Introduction

Over the last two decades, healthcare institutions in Canada and abroad have increasingly sought input from members of the public and, in particular, patients to improve the legitimacy of decision making (Reference Dhamanaskar, Boothe and Massie1;Reference Manafo, Petermann, Mason-Lai and Vandall-Walker2). Recently, Canada has introduced both a new institution (Canada’s Drug Agency – CDA) as well as the beginnings of a national pharmacare program. With such developments, the question of how patients and the public interface with government decision making is particularly relevant. In this analysis, we aim to open the discussion surrounding such engagement as it is being undertaken in health technology assessment, advising, and regulatory decision making within the evolving Canadian pharmaceutical landscape. Patients and the public offer unique insights into health technology pricing and regulation that have too frequently been overlooked at the institutional level (Reference Wale, Thomas, Hamerlijnck and Hollander3–Reference Facey, Holtorf and Single5). Their experiential knowledge of disorders or conditions means that patients, and other members of the public, including caregivers and people with lived experiences of disorders or conditions, are key to ensuring that institutional decision making reflects the needs and interests of those they will impact most (Reference Wale, Thomas, Hamerlijnck and Hollander3;Reference Facey, Holtorf and Single5). Our analysis begins by addressing the values behind patient and public engagement (PPE) and ongoing developments in pharmaceutical assessments and regulation. We then take a closer look at the forms of PPE implemented by Canadian regulatory and advisory institutions. Finally, we raise questions to guide the further integration of PPE in Canadian institutions. The term patient and public engagement (PPE) is used throughout this article when addressing efforts by Canadian institutions to include impacted laypeople in their decision making processes. When referencing the “public,” we include the general Canadian population (taxpayers), caregivers, and people with lived experiences of disorders or conditions, who do not see themselves as patients but rather active participants in their medical care. Although we could simply use “public engagement,” we believe it is of value to highlight the interests and needs of patients within the medical system, who are most impacted by the outcomes of any decision made by the five institutions. We also aim to highlight the connection between the two terms, acknowledging that every member of the public has the potential to become a patient at any time, and to address the role that institutions have in creating a link between experiences of “patienthood” and the public interest.

What is PPE and why do it?

Motivations for advancing PPE in health institutions, including among Canadian health technology regulatory and advisory bodies, can be understood as emerging from three interconnected value systems, as outlined in a recent scoping review by Gradinger et al. (Reference Gradinger, Britten and Wyatt6), focused on varying approaches to conducting public involvement in health and social science research. These value systems are the process-oriented approach, which focuses on interpersonal ethics and fairness in the practice of PPE; the normative approach, concerning issues of justice and power dynamics; and the substantive approach, the primary concern of which is outcomes (Reference Gradinger, Britten and Wyatt6). In this commentary, we adapt this framework for understanding why and how Canadian health technology (HT) institutions may undertake PPE. In the concrete realities of practice and implementation, ethical concerns re-emerge as questions of political economy – such as: whose interests are prioritized? Who gets overlooked? And why?

We interpret Gradinger et al.’s three value systems as corresponding with three different systems of ethical reasoning: (i) process-oriented values correspond to contextual ethical reasoning; (ii) normative values come from a deontological ethical reasoning; (iii) substantive value systems reflect utilitarian ethical reasoning. No one strain of ethical reasoning provides a definitive or correct answer above the others. The different forms of ethical reasoning are not mutually exclusive and therefore may converge and overlap, find parallel or different reasons for the same conclusion, or conflict (Reference Badea, Bramer and Stahl7). For example, there is overlap between process-oriented values and normative values because justice intersects with the right to participate and because power plays a role in who has the ability to participate.

