A new digital tool aims to help the patient community to understand the agreements they might need to review when collaborating with pharma, says The Synergist’s Chi Pakarinen and Julia Tolley of Myeloma Patients Europe

Legal agreements are a must when it comes to ensuring all parties taking part in patient engagement activities are on the same page. 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, however, 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 goal of this specific tool, devised as part of the PARADIGM project, is to help the patient community to understand the various agreements they might be presented with when collaborating with pharma.

Although the work from the collaboration of European Cancer Patient Advocacy Networks (WECAN) and PFMD in the “Reasonable agreements between patient advocates and pharmaceutical companies” (RAPP) project has produced guiding principles and four reference agreements, there was still a clear need to make these materials more accessible to the patient community, says Chi Pakarinen.

She explains that this need was expressed at the Patient Engagement Open Forum session in 2019, where WECAN first introduced these tools. 

“Of course, access to these tools for all stakeholders is important; for pharmaceutical companies looking to work with patient representatives or patient groups, understanding the guiding principles and having examples of these principles applied in the reference agreements provides a solid basis for transparent, respectful and mutually beneficial collaborations and relationships between patient groups and pharmaceutical companies.”

The contributors’ group, comprising patients, patient organisation, industry and academia, scrutinised the feedback provided by patient reviewers on the co-created guiding principles and reference agreements. Where patient reviewers had indicated sections as hard to understand, or where further clarification was needed, the group provided explanations. The annotated versions of the documents were then checked by the group and subsequently went through two additional external review rounds that included the PARADIGM consortium and the PILG network, as well as public consultation.

In addition to the explained versions of the guiding principle and four reference contracts, and in order to respond to the need to make contracts easier to read, the working group created an online format where patients can scroll through the documents, easily navigate between clauses and see the sections and the explanations online in a clear, consistent format. This preliminary online tool was tested by patient reviewers and was also out for the public to test between June 25th and July 21st before it was finalised for use in August and launched in September 2020.

According to Pakarinen, the success of this project would not have been possible without the valuable insights of patients and patient advocates.

“Patients and patient advocates brought their needs to the table and helped the rest of the group understand the difficulties they face when negotiating and responding to contractual situations,” she says. “Patient organisations were the connecting point to help facilitate the patients’ participation in this project. Pharmaceutical companies, in particular representatives working in Legal and Compliance departments, contributed to understanding the difficulties from both sides, and working to reach a resolution in line with the guiding principles.”

All stakeholders contributed in designing the solution, participated in the rework/clarification of the existing documents, drafted and reviewed material and also tested the very first iterations of the tool to provide usability feedback – the entire process was “very straightforward”, adds Pakarinen.

She hopes that this tool will be of immense value to all of those commencing a patient engagement activity. 

“I hope it helps anyone who’s in the process of starting a collaboration with the pharmaceutical industry, or industry with patients, to see what a reasonable contract might look like and how to create one that really respects the other party as a partner. We have provided additional explanations to help the patient community to be able to navigate the legal landscape and also to be able to come to the table with a ready-made contract if they so wish. Hopefully this work helps to empower patients more in these collaborations, and lead to more fruitful mutual partnerships between pharmaceutical companies and the patient community in the future.”

Pakarinen also notes that this work is part of the PARADIGM Patient Engagement Toolbox to enhance the accessibility and usability of the co-created tools from the RAPP project. It’s a collaboration that aims to help the patient community to prepare for collaborations, but also other stakeholders who want to collaborate with patients to use co-created contract templates to avoid or reduce the past challenges and obstacles experienced by the patient community when looking to contract with a pharmaceutical company for the purpose of collaboration, participation in an Advisory Board, as a Community Speaker or to initiate a Community Advisory Board.