Pharma Integrity Event - May 2022
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IPPOSI CEO Derick Mitchell's presentation to the Pharma Integrity Conference in Dunboyne on May 10th, 2022.
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Pharma Integrity Event - May 2022
- 1. Working successfully with patient organisations in Ireland Derick Mitchell, PhD Chief Executive Officer IPPOSI 10/05/2022 Pharma Integrity Conference, May 2022
- 2. Presentation Outline • What is IPPOSI? • Compliance from a patient advocate perspective • From ‘patient centricity’ to ‘patient involvement’ • How patients, pharma industry can interact better Pharma Integrity Conference, May 2022
- 3. IPPOSI? Who? IPPOSI.IE A patient-led organisation that works with patients, government, industry, & science to put patients at the heart of health innovation Pharma Integrity Conference, May 2022
- 4. Pharma Integrity Conference, May 2022
- 5. PATIENT ORGANISATIONS - 105 SCIENCE – 200+ HEALTHCARE INDUSTRY - 23 PATIENT ADVOCATES (INDIVIDUALS) – 150+ Pharma Integrity Conference, May 2022 Teva Pharmaceuticals
- 6. EDUCATE INVOLVE IMPACT IPPOSI Pillars ACCESS TO INNOVATION PATIENT & PUBLIC INVOLVEMENT UNDERSTANDING PATIENT DATA Priority Areas Pharma Interaction: Pharma Integrity Conference, May 2022
- 7. IPPOSI Partnerships • Digital Discussions + Conferences • Patient ‘Dragon’s Den’ • Matchmaking of patient advocates with ‘involvement’ opportunities • Patient Education Programme • Capacity Building Programme • Citizen Juries Pharma Integrity Conference, May 2022
- 8. Compliance ensures independence & transparency • Existing codes good for: • Basic principles, values • Achieving financial transparency • Maintaining independence • Rules for reputation and credibility • There is scope (and appetite) for more Pharma Integrity Conference, May 2022
- 9. Challenges to interacting Lack of Trust Lack of mutual learning Perceived (or real) legal barriers, conflicts of interest Lack of capacity in patient organisations Lack of standardized metrics to measure impact and benefits of patient involvement
- 10. Challenges to interacting Siloed-thinking - leads to consolidation of individual, non- consolidated processes, rules and (interpretation of) codes Continuous cross-functional feedback, development and evolution to drive trustful, transparent collaborations Need to move towards measuring the value of the interaction Pharma Integrity Conference, May 2022
- 11. Pharma Integrity Conference, May 2022 Annex III of IPHA Code • Guidance on how to ensure relationship is positive, constructive, mutually beneficial, ethical • NOT on pre-competitive, long-term partnerships, non-promotional relationship-building • Patients are an increasingly important KOL in healthcare. • ABPI recognized this and developed ‘principles’ that sit alongside their (updated) code
- 12. Over-compliance? Compliance Rules for working with Pharma Company XYZ 10 pages 50+ pages Pharma Integrity Conference, May 2022
- 13. ‘Patient centricity’ vs ‘Patient involvement’ • For IPPOSI, involvement is beyond engagement (where patients or the public are provided with information or knowledge) and beyond participation (where patients or the public are invited to share their information or knowledge). • Involvement is typically something that happens ‘with’ or ‘by’ the individual or group, rather than ‘to’, ‘about’ or ‘for’ them 10/05/2022 Pharma Integrity Conference, May 2022
- 14. Building a new Irish healthcare + research environment • HSE Board • HPRA Patient Forum + Scientific Advice • HSE Rare Disease Tech Review Committee • Health Innovation Hub Steering Group • Health Research Board PPI review + Ignite Network • National Clinical Effectiveness Committee Pharma Integrity Conference, May 2022 In 2022, Patient Advocates are members of • Electronic Health Records • Patient Experience Data • EU Clinical Trials Directive • Health Information Bill Areas coming down the tracks
- 15. • Patient Advisory Board • Patient Focus Group • Podcast • Conference speaking https://ppihub.ipposi.ie/ Pharma Integrity Conference, May 2022 3 submissions of PPI from Pharma
- 16. Irish Healthcare Awards • Awareness Raising • Health Promotion • Patient Education • Patient Lifestyle 10/05/2022 Pharma Integrity Conference, May 2022 PATIENT CATEGORIES Are pharma companies concentrating on the ‘low-hanging fruit’?
- 17. How patients, pharma industry can interact better? • Work with patient groups to identify what needs to be changed in: • Health legislation development • Health regulations and regulators • Health codes of conduct • Avoid rhetoric of ‘the patient voice’ – not matched by reality • Promote longer-term, collaborative working across companies with patient groups • E.g. Patient Data / Health information • IPHA to appoint a patient advisory of POs and individual advocates Pharma Integrity Conference, May 2022
- 18. Guidances to facilitate interaction • Between patient organisations and pharmaceutical industry • Identify roles and opportunities for patients to interact in a systematic way • EUPATI Guidance contains: • Defining the patient • Defining the interaction • Ways for Identifying patients • Writing collaboration agreements • Rules of compensation • Transparency & Disclosure • Events & Hospitality • Appendices: Roadmap for PPI; Codes; Confidentiality agreement, Written agreement Pharma Integrity Conference, May 2022
- 19. TRAINING PRACTICES RESOURCES Pharma Integrity Conference, May 2022 ‘Patient Involvement’ IPPOSI TRAINING COMING!