Through a process-oriented lens, PPE is focused on participation and representation in developing safer and more effective medical services and technologies that better reflect patient and public needs, values, and preferences (Reference Gradinger, Britten and Wyatt6;8). In applying a process-oriented value system to PPE in health technology assessments (HTAs), a primary concern is ensuring best practice in the process of engaging patients and members of the public (Reference Gradinger, Britten and Wyatt6). This includes ensuring that those included feel respected and valued for their contributions and are treated with fairness and honesty by the institution, researchers, regulators, advisors, and others in positions of power. In an ideal process-oriented approach to PPE, patients should experience their involvement as a form of partnership – feeling that their contributions are valued equally, have clear information regarding their roles and the institution’s desire for PPE, and feeling comfortable providing their input independently and openly.

As a normative project, PPE practices draw on a historical legacy of social movement advocacy aimed at empowering patients and people with lived experience of illness (Reference Brown, Zavestoski and McCormick9–Reference Macdonald11). The desired result has often been to push institutional reform, or, at the very least, the development of policies and agendas that better reflect the realities and needs of those most impacted by them (Reference Tritter12). PPE undertaken based on normative values will tend toward measurable indicators of overall success, such as the number of patients or unique communities consulted and the level of change (e.g., policy change, service change, or organizational change) resulting from PPE-informed decisions (Reference Gradinger, Britten and Wyatt6). Additionally, normative-based PPE will tend toward ensuring accountability and transparency in outcomes.

From a substantive value perspective, PPE can encourage the public to take on a greater role in furthering the goals of health promotion. The substantive value perspective shifts PPE from a one-way channel of contributions made by patients, toward a two-way relationship between the public (including patients) and institutions: Institutions as a knowledge producer can disseminate or “mobilize” their knowledge to the public, creating a more informed public, and members of the public can use the knowledge from their lived experience to improve the quality, relevance, and validity of decision making. Institutions undertaking a substantive value PPE approach will make efforts to recognize the holistic needs and preferences of patients and the public, including by “asking research questions relevant to the public, developing research tools which are more meaningful, culturally relevant, sensitive or appropriate to the public” (Reference Gradinger, Britten and Wyatt6) (p. 668). In addition, by taking an opportunity to work collaboratively with marginalized communities when addressing issues disproportionately impacting them, healthcare decision-makers can make efforts to regain trust lost through decades of hegemonic decision making and address systemic disparities in treatment and health outcomes (Reference George and Abebe13).

Though the goals may vary or be approached from different angles, the core rationale for PPE is democratic reform of systems of health and social care to better serve the public interest. This framing is not meant to be used in an evaluative manner. We are not claiming that process, normative or substantive values are relatively better or worse than each other. As we will see in our description of PPE in Canada’s pharmaceutical system, priorities considered to serve the public interest vary according to the mandate of institutions. Recognizing that there is a balancing act among values and tension across the value systems can help organizational actors recognize what they are also not doing and/or expecting other components in the system to do for them. In essence, this framing may allow actors in the HTA system to be more deliberate and explicit in their approach to PPE.

The political economy of ethical priorities in PPE

When it comes to real-world implementation, abstract ethical ideas become concrete issues of political economy dealing with how and why resources are distributed and allocated. We combine Gradinger et al.’s framework (Reference Gradinger, Britten and Wyatt6) of the three value systems of PPE, with a political economy lens that maps their ethical priorities onto the economic (regarding allocation of resources and responsibilities), political (regarding distribution of resources and responsibilities), and axiomatic (regarding standards for justice in PPE) concerns, which they tend to focus when articulating a vision for PPE. In Table 1 below we offer a matrix that outlines key questions, concepts, traditions of ethics, and notions of justice likely to be of importance to each value orientation.

Table 1.

Value systems in patient and public engagement in terms of economic, political, and axiomatic foci

Table 1. Long description

The table consists of four columns and four rows including the header.

Column headers from left to right are: Value system in PP E, Economic focus, Political focus, and Axiomatic focus.

Row 1: Process-oriented (contextual ethics) asking ‘Is it fair?’. Economic focus: Inputs needed for P P E, including labor, resources, and time. Political focus: Representation, including agencies, organizations, and procedures. Axiomatic focus: Procedural justice regarding moral standards of governance.

Row 2: Substantive-oriented (utilitarian ethics) asking ‘Is it effective?’. Economic focus: Outputs of P P E and goal outcomes. Political focus: Measurement and standards for evidence in evaluation. Axiomatic focus: Epistemic justice regarding the representation of the public good.

