Workshop highlights the challenge of drafting contracts for patient-pharma collaboration but aims to make co-created legal agreements the norm.

As patients become indispensable partners in medicines development, stakeholders have a growing need for legal agreements that cover collaboration, consultancy and other interactions.

These were some of the issues tackled during a highly-interactive workshop at the Patient Engagement Open Forum. The event took place against a backdrop of several collaborations on fair market value and reasonable agreements in the US led by the National Health Council, a sure sign that reasonable agreements are ready to go mainstream.

The WECAN Network, Myeloma Patients Europe and PFMD started the reasonable legal agreement work and have been working with stakeholders in Europe to explore the co-creation model of writing reasonable agreement guiding principles and reference contracts.

The workshop, led by Jan Geissler, co-founder of Patvocates, and Nicholas Brooke, Executive Director of PFMD, examined a sample contract for the patient-industry collaboration and email exchange on the contract. All participants had to form their opinion from the patient perspective and simulate the next steps discussion helping to tease out the problems each side encounters while trying to meet in the middle. The workshop was scheduled for two hours but lasted almost three hours due to the high level of participant engagement.

Each table of participants focused on a specific aspect of the agreement – such as confidentiality or privacy. They considered how a patient might respond to a proposal from a pharma partner, and used the guiding principles as a reference document to help overcome challenges.

For example, pharma companies’ default contract for partnership agreements sometimes includes clauses requiring the patient to grant the company rights to use their image indefinitely for any purposes. For a patient advocate participating in a short meeting or delivering a once-off speech, this was described as ‘unacceptable’ by all stakeholders during the workshop, yet this is still appearing regularly in contract proposals.

‘The Guiding Principles move the discussion forward by helping each party see the other side’s perspective,’ explained Nicholas Brooke. ‘The goal is to have something as simple as possible so that the agreement is clear to everyone. To achieve this, we aim to simplify the language and boil it down to the minimal elements required. We may also need to think about a toolkit that explains the meaning of each clause in lay language and PARADIGM is considering developing these toolkits.’

In addition to the Guiding Principles, WECAN & PFMD have developed a contract template for patient advisory boards and are currently working on templates for speaking agreements, collaboration and consultancy arrangements that are in review with the 12 pharma companies co-creating these contract templates with WECAN, MPE, PFMD and NHC.

The session concluded with a discussion on how to ensure these tools are disseminated and adopted by all stakeholders. This is a question IMI Paradigm and PFMD will seek to answer in 2020.