CODE OF ETHICAL BUSINESS PRACTICE

CODE OF ETHICAL

BUSINESS PRACTICE

July 2018

www.abhi.org.uk

INTRODUCTION 2

Promoting an Ethical Industry 2

Key Legislation 3

Aims and Principles of the Code 4

Interpreting the Code 6

Administering the Code 6

Implementation and Transition Period 7

Transition Period to phase out direct support for HCP

attendance at Third Party Organised Educational Events

and for HCP speakers at satellite symposia 7

PART 1: Guidelines on the Interactions with

Healthcare Professionals and Healthcare

Organisations 8

Chapter 1: General Criteria for Events 9

1. Event Programme 9

2. Event Location and Venue 10

3. Guests 11

4. Reasonable Hospitality 11

5. Travel 12

6. Transparency 13

Chapter 2: Third Party Organised Educational Events 14

1. Third Party Organised Educational Conferences 14

2. Third Party Organised Procedure Training 16

3. Transition Period: Support of Individual Healthcare

Professionals to Third Party Organised

Educational Events 17

Chapter 3: Company Events 18

1. General Principles 18

2. Product and Procedure Training and

Education Events 19

3. Sales, Promotional and Other Business Meetings 22

Chapter 4: Grants and Charitable Donations 23

1. General Principles 23

2. Charitable Donations 25

3. Educational Grants 27

4. Research Grants 31

Chapter 5: Sponsored Posts 32

Chapter 6: Arrangements with Consultants 33

1. General Principles 33

2. Criteria for Genuine Consulting Arrangements 34

3. Remuneration and Fair Market Value 35

4. Disclosure and Transparency 35

Chapter 7: Research 36

1. Member Company-Initiated Research 36

2. Member Company Post-Market Product Evaluation 37

3. Third Party-Initiated Research 38

Chapter 8: Royalties 39

Chapter 9: Educational Items and Gifts 41

Chapter 10: Demonstration Products and Samples 43

1. General Principles 43

2. Demonstration Products (Demos) 44

3. Samples 45

PART 2: Disclosure Guidelines 46

Preamble 47

Chapter 1: Applicability of these Guidelines 48

Chapter 2: Disclosure Obligation 50

Chapter 3: Form of Disclosure 51

PART 3: Guidelines on Advertisements and

Promotions addressed solely or primarily to

Healthcare Professionals 53

Preamble 54

Guidelines 55

1. Scope of Guidelines 55

2. Accuracy and Substantiation of Claims

and Information 55

3. Comparative Advertising 57

4. Requests for Substantiating Data 57

5. Use of Published Data to Support Advertising 58

6. No Disparagement 58

7. Non-Referreed Articles 58

8. Off-Label Use 59

9. Quotations 59

10. Material Commissioned by the Advertiser 59

11. Testimonials and Endorsements 59

12. Reimbursement of Expenses for Providers of

Testimonials or Endorsements 60

13. Effect of Background Collaboration or

Sponsorship on Testimonials and Endorsements 61

14. Annex 1: General Advertising Law and Codes 62

PART 4: Complaints Principles, Procedure & Panel

Constitution 63

Introduction 64

Dispute Resolution Principles 65

Structure & Responsibilities 65

Complaints Procedure 66

General Provisions 66

PART 5: Glossary and Definitions 70

PART 6: Annexes 75

Annex I: CVS scope: When are CVS assessments

required? 76

Annex II: Disclosure Guidelines Template Example 77

Annex III: MedTech Europe Geographical Area 78

Annex IV: Verification Of The Use Of Funds 79

Annex V: Example of Disclosure Guidelines

Methodology Note 80

Annex VI: Direct support to HCP Participation

in Events as of 1st January 2019 81

CONTENTS

CODE

PROMOTING AN ETHICAL INDUSTRY

ABHI is the industry

association for the health

technology sector in the UK.

INTRODUCTION

The Association of British HealthTech Industries (ABHI) supports the health technology

community to provide products and services that help people live healthier lives.

With over 275 members, ABHI’s work is focused on showing the value of healthtech

and encouraging a healthy environment for economic growth. ABHI help Members

understand healthtech regulation and our work is underpinned by our Code of Ethical

Business Practice, which all Members adhere to.

The Code sets out the minimum standards appropriate to the various types of activities

carried out by the Members. 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 and all Members should independently

ascertain that their activities comply with all current national and local laws, regulations

and professional codes.

Furthermore, Member Companies must be mindful of the fact that they may be

liable for the activities of third party intermediaries who interact with Healthcare

Professionals or Healthcare Organisations in connection with the sale, promotion or

other activity involving Member Companies’ products. Accordingly, it is recommended

that where such arrangements are entered into, the relevant contractual documentation

impose obligations upon the third party (for example, third party sales & marketing

intermediaries (SMIs), consultants, distributors, sales agents, marketing agents,

brokers, commissionaire commercial agents and independent sales representatives)

to comply with provisions set out in the Code or equivalent guidelines

KEY LEGISLATION

The health technology industry in the UK and Europe, in common with other

industries, is subject to national and supranational laws which govern many aspects

of their business operations. ABHI underlines compliance with the following laws and

regulations as having particular relevance to the health technology industry:

• Safety, Quality and Performance Laws;

•

Advertising and Promotion Laws;

•

Data Protection Laws;

•

Anti-corruption Laws;

•

Environmental Health and Safety Laws;

•

Competition Laws.

National and European Union (EU) competition legislation applies not only to Members

in their business operations, but also to ABHI, each of the association’s working groups

and any sub-group within the association, irrespective of size and name. Liability under

competition laws may be strict and a Member may become liable for the infringement

of such laws by other Members of an association group in which it participates.

Accordingly, Members must make every effort to observe UK and EU competition laws

in all their interactions.

. For further details, please refer to the Eucomed/AdvaMed Third Party SMIs guidance

CODE QUESTIONS AND ANSWERS

AIMS AND PRINCIPLES

OF THE CODE

The interaction between Members and Healthcare

Professionals and Healthcare Organisations is an important

feature in achieving ABHI’s mission to make safe, innovative

and reliable technology and related services available to

more people. For example:

• Advancement of

Health Technologies

The development of innovative medical devices,

technologies and in vitro diagnostics and the

improvement of existing products require collaboration

between Member Companies and Healthcare

Professionals and Healthcare Organisations. Innovation

and creativity are essential to the development and

evolution of health technologies and/or related services.

•

Safe and Effective Use

of Health Technology

The safe and effective use of health technology and

related services requires Member Companies to offer

Healthcare Professionals and Healthcare Organisations

appropriate instruction, education, training, service and

technical support.

•

Research and Education

Member Companies’ support of bona fide medical

research and education, serves to enhance Healthcare

Professionals’ clinical skills and thereby contribute to

patient safety and increase access to new technologies

and/or related services.

In each such interaction Member Companies must continue

to respect the obligation of Healthcare Professionals to

make independent decisions regarding treatment and

safeguard the environment in which the interaction takes

place to ensure the integrity of the industry. To achieve

this aim, the Code provides guidance on the interactions

of Member Companies with both Healthcare Professionals

and Healthcare Organisations, based upon the following

underlying principles:

Q1: Does the definition of Healthcare Professional

include purchasing professionals employed in the retail

sector, such as a purchasing professional employed by a

supermarket chain?

A1: No, the definition of Healthcare Professional does not include

a purchasing professional employed in the retail sector unless

that individual purchaser arranges for the purchase of Member

Companies’ medical devices for or on behalf of medical or clinical

personnel. For example, if a Member Company’s medical devices

are sold as part of the common merchandise of the retail outlet,

interactions between the Member Company and the purchasing pro-

fessional do not fall under the Code. However, where the Member

Company’s medical devices are sold in a retail pharmacy (even if

this is located within a supermarket unit), interactions between the

Member Company and the responsible purchasing professional will

fall under the Code.

CODE QUESTIONS AND ANSWERS

•

The Principle of Image

and Perception

Member Companies should, at all times, consider the

image and perception of the health technology industry

that will be projected to the public when interacting with

Healthcare Professionals and Healthcare Organisations.

•

The Principle of Separation

Interaction between industry and Healthcare

Professionals / Healthcare Organisations must not

be misused to influence through undue or improper

advantages, purchasing decisions, nor should such

interaction be contingent upon sales transactions or use

or recommendation of Member Companies’ products.

•

The Principle of Transparency

Interaction between industry and Healthcare

Professionals / Healthcare Organisations must be

transparent and comply with national and local laws,

regulations or professional codes of conduct. In

countries where specific provision is not made, Member

Companies shall nevertheless maintain appropriate

transparency by requiring prior written notification to the

hospital administration, the Healthcare Professional’s

superior or other locally-designated competent authority,

fully disclosing the purpose and scope of the interaction.

•

The Principle of Equivalence

Where Healthcare Professionals are engaged by a

Member Company to perform a service for or on behalf

of a Member Company, the remuneration paid by the

Member Company must be commensurate with, and

represent a fair market value for, the services performed

by the Healthcare Professional.

Q2: Must a Member Company require Employer

Notification to be given whenever Company personnel

meet HCPs at an HCO? (added in May 2017)

A2: No. Unless the Member Company’s interaction with an HCP

entails a transfer of value or raises a potential conflict of interest

there is no requirement for Employer Notification. However, Member

Companies must comply with any access requirements imposed by

HCOs to visiting Member Company personnel.

CODE QUESTIONS AND ANSWERS

•

The Principle of Documentation

For interactions between a Member Company and

a Healthcare Professional, such as where services

are performed by a Healthcare Professional for or on

behalf of a Member Company, there must be a written

agreement setting out, inter alia, the purpose of the

interaction, the services to be performed, the method for

reimbursement of expenses as well as the remuneration

to be paid by the Member Company. The activities

envisaged by the agreement must be substantiated

and evidenced by activity reports and the like. Adequate

documentation such as the agreement, related reports,

invoices etc. must be retained by the Member Company

for a reasonable period of time to support the need

for, and materiality of, the services as well as the

reasonableness of the remuneration paid.

INTERPRETING THE CODE

The use of capital letters indicates that a word or expression

is a defined term, the meaning of which is set out in the

Glossary

Any phrase introduced by the terms: including, include, in

particular, or any similar expression shall be interpreted

as illustrative and shall not limit the sense of the words

preceding those terms.

ADMINISTERING THE CODE

The Code operates within a procedural framework which

includes procedures designed to provide an effective and

efficient complaint-handling process, to ensure compliance

with the Code. ABHI’s complaints handling system is based

on the principle that disputes are best resolved through

mediation.

The Conference Vetting System

is an independently-

managed system which reviews the compliance of Third

Party Organised Educational Events with the Code.

For scope of application of CVS please refer to:

www.ethicalmedtech.eu

Q3: What is the Conference Vetting System (CVS) and,

is CVS approval required for all Third Party Organised

Educational Events before a Member Company can

provide support to these events? (added in May 2017)

A3: The Conference Vetting System (see the Glossary) has been

established as the online, binding and centralised decision-making

process to help Member Companies review the compliance of

relevant Third Party Organised Educational Events with the Code.

It is managed independently of the MedTech Europe Secretariat

and Members and is under the supervision of the MedTech

Europe Compliance Panel. CVS approval is only required for Third

Party Organised Educational Events which fall within its scope, as

provided here. Where there is a CVS decision in relation to a specific

Third Party Organised Educational Event, this decision is binding

upon all Member Companies.

CODE QUESTIONS AND ANSWERS

IMPLEMENTATION AND

TRANSITION PERIOD

This edition of the Code comes into force as follows:

• PART 4: The Complaints Procedure & Panel

Constitution shall enter into force on 1 January 2017;

and

• The balance of the Code i.e. Introduction, PART 1 and

PART 2, shall enter into force on 1 January 2018.

For the avoidance of doubt, during the transposition period

1 January 2017 to 31 December 2017, no material or activity

will be regarded as being in breach of the Code if it fails to

comply with its provisions only because of requirements

which this edition of the Code newly introduces.

TRANSITION PERIOD TO PHASE

OUT DIRECT SUPPORT FOR HCP

ATTENDANCE AT THIRD PARTY

ORGANISED EDUCATIONAL EVENTS

AND FOR HCP SPEAKERS

AT SATELLITE SYMPOSIA

After the end of the Transition Period (see the Glossary)

on 31 December 2018, Member Companies shall no

longer provide financial or in-kind support directly to

individual Healthcare Professionals to cover costs of their

attendance at Third Party Organised Educational Events

with the exception of Third Party Organised Procedure

Training meetings or pursuant to a consulting agreement

with a Healthcare Professional speaker engaged by a

Member Company to speak at a satellite symposium. This

means that support of individual Healthcare Professionals

to attend Third Party Organised Educational Events (as

provided for at Chapter 2, Section 3) shall no longer be

permitted under the Code.

After the Transition Period, Member Companies may

provide financial or in-kind support to Third Party Organised

Educational Events only through Educational Grants or

other types of funding in accordance with the rules of

Chapter 2: Third Party Organised Educational Events and

Chapter 4: Grants and Charitable Donations.

Q4: What is the difference between the Transposition

period and the Transition Period as defined in the

Glossary? (added in May 2017)

A4: Transposition means the process of incorporating the Code

within the Member Company’s own policy and procedures. This

process must be completed by 1 January 2018.

Transition Period means the period between 1 January 2017 and

31 December 2018 by the end of which Member Companies must

have ceased all financial or in-kind direct support to Healthcare

Professionals to attend Third Party Organised Educational

Conferences. Any exceptions to this rule are outlined in the Code

GUIDELINES ON THE INTERACTIONS

WITH HEALTHCARE PROFESSIONALS

AND HEALTHCARE ORGANISATIONS

PART 1

CODE QUESTIONS AND ANSWERS

GENERAL

CRITERIA

FOR EVENTS

Member Companies may invite Healthcare Professionals

to Company Events and Third Party Organised

Educational Events. The principles and criteria set out in

this Chapter 1 shall apply to all such Events supported

in any way by Member Companies, irrespective of who

organises the Event.

1. EVENT PROGRAMME

The Event programme should directly relate to the specialty

and/or medical practice of the Healthcare Professionals

who will attend the Event or be sufficiently relevant to justify

the attendance of the Healthcare Professionals. For Third

Party Organised Educational Events, the agenda should be

under the sole control and responsibility of the third party

organiser.

A Member Company shall not organise Events which

include social, sporting and/or leisure activities or other

forms of Entertainment, nor support such elements where

Q5: What is meant by “legitimate” or “genuine” as used

in the definitions of ‘Company Event’ and ‘Third Party

Organised Educational Conferences’?

A5: Any Event should be relevant to the Healthcare Professional

attendees; the detailed programme should be available sufficient

time prior to the Event; present a clear schedule with no gaps

during the sessions, (e.g., the minimum duration for a full day

Event should be 6 hours or 3 hours for a half day Event including

refreshment breaks). If it is a Third Party Organised Educational

Event the Faculty must be identified. It is also important that

all supporting materials (e.g. flyers, brochures and website)

are consistent with the scientific or promotional nature of the

programme content, as the case may be.

CODE QUESTIONS AND ANSWERS

part of Third Party Organised Educational Events. For

Third Party Organised Educational Events, Entertainment

must be outside of the educational programme schedule

and paid for separately by the Healthcare Professionals.

Entertainment should not dominate or interfere with the

overall scientific content of the programme and must

be held during times that do not overlap with a scientific

session. The Entertainment should not be the main

attraction of the Third Party Organised Educational Event.

2. EVENT LOCATION AND VENUE

The Event location and venue should not become the main

attraction of the Event. For the location and the venue,

Member Companies must take into account at all times the

following considerations:

a. Potential adverse public perceptions of the location and

venue for the Event. The perceived image of the location

and venue must not be luxury, or tourist/holiday-oriented,

or that of an Entertainment venue.

The Event location and venue should be centrally located

when regard is given to the place of residence of the

majority of invited participants.

The need for ease of access for attendees.

The Event location and venue should be in or near a city or

town which is a recognised scientific or business centre,

suitable for hosting an Event which is conducive to the

exchange of ideas and the transmission of knowledge.

Member Companies must take into account the season

during which the Event is held. The selected time of year

must not be associated with a touristic season for the

selected geographic location.

Q6: Can a Member Company organise or support an

Event at a hotel or resort that offers significant leisure

facilities such as golf, casino or ski/water sports?

(Amended in July 2018)

A6: In principle, no. It is not appropriate for a Member Company to

organise or support Events at hotels or resorts renowned for their

entertainment facilities or centred around recreational or sporting

activities such as golf, private beach or ski/water sports.

Exceptions might be considered for venues well adapted to

business meetings in an otherwise compliant geographic location

where there is a compelling need to use the chosen venue, for

example, a lack of alternative venues or genuine safety or security

issues. In certain circumstances, hotel accommodation separate

from the Third-Party Organised Event venue might be required for

compliance.

Q7: Under the Code, what is meant by “ease of access”

in relation to Event location and venue?

A7:When originating location of the majority of attendees is

considered, Event location and venue need to be in close proximity

to an airport and / or train station with appropriate connections,

with associated reliable ground transportation infrastructure to

the venue.

Q8: Under the Code, how does the “season” impact

evaluation of Event location? (Amended in July 2018)

A8: Even assuming a location or venue meets all other applicable

requirements under the Code, geographic locations renowned

primarily as seasonal vacation or holiday destinations (for example,

ski-, island-, or beach resorts) are still not appropriate locations

during the season in question. For this purpose, in Europe, the ski

season is considered to run from 20th December to 31st March

and the summer season from 1st June to 15th September.

Equivalent, seasonally adjusted dates apply in other regions of the

world. Member Companies must not support or organise Events

at these locations if they take place during those seasons, even if

only in part.

CODE QUESTIONS AND ANSWERS

3. GUESTS

Member Companies are not permitted to facilitate or pay

for meals, travel, accommodation or other expenses for

Guests of Healthcare Professionals, or for any other person

who does not have a bona fide professional interest in the

information being shared at the Event.

4. REASONABLE HOSPITALITY

Member Companies may provide reasonable hospitality to

Healthcare Professionals in the context of Company Events

and Third Party Organised Educational Events but any

hospitality offered must be subordinate in time and focus

to the Event purpose. Member Companies must in any

event meet the requirements governing hospitality in the

country where the Healthcare Professional carries on their

profession and give due consideration to the requirements

in the country where the Event is being hosted

The Code seeks to find a balance between the courteous

and professional treatment of Healthcare Professionals

by Member Companies, with the desire to avoid

even the appearance that hospitality may be used by

Member Companies as a means to induce Healthcare

Professionals to purchase, prescribe or recommend

Member Companies’ products.

Q9: What does the term “facilitate” mean where used in

connection with the Guest expenses?

A9: The term “facilitate” refers to the prior arrangement,

organisation or booking of meals, travel or accommodation

by or on behalf of a Member Company on behalf of the Guest

of a Healthcare Professional participant. Such organisation

or booking is not permitted unless the individual qualifies as a

participant in his/her own right, irrespective of who pays. Such

actions are open to misinterpretation. If Healthcare Professionals

attending the Event wish to be accompanied by a Guest who does

not have a professional interest in the information being shared,

the Healthcare Professional must take sole responsibility for the

payment and organisation of the Guest’s expenses.

Q10: In the event that a Healthcare Professional is

accompanied by a Guest at the Event, may this Guest be

admitted to any Company Event, or Third Party Organised

Educational Events?

A10: It is not appropriate for a Guest of a Healthcare Professional to

attend either Company Events (including Satellite Symposia) or Third

Party Organised Educational Events (unless the individual qualifies as

a participant in their own right), nor is it appropriate, in the interest of

maintaining the scientific exchange, for a Guest to participate in related

hospitality during such Events (for example, lunches and coffee breaks)

even when the Healthcare Professional pays for the Guest’s expenses.

Member Companies, however, may financially support Third

Party Organised Educational Events which offer extra-curricular

programmes/activities beyond the scientific, educational or training

sessions for Guests of Healthcare Professionals (such as touristic

activities and hospitality), always 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, facilitated or reimbursed by, a Member Company.

Q11: Is it acceptable to offer a cash advance by way

of a cheque or bank transfer payable to a Healthcare

Professional for a specific amount to cover all or part of

the Healthcare Professionals’ travel or accommodation

expenses for attendance at the Event?

A11: It is not acceptable to make an advance payment to a

Healthcare Professional to cover prospective expenses. Payments

should generally be made to the supplier/vendor or intermediary

agency. Alternatively Member Companies may reimburse

individual Healthcare Professional expenses retrospectively

against original invoices or receipts.

In the UK, the NHS England document Managing Conflicts of Interest in the NHS

(Publications Gateway Reference: 06419) sets the upper limit for meals and refresh-

ments that may be accepted by NHS HCPs at £75. While this only directly applies to

the NHS in England it should be taken as indicative of what is acceptable in the rest

of the UK, including in relation to HCPs working in the non-NHS sector. Different lim-

its may apply in other territories and Member Companies should comply with these

as appropriate. Where no such limits apply, the UK figure may be taken as indicative

of what is acceptable under the Code although in exceptional circumstances local

considerations may allow the £75 limit to be exceeded.