Row 3: Normative (power and justice)-oriented (deontological ethics) asking ‘What does it change?’. Economic focus: Mechanism of action to make P P E effective and power conferral to participants. Political focus: Empowerment and cultural change, contrasting technocratic versus democratic governance. Axiomatic focus: Social justice and the protection of the public interest.

A footnote defines PPE as patient and patient engagement.

PPE, patient and public engagement.

This matrix provides an opportunity for reflecting on and articulating the real-world challenges that people and organizations with various value-orientations face when implementing or doing PPE. For example, although those who are driven by normative concerns may have a strong axiomatic case for PPE, a focus on the day-to-day mechanisms of operation that would set those notions of justice into motion may be a weak point. Likewise, those who are inclined toward substantive concerns may have a sense of which outputs would be most economically or clinically effective, although they may fail to consider matters of epistemic justice that shape how the experiences of marginalized people are accounted for (Reference Dhamanaskar, Abelson, Gavin, Schwartz, Vanstone, Facey, Holtorf and Single14;Reference Vanstone, Abelson and Bidonde15). A process-oriented approach may be preoccupied with consensus-building among unequal parties, risking the replication of unjust power structures (as seen in tokenism (Reference Hahn, Hoffmann and Felzien16)) and obscuring division that can complicate meaningful reconciliation. Similarly, the same orientation may lead to protracted debates about representation (Reference Scholz, Kirk and Warner17;Reference Maguire and Britten18) that are in danger of conflating PPE’s political capacity to be representative and fair with its economic capacity to affect systemic change (Reference Madden and Speed19). Any institution taking a serious approach to PPE cannot afford to disregard any of these angles of critique, as they all raise potentially valid concerns.

The next section gives a descriptive overview of PPE in Canada’s HT and pharmaceutical regulation system, derived from an exploratory review of the scientific literature, gray literature, and publicly available information from the organizations in question. Following this descriptive section, our commentary analyzes PPE in this regulatory landscape using the framework outlined above.

PPE in Canada’s evolving pharmaceutical system

Regulatory approval, advisory, and pricing processes are valuable opportunities for PPE, as the decisions made at these points will impact how HTs are used down the line. HTs include medicines, medical devices, vaccines, assistive technologies, as well as procedures and techniques, and are a key component of effective health systems (20).

In spite of this, a recent report by the Canadian Drug Agency Transition Office identified a lack of systematic patient engagement across the pharmaceutical system (21). Such a finding is especially disconcerting when considering the public’s support for engagement: In a 2016 survey of 182 patients across Canada, “more than half prefer regular input to all agencies in drug review process”; many believe that patients should be consulted as needed or provide feedback on recommendations; and almost none believe that input is not necessary at any stage of the review process (22).

Likewise, in a 2020 series of focus groups with members of the Canadian public, most participants believed public input to be important for HTA funding decision making “especially when research evidence is not clear on whether the benefits of a health technology outweigh its harms” (Reference Lopes, Street, Stafinski, Merlin and Carter23) (p. 594). Many participants felt that they did not properly understand the decision making processes being undertaken and saw a need for greater involvement from the government in educating and informing the public on engagement opportunities.

In February 2024, the Canadian Minister of Health advanced an important step in a path toward a universal single-payer “pharmacare” framework (Reference Zimonjic24) with the Pharmacare Act granting Canadians access to a number of publicly funded contraception and diabetic medications (25). In December 2023, Health Canada announced the creation of CDA, which expands a role previously held by the Canadian Agency for Drugs and Technologies in Health (CADTH), improving the coordination and monitoring of Canada’s federal and provincial drug regulatory systems and ensuring more appropriate prescription of medications (26;27).

