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Corporate Compliance & Transparency in the Pharmaceutical Industry
Zurich, 21 Feb 2019
Jan Geissler, WECAN
Workshop on reasonable legal
agreements between patient
advocates and pharmaceutical
companies
Objectives of this session
• Provide patient perspective on the challenges of
legal agreements between patient advocates and
pharmaceutical companies
• Give an update on WECAN‘s „Reasonable Legal
Agreements“ collaboration project
• Give an introduction to our Guiding Principles
• Introduce the concept of template contracts
• Making you work!
What patient advocates do
Support patients
 Inform, support, provide navigation to patients
 Run services and meetings, provide tools and apps
Patient-centric policy
 Influence health policy and healthcare provisioning
 Provide input to regulators and institutions
Research reflecting patients's needs
 Provide patients needs to academic and industry
research
 Participate in publicly funded projects
Why the reasonable legal agreements
project?
• Collaboration between pharma and patient advocates
requires them to sign contracts, e.g. speaker agreements,
advisory agreements, consultancy or collaboration contracts
• The contracts are often too long and difficult to understand,
unilateral, disproportionate, and contain ambiguous clauses or
terms that are in conflict with the nature of patient advocacy.
They may even put the patient advocate at legal risk
• WECAN, the Workgroup of 22 pan-European Cancer Patient
Advocacy Networks wanted to change this and initiated this
project in 2016, based on data from a survey
Main issues identified in major survey
to over 80 patient advocates in 2016
• The contracts provided to patient advocates are often too long and are
difficult to understand
• 81% said all contracts are unreasonably extensive in length (6 pages or
more, 19% even said they usually get contracts with more than 10
pages)
• Patient advocates invest on average 295 minutes (almost 5 hours) into
reading negotiating and processing each contract
How much
time (in
minutes) do
you usually
invest for
each
agreement?
36 7 10 15 220
0 50 100 150 200 250 300
Minutes
Reading Printing Scanning Sending Negotiating
Source: WECAN survey “Reasonable agreements between patient advocacy and the pharmaceutical industry”, WECAN (2016)
54% of patient advocates only understand
some, few or none of the contracts they
receive
Almost all of then
Some
Few
None
Always
Sometimes
Rarely
Never
11,11%
36,51%
34.92%
17,46%
If you tried to change unreasonable
clauses, did the companies agree to
change these clauses to your satisfaction?
~20% rarely or never read all legal
agreements in detail before signing
because:
● no legal support,
● no time to check contracts,
● trusting pharmaceutical companies,
● other reasons such as the length of
the contract, or the confusing terms
used
Source: WECAN survey “Reasonable agreements between patient advocacy and the pharmaceutical industry”, WECAN (2016)
Main issues identified in major survey
to over 80 patient advocates in 2016
The contracts provided to patient advocates contain ambiguous clauses or
terms that are in conflict with the very nature of patient advocacy.
Source: WECAN survey “Reasonable agreements between patient advocacy and the pharmaceutical industry”, WECAN (2016)
Main issues identified in major survey
to over 80 patient advocates in 2016
• Litigation will ruin the organization or
individual if ever executed
• Losing the rights on your own ideas and
contributions
• Time invested in work not fairly reflected
• Confidentiality of non-sensitive work blocks
important patient advocacy work
• Unfair travel conditions for busy patient
advocates and for frail individuals
• Unlimited use of photos, quotes and
recordings put credibility at risk
Overall objectives and goals
of the project
• Improve balance between parties by establishing contracts
• Allowing patient organisations to operate in their role and purpose
while protecting the pharmaceutical companies from reasonable risk
• Incorporate patient organisation’s capacity, legal expertise and
experience on potential consequences in legal contracts
• Better reflect the diversity of relationships in consultancy, advisory,
speaker and collaborative roles, which are usually totally different to
classical consultancy
• Provide guiding principles for reasonable legal agreements
• Provide template contracts with simplified terms and language
• Prevent from unnecessary clauses (that create unnecessary
uncertainty)
Objective
Our goal
Who is involved?