CODE QUESTIONS AND ANSWERS

Accordingly, Member Companies must assess what

is “reasonable” in any given situation and regional

variations will apply. As a general guideline, “reasonable”

should be interpreted as the appropriate standard for the

given location and must comply with the national laws,

regulations and professional codes of conduct. The term

“hospitality” includes meals and accommodation and it is

important that Member Companies differentiate between

“hospitality” which is permitted and Entertainment which

is not. Please refer to the Glossary for the definition of

Entertainment.

Member Companies may not pay for or reimburse

Healthcare Professionals’ lodging expenses at top category

or luxury hotels. For the avoidance of doubt, if the Event

venue is a hotel which complies with the requirements of

the Code, it would be acceptable for Member Companies to

offer participants meals and accommodation at the same

hotel. However, accommodation and/or other services

provided to Healthcare Professionals should not cover a

period of stay beyond the official duration of the Event.

5. TRAVEL

Member Companies may only pay or reimburse for

reasonable and actual travel. Travel provided to Healthcare

Professionals should not cover a period of stay beyond the

official duration of the Event.

For air travel, in principle, this means that Member

Companies can only pay or reimburse economy or standard

class unless the flight time is of a duration of greater than 5

hours including connection flights, in which case business

class can be considered. First class is never appropriate.

Q12: May Member Companies offer to cover the

travel and accommodation expenses of Healthcare

Professionals for periods that extend beyond the

duration of the Event programme attended?

A12: Generally, travel and accommodation support offered

by Member Companies to Healthcare Professionals should be

tailored to the duration of the Event. Member Companies must

always keep in mind the impression which may be created by the

arrangements for any meeting.

CODE QUESTIONS AND ANSWERS

6. TRANSPARENCY

Member Companies must ensure full compliance with

national laws with regard to the disclosure or approval

requirements associated with such financial support

and where no such requirements are prescribed, shall

nevertheless maintain appropriate transparency, as a

minimum, by requiring Employer Notification (as defined in

the Glossary) is made prior to the Event.

Q13: Under the Code, is Employer Notification required

for each interaction with a Member Company? For

example, is such notification required each time a

Member Company pays for a reasonably priced meal or

gives a Healthcare Professional a gift, which is otherwise

in line with the requirements of the Code?

A13: Employer Notification is required whenever a Member

Company engages a Healthcare Professional or whenever

a member makes a financial contribution to the Healthcare

Professional’s medical education. Incidental interactions arising

in the normal course of business such as meals associated with

educational or business meetings or the receipt of modest gifts

related to the Healthcare Professional’s practice, do not require

Employer Notification.

Q14: Are members required to provide additional

written notification under the Code to the hospital

administration, Healthcare Professional’s superior (or

other locally-designated body) for Member Company/

Healthcare Professional interactions in countries where

there are compulsory notification systems already in

place?

A14: No. Only the compulsory notification is required. Additional

notification under the Code is not required in countries where

specific notification requirements of law or regulation govern the

transparency of interactions between industry and Healthcare

Professionals. The transparency provisions of the Code apply only

in countries where there is an absence of national transparency

laws and regulations.

Q15: When making Employer Notification, are Member

Companies required to provide details of the proposed

financial contribution Member Companies will make to

the Healthcare Professional in exchange for the services

rendered?

A15: The written notification must comply with national laws,

regulations and professional codes of conduct. In countries

where specific provision is not made, there is no requirement

to notify employers of the amounts involved. Under the Code,

Member Companies must ensure that the level of remuneration

is commensurate with the services provided and not greater

than a fair market value. However, the purpose of the Employer

Notification is to provide transparency on the nature of the

interaction between the Member Company and the Healthcare

Professional and to enable the employer to raise objections if they

perceive a potential conflict or have other issues concerning the

interaction.

CODE QUESTIONS AND ANSWERS

Member Companies may provide financial and/or in-kind

support (e.g. Member Company products) to Third Party

Organised Educational Events in accordance with the rules

of this Code. Such Events include:

•

Third Party Organised Educational Conferences;

•

and Third Party Organised Procedure Training meetings.

1. THIRD PARTY ORGANISED

EDUCATIONAL CONFERENCES

Member Companies may support in cash and/or in-kind

Third Party Organised Educational Conferences (see the

Glossary) which comply with:

•

Chapter 1: General Criteria for Events

;

•

and where applicable, has approval via the

Conference

Vetting System

(see the

Glossary

Q16: What is meant by “in-kind support” as used in

Chapter 2, Section 1 of the Code in connection with

“Third Party Organised Educational Conferences”?

(Amended in July 2018)

A16: “In-kind support” can be provided to the Healthcare

Organisation (HCO) and Member Companies should ensure that

any such in-kind support does not, nor is perceived to, circumvent

the prohibition of Member Companies providing direct financial

support to identifiable Healthcare Professionals to attend Third

Party Organised Educational Conferences. For example, after

the Transition Period, it would not be appropriate for Member

Companies to directly handle the conference registration, travel,

or accommodation arrangements for individual (and identifiable)

HCP delegates at a Third Party Organised Educational Conference.

Examples of “in-kind support” which Member Companies may

provide could include modest secretarial and/or logistical support

to assist with meeting arrangements.

For scope of application of CVS please refer to:

www.ethicalmedtech.eu

THIRD PARTY

ORGANISED

EDUCATIONAL

EVENTS

CODE QUESTIONS AND ANSWERS

Where permitted under national laws, regulations and

professional codes of conduct, Member Companies may

provide financial and/or in-kind support to Third Party

Organised Educational Conferences (always provided that

the Third Party Organised Educational Conference has

been approved via the Conference Vetting System, where

appropriate) through grants and other types of funding,

such as:

a. Educational Grants

Please refer to

Chapter 4: Grants and Charitable Donations

for guidance on Educational Grants.

b. Promotional Activity

Member Companies may purchase packages that may

include promotional and advertising services, for example,

advertisement space and booth space for company

displays. Member Companies should ensure that the

overall image projected by the promotional activity at Third

Party Organised Educational Conferences is perceived as

professional at all times. It should never bring discredit

upon or reduce confidence in the health technology

industry.

c. Satellite Symposia

Member Companies may purchase satellite symposia

packages at Third Party Organised Educational

Conferences and provide presentations on subjects that

are consistent with the overall content of the Third Party

Organised Educational Conference. Member Companies

may determine the content of these satellite symposia and

be responsible for speaker selection.

Q17: Please provide examples of appropriate booth

activities which will be perceived as professional?

A17: Booth activities at Third Party Organised Educational

Conferences should aim primarily at displaying Member

Companies’ products and services and related literature.

Therefore, other activities should be limited and reasonable and

in principle, only soft drinks and snacks should be served.

Q18: Can a Member Company, for example, be present

via a satellite symposium or rent booth space at a Third

Party Organised Educational Conference which was

assessed as non-compliant by the Conference Vetting

System (CVS)? (Amended in May 2017)

A18: Please refer to Annex I for a detailed visualisation of the

scope CVS and its impact on commercial activities.

Q19: Can Member Companies directly support

attendance by Healthcare Professionals engaged to

speak only at satellite symposia at Third Party Organised

Educational Conferences, e.g. registration fee, travel

and/or accommodation? (Amended in July 2018)

A19: Member Companies must ensure all aspects of the

arrangement comply with the Code, including entering into a

consulting agreement with Healthcare Professionals engaged

to speak at satellite symposia. The consulting agreements

may provide for payments to be made in respect of travel and/

or accommodation for the purpose of delivering the speaker

services. Where payment of a registration fee is required in order

for speakers to access satellite symposia, Member Companies

may also pay for the registration fee.

CODE QUESTIONS AND ANSWERS

2. THIRD PARTY ORGANISED

PROCEDURE TRAINING

Member Companies may support Third Party Organised

Procedure Training either via Educational Grants (in

accordance with

Chapter 4: Grants and Charitable Donations

)

or by providing financial support directly to individual

Healthcare Professionals to cover the cost of attendance

at Third Party Organised Procedure Training sessions in

accordance with the following rules:

Financial support must comply with the criteria provided

Chapter 1: General Criteria for Events

. Member

Companies may therefore pay travel, hospitality and the

registration fee.

Where applicable, the Third Party Organised Procedure

Training has approval via the Conference Vetting System

(see the

Glossary

)

For financial support to Third Party Organised Procedure

Training meetings Member Companies must apply the

requirements governing conduct and attendance at

such meetings in the country where the Healthcare

Professional carries on their profession and give due

consideration to the requirements in the country where

the meeting is being hosted.

Q20: What are the main differences between Third Party

Organised Educational Conferences and Procedure

Trainings? (added in May 2017)

A20: Both Third-Party Organised Educational Conferences (see the

Glossary) and Third-Party Procedure Trainings (see the Glossary)

are a type of Third Party Organised Educational Events. Therefore,

they must comply with Chapter 1. General Criteria for Events; and,

where applicable, are subject to the Conference Vetting System (see

the Glossary). However, unlike Third Party Organised Educational

Conferences, Third Party Organised Procedure Training is not

subject to the phase out of direct support for the attendance of

Healthcare Professionals. Nonetheless, for Third Party Organised

Procedure Training the following three criteria shall apply:

• Programme: Unlike Third Party Organised Educational Conferences

which are theoretical in nature, Third Party Organised Procedure

Training consists of practical, hands-on training, generally involving

more than one provider/ manufacturer/sponsor. This must be

evident by the programme of the Event.

The programme, which is often referred to as a “course”, rather than

a conference or seminar, must be focused on acquiring specific

medical skills relevant to certain medical procedures (rather than

products, or health technologies). Examples may include courses

aimed at acquiring or improving the Healthcare Professional’s skills

in minimally invasive surgery; orthopaedic trauma surgery; or the

implantation of cardiac rhythm devices; etc. The programme must

also include practical demonstrations (and/or actual live surgeries,

where allowed). Examples of practical demonstrations may include

surgery simulations where technologies are used on cadavers; skin

models; synthetic bones; cath labs; etc.

• Venue: Third Party Organised Procedure Training is typically

organised in a clinical environment, as opposed to, e.g., a classroom

setting.

For the avoidance of doubt, the adjective “clinical” includes places

suitable for the simulation of medical procedures, rather than just

the medical treatment of real patients.

Examples of clinical environment include hospitals or clinics,

where medical treatment on real patients may be given; as well as

conference rooms which are appropriately set up to simulate medical

procedures, for example with the presence of health technologies to

be used on cadavers; skin models; synthetic bones; etc.

• Stand-alone event: Third Party Organised Procedure Training must

stand alone. Where the majority of the Training is not given in a

clinical environment, for example, where the Training is organised

in connection, adjacent to or at the same time as a larger Third

Party Organised Educational Conferences, that Training will not

qualify as a Third Party Organised Procedure Training, as defined

in the Code.

For scope of application of CVS please refer to:

www.ethicalmedtech.eu

CODE QUESTIONS AND ANSWERS

Q21: In the definition of Third Party Organised

Procedure Training, what is meant by “Proctorship”

and “Preceptorship”? Further, do Proctorships and

Preceptorships require CVS approval before they can

be provided and/or supported by a Member Company?

(added in May 2017)

A21: For the purpose of the Code both Proctorship and

Preceptorship are types of clinician-to-clinician trainings funded

by a Member Company.

Proctorship is where the trainee clinician performs a procedure

under the supervision of another clinician and where the trainee

clinician has primary responsibility for the patient undergoing the

procedure.

Preceptorship is where the supervising clinician oversees the

procedural training of the trainee clinician and the trainee does

not have primary responsibility for the patient undergoing the

procedure.

Such Proctorships and Preceptorships normally take place on

Healthcare Organisation premises and are not subject to CVS

approval as it is not considered to be either a Third Party Organised

Educational Event or a Third Party Organised Procedural Training.

3. TRANSITION PERIOD:

SUPPORT OF INDIVIDUAL

HEALTHCARE PROFESSIONALS

TO THIRD PARTY ORGANISED

EDUCATIONAL EVENTS

Member Companies may provide financial support directly

to individual Healthcare Professionals to cover the costs of

attendance at Third Party Organised Educational Events

where this is permitted under national laws, regulations

and professional codes of conduct. Such support shall be

in accordance with the following rules:

Financial support must comply with the criteria provided

Chapter 1: General Criteria for Events

. In addition

Member Companies may pay the registration fee.

Where applicable, the Third Party Organised Educational

Event has approval via the Conference Vetting System

(see the

Glossary

c. For financial support to Third Party Organised

Educational Events Member Companies must apply

the requirements governing conduct and attendance

at such Third Party Organised Educational Event in

the country where the Healthcare Professional carries

on their profession and give due consideration to the

requirements in the country where the meeting is being

hosted.

For scope of application of CVS please refer to:

www.ethicalmedtech.eu

CODE QUESTIONS AND ANSWERS

1. GENERAL PRINCIPLES

Member Companies may invite Healthcare Professionals

to Company Events. Such events include, as defined in the

Glossary

•

Product and Procedure Training and Education Events

•

Sales, Promotional and Other Business Meetings

Company Events should comply with the principles

mentioned in

Chapter 1: General Criteria for Events

Where there is a legitimate business purpose, Company

Events may include or take place in Member Company’s

manufacturing plant or Healthcare Organisations, used by

the Member Company as reference centres.

Q22: Is it appropriate for Member Companies to invite

Healthcare Professionals on company plant or factory

tours where the Healthcare Professionals reside outside

the country of location of the plant or factory?

A22: Yes, it is appropriate for Member Companies to invite

Healthcare Professionals to plant or factory tours in countries

outside their country of residence if there is a legitimate business

purpose and the tour complies with the Code in all respects.

CODE QUESTIONS AND ANSWERS

COMPANY

EVENTS

CODE QUESTIONS AND ANSWERS

2. PRODUCT AND PROCEDURE

TRAINING AND COMPANY

ORGANISED EDUCATION EVENTS

Where appropriate, in order to facilitate the safe and

effective use of health technologies, therapies and/or

services, Member Companies should make product and

procedure training and education available to relevant

Healthcare Professionals.

Member Companies shall ensure that personnel conducting

the Product and Procedure Training and Education Events

have the appropriate expertise to conduct such training.

Q23: Can Member Companies directly support travel

and/or accommodation or other expenses of individual

Healthcare Professionals for attendance as delegates at

Company Organised Events happening during or around

a Third-Party Organised Educational Event? (Added July

2018)

A23: No, as from 1st January 2019, Member Companies cannot

directly support travel and/or accommodation or other expenses

of individual Healthcare Professionals participating as delegates

in Company Organised Events which take place during, around, or

at the same time and in the same approximate location as a Third-

Party Organised Event.

Company Organised Events, including fee-for-service arrangements

like Advisory Boards and Clinical Investigator meetings, may be

organised at or around a Third-Party Organised Educational Event

for reasons of convenience and efficiency, given the attendance

of Healthcare Professionals at that Third-Party Organised

Educational Event. In order for Member Companies to be able to

directly support travel and/or accommodation or other expenses

at such Company Organised Events the Healthcare Professionals

must have an active role at such a Company Organised Event,

rather than being mere passive attendees. [For example, no

support shall be provided by Member Companies to Healthcare

Professionals attending a Company Organised Educational Event

as a delegate or trainee where this is organised at or around a

Third-Party Organised Educational Event.] Where there is active

participation by the attending Healthcare Professional, the Member

Company may still only pay for the contractual remuneration

and expenses agreed for the provision of the services by the

healthcare Professional at the Company Organised Educational

Event itself. Under no circumstances may a Member Company

pay for incremental costs relating to the Healthcare Professional’s

attendance at the Third-Party Organised Educational Event, such as

registration costs, hospitality, additional travel or accommodation.

Specific examples of support which can and cannot be provide

include the following:

For an advisory board or a clinical investigator meeting organised

at or around a Third-Party Organised Educational Event:

– the registration fee of the Healthcare Professional to the Third-

Party Organised Educational Event shall in no circumstances be

covered by the Member Company as this would not be related to

the services to be provided.

– the flight and accommodation costs can be covered where these

are tailored to the services to be provided for the advisory board

or clinical investigator meeting. However, any possible additional

costs, e.g. arising in consequence of changes to travel plans

must be borne by the Healthcare Professional.

For a satellite symposium or a booth speaker engagement taking

place during the Third-Party Organised Educational Event (i.e. as

part of that Third-Party Organised Educational Event):

– the Healthcare Professional’s registration fee for the Third-

Party Organised Educational Event can be covered but only if

the Healthcare Professional’s access to the satellite symposium

CODE QUESTIONS AND ANSWERS

or booth at the Third-Party Organised Educational Event is

conditional upon the payment of the registration fee. Where

this does apply, the registration fee must, where possible, be

pro rata’d to the actual attendance required in order to deliver

the required services. E.g. if the satellite symposium is held on a

single day of the three-day event, and it is possible to choose a

one-day registration, that option should be selected.

– the flight and accommodation costs can only be covered if

the Healthcare Professional is not already benefiting from an

educational grant covering his/her attendance at the event.

The costs shall be tailored to the services to be provide and any

possible additional costs, e.g. arising from changes to travel

plans must be borne by the Healthcare Professional.

Q24: Under the Code, Chapter 3, Point 2, what is meant by

“Company Organised Education Events”? (added in May

2017)

A24: A “Company Organised Education Event” is a Company

Event as defined in the Glossary, whose objective is genuine and

bona fide medical education, and the enhancement of professional

skills. “Educational” or “education” means communicating

information directly concerning or associated with the use of

Member Companies’ health technologies, e.g., information about

disease states and the benefits of health technologies to certain

patient populations. In all cases the information and/ or training

must directly concern a Member Company’s health technologies,

therapies and/or related services.

This means that a Member Company must meet the following tests

when organizing such an Event in order to be compliant with the Code:

a) The entire Event must comply with the criteria of Chapters 1 and 3;

b) The programme must be rigorous from a scientific and/or

educational point of view. This means that its content must

include current scientific information of a nature and quality

which is appropriate to the Healthcare Professionals who are

attendees at the Event.

c) The programme must be genuine and bona fide educational, and

therefore cannot have a primary sales and marketing objective. This

means that the education part must fill most of the programme.

d) Information on the programme, clearly indicating the name

of the Company organising the Event, should be made

available sufficiently in advance in order for invited Healthcare

Professionals to be able to make a reasoned judgment as to

the rigor and quality of the programme, provided however that

subsequent changes, deletions and additions to the programme

are acceptable to the extent that such changes, deletions and

additions are reasonable and do not significantly modify the

quality or nature of the programme.

e) The programme should in principle involve full days, with the

majority of the morning and afternoon parts dedicated to

scientific and/or educational sessions, unless the Event is a half

day event, commences or ends on a midday or lasts less than

half a day. Such half-day or less sessions are permissible, but

there should not be any non-scientific or non-educational events

or activities organised for the other part of the day. Furthermore,

CODE QUESTIONS AND ANSWERS

there should be no significant gaps in the programme which

would permit Healthcare Professionals to engage in non-

scientific or non-educational activities. For example, early

morning sessions should not be followed by late afternoon or

evening sessions with large blocks of free time in between.

Q25: Are cruise ships or golf clubs appropriate venues for

Product and Procedure Training and Education Events?

A25: No. Cruise ships, golf clubs or health spas and venues

renowned for their entertainment facilities are not appropriate

venues and should not be used. Appropriate examples include

hospital, clinic or surgical centre laboratory, educational,

conference, or other appropriate settings, including Member

Companies’ own premises or commercially available meeting

facilities, that are conducive to effective transmission of

knowledge and any required “hands on” training.

Q26: What criteria should a Member Company apply

when considering the country location of Product and

Procedure Training and Education Events?

A26: If the participants are primarily of one country, the venue

should be in the specific country involved. If the participants

are from multiple countries in Europe, then a European country

affording ease of access for participants should be chosen. It

is expected that the country selected is the residence of at least

some of the participants of the Product and Procedure Training

and Education Event.

Q27: Can a Member Company use a meeting venue

outside Europe?

A27: Yes, provided the participants are from multiple countries

outside Europe. If the participants are primarily from within

Europe, the venue should be in Europe. It is expected that the

country selected (and the state, if the location is in the United

States) is the residence of at least some of the participants of the

Product and Procedure Training and Education Event.

Q28: Can Member Companies directly support travel and/

or accommodation of individual Healthcare Professionals

at Company Events, which include new product launches,

even if only portable equipment or solutions are being

demonstrated. (Added July 2018)

A28: Member Companies can pay for travel and/or

accommodation of individual Healthcare Professionals to attend

Company events which include product launches provided that

such Events fall within the scope of Chapter 3, Section 2, of the

Code (“Product and Procedure Training and Educational Events”).

