The subject
The first reference point addresses the subject of responsibility and draws attention to PAOs as collectives and, therefore, to the underlying question whether collectives could be assigned moral responsibility. According to French “[…] something must, at least, be an intentional agent to be properly held morally responsible for its actions” [37]. The debates on responsibility exhibit a close systematic connection between responsibility and intentionality, but also a strong dispute about this relation [46,47,48,49,50,51,52,53,54]. Following French’s argumentation, some collectives are capable of intentionality and can, consequently, bear moral responsibility [37].
French differentiates between aggregate and conglomerate collectivities. A collectivity can be understood as an aggregate “[…] if the identity of that collectivity consists in the sum of the identities of the persons who comprise the membership of the collectivity” [37]. An aggregate is, for example, the people standing on the corner [37]. By contrast, “[…] conglomerates are such that their identities do not entirely consist in or are not exhausted by the identities of the persons that are associated with them” [37]. The conglomerate’s identity is insofar independent of its individual members as it is consistent with a (constantly) changing membership. An example is a clinic whose identity remains the same even if all employees change over time. The crucial factor is that conglomerates, in contrast to aggregates, have a decision procedure for determining group actions [37]. This decision structure transforms the individual intentions and acts into a corporate decision. According to French’s argument, the decision structure provides the basis for the attribution of intentionality and, consequently, moral responsibility. In line with French’s argumentation, the strategy of the current paper is to assign collective responsibility to those collectives, which have decision-making procedures, including (1) the capacities for forming intentions and (2) the capacities to act. Then, collectives qualify as moral agents and hence can be attributed moral responsibility.
Depending on their size and degree of professionalization, PAOs show the elements of French’s approach. Due to the complexities of translational activities and the integration of different subgroups, larger and internationally organized PAOs are highly structured with different levels and positions, such as boards of directors, advisory committees and administration services. In addition, most PAOs have policies, often documented in statutes or mission statements, which make clear whether a decision has been made for corporate reasons. Since PAOs have structures for determining corporate decisions, they can be understood as conglomerates and, according to French’s argument, fulfill the conditions of intentionality and moral responsibility.
In addition to the collective dimension of PAOs as subjects of moral responsibility, there is also a future-looking aspect. The prospective dimension of PAOs can be explained in terms of stability and persistence. The PAOs usually have long-term structures and pursue future-oriented goals. Moreover, when understood as conglomerates, the identity of PAOs remains even if the individual members change. Based on these long-term structures, the concept of PAOs as subjects of responsibility can be understood as extending into the future and, consequently, show the forward-looking dimension.
The object
If PAOs are the subjects of responsibility, what are they responsible for? One way to answer this question concerns roles. Roles are often linked to specific behavior and can, therefore, help to narrow down the scope of responsibility. However, the various roles of PAOs lead to different objects of responsibility. Involvement in research, for example, is accompanied by other responsibilities than engagement in politics. However, despite the diversity of PAOs, one mission seems to be common: “Many PAOs characterize their efforts as attempts to give patients a greater voice and ensure that patients’ interests are acknowledged by those in positions of power” [10]. The PAOs typically understand themselves as advocates that represent the interests of those affected [1, 3]. This advocacy role of PAOs, although initially self-attributed, is increasingly confirmed by society and policy. The PAOs, for example, are often promoted by political organizations, such as the World Health Organization (WHO) because of their specific function to speak on behalf of patients [55, 56]. Due to this strong weighing, patients’ representation and advocacy can be seen as the primary role and, therefore, as the main object of PAOs’ responsibility. While this view does not yet provide concrete ethical obligations, it highlights the moral character of PAOs’ engagement and can encourage them to emphasize their core values—representing patients and advocating their interests. Responsibilities that are more concrete, for example, regarding certain cooperation partners can build on these basic values.
However, there are several points to consider. Firstly, due to the diversity of the tasks (e.g. policy, education, promoting research) and several interests to be represented within a PAO (e.g. patients, families, carers), it is not straightforward to specify the patient representation by a PAO in a concrete task and it is often unclear who can represent the members of the PAO adequately [17,18,19]. The object of PAOs’ responsibility remains to some degree unspecified because the concrete forms and implementation of patient representation are manifold, ranging from interaction with individual patients, public communication and educational activities, to political and industry engagement. Secondly, even with such a broad topic as patient representation, a limit to the scope of PAOs’ responsibility must be drawn. If issues are not covered or excluded from the domain of PAOs’ responsibility, they must be moved to the area of someone else’s responsibility in order not to be overlooked. For example, a PAO may set itself the mission of improving patient care for patients with a particular rare disease and, therefore, seek to raise awareness of that disease within medical education. However, it is not the role of the PAO to decide on the content of the medical education or to ensure the quality of the education. This remains the responsibility of the teaching institutions and the medical profession.
