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The dynamics of patient organizations in Europe

Madeleine Akrich
João Nunes
Florence Paterson
et al.

Chapter 2. Patient organizations and the economic and industrial world - Towards new types of relationship?

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1Vololona Rabeharisoa

2The literature on patient organizations provides a wealth of examples and analyses attesting to these organizations' significance as social and political actors in the domain of health and medicine. In contrast, few studies have been devoted to their relations with the economic world, although interest in the subject is growing, motivated by two issues: the pharmaceutical industry's funding of patient organizations, and certain organizations' support for therapeutic research on their diseases. Apart from these issues, the few existing studies also show that the economic dimension of associative action can come in various forms. This is what we would like to highlight.

Non-profit organizations: an economic sector in its own right

3One of the main reasons for which patient organizations' economic role has often been underrated is that they belong to the non-profit sector. The precise delimitation of this sector is so conceptually and methodologically complicated that for a long time is was defined only by contrast to the so-called market sector. The work by Anheier (2000) aims to renew reflection on the managerial features of the non-profit sector. A few years ago, Anheir also initiated an international network of economists and social scientists to produce and up-date figures on the non-profit sector (Salamon, Anheier et al., 1999). In France the MATISSE laboratory at the Pantheon-Sorbonne University has been one of the kingpins in this respect. For several years researchers have been undertaking extensive field surveys to identify organizations operating in various fields (culture, sport, medicine and health, social action, etc.), and to collect, standardize and disseminate indicators on their economic weight (Archambault, 1996; Tchernonog, 2007; Tchernonog and Vercamer, 2006). Two indicators in particular reflect this weight, especially in the health and social sectors: first, the number of salaried workers in these organizations and, second, the quantity of work produced by their volunteers (Prouteau, 2006). More generally, financial flows related to their collaboration with public institutions bear witness to non-profit organizations' importance as economic actors, even though their aim is not to generate and redistribute profits.

4As an illustration, consider the early stages of disabled persons' organizations in France, which preceded patient organizations as such. The most emblematic of them was certainly the APF (Association des Paralysés de France), created in 1933, originally for individuals with poliomyelitis and then anyone suffering from an acquired physical impairement. The APF was the product of a public service delegation mechanism consisting, in the welfare state, in entrusting intermediaries with the task of dealing with a particular collective problem, on the basis of terms of reference and negotiated funding.

5In the field of disability, Barral (1991), following Stiker (1982), notes that the creation of non-profit organizations and laws have tended to go together. It all started with laws that revised the professional classification of veterans mutilated in WWI. In the associative sector, veterans were relayed by tuberculosis patients who demanded and secured the right to social reinsertion through employment, and then by poliomyelitis victims who founded the APF. The APF's power stemmed from the fact that it became both the mouthpiece of disabled people and an intermediary for public authorities. It federated disabled people around the gradual recognition of their own collective strength, by demanding that the state guarantee their basic rights and their capacity to exercise them. Consistent with the spirit of the 1901 law which instituted the associative sector in France, the APF took on the mission of serving as a substitute for the welfare state. By obtaining the status of manager of institutions, it acted as a relay for public authorities, thus combining its power to represent disabled people with the institutional power that the state delegated to it on its own ground. In the wake of the APF model arose the very powerful UNAPEI (Union Nationale des Associations de Parents d'Enfants Inadaptés), which managed its own institutions for mentally disabled children.

6These “associations gestionnaires” ("managing organizations"), as we call them, are key economic actors in their field: their budgets finance jobs, facilities and services now scattered across the country. Similar examples probably exist in other countries. They show that patient and disabled people's organizations irrigate the national and local economic fabric through various mechanisms.

The question of funding associative action

7This brings us to the funding of associative action, an issue that has been debated extensively as it involves the question of non-profit organizations' independence from their funders, whether these are public authorities or private corporations. In particular, relations between these organizations and the pharmaceutical industry, when it sponsors them, have raised many questions as to possible manipulation of the former by the latter. In the Anglo-Saxon world the term "astroturfs" has been invented to denote patient organizations set up and financed by pharmaceutical firms. It is often said that, unlike real grassroots organizations, they are the Trojan Horses of the pharmaceutical industry which takes advantage of them for purely mercantile purposes. In many countries initiatives have recently been taken to distinguish "authentic" patient organizations from those which are assumed to be the "showcases" of industry, based on the proportion of their budgets provided by firms. Yet, apart from these concerns shared by patient organizations, due to the giant asymmetries between themselves and pharmaceutical firms, few studies have been devoted to the nature of the relationships accompanying these corporate sponsorships. The work of Orla O'Donovan (2007) is an exception in this respect.

8Based on a questionnaire sent to 167 Irish health advocacy organizations (112 of which replied), as well as a series of interviews with some of their leaders, Orla O'Donovan highlights the plurality of these organizations' modes of engagement with the pharmaceutical industry. She qualifies the criticism often levelled at the corporate colonization of health activism by showing that relations between health advocacy organizations and pharmaceutical firms are rooted in the organizations' cultures of action, and can change with time. In relation to the causes defended by an organization, its work of public identification, the way in which it envisages its political action, and its positioning in the network of actors concerned, she distinguishes three forms of interaction with the pharmaceutical industry: corporatist, cautious cooperation, and confrontational.

