or surgical gloves for
Christmas.

YES

c.

The employee cannot offer a gift of modest value that relates either to the25th anniversary of the HCP's practice or for the occasion of Christmas.
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Demonstrationand Evaluation Products• Member companies may provide Demonstration Products
and/or Samples at no charge in order to:

Enable HCPs/HCOs to evaluate/familiarise themselves with safe and appropriate
use/funcionality of the product/related service

Determine if to use order, purchase etc. the product and/or service in the future

Provision of such products must not improperly reward, induce and/or
encourage HCPs/HCOs to purchase, lease, recommend, prescribe, use, supply
or procure Member Companies’ products or services
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58

What does the Code requirefor Demonstration Products and Samples?

•

Maintaining appropriate
records, e.g.:•Documenting the no-charge
basis and other applicableconditions no later than thetime of the supply:- Proof of delivery for any
Demonstration
Products/Samples
provided- Clear record in the Member
Company’s records- Receipt of return for
multiple-use products- Clear disclosure in writing to
HCPs/HCOs

www.medtecheurope.org

59What are other requirements?

Demonstration Products

Samples

Provided solely for the purpose ofdemonstrating safe and effective use andappropriate functionality of a product and are
not intended for clinical use

Provided in order to enable HCPs tofamiliarise themselves with the products inclinical use

Single-use Samples:- Quantity not exceeding the amountreasonably necessary to acquire adequate
experience
Multiple-use Samples:- Specific length of time (depending on thefrequency of anticipated use, duration of the
training, the number of HCPs etc.)- Company to retain title to Samples- Process in place to remove Samples at theconclusion of the periodwww.medtecheurope.org

60How the Code will be enforced?

Independent body
MedTech Europe
Compliance Panel

Procedural Framework
Disputes are generally best
handled by national panels
subject to certain
exceptions
www.medtecheurope.org

61

FOR MORE INFORMATION

Aline Lautenberg

Pablo Rojas Abad

General Counsel – Director
Legal & Compliance

Legal & Compliance Officera.lautenberg@medtecheurope.org

p.rojas@medtecheurope.org+32 2 775 92 31+32 2 761 22 82

www.medtecheurope.org

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