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The dynamics of patient organizations in Europe

Madeleine Akrich
João Nunes
Florence Paterson
et al.

Chapter 4. Working with Patient. Organizations: A Few Institutional Experiences

Texte intégral

Involvement of patient and user organizations in public health institution: the case of the Haute Autorité de Santé1 (HAS) in France

1Etienne Caniard, HAS

2The role of patient organizations and users of the health care system has changed considerably over the past two decades. From the pioneering role of Aids organizations to the successful structuring of rare diseases at European level, the reality of non-profit organizations is marked by diversity.

3In France, Bernard Kouchner, then Minister of Health, decided in 1998 and 1999 to hold the Etats Généraux de la Santé, consisting of a large number of debates (over 1,000 meetings and several hundred thousand participants). This event was an opportunity for patients' expectations to be expressed, and led to the recognition of their organizations.

  • The Etats Généraux de la Santé was an important step in developing a process of health democracy. It resulted in the recognition of patients' rights, by law, and the emergence of a new role for non-profit organizations. Interestingly, during this consultative conference, rather than demanding more medical care, drugs and techniques, citizens called for more information, attention, transparency and consideration.

  • This phase was followed by a period of "recognition of rights", with the implementation of the measures provided for by law, such as the official approval of patient organizations.

  • Today we are entering into a new phase, that of putting rights into practice. It is not the easiest, as patient organizations need to avoid two pitfalls: being instrumentalized, and being nothing more than "window-dressing" for health democracy.

4These three phases corresponded to three different mindsets in nonprofit organizations. The considerable mobilization that accompanied the advocacy period probably led to an over-estimation of the capacity of these associations as a whole, to exercise the responsibilities they were demanding.

5A feeling of "euphoria" prevailed after the 4 March 2002 law was passed on patients' rights and the quality of the health system. This was probably why the concrete implementation of the law was neglected, despite it being indispensable, especially in terms of training. Today the phase of exercising rights highlights non-profit organizations' difficulties in fulfilling the role entrusted to them.

  • 2 L'Agence nationale d'accréditation et d'établissements de santé (Anaes) was founded by decree in 19 (...)

6How are the different stages reflected in relations between the HAS (formerly the Anaes2) and patient organizations?

Patient organizations and the HAS

7From its inception the Anaes included representatives of patients, both on its governing board and on its scientific and technical committees. It is as "facilitators" that patient organizations have the most decisive role, for instance in transparency of information.

8This was the case as regards the communication of information stemming from the self-evaluation of health institutions. The Commission d'Accès aux Documents Administratifs (CADA) had ruled that these documents could be considered as public even before the conclusion of the official approval procedure. This type of situation seems to have altered the sincerity of this self-evaluation. After consulting the patient organizations, it was decided to amend the law, so that the publicizing of the self-evaluation would be postponed until the end of the consultative period. This was possible only by involving the organizations, as it avoided the otherwise inevitable accusation of withholding information.

9Yet - and this was pointed out in the report on recommendations for good practice that I submitted to Bernard Kouchner in 2002 - the patient organizations' participation in the production even of the Anaes, and especially its recommendations, remained limited. The Anaes was perceived as a professional organization designed to spread an evaluation culture to other professionals.

10The creation of the HAS has altered the situation. Apart from extending the missions of the Anaes, it was created as an institution at the service of all the actors in the health system: the public authorities but also funding-bodies, the general public and patient organizations which, in terms of the law, have the right to demand intervention.

11Paradoxically, its status as an independent administrative authority (AAI) and its collegial mode of governance, with intuitu personae appointments by the highest state institutions, does not guarantee representation of the different actors, whether users or others.

12It is therefore in the composition of its commissions (at least those not based on regulations, such as the Transparency Commission) that the HAS has shown its will to include user representatives.

13Reflection has also been initiated to define more clearly the role that patient organizations can play in the HAS's missions.

The HAS, an institution with numerous and varied missions

14The HAS is responsible for periodic evaluation of services and products. It also produces and disseminates handbooks on healthcare or recommended good practice, and contributes towards informing health professionals and the general public. It implements procedures for evaluating professional practices and accrediting certain professionals and medical teams. It officially approves health institutions and participates extensively in the development of evaluation of the quality of healthcare provided. Finally, it gives an opinion on the list of pathologies for which patients are fully refunded by social security.

15In addition, the Authority has numerous occasional missions concerning the quality of information. Work with users or their representatives cannot be envisaged in the same terms when it concerns officially approving health institutions, producing recommendations, writing handbooks for patients with long-term diseases totally covered by social security, or approving the quality of information on e-health sites.

Seeking consultation methods suited to the diversity of the HAS's missions

16Formalization of mutual expectations based on the critical analysis of former modes of collaboration.

17From the outset the HAS has tried to define the expectations of each of its divisions, in order to help patient organizations respond to calls for proposals with a better idea of what is expected of them.

