In this #TalkClinicalTrials blog, Laurie Proulx & Dawn Richards explore how lived experience must be embedded in pharmaceutical policy—not just as consultation, but as a foundation for decision-making.
We live in a time marked by widespread distrust and unpredictability is the norm. Access to medications that help keep people healthy are being scrutinized and difficult resource allocation decisions are unavoidable in healthcare. Addressing these complex problems requires innovative approaches and the recognition that not a single person or perspective holds all of the answers.
In the midst of these challenges, people such as members of CTO’s College of Lived Experience, who have a range of disease and other lived experiences, bring those experiences to the clinical trials and broader health policy making space as patient partners. These individuals stand at the true front line of healthcare – not in hospitals or government agencies – but in the daily lives of people navigating immense challenges.
In contrast, pharmaceutical policy making often relies on traditional consultation processes that struggle to adapt to the needs of the communities they serve, like those the College of Lived Experience members are part of. Decisions are frequently made behind closed doors at high-level meetings with little direct engagement of patient communities. When these organizations do engage patient communities, many of these organizations hire others to do the work, instead of building the capacity within their organizations for this essential work. Moreover, many staff working in these organizations enjoy stable incomes and comprehensive benefits – privileges not shared by many patients whose lives they aim to support.
The result? A growing disconnect between pharmaceutical policy makers and people they aim to serve, fueling frustration and mistrust. But change is possible. By fostering dialogue and patient engagement, pharmaceutical policy makers can rebuild trust, leverage the strengths of interest holders and fulfill their responsibility to govern inclusively and effectively.
“It takes too much time to engage patients”
In August 2024, a report about Patient Engagement in Canada’s Pharmaceutical System was released. Penned by the first-ever Patient Advisor (LP) hired by the Canadian Drug Agency Transition Office at Health Canada, this report provides a roadmap for integrating lived and living (aka ‘patient’) experiences into pharmaceutical policy decision-making. However, feedback received from policy makers since its release highlights persistent challenges and attitudes: “It takes too much time to engage patients”, “Our work is confidential”, or “We just use the patient input submission provided to Canada’s Drug Agency (CDA)”.
In our view, these comments miss the mark. Instead of patching up existing methods or simply brushing off an investment into meaningful engagement, how about co-creating streamlined processes across the federal pharmaceutical system (Health Canada, CDA, Patented Medicine Prices Review Board, and the pan-Canadian Pharmaceutical Alliance) that are meaningful and effective? This doesn’t mean adding another layer to the already burdensome patient input submission process. Instead, it calls for identifying opportunities—from the earliest stages of clinical trials and regulatory approvals—to embed patient perspectives directly into decision-making. Confidentiality concerns can also be addressed with thoughtful planning (as is done in many organizations). For instance, engagement processes can be designed to protect sensitive information while allowing patients to contribute meaningfully to areas such as clinical trial design, pricing strategies, and product listing agreements.
Patient community-led solutions
The report goes a step farther, recommending that individuals with lived experience be hired into the organizations involved in pharmaceutical policy making. This idea is not new with rare examples in Canada and across the globe. Who better to rebuild trust and understand the patient experiences than patients themselves? With each organization embracing this approach, these patient leaders could form a community of practice across the sector to share best practices, develop and coordinate aligned approaches, and guide systemic change. The people employed in the federal pharmaceutical organizations often have advanced degrees though most have not received formal training in meaningful patient engagement. Patient leaders can help bridge this gap by guiding organizations in adapting engagement processes, such as :
- Acknowledging that learning is part of the process. Patient engagement was not in your university textbook and it’s a process, not an output. It involves building trust, creating safe spaces, and building relationships. This takes time, but it is worth it.
- Creating opportunities for diverse perspectives. Set up a panel of people with lived and living experience to provide feedback similar to CTO’s College of Lived Experience. Don’t feel the need to have all the answers—in fact, it’s better if you don’t. Include voices you haven’t heard before and avoid creating an echo chamber of familiar perspectives. The goal is to hear from people who can challenge assumptions and improve decision- and policy-making.
- Prioritizing inclusivity and transparency. Use transparent recruitment processes, such as public notices that explain how selection decisions will be made. Don’t default to patient partners you’ve worked with in the past; make a concerted effort to broaden the pool of participants and ensure diverse representation.
- Embracing difficult feedback as an opportunity to grow. Healthcare has failed people with real-life consequences. Some have lost loved ones or face challenges that don’t fit conventional medical models. These realities can be painful to hear but are essential to understanding how to improve the system. Listening with empathy and with intent to act is key.
Now is the time to reflect on whether we’re addressing the root causes of the challenges facing pharmaceutical policy and healthcare. Embedding lived experiences must be a priority and a foundational principle guiding decision- and policy-making. To achieve this, pharmaceutical policy makers must come together to take a system-wide approach to engaging the communities they serve, simplify and better coordinate these efforts across organizations. The complexity of today’s problems, and those we will face in the future, require bold, inclusive, and innovative approaches.
#TalkClinicalTrials is a campaign led by CTO with the goal of building awareness around clinical trials. Why? Because clinical trials matter to all of us. They help to generate better treatments and technologies and ultimately help shape the future of medicine. Explore more stories from the series and join the conversation on social media using #TalkClinicalTrials.