CODE QUESTIONS AND ANSWERS

3. SALES, PROMOTIONAL AND

OTHER BUSINESS MEETINGS

Where it is appropriate, Member Companies may organise

Sales, Promotional and Other Business Meetings where

the objective is to discuss product and related services

features and benefits, conduct contract negotiations, or

discuss sales terms.

In addition to the principles laid down in the

Chapter 3,

Section 1

, Sales, Promotional and Other Business Meetings

should also comply with the following more stringent

requirements:

Such meetings should, as a general rule, occur at or

close to the Healthcare Professional’s place of business;

It is not appropriate for travel or accommodation

support to be provided to Healthcare Professionals by

Member Companies, except where demonstrations of

non-portable equipment are necessary.

CODE QUESTIONS AND ANSWERS

1. GENERAL PRINCIPLES

a. Grants and Charitable Donations (see the

Glossary

)

shall not be contingent in any way on past, present

or potential future purchase, lease, recommendation,

prescription, use, supply or procurement of the Member

Company’s products or services. It is important that

support of charitable and/or philanthropic programmes

and activities by Member Companies is not viewed

as a price concession, reward to favoured customers

or as an inducement to purchase, lease, recommend,

prescribe, use, supply or procure Member Companies’

products or services.

b. A Member Company shall not provide Grants or

Charitable Donations to individual Healthcare

Professionals. Grants and Charitable Donations must be

provided directly to the qualifying organisation or entity,

CODE QUESTIONS AND ANSWERS

GRANTS AND

CHARITABLE

DONATIONS

CODE QUESTIONS AND ANSWERS

as the case may be. Grants and Charitable Donations

shall not be provided in response to requests made

by Healthcare Professionals unless the Healthcare

Professional is an employee or officer of the qualifying

organisation or entity and submits the request in writing

on behalf of the qualifying organisation or entity.

c. The payment (or provision of other support) by way of

any Grant or Charitable Donation shall always be made

out in the name of the recipient organisation and shall

be paid directly to the organisation. A Member Company

shall not provide Grants or Charitable Donations in

the name of any Healthcare Professional. In addition,

all Grants and Charitable Donations shall identify the

Member Company as the provider of the Grant or

Charitable Donation.

d. It must in all cases be lawful under applicable national

laws and regulations for the Grant or Charitable

Donation recipient to receive and benefit from the

particular type of Grant/Charitable Donation.

e. Member Companies shall implement an independent

decision-making/review process to identify, prevent

and mitigate against potential bribery and corruption

risks arising in connection with the provision of a Grant

or a Charitable Donation to a specific prospective

recipient. This process shall include a documented,

prior evaluation of any such associated risks and of the

relevant information concerning the intended recipient

organisation or entity.

Q29: Under the General Principles in Chapter 4.

Grants and Charitable Donations, what is meant by an

“independent decision-making/review process”?

A29: In accordance with the Principle of Separation, an

“independent decision-making/review process”, is a process

where the decision-making criteria are not primarily sales-

driven and where the Member Company’s sales function does

not decide upon and/or approve a decision to provide a Grant or

Charitable Donation. For example, such a process could be led

by a Member Company’s legal, finance or compliance functions,

operating within a robust governance framework and according to

clear, consistent and transparent criteria for review and decision-

making.

Q30: Under the Code, what is meant by “prior evaluation

of any associated risks and of the relevant information”

relating to a Grant or a Charitable Donation?

A30: Prior to deciding to provide a Grant or a Charitable Donation,

the Member Company must evaluate the appropriateness of

the award of the proposed Grant or Charitable Donation to the

proposed recipient. Such an evaluation shall consider all the

circumstances including, but not limited to, consideration of

the legal status and structure of the requesting ( i.e. prospective

recipient) organisation as well as of the nature and scope of

its activities and the terms and conditions to which the Grant

or Charitable Donation will be subject. The evaluation shall be

documented and shall be based on information available to

the Member Company, such as information or documentation

available from public sources.

For Educational Grants provided in relation to Third Party

Organised Educational Events, this may also include information

of how the funds have been applied by the recipient in relation to

previous equivalent Events and whether funds have been spent in

accordance with the terms and conditions of any previous Grant.

CODE QUESTIONS AND ANSWERS

f. All Grants and Charitable Donations must be

appropriately documented by the Member Company.

Moreover, Grants and Charitable Donations shall only be

provided in response to a written request submitted by

the requesting organisation or documented initiative from

a Member Company containing sufficient information to

permit an objective evaluation of the request to be carried

out by the Member Company. No Grant or Charitable

Donation shall be provided until a written agreement

documenting the terms of this is signed by both parties.

g. This section of the Code (Chapter 4: Grants and

Charitable Donations) is not intended to address the

legitimate practice by Member Companies of providing

appropriate rebates, additional product and/or service

offerings, including free of charge, or other comparable

pricing incentive mechanisms (“value adds”) which are

included in competitive and transparent centralised

purchasing arrangements, such as, for example, tenders.

2. CHARITABLE DONATIONS

Member Companies may make unrestricted Charitable

Donations for genuinely charitable or other philanthropic

purposes. “Unrestricted” in this context means that

Member Companies shall have no control over the final

use of funds (or other support) they provide as Charitable

Donations beyond general restrictions to ensure that the

funds (or other support) are applied for charitable and/or

philanthropic purposes.

Charitable Donations may be made only to charitable

organisations or other non-profit entities which have

charitable and/or philanthropic purposes as their main

purposes and which are objectively engaged in genuine

charitable or philanthropic activities. Charitable Donations

shall always be made in accordance with the general

principles set out in

Chapter 4: Grants and Charitable

Donations

Restricted Charitable Donations to non-profit hospitals may

be permissible in case of demonstrated Financial Hardship

(see

Glossary

), when Charitable Donations serve exclusively

the benefit of the patient, are limited in value, or explicitly

permitted by applicable national laws.

This section of the Code (Chapter 4: Grants and Charitable

Donations – Charitable Donations) is not intended to

address legitimate commercial transactions by Member

Companies in the form of leasing of stands or booth space

at Third Party Organised Educational Events and/or at

any conference or event organised by a charity or other

philanthropic organisation. Such activity is considered to

be part of Member Companies’ normal marketing activity.

Member Companies should, however, always consider

the appropriateness of the location, venue and the general

arrangements for any such events and the impression that

may be created by the arrangements in order not to bring the

industry into disrepute.

Q31: What does “sufficient information” mean where

used in connection with documentation of Grants and

Charitable Donations?

A31: The written request by a requesting organisation should

include as a minimum a detailed description of the scope and

purpose of the programme, activity or other project, which is the

object of the Grant or Charitable Donation. It shall also contain

a description of the proposed recipient, its legal status and

structure, and where relevant, a budget.

Q32: Under the Code, can a Member Company make a

Charitable Donation to support the general running of

hospital or other Healthcare Organisation?

A32: No, a Member Company cannot make available a

Charitable Donation to support the general running of a hospital

or other Healthcare Organisation. A Charitable Donation shall

only be given to a legal entity or body which has charitable and/

or philanthropic purposes as its main purposes. For the purpose

of the Code and irrespective of their legal status, hospitals and

Healthcare Organisations are considered to generally have

health functions as their main purposes and accordingly are

not generally considered to have charitable and/or philanthropic

functions as their main purposes. It is not therefore appropriate

to provide Charitable Donations to support their general running.

Q33: Is it permissible for a Member Company to specify

restrictions in relation to the final use of a Charitable

Donation where a Member Company wishes its

Charitable Donation to be applied as part of a specific

aid programme or as part of the relief effort following a

specific natural disaster, such as a major earthquake in

a particular country? (added in May 2017)

A33: Under the Code it is not appropriate for a Member Company

to apply conditions or restrictions to the final use of a Charitable

Donation which go beyond general restrictions to ensure that

the funds (or other support) are applied for charitable and/or

philanthropic purposes. Member Companies may therefore impose

general restrictions concerning the final use, such as the relief

of a specific disaster in a particular country (e.g. for use to aid

reconstruction and/or re-equipping of healthcare facilities following

the earthquake in that country). However, Member Companies must

take care that such general restrictions are not so specific that

the Charitable Donation is no longer unrestricted. The Charitable

Donation must not be misused or be perceived to influence through

undue or improper advantages, purchasing decisions, nor should

such Donation be contingent upon sales transactions or use or

recommendation of Member Companies’ products.

CODE QUESTIONS AND ANSWERS

3. EDUCATIONAL GRANTS

Member Companies may provide restricted Educational

Grants (see the

Glossary

) for the advancement of genuine

medical education. “Restricted” in this context means that

Member Companies shall specify the intended purpose of

the Educational Grant in the Grant agreement. A Member

Company shall also ensure that the Educational Grant

agreement with the recipient organisation includes rights

to enable it to verify that the Grant is in fact used for the

agreed intended purpose.

Member Companies shall document and publicly disclose

all Educational Grants in accordance with the Code’s

Disclosure Guidelines, and publication shall commence no

later than the end of the Transition Period.

Member Companies may provide Educational Grants for

the following (non-exhaustive) purposes:

Q34: Is it permissible for a Member Company to make

a Charitable Donation to a Healthcare Professional’s

designated charity in instances where the Healthcare

Professional has requested the Member Company to do

so in lieu of receiving a professional fee for the provision

of consultancy or speaking services to the Member

Company?

A34: No. Under the Code it is not appropriate for a Member

Company to support the favourite charity of a Healthcare

Professional in response to a request by that Healthcare

Professional irrespective of the underlying reasons. No exception

can be made for sport events, such as payment of the registration

charge to participate in a charity run.

Q35: Under the Code, may a Member Company make a

Charitable Donation such as the purchase of a table of

dinner invitations at a fundraising dinner or entries to

participate in, or attend at, a fundraising sports or other

event?

A35: Yes, Charitable Donations made by Member Companies

may take the form of dinner invitations for a fundraising dinner

or participating in other recreational events such as a fundraising

golf tournament, if arranged by a charitable or other non-profit

philanthropic organisation. The Member Company may use some

or all of its ticket allotment for its own employees and return

any unused portion to the sponsoring charitable or non-profit

philanthropic organisation for use as the sponsoring organisation

sees fit. However, the Member Company should not invite

Healthcare Professionals to attend such an event at the Member

Company’s expense. Furthermore, the Member Company is not

permitted to suggest to the sponsoring organisation, the names

of Healthcare Professionals who could be invited to attend the

event, irrespective of whether or not the specified Healthcare

Professionals will be seated at the Member Company’s table.

Q36: Can a small sized Healthcare Organisation receive

Educational Grants to support Healthcare Professionals

participation at Third Party Organised Educational Events?

(added in May 2017)

A36: Yes, in principle. There are no size limits for Healthcare

Organisations to receive Educational Grants; however, Member

Companies must ensure that the final beneficiaries of the Educational

Grant cannot be identified beforehand. For example, Healthcare

Organisations composed of a single Healthcare Professional will

in practice not be allowed to receive Educational Grants to support

Healthcare Professionals participation at Third Party Organised

Educational Events, as the final beneficiary is known upfront.

CODE QUESTIONS AND ANSWERS

For scope of application of CVS please refer to: www.ethicalmedtech.eu

a. Support for Third Party

Organised Educational Events:

As a general principle, any Third Party Organised

Educational Event supported by way of an Educational

Grant from a Member Company to a Healthcare

Organisation must:

•

Comply with Chapter 1. General Criteria for Events; and

•

Where applicable, have approval via the Conference

Vetting System

(see the

Glossary

)

a.1. Support for HCP Participation at Third

Party Organised Educational Events:

Where the Educational Grant is provided for the purpose

of supporting Healthcare Professionals’ attendance at

Third Party Organised Educational Events, the Healthcare

Organisation receiving the Grant shall be solely

responsible for selection of participants and this shall be

expressly reflected in the written Grant agreement.

Q36-bis: Can an Educational Grant or funds earmarked

for education be provided to a specific hospital or

department or specify individual hospital or department

as criteria for HCOs and/or PCOs? (Added July 2018).

A36-bis: One of the guiding principles in the Code is that

companies should not receive or be able to determine the names

of the ultimate HCP beneficiaries and the inclusion of a criterion

specifying an individual hospital or hospital department is not

prohibited under the Code. However, companies should bear in

mind that the smaller the hospital or department, the greater will be

the risk that companies will be able to make such a determination

making the use of such a criterion inappropriate under the Code. In

addition, companies should be mindful of any proximate or ongoing

tender proceedings with that specific hospital, as such tenders may

raise additional red flags.

Q37: How can Member Companies in practice ensure

that Educational Grants made available for Third Party

Organised Educational Events which are subject to the

Conference Vetting System, are positively reviewed by

CVS?

A37: It is the responsibility of Member Companies to individually

ensure compliance with this Code obligation. For example,

Member Companies may themselves consider submitting

relevant Third Party Organised Educational Events for CVS review

or they may decide to include appropriate contractual obligations

making it a pre-condition for an Educational Grant that the Third

Party Organised Educational Event be submitted and positively

assessed via the CVS, for example by the prospective Grant

recipient or by a third party.

Q37-bis: Can Member companies give criteria for HCOs

and/or PCOs to allocate their Educational Funds? (Added

July 2018)

A37-bis: Yes, objective criteria for HCOs or PCOs to select HCPs

to benefit from Educational funds may be given as long as such

selection criteria are relevant to the HCPs’ educational needs and

are not so specific that it would effectively select individual HCPs.

Examples of criteria for selecting Educational Grant Recipients are

Healthcare Professionals’ speciality, years of practice, country,

city/region of practice and/or academic criteria such as number

of publications, participation in clinical trials in a given pathology.

Q38: Is it appropriate for a Member Company that has

provided an Educational Grant to support Healthcare

Professional attendance at a Third-Party Organised

Educational Event to receive the names of the Healthcare

Professionals benefiting from the Educational Grant?

(Added July 2018).

A38: A Member Company should not proactively seek to receive

the names of the healthcare Professionals benefiting from its

Educational Grant. Generally, when a Third-Party Organised

Educational Event is supported by more than one company, all

CODE QUESTIONS AND ANSWERS

a.2. Support for Third Party Organised

Educational Events:

Where the prospective beneficiary of an Educational

Grant is the organiser of the Third Party Organised

Educational Event and is also a Healthcare Organisation,

the recipient Healthcare Organisation shall be solely

responsible for:

•

The programme content;

•

The selection of Faculty; and

•

The payment of Faculty honoraria, if any.

Member Companies shall not have any detailed

involvement in determining the content of the

educational programme for selection of Faculty (see

Glossary

) and this shall be reflected in the written Grant

agreement. If expressly requested to do so, Member

Companies may recommend speakers or comment on

the programme.

companies should receive the same attendance list, from which it

should not be possible to identify which Healthcare Professionals

have benefited from a particular Member Company’s Educational

Grant.

However, where required by law, a Member company may, in

accordance with the applicable legal requirements, request and

obtain the names of the Healthcare Professionals participating in

the Event, who are benefiting from the Company’s Educational Grant.

For purposes of auditing, compliance and monitoring by relevant

Company functions, it may be necessary for a Member Company

to request and receive the names of the Healthcare Professionals

who have benefited from the Educational Grant provided by the

Member Company after the Event has taken place.

In either of the above cases, unless required by law, such

Healthcare Professional names should never be received by the

Member Company until the Educational Grant agreement has been

signed and the independent selection process of the Healthcare

Professionals has been completed.

Q38-bis: Under the Code, can a Member Company

provide an Educational Grant or Educational funds directly

to a Third Party Travel Agency? (Added in July 2018)

A38-bis: No, under the Code, Member Companies cannot

directly take care of the travel, [registration] or accommodation

arrangements of Healthcare Professionals attending Third-Party

Organised Educational Events so it is not permitted under the

code to make an Educational Grant available to a third party travel

agency for this purpose.

However, a Member Company may provide an Educational Grant to

a Healthcare Organisation (HCO) or funds earmarked for education

to a Professional Conference Organiser (PCO) which is structured

so that payments for travel, accommodation [and registration] are

remitted directly by the Member Company to a third party travel

agency on behalf of the HCO/PCO, which is the recipient of the

Educational Grant or the funds earmarked for education. In these

circumstances, the Member Company may choose to establish

a tri-partite contract, with the HCO/PCO and the third party travel

agency. Such a third party travel agency could in principle include

a third party travel agency also used by the Member Company for

its own internal travel arrangements provide this is not a Company-

internal function or Company-owned entity. In any event, where a

Member Company decides to use any such arrangement involving

funding for, or payments to a third party travel agency to arrange

travel, accommodation (and/or registration) it is important that the

Member Company carries out appropriate, prior due diligence on a

country-by country and case-by-case basis in order to evaluate and

mitigate the particular compliance risks and practicalities where

such an arrangement is considered. Additionally, the Member

Company must include in all of the contractual arrangements

appropriate and specific compliance-related criteria and conditions

for the HCO/PCO to outsource travel arrangements to a third party

travel agency, which should include appropriate provisions to allow

the monitoring and controlling the activity of the third party travel

agency.

CODE QUESTIONS AND ANSWERS

Q39: Does Chapter 4: Donations and Grants –

Educational Grants of the Code apply to requests

received by Member Companies in the context of public

procurement processes for educational support for Third

Party Organised Educational Events from Healthcare

Organisations and purchasing bodies?

A39: No. Such requests and any subsequent financial or other

support provided by a Member Company are not considered

to be Educational Grants for the purpose of the Code. Such

arrangements are commercial in nature and not philanthropic

and should be documented in a written commercial agreement

in accordance with normal business practice.

Q40: In the event that a commercial organisation, such

as a Professional Conference Organiser, organises a

Third Party Organised Educational Event independently

of any Healthcare Organisation, is it appropriate for

Member Companies to sponsor such events and what

rules shall apply? (modified in May 2017)

A40: Member Companies may enter into a commercial sponsorship

arrangement with a Professional Conference Organiser organising

a Third Party Organised Educational Event independently of any

Healthcare Organisation. However, such arrangements do not fall

within the definition of Educational Grant as Professional Conference

Organisers are for-profit organisations. Sponsorship arrangements

are therefore commercial in nature and Member Companies should

consequently document these in a written commercial agreement in

accordance with normal business practice and the requirements of

the Code (Chapter 2: Third Party Organised Educational Events). In

addition, where a Member Company provides funds earmarked for

the advancement of genuine educational purposes to a Professional

Conference Organiser, acting independently of any Healthcare

Organisation, all the Code provisions governing Educational Grants

shall also apply. For example, if a Member Company provides

funding to a Professional Conference Organiser to fund Healthcare

Professional delegate places and expenses at a Third Party Organised

Educational Conference, such Events, where applicable, must have

CVS approval and the Member Company shall publicly disclose such

funding in accordance with the Code’s Disclosure Guidelines.

Q41: Can a Member Company pay for or reimburse travel

costs to a Third Party Organised Educational Event for a

Scholar or Fellow?

A41: No, a Member Company cannot additionally pay for, or

reimburse, the travel or other participation costs incurred by a

Scholar or Fellow attending a Third Party Organised Educational

Event. Such costs shall be included in the Educational Grant

supporting the Scholarship or Fellowship if it is intended that the

Grant should extend to such attendance.

Q42: Can Member Companies support professional

training of Healthcare Professionals on general medical

education topics, such as courses on health economics/

b. Scholarships and Fellowships

Member Companies may provide Educational Grants on

a restricted basis in the form of Grants for Scholarships

and Fellowships to support advancement of genuine

medical education of Healthcare Professionals (see the

Glossary

). Only Healthcare Organisations where Healthcare

Professionals are in training shall be eligible to request

and/or receive such Educational Grants. A Member

Company shall not provide Educational Grants to support

Scholarships and Fellowships upon request of individual

Healthcare Professionals. Similarly, the Member Company

shall not have any involvement in any way in the selection

of the HCPs who will benefit from the Educational Grant

and this shall be reflected in the written Grant agreement

between the Member Company and the recipient HCO.

CODE QUESTIONS AND ANSWERS

health technology appraisal, good laboratory practices

or similar topics that promote patient care? (Added in

July 2018).

A42: Member Companies can support genuine medical

education for Healthcare Professionals on general healthcare-

related topics through Educational Grants in accordance with

Chapter 4 of the Code.

Member Companies can also support genuine medical training

on general healthcare-related topics through company-organised

“Product and Procedure Training and Education Events” as long as

the information directly concerns the Member Company’s health

technologies, therapies, and/or related services. The Event must

be conducted in accordance with and meet the other requirements

of Chapter 3, Section 2 of the Code.

Q43: What are examples of relevant disease awareness

and health education for patients, carers and the general

public for which a Member Company may legitimately

provide an Educational Grant?