9An alliance like the MRCG (Medical Research Charities Group), formed around the promotion of biomedical research in the struggle against certain diseases (e.g. rare diseases), considers the pharmaceutical industry as an unavoidable partner in furthering its cause. The group not only accepts the industry's money, it also organizes dialogue that it wants to be as consensual as possible, around a number of subjects considered to be of common interest, such as over-regulation of drugs markets. The MRCG considers such a corporatist relationship as not only desirable but also made possible by a set of rules of conduct to protect the interests and prerogatives of the various stakeholders, as stipulated in the Irish Pharmaceutical Healthcare Associations' Industry Guide to Working with Patient Associations.

10The Dublin Aids Alliance fights to improve the living conditions of patients, especially those whose socio-economic status is precarious, with a view to contributing to a humane and just society. Irrespective of the circumstances in which patients have contracted the virus, or their living conditions, the alliance considers that all deserve to be treated and considered on an equal footing. To defend its cause, the alliance works with like-minded organizations such as the Irish National Organization on the Unemployed, or the HIV Services Network. Universal access to medication is one of its main claims. It not only agrees to be financed by public institutions and to collaborate with them, but also refuses any alliance with the pharmaceutical industry which, from its point of view, practises prohibitive prices that make drugs inaccessible to countries of the South. That is why Orla O'Donovan describes the alliance's relations with the pharmaceutical industry as confrontational. This does not however mean that it is averse to relations with industry in general; it accepts sponsorship from the condom and cosmetic industries, for instance.

11Somewhere between these two situations, Aware-Helping to Defeat Depression has developed "cautious cooperation" with the pharmaceutical industry. Its main struggle is to secure recognition of depression, especially some of its forms, as a serious disease whose causes are biological and whose treatment involves a combination of psychotherapies and anti-depressants. The organization clearly takes a stand against those who consider depression as the result of a lack of will-power, and fights against the stigmatization of anti-depressants. Its relations with the pharmaceutical industry have gradually turned into "cautious cooperation", although their interests are in a sense aligned. Aware's main concern today is to ensure that depression is a civically authorized disease, like common organic diseases. It is investing more than before in fund-raising to finance its actions and is therefore careful to ensure that its historically strong ties with industry do not tarnish its public image.

12To our knowledge, Orla O'Donovan's work is the first and only study to have examined the different contexts in which the funding of patient organizations by the pharmaceutical industry takes place. Further research of the same kind would be interesting. Over and above the numerous normative findings on the colonization of the associative world by the pharmaceutical industry, it would provide insight on the conditions that make relations between non-profit organizations and industry possible, as well as the nature of those relations.

Patient organizations: actors in innovation processes in the domain of health and medicine

13Apart from the economic weight of the non-profit sector in the field of health and medicine, and the funding of associative action, many studies have focused on a third aspect of relations between patient organizations and the economic and industrial world: the role of non-profit organizations in innovation processes. Most of these studies are a continuation of Science and Technology Studies and show how certain patient organizations, as representatives of consumers, future beneficiaries and final users of medical and biotechnological innovations, are involved in designing those innovations and in the construction and regulation of drug, diagnostic and therapeutic tool, and medical technology markets.

14In a recent book Nikolas Rose (2006) shows that one of the main changes in the health and medical field today is the upsurge of what he calls "biocapitalism", that is, a fast-growing economic activity based on the "valuation" of biomedical entities, not only by industry but also by patient organizations. The case of the organization PXE US, studied by Heath et al. (2004), is a striking example. The families concerned by this rare skin disease of genetic origin contributed to researchers' work to locate and identify the implicated gene, including participation in laboratory work. They then imposed themselves as co-inventors of the patent on the genetic sequence of their disease, to ensure that power remained in their hands for negotiating the price of any future derived drugs. This example shows that the structure of intellectual property in the biomedical field is an important subject that warrants in-depth study.

15Apart from these cases of "economization" of original biomedical entities, other studies show the intervention of certain organizations prior to the commercialization of new molecules and innovative diagnostic and therapeutic tools. In our study of the engagement of the AFM (Association Française contre les Myopathies) in biological, clinical and therapeutic research on neuromuscular diseases (Rabeharisoa and Callon, 1999), we show how the organization, faced with industry's lack of interest in these rare diseases, endeavoured to create the conditions for the development of a drug and therapeutics market. It did so by contributing to the creation of facilities (DNA banks), equipment (techniques for monitoring effects of innovative molecules on muscle regeneration) or intermediate objects (the vectors necessary for introducing modified genes into an organism). Another illustration of the role of certain patient organizations or health advocacy movements in the prescription and evaluation of medical innovations is the feminist movements studied by Anita Hardon (2006). She shows how, through their worldwide networking, these movements have participated not only in the different commissions responsible for evaluating transdermal contraceptive patches, but also in the monitoring of their implementation in the field, in India, which revealed the technical, social and cultural inappropriateness of the technique.

