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PART 2: Creating future patient engagement tools

Open Forum on Patient Engagement19 September 2019

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Outline of the session

• Work under development

• Main gaps following WP2 prioritization

• Breakout session

• Plenary discussion

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Work under developmentCoI, CABs, EUPATI, Code of Conduct

Open Forum on Patient Engagement19 September 2019

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Conflict of Interest

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"Guidance to medicine developers on the impact of the interaction between patients and stakeholders: Raising awareness on managing competing

interests and avoiding conflicts of interest"

List of contributors:

• Authoring group: Walter Atzori (Alexion), Julie Bonhomme (EFPIA), Karen Druckman (EURORDIS pool of expert patients), Maria Cavaller (EURORDIS), Elisa Ferrer (EURORDIS), Virginie Hivert (EURORDIS), Giulio Corbelli (EATG), Giorgio Barbareschi (EATG), Ana Diaz (Alzheimer Europe)

• Reviewers: Wolf See (Bayer), Nathalie Bere/Maria Mavris (EMA), Camilla Habre(EPF), Cristian Andriciuc (EPF pool of expert patients), Sheuli Porkess (ABPI), Malene Gronwald (NovoNordisk), Stephanie Ribbe (Novartis), Helen Robertson (J&J), Cristina Padeanu (EFGCP), Stuart Faulkner (Oxford University), Anne-Claire Julienne (Servier)

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Outline

1. Introduction

2. Main sections:

• a) Patients’ interaction with developers - Patients, whether receiving or not a financial incentive for interacting with medicine developers, could be perceived as consultants and therefore considered as having a potential conflict of interest. In the same way as it applies for instance to prescribers, any type of reward may be perceived as a potential influence on a patient opinion/statement about any medicinal product/medical device, etc. This may apply to different phases of medicines development:

– Prioritisation of research - patients engaged in early development and preclinical research phases of medicines development

– Design of clinical trials - patients engaged in clinical research phases

– Patients engaged in early dialogue with regulators and HTA

• b) Confidentiality and use of Community Advisory Boards (CABs) for managing potential issues when patients are involved in parallel with several developers.

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Outline

2. Main sections: to be continued

• c) Patients’ interactions with Regulators/HTA/Payers - Patients can interact with several different stakeholders, leading to a potential situation of CoI for them when it comes to engaging with Regulators/HTA/Payers on the same technology under review or appraisal, and potentially on a different technology developed by the same manufacturer (Declaration of interest and management of conflict)

• d) Relevant policies/ frameworks needed to protect the engagement process - Transparency measures, mitigation measures (e.g. log of activities), breach of trust management

3. List of guidances and resources & References

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Gaps addressed Material under development/to be develop

Communicating any changes that could occur during the PE initiative up-front

Declaration of interest form, log of activities

Legal agreements written in a clear and accessible way and adapted to the target population

Declaration of interest form, guidance document

Management of potential conflict of interest (up to avoidance)? disclosure, transparency and accountability

Declaration of interest form, guidance document, log of activities

Presentation of the terms and conditions of all policies and confidentiality agreements in a clear and accessible way to the stakeholders involved

Declaration of interest form, guidance document, log of activities

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Community Advisory Boards

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Guiding document to establish and maintain community advisory boards"

List of contributors:

• Authoring group: Giorgio Barbareschi Giulio Maria Corbelli – EATG; Ana Diaz -Alzheimer Europe; Manuela Bruegger – Novartis

• Reviewers: Daniel De Schryver – Janssen; Teresa Finlay - Oxford University; Begonya Nafria Escalera - SJD Hospital Barcelona; Chi Pakarinen - The Synergist; Lidewij Vat - Athena VU Amsterdam; Russell Wheeler - EURORDIS

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Outline of the document

• A guiding document with different sections addressing several topics which are relevant to different stakeholders:

– From the perspective of the organisations setting up/organising a CAB

– From the perspective of organisations contacting/ working with CABs (other stakeholders)

• Each sub-section will consist of a brief introduction about the topic and templates or other relevant documents to consider/use at each stage

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Gaps addressed

• Several gaps identified in PARADIGM will be addressed in the guiding document, but only in the context of working with a CAB. For example– Members of the CAB

– Training/ ongoing information for CAB members and stakeholders

– Terms of reference, code of conduct, legal agreements which are typically used in CABs

– Financial models used in CABs

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EUPATI Guidelines

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"Guidance to medicine developers on the impact of the interaction between patients and stakeholders: EUPATI Guidelines"

List of contributors:

• Authoring group: Kay Warner, GSK; Irmi Gallmeier, Roche; Wolf R See; Karina Huberman, EATG; Ingrid Klingmann, EFGCP; Giulio Maria Corbelli; Maes, Laurence Maes, J&J; Dominique Hamerlijnck; Matthew May, EPF; Camilla Habre, EPF