A43: A Member Company may provide an Educational Grant to

support the provision of high quality information to patients and the

public about health and disease provided there is an objective patient

or public need for such information and the topics covered are linked

to the therapeutic areas in which the Member Company is interested

and/or involved. Such disease awareness campaigns must not,

however, promote the use of particular therapies, services or promote

specific HCOs, nor may they aim to stimulate demand by the public

for specific therapies or for specific Healthcare Organisations.

c. Grants for Public Awareness

Campaigns

Member Companies may also provide Educational Grants

on a restricted basis to Healthcare Organisations for the

legitimate purpose of providing information, promoting

awareness and/or educating patients, carers or the

general public about relevant healthcare topics or medical

conditions or diseases in therapeutic areas in which the

Member Company is interested and/or involved.

4. RESEARCH GRANTS

Where permitted by national laws, regulations, national

guidelines and professional codes of conduct, Member

Companies may provide restricted Research Grants (see

the

Glossary

) to support clearly defined third party-initiated

research studies for clinical or non-clinical research

programmes in therapeutic areas in which the Member

Company is interested and/or involved. Research Grants

may include in-kind or financial support for legitimate,

study-related, documented expenses or services, and/or

reasonable quantities of single-use and/or multiple-use

free of charge product(s) for the limited duration of the

research.

Member Companies providing Research Grants shall

ensure that they do not influence the research. However,

in order to ensure that Research Grants are provided

on a “restricted” basis, Member Companies shall clarify

the intended research scope and purposes for which

the Grant is requested and shall ensure that the written

Grant agreement with the recipient organisation includes

rights for the Member Company to verify that the Grant

CODE QUESTIONS AND ANSWERS

is applied solely for the agreed intended research use.

Such verification may include a request for study-related

documentation, such as a copy of the research protocol, a

copy of the ethics committee and/or regulatory approvals

or a copy of the study report upon completion or earlier

termination of the research.

All requests for Research Grants from prospective Grant

beneficiaries must be in writing and must detail, as a

minimum, the type, nature and objectives of the research

activity, the milestones and budget, the approximate

duration of the research, and where applicable, the

requirements for ethics committee, regulatory and/or

other authorisations or approvals. A Member Company

may give consideration to a request for a Research Grant

prior to ethics committee approval for the specific research

project but shall not take any final decision regarding the

Grant request unless and until the research receives formal

ethics committee approval.

Research Grant agreements shall include provisions

relating to adverse event reporting where appropriate, and

shall require full disclosure of the Member Company and

of the Grant by the Grant recipient organisation and the

lead- investigator in all oral or written presentations of the

results.

For guidance on how Member Companies may undertake

Member Company-initiated research please refer to

Chapter

6: Research: Member Company-Initiated Research

CODE QUESTIONS AND ANSWERS

Safeguards are required to ensure that the deployment

of sponsored posts does not cause a conflict of interest

between the aims of the sponsoring Member Company

and the aims of the Healthcare Organisation, particularly in

relation to procurement and competition.

Where a Member Company sponsors part or all of the salary

of a Healthcare Professional employed by a Healthcare

Organisation, they must have due regard to national rules

or relevant codes of practice that may apply. Sponsorship

must be with the Healthcare Organisation not the HCP and

must be in response to a request from the HCO through

a formal and transparent procurement process. Written

agreements should detail the circumstances under which

the HCO may exit from the sponsorship arrangement if

conflicts of interest which cannot be managed arise.

There should be written affirmation that the arrangements

will have no effect on purchasing decisions or prescribing

and dispensing habits and no pressure must be exerted

on the sponsored HCP to favour the Member Company’s

products over any other. For the duration of the Sponsored

Post, auditing arrangements should be established to

ensure independence of product or service choice.

Q44: If part of the funds provided to a Healthcare

Organisation for a Sponsored Post are intended to cover

training and education of the sponsored Healthcare

Professionals, is it necessary to declare these monies

as part of the annual declaration of indirect sponsorship

of HCP attendance at Third Party Organised Educational

Events or Conferences?

A44: If the funds are specifically linked to attendance at particular

Third Party Educational Events or Conferences then this should be

declared in the normal way as set out under the Part 2 Disclosure

Guidelines in this document. If the funds are specified as being for

general training and education needs of the sponsored HCP(s) and

the decisions on how those funds are spent in this regard are under

control of the Healthcare Organisation rather than the HCP(s) then

it is not necessary to disclose under Part 2.

CODE QUESTIONS AND ANSWERS

SPONSORED

POSTS

(Added in May 2017)

CODE QUESTIONS AND ANSWERS

1. GENERAL PRINCIPLES

Member Companies may engage Healthcare Professionals

as consultants and advisors to provide bona fide consulting

and other services, including but not limited to research,

participation on advisory boards, presentations at Company

Events and product development. Member Companies may

pay Healthcare Professionals reasonable remuneration

for performing these services. In all cases, consulting

arrangements must be permitted under the laws and

regulations of the country where the Healthcare Professional

is licensed to practise and be consistent with applicable

professional codes of conduct in that country.

The principles in this chapter are applicable to all consulting

arrangements between Healthcare Professionals and

Member Companies including where a consultant Healthcare

Professional declines a fee for provision of their services.

Consulting arrangements shall not be contingent in any way

on the prospective consultant’s past, present or potential

future purchase, lease, recommendation, prescription, use,

supply or procurement of the Member Company’s products

or services.

CODE QUESTIONS AND ANSWERS

ARRANGEMENTS

WITH CONSULTANTS

CODE QUESTIONS AND ANSWERS

When selecting consultants, Member Companies shall

implement an independent decision-making/review process

to identify, prevent and mitigate against potential bribery and

corruption risks arising in connection with use of consultants.

This process shall include a documented, prior evaluation of

any such associated risks and of the relevant background

information concerning each prospective consultant.

2. CRITERIA FOR GENUINE

CONSULTING ARRANGEMENTS

In addition to the general principles above, the arrangements

which cover genuine consultancy or other services must, to

the extent relevant to the particular arrangement, fulfil all

the following criteria:

a. Consulting arrangements must be entered into only

where a legitimate business need for the services is

identified in advance.

b. The number of consultants retained must not be greater

than the number reasonably necessary to achieve the

identified need.

c. Selection of consultants must be based on criteria

directly related to the identified business need and the

relevance of the consultant’s qualifications, expertise and

experience to address the identified need. The volume or

value of business generated by a prospective consultant

or the Healthcare Organisation where s/he performs her/

his professional activity is not a relevant criterion.

d. Consulting arrangements with Healthcare Professionals

must be documented in a written agreement, signed

by the parties in advance of the commencement of the

services, which must specify the nature of the services to

be provided and the basis for payment for those services.

e. The hiring of the consultant must not be an inducement

to purchase, lease, recommend, prescribe, use, supply or

procure the Member Company’s products or services.

f. The remuneration for the services rendered must be

reasonable and reflect the fair market value of the

services provided.

g. Member Companies must maintain records of the

services, and associated work products, provided by

the consultant Healthcare Professionals and of the use

made of those services by the Member Company.

h. The venue and other arrangements (e.g. hospitality,

travel etc.) for Member Company meetings with

consultants shall follow the rules for Events set out in

Chapter 1: General Criteria for Events.

CODE QUESTIONS AND ANSWERS

3. REMUNERATION

AND FAIR MARKET VALUE

The remuneration paid to Healthcare Professionals

engaged as consultants by Member Companies shall reflect

fair-market-value for the services provided. It shall not be in

any way contingent upon the value of products or services

which consultants may purchase, lease, recommend,

prescribe, use, supply or procure in the course of their own

professional practice or that may be purchased, leased,

recommended, prescribed, used, supplied or procured by

HCOs where they carry on their professional activities.

All payments made for services must comply with all

applicable tax and other legal requirements. Member

Companies may pay for expenses reasonably incurred

by consultants in providing the services which are the

subject of the consulting agreement including reasonable

travel, meals and accommodation expenses incurred by

consultants if attending meetings with, or on behalf of

Member Companies. The written consulting agreement

must detail which expenses can be claimed by the

consultant in relation to the provision of the services and

the basis for payment of these by the Member Company.

4. DISCLOSURE

AND TRANSPARENCY

Member Companies shall ensure they fully comply with

all applicable national laws, regulations and professional

codes of conduct requiring any publication, disclosure or

approval in connection with the use by Member Companies

of Healthcare Professionals as consultants. All required

consents and approvals shall be obtained, including from

the hospital or other Healthcare Organisation administration

or from the Healthcare Professional’s superior (or locally-

designated competent authority), as applicable. Where no

such national requirements apply, Member Companies

shall nevertheless maintain appropriate transparency

by requiring the relevant Employer Notification which

shall disclose the purpose and scope of the consultancy

arrangement.

Member Companies shall also include appropriate

obligations on the consultant to ensure that the consultant’s

status as a consultant for the Member Company and his/

her involvement in the research for, or the preparation of,

material for scientific publication is disclosed at the time of

any publication or presentation.

Q45: What is meant by fair market value (FMV) in the

context of consulting arrangements?

A45: Fair market value is the value of the specified consultancy

services which would be paid by the Member Company to

the consultant, each dealing at arm’s length in an open and

unrestricted market, and when neither party is under any

compulsion to buy or sell, and both parties have reasonable

knowledge of the relevant facts.

Q46: How should Member Companies determine FMV

for a service?

A46: A Member Company must be able to demonstrate internal

methodology to determine fair market value. Amongst other

matters this shall take account of the consultant’s qualifications,

expertise and experience as well as the actual services to be

provided to the Member Company.

CODE QUESTIONS AND ANSWERS

1. MEMBER COMPANY-

INITIATED RESEARCH

Where there is a legitimate business need to do so, Member

Companies may initiate, conduct, manage and finance

scientifically valid research to generate data, whether

pre- or post-market. In this context, legitimate business

needs for data include medical needs, including patient

safety; research and development; scientific purposes (e.g.

performance indicators, comparing objective scientific

parameters); regulatory, including post-market surveillance

(PMS) and post-market clinical follow up (PMCF), vigilance,

safety, or reimbursement and health economic, including

clinical and cost-effectiveness and outcomes data

relevant to health technology assessments (HTA) and

reimbursement decision-making.

RESEARCH

CODE QUESTIONS AND ANSWERS

Where a Member Company uses a Healthcare Professional

as a consultant, for example to lead a study on the Member

Company’s behalf (i.e. act as Principal Investigator), the

Member Company shall ensure that such consulting

arrangements comply fully with

Chapter 5: Arrangements

with Consultants

In accordance with the Documentation Principle, any

arrangements made by a Member Company to procure

research-related services shall be set out in a written

agreement which shall reference a written research

protocol, written schedule of work and provide for all

required consents, approvals and authorisations to be

obtained prior to the commencement of the study.

Member Companies must ensure that their research

activities comply with all applicable national laws,

regulations and researchers’ own professional codes of

conduct, as well as with applicable Good Clinical Practice

guidelines, if relevant.

In accordance with the Principles set out in the

Introduction:

Aims and Principles of the Code

, Member Companies shall

also ensure appropriate clinical trial transparency in relation

to their research activities and results. This shall include

appropriate disclosure of information about Member

Companies’ clinical trials, for example in external public

registries and peer-reviewed journals.

Where Member Companies engage third party

intermediaries for research (e.g. contract research

organisations (CROs)), they shall ensure that the research

conducted by these third parties on behalf of the Member

Company is carried out in accordance with all applicable

legal and ethical requirements, including the applicable

requirements of the Code.

2. MEMBER COMPANY POST-

MARKET PRODUCT EVALUATION

Where there is a legitimate business need to do so, Member

Companies may initiate, post-market third party evaluation

of their products, therapies and/or related services and

may therefore provide Evaluation Products under a written

contract for services in order to obtain defined user

evaluation by Healthcare Organisations in relation to the

Evaluation Products. Evaluation Products may be provided

on a no charge basis in return for the requested user

feedback from Healthcare Professionals at the Healthcare

Organisation, which shall be formally described in a written

protocol or questionnaire forming part of the contract.

Q47: What is an example of an external public registry

for clinical trial transparency?

A47: Examples of an external public register for clinical trial

transparency are www.clinicaltrials.gov or www.who.org

CODE QUESTIONS AND ANSWERS

Where the Evaluation Products are multiple-use Evaluation

Products the defined period of time necessary for the

evaluation and feedback to occur will depend on the

frequency of anticipated use; the nature of the user

evaluation feedback requested; the duration of any required

training and similar considerations. Member Companies

shall in all cases ensure that they retain title to multiple-

use Evaluation Products and that they have a process in

place for promptly removing such multiple use Evaluation

Products and/or any unused single-use Evaluation

Products from the Healthcare Organisation’s location at

the conclusion of the evaluation period unless these are

purchased by the Healthcare Organisation.

Provision of Evaluation Products and/or related services

must not improperly reward, induce and/or encourage

Healthcare Professionals and/or Healthcare Organisations

to purchase, lease, recommend, prescribe, use, supply or

procure Member Companies’ products or services. Any

offer and/or supply of Evaluation Products shall always

be done in full compliance with applicable national laws,

regulations and industry and professional codes of

conduct.

3. THIRD PARTY-INITIATED

RESEARCH

Please refer to

Chapter 4: Grants and Charitable Donations:

Research Grants.

CODE QUESTIONS AND ANSWERS

Healthcare Professionals, acting individually or as part of

a group in which they are an active participant, often make

valuable contributions that improve products or health

technologies. They may develop intellectual property, for

example, patents, trade secrets, or know-how, under a

product or technology development or intellectual property

licensing agreement.

A royalty arrangement between a Member Company and

a Healthcare Professional should be entered into only

where the Healthcare Professional is expected to make or

has made a novel, significant, or innovative contribution

to, for example, the development of a product, technology,

process, or method, such that the Healthcare Professional

would be considered to be the sole or joint owner of such

intellectual property under applicable laws and regulations.

The foregoing is without prejudice to Member Companies’

CODE QUESTIONS AND ANSWERS

ROYALTIES

CODE QUESTIONS AND ANSWERS

obligations to comply with any applicable obligations to

pay royalties which may arise under applicable laws and

regulations in some countries.

Arrangements involving the payment of royalties by or on

behalf of Member Companies to a Healthcare Professional

must be set out in a written agreement providing

appropriate and reasonable remuneration in accordance

with applicable laws and regulations. For example, royalties

paid in exchange for intellectual property should not be

conditional on:

A requirement that the Healthcare Professional purchase,

order or recommend any product, services or health

technology of the Member Company or any product or

technology produced as a result of the development

project; or

A requirement to market the product or health technology

upon commercialisation.

Subject to national regulations and requirements, Member

Companies should exclude from the calculation of royalties

the number of units purchased, prescribed, used, or

ordered by the Healthcare Professional and/or members

of the Healthcare Professional’s practice or Healthcare

Organisation.

CODE QUESTIONS AND ANSWERS

Member Companies exceptionally may provide inexpensive

educational items and/or gifts, in accordance with national

laws, regulations and industry and professional codes of

conduct of the country where the Healthcare Professional

is licensed to practise

. Member Companies may only

provide such educational items and/or gifts in accordance

of the following principles:

a. Educational items and/or gifts may be provided but these

must relate to the Healthcare Professional’s practice, or

benefit patients, or serve a genuine educational function.

b. No educational items and/or gifts should be provided in

response to requests made by Healthcare Professionals.

c. Educational items and/or gifts must not be given in the

form of cash or cash equivalents.

d. Educational items and/or gifts must be modest in value,

and can be branded or non-branded items.

Q48: What are examples of items of modest value that

are “related to the Healthcare Professional’s practice or

for the benefit of patients”.

A48: Stationery items, calendars, diaries, computer accessories

for business use and clinical items such as wipes, nail brushes,

surgical gloves and tourniquets are examples of modest value

items that could be appropriately provided as gifts to Healthcare

Professionals provided their value falls within the maximum value

prescribed under national laws, regulations and industry and

professional codes of conduct. Food, alcohol and items which are

primarily for use in the home or car are not appropriate as they are

not related to the Healthcare Professional’s practice nor are they

for the benefit of patients.

CODE QUESTIONS AND ANSWERS

EDUCATIONAL

ITEMS AND GIFTS

In the UK, the NHS England document Managing Conflicts of Interest in the NHS

(Publications Gateway Reference: 06419) sets the limit for such items at £6. While

this only directly applies to the NHS in England it should be taken as indicative of

what is acceptable in the rest of the UK, including in relation to HCPs working in the

non-NHS sector. Different limits may apply in other territories and Member Compa-

nies should comply with these as appropriate. Where no such limits apply, the UK

figure may be taken as indicative of what is acceptable under the Code.

CODE QUESTIONS AND ANSWERS

e. A Member Company may occasionally provide

educational items of greater value to a Healthcare

Organisation always provided that the item serves

a genuine educational function for the Healthcare

Professionals at that Healthcare Organisation and is

of benefit to patients. Such items shall not be provided

to Healthcare Professionals for their personal use.

The item shall also be related to the therapeutic areas

in which the Member Company is interested and/or

involved. For higher value educational items, Member

Companies must maintain appropriate records of their

provision of such educational items to Healthcare

Organisations. Such items should not be part of the

Healthcare Organisation’s normal overheads or routine

costs of operation.

f. Provision of educational items and/or gifts must not

improperly reward, incentivise and/or encourage

Healthcare Professionals to purchase, lease,

recommend, prescribe, use, supply or procure the

Member Company’s products or services.

Prize draws and other competitions at Events are

permissible if the prize awarded complies with

Chapter 8.

Educational Items and Gifts.

In addition, it must comply with

national laws, regulations and industry and professional

codes of conduct.

This Chapter is not intended to address the legitimate

practice of providing appropriate Evaluation Products,

Demonstration products or Samples. For guidance on how

Member Companies may provide Evaluation Products,

Demonstration products or Samples, please refer to

Chapter 6: Research

and

Chapter 9: Demonstration Products

and Samples

, as applicable.

Q49: May a Member Company provide a small gift to a

Healthcare Professional to mark significant life events

such as a marriage, birth, birthday or death?

A49: The Code restricts the types of gift that may be given to a

Healthcare Professional and it would not be appropriate to give

gifts to mark significant life events such as a marriage, birth or

birthday. However, in the case of death, it is for each Member

Company to determine the appropriateness of making a tasteful

gift as a mark of respect.

Q50: Where Healthcare Professionals engaged by

Member Companies as consultants or speakers decline a

professional fee for their services, would it be appropriate

for the Member Company to show its appreciation by

giving the Healthcare Professional a small gift such as

a bottle of wine or a bouquet of flowers?

A50: No, it would not be acceptable for the Member Company

to make such a gift because to do so could be open to

misinterpretation and would be likely to breach the Principle of

Image and Perception. Moreover such gifts would not comply

with Chapter 8. Educational Items and Gifts as they neither relate

to a Healthcare Professional’s practice nor serve an educational

function.

Q51: Please provide examples of educational items

of greater value that can be provided to Healthcare

Organisations under the Code?

A51: Examples of educational items of greater value that can be

provided may include medical textbooks or anatomical models,

but only if those relate to the therapeutic areas in which the

Member Company is interested and/or involved.

CODE QUESTIONS AND ANSWERS

1. GENERAL PRINCIPLES

Member Companies may provide their own products as

Demonstration Products and/or Samples (see the

Glossary

)

at no charge in order to enable Healthcare Professionals

and/or Healthcare Organisations (as applicable) to evaluate

and/or familiarise themselves with the safe, effective and

appropriate use and functionality of the product and/or

related service and to determine whether, or when, to use,

order, purchase, prescribe or recommend the product and/

or service in the future.

Demonstration Products and/or Samples may be either

single- or multiple-use products. Member Companies may

also provide products from another company in conjunction

with the Member Company’s own Demonstration Products

CODE QUESTIONS AND ANSWERS

DEMONSTRATION

PRODUCTS

AND SAMPLES

CODE QUESTIONS AND ANSWERS

and/or Samples on an exceptional basis if those other

company’s products are required in order to properly and

effectively demonstrate, evaluate or use the Member

Company’s products, e.g. computer hardware and software

produced by a company other than the Member Company.

Provision of Demonstration Products and/or Samples

must not improperly reward, induce and/or encourage

Healthcare Professionals and/or Healthcare Organisations

to purchase, lease, recommend, prescribe, use, supply or

procure Member Companies’ products or services. Any

offer and/or supply of such products shall always be done

in full compliance with applicable national laws, regulations

and industry and professional codes of conduct.

Member Companies shall in all cases maintain appropriate

records in relation to the provision of Demonstration

Products and/or Samples to Healthcare Professionals

and/or Healthcare Organisations, for example recording

proof of delivery for any Demonstration Products and/

or Samples provided and receipt of return for multiple-

use Demonstration Products and/or Samples. Member

Companies shall clearly record in the Member Company’s

records as well as clearly disclose to Healthcare

Professionals and/or Healthcare Organisations the

no-charge basis and other conditions applicable for the

supply of such Demonstration Products and/or Samples

no later than the time of the supply. The disclosure to

Healthcare Professionals and Healthcare Organisations

shall be in writing.

