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Challenges of Biomedicine – Socio-Cultural Contexts, European Governance, and Bioethics

Final Online Publication, edited by Ulrike Felt and Maximilian Fochler

Challenges of Biomedicine

Recommendations on socio-cultural, ethical and participatory issues

S. Schicktanz, K. Amelang, V. Anastasiadou, S. Beck, Ph. Chavot, C. Constantinou, A. den Dikken, M. Düwell, U. Felt, M. Fochler, A. Masseran, A. Putnina, Fl. Quinche, M. Schweda, D. Shickle

(All authors contributed equally to the recommendations. S. Schicktanz was additionally responsible for coordination and sum up of the recommendations)


This document is the result of research and discussion by members of the European Research Project “Challenges of Biomedicine – Socio-cultural Contexts, European Governance and Bioethics”. It presents recommendations on the basis of interdisciplinary socio-empirical research and ethical reasoning on attitudes of European citizens (lay people and patients) in the field of biomedicine (predictive genetic testing and organ transplantation). The focus of our research project was threefold: a) the role of identity and body-concepts in public attitudes towards biomedicine, b) public attitudes towards and experience with the role of participation and governance in biopolitics, and c) the dealing with the variety and diversity of values and moral opinions within a medical-cultural framework.
The objective of our considerations is to establish a broader awareness for cultural embeddings of science and medicine and, additionally, lay peoples’ and patients’ needs for information and participation. We address three different levels: a) European policy, b) health care policy and c) national problems. For the extended version of the recommendations and a project summary please see “Biomedicine as a Socio-cultural and Ethical Challenge: Final Points to Consider and Recommendations for European and National Policy Makers and European Research” at http://www.univie.ac.at/virusss/cobpublication

European Policy Level

European Harmonisation and Diversity of Cultures

Rec. 1: The harmonisation of Europe should be re-thought while  the richness of the large diversity as well as shared communalities of techno-political cultures should be acknowledged

Our research shows the fundamentally different ways biomedical technologies are inscribed into society. Though quite similar basic challenges posed by the technologies were perceived, such as the danger of genetic discrimination or an unfair allocation of organs, the way they were addressed was very different. The respective technologies have been inscribed into and become blended with technopolitical culture in the different national contexts. The regulation of bioethical and biopolitical issues on the EU-level has to take cultural, normative differences into account in a more systematic fashion in order to avoid feelings of biopolitical domination.

Rec. 2: Civic and citizen epistemologies should be recognized

Knowledge as a resource, but also as a form of legitimating political action, has become central to the political process. Our research shows a strong heterogeneity between national political cultures and technological contexts concerning which different forms of knowledge people refer to, how they assess its legitimacy as well as its political implications. Also, it plays an important role whether they are directly, indirectly or hypothetically affected by the respective biomedical technology. Policy needs to be attentive to these different forms of knowledge, if it is not to face the danger of public rejection of policies based on a reductive understanding of public knowledge.

Rec. 3: The search for common values and overlapping consensus is in need of deeper reflections about impacts of medicine and technology on culture and identity

An important step in an adequate discussion of new biotechnologies is to describe the different ways in which the forming of identity is interrelated with different social and cultural factors. Value differences are in this context not differences in convictions between members of various nations, but national and cultural contexts constitute a context in which identities are formed. Thus, the values of individuals and groups have to be interpreted against this complex background. Any attempt to simply harmonise values or explicate an overlap of different values fails to understand the context of our evaluative frameworks of technology perception.

Rec. 4: Ethical discourses should be understood as mutual learning processes instead of static mapping of recent values

The bioethical discourse on the European level should not be conceptualized as a harmonization of European values but as a process of learning and development. Such a process requires a twofold procedure: first a theory of the interpretatory schemes in evaluating new technologies, second a discourse about the justification of our evaluative schemes. The guiding question should not be what are existing overlaps of values but what are the necessary prerequisites in order to enable European citizens to actively participate in the guidance and developments of technology policy.

