Reasonable Legal Agreements – 2020 - Patient Focused Medicines Development

Reasonable agreements between patient advocates and pharmaceutical companies

Improving legal agreements between patient advocates and pharmaceutical companies while providing adequate protection and rules for both sides

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Reference Agreements

Advisory Board Reference Agreement
Consultancy Reference Agreement
Community Speaker Reference Agreement
Collaboration Reference Agreement

Collaboration between pharmaceutical companies and patient advocates often requires both parties to sign contracts that can often be very long, difficult to understand and may contain ambiguous clauses. To constitute a resource for legal parties responsible for drafting agreements with patient advocates, four Reference Agreements have been released for use in varied patient community representative engagements, such as Advisory Boards, Collaborations, Speaking Engagements and Consultancy.

These agreements are co-developed to be aligned with the previously released Guiding Principles under the multi-stakeholder project Reasonable agreements between patient advocates and pharmaceutical companies (RAPP) – a project of the Workgroup of European Cancer Patient Advocacy Networks (WECAN), coordinated by Myeloma Patients Europe (MPE) in collaboration with Patient Focused Medicines Development (PFMD) and independent participation of over 10 pharmaceutical companies respectively.

Download the Communication Package to disseminate information about the Reference Agreements within your company and network

1. Summary sheet (background information about the project)
2. Presentation (including ready-made social media messages)

Download the communication package

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Reference Agreements

The Reference Agreements require tailoring by a competent legal advisor according to the needs of the users and the context of use, although flexibility has been safeguarded to ensure the templates can be used in the widest possible set of circumstances.

Adaptation on a case by case basis to comply with national legislation and language requirements is recommended. The Reference Agreements represent a sensible approach but are not meant to be a substitute for taking appropriate legal advice on the agreements in question.

Next steps for the RAPP project

The Guiding Principles and the corresponding Reference Agreements are available for use and consultation. Contributors will continue to collaborate to support all parties in the uptake and implementation of the RAPP tools and their dissemination across geographies, conditions and various communities and networks.

This will include periodic teleconferences to discuss challenges in implementation and opportunities to leverage the multi-stakeholder group and maintain the project’s ambitions to safeguard a constructive legal framework and contracting relationship between parties. The patient community strongly encourages pharmaceutical partners in the RAPP project and beyond to highlight this initiative and resources to local and European trade federations.

The RAPP project members are also partnering with IMI PARADIGM to develop a toolkit for patient advocates to aid in navigating legal parameters in engagements with the pharmaceutical industry, leveraging the Guiding Principles and the Reference Agreements.

Establishing Project Partners and Workgroups

To launch the project, two workgroups were established – the Drafting Workgroup and the Multi-Stakeholder Alignment Workgroup (MSAW). The Drafting Workgroup consisted of seven patient advocates, two legal experts, a PFMD representative and three representatives from pharmaceutical companies.

The MSAW represents all RAPP project partners with legal expertise from patient advocacy and pharmaceutical companies. Both workgroups provided multiple cycles of review and feedback throughout the project and ideas and advice on all documents drafted. Legal experts from the following companies were involved: Bayer, Bristol-Myers Squibb, Celgene, Janssen, Merck MSD, Novartis, Novo Nordisk, Pfizer, Roche, Servier, Takeda.

Ananda Plate (MPE)

Advocate, lawyer, internal/external representation of the project, co-author and reviewer

Andrea Herrmann (Takeda)

Pharmaceutical company representative

Ana Vallejo (MPE)

Advocate and project

Charlotte Roffiaen

Advocate and lawyer

Imma Barral (University of Barcelona)

External legal expert and reviewer

Gordon Oliver (IBTA)

Advocate, lawyer and reviewer

Gregor von Arx (Novartis)

Pharmaceutical company representative

Jan Geissler (CML Advocates Network)

Advocate, co-author and reviewer

Kathy Oliver (IBTA)

Advocate and reviewer

Nicholas Brooke (PFMD)

Multi-stakeholder input and reviewer

Šarunas Narbutas (POLA)

Advocate and lawyer,
co-author and reviewer

Virginie Vassart (Merck MSD)

Pharmaceutical company representative

Guy Bouguet
(Lymphoma Coalition Europe)

Marc Boutin
(National Health Council)