This Chapter is limited to the provision of Demonstration

Products and/or Samples and related services at no

charge and is not intended to apply to provision of products

or related services under any other arrangements, for

example (but not limited to) provision within the framework

for clinical trials and/or other research or commercial

supplies by way of rebates or pricing incentives in a public

procurement context.

2. DEMONSTRATION

PRODUCTS (DEMOS)

Member Companies may provide examples of their

products to Healthcare Professionals and/or Healthcare

Organisations in the form of mock-ups (such as unsterilised

single use products) that are used for Healthcare

Professionals and patient awareness, education and

training. For example, a Healthcare Professional may use

a Demonstration Product to show a patient the type of

technology which will be implanted in the patient or may

use the Demo to train other Healthcare Professionals in the

use of the product.

CODE QUESTIONS AND ANSWERS

Demonstration Products are not intended for clinical use in

any patient care nor are they intended for on-sale or other

transfer. Member Companies shall clearly record in the

Member Company’s records as well as clearly disclose to

Healthcare Professionals and/or Healthcare Organisations

the no-charge basis and other conditions applicable for the

supply of such Demonstration Products no later than the

time of the supply. It is recommended that the disclosure

to Healthcare Professionals and Healthcare Organisations

be in writing.

3. SAMPLES

Member Companies may provide a reasonable number of

Samples at no charge to allow Healthcare Professionals

and/or Healthcare Organisations to familiarise themselves

with the products and/or related services, to acquire

experience in dealing with them safely and effectively in

clinical use and to determine whether, or when, to use,

order, purchase, prescribe or recommend the product and/

or service in the future.

For Samples, which are single-use products, the quantity

provided for purposes of familiarisation must not exceed

the amount reasonably necessary for the Healthcare

Professionals/Healthcare Organisation to acquire adequate

experience in dealing with the products.

For Samples, which are multiple-use products, the specific

length of time necessary for a Healthcare Professional

to familiarise him/herself with the product will depend

on the frequency of anticipated use; the duration of

required training; the number of Healthcare Professionals

who will need to acquire experience in dealing with the

product and similar considerations. Member Companies

shall in all cases ensure that they retain title to multiple-

use Samples and that they have a process in place for

promptly removing such multiple use Samples from the

Healthcare Professional’s location at the conclusion of the

familiarisation period.

CODE QUESTIONS AND ANSWERS

DISCLOSURE GUIDELINES

PART 2

Adopted by the ABHI in May 2017

PREAMBLE

Under the ABHI Code of Ethical Business Practice (the “Code”), Member Companies are not permitted to

pay registration fees, travel or hospitality expenses directly to individual Healthcare Professionals for their

participation in educational conferences organised by third-parties as of 1st January, 2019.

Medical Education may be supported through the provision of Educational Grants to Healthcare

Organisations in compliance with the rules set out in the Code. To prevent abuses, specific safeguards

when providing Educational Grants have been developed, including the obligation to disclose these

Educational Grants.

Section 3 of Chapter 4 of the Code states that Member Companies shall document and publicly disclose

all Educational Grants in accordance with these Disclosure Guidelines. These Disclosure Guidelines are

therefore an integral part of the Code, and need to be interpreted as such.

For the avoidance of doubt, all funds provided by a Member Company for the advancement of genuine

educational purposes to a Professional Conference Organiser (“PCO”), acting independently of any

Healthcare Organisation, fall under the scope of these Disclosure Guidelines and are subject to the same

conditions as Educational Grants. Whenever these Disclosure Guidelines refer to Healthcare Organisations,

these shall also include Professional Conference Organisers. All capitalised concepts used in the Guidelines

are concepts defined in the Code.

CODE QUESTIONS AND ANSWERS

CHAPTER 1:

APPLICABILITY OF THESE

GUIDELINES

1. Scope

These Disclosure Guidelines apply to Member Companies

in their interactions with Healthcare Organisations based or

registered in the ABHI Europe Geographic Area.

Separate entities belonging to the same multinational

company (“Affiliates”) – which could be the parent company

(e.g. the headquarters, principal office, or controlling

company of a commercial enterprise), subsidiary company

or any other form of enterprise or organisation – shall be

deemed to constitute a single company, and are as such

committed to compliance with these Disclosure Guidelines.

Transfers of value that are not included in the definition of

Educational Grants (as described in Chapter 4, Section 3 of

the Code) and that consequently cannot be allocated to any

of the categories set forth in Chapter 2, Section 2 Aggregate

Disclosure are not within the scope of these Disclosure

Guidelines.

2. Applicability of these Disclosure

Guidelines

Member Companies need not report the same information

twice due to being bound by national laws, regulations

or professional codes imposing disclosure obligations

regarding Educational Grants (as described in Chapter 4,

section 3 of the Code) equivalent to the ones imposed by

these Disclosure Guidelines.

Q1: Does the Disclosure Guideline’s definition of

“Affiliate” include legal entities belonging to the same

parent Member Company but registered outside Europe?

A1: Yes. Educational Grants made by Affiliates (parent companies

are included in the definition of Affiliates to the effect of the

Disclosure Guidelines) incorporated outside of MedTech Europe

Geographical Area to Healthcare Organisations registered in

Europe are within the scope of these Disclosure Guidelines. Any of

the Affiliates registered in Europe can disclose these Educational

Grants. Each Member Company can choose which Affiliate will

report these Educational Grants made by Affiliates from outside

the MedTech Europe Geographical Area.

Q2: Are these Disclosure Guidelines applicable to

third party intermediaries who interact with Healthcare

Organisations in connection with the sale, promotion or

other activity involving Member Companies’ products?

A2: No, these Disclosure Guidelines are not applicable to third

parties such as third party sales & marketing intermediaries

(SMIs), consultants, distributors, sales agents, marketing agents,

brokers, commissionaire commercial agents and independent

sales representatives (list not exhaustive). Nevertheless, it is

recommended to document arrangements concluded between

Member Companies and third party intermediaries in order to

comply with the provisions set out in the Code.

Q3: Where a national code already imposes disclosure

obligations in a given country, where may Corporate

Members disclose the Educational Grants?

A3: Where a national code imposes disclosure obligations

regarding Educational Grants (as regulated in Chapter 4, Section 3

of the Code) to the same extent as regulated by these Guidelines,

Corporate Members, who are not a member of the National

Association responsible for that national code, may choose either:

− To disclose only on the MedTech Europe platform; or

− To disclose on the national platform, if that possibility is

provided for.

Corporate Members who are bound by this national code may

choose either:

− To disclose only on the national platform or

CODE QUESTIONS AND ANSWERS

− To disclose both on the MedTech Europe platform and the

national platform.

This selected option shall be included in the Methodology Note.

Q4: Who will decide if a national law, regulation or code

imposes disclosure obligations regarding Educational

Grants equivalent to the ones imposed by the Disclosure

Guidelines?

A4: The MedTech Europe Secretariat shall conduct a yearly

assessment of the equivalence of national laws, regulations

and/or professional codes imposing disclosure obligations with

the MedTech Europe Transparency Obligations (as regulated in

Chapter 4, Section 3 of the Code).

Members can at any time submit any information or documentation

they possess that could be relevant for this assessment to the

Secretariat.

The MedTech Europe Secretariat shall submit its assessment

to the MedTech Europe Transparency Task Force, who will

analyse the proposal. If the MedTech Europe Transparency Task

Force agrees with the proposal, it will be submitted for approval

to the MedTech Europe Compliance Network. If the disclosure

obligations imposed by a national law, regulation or professional

code are deemed equivalent to the ones imposed by the Disclosure

Guidelines, the assessment will be made public on the MedTech

Europe Transparency website. This selected option shall be

included in the Methodology Note.

3. Applicability to Non-Member Companies

Non-member companies may implement these Disclosure

Guidelines provided they are committed to ethical standards

equivalent to those enshrined in the Code. Non-member

companies may prove this commitment by signing up to

the ABHI Code of Ethical Business Practice

Non-members can sign up to the ABHI Code of Ethical Business Practice at

abhicodeofpractice.org.uk

CODE QUESTIONS AND ANSWERS

Q5: Which Affiliate should disclose a particular

Educational Grant?

A5: To facilitate the tracking of Educational Grants made to

individual Healthcare Organisations, it is recommended that the

Affiliate making the payment in relation to a particular Educational

Grant is the one disclosing the Educational Grant, but this is an

internal decision of each Member Company.

A Member Company may choose to use internal arrangements of

its choice to report the aggregated sum in relation to Educational

Grants made by each legal entity composing the company

(Affiliates) to a particular Healthcare Organisation during a

disclosure period.

CHAPTER 2:

DISCLOSURE OBLIGATION

1. General Obligation

Subject to the terms of these Disclosure Guidelines,

each Member Company shall document and disclose all

payments related to Educational Grants (as described

in Chapter 4, section 3 of the Code) that it makes to a

Healthcare Organisation based or registered in Europe,

without limitation of value. The disclosure of Educational

Grants provided by Affiliates of the Member Company

described above, but which are not registered in the

MedTech Europe Geographic Area shall be made by any of

the Affiliates comprising said Member Company that are

registered in the MedTech Europe Geographic Area.

2. Aggregate Disclosure

Educational Grants shall be disclosed on an aggregate

basis. Each Affiliate of a Member Company shall disclose,

for each clearly identifiable and separate recipient, the

amounts paid as Educational Grants to such recipient in

each Reporting Period

which can be reasonably allocated

to one of the categories set out below. Such amounts

will be aggregated on a category-by-category basis, but

itemised disclosure shall be made available upon request

by the Member Company, as deemed necessary, to (i) the

relevant recipient, and/or (ii) the relevant authorities.

Member Companies shall disclose an aggregate amount

related to any of the categories set forth below:

a. Educational Grants to support Third Party Organised

Events (including Support for HCP Participation at Third

Party Organised Educational Events) and,

b. Other Educational Grants to Healthcare Organisations

(including Scholarships, Fellowships and/or Grants for

Public Awareness Campaigns).

3. Optional Object Specification

If desired, Member Companies may indicate the object of

the Educational Grants disclosed for one or both categories

set forth in Chapter 2, Section 2 Aggregate Disclosure.

Reporting Period means a full calendar year (starting on the 1st of January and

ending in the 31st of December).

CODE QUESTIONS AND ANSWERS

Q6: When should a Methodology Note be made available?

A6: Member Companies should create a comprehensive

Methodology Note that would allow any Healthcare Organisation

directly affected by a disclosure to understand how the amount

disclosed was aggregated. The Methodology Note should therefore

be made available upon specific request to Healthcare Organisations

concerned about particular disclosure that directly affects them.

Q7: When will the first Reporting Period start?

A7: Chapter 4, Section 3 of the ABHI Code of Ethical Business

Practice establishes that the first disclosure shall occur no later than

the end of the Transition Period. The Transition Period ends on the

31st December 2018. As a consequence, the first Reporting Period is

the calendar year 2018, starting on the 1st January 2018, and ending

on 31st December 2018.

Q8: In what currency should the amounts payed be

disclosed?

A8: Disclosed amounts should be in the currency used in the

payment. In the event the aggregate amount includes Educational

Grants made in different currencies, the reporting company may

choose in which currency they wish to disclose the aggregate

amount, and keep appropriate record of the exchange rate used

to convert the different currencies. This information will then be

included in their Methodology Note.

4. Methodology

Each Member Company shall create a note summarising

the methodologies used by it in preparing the disclosures

and identifying Educational Grants for each category

described in Chapter 2, Section 2 Aggregate Disclosure.

The note, including a general summary and/or country

specific considerations, shall describe the recognition

methodologies applied, and should include the treatment

of VAT and other tax aspects, currency aspects and other

issues related to the timing and amount of Educational

Grants for purposes of these Disclosure Guidelines, as

applicable. This Methodology Note shall be made available

upon request by an interested party.

CHAPTER 3:

FORM OF DISCLOSURE

1. Reporting Period

Disclosures shall be made on an annual basis and each

Reporting Period shall cover a full calendar year.

2. Time of Disclosure

Disclosures shall be made by each Member Company

within 6 months after the end of the relevant Reporting

Period

3. Time of Publication

The disclosures shall be made public at the time of

publication. The time of publication is the 31st August of

the year of the relevant time of disclosure.

4. Template and Language of Disclosure

For consistency purposes, disclosures made pursuant to

these Disclosure Guidelines shall be made in English using

the template set forth in the Annex.

CODE QUESTIONS AND ANSWERS

5. Disclosure Platform

Disclosures shall be made on the EthicalMedTech website

unless the Member Company is already bound by national

laws, regulations or professional codes as regulated in

Chapter 1, Section 2 Applicability of these Disclosure

Guidelines. Member Companies will remain liable for the

accuracy of the disclosed data. For the avoidance of doubt,

MedTech Europe shall not be held liable for (i) maintaining,

correcting, deleting the published data nor (ii) for the

storage of data after the three years period of disclosure in

the public domain.

6. Disclosures Retention and Modification

Member Companies shall be able to modify, delete or in any

way alter their disclosures at any time before or after the

time of publication.

The information disclosed shall remain in the public domain

for 3 years after the time such information is first published.

7. Enquiries Regarding Reported Disclosures

Member Companies shall be able to modify, delete or in any

way alter their disclosures at any time before or after the

time of publication.

Member Companies shall make available to Healthcare

Organizations upon request any data concerning their

common contractual relations published in accordance

with these Disclosure Guidelines at any time while the

disclosed information remains in the public domain as

stated in Chapter 3, Section 3 Time of Publication.

www.ethicalmedtech.org

GUIDELINES ON ADVERTISEMENTS

AND PROMOTIONS ADDRESSED

SOLELY OR PRIMARILY TO

HEALTHCARE PROFESSIONALS

PART 3

PREAMBLE

Introduction

These Guidelines are published by ABHI because under

current UK law and other advertising codes it is difficult to

take legal action or to complain against a person or company

who publishes misleading promotional material directed

solely or primarily at Healthcare Professionals.

Consumer advertising is governed both by legislation (the

main legal instruments being listed in Section 1) and by

the codes of advertising practice issued by the Committee

of Advertising Practice and the Broadcast Committee of

Advertising Practice and administered by the Advertising

Standards Authority. However, Advertising directed at

Healthcare Professionals is not clearly caught by these

provisions.

The intention of these Guidelines is to set out principles

to be applied to Advertising directed solely or primarily at

Healthcare Professionals. These principles will be part of

the ABHI Code of Ethical Business Practice with which all

ABHI Members agree to comply. The principles apply to all

such Advertising issued by or on behalf of ABHI Members

where it is directed at Healthcare Professionals in the UK.

The principles set out in these Guidelines are, however, based

upon the general principles contained in existing laws and

codes of practice and are therefore generally applicable to

all medical devices advertising. ABHI therefore encourages

all persons advertising medical devices, not just ABHI

Members, to ensure that Advertising published by them or

on their behalf complies with these Guidelines.

Complaints that any ABHI Member has failed to comply

with these Guidelines will be handled in accordance with the

established Complaints Procedure set out in the ABHI Code

of Ethical Business Practice Complaints Procedure and Panel

Constitution, as amended from time to time.

Interpretation

The singular includes the plural.

Reference to any “commissioned” article, study or material

is a reference to work done at the request or on behalf of

an Advertiser, often in return for payment or some reward

or other support. It may include the work of a journalist or

opinion leader carried out directly or indirectly as a result of

such request. However, reports on collected medical device

clinical data (including reports on clinical investigations, as

the expression is used in the Medical Devices Directives/

Regulation) that are written by or at the direction of the

clinical investigator (“investigator-initiated reports”) shall

not be considered to be “commissioned” whether or not

payments have been made in respect of the investigators’

services or expenses reimbursed or other in-kind support

has been provided if they meet the conditions below. Equally,

reports on collected medical device clinical data (including

clinical investigations, as the expression is used in the

Medical Devices Directives/Regulation) that are written by or

at the direction of the Advertiser pursuant to an agreement

to conduct the clinical data collection (“Advertiser-initiated

reports”) shall not be regarded as “commissioned”, always

provided that such investigator-initiated or Advertiser-initiated

reports relate to clinical data collection and evaluation

processes which are:

a. performed according to scientifically valid standards;

b. subjected to ethical review independent of the Advertiser,

e.g. hospital ethics committee; and

c. initiated and conducted for scientifically and/or medically

legitimate purposes.

GUIDELINES

1. SCOPE OF GUIDELINES

1.1 These Guidelines apply to all Advertisements

produced by or on behalf of Advertisers.

Advertising directed wholly or mainly at consumers,

patients or others who are not Healthcare

Professionals is not covered by these Guidelines.

However, such advertising is subject to general UK

advertising law as well as to the industry regulatory

codes administered by the Advertising Standards

Authority, and it should consequently comply with

the law and with those rules.

ABHI and its Members encourage all persons

advertising medical devices, not just ABHI Members,

to ensure that advertising directed at non-Healthcare

Professionals which is published by them or on their

behalf complies with these Guidelines.

1.2 The following is a non-exhaustive list of the forms

of Advertising that may be captured by these

Guidelines:

• Advertisements in Healthcare Professional

journals, brochures, leaflets, circulars, mailings,

e-mails, text transmissions (including SMS and

MMS), social media sites, fax transmissions,

catalogues, follow-up literature and other

electronic or printed material and/or verbal

communications;

• detail aids and other printed material used by

representatives;

• posters and other promotional media in public

places at Healthcare Professional events,

including moving images;

• video and DVD Advertisements intended solely

or primarily for release or use at Healthcare

Professional events;

• audio-cassettes, films, records, tapes, video

recordings intended solely or primarily for

release or use at Healthcare Professional events;

• Advertisements in non-broadcast electronic

media, including but not limited to: online

Advertisements (including banner or

pop-up Advertisements and online video

Advertisements); search listings; commercial

classified Advertisements;

• Advertisements transmitted by Bluetooth;

Advertisements distributed through web widgets

and online sales promotions and prize promotions

• web-based data services;

• Advertisements in marketing databases containing

Healthcare Professionals’ contact information;

• Advertorials.

1.3 To comply with these Guidelines, Advertising

must also comply with all other applicable laws

and regulations. For example, Advertising that

is in breach of the requirements of the Business

Protection from Misleading Marketing Regulations

2008 will also be a breach of these Guidelines and

therefore of the ABHI Code.

1.4 Advertising must be suitable for the intended

audience and must conform to generally acceptable

standards of good taste. It should respect the

principles of fair competition generally accepted in

business.

1.5 An Advertisement should be readily recognisable

by the intended audience as an Advertisement and

its commercial intent must be made clear if that is

not obvious from the context.

2. ACCURACY AND SUBSTANTIATION

OF CLAIMS AND INFORMATION

2.1 Information, claims and comparisons included in

or as part of any Advertisement must be accurate,

balanced, fair, objective and unambiguous and must

be based on a fair evaluation of appropriate evidence

and reflect that evidence clearly. They must not

mislead the intended audience either directly or by

implication, by distortion, exaggeration or undue

emphasis. All reasonable efforts must be used to

ensure that the substantiation for all information,

claims and/or comparisons in an Advertisement is

in accordance with an up to date evaluation of all the

relevant clinical and scientific evidence.

Material used in or as part of any Advertisement must be

sufficiently complete to enable the intended audience to form

their own opinion of the therapeutic value of the device.

2.2 Different types of evidence are permissible to

support claims in Advertisements. The evidence

may include clinical data (which could be pre- or

post-market data, including registry data); the

results of a clinical investigation; laboratory data

and testing, including in vitro test data; engineering

data; and historical post-market experience.

All evidence must be relevant, balanced,

comprehensive and credible and must in all

cases be consistent with any specified device’s

CE marked Intended Purpose, as must the overall

impression created by the Advertisement, including

any graphics or artwork. Advertisers must in

all cases hold documentary evidence (which

includes equivalent recorded evidence, e.g. video)

to substantiate all claims (direct or implied). This

documentary evidence must be in existence

before or at the time of the publication of the

Advertisement.

2.3 Claims or comparisons made, or information

included, in Advertisements must accurately reflect

the balance of all relevant evidence. If justification

for the content of an Advertisement relies on any

selection from the available evidence, that selection

must be fair and balanced so that the Advertisement

does not mislead or give a false impression.

Evidence should be scientifically robust. If there

is a significant division of scientific, medical or

other expert opinion about any claims made in an

Advertisement, those claims must not be presented

as being generally agreed and it should be clear

from the Advertisement that there is a division of

opinion on the relevant matter.

Advertisers must make clear whether the evidence

relied upon to substantiate claims used in an

Advertisement is clinical or some other type of

evidence or a combination. If the Advertisement

includes claims that rely on a particular clinical

investigation, that investigation must have been

carried out to a standard equivalent to that required

for clinical evaluation of a device under Annex X of

Directive 93/42/EEC or Annex 7 of Directive 90/385/

EEC or Annex XV of Regulation (EU) 2017/745, as

applicable, as at the date of the Advertisement.

Advertisers must not imply that claims are based

upon peer-reviewed clinical investigation evidence

where this is not the case as this will create a

misleading impression.