• Reviewers: Daniel De Schryver – Janssen; Teresa Finlay - Oxford University; Begonya Nafria Escalera - SJD Hospital Barcelona; Chi Pakarinen - The Synergist; Lidewij Vat - Athena VU Amsterdam; Russell Wheeler - EURORDIS

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Outline

- Focus on the specific items around the guidance but not update the guidance document itself. - Add to the guidance (specific sections) in the form of addendums or appendices (or links to external reference material). - The toolbox will be the host for additional specific material (i.e., how to guides, templates, references for FMV, contract templates (WE CAN), etc), with the editorial board quality checking any external content identified to ensure it meets existing standards, applied throughout the EUPATI materials. - Defined focus of the working group looking at the points people are asking for more information on and the practical steps to follow, for example, common questions such as ‘how do I identify patients?’

- Timeline: target completion end 2019

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Status of material

Suggested working practices Need to define what we mean by long-term partnerships through examples to bring this to life through EATG experience, including roles of patient groups, plus the whole structure including interface with contract research organisations to show the role and relation they have in patient engagement

Examples (appendix to guidance)

Suggested working practices Need to describe what would happen during pre-engagement discussions and will also inform defining the interaction.

Template (appendix to guidance)

Patient identification/interaction

Patient identification screening checklist Checklist (appendix to guidance)

Compensation Cross-reference EFPIA guidance and NHC FMV calculator Reference LinkWritten agreement / contract template

Cross-reference output from WE CAN initiative Reference Link

Events and Hospitality Cross-reference PFMD 7 quality criteria to ensure there is list of considerations to include accessibility.

Checklist (appendix to guidance) + cross reference to compensation section (FMV guidance)

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Code of Conduct

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“PARADIGM Code of Conduct”

List of contributors:

• Authoring group: Ingrid Klingmann, Karina Huberman, Wolf See, Isabelle Huys, Arielle Kelman, Uta Baddack-Werncke, Bob Wilffert, Kay Warner, Lynne Van Poelgeest-Pomfret, Matthew May, Julieth Katherinne Bejarano Mojica, Lukas Eichmann, Maria Gonzalez Hinjos, Cristina Padeanu, Katja Standke

• Review: First within the Authoring Group, then within WP4, then within the Consortium, then external consultation

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Outline1. Introduction2. Scope3. Purpose4. Guiding Principles5. Values6. Conflict of Interest, Competing Interests and Conflict Management7. Contractual Framework8. Privacy, Data Protection and Intellectual Property9. Transparency10. Universal Accessibility to Information11. Access to Patient Engagement Opportunities12. Representativeness13. Competencies and Capacity Building14. Rights and Obligations15. Accountability and Responsibility16. Adherence to the Code of Conduct17. Efficiency18. Willingness and Readiness19. Appropriateness of Communication and Feedback20. Concluding Remarks

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Status of the document:

• Kick-off meeting took place 17th April 2019

• Agreement on Outline and production process

• Outline with first text parts sent to authoring group

• Currently collecting text contributions

• Alignment with results jointly identified at the Open Forum to ensure comprehensive filling of identified gaps

• First draft to be ready by 30th October 2019

• Consortium Review cycle will start 30th November 2019

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Gaps following WP2 prioritisation

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lack of reporting

propose metrics to measure impact of PE

clear, transparent and equitable (fair) financial compensation framework to be in…

presentation of the terms and conditions of all policies and confidentiality…

management of potential conflicts of interest (up to avoidance)? disclosure,…

identification and addressment of potential discriminatory, coercive,…

privacy policy that describes policy to maintain data privacy of engaged patients…

Code of conduct, which clearly states the (ethical) principles, governance…

ensure the formation and maintenance of a partnership between all stakeholders

include a dissemination and communication plan sharing the process and…

communicating any changes that could occur during the PE initiative up-front

legal agreements written in a clear and accessible way and adapted to the target…

training for their roles and responsibilities with training material accessible to…

clear description of the criteria followed to identify patient representatives needed

Green Orange Yellow

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Gaps to be addressed:

1. Clear description of the criteria followed to identify patient representatives needed

2. Lack of reporting, dissemination and communication plans to share processes and outcomes

3. Formation and maintenance of a long-term partnership

4. How to get started? (“Starter Kit”)

(Additional proposal based on Open Forum discussions)

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Breakout Session

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Expected outcomes of the discussion

• Suggestions for contents (material and tools)

• How to ensure inclusiveness

• How to make the tools easy to use (type of document, format, methodology, technology?)

• Suggesting existing documents covering those gaps