16Further downstream from the innovation process, patient organizations' growing intervention in the design and implementation of clinical trials has also been noted. One of the most well-known cases is that of Aids organizations which, on both sides of the Atlantic, succeeded in imposing a compassional protocol for clinical trials, to afford patients access to innovative molecules on the basis of non-standard criteria (Epstein, 1996; Barbot, 1998). In a recent book Steven Epstein shows how the institutionalization of the paradigm of minorities' inclusion in clinical trials submitted to the FDA spawned a new recruitment science. In certain circumstances this implies negotiations between the promoters of the trials and the communities concerned, on the modalities of the subjects' inclusion. Alberto Cambrosio and Peter Keating (submitted) show the concomitant emergence and evolution of the figures of the patient and of the organization of research and care provision in the case of cancer. In particular, they highlight the gradual "protocolization" of patients, both as rare resources and as active subjects, linked to the development of clinical trials.

17These studies show that patient organizations' therapeutic activism in innovation processes is worth analysing in relation to the networks of knowledge and practices that mobilize groups of researchers and clinicians, insurance companies, medical institutions, regulatory organizations and industry. In these networks, patient organizations often act as mediators between the various stakeholders, without them necessarily maintaining consensual relations with the actors involved. Examples are NORD in the US and EURORDIS in Europe, which were mediators in the promulgation of laws and directives enabling the public authorities to implement incentive measures to develop the orphan drug market. In the same spirit, recent studies highlight the role of patient organizations in the regulation of drug markets and their simultaneous development of expertise in health technology assessment (Moreira, submitted). In some countries institutional apparatus exists which recognizes this role of patient organizations. An empirical analysis of the functioning of such apparatus would enable us to further our understanding of the conditions in which patient organizations play the part of stakeholders in innovation projects and programmes.

Collecting other experiences to document the economic dimension of associative action

18This literature review points to several topics that would be worth documenting further to gain insight on relations and conflicts between patient organizations and the economic and industrial world. Three topics in particular stand out.

19Related to the "corporate colonization" discourse, the question is currently emerging of the conditions that make collaboration between patient organizations and industrial and economic actors possible, viable and credible. This question is fairly general as it arises recurrently when actors with seemingly different interests, and in asymmetrical positions of power, engage in common projects. It has arisen, for example, in the case of relations between patient organizations and the medical and scientific world. Does it arise in comparable terms in the case of their relations with the economic world? The above-cited work by OrlaO'Donovan suggests the need for empirical studies of a relatively wide scope to answer this question.

20In what forms and at which stages of the process of elaboration and implementation of research and innovation projects and programmes do patient organizations intervene? What means do the organizations that participate in such projects and programmes use to familiarize themselves with the modes of functioning of the industrial and economic world, and to influence it? In particular, what alliances do patient organizations form with biomedical institutions, regulatory agencies, etc. to be able to impact on the nature and course of industrial innovation projects and programmes? Can we talk of a "triangulation" between the world of patients, the economic world, and the institutional and political world, as the above-mentioned studies tend to show?

21How do patient organizations evaluate their contribution to these projects and programmes? In other words, what management tools do they invent or use to define and exercise their decision-making and control powers? How do they negotiate intellectual property rights and access to the drugs, products and services that may stem from these projects and programmes? More generally, can we say that a redistribution of powers between patient organizations, medical and scientific institutions, and firms is underway today, via new forms of collective action? Can we say, as some of the cases mentioned above suggest, that patient organizations, at least in some situations, are the promoters and/or actors of new forms of entrepreneurial action?


How do patient organizations work with the industry and keep their freedom and strategic position?

22AnneLaure Pham, AFD, French Association of People with Diabetes & Isabelle Aubert, Medtronic

A partnership between the AFD and Medtronic

23The Association Française des Diabétiques (AFD) and the company Medtronic have a partnership agreement since the end of 2005, which aims at providing better information to people with diabetes on the insulin pump therapy.

24The Association Française des Diabétiques1 is the French national Federation of 133 Associations of People with Diabetes. The former association was created in 1938, and became a federation in 1993. The main objectives of the AFD are: support, information, prevention and education.

25Medtronic2 is a company specialised in medical technology; it applies biomedical engineering in the research, design, manufacture, and sale of health instruments or appliances, among which insulin pumps.

26The insulin pump is a medical device that represents a big change in the daily treatment of insulin-dependent diabetes. The pump which delivers the insulin directly in the body is an alternative to multiple daily injections. All the board members of the AFD, who are all people with diabetes, progressively adopted this new therapy, and the board has been for the association the first place of the exchanges between pump users about their experience with this therapy. Based mainly on this collective experience the board decided that the association had to take position about the insulin pump therapy.

  • 3 The reduction is from one shot every three days instead of 15 shots for the same period of time (wh (...)

27The policy statement of the AFD about the pump therapy asserts that the two main reasons to foster the diffusion of this new therapy are a medical reason - the pump improves glycaemia control - and a social reason related to daily life - the pump therapy provides a better quality of social life-. The use of an insulin pump considerably reduces the number of shots3, therefore it has a very strong impact on the professional life as well as on leisure or social activities of insulin-dependant people (for instance, there is no need to make an injection when going to the restaurant).

28The position of the AFD on the diffusion of this therapeutic innovation is to foster an equal access to the treatment for the persons with insulin-dependent diabetes who wish that treatment. The AFD took action as concerns the financial aspect of the access to treatment, the problems of the availability of medical infrastructure, but also the question of the information that enhances the knowledge and then the capacity of the diabetic people to participate in the choice of their treatment. In 2000, the AFD addressed the Ministry of Health for the reimbursement of the insulin pump treatment by the social security heath insurance. 6500 people were using the pump in 2002, and they are more than 15000 today. In 2006, the AFD with the support of Medtronic launched a survey on the access to the insulin pump in France, which showed inequalities in the access to the therapy on the French territory by regions and departments. Finally, the AFD started organizing information meetings through its local associations. The AFD is a patient centred organization, and the local meetings are one of the means used to develop “patient consciousness”. The information meetings on insulin pumps, intended to people with diabetes and their families, are the place where actual users of the therapy share their daily experience of it.