Rec. 5: Bioethics in Europe needs multilayer empowerment on decision making instead of ensuring informed consent procedures

In the light of the inherent worth of the individual it seems necessary to ask for an empowerment of European citizens for an active role in the development of the technologies. The task of enabling European citizens for participation in (bio)technology policy seems to presuppose a deeper reflection of the potential of European institutions to develop their own discourses on (bio)technology policy. These discourses will fail right from the beginning if they are only conceptualized as activities to increase the public understanding of science. The aim should be the active empowerment of citizens in a common learning process in dealing with new (bio)technological opportunities.

Citizen Participation and Governance

Rec. 6: The concept of participation is in need of differentiation

One significant result of the project is the broad spectrum of different forms and modi of participation respondents alluded to. Altogether, the term ‘participation’ is used in a very broad sense, and the related understandings and meanings need more systematic consideration and differentiation – otherwise ‘participation’, with its broad application and usage in policy, everyday as academic discourse, runs a risk of becoming a mere “plastic word”.

Rec. 7: Participation should not be seen as ‚standard recipe’ solution, because it is not unconditionally welcomed by citizens

Our research shows that citizens have quite complex and often intuitive understandings of the governance of the medical technologies discussed in our project. They do not unconditionally welcome public participation. Rather, in a number of cases, participation in its ‘standard form’ was seen as either undesirable, unrealistic or counterproductive. Engaging with these public meanings seems of key importance if the involvement of the public as a strategy to build more socially robust policies is to be successful.

Rec. 8: Context matters –  The differences of technology and political culture should be taken into account

Our research shows that public expectations towards participation as well as the perceptions of its role in a governance of technology vary strongly in the context of different political cultures, but also between different technological settings within one political culture. Therefore, it is important to consider the various representations of citizens’ participation according to country and technological setting.

European Research Policy

Rec. 9: Strengthening qualitative comparative research in Europe is in need of specific financial support and structural conditions

A comparative perspective based on qualitative data is theoretically, methodologically and logistically extremely sophisticated and has to take rather diffuse contexts into account – a highly diverse landscape of institutional, legal, and cultural settings, historically different collec­tive experiences and culturally specific imaginaries of statehood, citizenship, solidarity.
Developing good qualitative comparison entails intense face-to-face interactions between the participating researchers, which is currently constrained both by project size and limited amounts of travel money. Further, it seems often to be overlooked that it is not only the production of qualitative data, but also and foremost its context-sensitive interpretation, which is time- and thus cost-intensive. More focussed project endeavours seem needed to do this kind of research, equipped with ample travel and personal resources to adequately address the methodological challenges of comparative qualitative research.

Rec. 10: Cross-disciplinary research in social science and ethics needs dense expert exchange and time for mutual learning

The experience of the project provides further important points to be considered in planning and funding research on issues of values and European development, which might bring together people from different disciplinary backgrounds. We do perceive a value of this type of cooperative research within the framework of the European Union, however see that the budgetary and time constraints do not really allow for sufficiently dense exchange and learning opportunities. Good interdisciplinary work entails intense face-to-face interactions between the participating researchers. Thus it seems central that within FP7 research the budget size for such projects should reflect the challenges this research poses.
In the field of cross disciplinary studies, ethics and social science studies could be seen as a special case. It is necessary to define needs and requirements of each discipline for other disciplines in the beginning. Without the sensitivity and awareness of the limits of their own disciplinary background, such a cooperation will have no additional value other than the serial addition of disciplinary results. This attitude should be promoted as early as possible in the education programmes. Additionally, it seems necessary to allow fruitful process of mutual learning of how their own and the others’ discipline are respectively built upon descriptive, normative, practical and theoretical assumptions.