- 20. Companies could consider... • Deepening staff’s appreciation and understanding of the role of patient groups in certain disease areas • General training of staff on PPI and the patient community landscape in Ireland • Adhering to the principle of respect when it comes to patient groups Pharma Integrity Conference, May 2022
- 21. Take home messages • Patients and Patient Groups are inherently innovative and willing to work in long- term, professional partnerships • Irish patient groups are well-networked but some are struggling financially, may not survive current crisis • Growing body of evidence that Patient & Public involvement is impactful + vital • Compliance is currently focused on trust and transparency, not on collaborative relationships with patients Pharma Integrity Conference, May 2022
Hinweis der Redaktion
- A patient-led platform that provides a structured way of facilitating interaction between patients, government, industry, science and academia to put patients at the heart of policy and medicines development. In pursuit of this we hold workshops, discussion groups, training days and conferences on policy, legislation and regulation around the development of new medicines, products, devices and diagnostics for unmet medical needs.
- IPPOSI is a KOL in PPI across research, policy, services and innovation. We educate & train patients to provide their input in an informed, evidenced way We are passionate about preparing healthcare professionals, researchers, state agencies and companies and to develop partnerships with patients
- The EFPIA Code constitutes the collection of ethical rules agreed by EFPIA members for the Promotion of Medicinal Products to HCPs and the interactions with HCPs, HCOs and POs, with the intent of guaranteeing that these activities are conducted while respecting the most stringent ethical principles of professionalism and responsibility.
- Cultivating your own garden, Agreed Values Harmonized processes Quality Standards
- Standards and processes governing ways of working will always be required (so Compliance as a key function in relationships between companies and patient organisations will remain). However, companies should challenge themselves as to what end their policies and procedures serve – what are they looking to ensure, or prevent, and if anything is excessively burdensome, this should be challenged, assessed, and revised where possible. Developing longer-term strategic partnerships, particularly to support initiatives that are driven by patient groups.
- The truth is that existing codes (EFPIA, IPHA, EMA-PCWP, HTAi framework) hold mostly ethical & legal content (collaboration, communication, funding etc.). Focuses on control of advertising regs, marketing of individual products, not ‘higher-level patient involvement (e.g. in R&D). IPHA code does not apply to ‘pre-competitive activity’
- Are Irish patient organisations being ‘over-complianced’? Reporting can often be quite onerous, depending on the initiative Pharma in Ireland are predominantly global companies with issues experienced with POs in other jurisdictions possibly leading to internal company cultures being applied in Irish context? Are companies sticking to internal company + external trade codes with little flexibility? We are in the danger zone of losing some POs - is that something that pharmaceutical companies are concerned about/can do anything about? What about other healthcare industries?
- What is PPI and why is it gaining momentum? Efforts to improve public and patient involvement (PPI) across the health sector in Ireland are ongoing, with many recognising that PPI is an integral part of effective and quality health policy development, health service design and improvement, health research, and health industry work processes.
- Health services in Ireland are including patient voices in decision making to a greater extent now than ever before. The HSE’s National Strategy for Service User Involvement 2008-2013, the National Patients Forum, the National Patient Experience Survey and the IPPOSI-led Patient Narrative project are examples. Furthermore, the Department of Health is working with IPPOSI and other relevant patient-led organisations in areas such as rare diseases, dementia and others.
- 3 Pharma Companies submitted examples of PPI Where are the collaborative projects working with the Irish health service and including patient groups as KOL in the design and implementation of solutions? (a la the NHS)
- Awareness raising’ is easy to measure by traditional PR metrics. Is long-term involvement (esp. in research & development) more difficult to measure? Companies have a commercial interest in patients talking about a particular condition – we’re all lying to each other if we don’t admit that. If we are delivering services that is gained through honest conversations, then fine, but short-termism would not be in POs best interest.
- POs experience of patient group-facing team is patient-centred. Majority of companies are prudent, helpful, but is the pragmatic approach wrong..?
- Raising awareness for an area that support doesn’t exist for is wrong – compliance won’t let that happen. But compliance also need to be brave – the purpose is to improve healthcare, and deepen people’s appreciation of certain disease areas, not to ‘sell red tops’. Can compliance officers be more patient-facing? Can compliance officers be informed more about the typical existence/work of patient groups?
- Patients and Patient Groups are inherently innovative and willing to work in professional partnership relationship is fragile, dynamic, uncomfortable, ambitious, and goal-oriented very often, all that patient organisations have is their credibility but they also must be effective and feel trusted Irish patient groups are well-networked but some are struggling financially, may not survive current crisis Growing body of evidence that Patient & Public involvement is vital for reducing healthcare inequities improving health and wellbeing outcomes ensuring the overall quality of health care and health R&D improving data quality & sharing Compliance is currently focused on trust and transparency, not on collaborative relationships with patients Are pharma companies in danger of losing ground due to over-compliance? When it comes to patient community engagement, you can't only reach out when there is an ask. Proper investment in communities 'pre-engagement' is important for building relationships and trust.