Perspective Chapter: Patient Advocacy - From a Seat at the Table to Equal Stakeholders

Abstract

Much has changed in individual and policy level patient advocacy in the years since the late 1980s when HIV/AIDS activists challenged the United States medical product regulator and aspects of how randomised controlled trials are conducted. Delays in access to innovative, life-saving medical interventions continue to be a key topic. We provide storylines to explore three interrelated pathways. The first follows the involvement of patients in the medical product lifecycle and clinical trial regulation, where the biopharmaceutical industry is a major stakeholder. The second follows the course of evidence-based practice and patients, the need for outcome measures of patient experience data and patient-relevant outcome measures that incorporate the patient voice into person-centred models of healthcare; and how regulators and HTA bodies are accelerating access to innovative medical products. The third storyline uses the European Union with its public-private funding of medical and healthcare research as a case study to highlight how patient advocacy is changing. Following the maturation of patient advocacy from patients as research subjects to patient involvement and centredness throughout the medical product lifecycle, we suggest possible next steps to continue to evolve patient advocacy into equal stakeholders within healthcare and innovative medical product development.