Rec. 11: Research on gender issues in the medical system should be enforced on the qualitative and quantitative level

The role and status of women in the medical and health care system and its cultural background con­ditions clearly need further scientific investigation and political consideration. For example, there are significant gender differences in organ donation, especially in living organ donation in many European countries such as Germany, Austria, Belgium, Switzerland, Netherlands: Women donate organs more frequently, but receive donor organs less often than men. This gender disparity raises different serious ethical and practical questions to European health care systems and whether they guarantee equal access for all patients. It would be necessary to increase the awareness and sensitivity of health care professionals who eventually have a gate keeper position in health care decision making processes. Nevertheless, there is a lack in recent quantita­tive data (e.g. in Eurobarometer or Euroransplant data) on how gender differences show up in concrete acceptance, denials or concrete practise of biomedical technologies. Moreover, qualitative research is needed to explore why and where gender difference occur and how this is influenced by socio-economic structures, information policies or values.

Health Care Policy Level

Rec. 12: Informal forms of knowledge should be recognized

It is important that medical professio­nals in the whole of Europe learn to take into account informal forms of knowledge and how to consider them as an opportunity to learn something about the disease. This informal knowledge includes personal knowledge, experience of illness, symbolic and family values, information coming from the internet or originating from the media in general. This could be part of a shared decision making process in which both scientific infor­mation and knowledge originating from experience by professionals and patients are shared.

Rec. 13: Self-help groups and patients associations should be engaged as mediators between individual patients and professionals

Patients associations play – and should play – a fundamental role in the relation between patient and medical system. They often compensate for the lack of "humanity" displayed by the medical system, offering support at all stages of a patient’s care. They can also have a role in guiding the prioritisation of research questions, as bearers of knowledge based on experience. These functions of associations should be supported and spread out as they allow trust and genuine continuity between the world of research, biomedicine and persons who live with the disease.

Rec. 14: Participatory elements in the health care sector should be strengthened and expanded

I f affected peoples’ role in decision making process is to be strengthened, collective participation should be established on a regular basis in decisional, scientific and ethics committees in the national health care system and supra-national institutions. International cooperation between NGOs at EU level allows strengthening of the capacity for public participation in the new member states and brings changes in understanding of the concepts of public and governance.

Rec. 15: Public information policies should not be built upon the idea of public’s deficit of information but on public’s demand for information

The public should be provided with more information, but the information should be well adapted to their interests and needs. It would be important to establish an inventory of the requests for information as voiced by people. This inventory may not be limited to a quantitative survey carried out through the means of questionnaire or Eurobarometer, but rather with qualitative methods, e.g. focus group discussions or citizens’ conferences.

Rec. 16: Ensuring the right not to know should be based on the right to refuse modern medicine and to refuse personal support/donations.

There is no dichotomy whereby ignorance and knowledge would exclude one another, indeed there are rather various forms of more or less ‚active’ ignorance. Taking into account such forms of decided non-knowledge on an individual basis would allow better dialogue between, on the one hand, doctor and patient and, on the other hand, biomedicine and society generally. More sensitivity and transparency towards verbal manipulation and communication strategies is needed.

Rec. 17: Information policies should avoid stigmatisation of patients and disabled people and stress the individual.

If single identities were represented and more taken into account by members of the medical community, a symmetrical trusting relationship could be facilitated. De-stigmatising communication should be aimed at the general public. This encompasses clear statements that the disease is indeed an element of the person’s identity, but that the affected person has a personality that may not be reduced to the disease. It might be instructive to inform people about the use of less stigmatizing descriptions of disease.

Rec. 18: Bioethics and public policies should acknowledge the variety of body concepts and anthropological premises in bioethical arguments and biopolitical efforts

Ethical discussions, political decisions and legal regulations concerning medicine and health care often implicitly involve ‚thick’, anthropologically loaded concepts of and premises about human nature, the body, personal well-being, health and disease etc. On the one hand, these anthropological con­cepts and premises can vary strongly within and between different cultural contexts. On the other hand, their role could still be more sufficiently considered in clinical practice, ethical debates and political decision making processes.

Rec. 19: A more patient adequate communication should avoid simple one-side rhetorics of science, progress and innovation.

