A collaboration between patient advocates and pharmaceutical companies usually requires both parties to sign contracts for different engagements such as for advisory, consultancy, collaborative or speaker engagements. These contracts usually cover areas such as confidentiality, intellectual property, data protection, financial compensation and travel expenses. However, according to the Workgroup of European Cancer Patient Advocacy Networks (WECAN), most of these contracts may be difficult for patient advocates to understand or contain inadequate terms. Aiming to create a simpler legal framework, WECAN is conducting a project coordinated by Myeloma Patients Europe (MPE) in collaboration with Patient Focused Medicines Development (PFMD) and legal experts from 12 pharmaceutical companies. The joint initiative has now released guiding principles for reasonable legal agreements that adequately protect both parties while safeguarding independence and individual interests.

Brussels, 28 November 2018 – According to the results of a survey by the Workgroup of European Cancer Patient Advocacy Networks (WECAN), contracts between pharmaceutical companies and patient advocates, patient organisations or individual patients to act as advisors, speakers or collaborators are often very lengthy and may contain ambiguous clauses. “Patient organisations struggle with these contracts because the majority do not have legal departments or lawyers to review them. Furthermore, patient advocates often do their advocacy and advisory work as volunteers in addition to a regular day job and do not have the time and support to comprehensively review contracts or negotiate changes. Therefore, many patient advocates sign them blindly, which is far from ideal,” says Ananda Plate, CEO of Myeloma Patients Europe, patient advocate, lawyer and co-ordinator of the WECAN project.

The new “Guiding Principles for Reasonable Agreements between Patient Advocates and Pharmaceutical Companies” provides guidance regarding how these contracts can adequately protect both contractual parties while safeguarding their independence and individual interests. The document is based on discussions conducted by a multi-stakeholder workgroup of patient advocates and legal experts from the pharmaceutical companies Amgen, Bayer, Bristol-Myers Squibb, Celgene, MSD, Novartis, Novo Nordisk, Pfizer, Roche, Servier, Takeda and Janssen, the pharmaceutical companies of Johnson & Johnson, supported by independent legal experts from academia and a law firm.

Structure and content

The guiding principles cover 10 contractual areas including confidentiality, intellectual property, recordings, data protection, personal data, indemnification, remedies, conflict resolution, financial compensation, reimbursement of expenses, adverse event reporting and conflict of interest. Each section covers the rationale, examples and guiding principles to address the relationship between both parties.

“The guiding principles will help us to agree more quickly on terms that are acceptable to both sides, instead of spending many hours on lengthy legal documents that are not fit for purpose in the area of patient advocacy,” says Jan Geissler, former director of the European Patients’ Academy on Therapeutic Innovation (EUPATI) and co-founder of the global CML Advocates Network. “For example, reasonable confidentiality clauses safeguard commercially sensitive information, while allowing patient advocates to share information with their member organisations. Patient advocates also need to retain their rights on use of documents and ideas they develop and provide during the collaboration.”

Kathy Oliver, Chair of the International Brain Tumour Alliance (IBTA), adds that “Clauses on indemnification of the company against litigation of third parties that may arise from the collaborative work, if ever executed, would put patient advocates at existential risk, as they mostly do not have international liability insurance. In addition, any external use of names and quotes of the patient advocates should always require prior written consent. Fair compensation for the time invested in collaborative work, as well as the right to refuse any honoraria, is also reasonable. I am really happy we have reached consensus on these principles.”

After finalising this first part of the project, WECAN, in collaboration with PFMD and all other parties involved in this initiative, will draft templates for consultancy, collaboration, advisory board and community speaker agreements that may facilitate contractual arrangements in the future. These templates will reflect the guiding principles and will then need to be adapted on a case by case basis to comply with national legislation and relevant industry codes. In addition, a Toolbox will be developed to help patient organisations and other stakeholders identify potentially problematic clauses and guide negotiations. “Legal barriers are an unnecessary obstacle to patient engagement. The Guiding Principles are a great step forward. Alongside the Toolbox and the contract templates, they will be very helpful in facilitating and accelerating meaningful and trusting relationships between companies, patients, patient advocates and patient organisations,” says Nicholas Brooke, Executive Director of the multi-stakeholder initiative Patient Focused Medicine Development (PFMD). “These resources will complement the Patient Engagement Management Suite (PEMS), including the Patient Engagement Quality Guidance, the Book of Good Practices and the Synapse patient engagement networking and management online platform at PFMD.org that were recently co-created and released by PFMD.”