29The contacts between the AFD and Medtronic started because the AFD was looking for a partnership to support its action on the questions related to the insulin pump. The partnership with Medtronic allowed the AFD to set up a national operation called "éclairer sur la pompé'4, which means shedding light on pump therapy.

30A partnership between a patient organization and a healthcare products company raises number of questions. The objective of our presentation - which is a two-voice presentation - is to speak about our respective experience of this partnership, as the Executive Director of the French Association of People with Diabetes and as Medtronic Marketing Manager.

What do patient organizations look for through relationships with the industry?

31AnneLaure Pham: The missions of our patient organization are to stand up for the people who live with diabetes and their families, to provide information and advices to them, and to give them support by creating social links and a sense of conviviality.

32The outcome expected - and reached - by the AFD from its relationship with the industry is that a partnership facilitates its action as concerns (i) patient information, (ii) patients' access to new treatments and (iii) support to research.

33As concerns, the specific question of the information on therapies, the relations with the industry are at best when the patient organization is concerned with the diffusion of a new form of treatment developed by the industry, as it is the case with insulin pumps.

What does the industry look for through relationships with patient organizations?

34Isabelle Aubert: The three main outcomes expected by Medtronic through relationship with patient organizations are (i) to enhance the image of the medical industry, (ii) to develop corporate brand and (iii) to inform on new treatments.

35The relationships that exist today are grounded, on one hand, on the strategies developed by the patient organizations since the 1990' to benefit from the support of the industry, and on the other hand, on the efforts made by the industry to develop its image and the company to promote treatments.

36Medical technologies, as compared to drugs, have a short cycle of life, which is of around two years. The rapid evolution of high technologies means that companies compete for the regeneration of medical devices and that the industry produces therapies that are in a continuous motion towards improvement.

37Two types of contributions are expected by our company from a partnership with a patient organization.

38The fist one is a contribution to the adoption of a new therapy such as the insulin pump. The marketing of new therapies relies on the fact that the therapies are adopted both by the physicians who might prescribe them and by a growing number of patients. The adoption depends on:

  • The evidence of the medical capacity of implementation of the new treatment. Evidences are necessary to demonstrate the efficiency of the new therapies.

  • The funding, which is the fuel for the adoption of new therapies. The access to new therapies starts with their reimbursement by social health insurance; in France, without this source of funding it would have been impossible for most patients to access pump therapy.

  • The capacity of implementation related to medical infrastructures. Insulin pumps are first prescribed within specific medical structures called Insulin Pump Centres (centres de prescription), even though the treatment may later be monitored by private sector diabetologists. The capacity of implementation of insulin pumps depends on the ability to create Insulin Pump Centres. The survey conducted in 2006 shows that 20% of the centres prescribe 55% of the insulin pumps, and that the number of Insulin Pump Centres vary from one to six per department. Consequently, in France, the access to the pump therapy is far from being equal for every diabetic patient.

39This new therapy, as a physician told me, does not spread out by convincing the physicians or by offering them financial incentives, but because some physicians involve themselves in the creation of new Insulin Pump Centres. What we have seen is that the adoption of the pump therapy also depends on the generations of physicians, the younger generation being more interested in this technological therapeutic innovation.

40The second type of contribution expected from our patient organization partner is towards the acceleration of the cycle of time towards the Standard of Care.

41This acceleration can increase the rates of access to the therapy. Patient organizations can help developing patient targeting and the definition of new indications for the treatment. They may also raise patient awareness and interest in the treatment.

42The aim is to shorten the time taken to access to this therapy, and patient organizations help in acting as patient ambassadors or advocacy groups.

43In market development, acceleration of patient access to a therapy is an approach designed to accelerate cycle time to standard of care. A standard treatment is what any physician would provide under same circumstances.

What makes the closeness necessary and viable?

44AnneLaure Pham: As concerns the insulin pump therapy, Medtronic and the AFD have the same targeted stakeholders: the patients, the physicians, the health care authorities and the payers. We also have the same goals, which are to increase the patients' quality of care and quality of life.

45The AFD, which was founded seventy years ago, is one of the first patient organizations created in France. For some decades, the action led by patient organizations has been constructed around a narrow definition of health issues referred to the patients' daily life and the physicians' medical and social practices. For the AFD, the main issue has long been to provide support and education to patients who have to be their own care giver and be able to do the glucose controls, the injections, etc, by themselves. Today, the scope of action of the patient organizations is much wider: because the daily life and the quality of life of the patients are at stake, they have to invest all the domains of health, which include health economy, health regulations and policies, but also the political aspects of health as well as its international dimensions. The fact that we are now using the notion of quality of care, the notion of therapy or the notion of quality of life goes along with the evolution of the society.

46The dialogue with the whole range of stakeholders targeted by the AFD makes it necessary to build partnerships. According to the position of the AFD about the insulin pumps, and to all the changes its diffusion supposes, the partnership with a company such as Medtronic is necessary and is viable inasmuch as it serves and preserves both interests and principles of action.