2.4 Testimonial evidence on its own is not sufficient

substantiation for objective claims. However,

provided the overall effect is not misleading, it

may be sufficient to use testimonial evidence to

justify subjective claims (for example based upon

subjective perception) or opinions. Testimonial

evidence must not be misleading and must illustrate

typical examples only. (See also section 11.1 below.)

2.5 If engineering data or in vitro or other laboratory

test data is used to substantiate claims made in

Advertisements it must be directly relevant to,

and significant for, the product being advertised.

Particular care must be taken in extrapolating from

such data to avoid any misleading impression as to

the significance of the data.

2.6 Information and claims about side-effects used

in or as part of any Advertisement must reflect

available evidence or be capable of substantiation

by clinical experience. It must not be stated that a

product has no side-effects. The word ‘safe’ must

not be used without qualification. Medical devices

are all CE marked on a risk-benefit balance. No

medical device is 100% safe and advertising claims

should not create such an impression i.e. that the

medical device is absolutely or completely safe as

this is likely to be misleading.

2.7 Advertisements must encourage the appropriate

use of a device (or Related Service) by presenting it

objectively and without exaggerating its properties.

Exaggerated or all-embracing claims must not be

made, and superlatives must not be used except for

those limited circumstances where they relate to a

clear fact about a device.

Any claim that a device (or a particular material,

component comprised in a device or an active

ingredient forming an integral part of that device)

has some special merit, quality or property must be

substantiated.

2.8 The word ‘new’ must not be used for more than

twelve months from the date on which a device or

an Intended Purpose of that device or any Related

Service has been generally available in the UK in the

form referred to in the Advertisement.

The claim that the medical device or Related Service

(or new indication or feature) is “new” is no longer

acceptable after the device or Related Service (or

new indication or feature) has been available for

more than a year as this is no longer up-to-date

and therefore misleading. While Advertising already

in circulation need not be actively withdrawn,

Advertisers should not continue to use these once

the new device or Related Service (or new indication

or feature) has been placed on the market in the UK

for more than 12 months.

Where a device or Related Service (or new indication

or feature) has been available in the UK in only one

sector but subsequently becomes available in

additional sectors (e.g. private healthcare sector

availability is expanded to include NHS availability)

it is still not possible to claim the device or Related

Service (or new indication or feature) is “new”

though it is allowable to refer to the fact that the

device or Related Service (or new indication or

feature) is “new to the NHS” provided the overall

impression this creates is not misleading.

3. COMPARATIVE ADVERTISING

3.1 A comparison used in or as part of any

Advertisement is only permitted if:

• it is not misleading;

• devices or services for the same needs or for

the same Intended Purpose are compared;

• one or more material, relevant, substantiable

and representative features are compared;

• no confusion is created between the device or

service advertised and that of a competitor or

between the Advertiser’s trade marks, trade

names, other distinguishing marks and those

of a competitor;

• the trade marks, trade names, other

distinguishing marks, products, services,

activities or circumstances of a competitor are

not discredited or denigrated;

• no unfair advantage is taken of the reputation of

a trade mark, trade name or other distinguishing

marks of a competitor; and

• the Advertiser’s devices or services are not

presented as imitations or replicas of goods or

services bearing a competitor’s trade mark or

trade name.

3.2 Where comparative claims are made there should

be clear evidence to support the claim bearing

in mind the potential commercial impact of

comparative claims. The intent of any comparison

should be that it provides valuable, objective and

accurate information comparing products and/or

associated services for the benefit of Healthcare

Professionals and their patients. It should not simply

be a means of denigrating a competitor’s product or

Related Service.

3.3 Care must be taken not to mislead when expressing

data as percentages. Patient numbers should be

included whenever possible. Differences which

do not reach statistical significance must not be

presented in such a way as to mislead.

3.4 It is acceptable for a member to report on the

outcomes of comparative testing of medical

devices in an Advertisement provided:

a. the devices have been subjected to the same

and appropriate testing; and

b. the outcomes are reported in a fair and balanced

manner; and each outcome is referenced and

consistent with the body of evidence.

3.5 It is acceptable to report on the outcomes

of separate testing of medical devices in an

Advertisement provided a qualifying statement is

included to make clear that the substantiating data

comes from separate studies.

3.6 Hanging comparisons whereby a device or Related

Service is described as being better or stronger or

such like without stating that with which the device

is compared must not be made.

4. REQUESTS FOR SUBSTANTIATING

DATA

4.1 If a bona fide request is made to an Advertiser to

substantiate any information, claim or comparison

used in or as part of any Advertisement, the enquiry

must be acknowledged within ten working days of the

date when the Advertiser has sufficient information

to understand the nature of the enquiry or complaint.

The initial response should where relevant indicate

when a full response will be provided.

Unless section 4.2 applies, a full response together

with relevant substantiating data must be provided

within thirty working days of an adequately clear

request being received.

A bona fide request means one received from an

independent Healthcare Professional or from

another person (including from companies) having

a legitimate interest in the substantiation requested.

However, there is no requirement to respond

to fishing expeditions by competitors or others

that are simply designed to obtain confidential

or commercially sensitive information about the

Advertiser’s products or business.

There is no need to supply information relating

to the validation of a device’s explicit CE marked

Intended Purpose or for claims that are expressly

covered by the Intended Purpose of the device.

4.2 In justifying an Advertisement, the Advertiser

must be prepared to give relevant technical, clinical

and scientific data. The Advertiser may be justified

in requiring the person requesting substantiation

of the Advertisement to enter into a confidentiality

agreement in relation to information disclosed.

An Advertiser shall not be obliged to disclose

confidential or commercially sensitive data or

material directly to the person requesting it where

such disclosure might cause financial harm or

otherwise damage the business of the Advertiser.

In such cases confidential disclosure to an

independent mediator or expert or, (if a formal

complaint is to be lodged under the Code) to

the Panel, for consideration may be appropriate.

Confidential disclosure of this type shall not be

appropriate in cases where it is primarily the

insufficiency of the Advertiser’s substantiating

data, which is likely to result in the financial harm or

damage to the Advertiser’s business.

5. USE OF PUBLISHED DATA TO

SUPPORT ADVERTISING

5.1 When promotional material used in or as part of

any Advertisement refers to published studies,

including clinical investigations, clear references

must be given.

5.2 All artwork used in or as part of any Advertisement

including illustrations, graphs and tables must

conform to the letter and spirit of these Guidelines

and of the CoBP. If artwork or data is taken from

published studies a reference must be given. Graphs

and tables must be presented in such a way as to

give a clear, fair, balanced view of the matters with

which they deal, and must not be included unless

they are relevant to the claims or comparisons being

made.

If a graph or table is reproduced from a published

study, it should not be altered unnecessarily. In any

event, the way in which the material is used must

not distort or give a false impression of the evidence

published in that study and the Advertiser must

clearly state that the material has been modified.

5.3 Advertisers may use scientific peer-reviewed

journals, clinical or otherwise, to substantiate

claims made in an Advertisement. There may

also be relevant data to be found in publications

of patient data and case studies, whether or not it

is published in a scientific journal. The key issues

are the quality, relevance and overall credibility of

the data when relied upon to support claims made

in an Advertisement. (See also section 7.1 of these

Guidelines).

6. NO DISPARAGEMENT

6.1 The products and activities of other medical

device companies must not be disparaged in an

Advertisement.

6.2 Healthcare Professionals and the clinical and

scientific opinions of Healthcare Professionals

must not be disparaged in any Advertisement.

7. NON-REFEREED ARTICLES

7.1 Journal or other articles which have not been

refereed are unlikely to be sufficiently robust to

justify science-based claims about a device’s safety

or performance on their own. It also follows that

reprints of such material must not be provided to

Healthcare Professionals unsolicited.

However, if claims in an Advertisement are based

upon subjective patient or consumer perceptions,

it may be acceptable to use non-refereed articles to

promote those specific aspects of a product.

8. OFF-LABEL USE

8.1 If Journal articles discuss off-label use of a

particular device, such discussion must not be

used with the intention of promoting such off-label

use. For example, the unsolicited supply of such

materials to Healthcare Professionals would be

an infringement of these Guidelines. However, it is

permissible to supply such articles upon receipt

of a bona fide unsolicited, written request from a

Healthcare Professional. Care should be taken to

record the written request and the response sent.

9. QUOTATIONS

9.1 Quotations from medical and scientific literature or

from personal communications must be accurate

and must reflect the meaning of the author. The

precise source of the quotation must be identified.

9.2 Quotations relating to devices taken from public

broadcasts, for example on radio and television,

and from private occasions, such as medical

conferences or symposia, must not be used without

the formal permission of the speaker.

9.3 Where references are made to medical and

scientific literature or to personal communications

these must accurately reflect the author’s meaning.

9.4 All reasonable care must be taken to avoid

ascribing claims or views to authors when these no

longer represent the current views of the authors

concerned.

10. MATERIAL COMMISSIONED BY

THE ADVERTISER

10.1 An article or piece of information that is

commissioned by or on behalf of the Advertiser

must be clearly identified as such on its face and

the Advertiser must also be clearly identified.

In line with the Introduction, Section 1.2 of these

Guidelines, “commissioning” of an article in this

context means the provision of any financial or other

support or reward to the author for the purpose of

producing the article. This includes the provision

of any in-kind support, e.g. products, facilities,

secretarial or administrative support by Advertisers.

However, reports on collected medical device clinical data

(including reports on clinical investigations, as the expression

is used in the Medical Devices Directives / Regulation) that

are written by or at the direction of the clinical investigator

(“investigator-initiated reports”) shall not be considered to be

“commissioned” whether or not payments have been made in

respect of the investigators’ services or expenses reimbursed

or other in-kind support has been provided if they meet the

conditions below. Equally, reports on collected medical device

clinical data (including clinical investigations, as the expression

is used in the Medical Devices Directives / Regulation) that are

written by or at the direction of the Advertiser pursuant to an

agreement to conduct the clinical data collection (“Advertiser-

initiated reports”) shall not be regarded as “commissioned”,

always provided that such investigator-initiated or Advertiser-

initiated reports relate to clinical data collection and evaluation

processes which are:

a. performed according to scientifically valid

standards;

b. subjected to ethical review independent of the

Advertiser, e.g. hospital ethics committee; and

c. initiated and conducted for scientifically and/or

medically legitimate purposes.

10.2 Where such a commissioned article is used

solely or primarily for the purpose of supporting

a claim, including a comparative claim, the article

cannot be the sole or primary evidence relied on

to substantiate the claim – the claim must also

be separately substantiated by other, additional

evidence of sufficient quality and quantity to

meet the standards specified in these Guidelines.

Investigator-initiated or Advertiser-initiated reports

which meet the conditions set out in the Preamble,

Interpretation of these Guidelines may, however,

provide independent substantiation for the safety

or performance of a device or Related Service.

11. TESTIMONIALS AND

ENDORSEMENTS

11.1 For testimonials and/or endorsements (including

but not limited to blogs) to be used in or in support

of any Advertisement, the Advertiser must ensure

that the testimonials or endorsements (whether

from patients, suitably qualified Healthcare

Professionals, celebrities or members of the

public generally) whether written or spoken, are

documented, genuine, not misleading and illustrate

typical examples only, except where these are

obviously fictitious.

In this context “typical” means something that is

experienced by the great majority of patients or

users, as applicable. If a testimonial or endorsement

refers to a condition or situation experienced

by only one or very few patients or users, this

must be made clear. Also in this context “suitably

qualified Healthcare Professionals” means persons

who can provide suitable credentials evidencing

relevant professional expertise or qualifications

and accreditation by a professional or regulatory

body that has systems for dealing with complaints

and taking disciplinary action and has registration

based on minimum standards for training and

qualifications.

If a testimonial or endorsement which is used in

Advertising is presented by a person other than

the person originally providing the testimonial /

endorsement – for example when presented by

an actor or model – the effect must not mislead

or otherwise distort the nature of the testimonial

or endorsement. For example, Advertisers could

include a suitable caption or other notice where an

actor speaks the words of the actual provider of the

testimonial to make the actual position clear.

Testimonials or endorsements must relate to the

product being Advertised.

If a testimonial or endorsement is used in or in support

of any Advertisement, the Advertiser must hold

signed and dated documentary evidence, including

contact details, for the provider of the testimonial

or endorsement in question. The Advertiser must

also ensure that he has the consent of the person

providing the testimonial or endorsement both to use

it in connection with Advertising and (if necessary)

to disclose it in connection with the substantiation of

any claim.

Testimonials or endorsements taken from published

articles should be treated in the same way as

quotations (Section 9 above) and in accordance with

any other relevant provisions in these Guidelines.

12. REIMBURSEMENT OF

EXPENSES FOR PROVIDERS

OF TESTIMONIALS OR

ENDORSEMENTS

12.1 Any payment made to a person providing a

testimonial statement or endorsement (or any other

in-kind benefit or advantage provided) must not be

an inducement or reward for giving that statement.

Similarly, no testimonial or endorsement (including

any blog) by any person should be used in or to

support Advertising if the provider of the testimonial

or endorsement has been paid directly or indirectly

(including via in-kind benefits or advantages) on

behalf of the Advertiser to endorse the device or

Related Service or to provide the testimonial.

Reimbursement of reasonable and proportionate

expenses either by or on behalf of an Advertiser,

where the expenses have been incurred by an

individual or a company providing a testimonial or an

endorsement for use in or in support of Advertising,

is permitted always provided such reimbursement:

a. is limited to out-of-pocket expenses reasonably

incurred by the provider of the testimonial or

endorsement in connection with its provision

(e.g. reasonable travel costs to reach the filming

location provided the location chosen and the

mode of travel do not themselves constitute

an inducement or reward for providing the

testimonial / endorsement); and

b. is either paid to a third party travel agent /

vendor to organise the travel / accommodation

or only reimbursed to the testimonial /

endorsement provider against original invoices

or receipts; and

c. is kept entirely separate from any payments or

other arrangements relating to any background

collaboration or sponsorship activities so that

the reimbursement is not, and does not appear

to be, a payment made in connection with, or as

part of a broader scheme of, paid collaboration

or sponsorship between the provider of the

testimonial / endorsement and the Advertiser

(or any person or organisation connected to

him); and

d. specifically in the case of Healthcare

Professionals, such reimbursement is only paid

in circumstances where the reimbursement

payment does not in any way amount to a

payment (i.e. as an inducement or reward) for

the testimonial or endorsement to be provided

as a service by the Healthcare Professional (nor

does it have the appearance of being such a

payment).

12.2 There should be a written agreement (e.g. letter

agreement) signed and dated by or on behalf of both

the Advertiser and the provider of the testimonial /

endorsement setting out which expenses will be

reimbursed and the mechanism of reimbursement

(as well as also meeting the other requirements

stated at sections 11 and 12.1 above). Expenses

should only be reimbursed to the testimonial

/ endorsement provider by or on behalf of the

Advertiser against original invoices or receipts.

If the provider of the testimonial / endorsement is

a Healthcare Professional, the written agreement

must also comply with the requirements of Part 1,

Chapter 6 of the ABHI Code (Arrangements with

Consultants).

It is important that any reimbursement of out-

of-pocket expenses should not be, or appear

to be, a contrived payment for a testimonial or

endorsement. No payment is permitted simply

to obtain the testimonial / endorsement of a

Healthcare Professional or any other person, and

the written agreement must make this clear.

13. EFFECT OF BACKGROUND

COLLABORATION OR

SPONSORSHIP ON

TESTIMONIALS AND

ENDORSEMENTS

13.1 Advertisers may use testimonials or endorsements

of a device or a Related Service by patients,

celebrities, suitably qualified Healthcare

Professionals or members of the public in, or in

support of, Advertising where there is background

collaboration or sponsorship by or on behalf of the

Advertiser only if:

a. the background collaboration with or sponsorship

by the Advertiser of the individual or company

providing the testimonial or endorsement is

made clear in the Advertisement; and

b. the testimonial or endorsement meets

the requirements for testimonials and

endorsements contained in these Guidelines

(see Sections 11 and 12).

“Background collaboration or sponsorship” in this

context means any relationship or arrangement(s)

(including for example consultancy arrangements

or any other type of service provision) between the

provider of the testimonial or the endorsement and

the Advertiser (or its representatives or affiliates)

which is not connected with the provision of the

testimonial or the endorsement, irrespective of

whether such relationship or arrangement involves

any payments (or any other in-kind benefit or

advantage) or not.

Examples of background collaboration or

sponsorship could include arrangements for

research, participation on advisory boards or

product development.

Reports of clinical investigations shall not be

regarded as testimonials or endorsements of

a product or Related Service. Rather, they may

provide independent substantiation for the safety

or performance of a device or Related Service.

Statements made of his/her own volition by a

Healthcare Professional (including but not limited

to off-the-cuff statements) shall not be treated as

testimonials or endorsements even if they have

been made at an occasion (such as a conference

or meeting) where the meeting organizer is directly

or indirectly supported by the Advertiser, always

provided such support is incidental to the statement

made. If the Advertiser subsequently wishes to use

such a statement in or in support of Advertising the

Advertiser must ensure all the requirements of these

Guidelines regarding testimonials or endorsements

(see under sections 11 and 12) are met.

13.2 When Advertisers enter into written agreements

covering potential background collaboration or

sponsorship activities, Advertisers should anticipate

the possibility that the party providing the services

under the relevant agreement may at some future

time provide a testimonial or endorsement in relation

to a device or a Related Service. Advertisers should

therefore include provisions in such agreements to

cover this eventuality (specifically points (i) and (ii)

below) in order to ensure that they will be able to

meet the requirements in these Guidelines relating

to transparency of background collaboration

and sponsorship and use of testimonials and

endorsements generally. Such agreements should

therefore include written agreement by the potential

future testimonial / endorsement provider to:

a. disclose clearly and conspicuously in any

testimonial / endorsement any background

collaboration with, or sponsorship by or on

behalf of, the Advertiser; and

b. promptly withdraw, or revise and re-publish any

testimonial / endorsement at the Advertiser’s

reasonable request where the request is made

on objective grounds of ensuring safety and

effective use within the Intended Purpose of the

device or Related Service.

Such agreements should be in writing and signed

and dated by both the Advertiser and the potential

provider of the testimonial / endorsement.

14. ANNEX 1 GENERAL

ADVERTISING LAW

AND CODES

The Business Protection from Misleading Marketing

Regulations 2008

The Consumer Protection from Unfair Trading

Regulations 2008

The UK Code of Non-Broadcast Advertising, Sales

Promotion and Direct Marketing (CAP Code)

The UK Code of Broadcast Advertising (BCAP Code)

COMPLAINTS PROCEDURE

AND PANEL CONSTITUTION

PART 4

INTRODUCTION

A Code of Ethical Business Practice (“Code”) has been

adopted by the Association of British Healthcare Industries

(“ABHI”) to set standards for ethical behaviour and to govern

ethical promotion and sales practices in the medical devices

industry in the UK (“the Industry”). The Code is administered

by the ABHI secretariat in conjunction with the

“Chairman” of the Complaints Adjudication Panel,

“Panel”, which comprises a number of individuals with

relevant industry and/or other experience. Compliance

with the Code and with this Procedure is mandatory

for members of ABHI and companies which (although

not members) (together “Applicable Companies”) have

agreed to comply with the Code and this Procedure

and accept the jurisdiction of the Panel. “Complaints”

made under the Code include direct complaints, as well

as indirect complaints made to MedTech Europe and

referred to ABHI for adjudication, and may also include

issues raised in the media or otherwise that fall within the

remit of the Code.

The Panel is not an investigatory body as such. It asks the

company whose activities are the subject of a complaint

(“respondent”) for a complete response and may ask

the parties to a case for further information in order to

clarify the issues. The company or individual making the

complaint (“complainant”) has the burden of proving their

complaint on the balance of probabilities.

Any company wishing to make a complaint against an

Applicable Company utilising this Complaints Procedure

must initially attempt to reconcile any dispute with that

company through conciliation or mediation procedures

or mutual settlement. Any individual wishing to make a

complaint against an Applicable Company utilising this

Complaints Procedure must initially attempt to resolve

the complaint utilising that company’s internal or external

whistleblowing and/or dispute resolution procedures. If, in

either case, this does not prove possible then complaints

are initially considered by the Chairman who will determine,

if appropriate in consultation with the complainant and/or

respondent, whether there is a case to answer.

Anonymous complaints (where the complainant does not

disclose their identity to the Panel or Chairman) may be

accepted in exceptional circumstances at the discretion

of the Chairman, however the weight to be attached to

any evidence may be adversely affected if the source

is anonymous, and thus in many instances it will not be

possible for such a complaint to proceed.

Confidential complaints (where the complainant does

disclose their identity to the Panel or Chairman but

requests (whether at the outset or during the course of the

complaint) that their identity remains confidential) are not

encouraged but may be accepted at the discretion of the

Chairman, however the ability of the respondent to respond

properly to information or matters put to them and therefore

the Panel’s ability to adjudicate properly on any particular

complaint may be adversely affected if the identity of the

complainant is kept confidential, and therefore in certain

instances it will also not be possible for such a complaint to

proceed. Confidential complaints will not be accepted from

Applicable Companies.