Drafting group
Multi-stakeholder Alignment Workgroup (MSAW)
Legal experts 3 pharmaceutical companies’
representatives
 Ananda Plate (MPE,
project lead)
 Ana Vallejo (MPE)
 Šarunas Narbutas (POLA)
 Gordon Oliver (IBTA)
 Jan Geissler (CMLAN)
 Kathy Oliver (IBTA)
• Nicholas Brooke (PFMD) • Jean-Francois Germain
(Fieldfisher)
• Imma Barral (University of
Barcelona)
 Andrea Herrmann
(Takeda)
 Jordane Fura Cosse
(Novartis) – now replaced
by Gregor von Arx
 Virginie Vassart (Merck
MSD)
Guiding Principles
• After several rounds of multi-stakeholder consultation, the
“Guiding Principles on reasonable agreements between patient
advocates and pharma companies” are finalised, based on
feedback from advocates and company representatives.
• Contract types: Covered topics:
• Consultancy agreement
• Collaboration agreement
• Advisory Board agreement
• Speaker agreement
• Confidentiality
• Intellectual property
• Recordings of meetings
• Data protection and use of personal
data
• Indemnification, remedies and conflict
resolution
• Financial Compensation and
reimbursements of expenses
• Adverse event reporting
• Independence and conflict of interest
• Glossary
Structure and sections of
Guiding Principles
All sections have 3 parts:
1. Rationale
2. Examples
3. Guiding principles
Guiding Principles document finalized on
16 Oct 2018, ratified by WECAN on 21 Oct
2018 and PFMD on 25 Oct 2018
For download at
http://www.wecanadvocate.eu/rapp
For download: www.wecanadvocates.eu/rapp
Templates for
- Advisory Agreement
- Consultancy Agreement
- Speaker Agreement
- Collaboration Agreement
currently under development
Soon for download at
http://www.wecanadvocate.eu/ra
pp
Status and next steps
2017-
2018:
Drafting
work
15 Oct
2018:
End of
multi-
stakeholder
consultatio
n
21 Oct
2018:
WECAN
meeting:
approval of
guiding
principles,
advocacy
strategy
25 Oct
2018:
PFMD
Board
Meeting
5 Nov 2018:
Publication of
guiding
principles,
communicati
on
29 Oct-9
Nov:
Collection
of “best
contracts”
from
workgroup
members
10 Nov
2018:
Start of
template
and
toolbox
develop
ment
January
2019:
First
contract
template
finalised
June
2019:
toolbox
finalised
Advocacy for & adoption of guiding
principles
Group exercise
• Make sure you have the following documents:
• Copy of the legal agreement for a speaker at a
meeting organized by a pharma company
• Copy of the emails sent between the company
and the advocate
• Guiding Principles on Legal Agreements
between industry and advocates
• Choose a clause from the speaker agreement on
which you will work (clauses 2-9). There needs to be
at least one person allocated per clause!
Exercise:
1. Each table builds a team and chooses a rapporteur (1 minute)
2. Choose one clause from the speaker agreement on which you will work (5 minutes)
3. Look for “your clause” in the Guiding Principles document and read the rationale,
examples and principles (5 minutes)
4. Make notes of the changes you would request if you were a patient advocate and the
reason why you would want those changes (10 minutes)
5. Make notes of the changes you would accept if you were industry (5 minutes)
6. Make notes of the changes you would not accept and the reason why you wouldn’t (5 min)
7. Each table to report back & discuss (20 min)
Thank you!
More information:
http://www.wecanadvocate.eu/rapp
Jan Geissler <jan@patvocates.net>
Leave your business card to be updated about
the project
Guiding principles:
Summary of key points
Confidentiality
Rationale Examples Guiding Principles
• Protect sensitive information of
both contractual parties
Take into account that
• company representatives may
forget to label confidential
• patient advocates’ core task is
spreading information and
knowledge
• Commercially sensitive
information about products or
services
• Strategic plans, project plans,
concepts or processes
• Unpublished scientific data of
either contractual party
• Planned campaigns or policy
actions
• Personal data, patient data
• Provide definition of confidential
information
• Have consent on disclosure of
confidential information
• Provide justification for
requesting confidentiality
• Ensure labelling of
confidentiality level of information,
define status of unlabeled
information
• Agree that public information is
no longer confidential
• Ensure deletion of confidential
information
• Acknowledge that legal
requirements and disclosure
obligations may override
confidentiality
Intellectual property (IP)
Rationale Examples Guiding Principles
• IP protects creations of the
mind, which have both a moral
and a commercial value
• IP gives both parties the
opportunity to further develop
ideas and concepts brought in
and generated in such meetings,
either jointly or separately, and
also with competing
organisations
• IP allows to exploit the results
of work in products, initiatives
and services
• IP rules ensure information,
projects and work owned by a
party prior to the collaboration
remains their property
• Most content or results of a
meeting are not commercially
sensitive
• Consultancy work: Advice
provided on company documents,
strategic initiatives and other
commercially sensitive projects.