18This work has revealed that all too often the absence of prior reflection on the expression of those expectations, and the absence of communication to organizations, has been the main source of the HAS services' disappointment regarding the organizations' contribution, and of the organizations' feeling of being instrumentalized.

19The patient organizations were also asked to define their expectations but this has not led to a clear formalization of the situation, apart from their presence, the purpose of which is sometimes ambiguous. On the other hand, the organizations' reasons for dissatisfaction have appeared clearly:

  • first, a huge lack of feedback;

  • opacity of criteria for choosing organizations;

  • absence of information on what the HAS expects of them and, more generally, a large demand for training/information.

20On this basis, the construction of a "collaborative framework" was undertaken (currently being finalized)

21This collaborative framework is grounded in three main principles:

  • recognition and formalization of patients and users' expertise;

  • harmonization of patient organizations' rules of selection: creation of a common framework for all forms of cooperation with the HAS;

  • transparency of the rules of selection and functioning: publication of the framework of cooperation.

22This collaborative framework defines the criteria of choice of the organizations selected to cooperate with the HAS, and the different conceivable levels of involvement:

  • participation on the Commissions;

  • participation on the organizing committees or in the working groups, or opinion on the composition of the groups (categories of experts who should be represented);

  • participation in reading groups.

23An important innovation is the collection of patient organizations' opinions on the composition of working groups. Without mobilizing the representatives of organizations to participate in work, sometimes with an "ambiguous" role, these opinions make it possible to take action early in the process. For instance, they avoid biases stemming from choices that exclusively favour scientific expertise and neglect certain aspects that the organizations see as essential, such as quality of life.

24Finally, recognition of the status of expert, or of health professionals, entails full application of the rules relative to the declarations of interest and modalities of remuneration or indemnity.

25These two points are of course essential for the organizations: first, because they facilitate their participation in various projects; and, second, because they reveal potential conflicts of interest. The numbers of such conflicts are increasing with the diversification of means of financing and the growing involvement of pharmaceutical companies, in particular.

26The collaborative framework is being finalized with the patient organizations and will be applied in the autumn of 2007. A phase of consultation with all the organizations is planned, to amend it if necessary.

The main lessons learned from this approach

On the capacity of the patient organization movement to meet health institutions' expectations

27Even if today's discourse focuses primarily on the responsibility of users of the health system, rather than on the points of view of patients and their families, the representation of users is an irreversible trend. It is the result, in the health world, of an underlying current found everywhere. The place of users in a decision-making system concerning them is questioned, and decision-making procedures are being made transparent to ensure respect for the individuals and singularities that institutions deal with. To contribute towards this trend, non-profit organizations are tending to form national, thematic or general (e.g. the CISS) collectives, and sometimes regional branches of those collectives. In parallel, the role of patients' families is recognized more and more.

28It is in this context that the procedure of official approval is developing (possibility for organizations to exercise the right to representation, at national or regional level, based on criteria of representativeness, age and independence), along with the risk of the legal approach superseding the capacity of non-profit organizations to bring new issues to the fore.

29The Etats Généraux de la Santé showed that dialogue is possible to achieve an adaptation and transformation of our healthcare system by placing the citizen-patient at the heart of its organization. In this way a healthcare project can be built up with patients and their families, based on shared information, attentive listening, and unfailing support.

30Unfortunately, exercising the right of representation sometimes seems to be considered as an end in itself. This can lead to disappointment and frustration concerning the actual results of such representation. Patient organizations' status is likely to be recognized far more if they no longer shift debates and destabilize the established order. This likelihood is increased by the inability of the public authorities to guarantee financing, especially to organize training, so that the organizations can be independent. Their new role as actors in their own right has aroused interest and envy, as the proliferation of funds related to particular interests attests. This may seem to be a passing phase, a necessary step in the construction of a non-profit movement capable of assuming the new role entrusted to it. However, it is important to be careful to avoid the risk of a "formalization" of representation and organizations' dependence on the economic interests at stake in the field of health.

31The difficulty of identifying patient organizations' expectations as regards their presence in health institutions clearly illustrates this need for reflection and debate on the meaning of such presence.

On the institutions' attitude

32The urgency is now to conceive of forms of collaborative work that need little time, so that patient organizations can acquire competencies and share their experiences. It is essential to avoid "competition" between institutions, to know which one has the most favourable "quantitative" results of work with patient organizations: this would put the organizations in a situation in which they are unable to fulfil all their representative missions. The proliferation of officially-approved patient organizations will widen the choice, but it is important to organize interaction and the sharing of experiences between these sometimes very different bodies.

33Clarification on the expectations of institutions, on collaboration between them, on calls for proposals and on training for non-profit organizations is imperative. The systematic presence of these organizations in all governmental agencies and working groups is not essential - provided that choices are made on the basis of dialogue with them, and that the institutions ensure feedback to those organizations that are not present.