What are the conditions which make the collaboration possible, viable and credible?

47AnneLaure Pham: We have identified four conditions under which collaboration between a patient organization and a company is possible, viable and credible.

48The first of these conditions is the encounter of our mutual interests, which of course responds to different needs:

  • Patient organizations need to act, inasmuch as the legitimacy of a patient organization is governed by the actions it takes. The more a patient organization develops its activity the more it becomes acknowledged and powerful.

  • The industry needs to acquire a favourable image and social acknowledgement. The collaboration between a patient organization and a company gives the company access to what a patient organization can represent for its members or for the patients in general. A partnership is a question of trust, inasmuch as the industrial partner has access to the patient organization's ethical integrity.

49The patient organization's independence is a second condition of a viable and credible collaboration with the industry. The independence of the patient organization relies on its representativeness: it has to be an organization which voices on behalf of its members. Representativeness supposes that the organization has to have a reliable structure that enables the consultation of its members. This is a question of credibility of the patient organization itself. For example, a PO that is directly and completely financed by the industry is nothing more than a façade, and some are in this situation.

50A third condition is that this collaboration needs to be fed by both expertises:

  • The expertise of patient organizations is to have knowledge on how to do in the patient environment and this facilitates the contact with patients, users of medical devices or medical product consumers. Its expertise is also related to applied medical culture, to the patient's role in the use of a therapy, to patient education and observance and a patient organization is a provider and a partner of the dissemination of information.

  • Industrial companies have specific competencies and means which contribute to the professionalization of patient organizations and to develop the competencies of patient organization in health issues.

51A fourth condition is that the collaboration develops with a sound ethic. As a patient organisation, we need sound ethic in accordance with our mission. But ethics also needs to be an expression of the mission of the industrial partner.

What means do the PO have to influence the modes of functioning of the industry?

52AnneLaure Pham: Patient organizations have three characteristics which are specific and that the industry cannot find elsewhere.

  • Legitimacy and power.. Patient organizations have gained legitimacy and are becoming unavoidable actors of the health care system. In France, patient organizations sit as other stakeholders in number of commissions of the health system. The laws adopted in 2002 and 2004 redefine their place and their role and associate the patients to heath governance. Therefore while POs have become impossible to circumvent, they have gained access to working-out information.

  • Authority. Patient organizations are "the voice of patients to patients" and this gives them authority in the communication of advices and recommendations to the patients. As concerns the AFD, we consider having authority on questions dealing with diabetes; the advices we provide are given in respect of the free will of the patients.

  • Networking. A patient organization is the place where the patients who need it can meet other patients. They share patients' stories, talk about the disease, the treatments, daily life, exchange physicians names. The AFD gathers a lot of patients and families (27000 members and about 85000 backers), but the whole network around the association also includes the physicians and care givers. Despite the large number of persons involved, there is proximity between people within the network. And a lot of people have a role of ambassadors and prescribers.

53In the collaboration with a patient organization, the industry is able to benefit from the legitimacy, the authority and the networking of the patient organization. This is particularly important for the information plans about the insulin pump treatment, for example.

Is there today an ongoing redistribution of power between PO and industry?

54Isabelle Aubert: Patient organizations are the promoters of new forms of entrepreneurial action. They act as facilitators of contacts. As advocates of new therapies, they have a political commitment. As developers of therapies, they have communication plans towards the patients.

55The patients have become actors of this new business and that is why the industry needs to develop close relationships with the patient organizations. The industry has a lot of questions the patient organization can help to respond, for instance: how to built targeted offer? How to serve the patients? How to gain the patients and develop loyalty and outcover to cover the market and build strategies without advertising and communication?

What are the mechanisms that rule the collaboration?

56AnneLaure Pham: We have taken four similar dimensions that rule the action of our patient organization as well as the action of our partner Medtronic: time, results, production and success. Our purpose is to show the differences between the AFD and Medtronic on these four dimensions in order to underline that our collaboration relies on the capacity to take account of our respective needs and differences.


57AnneLaure Pham: The action within a patient organization requires taking a substantial length of time, especially to respect its democratic functioning. The more rapidly the activities are implemented the more it comes to be violent to the patient organization's members. Democracy is observation, recognition, explanation, comprehension and finally adherence to the objectives and positions of the organization.

58Isabelle Aubert: For the industry, time is money.


59AnneLaure Pham: The results obtained through the activities undertaken by a patient organization concern the quality of social links and behavioural changes. These kinds of results are issued from a very long process.

60Isabelle Aubert: The industry expects quantitative and short term results. Its production is measurable trough short terms results, and results create productivity.


61AnneLaure Pham: The productions of a patient organization are performed through the work of volunteers and of professionals. The tasks which are implemented cannot only be considered as work but are an involvement in a cause, even for the professionals.

62Isabelle Aubert: In a competitive environment results are required and the key for success is productivity.


63AnneLaure Pham: For a patient organization, success depends on identity. The identity of a patient organization is composed of its history, of the cause it stands up for and of the principles of action which are implemented.

64Isabelle Aubert: For the industry, success depends on profit. Making profit is what makes it possible to reinvest, pursue new product development and foster innovation.

