INVOLVE is a National Advisory Group and part of the UK’s National Institute for Health Research. For over 20 years, this government-funded organisation has been providing advice and resources to…
Framework building task forces
Three specific task forces (TFs) were created to start on a number of prioritised action items identified in the Working Group (WG) meetings. The participants of these task forces included some WG volunteers and external stakeholders who matched the profiles identified as needed in the WG meetings. Together these groups of people are called Expert Collaborators in the PFMD website and in SYNaPsE Mapping and networking tool.
See all PFMD Contributors here.
The Book of Good Practices
The objective of this TF is to create one part of the PE meta-Framework that collects existing good/best patient engagement practices from all stakeholders, throughout the medicines development lifecycle. In addition, they work on creating a preliminary set of criteria to identify and assess the quality and level of PE in order to help stakeholders plan better, compare results and learn from completed PE activities.
The outputs include
- a guidance on why, how and when to involve and engage with patients from each stakeholder’s perspective,
- a template to use in planning and assessing PE activities,
- a collection of good/best PE practices from all stakeholders, that helps to showcase the value of patient input, and
- a selection of “quick wins” like the Do’s and Don’ts in PE activities.
Meetings and draft outputs
TF meetings were held in London, Basel and Chicago during spring and summer of 2017. The preliminary version of The PE Quality Guidance will go through three feedback and validation rounds: first round within the task forces, second round within the whole framework building network (including all collaborators from WGs and TFs), and third round with a public consultation (end of 2017).
An updated version of the PE Quality Guidance is expected to be released by Q2 2018, stay tuned for that!
Legal and Compliance Hurdles
The topic of contractual and administrative barriers surfaced in discussions both in the WG sessions and during PFMD’s Board meetings during 2016. The Legal and compliance hurdles- task force came together 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, the 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, the 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, and 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.