Finally, patient representation, for example in health politics, is the result of various activities of multiple agents and is only partially modifiable by PAOs. Consequently, PAOs should not be understood as being responsible for patient representation alone. Other stakeholders in health policy, for example, governments, political organizations such as the WHO and CSOs, whose remit can overlap with that of PAOs, should not be relieved of their responsibilities. For example, a PAO that advocates for a specific rare disease at the regional level and therefore has few members and resources might not be able to carry the overarching responsibility to represent all patients with rare diseases in international health policy. This would lie beyond the scope of that PAO and would instead be the task of international (political) bodies such as the WHO and CSOs advocating on a global level. On the national level, the PAO is also not responsible for the needs of these particular patients alone. National governments, health policy-making institutions, publicly funded healthcare systems and CSOs cannot transfer their responsibility to care for patients with rare diseases to the PAO. Regardless of these points, campaigning for a shared interest bears a collective dimension and since the relevant question “what needs to be done to help those affected?” refers to future activities and states, PAOs’ responsibility for patient representation is also prospective in its direction.
The addressee
Having identified what PAOs are responsible for, the question of the addressee remains. Given their advocacy role, it seems acceptable that the addressee of PAOs’ responsibility is primarily their targeted (patient) group. However, only considering distinct groups of patients can be too shortsighted in some situations. Issues regarding genetic contexts, for example, might go beyond the patients and affect other individuals or groups. A PAO that supports patients with a genetically determined condition and advocates for genetic testing in childhood or pregnancy should also consider the impact of such testing on families, patient groups with other genetic conditions and society. As this example shows, PAOs are frequently confronted with issues of ethical significance that not only affect their own members but also other groups. If PAOs only take the interests of a certain patient group into account, this can lead to questionable consequences for others. It is, therefore, within the responsibility of PAOs to consider the ethical implications of their activities. This means that PAOs should be committed to a wider range of addressees, however, the question inevitably arises regarding how far the scope of the addressees should extend.
In the context of health policy, for example, Onora O’Neill emphasizes that health issues cannot be restricted to limited groups but need to be considered in a broader context [57]. She claims that measures which are targeted at certain groups can, simultaneously, have collective benefits [57]. O’Neill’s idea can be transferred to PAOs: They can be structured in such a way that they produce direct benefit for their defined target group and, in addition, indirect benefit for others. Exemplarily, although a PAO is committed to a specific disease, successfully (co-)funded basic research can help other and future patients. This does not mean that PAOs should override the interests of their target group. An expansion of the addressees, for example, to patients with similar conditions, always needs to be critically assessed. A crucial point is to find a balance between the group’s own interests and the interests of other groups. Finding this balance can be especially difficult for PAOs, as PAOs are often built bottom-up. In many cases, PAOs are driven by the individuals affected who often belong to overlooked or discriminated populations. It may be difficult for them to accept that the PAO, which was established to advocate for their specific interests, is now supposed to advocate for the interests of others. However, as argued above, health issues cannot be restricted to limited groups and it is within the responsibility of PAOs to consider the ethical implications to a broader range of potentially affected individuals. Depending on the size and structure of a PAO, the leaders or board members might be in the position to undertake the difficult task of balancing.
Other addressees of PAOs’ responsibility could be politicians, scientists and private stakeholders. Although they form a fruitful network for PAOs, such relationships, especially if they are financial, may lead to conflicts of interest and create, for example, biases in PAOs’ educational activities [7, 8, 22]. The PAOs that establish such relationships run the risk of becoming financially dependent and influenced in their activities and might fail to represent the patients’ perspective [7, 8, 21, 22]. Due to the frequent lack of independent and adequate resources for PAOs’ activities [9], PAOs are often dependent on external funding and, thus, particularly susceptible to dependencies and influences from outside. As long as patient representation is the object of a PAO’s responsibility, political, scientific and private stakeholders may be helpful network and cooperation partners for PAOs, but they do not seem to be legitimate addressees of PAOs’ responsibility because of the risk of ignoring the advocacy role and pretermitting the interests of the patients. Of course, PAOs have responsibilities towards politicians, scientists and industrial partners when they work together with them, for example, to keep agreements, but these responsibilities are not the subject of the current paper.