Reports on cases that are subject to a Panel decision

are published and are available on request and on

the ABHI Code of Ethical Business Practice website

www.abhicodeofpractice.org.uk. Information on cases that

are resolved through mediation are published in a summary

report although the names of the companies or individuals

involved will not be disclosed.

Complaints about the conduct of any Applicable Company

under the Code should be submitted to:

Telephone: +44 (0)20 7960 4360,

E-mail: complaints@abhi.org.uk.

DISPUTE RESOLUTION PRINCIPLES

General framework

The procedures set out below are intended to provide an

effective and efficient complaint-handling process, the

object of which is to ensure compliance with the Code. It is

based on principles of proportionality, speed, due process,

fairness and transparency.

Applicability of the Code

Member Companies must comply with the Code as a

minimum standard when:

a. Member Companies interact with Healthcare

Professionals and Healthcare Organisations registered

and practising in the UK irrespective of where the

activity takes place; and/or

b. Activities take place in MedTech Europe Geographic

Area, irrespective of where Healthcare Professionals

and Healthcare Organisations are registered and

practicing.

MedTech Europe Geographic Area includes the countries

in the European Economic Area as well as those countries

where MedTech Europe Member Associations are located.

STRUCTURE AND

RESPONSIBILITIES

1. The Panel

1.1 The Panel is responsible for resolving complaints

made under the Code. It may also assist in

arranging for conciliation and/or mediation

between companies when requested to do so.

1.2 The Panel and Chairman report to the ABHI Board

in respect of their activities and the operation and

administration of this Complaints Procedure.

2. The Panel – Constitution and Procedure

2.1 The members of the Panel and the Chairman and

Vice-Chairman shall be appointed yearly by the

ABHI Board. The Panel shall comprise individuals

with a background in the industry and who have

relevant expertise for assessing Complaints under

the Code. The names of the members of the Panel

shall be published on the ABHI website. There is

no limit on the length of time that the Chairman,

Vice-Chairman or other members of the Panel

may serve in those capacities.

2.2 In the event that a Complaint cannot be resolved

through mediation by the Secretariat, Chairman

and such members of the Panel who may be

enlisted for this mediation, the Complaint shall

be referred to the Panel for formal adjudication.

Each individual Panel appointed to consider any

particular complaint shall, so far as possible,

comprise of an appropriate cross-section of Panel

members and shall be appointed by the Chairman

from the wider list of Panel members referred to.

The Chairman shall ensure that a Panel contains

as far as possible individuals with expertise in

relevant areas, e.g. legal, ethical compliance,

advertising and promotion, scientific, business, as

appropriate. Each individual Panel shall comprise

of a minimum of the Chairman and three further

Panel members and decisions shall be made by

majority voting. The Chairman, and in his absence,

the Vice-Chairman, acts as Chairman of the Panel

and has both an original and a casting vote.

2.3 Rulings are made on the basis that a complainant

has the burden of proving their complaint on the

balance of probabilities.

2.4 In advance of their appointment to an individual

Panel to consider any particular complaint, all

Panel members involved shall sign an agreed form

statement of independence confirming that they

have no conflict of interest in adjudicating on the

particular complaint.

2.5 The Panel may obtain expert assistance in any

field. Expert advisers who are consulted may be

invited to attend a meeting of the Panel, but have

no voting rights. Each such expert shall also be

required to confirm that they have no conflict of

interest in providing expert assistance on any

particular case.

2.6 Subject to paragraphs 2.7 and 2.8 below, any

decision of the Panel shall be final, and there

shall be no appeals procedure against any Panel

rulings.

2.7 At any time during a complaint handling process

the Chairman or the Panel shall be entitled to refer

questions of interpretation of the Code in writing

to the MedTech Europe Compliance Panel. The

MedTech Europe Compliance Panel may at its

discretion either decline to entertain the matter if

it is felt that no question of principle is at issue or

accept the interpretation referral, and review and

provide guidance on the interpretation of the Code.

Where such a request has been made, the

Chairman and the Panel shall be obliged to

follow and apply any such guidance provided by

MedTech Europe unless so doing would conflict

with UK law. For the avoidance of doubt MedTech

Europe shall not rule on the merits or facts of

any particular complaint but only on questions of

interpretation of the Code.

2.8 This Procedure shall not preclude complainants

from having recourse to courts or other

tribunals to seek resolution of complaints and

any complaints made under the Code and this

Procedure should not be initiated or should be

suspended in case of initiation of formal civil court

proceedings with respect to the same subject

matter. Where a governmental or regulatory

investigation or criminal proceedings are either

initiated or threatened against an Applicable

Company with respect to the same subject

matter, that company shall notify the Chairman of

the same in confidence, who shall then have the

discretion whether or not to suspend any relevant

proceedings under this Procedure.

2.9 For the avoidance of doubt, all companies or

individuals that wish to utilise this Complaints

Procedure to submit a Complaint, and all

Applicable Companies that have agreed to

submit to the jurisdiction of the Panel in respect

of a Complaint, shall not, save in respect of fraud,

fraudulent misrepresentation, manifest error

or gross negligence by the Panel (or a member

thereof) in arriving at a Panel ruling, commence

legal proceedings or any analogous contentious

or complaint proceedings against ABHI, the Panel,

or any Panel member, in respect of any loss or

damage they may suffer as a consequence of any

such Panel ruling.

COMPLAINTS PROCEDURE

3. Action on Complaints

3.1 Prior to lodging a formal complaint against an

Applicable Company under this Procedure, any

company wishing to make a complaint against an

Applicable Company shall first attempt a genuine

mediation with that company in an attempt to

reach an amicable solution. For complaints

between Applicable Companies, such genuine

attempt at mediation shall be a pre-condition

before a complaint can be made utilising this

Procedure and any such complainant shall

adduce sufficient evidence to the Panel to prove

such genuine attempts at mediation have been

made. Any individual wishing to make a complaint

against an Applicable Company utilising this

Complaints Procedure must initially attempt to

resolve the complaint utilising that company’s

internal or external whistleblowing and/or

dispute resolution procedures. If, in either case,

no amicable resolution of the complaint can be

reached through such means within a reasonable

timeframe however, the complainant shall be

entitled to pursue the matter further directly via

this Procedure.

3.2 Any individual or company making a complaint

under this Procedure that is not an Applicable

Company shall be required (in the case of a company

for a minimum of 18 months, and in the case of

an individual for the duration of the Procedure) to

undertake to abide by the provisions of the Code

and of this Procedure as a pre-condition before a

complaint can be made utilising this Procedure.

3.3 If a complaint is received about a company other

than an Applicable Company, such company will

be invited to agree to comply with the Code and

accept the jurisdiction of the Panel. In the absence

of such agreement however, the complaint will not

be accepted for adjudication using this Procedure.

Notwithstanding the foregoing, where a complaint

is brought in respect of activities undertaken or

instigated by an Applicable Company’s parent

or other affiliated company which is not itself an

Applicable Company, the Applicable Company will

be deemed as the respondent company for the

purposes of this Procedure and the complaint will

proceed accordingly.

3.4 When the Chairman receives information from

which it appears that an Applicable Company

may have contravened the Code, the Chairman

shall undertake an initial review of the complaint

and will determine (if appropriate, in consultation

with the complainant and/or respondent) whether

there is a prima facie case to answer.

3.5 If, in the view of the Chairman, a complaint does

not show that there may have been a prima facie

breach of the Code, the complainant shall be so

advised. If the complainant does not accept that

view, the following paragraphs of this Section 3

shall apply.

3.6 In the event that the Chairman determines that

there is either a prima facie case to answer, or

(pursuant to paragraph 3.5) the complainant

insists that the complaint is referred to the Panel

for adjudication, then the Chairman shall write

to the managing director or chief executive or

equivalent of the Applicable Company against

whom the complaint has been made requesting

that it provide a complete response to the matters

of complaint.

3.7 The respondent company shall provide such

a response in writing to the Chairman within 10

working days. If no such response is provided by

the respondent company within these timescales

then, save as otherwise provided in paragraph 7,

the Panel shall make it’s adjudication on the basis

of the information provided by the complainant

only. Following receipt by the Chairman of the

respondent company’s response, the case shall

be referred to the Panel to determine whether or

not there has been a breach of the Code.

3.8 To assist companies in ensuring that a complete

response is submitted, the Chairman may suggest

relevant supporting material to be supplied,

although it is the responsibility of the respondent

to ensure that a full response is submitted.

3.9 In addition, the Chairman may request (whether

at the suggestion of the complainant or

respondent or at the behest of the Panel) such

further clarifications or documents from either

the complainant or respondent within such

reasonable timescales as he shall deem prudent

and necessary to assist the Panel in making its

determination.

3.10 As an alternative to proceeding directly to the

Panel, the Chairman may offer to facilitate a

time-limited mediation between the parties. Such

mediation shall normally be limited to six working

weeks but may be extended at the Chairman’s

discretion. Both parties shall make every effort

to ensure that relevant personnel are available to

participate in the process as and when they are

required.

The parties shall agree at the outset to the terms

of mediation and that the costs incurred in running

the process shall be divided equally between

them. Only Applicable Companies shall be liable

for mediation costs.

3.11 If the complainant is not an Applicable Company,

the Chairman may suggest the paragraphs of

the Code to be addressed, however when the

complaint is from an Applicable Company, the

complaint must be signed or authorised in writing

by the company’s managing director or chief

executive or equivalent and must state those

paragraphs of the Code which are alleged to have

been breached.

3.12 U n l e s s the information is disclosed in the

complaint, any complainant other than an

Applicable Company will be asked to confirm in

writing whether or not they have any commercial,

financial or other interest in the matter of

complaint or in the company concerned, such

as whether the complainant is an employee or

ex-employee, a consultant or ex-consultant.

Adjudication of a complaint without this written

confirmation will not be permitted to proceed.

Such interests will be disclosed to the respondent

company and will normally be included in the case

report.

3.13 W h e n an Applicable Company advises the

Chairman or Panel that it may have breached the

Code, the Chairman shall treat the matter as a

complaint if it relates to a potential breach of the

Code or if the company fails to take appropriate

action to address the matter. The company’s

response is invited and the procedure set out in

this Section 3 shall be followed.

4. Complaints Arising from Media Criticism

4.1 If it appears to the Chairman from media reports

that an Applicable Company may have breached

the Code, the Chairman may at his discretion

treat such reports as a complaint if it relates to

a potential breach of the Code or if the company

fails to take appropriate action to address the

matter. The company’s response is invited and the

procedure set out in Section 3 shall be followed.

4.2 The author or editor (as applicable) of the relevant

media report may be asked if they want to be

involved in the case and whether they have any

additional information to submit. If the editor or

author declines involvement, this is stated in the

case report.

4.3 A published letter from which it appears that

an Applicable Company may have breached the

Code may also at the discretion of the Chairman

be treated as a complaint. The procedure set out

in Paragraph 4.1 above shall be followed.

5. Panel Rulings

5.1 Where the Panel rules that there is a breach of the

Code, the Panel shall advise the complainant and

the respondent of such in writing and give their

reasons for the decision.

5.2 The respondent company has ten working days

to provide a written undertaking that the activity

in question (if not already discontinued) will cease

forthwith and that all possible steps will be taken

to avoid a similar breach of the Code in the future.

This undertaking must be signed by the managing

director or chief executive or equivalent of the

company and must be accompanied by details of

the actions taken by the company to implement

the undertaking, including dates and timings and

training undertaken.

5.3 In extenuating circumstances, an extension

in the time allowed in which to respond may be

granted at the discretion of the Chairman in

accordance with paragraph 7.

5.4 The respondent company must also pay within

twenty working days an administrative charge

based on the cost of convening the Panel and

dealing with the complaint as determined by

the Chairman.

5.5 Where the Panel rules that there is no breach of

the Code, the Panel shall advise the complainant

and the respondent of such in writing and

give their reasons for the decision. Where the

complaint is from an Applicable Company, the

complainant must pay within twenty working

days an administrative charge based on the

cost of convening the Panel and dealing with the

complaint as determined by the Chairman.

5.6 In addition to the foregoing, the Panel may impose

additional or alternative sanctions on either of the

respondent company (in the event of its breach of

the Code) or complainant company (in the event of

no breach of the Code) as appropriate in respect of

any particular complaint. In particular, the Panel may:

a. Require the relevant company to publish any

communication required by the Panel, including

but not limited to explanatory information or

statements of future intent or policy;

b. Issue a formal reprimand;

c. Recommend to the ABHI Board to suspend

the offender from membership of ABHI for

a specified period and impose conditions on

readmission;

d. Recommend to the ABHI Board to expel the

offender from ABHI;

e. Set time-limits for compliance with any

sanction imposed or order made by the Panel

in addition to those specified in paragraphs

5.1 to 5.5 above;

f. Order that either party pay the costs of the

Panel, in whole or part, having regard to a

standard scale published by ABHI and any

other matters considered appropriate;

g. Provide for further sanctions in the event

of further breaches of or non-compliance

with the Code or any order, sanction or

requirement of the Panel (including time

limits), with or without the right to make

further representations before such further

sanctions are to take effect.

6. Case Reports

6.1 At the conclusion of any case under the Code,

the Panel shall advise the complainant and the

respondent of the outcome and a report shall be

published summarising the details of the case.

6.2 In a case where the complaint was initiated by

an individual, other than in those circumstances

where an anonymous or confidential complaint is

accepted for adjudication, that individual shall be

named in the report.

6.3 In a case where the complaint was initiated by a

company or by an organisation or official body,

that company or organisation or official body shall

be named in the report. The respondent company

and the product(s) concerned will usually be

named in the report unless the Chairman in

his discretion deems this inappropriate. Any

information given must not, however, be such

as to identify any individual person within such

company, organisation or official body.

6.4 Where expert assistance has been obtained by

the Panel, the report will include the name and

qualifications of the expert concerned.

6.5 Where guidance has been sought from MedTech

Europe, the question raised by the Chairman or the

Panel and the guidance received from MedTech

Europe shall be included in the report.

6.6 Where a company has been required to issue a

statement of its corrective actions, the report will

reproduce its text and provide details of how the

corrective actions statement was disseminated.

6.7 A copy of the report on a case is made available

to both the complainant and the respondent

company prior to publication. Any amendments

to the report suggested by these parties are

considered by the Chairman, consulting with the

other party where appropriate. The Chairman’s

decision is final.

6.8 Full case reports will appear on a specified

section of the ABHI Code of Ethical Business

Practice website. Access to the relevant section

of the relevant ABHI website referring to cases or

decisions is unrestricted.

GENERAL PROVISIONS

7 Amendments to Time Periods

7.1 The Chairman shall, in extenuating circumstances

and at his discretion, be entitled to grant any party

to this Procedure an extension in time or amend

any timescales specified in this Procedure to the

extent that to do so would be fair and reasonable

in the circumstances.

8. Withdrawal of Complaints

8.1 A complaint may be withdrawn by a complainant

with the consent of the respondent company up

until such time as the respondent company’s

comments on the complaint have been received

by the Chairman, but not thereafter. In either

case, the complainant shall pay an appropriate

administrative charge.

9. Charges

9.1 The administrative charges referred to in

Paragraphs 5.4, 5.5 and 8.1 above are determined

by the Chairman based on the costs of formally

convening the Panel and in dealing with the

complaint.

9.2 Administrative charges are payable only by

Applicable Companies, and these companies are

liable for such charges whether they are members

of the ABHI or not.

9.3 Where two or more companies are ruled in breach

of the Code in relation to a matter involving a joint

activity, each company shall be separately liable to

pay any administrative charge which is payable.

9.4 Failure to pay any of the administrative charges

provided for by this paragraph must be reported

by the Chairman or the Panel to the ABHI Board.

In such circumstances, the Panel shall be entitled

to impose or recommend such further sanctions

as it deems appropriate, including (but not limited

to) those referred to in paragraph 5.6.

10. Anonymity and Confidentiality

10.1 Any complainant or respondent shall be entitled

to request that any document or information

provided to the Panel or Chairman pursuant to this

Procedure is not disclosed further on the grounds

of confidentiality, in particular to either the

complainant or respondent as the case may be

or in any case report. The Chairman shall decide

in his discretion whether to grant such request, in

particular taking in to account the ability of either

the complainant or the respondent to respond

properly to information or matters put to them if

such documents or information is excluded and

therefore the Panel’s ability to properly adjudicate

on any particular complaint. The Chairman’s

decision on this issue shall be final.

10.2 Anonymous complaints (where the complainant

does not disclose their identity to the Panel

or Chairman) may be accepted in exceptional

circumstances at the discretion of the Chairman,

however the weight to be attached to any evidence

may be adversely affected if the source is

anonymous, and thus in many instances it will not

be possible for such a complaint to proceed.

10.3 Confidential complaints (where the complainant

does disclose their identity to the Panel or

Chairman but requests (whether at the outset

or during the course of the complaint) that their

identity remains confidential) are not encouraged

but may be accepted at the discretion of the

Chairman, however the ability of the respondent

to respond properly to information or matters

put to them and therefore the Panel’s ability to

adjudicate properly on any particular complaint

may be adversely affected if the identity of the

complainant is kept confidential, and therefore

in certain instances it will also not be possible

for such a complaint to proceed. Confidential

complaints will not be accepted from Applicable

Companies.

11. Amendments to the Code of Ethical Business Practice

and Complaints Procedure

11.1 The Code and this Procedure may be amended by

a simple majority of those present and voting at

the ABHI Board.

11.2 The Panel may, in the light of their experience,

make recommendations for amendment of the

Code and this Procedure.

GLOSSARY AND

DEFINITIONS

PART 5

ABHI: Association of British HealthTech Industries

Advertiser: the ABHI Member by or on behalf of whom

an Advertisement is placed and/or the ABHI Member

supplying the relevant product or Related Service if he has

approved the Advertisement or the Advertisement has been

approved or placed by the Member’s affiliated company

which is not a Member of ABHI.

The ABHI Member shall be treated as the Advertiser

where the ABHI Member, or the Member’s affiliated

company which is not a Member of ABHI, has approved

Advertisements placed by a third party distributor or other

service provider.

Advertisement or Advertising: any marketing

communication or Advertorial issued by or on behalf of

an Advertiser in whatever form (including but not limited

to verbal communications) and through whatever media

(including the world wide web) that is intended wholly or

mainly to influence Healthcare Professionals or Healthcare

Organisations directly or indirectly in (i) their choice of

medical devices (or Related Services) to be purchased,

leased, used or supplied for use by, or in connection with the

treatment of, human patients or in (ii) any recommendation

that they make to others about such purchase, lease, use

or supply.

An example of Advertising intended to influence Healthcare

Professionals or Healthcare Organisations indirectly would

be information provided by or on behalf of an Advertiser

to journalists working for publications which are directed

primarily at Healthcare Professionals or Healthcare

Organisations.

For the avoidance of doubt product labelling, packaging

and instructions for use shall not in the ordinary course be

treated as Advertising for the purpose of these Guidelines.

Advertorial: any communication, feature, announcement

or promotion in a form that resembles independent editorial

comment published by or on behalf of an ABHI Member,

the content of which is controlled by the Advertiser, not the

publisher, irrespective whether it is disseminated in return

for a payment or other reciprocal arrangement, or free of

charge.

Applicable Company: a member of ABHI or an organisation

that has undertaken to comply with the provisions of the

ABHI Code of Ethical Business Practice.

Charitable Donations: means provision of cash,

equipment, company product or relevant Third Party

product, for exclusive use for charitable or philanthropic

purposes and/or to benefit a charitable or philanthropic

cause. Charitable Donations may only be made on an

unrestricted basis and to bona fide charities or other non-

profit entities or bodies whose main objects are genuine

charitable or philanthropic purposes.

CoBP or Code: the code of ethical business practice

published by ABHI as amended from time to time.

Company Events: means activities of any type that are

planned, budgeted, managed and executed in whole or

in part by or on behalf of Member Companies to fulfil a

legitimate, documented business need of the Member

Company, including but not limited to a legitimate business

need to interact with customers including Healthcare

Professionals and/or Healthcare Organisations.

Conference Vetting System (CVS): means the

centralised decision-making process which reviews the

compliance of Third Party Organised Educational Events

with the Code and which is managed independently of ABHI

under the supervision of the MedTech Europe Compliance

Panel. For more information see:

www.ethicalmedtech.eu

Disclosure Guidelines: means the Code provisions

setting out the public disclosure requirements under the

Code.