34The example of work under way within the HAS shows the difficulties of this type of approach. The presence of a few accommodating organizations as "window-dressing" is still often seen by some institutions as a comfortable solution. They have to be made aware that the presence of organizations which fully play their part raises standards and helps them to fulfil their missions. At the HAS this awareness has been facilitated by the expansion of the Authority's missions and "clients". Because the HAS is an "independent administrative authority of a scientific nature", expertise of a professional nature is given preference. Yet scientific rigour does not exclude the advantage of another point of view which often ensures that scientific expertise is not too "decontextualized" and cut off from the patients' expectations or from organizational matters.

35Even though this analysis is now largely shared within the HAS, its actual translation into action has not yet been achieved.


36Much of the debate at the time the 4 March 2002 law was passed concerned the balance between rights and responsibilities. Today, responsibilities are at the centre of political debate, with the assertion of a necessity for accountability, often reduced to its financial dimension. These two approaches should not be confused. The development of the non-profit organization movement and the emergence of patient advocacy are not an alternative to a social democracy in crisis. They are the foundations of a sharing of information which, in certain cases, can go so far as shared decision-making. For that purpose, demands are not necessarily for more funds, but rather for coordinated competency networks. Thus, for patient organizations the idea is not to show their representativeness in the classical sense of the word, but rather to show that they have a point of view which allows for a better use of the potential of healthcare and prevention. One of the main outcomes of the Etats Généraux de Santé was to learn that patients and their organizations are not content simply to answer questions put to them; they want to ask their own questions. This is the core of debates on the role of users and their organizations.

37Criteria for official approval concern not only representativeness, but this is currently becoming the dominant criterion. There is the risk of this de jure representativeness being substituted for a legitimacy anchored in reality.

38To avoid that, the public authorities have to be more involved, by supporting the development of non-profit organizations and ensuring the conditions of their financial independence.

39We have already insisted on this aspect, in our report on the role of users, in 2000. It is just as relevant today.

Public involvement in Research, Promoting public involvement in NHS public health and social care: The case of Involve in the UK

40Roger Steel, INVOLVE

41Involve3 exist to promote public involvement in NHS, public health, and social care research in England. By involvement we mean active involvement - research done with or by people who use services, not to or for them.

42Involve is funded by the National Institute for Health Research, which is part of the Department of Health in the UK. It is an unusual organisation, and the best way to describe it is through its history. Early in the 1990's, the Department of Health (DH) first started exploring how patient involvement in the National Health Service (NHS) could be achieved in all areas of health care. It is a reality that has now been realised ten years down the track.

43About 1995 the Central Research and Development Committee that sits within the DH felt it should be doing something about getting public patient involvement in the area of research in the NHS. But the Committee didn't know how to do it or how to begin to approach it. So they appointed a sub-group to look at how patient involvement could be achieved in NHS research. They invited people from the NHS and the Departments at different levels, and people from patient organizations, and activists who were already involved in research, for example cancer charities and a voluntary organisation involved in HIV-AIDS work with experience of the difficulties of managing clinical trials in what was then a fatal condition.

44The group's remit was to advise the DH, but it quickly gained a reputation for being active in developing its own work. The group which was originally to be temporary, but became a ‘standing group’ which met four times a year and embarked on a programme of work which needed a secretariat to undertake its work.

45In 1999 the group became known as ‘Consumers in NHS Research’ and was for the first time was managed independently of the DH under a voluntary organisation. The group had a very small Support Unit of employed staff to undertake its work in influencing in the research and patient organisation world. It started to develop models and produce guidance and undertaking project work for the group.

46The group was doing all this by influence and persuasion to begin with. It wasn't a policy at all and we thought it was a good idea and we really wanted to commit some people to that it was a good idea. But in 2001, a piece of governmental legislation, the Research Governance Framework, was published by the DH. This was the first time that public involvement in research was included in government policy. The Research Governance Framework shifted the emphasis more towards good practice issues. For Involve this presented both solutions and problems. The good part is that it was a stick to drive people on to do this work. The bad thing was that being a stick it tended to encourage a tick box approach which could be tokenistic. Involve continue to influence as it is not a policy making body, and there is still a lot of work to do.

47In 2002 the DH asked the group to extend its remit to include social care and public health research that took place outside the NHS. As a result of the group was rebranded 'Involve.

48In 2006 the DH published a new clinical research strategy ‘Best Research for Best Health’ which includes a strong commitment to public involvement in research. Again, user involvement was included in the strategy. I joined the group Involve about six years ago and I came from community development background in the volunteer sector, I didn't come from the research background. I was amazed having spend so many years running projects for small amounts of money, how much money was spent on research, and also horrified to find that a lot of that research, which was publicly funded, didn't actually end up improving services at all. Research reports would often sit on shelves with little effect. I have to say that now that the situation has changed and I like to think that Involve helped that change to come about. The new research strategy tries to make sure that doesn't happen. Research isn't just there to fund the researchers' careers but should actually to benefit the people it is supposed to be addressing.

49Society is changing and institutions within society having to look atand respond to those changes. We have so much more information now and there are more active patient organizations. So this has influenced the way our organization has worked.