• Collaborative work: Jointly
developed concepts and servies,
e.g. reports, advice, workshop
agendas, patient information
materials
• Presentations, projects,
concepts, documents presented
at a meeting
• Third-party material: Illustrations
or slides of third parties in the
meeting
• Logos of organisations or
companies.
• Applicable law may prescribe
definition of IP terms
• IP on consultancy or collaborative
work on specific company
products should belong to the
company
• IP resulting from collaborative
work unrelated to a specific
product of the company should
be agreed on a case-by-case
basis
• Authorship rules apply for
publications
• Background IP remains with the
owner
• Rights of third-party material
need to be clear and cannot be
transferred
• Use of logos requires written
consent
Recordings of meetings
Rationale Examples Guiding Principles
• Recordings of the meeting and of
individual participants are made
for the purposes of compiling
minutes or a report of the meeting
• These may be produced for
• internal use
• external use
• Minutes, documents, quotes,
photos or audio-visual
recordings in joint meetings
• Summary of meeting outcomes
and concepts
• Presentations held by
participants of the meeting
• Agree about use of recordings
prior to meeting.
• Without agreement, internal use
of recordings only is a given.
• Any external use requires prior
consent.
Data protection and use of personal data
Rationale Examples Guiding Principles
• Personal data of patients or
patient advocates needs to be
protected in order to avoid any
misuse of the information
• Protecting patients’ medical
condition from becoming known
in the public domain
• Protecting the credibility of a
patient advocate in the public
• Ensuring all external data are
used for limited, specifically
stated purposes, and in a way
that is adequate, relevant and not
excessive
• Ensures data are kept for no
longer than is absolutely
necessary
• Personal data: information
related with an identifiable person
(e.g. name, age, position,
address, affiliation with
organisations, medical condition,
or other personal details)
• Third parties data: data acquired
from another source, confidential
or public
• Use in quotes, internal or external
reports, websites, campaigns,
social medica channels, offline
media
• Personal data is confidential by
default
• Agree on good reasons for data
disclosure
• Allow sharing of data with
affiliates and involved service
providers
• Respect right to withdraw
consent
• Data protection rules should
comply with applicable privacy
laws
• Ensure data protection also in
countries with lower privacy
standards
Indemnification, remedies, conflict resolution
Rationale Examples Guiding Principles
• Indemnification clauses seek the
financial responsibility for
specific types of damages,
claims or losses
• Remedies or liability clauses
should take into account that their
execution in a dispute would
certainly ruin a patient advocate
or organisation
• It is very unlikely that any
pharma company will ever
make use of such an
indemnification or liability clause
• Patient advocates usually don't
have sufficient resources and
capabilities to have an
international liability insurance
• Misconduct or violation of any
clause, which can include
disclosure of confidential
information
• Failure to deliver on the contract
• Misuse of the information
received, or any other kind of
conduct that is considered as a
major breach of contract
• No case is yet known where
liability cases were ever filed by a
pharmaceutical company against
a patient organisation on the
basis of a collaboration
agreement between such parties.
• Limit liability to a reasonable
level
• Do not require liability
insurance
• Define terms for mediation
• Applicable law of defendant
should apply
Financial compensation and
reimbursement of expenses
Rationale Examples Guiding Principles
• Patient advocates deserve a
reasonable financial
compensation for their time
and contribution when acting
in advisory roles, consultancy,
speaking roles or other
collaborative work
• Financial compensation is
offered in exchange for
contributing with time, ideas
or other means by patient
advocates
• Financial contribution is
based on a company and
expertise-related “fair market
value” and subject to local
laws and regulations
• Contribution to a meeting,
conference, advisory board or
committee organised by the
company itself or by a third
party.