To ensure both patient advocates’ and pharmaceutical companies’ perspectives were included in this document, WECAN created two workgroups:  in the Multi-Stakeholder Alignment Workgroup, representatives of 12 companies, PFMD and two patient organisations discussed the Guiding Principles and provided recommendations to the drafting group, composed of seven patient advocates, two legal experts, a PFMD representative and three pharmaceutical company representatives, which then developed the Guiding Principles document. “Being part of the drafting group was a powerful way to work collaboratively on recurring, complex contractual issues between patient advocates and the pharmaceutical industry. I am very proud of having been part of this conversation,” says Virginie Vassart from the MSD legal team that was selected by the Multi-Stakeholder Alignment Workgroup to join the drafting group of this project.

To better understand the underlying issue, WECAN carried out a survey of more than 80 European patient advocates in 2016. More than half of the patient advocates understood only some, a few or none of the clauses in the contracts they received. Approximately 20% of patient advocates rarely or never read all legal agreements in detail before signing them, and 63% of patient advocates stated that the contracts they received had six or more pages, while 85% of them thought that the reasonable length for a contract was between one and five pages. Patient advocates currently spend approximately five hours on negotiating, reading, printing, scanning and sending each contract. Only 18% of the patient advocates regularly tried to change those clauses they considered unreasonable. Among those patient advocates who tried to change clauses they considered unreasonable, more than half reported that the pharmaceutical company rarely or never agreed to change them, and only 11% said the company always agreed to make the changes. The results of the survey led to the establishment of the project and the collaborative Multi-Stakeholder Alignment Workgroup in order to develop a consensus on how to tackle these issues.

The Guiding Principles now provide a tool for patients, patient advocates, patient organisations and pharmaceutical companies to develop and assess contracts related to patient engagement.

Download link for the Guiding Principles:  www.wecanadvocate.eu/rapp

About the project

The project “Reasonable Agreements between Patient Advocates and Pharmaceutical Companies” was initiated by WECAN in 2016 and is co-ordinated by Myeloma Patients Europe in collaboration with PFMD and legal experts from 12 pharmaceutical companies. The project analyses legal contracts between patients’ organisations and pharmaceutical companies, develops guiding principles, tools and contract templates for reasonable legal agreements between patient advocates and pharmaceutical companies that make the legal relationship between both parties easier and more acceptable while safeguarding the independence and interests of all parties involved. See https://www.mpeurope.org/legal_agreements


WECAN is the Workgroup of 21 European Cancer Patient Advocacy Networks. WECAN is an informal network of leaders of cancer patient umbrella organisations active in Europe which aims to increase the level of collaboration and alignment between these organisations. It intends to share workloads when contributing to different stakeholder initiatives, and runs a number of joint flagship projects. WECAN is not a legal entity and does not receive any funding from any third party. Any activity of WECAN is funded and implemented by the participating patient organisations.
See https://wecanadvocate.eu

About MPE

Myeloma Patients Europe (MPE) is an umbrella organisation of myeloma and AL amyloidosis patient groups across Europe. MPE currently has 43 members based in 29 countries. The mission of the organisation is to provide education, information and support to member groups and to advocate at European, national and local levels for the best possible research and equal access to treatment and care. To achieve its aims, MPE works directly with members, healthcare professionals, reimbursement authorities, regulators, politicians, pharmaceutical companies and the media to ensure all stakeholders are collaborating to improve patient outcomes and reduce inequalities across Europe.

About PFMD

Patient Focused Medicines Development (PFMD) aims to transform the way in which stakeholders understand, engage, and partner with patients globally in the design and development of research and medicines by focusing on unmet patient needs. PFMD is bringing together and synergizing disparate but complementary efforts that integrate the voice of the patient across the lifecycle of medicine. PFMD was established in October 2015 as an open, independent global coalition of health stakeholders. See https://patientfocusedmedicine.org

More information

Ananda Plate [email protected]
Ana Vallejo [email protected]