50Involve continue to meet as a group four times a year, but the membership has changed and now includes people from an increasingly broad range of backgrounds. The group tended to be more people who were well known in the fields they were in, but it has changed in that it includes people with direct experience as users of health and social care services, as well as senior and other professionals from organisations, both statutory and voluntary. Recruitment to the group is transparent, and members are recruited on the basis of their individual experience and networks, and not as ‘representatives’ of particular organisations of constituencies.

51It remains an advisory group but its advisory capacity has expanded, not just to advising in the Department of Health but also advising researchers, research funders and commissioners as well as people who use services and carers. To that end the group produces a number of publications and has a website. One of Involve's earliest pieces of work was ‘Involving the public in NHS public health and social care research: Briefing Notes for Researchers’. It sketches models on how to identify, find, and involve people. This was followed by a publication for patients and public on how to get involved in research, how to engage with research role. On our latest version is actually a pack of four booklets.

52What do we mean by public involvement in research? We mean active partnership in research, where the people involved are not the ‘subjects’ of research but are active participants, e.g. on a research steering committee. It means doing research 'with' or ‘by’ people who use services, not ‘to’, ‘about’ or ‘for’ them.

53Involve believes that the involvement of people who use services improves the way that research is prioritized, commissioned, undertaken and disseminated. If research reflects the needs and views of people who use services it is more likely to produce results that can be used to improve practice in health services. This is the view of the group and gradually we are gathering evidence that this is in fact the case.

54We don't do research ourselves, but within health and social care we advise across a large range of types of research. In mental health for example, the influence of service user on the design of the clinical trials has been really important. Research designs suggest measuring for potential improvements in very specific symptoms to see if a particular drug works. However, the patients may ask for the use of additional indicators in the design to measure particular side effects. These are of importance to improve the quality of life of the users.

55At the other end of the spectrum we are also dealing with research that is actually done by patients, done by people who use a service and carers. There is a history of this user-controlled research. As far as we know, user-controlled research started in the feminist movement, when women had had enough of white middle class male researchers researching women's issues and often making assumptions about women's issues and about their position in society. But more women got into women studies in universities, and they started to do research on their own issues, which questioned the very premises from which those first questions were asked. It was a matter of asking the right questions in the first place, which is crucial. This was very quickly taken up by the disability movement at the time where the majority of the disabled people were kept in homes and weren't actors in the society at all. And they very quickly took this on because they were being researched a lot, but it didn't bring any difference to them, or improve the stigma that was there. So they too started to do their own research, or they would lead research and invite academic to help them to do it well. So they would frame their own questions in their own terms, not in a way, which they would find stigmatizing. So that is the history of the controlled research, very briefly, but I think it sheds light on the whole involvement in research agenda. It is about asking the right questions. Questions that is important to patients and people who really experience the conditions being researched.

56In order to achieve its aims there are three distinct areas of work in which Involve is engaged.

Developing Strategic Alliance

57As a group and organisation, Involve have developed extensive networks with both patient, service use, carer and research organisations. There are also formal and semi-formal strategic alliances and links with a wide range of organisations, and new opportunities for joint work are being sought all the time. For example, the Involve does extensive work with research commissioners and funders, as these organisations are very influential in what research can go forward and how.

Evidence, knowledge and learning

58Involve have long collected examples of public involvement in research and used these extensively in persuading others of its merits. Involve continues to collect these in order to extend its own knowledge and learning, and in the coming year will be doing this more systematically. We are looking on what is the added value of this involvement in research, which is quite critical because it is lots of rhetoric around it, so we have to start on looking at what is it that actually makes a difference and really put the evidence behind our work. That is very important, not just in convincing the researchers they got to do it, but important to us so that we know we are giving the right kind of advice. We produce good practice documents and leaflets and we are keeping up to date with what good practices is because it is developing all the time, the values and standards are developing all the time.

59The organisation also acts as a host to ‘INVONet’ which is a web-based network of researchers working in the field of research on public involvement in health services and research. There is more pressure from the research establishment to provide hard evidence that public involvement actually improves research and services as a result. However, this is a problematic area as there are often different criteria for different communities of interest. It raises questions of what evidence is, whose evidence it is, and therefore whose evidence counts.


60Involve provides guidance and ‘tools’ for researchers and people who use services to help them involve and be involved as members of the public and research providers. Involve does not have the capacity to make links on behalf of researchers and the public, so it relies on making helpful guidance available. Typical are Involve's publications, including the 'Briefing Notes for Researchers' and the recent 'Public Information Pack'. Guidance is also available in other forms, including web based information, talks and workshops as well as individual advice from staff. Involve also contribute to policy and processes across the research world in order to help remove barriers and increase the drivers for public involvement in research.

61Involve covers a very wide range of different kinds of research within the health and social care field. There are also many different kinds of activity within the research cycle, and different levels of involvement across a range from consultation, to collaboration, to user control. For example, patients could be working with researchers to broaden the indicators for a new drug in a controlled trial to include quality of life measures and potential side effects. In another example service users might start their own research on the services they receive or need because they decided it would be worthwhile doing. But there are many different kinds of involvement examples.

