Starting a patient engagement initiative in medicines and device development?
Creating a reasonable legal agreement from scratch between patient advocates and industry can be challenging.
You can now use co-created guiding principles for the development of reasonable legal agreements and contract templates, as well as a toolbox for patient advocates and companies.
An adapted reference contract for collaborations between patient advocates and the medical technology industry is now available, applicable for use in the USA.
Managing competing interests and conflicts of interest is of utmost importance when planning, considering and conducting patient engagement activities in medicines development.
You can now access a set of co-created tools to help manage competing interests and conflicts of interests.
If you are intrigued by these guiding principles or reference agreements but want to better understand them first, an interactive version including extra explanations, in-depth descriptions for the terminology, clauses, sections and a rationale to each agreement is available.
*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.
All the PEM Suite tools are designed to work together.
Interested to learn more about patient engagement?
Starting a patient engagement initiative and need support? Explore our co-created guidance for qualitative patient engagement.
How were these tools developed
Reasonable agreements between patient advocates and pharmaceutical companies (RAPP)
This patient-driven multi-stakeholder project was led by 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.
The National Health Council adapted co-created reference contracts from the RAPP-project to the US context. This was reviewed and aligned for the US medtech sector.
Conflict of interest
The process of creating this tool started with a comprehensive methodology including a non-systematic literature search, followed by forming a balanced authoring group. Efforts were made to include legal and compliance industry representatives, patient representatives with legal background and with personal experience on the topic of conflict of interest.
Representatives from the European Medicines Agency also contributed to content development and document review.
A dedicated workshop focused on getting additional feedback. The documents underwent a second consultation with the PARADIGM consortium and the PILG and a public consultation.
Subscribe to get the latest updates
The “Patient Engagement Management Suite” is brought to you by the PFMD partnership.