• Reviewing materials, leaflets,
protocols, guides, recordings,
concepts, etc. and providing
feedback on those.
• Consultancy work on
products or services of the
company.
• Develop materials together
with pharmaceutical
companies e.g. patient
information.
• Compensate according to fair market
value, taking into account e.g.
individual expertise and training, total
amount of time invested, complexity of
tasks, country of origin, similar to other
highly trained professionals
• Reflect total time invested, incl.
physical presence and preparatory time.
Consider also part of travel time.
• Respect the right to refuse
compensation
• Cover reasonable travel expenses
• Long-distance flights justify higher flight
class
• Reasonable 3-way travel costs on
advocacy duty should be covered
• Multi-day stopover on advocacy duty
should be permitted
• Pay within 30 days
Adverse event reporting
Rationale Examples Guiding Principles
• Regulatory provisions require
pharmaceutical companies and its
employees and contractors to
report adverse events through
its pharmacovigilance
department to regulators
• Legal agreements from
pharmaceutical companies often
require consultants to notify the
company in writing of any
adverse event occurring
relating to company’s products
• Due to the nature of an
independent advisory/speaker/
consultancy role and the
organisational structure of POs,
these obligations are
impossible for patient
advocates to fulfil
• "The Consultant will inform the
company within twenty-four (24)
hours of becoming aware of any
adverse event".
• "The Consultant will cooperate
with the company to enable the
company to comply with
applicable laws and regulations."
• Company remains responsible
for adverse event reporting
• An agreement between
pharmaceutical companies and
patient advocates should not
require the patient advocates to
do adverse event reporting, or it
should be limited strictly to the
adverse events detected within
the collaborative work
Independence and Conflict of Interest
Rationale Examples Guiding Principles
• Patient advocates promote the
interest of their constituencies,
usually patients and carers, and
the broader patient community.
• Patient advocates and
pharmaceutical companies may
have similar interests regarding
topics that can affect patients'
lives in areas such as research,
treatment, care and access.
• Interactions between patient
advocates and pharmaceutical
companies shall be done in a way
that ensures that the decision -
making of the patient advocate
side is respected and not
influenced by the
pharmaceutical company.
• Any incentive or reward of any
type that would influence the
decision making, the opinion or
statements a patient advocate
could do about any drug or
diagnostic tool, among others.
• Respect the independence and
autonomy of patient advocate
• Safeguard the independence of
patient advocates by avoiding
conflicts of interests and
declaring potential conflicts of
interest
• Avoid exclusivity clauses
• Refer to applicable Codes and
Guidelines

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Reasonable Legal Agreements between Patient Advocates and Pharma Companies

  • 1. Corporate Compliance & Transparency in the Pharmaceutical Industry Zurich, 21 Feb 2019 Jan Geissler, WECAN Workshop on reasonable legal agreements between patient advocates and pharmaceutical companies
  • 2. Objectives of this session • Provide patient perspective on the challenges of legal agreements between patient advocates and pharmaceutical companies • Give an update on WECAN‘s „Reasonable Legal Agreements“ collaboration project • Give an introduction to our Guiding Principles • Introduce the concept of template contracts • Making you work!