62Involve is not prescriptive about how exactly to do involvement. Rather, it offers broad models that can be adapted in different situations. It also encourages innovation by sharing examples.

63Involve has ‘evolved’ within a particular research politics and systems environment, and as an ‘actor’ in that environment has contributed to wider ‘evolutionary’ change. That change means there is increasing influence of people who use services on what and how research takes place. However, there is much further to go. Involve remains an influencer, rather than a policy making body, so progress is often uncertain.

Mediation between research institutions and patient organizations: the “Mission Association” of the French National Institute for Health and Medical Research

64Dominique Donnet-Kamel, Inserm

65The Inserm, which is the French National Institute for Health and Medical Research, is a public research institution dedicated to research in human health, with 335 research laboratories working in all the fields of fundamental, physiopathology, public health and clinical research. At the end of 2003, the Inserm has launched a policy of dialogue and partnership with patient organisations.

What has changed in 2003?

66The relationship between researchers and patient associations is not a new phenomenon. Researchers are members of the Scientific Committees of many associations, and research projects are funded by associations. They have indeed developed project collaborations and many are participating in scientific and medical information tasks with associations.

67The change that occurred in 2003 is that the Inserm set up a policy that recognises the legitimacy of patient associations as “patients' representatives”, and their specific competences. The general direction convened a task force to report and to give the main orientations for an institutional policy of dialogue and partnership with the patients, disabled people and families associations. A meeting organized with more than 100 associations to discuss the report confirmed the major conclusions of the task force. It led to the organisation of an institutional setting built around three pillars and enabled the Inserm to identify a series of projects that should first be set up.

An institutional organisation built around three pillars

68The first pillar is the GRAM (Groupe de Réflexion avec les Associations de Malades), a consultative body linked to the general direction, composed of eight association representatives, four researchers, and four operational administrative directors. This body makes recommendations on strategic orientations, sets the priorities and follows the actions.

69The second one is a liaison office called “Mission Inserm associations”, which implements and coordinates the actions.

70The third one is an annual meeting with the associations which aim is to present what has been done and discus the forthcoming actions

Principles of action

71The principles of action elaborated by the GRAM are the following:

  • The patients' associations are not all interested in research, but those that are interested are privileged interlocutors for the Inserm, without size or financial requirement.

  • Our action has to rely on the principle of transparency.

  • The decision on which associations will participate to the actions of the Inserm has to be based on a dynamic of self-determination of the associations.

72To implement these principles we have created a database of all the French patient organisations interested in research, which is a cognitive as well as a communication tool.

Interested in research?

73What does “interested in research” mean? We have identified four major types of activity that manifest the interest patient associations have in research:

  • To take part in clinical trials, cohorts, data bases, surveys, etc.

  • To sustain research projects financially.

  • To be active in the diffusion of recent scientific information.

  • To organise “large” public scientific communication events. We consider the associations interested in at least one of these types of activity as a natural interlocutor of the Inserm.

A database of 350 French associations

74The major inclusion criterion used to build our database is the interest of the associations in research. At present, 350 associations of patients, disabled people and families are documented in our database. We try to work with them by circulating the information on our actions to all the associations registered in the database. This database is available through our web platform (, and the researchers as well as the associations may use it.

Four projects

75The four projects first set up by the Inserm are:

  1. Training

  2. Upstream participation in clinical research

  3. The integration of patients associations in the scientific committees

  4. Information and communication

76Details are provided below on the first three projects.


A step to build a partnership

77Training is one of the four projects set up by the Inserm. The GRAM has given a strong support to the training project, considering it is a step to the building of a partnership between patient associations and the Inserm.

Capacity building

78The training programmes have been designed as capacity building, so as to share the concepts, methodology, vocabulary and tools useful to create a solid dialog between the associations and the researchers.

The training programmes

79Because upstream participation in clinical research was a priority, the first training sessions have been launched on “how to read a clinical protocol”.

80The second training program was built according to the acknowledgement that patient organisations are major actors of the dissemination of scientific and medical information for the patients and the general public. Three sets of training sessions were dedicated to information: the first one was “How to research biomedical information on the web”, the second one "How to organise a scientific survey" (it consisted in learning how to use the pubmed database), and the third one "How to get the French resources data", because a lot of persons involved in the activity of patient associations do not master English.

81We have organised another training programme, which was “How to build a database”. The aim of this training programme is to provide a methodology in terms of project building and also to indicate the legal framework of such a project. For a patient organization, this kind of project is a long-term initiative and supposes a strong involvement.

82The training sessions have all been set up in partnership with the association Eurordis4 and the LEEM (Les Entreprises du medicament)5, which is an association of pharmaceutical companies.

83This training project is quite successful, as 45% of the 350 associations registered in our database have followed one or more of the training sessions we are organizing for several years.