When PAOs think about collaboration with politicians etc., they should critically consider their own role and underline their core values—representing patients and advocating their interests. Emphasizing these values highlights the moral character of PAOs’ work and the moral character, in turn, creates the basis for the claim that PAOs should not only consider their direct target group but also others in the domain of health. The PAOs are encouraged to go beyond their own interests and to see themselves in a broader social context. Understood in this way, the addressees of PAOs’ responsibility covers collective and prospective dimensions.
The normative standard
If responsibility is assigned to PAOs, a normative judgement is rendered on their activities in relation to a normative standard [35]. Typical standards for attributing responsibility are, for example, legal frameworks or ethical principles. Which standard is chosen depends, inter alia, on the concrete situation in which the subject is located, the activities being judged and the type of responsibility (e.g. legal, political or moral) being considered. If PAOs are seen as morally responsible for patient representation and advocacy, the question remains on which standards this can be claimed.
The PAOs’ demand for more patient participation in research and health policy has been increasingly recognized both legally and politically in recent decades, particularly in Europe [55, 56, 58,59,60]. Governments are committed, for example by the WHO, to establishing structures that enable the involvement of groups such as disease-specific advocacy organizations [56]. The way in which PAOs are supported varies greatly from country to country and the legislation is often not properly enforced [9]. However, despite this inconsistent legislative landscape, there is a tendency to see PAOs as responsible for representing the interests of the patients. Institutions, such as ethics councils, also give statements about patient and public participation in healthcare. The British Nuffield Council on Bioethics [61], the French National Consultative Ethics Committee on Health and Life Sciences [62] and the German Ethics Council [63] are examples of these and support patient and public participation as they regularly consult affected groups [64]. Insofar as laws, policies and institutional statements assign PAOs certain tasks and enable them to implement patient participation, they can serve as a normative basis for attributing responsibility for patient representation and advocacy to PAOs.
However, although social and political institutions attribute the responsibility for patient representation and advocacy to PAOs, the assignment of this responsibility comes primarily from the PAOs themselves, because the PAOs have assigned themselves this role. Looking at the PAOs’ own statements and constitutions can, therefore, help to identify the normative principles for attributing this responsibility. The constitutions of the PAOs usually define their tasks, missions and core values. Consequently, it would be helpful to examine what role each PAO assigns to itself and which specific responsibilities are associated with this. A PAO that promotes patient advocacy on political committees, for example, has different responsibilities than one that supports patient involvement in clinical trials. Nevertheless, if the common goals and core values behind these specific aims are considered, normative principles can be identified.
The common mission of PAOs to campaign for those affected can often be traced back to the experience of injustice, as many PAOs represent, for example, groups that are stigmatized or diseases that are not sufficiently recognized [1, 3]. One core value that can be identified in the PAOs’ statutes is, consequently, social justice. Furthermore, the wish to help each other and the benefits for their own group as well as for others might be strong motivations for PAO members to join their organization. Mutual support and empowerment are values that are strongly represented by the PAOs. By considering the common goals and core values of the PAOs, the principles of justice, beneficence and empowerment emerge. These bioethical principles can capture the PAOs’ motivations, form the normative basis for their role and work and therefore for their responsibility. While these principles provide a general ethical orientation, they also leave considerable room for interpretation. Although the principles need to be concretized and weighed against each other in specific situations, PAOs can be encouraged to emphasize these ethical principles in their work and consider the implications of their activities regarding these principles.
If the PAOs are assigned responsibility, a normative standard is needed: Legal and political frameworks, but also the PAOs’ own constitutions and the ethical principles of justice, beneficence and empowerment contained therein can be used. Which standards are used may vary depending on the circumstances, in which the PAOs find themselves. The collective dimension can be seen in standards that are the result of a shared deliberative process. The constitutions of PAOs might be assumed to have been elaborated and developed in such a joint process. At least, the ethical principles behind allow room for such processes. If the normative standards also show a long-term orientation, as it is often the case with PAO statements, there is additionally a prospective dimension.