Patient Engagement Agreements explained

For collaborations between the patient community and stakeholders in the health care system

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1. Introduction

PARADIGM is a public-private partnership that brings together 34 partners with the mission of developing a framework that enables structured, effective, meaningful, ethical, innovative, and sustainable patient engagement (PE) and demonstrates the ‘return on the engagement’ for all players.

As part of this objective, PARADIGM has created this Patient Engagement Agreements Explained- tool to enable the suitability and usability of the co-created Guiding Principles and the four reference agreements – a project led by the pan-European cancer patients’ network through WECAN/MPE and partnered with PFMD – for all stakeholders.

The dedicated PARADIGM task force for the tool started its work by organising a review by the patient volunteers within the consortium to understand which reference contracts, concepts, terminology and clauses were difficult to understand and where this task force could create additional value by bridging those gaps. The review highlighted the problematic areas which the task force started to work on to provide additional descriptions to increase the usability of the agreements.

The final outcome of this task force is a digital tool that will assist users from any stakeholder group to understand the legal requirements of these four agreements and in doing so, hopefully enables the creation and usage of agreements that are more agreeable to both the parties that are in collaboration.

2. Background of the work and problems addressed

The way patients interact with regulators, payers, policymakers, researchers, and the industry is evolving and the patient community is playing an active role in the healthcare ecosystem. By drawing upon the unique expertise and experiences of the patient community we can make healthcare more patient-centered. 

Collaboration between pharmaceutical companies and patient advocates should be based on contracts signed by both parties covering various types of activities such as consultancy, collaborations, speaking engagements and advisory boards. These contracts define the terms and conditions of the engagements, covering such matters as confidentiality, intellectual property, copyright, data protection, compensation and other responsibilities of both parties. They typically also contain provisions, mandated by the pharmaceutical industry or regulatory authority codes, designed to ensure an appropriate relationship between a patient and the engaging partner. In the past, the complexity of these agreements has often been challenging for the patient community and in particular patient advocates to work with due to the contracts being long, difficult to understand and sometimes containing ambiguous clauses.

The patient-led multi-stakeholder project led by WECAN/MPE/PFMD, “Reasonable agreements between patient advocates and pharmaceutical companies (RAPP)”, aimed to streamline the legal framework between the patient community and the pharmaceutical industry, providing guidance for the content of legal contracts while maintaining reasonable safeguards for both contractual parties. The RAPP project applied a collaborative and consensus-driven approach to developing the “Guiding Principles on Reasonable Agreements between Patient Advocates and Pharmaceutical Companies”. The Principles aim to serve as a baseline for the development of contracts and contract templates for patient advocate engagements with industry to ensure reasonable protection for signing parties and to provide guidance to patient advocates whenever they need to review a legal agreement. The goal of the Guiding Principles is not only to simplify the language and terms of typical agreements but also to prevent the addition of unnecessary clauses for either party. These Principles were then applied in the development of Reference Agreements, which are meant to be used as a resource for legal parties and patient advocacy leaders in an industry responsible for drafting agreements with the patient community.

3. How to use this tool

The Reference Agreements require tailoring depending on the situation: each country has rules and regulations, different types of engagements may have unique parameters, and the people signing the agreement may have unique needs that need to be considered. Legal agreements typically need to address similar aspects of cooperation, however, the four Reference Agreements have some key differences due to the nature of the different types of activities. This depends on whether the engagement has shared objectives (e.g. collaboration), or if the patient or patient advocate is offering a service (e.g. speaking, consultancy, participation in an advisory board).

The Reference Agreements aim to be as simple as possible. However, they are still legal documents that need to be precise in order to ensure that both parties signing the contract have their interests, their rights, and the nature of their work protected

Within this tool you will find:

  1. The annotated versions of the reference documents listed in point 2. These versions will provide you with additional descriptions to the sections and terminology used in the reference agreements.