  • 3. What patient advocates do Support patients  Inform, support, provide navigation to patients  Run services and meetings, provide tools and apps Patient-centric policy  Influence health policy and healthcare provisioning  Provide input to regulators and institutions Research reflecting patients's needs  Provide patients needs to academic and industry research  Participate in publicly funded projects
  • 4. Why the reasonable legal agreements project? • Collaboration between pharma and patient advocates requires them to sign contracts, e.g. speaker agreements, advisory agreements, consultancy or collaboration contracts • The contracts are often too long and difficult to understand, unilateral, disproportionate, and contain ambiguous clauses or terms that are in conflict with the nature of patient advocacy. They may even put the patient advocate at legal risk • WECAN, the Workgroup of 22 pan-European Cancer Patient Advocacy Networks wanted to change this and initiated this project in 2016, based on data from a survey
  • 5. Main issues identified in major survey to over 80 patient advocates in 2016 • The contracts provided to patient advocates are often too long and are difficult to understand • 81% said all contracts are unreasonably extensive in length (6 pages or more, 19% even said they usually get contracts with more than 10 pages) • Patient advocates invest on average 295 minutes (almost 5 hours) into reading negotiating and processing each contract How much time (in minutes) do you usually invest for each agreement? 36 7 10 15 220 0 50 100 150 200 250 300 Minutes Reading Printing Scanning Sending Negotiating Source: WECAN survey “Reasonable agreements between patient advocacy and the pharmaceutical industry”, WECAN (2016)
  • 6. 54% of patient advocates only understand some, few or none of the contracts they receive Almost all of then Some Few None Always Sometimes Rarely Never 11,11% 36,51% 34.92% 17,46% If you tried to change unreasonable clauses, did the companies agree to change these clauses to your satisfaction? ~20% rarely or never read all legal agreements in detail before signing because: ● no legal support, ● no time to check contracts, ● trusting pharmaceutical companies, ● other reasons such as the length of the contract, or the confusing terms used Source: WECAN survey “Reasonable agreements between patient advocacy and the pharmaceutical industry”, WECAN (2016) Main issues identified in major survey to over 80 patient advocates in 2016
  • 7. The contracts provided to patient advocates contain ambiguous clauses or terms that are in conflict with the very nature of patient advocacy. Source: WECAN survey “Reasonable agreements between patient advocacy and the pharmaceutical industry”, WECAN (2016) Main issues identified in major survey to over 80 patient advocates in 2016 • Litigation will ruin the organization or individual if ever executed • Losing the rights on your own ideas and contributions • Time invested in work not fairly reflected • Confidentiality of non-sensitive work blocks important patient advocacy work • Unfair travel conditions for busy patient advocates and for frail individuals • Unlimited use of photos, quotes and recordings put credibility at risk
  • 8. Overall objectives and goals of the project • Improve balance between parties by establishing contracts • Allowing patient organisations to operate in their role and purpose while protecting the pharmaceutical companies from reasonable risk • Incorporate patient organisation’s capacity, legal expertise and experience on potential consequences in legal contracts • Better reflect the diversity of relationships in consultancy, advisory, speaker and collaborative roles, which are usually totally different to classical consultancy • Provide guiding principles for reasonable legal agreements • Provide template contracts with simplified terms and language • Prevent from unnecessary clauses (that create unnecessary uncertainty) Objective Our goal
  • 9. Who is involved? Drafting group Multi-stakeholder Alignment Workgroup (MSAW) Legal experts 3 pharmaceutical companies’ representatives  Ananda Plate (MPE, project lead)  Ana Vallejo (MPE)  Šarunas Narbutas (POLA)  Gordon Oliver (IBTA)  Jan Geissler (CMLAN)  Kathy Oliver (IBTA) • Nicholas Brooke (PFMD) • Jean-Francois Germain (Fieldfisher) • Imma Barral (University of Barcelona)  Andrea Herrmann (Takeda)  Jordane Fura Cosse (Novartis) – now replaced by Gregor von Arx  Virginie Vassart (Merck MSD)
  • 10. Guiding Principles • After several rounds of multi-stakeholder consultation, the “Guiding Principles on reasonable agreements between patient advocates and pharma companies” are finalised, based on feedback from advocates and company representatives. • Contract types: Covered topics: • Consultancy agreement • Collaboration agreement • Advisory Board agreement • Speaker agreement • Confidentiality • Intellectual property • Recordings of meetings • Data protection and use of personal data • Indemnification, remedies and conflict resolution • Financial Compensation and reimbursements of expenses • Adverse event reporting • Independence and conflict of interest • Glossary