Some one-sided discourse on progress aiming at promoting any type of technical progress tends to discredit any refusal of new technologies, whereas such refusals may be perfectly justified. Therefore, the fact that people may refuse something new should not merely be ignored or despised, but should be taken into account. The discourse promoting ‚innovation’, pure science or progress, should also take into account health technology which may be ‚older’ but which has also proved its value and benefits from a good public image.

National Policy Level: Recognising Problem Areas in National Policy and Infrastructures

Ulrike Felt, Maximilian Fochler

Governance built on public uninformedness is fragile
The Austrian focus groups reveal that in some areas of Austrian technology policy, current regulations may be built on fragile foundations. In the field of organ transplantation, large parts of the public are unaware of the current objection solution regulation. Our research shows that the lacking public information may be seen as governmental paternalism and cause distrust.  It hence provides strong arguments for more public information and discussion of organ transplantation regulation and practice in order to build a stable relation.

Technology as an ‚alien’ issue – Missing cultural reference points
Compared to other countries, Austrian participants seem to lack cultural frameworks or clear reference points to come to terms with a particular technology and to assess if they could trust governance in a particular technological setting. Public engagement initiatives which raise questions about the ways Austrian culture is intrinsically linked to technology and which open discussions on the societal impacts of technology seem needed.

Costas Constantinou
Information and counselling of chronically ill patients should be improved
Patients who suffer from chronic diseases lose control over their body and social life and experience feelings of uncertainty. They look for ways to regain control over their body and restore psycho-social integrity. Therefore, therapeutic procedures should incorporate careful counselling sessions for patients that pay particular attention to patients’ preconceptions as well as other aspects in their psycho-social environment.

Physicians should take into account patients’ ambivalent perceptions and expectations
Being in a constant dialogue, patients would have the opportunity to be better informed about the causes of their diseases and the therapeutic means, and would thus feel that they acquire control of their body and disease, which would contribute to better compliance and ameliorating psychological state. Physicians are recommended to attend information and training sessions about patients’ perceptions, worries, psycho-social and bodily disruption. They should pay particular attention to patients’ perceptions and attitudes and work together for the most appropriate therapeutic procedure.

Silke Schicktanz, Mark Schweda

Recent strategies to increase the number of donor organs are in need for reconsideration
Stimulating the public’s readiness to donate organs might not so much require changes to the legal or organisational system as such, but rather an increase in its publicity and transparency. In the German Focus Groups, one of the main factors impairing the participants’ motivation to donate was a lack of information on the political and organisational aspects of the transplantation system. This leads us to the assumption that not being able to exclude inefficiency, wastage, injustice or even abuse in the system can nurture distrust and can be a reason for reluctance to donate.

Genetic testing is discussed in the context of  an erosion of the German welfare state
The erosion of the present welfare state and its solidarity-based health care system constitutes an important reference point in many discussions of the risks and potentials of biomedical technologies. Especially with respect to genetic testing, the fear is expressed that it could prepare the ground for or advance the evolution of a two-tier medical system by shifting the responsibility for health care from the state to the individual. A clear regulation that provides legal certainty, especially with respect to data security in the context of insurance and employment law, is still lacking, although it could be pivotal to reduce some of these fears.

(In Latvia, no focus groups or interviews were conducted within the framework of the project.)
Aivita Putnina

Organizing participation as a trust building mechanism
In Latvia, patients and patient organisations have a comparatively weak role in decision-making processes. However, much should be done to strengthen the capacity of patient NGOs both in terms of their ability to lobby for the interests of patients and to provide them with a secure financial basis. Patient NGOs emerge not only in the situation of economic insecurity hindering citizens and especially those chronically ill invest time in participatory activities. The public and governance in its democratic sense is missing from Latvian public debate on biotechnologies. Scientists, doctors and politicians play the main role in defining the policy agenda and they see normative regulations as means to replace transparency and accountability of the policy process in the area. At the same time, decline in trust and support for biotechnologies can be observed. Insofar failure in trust towards technologies can be explained by individual factors towards science will remain intact and only behaviour as adaptation to particular situation will change. Participation without granting access to decision-making will further corrupt eroding trust relationship between the public and the technologies. Public participation traditions, accountability and transparency of should emerge as a factor balancing trust towards the technologies.