65Isabelle Aubert: We are working together for the same action -developing the access to insulin pump therapy. But the cycle of time is not at the same speed. Here is the main difference between us. For the industry, short product cycles provide higher value, which enables higher investments in research and development.

66AnneLaure Pham: On our side it is the opposite: the more we take time to implement an action the stronger the PO.

67In conclusion, I wonder who pays for the discordance between our different conceptions of the time and the criteria necessary to produce good results?

Patient organisations and economic actors: Eurordis round table of companies

68Christel Nourissier, Eurordis

69Eurordis round table of companies (ERTC) is a "club" for companies with a common interest in rare diseases and orphan medicinal products development. ERTC members provide financial support to Eurordis, in return, their company benefits from the constructive dialogue that is being developed between industry, patients' organisations, and national and European authorities in a neutral environment.

70ERTC represents a very small part of the activity of Eurordis. Before explaining its aims and activity, I will briefly describe who we are and what we are working on.

Eurordis, the European Organisation for Rare Diseases

  • 5 Regulation (EC) N° 141/2000 of the European Parliament and of the Council of 16 December 1999 on or (...)

71In Europe, a rare disease is a disease affecting less than 1 in 2,000 citizens. This threshold has been set in the orphan drug regulation adopted by the European Parliament in 19995. By definition rare diseases are rare, though about 30 million people are affected in the EU (6 to 8% of the EU population).

  • 6 Contacts: Yann Le Cam, Chief Executive Officer. Fabrizia Bignami, Therapeutic Development Officer. (...)

72Eurordis6 was founded in 1997. It is a patient-driven organization. All the board members are either patients or parents. Eurordis brings together 300 member organisations in 33 countries. Most of them are very small organizations, run by volunteers. Among the member organizations there are eleven National Alliances. As an example, the French National Alliance alone brings together 170 groups, so on the whole we bring together more than 600 groups in Europe.

73Eurordis counts 17 staff in Paris and Brussels and 60 volunteers involved in task forces, steering committees, working groups and the Board of Directors. On the whole, 400 patient groups participate in Eurordis' activities every year.

74Eurordis is a partner in the Rare Disease Platform, in Paris, together with Orphanet, the telephone line for Rare Diseases and the French Rare Diseases Alliance.

75Eurordis' mission is to build a strong pan-European community of patient organisations and people living with rare diseases, to be their voice at the European level and to improve their life expectancy and quality of life. This community gathers all the people working for rare diseases, which also means scientists or pharmaceutical industries when they are working on drugs for the treatment of rare diseases.

76Eurordis is today the key representatives for rare diseases at the European level. It is present in many European institutions and platforms:

European Institutions:

77Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMEA). We have been involved as members of the COMP from the very beginning. The current vice-President of the COMP is Birthe Byskov Holm. She is the President of the Danish Osteogenesis Imperfecta Association, and the former vice-President was Yann Le Cam, who is the executive director of Eurordis.

  • EMEA/CPMP (Committee for Proprietary Medicinal Products) Working Group with Patients' Organisations.

  • Rare Disease Task Force at DG Health and Consumer Protection.

  • EU Health Policy Forum at DG Health and Consumer Protection.

European Platforms:

  • European Patients' Forum (EPF).

  • European Platform for Patients' Organisations, Science, and

  • Industry (EPPOSI).

  • European Forum for Good Clinical Practice (EFGCP).

  • International Alliance of Patients' Organizations (IAPO).

Eurordis' funding sources

78The patient groups, members of Eurordis, come from different cultures. We have had long discussions about the funding by pharmaceutical companies in our board. In the board we have people from different European countries; for example, Terkel Andersen, our President is from Denmark and in Denmark funding of patient groups by pharmaceutical industry is strictly forbidden because it is considered as conflict of interest. In Sweden it is not very well considered either. We had to find agreements between all our members.

79The Board of Directors has decided to adopt two main rules about our funding sources. The first rule is the diversification of the types of funding by commercial companies in order to avoid risks inherent to a relationship with a single company, or a limited number of companies.

80The second policy rule is transparency regarding its relations with commercial companies, which are published within its documents and on its website. Eurordis is creating wider opportunities for future funding while making clear that this will not compromise its independence and future policy decisions. The Annual Financial Statements of Eurordis reflect the level of funding received from corporate sponsors and provide fair and reliable information to its members and the public (this appears in both the printed report and on the Eurordis website).

81«Eurordis limits the total annual financial support from commercial companies to an annual maximum of its budget, which should not be superior to the total amount of funding provided by Eurordis' members, including the AFM, which is our main funder.»

82The rules established about corporate funding are mentioned in a document entitled Eurordis Policy on Financial Support by Commercial Companies that has been revised on a regular basis (in 2001, 2003 and 2007). This document can be found on the website

Financial support by commercial companies concerns:

  • Project funding

  • Funding of special initiatives or activities, such as conferences, workshops, communication.

  • One-off charitable donations

  • Membership in the Round Table of Companies

83Eurordis does not endorse medicinal products, brands or health services.

84Eurordis has decided that the amount of funding from pharmaceutical industry should not exceed the financial contribution of its members. The structure of the budget of 2007 by sources of revenues shows the contribution brought by the pharmaceutical companies represents 19% of the budget.

Financial Report
Revenues by origin

Financial ReportRevenues by origin

Budget 2007 by source of revenues

Eurordis round table of companies

Specific purposes of ERTC

  • 7 The National Organization for Rare Disorders (NORD) is a private charity that was established in th (...)