  • 11. Structure and sections of Guiding Principles All sections have 3 parts: 1. Rationale 2. Examples 3. Guiding principles Guiding Principles document finalized on 16 Oct 2018, ratified by WECAN on 21 Oct 2018 and PFMD on 25 Oct 2018 For download at http://www.wecanadvocate.eu/rapp For download: www.wecanadvocates.eu/rapp
  • 12. Templates for - Advisory Agreement - Consultancy Agreement - Speaker Agreement - Collaboration Agreement currently under development Soon for download at http://www.wecanadvocate.eu/ra pp
  • 13. Status and next steps 2017- 2018: Drafting work 15 Oct 2018: End of multi- stakeholder consultatio n 21 Oct 2018: WECAN meeting: approval of guiding principles, advocacy strategy 25 Oct 2018: PFMD Board Meeting 5 Nov 2018: Publication of guiding principles, communicati on 29 Oct-9 Nov: Collection of “best contracts” from workgroup members 10 Nov 2018: Start of template and toolbox develop ment January 2019: First contract template finalised June 2019: toolbox finalised Advocacy for & adoption of guiding principles
  • 14. Group exercise • Make sure you have the following documents: • Copy of the legal agreement for a speaker at a meeting organized by a pharma company • Copy of the emails sent between the company and the advocate • Guiding Principles on Legal Agreements between industry and advocates • Choose a clause from the speaker agreement on which you will work (clauses 2-9). There needs to be at least one person allocated per clause! Exercise: 1. Each table builds a team and chooses a rapporteur (1 minute) 2. Choose one clause from the speaker agreement on which you will work (5 minutes) 3. Look for “your clause” in the Guiding Principles document and read the rationale, examples and principles (5 minutes) 4. Make notes of the changes you would request if you were a patient advocate and the reason why you would want those changes (10 minutes) 5. Make notes of the changes you would accept if you were industry (5 minutes) 6. Make notes of the changes you would not accept and the reason why you wouldn’t (5 min) 7. Each table to report back & discuss (20 min)
  • 15. Thank you! More information: http://www.wecanadvocate.eu/rapp Jan Geissler <jan@patvocates.net> Leave your business card to be updated about the project
  • 17. Confidentiality Rationale Examples Guiding Principles • Protect sensitive information of both contractual parties Take into account that • company representatives may forget to label confidential • patient advocates’ core task is spreading information and knowledge • Commercially sensitive information about products or services • Strategic plans, project plans, concepts or processes • Unpublished scientific data of either contractual party • Planned campaigns or policy actions • Personal data, patient data • Provide definition of confidential information • Have consent on disclosure of confidential information • Provide justification for requesting confidentiality • Ensure labelling of confidentiality level of information, define status of unlabeled information • Agree that public information is no longer confidential • Ensure deletion of confidential information • Acknowledge that legal requirements and disclosure obligations may override confidentiality
  • 18. Intellectual property (IP) Rationale Examples Guiding Principles • IP protects creations of the mind, which have both a moral and a commercial value • IP gives both parties the opportunity to further develop ideas and concepts brought in and generated in such meetings, either jointly or separately, and also with competing organisations • IP allows to exploit the results of work in products, initiatives and services • IP rules ensure information, projects and work owned by a party prior to the collaboration remains their property • Most content or results of a meeting are not commercially sensitive • Consultancy work: Advice provided on company documents, strategic initiatives and other commercially sensitive projects. • Collaborative work: Jointly developed concepts and servies, e.g. reports, advice, workshop agendas, patient information materials • Presentations, projects, concepts, documents presented at a meeting • Third-party material: Illustrations or slides of third parties in the meeting • Logos of organisations or companies. • Applicable law may prescribe definition of IP terms • IP on consultancy or collaborative work on specific company products should belong to the company • IP resulting from collaborative work unrelated to a specific product of the company should be agreed on a case-by-case basis • Authorship rules apply for publications • Background IP remains with the owner • Rights of third-party material need to be clear and cannot be transferred • Use of logos requires written consent
  • 19. Recordings of meetings Rationale Examples Guiding Principles • Recordings of the meeting and of individual participants are made for the purposes of compiling minutes or a report of the meeting • These may be produced for • internal use • external use • Minutes, documents, quotes, photos or audio-visual recordings in joint meetings • Summary of meeting outcomes and concepts • Presentations held by participants of the meeting • Agree about use of recordings prior to meeting. • Without agreement, internal use of recordings only is a given. • Any external use requires prior consent.