Upstream participation in clinical research

84The GRAM has recommended upstream participation of the patient associations in clinical research. Two types of actions have been implemented:

85The first one is the integration of six associations in the Strategic Planning and Clinical Trial Monitoring Committee of the Inserm.6 The Cossec is a decisional committee, which assess and gives the support of the Inserm to clinical trials.

86The second one, which is quite new as it has been implemented in April 2007, is the creation of a "reviewer college" in charge of reviewing clinical trial protocols and the related informed consent documents. The aim of the reviewer college is to assess the necessary information concerning the patients are all notified in the information sheet and to contribute to the discussion on the eligibility of the participants to the clinical trials.

87We have chosen to make a call for candidacy for this clinical research setting, and 69 patient organizations answered the call. Six associations have been selected on the basis of their experience of clinical trials to be members of the Cossec. The 69 patient organizations all participate to the “reviewer college” and benefit from a specific training on clinical research protocols. Since its beginnings in April 2007, the college has reviewed three clinical protocols.

88The involvement of associations in the committee and the college is a long-term work. It is a collective learning process for the researchers and the clinicians involved in clinical research as well as for the associations.

The integration of patients' associations in the scientific committees

89The last programme is related to what we call the “National research programmes”. These programmes have been set in disciplines concerned with “bone and articulation”, “nephrology urology”, “reproduction-endocrinology”, “cardiovascular diseases”, “alcohol addiction”, etc.

90The patient associations were invited to participate in the strategic committees of these programmes, with scientists and representatives of the industry, the health authorities and charities. Seven to twelve associations expressed interest in participating in the committee of each programme.

91For each programme we have made a leaflet, based on the results of a short survey addressed to all the associations, which is now disseminated to the members of the committees. Four questions were asked in the survey:

92What are the topics you would like to find in this program?

93On which topics do you need information?

94Concerning research, what types of action do you organize?

95What are your suggestions?

96We have also organised regular meetings with the scientists, designed as discussion groups built around questions raised by the associations.


97The process that started three years ago is today well recognised and perceived as legitimate by all the different institutional sectors of the Inserm. The next step will be to convince the scientists and the clinicians that working with the patients brings an added value to research.

Empowering patient organizations through social science research: the case of Innovia Foundation for Medicine, Technology & Society

98Stuart Blume, Innovia

Background assumptions

99Let me first start by saying where the idea for Innovia7 came from. It is something we are still in the process of inventing. The idea really emerged from a whole variety of experiences of my own, as a civil servant in the UK where I was, once upon a time, secretary of a Government Committee on Social Inequality and Health; my experiences as researcher, for many years, studying the origins and consequences of new health care technologies; my experiences as consultant with international organizations like OECD; but, most importantly of all, my experience as a parent of two deaf children.

100In that last capacity, I got invited to be on various committees as a representative of a parents' organization. And what I found, sitting there with perhaps another parent and one or two deaf people and lots of professors of medicine and such like, was that the parents, the patients -the deaf people don't call themselves patients, but let's call them patients for now - weren't really listened to. They were sitting there, they were hesitant to speak because they were so impressed by these professors of medicine, and when they did speak, frequently what they said was written off: 'oh but that's only your personal experience. You know we've all these clinical trials with five thousand participants that show something different'. And the questions I went away from all those meetings with were: 'how can the experiences these people are trying to articulate be given more authority? How can it be taken more seriously? And how can we learn how to do that?'

101It seemed to me there had to be some way of conferring on that experience something of the status, the aura of science. It seemed to me also that we had to learn somehow from what is called evidence-based medicine, clinical trials above all. Apart from their methodology, one thing that clinical trials often have in common is that they are conducted in a lot of different places. And then it's possible to make broad generalizations about the efficacy of a drug or an intervention decoupled from, cut loose from the context in which those studies were done: “because it's done in a lot of places we can say our conclusions are pretty well universally valid”.

102Within the social sciences research looking at experience is not like that. We know from endless research in sociology and anthropology that the experience of being ill, what it is especially to have a chronic condition, is so very different in one society or another, depending on how wealthy it is, on the culture, on a whole lot of things. If the experience of being ill is so different, it follows logically that the experiences of being made better must be different as well. To be deaf in Africa is not the same as to be deaf in Sweden, so being given hearing can't be the same either.

103Well, what that brought me to the question of how can we somehow synthesize experiences in different places. If there's one methodology that can capture this, and this is perhaps something only known to my academic colleagues, it would be the notion of meta-ethnography, but this is only a footnote. So how can this experience be given more weight, how can we learn from the power of clinical trials while at the same time acknowledging that the experiences of being ill, and so also of being cured or helped are culturally and socially shaped?

104Gradually, the kind of assumptions that underpin what I was trying to formulate were becoming clearer. These are some of them: patients and their representatives are increasingly invited to participate in decision-making bodies at least in a few enlightened countries. But when they are there, in my experience, they have frequently far less influence than we are led to believe, and in much of the world they are not there, or even organized at all. So, basically, it seemed to me there was a gap between the rhetoric and the reality. This gap, I think, was partially a result of lack of organizations in some countries, and to the lack of this authority of personal experience that I referred to previously in others.