  2. The Guiding principles as well as the four reference agreements as co-created by WECAN together with patients and pharmaceutical industry representatives.

    • The Guiding Principles aim to provide the basic understanding for the development of contracts and contract templates for patient engagements with industry to ensure reasonable protection for signing parties and to provide guidance to patient advocates whenever they need to review a legal agreement.
    • The four reference agreements are meant to be used as a resource for legal parties responsible for drafting agreements with the patient community ⇒ Use them as is if they fit your purpose or use them as a basis to create your own contracts.
  3. The glossary will provide you with detailed descriptions on the terminology that was highlighted as potentially difficult to understand.

4. Glossary

This glossary is the consolidated list of words highlighted and explained within the agreements and guiding principles.

Term Explanation
Adverse event An adverse event can therefore be any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product (see GVP Annex IV, ICH-E2D Guideline).
Agency A governmental body that gives marketing authorisation to a new medicine or decides on the conditions for access to it. 
Agent Agent in this context (in section 10.3 Data privacy) means that any 3rd party consultants or temporary staff within each contracting organisation (should also observe the data protection obligations within this agreement).
Alteration Making a change to
“Anything of value”  Anything of value refers to any good (or service provided) that has a certain benefit to the recipient that is real and that is ordinarily purchased rather than given away for free.
As per In accordance with
Assigns Gives
Construed To interpret or understand words or actions in a particular way.
Contemporaneous Existing or done at the same time
Data subject Data subject is a generic legal terminology used to mean the individual(s) to whom data that is being collected during the agreement/ project relates and who can be identified. Data subject also refers to the patient advocate (consultant) who is giving his or her consent for the purposes described specifically in the Appendices.
Declare In context of the contracts, “declare” means that, when presenting or referring to the project in public, the patient will need to formally disclose his/her collaboration with the Company

This term together with “liens” and “pledge” refers to interests of third parties in an asset that may restrict what the owner of the asset can do with the asset.  A classic example of this is a mortgage on a home or a builder’s lien on new construction. Usually it is a form of security for a lender: if the borrower doesn’t repay the money owed, the third party has a claim against the asset. This means the lender can be certain what is owed is repaid before the owner can get the full benefit of the asset (e.g. forced sale of the house so that the bank can recoup the outstanding debt under a mortgage).  

In other words, the broader term refers to any sort of claim against a property.

Improper Acts with “wrongful intent” which could include threats, violence, trespass, defamation, and misrepresentation of fact.
In-kind contribution In-kind contribution is a non-monetary contribution as opposed to “in cash” (=money), for example when the service is offered by the patient free of charge (e.g. the person prefers not to be paid for his/her involvement in the Project). On the company’s side, this could be providing a meeting room to a patient organisation.
Inter alia Among other things
Joint venture A commercial activity undertaken jointly by two or more parties which otherwise retain their distinct identities
Lien A right which entitles a party to hold on to assets in their possession pending payment of a debt owed. 
Pledge A form of security to assure that a person will repay a debt or perform an act under contract.
Performed hereunder Provided under this Agreement
Reasonable (expenses) Moderate travel, lodging, and subsistence expenses incurred during the allocated period
Rendered under For the services or charges “stated” or “delivered” in an agreement
Staff Employees, contractors, interns etc.  of a company/organisation
Seek to exert Aim to apply
Set forth herein Set forth herein means that a more detailed statement or explanation is addressed somewhere else in the document. 
Subsidiary An entity that is majority- or wholly-owned by another entity or a company or organisation owned and controlled by another company.
Supersedes Supersedes means to take the place of or replace something that is older. 
Wilful omission Deliberately or knowingly failing to do or say something

5. Methodology

PARADIGM is a public-private partnership that brings together 34 partners with the mission of developing a framework that enables structured, effective, meaningful, ethical, innovative, and sustainable patient engagement (PE) and demonstrates the ‘return on the engagement’ for all players. 