85Eurordis round table of companies (ERTC) was created in 2004, after a two years reflexion process together with the EMEA, the patient groups and the pharmaceutical companies, following the model of NORD's7 Corporate Council. It was set up with specific purposes:

  • To provide Eurordis with pooled financial support for unrestricted funding with no strings attached, in favour of activities of common interest and benefit for people living with rare diseases

  • To educate concerned companies on working with patient groups. When the idea of creating the ERTC was launched, we were busy setting up a charter on the relationship between pharmaceutical industry and patient groups for clinical trials; the charter has been published and has been already signed by a number of companies. Companies concerned with orphan drugs and patient groups work on the common goal of facilitating rapid development and availability of treatments and services. It is important that companies understand why, when, and how to work with patients. We believe we have an important role to play in the clinical trials and we wish to be involved at the very beginning, as early as possible, because we think that we can make the trials more successful and come to better outcomes.

  • To stimulate orphan drug companies to address patient's needs and to encourage other companies not yet involved in this field to develop treatments for rare diseases.

  • Networking patient groups, academics, companies regulatory agencies and policy makers and promote open and frank sharing of information, in a neutral forum (because we are organising the meetings), on the process, obstacles and incentives for the development of treatments. We believe in dialogue between the different stakeholders, we believe we are key actors in the field of health as the same level as the regulatory agencies, the scientists, the academics, the companies and we have a role to play in reassembling the relevant actors and act as a catalyst.

Membership benefits

86For the companies which become members of ERTC there are three kinds of benefits.

  • First, the ERTC members are invited to take part in two workshops per year, where they can find opportunities to interact with other companies in a neutral venue, opportunities for direct exchange of views with leaders of the rare disease community and opportunities to develop partnerships and collaborations with patient groups.

  • Second, there is a mention of ERTC members on Eurordis' website, with a logo and direct link to the websites of the companies.

  • Third, the financial support of ERTC members is acknowledged in the Annual Report.

87Companies joining ERTC have a choice of three types of membership, depending on their level of financial participation

ERTC biannual workshops

88The workshop topics are selected after consultation with the ERTC members. A concept paper of one or two pages is sent in advance to all the participants. There is no report of the workshop but proceedings.

89The format adopted for the workshops is educational and addresses only issues of mutual interest. The principle is to dedicate a large part of the workshop to questions and answers in order to have open and frank discussions, to let time for the sharing of experiences between companies (which usually don't much share experiences as they are in mutual competition) and to foster informal contact with key regulators and policy makers. And this format has proved to offer exceptional occasions for informal contacts and discussions.

90The presentations are given by the different stakeholders: representatives from the industry, the European Medicines Agency (EMEA), the Food and Drug Administration (FDA), the Committee for Human Medicinal Products (CHMP), the Committee for Orphan Medicinal Products (COMP), the Working Parties, the European Commission, government officials, Eurordis' spokespersons and members, NORD representatives and academic experts. The presentations on COMP are given by other persons than the Eurordis staff.

91Since 2004, we have organised six workshops on the following topics:

92Compassionate Access Programmes for Orphan Drugs in Europe: from Heterogeneity to Harmonised Practices?, Dec 2004.

93New Methodologies for Clinical Trials in Small Populations, July 2005.

94Rare Disease Clinical Trials: Ensuring Fruitful Collaborations between Sponsors & Patient Organisations, Nov 2005.

95“Common Drugs for Common Needs: the US vs. EU Approach to Orphan Medicinal Product (OMP) Development, July 2006.

96"Rare Disease Patient Registries: an Essential Tool in the Development of Therapies?", Nov 2006.

97“Do Rare Disease Patients Have Real Access to Orphan Drugs in Europe?”, July 2007.

98The 7th upcoming ERTC workshop planned for December 2007 will concern “Level of Evidence for Proof of Concept in Rare Disease Clinical Trials”.

Preventing potential Conflict of Interest

99To prevent any potential conflict of interest Eurordis has set an ERTC Code of Conduct that each ERTC member has to fill out and sign. By signing this Code of Conduct, each member pledges to conforms to the Eurordis Policy on Financial Support by Commercial Companies

100When becoming a member of the Round Table of Companies, the company accepts and adheres to the following rules:

  • Join to improve understanding of orphan drug issues and exclusively discuss issues of common interest to members of the Round Table with a public health view on the system and the process, and not to discuss their specific products or services.

  • Understand that the Round Table is not a platform to advocate or to attempt to influence specific decisions or positions of either Eurordis, regulators, public policy makers or other stakeholders, or to ask Eurordis to influence public policies that would benefit their products.

  • Understand that participation in the Round Table will have absolutely no influence on the decisions made by Eurordis representatives at the COMP and at the EMEA.

  • Fully respect the independence and integrity of Eurordis, its representatives and its members.

  • Recognise the role of Eurordis and its member organisations in representing people affected by rare diseases, who, as such, are entitled to express critical views on any relevant matter.

  • Recognise the role of patient groups in clinical trials and seek to encourage active partnership between patients, health professionals and industry.

  • Support the widest & quickest availability of treatments and services to patients at a fair price.

  • Respect and listen to the other members of the Round Table of Companies.