105And so here was the starting point, that we, as social scientists, have a contribution to make, and this is really the basic idea. Bram van der Ende has referred to the 'vital nature of the ownership of data' and that is certainly, potentially, the most important way of empowering patient organizations. There are other examples, like AFM in France, where having lots of money enables them to be listened to and indeed have influence.

106More generally, it seemed to me, and this is a conviction based on many years of experience, is that the sort of work we do can be an instrument in the empowerment of organizations. (Social) scientific research taking their expectations and experiences as its starting point can enable patients and their organizations to make a more effective contribution to debate


107Then we have to think about 'ok, this sounds great but what can we do with these thoughts? How do we turn them into anything at all?' The two things we had to think about were what kind of structure we want to have and what kind of more concrete objectives do we want to formulate.

Non-profit Foundation established in the Netherlands in October 2000
Board of Management (members from the Netherlands, France, UK)
Scientific Advisory Council (anthropologists, historians, sociologists, social medicine, from Canada, France, UK, USA)
Senior scientists and scholars working from a patient perspective, committed to the objectives of Innovia, and selected from different disciplines and the various regions of the world. Avoid overrepresentation of W.Europe/N. America

108So, the structure was easy, we established Innovia as a non-profit foundation some years ago. It has a board of management, I am not going to name them all, one of them was Johan Wesemann, who at one time was the chair of the European Disability Forum8. It has a scientific advisory council, of whom you may know Isabelle Baszanger from the CERMES (Centre de recherche médecine, science, santé et société, CNRS - Inserm), and it has a number of Fellows of whom Madeleine Akrich and Vololona Rabeharisoa are two. What I thought was important for us was to avoid filling it up with like-minded friends and colleagues from nearby. There are at the moment something like forty or fifty of these Fellows. It would have be quite easy to find enough people with similar concerns and commitments from France or the UK, from the Netherlands and the United States, but I wanted it be broader than that, so we've being struggling to find similarly-minded colleagues in Asia, Latin America, Eastern Europe, Africa. Eastern Europe and Africa have been the hardest until now. But I want to make sure that we can draw from experience in as much of the world as possible. We then had a conference to launch it, thanks to the Rockefeller Foundation.


109What are we trying to do? The formal objective that we formulated is “to facilitate a socially optimal development and deployment of new health care technology through (multidisciplinary) studies and related activities which focus in particular on the individual and collective experiences, concerns and aspirations of end-users”. It fits what I was saying before: it has to have ways of working that take the experiences of living with illness or impairment - that is a starting point - but also the aspirations of those living with illness or impairment, their expectations. And to translate that into something more concrete I'd say that in practice the objective is to produce and disseminate the basic knowledge to inform both public debate and the work of patient organizations specifically.

110If I had to sum it up in a few words, I would say what Innovia aspires to become is a resource for the patient and health advocacy organizations, a kind of think-tank, not doing advocacy because we're not the patients, we are not the advocacy organizations, but provide them with the kind of knowledge that our sort of research can provide and that can potentially be of use to them. So we then had to start thinking about how we can translate these wonderful sounding aspirations into anything that one can actually do. And to do that we had to consider what everybody else is already doing, because the world of health, health research, international health is a densely populated one: there are organizations doing pretty well everything one can think of. Well I think that actually none of them are doing what we are trying to do. We came up with three modes of action: research, dissemination and bridgebuilding.


111One of our modes of action is research, but research with certain particular characteristics: it would be largely international, comparative and collaborative, it would probably be interdisciplinary. Innovia doesn't want to be a research institute with lots of people on the payroll for whom we have to find money. The idea is not to compete with the universities where the expertise is, but to bring people from different institutions together temporarily on a contractual basis. And vitally: all the projects should be carried out in collaboration with some other national or international patient and/or advocacy organizations. As I said, we are still finding our way, we are still inventing all this as we go along.

112One example is the study that Bram van der Ende mentioned in his catalogue of Dutch failures - he didn't mean our study, he meant the organization that commissioned it. This was the study for Patienten Praktijk, and the question we were given was 'How to stimulate more research from a patient perspective' in the Netherlands, without a substantial injection of new funds?9 Patienten Praktijk was set up as a resource centre and think tank for the Dutch patient organizations, but was closed down. But for our setup it was a good way to start and to begin to do something.

113Another example is something that at the moment we are working out together with IAPO - the International Alliance of Patient Organizations10. The objective is to develop an instrument for (1) assessment of patient treatment experiences and preferences (especially with regard to medicines), (2) to serve as an input into national policies, guidelines, and adverse event reporting. We hope to be able to assess in how far standardized tools can be developed to assess patients' preferences with regard to drugs. This would be something that could provide an input into national decision-making about reimbursement, next to proofs of safety and efficacy, next to proofs of cost-effectiveness. That should be some sort of standardized possible assessment of whether people do want that drug, whether it fits their way of living, their expectations. In discussion with the IAPO, we came up with the idea of starting a pilot study of drugs used (or not!) for treating arthritis, and to do this in four countries, two in Europe where expertise for doing this kind of studies is available, and also outside Europe in two developing countries.