Canada’s five national bodies: Roles and responsibilities

At the national level, five institutions currently hold responsibility for assessing, regulating, and pricing drugs and other HTs at various stages in their lifecycle: (i) Health Canada; (ii) CDA; (iii) Institut national d’excellence en santé et en services sociaux (INESSS); (iv) the Patented Medicine Prices Review Board (PMPRB); and (v) the pan-Canadian Pharmaceutical Alliance (pCPA). These institutions work together to varying degrees and, in efforts to reduce redundancy, often rely on results from their partners in making their own decisions on given HTs (Table 2).

Table 2.

An overview of Canada’s five health technology regulatory and advisory bodies

Table 2. Long description

The table consists of two columns: Institution and Purpose and responsibilities.

* Health Canada: A federal department responsible for national health policy and services. It assesses the efficacy, safety, and benefits of health products before approval and conducts post-market surveillance.

* C DA: A Canada-wide organization (excluding Quebec) providing evidence-based advice on drugs and devices. It focuses on comparative effectiveness and cost-effective solutions for public health plans.

* IN E S S S: An independent advisory organization in Quebec that conducts H T As and provides recommendations on clinical advantages and costs for the Quebec public health plan.

* P M P R B: An independent quasi-judicial body that monitors the prices of patented medicines to ensure they are not excessive. It can order price reductions and offset excess revenues.

* p C P A: An alliance of provincial, territorial, and federal public health plans that negotiates drug prices with manufacturers to achieve greater value for Canadians after recommendations from C D A or I N E S S S.

CDA, Canada’s Drug Agency; HT, health technology; HTA, health technology assessment; INESSS, Institut national d’excellence en santé et en services sociaux; pCPA, Pan-Canadian Pharmaceutical Alliance; PMPRB, Patented Medicine Prices Review Board.

Based on the information we collected about each of the five HTA regulatory institutions, Figure 1 categorizes the institutions based on their key responsibilities, functions, and incorporation of PPE in decision making.

Figure 1.

Canada’s health technology ecosystem consisting of five major bodies, organized in this figure by their regulatory versus advisory roles and focus on safety/efficacy versus cost/pricing. This model provides a basic explanation of the primary purposes of the respective institutions, useful to understand before assessing whether the PPE initiatives being undertaken at each institution are appropriate.

Figure 1. Long description

Quadrant diagram of Canadian health technology bodies. The horizontal axis runs from Regulatory (left) to Advisory (right); the vertical axis from Safety/Efficacy (top) to Cost/Pricing (bottom). Shading shows extent of patient and public engagement (PPE). Top left: Health Canada, which assesses safety and efficacy for market approval; pale blue, committed to PPE but no clear effort. Top right: overlapping ovals for CADTH/CDA, which advises health authorities, hospitals and drug plans on purchasing new technologies, and INESSS, which assesses technologies for Quebec; both dark blue, extensive and established PPE. Bottom left: PMPRB, which regulates prices of patented medicines; medium blue, limited PPE, working toward more. Bottom right: pCPA, which negotiates prices for provincial and territorial health plans; white, no PPE and no commitment.

Methods

We conducted a structured search of publicly available documents for each of the five institutions to identify engagement efforts. This included a comprehensive review of each institution’s Web site and a structured keyword web search to identify institutional publications and guidance documents, news briefings, public reports, and presentations. For INESSS, which publishes mainly in French, we included French keyword searches for original source documents and English keyword searches of translated versions of the relevant Web sites. When necessary, French-only documents were translated to English prior to analysis. These searches were conducted in June 2024, September 2025, and then updated again in May 2026. We also consulted published scientific literature reporting PPE practices as they related to any of the five institutions of interest. We did not formally consult with representatives from the five institutions, but when relevant, we did contact institutional representatives to obtain previously unpublished reports, for example regarding the Orphan Drug Patient Involvement Pilot Project at Health Canada. Observations on PPE practices were also made from a formal public presentation on pharmaceutical decision making processes in Canada delivered at the National Congress on Pain (2024) (35). Our approach has clear limitations and is not intended to convey a full picture of PPE activities in the five institutions, but rather to serve as a sufficient basis for the analytic reflection we offer below. Specifically, observations have been made on limited publicly available information, and interpretations should be considered as provisional and may be useful in informing further empirical work.

