Collaboration between pharmaceutical companies and patient advocates often requires both parties to sign contracts 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 codes, designed to ensure an appropriate relationship between patient and pharmaceutical company. In the past, the complexity of these agreements has often been challenging for 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 “Reasonable agreements between patient advocates and pharmaceutical companies (RAPP)” is a project of the Workgroup of European Cancer Patient Advocacy Networks (WECAN), led by Myeloma Patients Europe (MPE) in collaboration with Patient Focused Medicines Development (PFMD) and independent participation of more than 10 pharmaceutical companies respectively. Altogether, the project represents 35 patient organisations, 16 pharmaceutical companies and 7 other project partners.
The project aims 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 joint initiative has collectively contributed to and previously released the Guiding Principles on Reasonable Agreements between Patient Advocates and Pharmaceutical Companies and is now launching four Reference Agreements for different types of engagements (Advisory Boards, Collaborations, Speaking Engagements and Consultancy) that have been developed in alignment with the Guiding Principles.
A series of Guiding Principles were developed via a collaborative approach between the involved parties. 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. Consult them here.
Using the Guiding Principles as a basis, the RAPP project members worked with external legal experts to draft four reference agreements for use in varied patient community representative engagements, such as Advisory Boards, Collaborations, Speaking Engagements and Consultancy. The MSAW worked together to review and provide comments on the content and structure of the agreements, identifying areas of consensus, compromise and non-consensus. Find here the four reference agreements:
- Advisory Boards reference agreement
- Collaborations reference agreement
- Speaking Engagements reference agreement
- Consultancy reference agreement
These Reference Agreements are intended to constitute a resource for legal parties responsible for drafting agreements with patient advocates. 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 also needed. The Reference Agreements represent a sensible approach but are not a substitute for taking appropriate legal advice on the documents in question.
Next steps for the RAPP project
The Guiding Principles and the corresponding Reference Agreements are now published and 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.
- See the project website: www.mpeurope.org/legal_agreements
- See WECAN project website: www.wecanadvocate.eu/rapp