Demonstration Products (Demos): means either single-

use or multiple-use products provided free of charge by

or on behalf of a Member Company to HCOs or HCPs,

who are equipped and qualified to use them. Demos are

supplied solely for the purpose of demonstrating safe and

effective use and appropriate functionality of a product and

are not intended for clinical use. Demos do not include the

following:

•

Samples;

•

Evaluation Products;

•

Products provided at no charge as part of a Charitable

Donation or as part of a Research or Educational Grant;

•

Products provided at no additional charge as part of

the overall purchase price in a commercial supply

arrangement, e.g. as part of an agreed discount

arrangement, or as substitute products provided

pursuant to a warranty agreement.

Educational Grants: means provision of funding, Member

Company or third party products or other in-kind support

to a Healthcare Organisation by or on behalf of a Member

Company on a restricted basis for use solely for the support

and the advancement of genuine medical education of

Healthcare Professionals, patients and/or the public on

clinical, scientific and/or healthcare topics relevant to

the therapeutic areas in which the Member Company is

interested and/or involved.

Employer Notification: means the prior written

notification provided to a Healthcare Organisation (e.g.

hospital administration), a Healthcare Professional’s

superior or other locally-designated competent authority

of any interaction, collaboration or other matter concerning

any Member Company and any Healthcare Professional,

the purpose and/or scope of which requires notification

under this Code.

Entertainment: Entertainment includes, but is not limited

to, dancing or arrangements where live music is the main

attraction, sight-seeing trips, theatre excursions, sporting

events (e.g. skiing, golf or football match) and other leisure

arrangements. For the avoidance of doubt, incidental,

background music shall not constitute Entertainment.

Evaluation Products: means either single-use or multiple-

use products and/or equipment provided free of charge to

a Healthcare Organisation by or on behalf of a Member

Company for purposes of obtaining defined, evaluative user

feedback over a defined period of use when used within the

scope of their intended purpose, as per the authorisation in

the country where the supply occurs. Evaluation Products

do not include the following:

• Demos;

• Samples;

• Products provided at no charge as part of a Charitable

Donation or as part of a Research or Educational Grant;

• Products provided at no additional charge as part of

the overall purchase price in a commercial supply

arrangement, e.g. as part of an agreed discount

arrangement, or as substitute products provided

pursuant to a warranty agreement.

Event: means either a Company Event or Third Party

Organised Educational Event.

Faculty: means a podium speaker, moderator and/or chair,

who presents during a Third Party Organised Educational

Event. Poster- and abstract-presenters are not considered

to be Faculty.

Financial Hardship: means in relation to a Healthcare

Organisation extreme and unavoidable financial

distress resulting from matters outside the Healthcare

Organisation’s control where the Healthcare Organisation

is unable to operate and where patient care is consequently

jeopardised. Financial distress resulting in whole or in part

from mismanagement of the Healthcare Organisation’s

funds or other matters within its control is not considered

to be financial hardship. Financial Hardship must be

documented and objectively substantiated.

Grants: means either an Educational Grant or a Research

Grant, or both.

Guests: means spouses, partners, family or guests of

Healthcare Professionals, or any other person who does

not have a bona fide professional interest in the information

being shared at an Event.

Healthcare Organisation (HCO): means any legal entity

or body (irrespective of its legal or organisational form)

that is a healthcare, medical or scientific association or

organisation which may have a direct or indirect influence

on the prescription, recommendation, purchase, order,

supply, utilisation, sale or lease of health technologies or

related services such as a hospital or group purchasing

organisation, clinic, laboratory, pharmacy, research

institution, foundation, university or other teaching

institution or learned or professional society (except for

patient organisations); or through which one or more

Healthcare Professionals provide services.

Healthcare Professional (HCP): means any individual

(with a clinical or non-clinical role; whether a government

official, or employee or representative of a government

agency or other public or private sector organisation;

including but not limited to, physicians, nurses, technicians,

laboratory scientists, researchers, research co-ordinators

or procurement professionals) that in the course of their

professional activities may directly or indirectly purchase,

lease, recommend, administer, use, supply, procure or

determine the purchase or lease of, or who may prescribe

health technologies or related services.

Intended Purpose: the use for which the device is intended

according to the data supplied by the manufacturer on the

label, in the instructions or in promotional or sales materials

or statements and as specified by the manufacturer in

the clinical evaluation (Medical Devices Regulation (EU)

2017/ 745).

Members: means all full and associate corporate

members (“Member Companies”) of ABHI as well as

association members of ABHI (“Member Associations”), as

defined in the ABHI statutes, as applicable and as amended

from time to time.

Professional Conference Organiser (PCO): a for-

profit company or organisation which specialises in the

management of congresses, conferences, seminars and

similar events.

Product and Procedure Training and Education

Event: means a type of Company Event that is primarily

intended to provide Healthcare Professionals with genuine

education, including information and/or training on:

• The safe and effective use of health technologies,

therapies and/or related services, and/or

• The 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 health technologies, therapies and/

or related services.

Related Service: in relation to a medical device, a related

service means an activity necessary to make the device

available for use. This may include specialist installation

services; repair and maintenance services; or end-of-use

services such as specialist disposal of the device.

Research Grants: means the provision by or on behalf

of a Member Company of funding, products/equipment

and/or in-kind services to any organisation that conducts

research which is made for the sole, restrictive purpose of

supporting the development or furtherance of bona fide,

scientifically valid and legitimate research by the recipient

the purpose of which is to advance medical, scientific and

healthcare knowledge, health technologies and/or clinical

techniques designed to improve patient outcomes.

Sales, Promotional and Other Business Meetings:

means any type of Company Event the objective of

which is to effect the sale and/or promotion of a Member

Company’s health technologies and/or related services,

including meetings to discuss product features, benefits

and use and/or commercial terms of supply.

Samples: means single-use or multiple-use products

provided free of charge by or on behalf of a Member

Company to HCOs or HCPs who are equipped and

qualified to use them in order to enable HCPs to familiarise

themselves with the products in clinical use. Samples do

not include the following:

• Demos;

• Evaluation Products;

• products provided at no charge as part of a Charitable

Donation or as part of a Research or Educational Grant;

• products provided at no additional charge as part of

the overall purchase price in a commercial supply

arrangement, e.g. as part of an agreed discount

arrangement, or as substitute products provided

pursuant to a warranty agreement.

Scholarships and Fellowships: means Educational

Grants provided to a Healthcare Organisation by or on

behalf of a Member Company to support fellowships

or scholarships offered by the Healthcare Organisation.

Scholarships in this context means an Educational Grant

provided to support a medical school undergraduate

whereas a fellowship is a period of intensive training for

post-graduate physicians in a chosen clinical sub-specialty

(e.g. medical training after a residency). “Scholars” and

“Fellows” shall be understood accordingly.

Sponsored Posts: Sponsored posts are positions within a

Healthcare Organisation that are funded, in whole or in part,

by a Member Company. Sponsored posts can offer benefits

to the delivery of care, providing expertise, extra capacity

and capability that might not otherwise be provided if

funding was to be found from within the Healthcare

Organisation’s budget.

Third Party Organised Educational Events: means

activities of any type that are planned, budgeted, managed

and executed in whole or in part by or on behalf of a person

or entity other than a Member Company to fulfil Healthcare

Professional medical educational needs.

Third Party Organised Educational Conferences:

means a type of Third Party Organised Educational Event

that is a genuine, independent, educational, scientific, or

policy-making conference organised to promote scientific

knowledge, medical advancement and/or the delivery

of effective healthcare and which is consistent with

relevant guidelines established by professional societies

or organisations for such educational meetings. These

typically include conferences organised by national,

regional, or specialty medical associations/societies,

hospitals, Professional Conference Organisers (PCOs),

patients organisations or accredited continuing medical

education providers.

Third Party Organised Procedure Training: means

a type of Third Party Organised Educational Event that is

primarily intended to provide Healthcare Professionals

with information and training on the safe and effective

performance of one or more clinical procedures in

circumstances where the information and training concern:

• Specific therapeutic, diagnostic or

rehabilitative procedures, namely clinical

courses of action, methods or techniques

(rather than the use of health 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.

Transition Period: means the period from 1 January

2017 up to and including 31 December 2018, following

which Member Companies shall no longer provide financial

or in-kind support direct to Healthcare Professionals to

cover costs of their attendance at Third Party Organised

Educational Events with the exception of Third Party

Organised Procedure Training meetings or pursuant to

a consulting agreement with a Healthcare Professional

speaker engaged by a Member Company to speak at a

satellite symposium.

ANNEXES

PART 6

WHICH TYPE OF

SUPPORT CAN

MEMBER COMPANIES

PROVIDE TO

WHICH THIRD PARTY

ORGANISED

EDUCATIONAL

EVENTS?

EDUCATIONAL

GRANTS

PROVIDED TO

SUPPORT A

ORGANISED

THIRD PARTY

CONFERENCE

Educational Grant to

support the general

running of a conference

Out of scope of the

application of the Code

Out of scope of the

application of the Code

N/A

INTERNATIONAL

(Third Party Organised

Educational Events to

which no Healthcare

Professionals registered

and practicing in the

MedTech Europe

Geographic Area attend,

neither as speakers or

delegates)

NATIONAL

Third Party Organised

Educational Events

attended by delegates

which are local HCPs

only)

IN MEDTECH EUROPE

GEOGRAPHIC AREA

OUTSIDE MEDTECH EUROPE

GEOGRAPHIC AREA

Educational Grants that

includes funds to support

HCP attendance to the

conference

Educational Grants that

includes funds to support

Faculty

Consultancy agreement

for speakers in satellite

symposia

Direct sponsorship of

HCPs as delegates

(passive participation)

Direct sponsorship of

HCPs as Faculty

(active p

articipation)

Booths/advertising

COMMERCIAL

ACTIVITIES

DIRECT SPONSORSHIP

OF HCPs REGISTERED

AND PRACTISING IN

THE MEDTECH EUROPE

GEOGRAPHIC AREA

2018 – Allowed.

Not subject to CVS decision

2019 – Subject to CVS

decision

2018 – Allowed

2019 – Allowed.

2018 – Allowed.

2019 – Allowed.

2018 – Allowed.

2019 – Allowed.

2018 – Allowed.

2019 – Allowed.

2018 – Allowed.

2019 – Allowed.

2018 – Allowed.

2019 – Not allowed.

2018 – Allowed.

2019 – Not allowed.

2018 – Allowed.

Not subjec

t to CVS decision

2019 – Subject to CVS

decision

2018 – Allowed.

Not subject to CVS decision

2019 – Subject to CVS

decision

2018 – Allowed.

Not subject to CVS decision

2019 – Subject to CVS

decision

2018 – Allowed.

Not subject to CVS decision

2019 – Subject to CVS

decision

2018 – Allowed.

Not subject to CVS decision

2019 – Subject to CVS

decision

2018 – Allowed.

Not subject to CVS

decision

2019 – Not allowed

2018 – Subject to CVS

decision

2019 – Not allowed

2018 – Allow

ed.

Not subject to CVS

decision

2019 – Not allowed

2018 – Subject to CVS

decision

2019 – Not allowed

2018 – Allowed.

Not subject to CVS decision

2019 – Allowed.

Not subject to CVS decision

2018 – Allowed.

Not subject to CVS decision

2019 – Allowed.

Not subject to CVS decision

2018 – Allowed.

Not subject to CVS decision

2019 – Allowed.

Not subject to CVS decision

2018 – Allowed.

Not subject to CVS decision

2019 – Allowed.

Not subject to CVS decision

INTERNATIONAL

(Third Party Organised

Educational Events

attended by delegates

coming from at least two

countries of the

MedTech Europe

Geographic Area

)

INTERNATIONAL

(Third Party Organised

Educational Events

attended by delegates

who are Healthcare

Professionals registered

and practising in the

MedTech Europe

Geographic Area

)

PRIOR CVS SUBMISSION

1. MedTech Europe Geographic Area includes the countries in the European Economic Area (EEA), as well as those other countries where Member Associations are located.

Formerly referred to as “Cross-border Events”.

For avoidance of doubt, in 2019, this category of “Third Party Organised Educational Events attended by delegates who are Healthcare Professionals registered and practicing in the

MedTech Europe Geographic Area” has to be understood as covering only Healthcare Professionals from the MedTech Europe Geographic Area benefiting from an Educational

Grant.

4. Educational Grants: means provision of funding, Member Company or third party products or other in-kind support to a Healthcare Organisation by or on behalf of a Member

Company on a restricted basis for use solely for the support and the advancement of genuine medical education of Healthcare Professionals, patients and/or the public on clinical,

scientific and/or healthcare topics relevant to the therapeutic areas in which the Member Company is interested and/or involved.

5. Allowed means no CVS decision is required but the provisions of the ABHI Code of Ethical Business Practice and national laws and regulations still apply.

6. Out of scope: Means the Code does not apply given that the situation does neither involve a Member Company interacting with an HCP or HCO registered and practicing in the

MedTech Europe Geographic Area nor does the activity take place in the MedTech Europe Geographic Area.

7. Please note that although international/cross-border Events are eligible to be submitted in CVS, the decisions rendered by CVS in 2018 will only pertain to the direct sponsorship of

HCPs to Third- Party Organised Events.

ANNEX I (ADDED IN MAY 2017)

CVS SCOPE: WHEN ARE CVS ASSESSMENTS REQUIRED?

Educational

Grants

to Support

Third Party

Organised

Events /or to

Support HCP

Participation

at Third

Party

Organised

Educational

Events)

Other

Educational

Grants to

HCOs

(including

Scholarships,

Fellowships

and Grants

for Public

Awareness

Campaigns).

TEMPLATE

Full HCO

Name

HCO/PCO 1 Yearly amount Optional

Optional

Yearly amount

Yearly amount Optional

Optional

Yearly amount

HCO/PCO 2

etc.

HCOs:

city where

registered

Country of

Principal

Practice /

Activity

Registered

Address

Unique

country

local

identifier

Object

(Optional)

Object

(Optional)

*Please note that this template is for illustrative purposes only. The template to be used for reporting purposes will be available

in the TransparentMedTech website.

ANNEX II (ADDED IN MAY 2017)

DISCLOSURE GUIDELINES TEMPLATE EXAMPLE*

Q: What is a “unique country local identifier”?

A: It refers to a specific, unique and sustainable reference to identify Healthcare Organisations. Reporting companies will use the Healthcare

Organisation’s VAT as unique country local identifier by default. In those countries where Healthcare Organisations do not necessarily have a VAT

number, another identifier, unique for this Healthcare Organisation and common for all reporting companies will be provided.

The MedTech Europe Geographic Area currently includes:

a) countries with National

Associations:

Austria

Belgium

Bulgaria

Czech Republic

Denmark

Finland

France

Germany

Greece

Hungary

Ireland

Italy

The Netherlands

Norway

Poland

Portugal

Romania

Russia

Slovakia

Slovenia

Spain

Sweden

Switzerland

Turkey

The United Kingdom

the countries where Mecomed

is active

b) countries party to the European

Economic Area agreement

without a MedTech Europe

National Association:

Croatia

Cyprus

Estonia

Iceland

Latvia

Liechtenstein

Lithuania

Luxembourg

Malta

c) countries where Medcomed

is active

Algeria

Bahrain

Egypt

Iran

Iraq

Jordan

Kuwait

Lebanon

Libya

Mauritania

Morocco

Oman

Pakistan

Quatar

Saudi Arabia

Sudan

Syria

Tunisia

UAE

Yemen

Please note that countries covered by Mecomed, the Middle East Medical Devices and Diagnostics association, are not currently

under the scope of the Disclosure Guidelines.

ANNEX III (ADDED IN MAY 2017)

MEDTECH EUROPE GEOGRAPHICAL AREA

How can a Member Company verify that the Educational Grant is in fact used for the intended purpose as agreed in the

Educational Grant agreement?

A Member Company should set up an internal verification process for the purpose of ensuring that the funds provided through

an Educational Grant are used for the agreed intended purpose. For example, such a process could include verification of every

single Grant provided by a Member Company or periodic verification of a selected sample of Grants, after the Event takes place

or before any subsequent application for an Educational Grant.

Examples of the documents requested by a Member Company for verification purposes could include, but are not limited to,

the following:

Grant to support Healthcare Professionals’ attendance at the Third Party Organised Educational Event:

• Attendance proof (e.g. hotel check-out form, signed attendance list, a digital certificate issued by the Event organiser etc.)

• Travel proof (e.g. flight/train tickets)

• Copy of the receipts of taxi fairs, meals etc.

• Where allowed, pictures of the Event.

Grant to support the costs related to organisation of the Third Party Organised Educational Event:

• Budget breakdown listing the general expenses of the Event

• Accounting records, copies of invoices, receipts

• Verifications performed by company staff on-site during the Event.

• Written confirmation from the Event Organiser that the funds were spent as intended

• Documentation of the speaker’s presentation (e.g. slides)

Grant provided in the form of a Scholarship or Fellowship:

• Activity records of the educational programme

• Certification of enrolment from the institution or professor in charge

• Progress report by or of the beneficiary

If a Grant recipient fails to provide the requesting Member Company with the documents or if a Member Company determines

that the Grant funds were not used as provided in the Grant agreement, the Member Company:

• Should take this into account when assessing any future funding request from the same Healthcare Organisation.

• May consider requesting MedTech Europe to withdraw the right to use the Logo, if the HCO/PCO is an MTE “Chartered

Organisation” under the Ethical Charter (https://www.ethicalmedtech.eu/ethical-charter/general-overview/)

ANNEX IV (ADDED IN JULY 2018)

VERIFICATION OF THE USE OF FUNDS

STRUCTURE

1 Introduction

2 Executive summary of the methodologies used for disclosure purposes and countries specificities

3 Definitions

• Recipients

• Types of Educational Grants

4 Disclosure scope and timelines

5 Disclosures in case of partial performance or cancellation

6 Cross-border activities

7 Specific considerations:

• Multi-year agreements

• Consent management (please note that some jurisdictions may require the legal entity’s consent for publication of

data)

– Consent collection

– Management of recipient consent withdrawal

– Management of recipient’s request

– Partial consent

8 Disclosure Form

• Date of submission

• Currency in case of aggregated payments made in different currencies

• VAT included or excluded and any other tax aspects

9 Disclosure financial data and amount of Educational Grants provided

10 Calculation rules

Disclaimer: This Methodology note is provided as a template to support Member Companies in the implementation of

these Disclosure Guidelines. Any other template may be equally valid provided it complies with the general

requirements set out in Section 2.4 Methodology.

ANNEX V (ADDED IN MAY 2017)

EXAMPLE OF DISCLOSURE GUIDELINES METHODOLOGY NOTE

ANNEX VI (ADDED IN JULY 2018)

DIRECT SUPPORT TO HCP PARTICIPATION IN EVENTS AS

OF 1ST JANUARY 2019

DESCRIPTION

Delegate: “Delegate” is any Healthcare Professional who is attending passively a Company Event or a Third Party Organised

Event (TPOE) and cannot be considered as “Faculty”.

For avoidance of doubt, poster- and abstract-presenters are considered to be Delegates.

Satellite Symposium: Common elements of Satellite Symposia are:

• It takes place at a TPOE and it is part of the TPOE official programme (i.e. not focused on marketing specific products);

• The Company is responsible for the content subject to review by the Organiser where required;

• It is open to any delegate, not only to selected individuals;

• It has Company branding and the Company can promote the Satellite Symposia to customers.

Speaker/Faculty: “Faculty/speaker” in this chart is someone who is considered as speaker, for example someone who gives a

presentation whether in a Company Event or a TPOE; is moderating/chairing a session and therefore needs to prepare ahead

of the presentation/moderation.

GUIDANCE

Speaker/Faculty: In order to determine whether an event is a TPOE or a Company Event, the following aspects should be taken

into account:

• Open events (not only Company’s customers) are typical of TPOE, and in this case, it is a Third Party that chooses HCPs

attending;

• Who is primary initiator of the Event: How much is the Third-Party vs. the Company involved, who is driving the agenda?

• CME accreditation is an TPOE indication;

• TPOE are generally broader than one or few products;

• Single-sponsored events are often Company Events.

Direct Support for HCP attendance(*)

Event Setting Faculty/speaker(s) Delegates

Third Party Organised

Educational Conference

Main Event / Independent Scientific Program Not allowed Not allowed

Satellite Symposium

Allowed

(through a consulting agreement)

Not allowed

Booth

Allowed

(through a consulting agreement)

Not allowed

Third Party Organised Procedure Training meeting*

*Criteria to distinguish a Third Party Organised Procedure Training meeting

can be found in Q&A 20

Allowed Allowed

Company Events

Product and

Procedure Training and

Education Event

NOT taking place around

or at the same time as a

Third Party Organised

Educational Event

Allowed Allowed

Taking place around or

at the same time as a

Third Party Organised

Educational Event

Allowed Not allowed

Sales, Promotional and

Other Business Meeting

NOT taking place around

or at the same time as a

Third Party Organised

Educational Event

Allowed

(through a consulting agreement)

Not allowed

(except for the demonstration of

non-portable equipment)

Taking place around or

at the same time as a

Third Party Organised

Educational Event

Allowed Not allowed