Disruption is coming to health and the life sciences, from telehealth and wearable devices to artificial intelligence and machine learning. Technological advances, coupled with policy initiatives around patients’ rights, transparency and the use of data, are charting new paths for all stakeholders in health.

Among these, one of the biggest disruptors – patient involvement and engagement – has been quietly progressing for decades. It is bringing much needed gains by ensuring that patients’ voices are heard in research and drug development, in the co-design of health and care, and in the strengthening of patient organisations.

For example, the winner of the PTT’s  Health Collaboration Awards – the International Map of Axial Spondyloarthritis (IMAS) – brings together patients, patient organisations, clinicians, researchers, and industry to evaluate patients’ experiences within healthcare systems and facilitate shared decision-making.

This collaboration is one of many positive initiatives paving the way for a more patient-driven culture. In the biopharmaceutical industry, for example, shifts in culture, leadership, and mindset, coupled with capacity building to expand the skillsets of individuals across company functions, can take patient engagement to the next level.

The desired individual skillset

The EFPIA Patient Think Tank, a group of patient leaders and industry representatives, imagined the ‘ideal profile’ for patient engagement leads within industry. Individuals fulfilling such an important role should ideally gather the following skills and knowledge:   

• Excellent communication and listening skills, which enables them to advocate internally for patient centricity, and build relationships and coalitions externally;
• The capacity to see the person not the disease, and have a person-driven approach;
• Knowledge about their focus disease area, the regulatory environment, and the health technology assessment (HTA) process;
• Awareness of the patient movement, and its key players, current trends and what may be coming next;
• Understanding of how their companies work, empowering them to identify meaningful engagement opportunities and advocate for the inclusion of patient voices in research & development, access, and regulatory aspects; and
• The ability to bring colleagues on board from key functions across the organization.

The EFPIA Patient Think Tank is not daydreaming. In fact, several guidelines have already codified these requirements. The Council for International Organisations of Medical Sciences (CIOMS) refers to two main skillsets for patient engagement: awareness and technical skills. The former entails an understanding of patients and patient organisations, and of where to find case studies and best practices. The latter comprises communication skills and concrete evaluation tools for handling data from patient engagement, as well as listening skills and cultural sensitivity.  

Equally, the IMI-Paradigm tool – Recommendations on the required capabilities for patient engagement – lists the competencies and resources that each stakeholder organisation needs to plan, implement and evaluate meaningful and sustainable patient engagement activities across the medicines lifecycle. Based on the IMI-Paradigm outputs, the key elements to consider are (1) shared purpose and roles and responsibilities of all stakeholders (2) respect and accessibility (3) representativeness of all stakeholders (4) transparency in communication and documentation[1] and (5) continuity and sustainability[2].

A distinction should be made between individual skills and enhanced capacity building and resources at an organisational level. Both need to be nurtured, and both are mutually reinforcing.

Several challenges persist at the organisational level. As a highly regulated industry, the pharmaceutical sector requires more internal leadership to incorporate patient engagement across all its relevant functions. Coupled with a commitment from leadership and an enabling administrative framework,[3] companies need to think long-term by taking a strategic approach to the staff capacity building and the allocation of internal funding.

Lingering questions remain: is patient engagement an overarching mindset or assigned to certain functions in the organisation (or both)? And how does building this capacity benefit the entire organisation?

What can be done in practice?

Several recommendations stand out.

A first step is to reach out to leadership for commitment and a strategic plan around the training of staff and allocation of resources.

Next, a framework of skills should be developed, including agreed quality criteria for optimal patient engagement training and a set of learning outcomes. This is best achieved in a multistakeholder collaboration including patients, industry, academia, and organisations currently providing this type of training (e.g., DIA, EFFCA, EPF, EUPATI, ISMPP, MAPS, PFMD, PCORI, and WECAN).

The agreed framework should reflect the different levels of skills required. For example, functions interacting directly with patient organisations will need more comprehensive training to become subject matter experts. For them, a ‘learning academy’ could be developed to support patient engagement leads to grow in their roles through a diverse curriculum. Similarly, joint trainings[4] on relevant topics for patient organisations and industry patient engagement leads may help build a common set of learnings and ways of working.

Equally important is updating the training needs to match developments in this space. For example, the increased interest in the generation, collection and use of patient experience and preference data should be matched by both internal competencies and mechanisms to manage and share the data, and an understanding of how this data generation can incorporate best practices in patient engagement.

For capacity building efforts to be successful, all players in the healthcare ecosystem should be aware of the patient engagement landscape. Regulatory bodies and country-level agencies need to be increasingly sensitised to the ways of working with patient communities, and to the meaningful, ethical, and transparent collaboration that industry and patient organisations have been developing.

Over the coming months, the EFPIA Patient Think Tank will continue acting as a forum for discussion and co-creation between industry, patient organisations, patient experts and researchers to advance these topics. 

Authors (in alphabetical order):

Magdalena Daccord, Executive Director, FH Europe
Maria Dutarte, Executive Director, European Patients Academy on Therapeutic Innovation (EUPATI)
Elsie Evans, Ambassador Programme Manager, FH Europe
Isabella Haaf, Head of Communications, European Federation of Crohn’s & Ulcerative Colitis Association (EFCCA)
Wafae Iraqi, EMEA Patient Engagement Manager, Janssen: Pharmaceutical companies of Johnson & Johnson
Mihaela Militaru, Senior Director, EU Patient Insights & Advocacy, Oncology, Merck
Dr. Paul Robinson, Patient Engagement Lead, Europe, MSD
Oana Scarlatescu, Associate Director, Strategic Partnerships and Healthcare Systems, EFPIA
Thomas Smith, EUPATI Fellow & Independent Patient Engagement Consultant
Martina Vaccariello, Public Affairs Manager – Oncology & Neuroscience Europe, Abbvie

This post is the work of a writing group representing patient experts, patient organisations (POs) and industry patient engagement (PE) leads, formed within the EFPIA Patient Think Tank (PTT). Together, the authors summarise the highlights and recommendations of a recent PTT workshop on capacity building in the context of patient engagement.

[1] For example, legal agreements and confidentiality, management of competing interests, codes of conduct and rules of engagement and reach-out to and interactions with patients and patient organisations. See Patient Focused Medicines Development (PFMD) Patient Engagement Quality Guidance, which provides an agreed set of overarching principles that help ensuring the quality of PE in existing and future projects and enables showcasing the results and impact of projects in a systematic way. Available at:  https:// patientfocusedmedicine.org/the-patient-engagement-quality-guidance/. Cited in the IMI-Paradigm tool Recommendations on the required capabilities for patient engagement, pp. 3-4.

[2] For example, financial compensation and measuring PE impact.

[3] See Workgroup of European Cancer Patient Advocacy Networks (WECAN), Reasonable Legal Agreements between Patient Advocates and Pharmaceutical Companies, available here: https://wecanadvocate.eu/rapp/.

[4] For example, the EUPATI Fellowship Programme, available here: https://eupati.eu/news/become-a-eupati-fellow/, and the Master in International Patient Advocacy, available here: https://www.eu-patient.eu/capacity-building-programme/master-in-international-patient-advocacy-management/.