114Another study we are discussing together with an organization called IDEA (International Association for Integration, Dignity and Economic Advancement11) is experiences in de-stigmatizing leprosy (or Hansen's disease).


115The second mode of action that we came up with is dissemination: to make the results of social scientific research, of the socio-medical sciences, available in places where they are not normally available and in a form in which people can actually make use of them. This relates in particular to developing countries, where most of ‘our’ literature, the vast bulk of published research on the experience of illness, is scarcely available even to professionals let alone to grassroots organizations. An example of that is a book we produced in collaboration with a programme of health promotion for people with disabilities, which is actually a programme seeking to empower organizations of people with disabilities, in Thailand. It became apparent that the whole literature that has been produced in the West (or in the North) over the past twenty or thirty years based on the social model of disability was simply unknown in most of Asia. The same would be true for Africa, but we haven't started there yet. And the agreement we reached with this Thai programme was to produce a distillation of this literature that could be used in teaching medical rehabilitation professionals: to introduce them to the social model of disability.

Reader on Disability and Society
• Commissioned by the Programme for the Health Promotion of People with Disabilities in Thailand
Consists of edited selection from the recent social scientific literature on disability
To introduce rehabilitation professionals in Asian countries to social and cultural aspects of life with a disability.
Editorial group drawn from Belgium, France, India, Japan and the Netherlands
To be published by Orient Longman, in Delhi

116The idea was also discussed with a number of organizations of people with disabilities both in Thailand and India, and all of them welcomed this as an introduction to all that we've learned in the West, but focused in so far as possible on studies based on research conducted in Asia. I did this together with colleagues from Belgium, France, India and Japan. The manuscript was recently sent off to the publisher in Delhi. It had to be published in Asia or else it would have been too expensive for anybody there to buy.


117The third mode of action is ‘bridge-building’: to try to build links between research communities and grassroots organizations at the national or regional level. We heard here over the last two days examples of very good collaborations: in France, in the Netherlands, in the UK they exist, there are good examples. In most of the world such collaborations do not exist at all, whether for reasons of status differences, or because patients are not organized at all: for a whole lot of reasons. We want to find ways to build connections between researchers and (emerging) patient or health-advocacy organizations in different parts of the world, drawing on the experience of how that can work that we have accumulated in Europe.

118So we had a workshop called “Working effectively with researchers” in Den Haag (Netherlands) in October 2005 supported by ZONMw12 (The Netherlands Organisation for Health Research and Development) and in collaboration with Pan-European Patient Groups. It was a first attempt at presenting some examples of effective collaboration, focussing on how these developed and what they offered. I hoped there would be a lot of people from Eastern Europe participating, because within Eastern Europe these things are less developed, but this was proved difficult. Those we could contact did not have the resources to participate and our funding did not enable us to pay their travel costs.

119The idea is that we should use examples of effective but local collaborations as exemplars to show to others, both the scientists in the region or country and the patient organizations, that working together is possible - though there are problems they can be overcome - and that it has something to offer both sides, to help build mutual interests, mutual trust, mutual respect. So we are now working on the second workshop that I hope will take place in Colombia (South America), possibly broader than Colombia. And here we are working with an organization called COHRED13 in Geneva (Council for Health Research and Development).

120This illustrates the kinds of things we're trying to do. As I said, this is all still in development, there is a lot to be done. A major problem is lack of resources: we have literally no money. Everything that has happened until now has been more or less on a voluntary basis. Everybody -including me - is busy with his or her own research and teaching and all the other things the scientist today is expected to do. It's hard with no staff, and trying to induce people to do things when there are ten other things they ought to be doing as well is quite difficult! Nevertheless, we are slowly but surely making progress.

121There are two other things that I think are vital to INNOVIA's future success. The first is to build more sense of commitment and community among the Fellows and Associates involved. So early in 2007 we started to produce an electronic Newsletter. #5 will be appearing shortly, and they are all to be found on the website. And finally, I hope we might be able to build a kind of advisory network of associated patient/health advocacy organizations.

122All this may sound quite idealistic, but I think there has to be room for a little idealism, even in our evidence-based world of pragmatism and commodification. Speaking personally, I know that there have been opportunity costs associated with all the work I have put into INNOVIA. It has been at the cost of what I might otherwise have been writing in academic journals. But I have no regrets on this score. I think INNOVIA is beginning to make a unique and eminently worthwhile contribution to things that matter to all of us here.


1 High Authority for Health

2 L'Agence nationale d'accréditation et d'établissements de santé (Anaes) was founded by decree in 1996 and was incorporated into the Haute Autorité de Santé (HAS) upon its creation by law on 13 August 2004.




6 Comité d'orientation stratégique et de suivi des essais cliniques (Cossec)



9 The report is available (in English and Dutch) at



12 ZONMw


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