Patient and public engagement in Canada’s HTA institutions

Health Canada outlines an intent for intentional and deep PPE in their Public Engagement Guideline yet has only vague descriptions of actual PPE activities undertaken and includes a minimal focus on PPE in their current Departmental Plan (36). A Patient Involvement Pilot Project was launched in August 2014 to support readiness for a proposed Orphan Drug Regulatory Framework (37). However, mechanisms for patient involvement piloted as part of this initiative do not appear to have been continued or expanded into other regulatory processes. Patients are occasionally included on advisory committees and task forces, such as the Canadian Pain Task Force (38), and invited to participate in online interactions, surveys, and in-person meetings to offer insights on particular drug submissions or address emerging and/or controversial postmarket issues (37;39). There is little evidence of such parallel input processes in recent years, and it has been suggested that between 2001 and 2021, most PPE at the federal level consisted of one-time feedback by self-selected individuals (Reference Dhamanaskar, Abelson and Boothe40). Health Canada published a policy document in 2022 on external advisory bodies, which Health Canada appoints based on their relevant knowledge, including “first-hand personal experience as a health professional, patient, people with lived and living experience (PWLLE), consumer, or caregiver” (41) (p. 7). Health Canada suggests that these bodies “provide Health Canada with expert advice from individuals who have relevant knowledge, expertise, or experience. The advice may relate to scientific, technical, policy, or program matters” (41) (p. 1). There are also occasional ongoing consultations happening at Health Canada, though very rarely about drugs and HTs (42). The Stakeholder Registry is run by Health Canada and the Public Health Agency of Canada to communicate directly with stakeholders about consultations and/or other health-related information. Both individuals and organizations can register to stay informed about consultations and engagement (43).

The pCPA, despite claiming an institutional priority focused on purpose-driven partnerships regarding external collaboration with partners and the community, does not engage in any form of PPE and does not see a need for “patient group representation for individual negotiations at the pCPA level” nor in how the organization operates (44) (p. 10). In its 2026–9 Strategic Plan, however, pCPA does mention patient groups as among the stakeholders whose feedback through surveys, consultations, and workshops has shaped the plan (45). The institution relies on recommendations from the CDA and INESSS in determining whether to enter negotiations on a particular drug; the pCPA appears to also rely on the PPE activities of these other organizations. In the development of their Temporary Access Process (pTAP), which grants certain patients access to innovative pharmaceuticals prior to their entrance into the market, the pCPA engaged with twenty-seven patient groups, as well as several clinicals and industry representatives, through a questionnaire, stakeholder engagement sessions, and written feedback in August 2023. These input opportunities granted patient groups an opportunity to provide feedback on the pTAP process (46). As the pCPA’s sole focus is price negotiations, any public input collected under their purview may only relate to pricing and institutional decisions and would not impact whether the HT is brought to market. Nevertheless, the pricing decision made through pCPA negotiations will have a direct impact on the public’s ability to access affordable pharmaceuticals; this remains an important potential space for PPE.

PMPRB seeks public input from patient organizations, individual patients and other interest-holders when a potential improvement to guidelines, regulations or policies may be made. In 2019, the PMPRB appointed a steering committee to provide insight on “stakeholder views on key technical and operational modalities” regarding new draft guidelines (47) (p. 1). This committee included representatives from pharmaceutical corporations, nongovernmental organizations, and governmental institutions, as well as representatives of a handful of patient communities (32). No public or patient representatives were on the committee, though a working group to inform the steering committee did include patient members (47). Substantive barriers to PPE engagement persist, including a lack of follow-up to input from patient groups, and a lack of resources and training for patient communities to support their meaningful contributions to pricing discussions (48).