  • 20. Data protection and use of personal data Rationale Examples Guiding Principles • Personal data of patients or patient advocates needs to be protected in order to avoid any misuse of the information • Protecting patients’ medical condition from becoming known in the public domain • Protecting the credibility of a patient advocate in the public • Ensuring all external data are used for limited, specifically stated purposes, and in a way that is adequate, relevant and not excessive • Ensures data are kept for no longer than is absolutely necessary • Personal data: information related with an identifiable person (e.g. name, age, position, address, affiliation with organisations, medical condition, or other personal details) • Third parties data: data acquired from another source, confidential or public • Use in quotes, internal or external reports, websites, campaigns, social medica channels, offline media • Personal data is confidential by default • Agree on good reasons for data disclosure • Allow sharing of data with affiliates and involved service providers • Respect right to withdraw consent • Data protection rules should comply with applicable privacy laws • Ensure data protection also in countries with lower privacy standards
  • 21. Indemnification, remedies, conflict resolution Rationale Examples Guiding Principles • Indemnification clauses seek the financial responsibility for specific types of damages, claims or losses • Remedies or liability clauses should take into account that their execution in a dispute would certainly ruin a patient advocate or organisation • It is very unlikely that any pharma company will ever make use of such an indemnification or liability clause • Patient advocates usually don't have sufficient resources and capabilities to have an international liability insurance • Misconduct or violation of any clause, which can include disclosure of confidential information • Failure to deliver on the contract • Misuse of the information received, or any other kind of conduct that is considered as a major breach of contract • No case is yet known where liability cases were ever filed by a pharmaceutical company against a patient organisation on the basis of a collaboration agreement between such parties. • Limit liability to a reasonable level • Do not require liability insurance • Define terms for mediation • Applicable law of defendant should apply
  • 22. Financial compensation and reimbursement of expenses Rationale Examples Guiding Principles • Patient advocates deserve a reasonable financial compensation for their time and contribution when acting in advisory roles, consultancy, speaking roles or other collaborative work • Financial compensation is offered in exchange for contributing with time, ideas or other means by patient advocates • Financial contribution is based on a company and expertise-related “fair market value” and subject to local laws and regulations • Contribution to a meeting, conference, advisory board or committee organised by the company itself or by a third party. • Reviewing materials, leaflets, protocols, guides, recordings, concepts, etc. and providing feedback on those. • Consultancy work on products or services of the company. • Develop materials together with pharmaceutical companies e.g. patient information. • Compensate according to fair market value, taking into account e.g. individual expertise and training, total amount of time invested, complexity of tasks, country of origin, similar to other highly trained professionals • Reflect total time invested, incl. physical presence and preparatory time. Consider also part of travel time. • Respect the right to refuse compensation • Cover reasonable travel expenses • Long-distance flights justify higher flight class • Reasonable 3-way travel costs on advocacy duty should be covered • Multi-day stopover on advocacy duty should be permitted • Pay within 30 days
  • 23. Adverse event reporting Rationale Examples Guiding Principles • Regulatory provisions require pharmaceutical companies and its employees and contractors to report adverse events through its pharmacovigilance department to regulators • Legal agreements from pharmaceutical companies often require consultants to notify the company in writing of any adverse event occurring relating to company’s products • Due to the nature of an independent advisory/speaker/ consultancy role and the organisational structure of POs, these obligations are impossible for patient advocates to fulfil • "The Consultant will inform the company within twenty-four (24) hours of becoming aware of any adverse event". • "The Consultant will cooperate with the company to enable the company to comply with applicable laws and regulations." • Company remains responsible for adverse event reporting • An agreement between pharmaceutical companies and patient advocates should not require the patient advocates to do adverse event reporting, or it should be limited strictly to the adverse events detected within the collaborative work
  • 24. Independence and Conflict of Interest Rationale Examples Guiding Principles • Patient advocates promote the interest of their constituencies, usually patients and carers, and the broader patient community. • Patient advocates and pharmaceutical companies may have similar interests regarding topics that can affect patients' lives in areas such as research, treatment, care and access. • Interactions between patient advocates and pharmaceutical companies shall be done in a way that ensures that the decision - making of the patient advocate side is respected and not influenced by the pharmaceutical company. • Any incentive or reward of any type that would influence the decision making, the opinion or statements a patient advocate could do about any drug or diagnostic tool, among others. • Respect the independence and autonomy of patient advocate • Safeguard the independence of patient advocates by avoiding conflicts of interests and declaring potential conflicts of interest • Avoid exclusivity clauses • Refer to applicable Codes and Guidelines

Editor's Notes

  1. Who is involved