Patient Engagement for Medicines Development in a nutshell

Co-Creation of Patient Engagement Meta-Framework

Co-creating a meta-framework for patient engagement takes collective effort, collaboration and commitment from all stakeholders.


In 2016, PFMD embarked on a journey to co-create a PE guidance and toolkit – that is valid across all phases of medicines lifecycle – to help and support stakeholders to implement more meaningful patient engagement measures and practices. The co-creation work stream is an iterative process that started with landscape mapping, literature review and analysis of existing PE frameworks and toolkits.

After the preliminary mapping exercise, the framework building Working Groups (WGs) were established to formulate a plan of actions, which specific Task Forces (TFs) then took on to complete.

The framework building roadmap below provides detailed descriptions for all stages from the beginning to the finalisation of the PE meta-framework. The current stage in the process is highlighted for clarity.

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Expected outcomes

Three task forces were created to address the next steps agreed on in the WGs. Two task forces were created for the PE guidance and toolkit, and the Book of Good Practices. These task forces aim at creating a preliminary criteria for PE best practices and a way to systematically capture and assess them from research to post-launch activities. 

The third task force focuses on lowering the legal, compliance and administrational barriers to PE collaboration between stakeholders, especially those between patients, patient organisations and industry.

Progress to date

PFMD has organised 6 workshops, with a total of 76 international participants representing patients/patient advocates, patient organisations, researchers, industry representatives (including CRO and biotech), independent experts, HTA and regulatory representatives.

A preliminary version of the PE Quality Guidance that has been created in these workshops is now going through a series of feedback and validation rounds. This version has gone out for its third feedback and validation round, the public consultation in December 2017 and an updated version of the PE Quality Guidance is expected to be released within Q2 of 2018.

The current draft version can be found in the PFMD resources.

PE Meta-framework – The Roadmap

Done so far:

1 3 multi stakeholder working groups per phase development of medicines

  • WGs 1 -3, Brussels
  • 11/ 2016, 02/ 2017

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2 Task forces on volunteer basis (PFMD and others) 

2.1. Book of Good Practices (collecting real examples) – TF1 London 05/ 2017, Chicago 06/ 2017

2.2. Legal and Compliance Guidebook – TF2 Brussels 04/ 2017

2.3. Good PE Practices Toolkit – TF3 Basel 06/ 2017

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3 Outcomes: good PE practices toolkit draft

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