INESSS has four permanent deliberative committees, all of which are mandated by legislation to include citizen representatives. INESSS also has an in-depth consultation process for the review of new drugs and health technologies undertaken by the Direction de l’évaluation des médicaments et des technologies à fins de remboursement (DER) (49). This directorate is responsible for assessing data, deliberating, and making recommendations to the Minister of Health for applications related to new drugs and changes to already-listed drug indications (50). During a drug assessment period, members of the public, patients, caregivers, and health professionals registered for INESSS communications will be informed of proposed decisions, and all interested members of the public are invited to participate in consultations (50). People with the disease or condition in question, caregivers, and patient groups are all invited to participate in consultations either by questionnaire or by applying to take part in interviews or focus groups (51). INESSS has had the advantage of a strong intellectual foundation upon which to build its PPE strategy, benefiting from the expertise and experience of work done at the University of Montreal to formulate the “Montreal Model” of patient engagement (Reference Pomey and Lebel52).

CADTH, prior to its transformation into the CDA, developed an active PPE strategy that involved opportunities for patients and caregivers to be included when designing protocols, aiding in interpreting trial results, and identifying ethical issues; small-group consultations on condition-related technologies with representatives from patient groups of varying sizes across Canada; and Patient Community Liaison Forums (discontinued in 2018), where patients can share information and collaborate on “high-level policy and process issues… e.g., training, dealing with conflict of interest requirements, feedback to patient groups, etc.” (53) (p. 1). As of 2019, CADTH (now CDA) has replaced these liaison forums with the Patient Community Advisory Committee.

With the transition from CADTH to the CDA, the new organization has expanded its scope and rationale for patient engagement. As of 2026, the CDA has four expert committees, each with between one and three patient members, on committees comprising between eight and nineteen total members (54–57). When the CDA wants to garner a greater understanding of public knowledge of HTs under review, the institution proactively communicates with patients via email and social media, particularly when no patient organization exists relevant to a given topic. Members of the public are also provided with opportunities to learn how they can best contribute through annual webcasts and lectures, and are provided honoraria for their time when appropriate (58). In December 2024, the CDA announced the appointment of the first-ever Patient Member on the institution’s Board of Directors (59). Due to the fast-moving nature of this field and recent developments at the CDA, an exhaustive review of the PPE activities of the CDA is beyond the scope of this commentary. Judging from publicly available information, however, deepening PPE at the CDA seems to be a clear aspiration of the organization. In the CDA’s online materials, it expresses a rationale for organizational embeddedness of PPE (60); openness to learning from other patient engagement efforts such as Strategy for Patient-Oriented Research (SPOR) and PaCER, which have deepened PPE practices (61); and sets out a clear framework for the rationale and standards of PPE.

Analyzing the current landscape of PPE in Canadian pharmaceutical and HT decision making

The case of PPE in Canadian HT and pharmaceutical regulation has relevance to other sectors and other levels of policy because it is one area where the ethics of engagement imply members of the public are more closely involved in the decision making of the regulatory state, including serving in organizational roles, such as appointed patient representatives, rather than as an input to a feedback mechanism (Reference Nabarette, Chastenay, Dupont, Ganache and Single62). In other words, this is an important and somewhat novel case for PPE where it has the potential to reach beyond “participation” and “being heard” to exert an influence on questions of political economy. Scholars have noted that PPE has struggled in making the leap from process and rhetoric to societal impact (Reference Madden and Speed19).

PPE is being undertaken in some form at all five national pharmaceutical and HT regulatory and advisory decision making bodies. Nevertheless, there is significant variability across the institutions in terms of the depth and breadth of patient and public involvement, ranging from ad hoc occasional input at the pCPA for the development of new institutional mechanisms (e.g., pTAP) to recurrent strategic partnerships at the CDA addressing a range of topics from high-level institutional governance to individual drug-specific decisions.

Across the institutions, three common tendencies in Canadian PPE practice are evident through this analysis: (i) input from patients and members of the public appear to have greater influence over decisions related to institutional guidelines, policies, and strategic planning, rather than to regulatory and pricing decisions regarding particular HTs; (ii) input has generally been sought from patient groups, self-help groups and condition-specific organizations rather than individual patients or members of the public; and (iii) surface-level forms of engagement, such as public feedback, questionnaires, and surveys, tend to be opted over deeper-level engagement, such as open dialogue and deliberation sessions and long-term patient representation opportunities – unless significant effort is made to integrate patient engagement into organizational structure, such as in CDA and INESSS. A recent report by a patient advisor to the Government of Canada echoes these findings, and research on trends in PPE in Canadian health policy more broadly shows that this is not unique to the pharmaceutical and HT sector nor is its relevance limited to national-level policy in Canada (Reference Dhamanaskar, Boothe and Massie1).