Biotechnological developments produce new forms of being affected
New technologies change boundaries of what it means to be ‘affected’. This poses threats for the development and application of the biotechnologies not only in terms of participatory practices. In Latvia, for example, participation in the genome project has led to broading of definitions of being ‘affected’ beyond that of current illness. The Latvian case study shows that patients are not willing/prepared to share this new definition of illness. The new technologies can only be applied on the condition that health and illness definitions change.

The importance of reciprocal relationships
Organ and gene donation set a particular relationship based on ‘gift’. The morality of gift depends on situation and mutuality of transaction. Therefore, trust building as an active mechanism of establishing mutuality should be stressed. The Latvian case study shows that reliance on solely legal regulations erodes trust. Similarly, despite the presumed consent regulation and very low public knowledge of this regulation the high number of potential donors does not play a crucial role in receiving formal consent for donation. Rather conversations and respect paid to relatives of the post-mortem donor become the main source for consent. Organ transplantation establishes imagined relationship between the donor and recipient, and relatives of the deceased donor and recipient. All these relationships are essential forms of engagement that should be taken into account considering the building of trust.

The Netherlands
Annika den Dikken, Marcus Düwell

Information policy concerning organ donation in need of revision
For years, the government and several patients associations have tried to increase the number of organ donors by informing the public about the positive effect of transplantation for the recipient. The focus group participants do not question that at all, but the persons who explicitly refuse registration as a donor criticise the lack of information about the procedures of organ removal. They fear that they will be declared brain dead too easily and that their relatives cannot say goodbye in a way that is good for them.

Information and medical care in need of standardisation
Especially in the case of genetic testing it is important to recognize that affected people notice that they are treated very differently in different hospitals. Further research is necessary to find out whether general, basic standards can be formalized for public information, covering medical aspects, but also reflection about guidance on the psychological, emotional, interpersonal, cultural and ethical aspects people are confronted with.

United Kingdom
(In the United Kingdom, no focus groups or interviews were conducted within the framework of the project.)
Darren Shickle

The role of patients in the health care system is changing
In Britain, there has been a change from patients being passive recipients of health care to consumers of health care. With the increasing presentation of the citizen as a consumer of social goods, there has also been increa­sing use of the term ‘social marketing’ and advertising techniques are being used to achieve behavioural and attitudinal changes amongst the public e.g. within health promotion. However, while a customer in a shop or some other service is able to form some judgement of quality of product/ service, this is much more difficult in the health sector as health interventions are much more complex, require different/deeper knowledge bases and the stakes involved of making wrong choices are much more serious.

Public and patient  involvement in decision making is seen as deficient and impedient
In Britain, public consultation is often perceived as a bureaucratic hurdle. It tends to be done late in the planning process after decisions are made and when it would be difficult to change plans. Most ‘ordinary people’ will be unaware that a consultation is taking place. Those who respond tend to be professionals or organised lobby groups with particular agenda, which follow the debate and hence know when consultations have been launched. Consultation methods are not developed to maximise input and responses to public consultation are poor. Historically, a key challenge has been characterised as one of representation versus representativeness. Representation should be meaningful, supported and of equal value, with clear lines of accountability. The agenda should be transparent to all. Proxy involvement should be valued equally with individual engagement.

Cite as: Challenges of Biomedicine. Final Online Publication, accessed at: [Mainpagepage: www.univie.ac.at/virusss/cobpublication]

This Final Online Publication is Deliverable No5, the comprised Short Report on Consequences and Recommendations Deliverable No6 to the Contract of the FP6 Project “Challenges of Biomedicine” (Project no. SAS6-CT-2003-510238)