Reasonable Legal Agreements
The topic of contractual and administrative barriers surfaced in multiple PFMD workshops and meetings. We have created a dedicated Legal and Compliance Hurdles Task Force to address the need to lower the legal, compliance, administrational and other perceived barriers that hinder the collaboration between stakeholders or the involvement and engagement of patients in the medicines development lifecycle.
The preliminary discussions identified a number of pain points, including the
- often unreasonable legal agreements and clauses,
- capacity and capabilities patients, expert patients, patient advocates and patient organisations have (or not have at the moment) to engage with industry and other stakeholders,
- practical barriers such as payment and compensation, assistance in practicalities, and accessibility.
The objective of the Legal and Compliance Hurdles Task Force is to produce a guidance for tackling legal and other barriers for all stakeholders who want to work with each other in the medicines development continuum.
As an output, the “Legal Guide” (working name) will also include tools for capacity building, such as:
- an online and interactive guide that explains the different clauses and sections in a template contract in lay language,
- a selection of alternative clauses and template contracts that can be suggested to the partnership,
- an interactive description of the usual processes for collaboration,
- a set of recommendations on the payment, practicality and accessibility issues,
- a listing of agencies or stakeholder that can provide assistance in legal questions or barriers (this preliminary plan may change as the project moves forward).
Partnership with MPE and WECAN
In order to ensure collaboration across stakeholder groups and geographically, and to avoid duplication of efforts, PFMD joins forces with Myeloma Patients Europe (MPE), along with the Workgroup of European Cancer Patient Advocacy Networks (WECAN), a network of 20 pan-European cancer patient organisations, in their initiated project “Reasonable agreements between patient advocacy and the pharmaceutical industry”.
Read more about the project on the dedicated website.