Advancing PPE in Canada’s pharmaceutical system and beyond

Our earlier discussion of the political economy of ethics can be useful in examining how and why the five national bodies tend to approach PPE. The pCPA and the PMPRB demonstrate an outcome-oriented, economically focused approach to the public interest, utilizing forms of measurement and expert knowledge that tend toward a technocratic rather than democratic approach to governance. INESSS appears to have taken a normative approach in which a philosophical (axiomatic) foundation for PPE has guided the elaboration of its principles into institutional processes, visible in its strong desire to keep members of the public informed and engaged in decisions and consultation. The CDA seems to have followed the lead of INESSS in advancing PPE but from a more process-oriented approach that places emphasis on fairness, making its commitments to PPE somewhat more tentative and measured.

There is a trend worth noting in our analysis: smaller organizations with smaller mandates (the pCPA and PMPRB) tend to piggyback on the PPE efforts of larger organizations like CDA and INESSS. Moreover, institutions with coherent strategies lead the way, with INESSS’s PPE strategies forming something of a model, being taken up in CADTH’s transformation into the CDA. From these two observations, one can infer that in the political economy of PPE efforts, a coherent strategy seems to require a scale at which such an approach is materially possible, and likewise that operating at a larger scale demands a more coherent and comprehensive strategy, owing to the broadened horizon on which ethical reasoning takes place (Reference Macdonald11).

There is little available information on Health Canada’s PPE efforts, though it is important to note they make axiomatic commitments to PPE that square with each ethical approach we have outlined – calls for measurable, fair, empowering PPE (36). In such a case, one ought to read ethical priorities as standards to be met for implementation, which in turn can become barriers if there is no clear sense of how such standards can be met. As the largest, highest-profile, and least specific organization among the five institutions under discussion, Health Canada also has the broadest ethical mandate to fulfill in the implementation of PPE. At such a scale, the endeavor of PPE (often a relatively small-scale practice) changes and grows more complex: political concerns like measurement of, representation in, and empowerment through PPE would need to be operationalized in an economy of inputs, outputs, and mechanisms of action, – although they must be seen to stay true to their stated axioms. The seriousness of such a task would require an approach that could leverage and coordinate an effort at PPE that would address each political-economic concern from every ethical axis at a standard worthy of implementation. This task would require a strategy that had a satisfactory answer for every question we pose in Table 1.

There have been calls for a national, health condition-agnostic, patient-led organization to coordinate PPE in the Canadian healthcare landscape, and to support the advancement of PPE specifically in the pharmaceutical and HT regulatory system (Reference Proulx63). Should momentum build for such a national institution, this matrix could help guide deliberations on how and why this can be done. Given the potential scope of activity and possible conflicting values and processes, a national body could support a more deliberate approach to PPE. No such process would be worth undertaking if: (i) there were not adequate inputs of resources to ensure fair representation; (ii) there were not outputs that could be measured in a way that broadly accounted for their contribution to the public good (particularly where marginalization and health inequality are concerned); and (iii) there were not a clear mechanism by which people were empowered to pursue social justice in this forum. PPE, most often undertaken at far smaller scales, could not reasonably be expected to meet all of these standards simultaneously owing to lack of resources, scope, and mandate. As such, PPE has largely remained a dream of democratic reform in the health system – with some scholars warning that PPE is either a zombie (something unviable that refuses to die) or a unicorn (something conceivable but that has never been seen) (Reference Madden and Speed19). In our view, however, there is likely no better place to accomplish the scale-up and realization of PPE as a project of democratic reform than in the HT and drug regulation sector.