Developing new scientific, medical, and technological innovations according to values of
“universality, access to good quality care, equity, and solidarity” [13] is highly prioritized in Europe [84]. In response to critiques that innovation is often too detached from the needs, values, and expectations of society [85], the European Union developed a normative framework for Responsible Research and Innovation (RRI) [17]. RRI is “an approach that anticipates and assesses potential implications and societal expectations with regard to research and innovation, with the aim to foster the design of inclusive and sustainable research and innovation” [86]. RRI can also be described as “the ongoing process of aligning research and innovation to the values, needs and expectations of society” [84] or as a strategy to move away “(…) from science in society to science for society, with society” [85].
PM, as a medical approach heavily relying on scientific research and innovation, typically falls into this category of innovations encompassed by the RRI framework. It is therefore important to develop PM in a way that aligns with the needs, aspirations, and core values of society. However, realizing PM brings a number of challenges. For instance, in its 2015 note on PM, the Council of the European Union observed that “not all patients have access to innovative methods of better-targeted prevention, diagnosis and treatments” [87]. This is
primarily because PM requires large investments in expensive technology that some European countries may not be able to afford. Targeted treatments are also often highly priced, as illustrated by cancer drugs, which frequently cost above $100,000 per year of treatment [88].
If European health care systems cannot handle such additional costs, the principle of equitable access to health care becomes threatened, leading to a situation that is quite contrary to the expectations of society [89]. As described in section 2.3, PM may also require that patients and citizens take greater responsibility for their health. However, we know relatively little regarding how realistic and desirable this requirement is, and what its impact may be across different socio-economic groups.
Discussing how to bring innovations such as PM to society in a way that complies with its needs, values, and expectations is the recommended strategy of the RRI framework. The EU Framework Programme for Research and Innovation [86] states that:
“Responsible Research and Innovation (RRI) implies that societal actors (researchers, citizens, policy makers, business, third sector organisations, etc.) work together during the whole research and innovation process in order to better align both the process and its outcomes with the values, needs and expectations of society.” (The EU Framework Programme for Research and Innovation) [20]
Although the framework does not outline clear rules and regulations, but rather is a “learning process with no fixed answers” [90], it encourages “ (…) all stakeholders including civil society [to be] responsive to each other and take shared responsibility for the processes and outcomes of research and innovation” [84]. This translates into an engagement of key stakeholders in consultations and deliberative processes that are transparent, encourage
interdisciplinarity, and are open to all those who may be involved in, or affected by, a research and innovation process [90]. Under the RRI framework, stakeholders are invited to discuss the implications of new innovations and “define an implementation plan for the responsible development” of these innovations [85]. In particular, stakeholders are encouraged to discuss “the direction of travel for science and innovation – from the outset – opening up opportunities for these to be directed towards socially desirable ends” [85]. RRI invites to “collective deliberation through processes of dialogue, engagement and debate” to learn more about the perspectives of different stakeholders [85]. Such processes are seen as useful to “provide continual input and substance to new governance practices” [90] and ensure that technological developments align with the values and aspirations of society [91].
Another benefit of this approach is that it provides a voice to stakeholders and give them more visibility [92].
Deliberative processes involving a range of stakeholders, spanning from researchers to patient groups and civil society, have been rather limited in number within the context of PM, at least in Europe. As explained earlier in section 2.4, the primary focus has been on developing a roadmap for PM consisting of action points or work areas to develop, and discussing the risks and benefits of using genomic technologies [83]. Understanding the views and perspectives of stakeholders in PM has received comparatively less attention. Studies targeting the public [93, 94], ethnic groups [95, 96], patients [97-100], physicians [101, 102], clinicians and researchers [103, 104] have been recently published, but these were primarily conducted in North America. To date, the number of studies (published in English) exploring the views of European stakeholders of PM on specific questions of relevance for PM remains limited, although this is progressively changing [67, 105-108]. This is problematic knowing that PM is developing rapidly in Europe. This thesis aims to help partly fill this knowledge gap by
investigating the views of key groups of European stakeholders of PM on specific themes of relevance for the PM agenda, following the principles of the RRI framework. Adopting such approach may help anticipate key challenges encountered by PM stakeholders at “the ground level”, and contribute to identify societal needs and social values that are relevant in the context of PM [91].