A new Code of Conduct for all stakeholders involved in patient engagement will facilitate trust and meaningful collaboration, say Ingrid Klingmann of EFGCP, Karina Huberman of the European Aids Treatment Group, and Wolf R See of Bayer
There are many existing codes of conduct that seek to ensure best practice and ethical standards when it comes to patient engagement. However, a new Code of Conduct for all stakeholders involved in patient engagement activities was needed because existing Codes cover the rules of individual stakeholders. Patient engagement means collaboration – and for that, we need common rules for all involved. That’s according to Ingrid Klingmann, Karina Huberman, and Wolf See.
Contributions of patients in medicines development and access to treatment processes are rapidly increasing, they note. The benefits of such collaboration have been widely accepted, however, in practical life, there are considerable hesitations on all sides on how to handle such collaboration under ethical conditions and without conflicts.
“Successful patient engagement, therefore, requires agreement on and adherence to common values and collaboration rules. A jointly developed Code of Conduct valid for all involved parties can lay the ground for trustful and efficient collaboration.”
An authoring group consisting of members of the PARADIGM Ethics Expert Panel and of the multi-stakeholder project team defined the objectives and the scope of this Code of Conduct in a brainstorming meeting in autumn 2018. They determined that any new code should:
- Give clear, relevant and practicable rules for all kinds of interactions
- Be equally applicable for all involved stakeholders
- Fill the gaps for guidance identified in the Work Package 2 gap analysis
- Apply the patient engagement principles worked out in the other PARADIGM guidances and
- Respect the diversity of the stakeholders with their particular needs and restrictions.
Based on the agreed scope of content the authoring teams created the texts for the different sections based on the key principles of the newly developed PARADIGM guidances, review of existing codes from different stakeholders and their own expertise. Differing expectations and positions were analysed in the authoring group and a mutually agreed text was worked out.
According to Klingmann, Huberman and See, the main difficulty was not an agreement on the rules as such but on finding the most suitable compromise on the level of detail to be presented within the Code. They explain that as a result, the compiled text underwent several rounds of internal review with requests for changes from within the consortium before the consolidated Code of Conduct was released for broad public consultation and discussion during a dedicated Code of Conduct session at the Patient Engagement Open Forum on July 9, 2020.
The resulting “Code of Conduct for all stakeholders involved in patient engagement activities within medicines development” is a stand-alone document that highlights, summarises and refers to the key patient engagement principles, rules, and recommendations for collaboration presented in the different PARADIGM documents in a comprehensive, understandable format. It is an essential tool in the PARADIGM Patient Engagement Toolbox.
“The now available Code is the result of the collaborative effort to balance the interests, viewpoints and needs of the different stakeholders and thus also a compromise in content and length but it fulfils the key expectations of all involved stakeholder groups, it strengthens the demand for fairness, trust and equity in collaboration and it gives guidance on how to structure the collaboration,” says the team.
It is envisioned that the new Code will be widely adopted as it fulfils an unmet need in patient engagement, offering a common platform for all stakeholders about to engage in a true collaboration.
“It will be important to communicate the existence of this joint Code of Conduct as broadly as possible with the recommendation to adapt it for all kinds of patient engagement activities as the basis for trustful collaboration and benchmark in case of conflicts or disagreements between the partners,” note the team.