The need for a legal framework within which collaboration between pharmaceutical industry and patients can happen in a mutually respectful way was identified by PARADIGM as part of its gap analysis on patient engagement tools and practices. To address this need, the co-created Guiding principles and reference agreements from the WECAN/MPE/PFMD project were tested and discussed at the Patient Engagement Open Forum in 2019 with a conclusion, that something additional was needed to make them more user-friendly and practical to the patient community. WECAN/MPE and PARADIGM consortium (including PFMD) agreed to collaborate to co-create this digital tool, which aims to provide more in-depth descriptions for the terminology, clauses, sections and a rationale to each agreement. 

A task force of volunteers gathered at the end of 2019, consisting of industry, an industry association, patient representatives, patient organisations and others. The group agreed on the scope of work, main objectives and the delivery timeline with milestones in January 2020. The next step was to  have a group of patient collaborators review the documents (February 2020). After the review, two work streams were created  to tackle the challenges (of difficult legal language) highlighted by the patient collaborators in an efficient way. Once the content is reviewed by the PARADIGM consortium, the toolkit will be finalised and released in August 2020. See the milestones detailed below.

  1. November | Task force convenes 
  2. January | Project scope and goals agreed with the task force 
  3. February | Paradigm’s patient collaborators reviewed the Guiding principles and reference agreements
  4. February – March | Task force worked on the problematic content and provided definitions
  5. March | Preliminary review by PARADIGM task 4.2 (the work package responsible for tools creation within the project)
  6. April – May | 1st semi-public consultation with PARADIGM and PILG partners on the content +Content re-reviewed by the patient collaborators
  7. May -June | Building the prototype for an online tool
  8. June – July | Public consultation for the usability of the online tool
  9. July – August | Finalisation of the digital tooland the outputs
  10. August | Release of the digital tool called Patient Engagement Agreements explained

6. Task force participants

Partners within this task force are presented in the alphabetical order after the task force lead.



The Synergist (task force lead)

Chi Pakarinen & Nicholas Brooke

with team: Bonaventure Ikediashi, Daniela Luzuriaga, Carina Prelucan


Sheuli Porkess


Wolf See

Alzheimer Europe

Ana Diaz (+ coordinating with reviewers living with dementia and carers)


Lisa Power & Nenad Petkovi (+Karina Huberman coordinating reviews by the patient community)


Ingrid Klingman


Julie Bonhomme


Susanna Van Tonder (coordination by Camilla Habre)


Karen Druckman


Anna Claire Julienne

University of Oxford, CASMI

Laiba Husain

WECAN (MPE Europe)

Nicole Wicki

* Field Fisher (lawyers involved in WECAN project)

Sixtine Crouzet

The Guiding Principles

The Guiding Principles on Legal Agreements between Patient Advocates and Pharmaceutical Companies aim to serve as a baseline for the development of contracts for patient advocate engagements with pharmaceutical companies. They are intended to ensure reasonable protection for those signing and to provide guidance to patient advocates whenever they need to review a legal agreement.

Read more about the guiding principles

Consultancy Agreement

Reference agreement for engaging a patient advocate as a consultant. Consultancy is usually a fee-for-service engagement between a patient advocate and a pharmaceutical company to support healthcare and/or research.

Read more about the consultancy agreement

Community Speaker Agreement

Reference agreement for engaging a speaker representing the patient community at an event hosted by a pharmaceutical company.

Read more about the community speaker agreement

Collaboration Agreement

Reference agreement for a collaboration between a patient advocate or patient organization and a pharmaceutical company. This kind of engagement is typically a co-creation project where both parties agree on the scope, contributions, and financial details.

Read more about the collaboration agreement

Advisory Board Agreement

Reference agreement for patient advocate participation in advisory boards. These are usually meetings organized by or for a pharmaceutical company where advocates and others provide advice to the company on different topics and questions.

Read more about the advisory board agreement