The result of a truly collaborative project, a series of reasonable legal agreement templates, offers protection for both patients and pharmaceutical companies, explains Federica Castiglione of Novartis

Achieving meaningful patient engagement necessitates all stakeholders being on the same page. 

Or, indeed, pages: collaboration between patient advocates and pharmaceutical companies is often dependent on a lengthy contract, clearly setting out the terms and conditions of the agreement to work together. 

Understandably, many patients can feel overwhelmed as they attempt to digest these onerous and invariably complex legal documents, finding themselves befuddled by legal jargon. These contracts may include ambiguous clauses, and may even expose the patient advocate to legal risk.

For these reasons, the multi-stakeholder project “Reasonable agreements between patient advocates and pharmaceutical companies” (RAPP) sought to make legal agreements between both parties easier and more acceptable while providing adequate protection and rules for both sides. Last year it developed a set of guiding principles, to act as a guiding baseline for the development of contracts and contract templates, as well as a toolbox for patient advocates and companies.

Now four reference agreements have been released for use in varied patient community representative engagements, namely Advisory Boards, Collaborations, Speaking Engagements and Consultancy. 

A true example of co-creation, the project is led by Myeloma Patients Europe on behalf of the Workgroup of European Cancer Patient Advocacy Networks (WECAN), in close partnership with Patient Focused Medicine Development (PFMD). It took shape thanks to a multi-stakeholder workgroup of patient advocates and legal experts from 10 different pharmaceutical companies, who were also supported by independent legal experts from academia and a legal firm.

One of those individuals responsible for patient engagement from the pharma industry was project partner and contributor Federica Castiglione, a Patient Relations Head at Novartis Oncology Region Europe. Castiglione has high praise for the collaborative approach that saw the RAPP project come to fruition. She believes that with the launch of the four reference agreements, it is clear that each party collaborated and respected the needs of all stakeholders in the project. The working group created an open dialogue sharing needs and expectations transparently, and how they could be brought together in a cohesive process producing documents that would benefit both parties, she explains.

“I found the discussion really enriching about how we could support the project and protect the interests of both parties. We understood the main concerns raised by the patient organizations and we were able to explain why it was important for us to include some of the clauses as we thought it would defend both the interests of industry and the patient community. It was great to see how all the involved pharmaceutical companies were working towards one goal of establishing a simpler and leaner process in the interest of all, but in particular of patients and their organisations,” Castiglione says, adding that she is especially grateful that WECAN/MPE/PFMD ensured all stakeholders were able to provide input. 

The process was, in general, a smooth one, and where common ground could not be reached, the door was left open for individual companies to make small amendments to the agreements.

“Maybe we didn’t find a common position for all the areas we discussed, but for those areas, the WECAN/MPE/PFMD team gave the possibility to keep some parts flexible, so every company had the opportunity to adapt based on its specific needs,” explains Castiglione.

Novartis is now proceeding with a launch plan, which will see the reference agreements rolled out across the company’s global operations.

“Within a few months the entire organisation will start using the templates,” says Castiglione, who says hopefully just minor adjustments based on local regulations will be necessary.

But the RAPP project isn’t over. Castiglione says there is now an opportunity to capture the “real-life experience” of using the agreements in practice; this could result in a further simplification of the documents.

“As time passes they will need to be adapted to reflect the new multi-stakeholder collaboration between different players such as regulators, HTA experts and policymakers.” 

Castiglione says she would appreciate a continuous collaboration with the RAPP working group and would like to ensure the opportunity remains to discuss the various agreement templates, adapting them based on experience and emerging needs. “Our work is not done,” she notes, adding that she would also like to see future WECAN/MPE/PFMD collaborations find a way to include other disease communities, such as rare diseases.

“We need to make sure that many patient organizations are informed and prepared to use these templates so that the broader patient community benefits from the collaboration.”

Patient engagement is a dynamic and fluid process. Castiglione points out that the legal aspect of collaboration between patient organisations and pharmaceutical companies is not only related to a single legal agreement. She believes that continuous collaboration and ongoing open dialogue between both parties is essential in order to discuss important issues such as any intellectual property resulting from any collaboration.

According to Castiglione, this was a unique opportunity where the patent community together with a multi-stakeholder alliance in PFMD were able to bring different, unique and complementary skills together for a shared purpose, “removing the burden of the legal process for the patient community”. PFMD’s involvement also provided a unique opportunity to connect the project with other important initiatives at a European and global level, she adds.

“Now the reasonable agreement will have a connection with IMI-PARADIGM and the EFPIA Patient Think Tank and that is an example of how this project can link to other initiatives and expand, which is really important.”