  • Read and conform to the Eurordis Policy on Financial Support by Commercial Companies.

  • Understand that the membership to the Round Table entitles a company to the benefits listed in "Membership Benefits" and that no other.

101The key in our code of conduct is mostly discussing issues of common interest. The participation to the round tables will have no influence on the decisions that Eurordis representatives could make at the COMP and the EMEA. That the companies recognise the role of patient groups in clinical trials is also an important concern. As I mentioned earlier, we have a charter for the relationship between the companies and the patient groups on the clinical trials. And we all support, if possible in the member states, the quickest availability of treatments and services at a fair price. That does not keep us from advocating for the follow up of these drugs after the marketing has been done.

102The responsibility of deciding of the ERTC membership comes to Eurordis. The inclusion of a member is a formal decision made by Eurordis. Exclusion is also a formal decision made by Eurordis, and -because the case has never happened - would be based on a breach of Code of Conduct or Eurordis Policy on Financial Support by Commercial Companies. Inclusion (or exclusion if needed) are discussed and cleared with the EMEA. Eurordis provides an annual declaration to the EMEA and to the Committee for Orphan Medicinal Products (COMP) when relevant. The actions developed thanks to ERTC funds have been:

1032005:- Remuneration of an Information Manager

104- More production of information

1052006:- Training sessions for patients, in partnership with the


107- German translation of the Eurordis website and Eurordis monthly newsletter

108- Continue Information

1092007:- Remuneration of an Information Assistant

110- Continue training activities

111- Continue information

1122008:- Rare Disease Awareness Campaign

113- Expand training activities

Collateral benefits

114ERTC has helped establish closer, regular and more in-depth dialogue with most of its members, as well as with other companies. It has generated a fruitful dialogue and better understanding and respect of the patient representatives' point of view, particularly concerning their participation in clinical trials.

115The ERTC has turned to be a very practical forum, in the sense that it is solution-oriented and problem-solving oriented. We are not into big thinking, we are down to earth, what we want is to improve the life of the people concerned with rare diseases.

116The EMEA, the COMP and other stakeholders are de facto using the ERTC as a neutral forum to foster dialogue with sponsors and patient groups. Eurordis transparency policy is a now a reference for the European Commission

117The ERTC has started with a very small group at a modest level. Today, 30 companies have joined the ERTC, and this steadily growing membership can be considered as an expression of their satisfaction.


118As a conclusion, I would like to say that the Round Table of Companies is only a very small part of what we are doing. I would like to come back to the title of this session, “Patient organizations and economic actors”, and to say a few words on my concern and share it with you. In fact the real issue that most of the people we represent in Europe are facing is that they currently live outside of economy. They have no social existence. There aren't even codes from the World Health Organisation for most rare diseases. When children or adults die, something else than their own disease appears on their death certificate, for instance, the death is registered under heart failure when they die of muscular dystrophy. They have problems of access to school, to employment. There is a big difference between people living with a rare disease compared, for example, with people living with HIV positive or living with AIDS. Those people are having a social existence. Among the 6000 rare diseases there are only 200, which have a treatment and most of the time it is not something that cures.

119My concern, as a Secretary General of Eurordis, is really that I would not want some of our patient groups to feel excluded from all that is going on around orphan drugs and this is why we are working so hard. Improving diagnosis, access to care, encouraging basic and clinical research is not simple. Networking is not easy, but it is the key.

Patients' Organisations and Economic Actors: Opposition, "Instrumentalisation"or Cooperation?

120Orla O'Donovan, University College Cork

  • 8 Mintzes, B. 2007. 'Should patient groups accept money from drug companies? No', BMJ, 334: 935 (5 Ma (...)

121As I'm sure many of you at this gathering know - one of the transformations in health activism that has taken place in recent years is that more and more patients' organisations internationally have formalised links with market actors, typically in the form of sponsorship links with private corporations. A further transformation is that the nature of these relations also appears to be changing. Pharmaceutical companies are prominent amongst the sectors of the globalised capitalist economy that have shown a keen interest in cultivating friendly relations with patients' groups mobilised around specific diseases8. Such relations are widely regarded as making common sense and reflecting the need for patients' organisations to be pragmatic. However, in some settings such relations are controversial and have become the focus of debates about the normative behaviour of patients' organisations, debates about what they should and should not do, as exemplified by a recent feature in the British Medical Journal entitled ‘Should patient groups accept money from drug companies?’.

Collaboration between POs and the industry: a widely spread practice

  • 9 Kent, Al. 2007. 'Should patient groups accept money from drug companies? Yes', BMJ, 334: 934 (5 May (...)

122One of the contributors to that feature article, Alastair Kent, director of the British Genetic Interest Group wrote about patients' groups and drug companies' ‘common objectives’ and why ‘collaboration is reasonable when these mutual interests overlap’9. Pointing to the frequent dearth of alternative sources of funding, he noted that ‘industry funding can be an important boost to the viability of patient groups’ and that it has been ‘an enabler for many patient groups - just as it has for clinicians and academics’. He also emphasised that patients' organisations are not naïve, but are adept at ‘spotting the strings that may be attached to funding’ and thus at ensuring their independence.

  • 10 O'Donovan, O. 2007. 'Corporate colonization of health activism? Irish health advocacy organizations (...)

123These are similar to the arguments made by many of the people I interviewed as part of a study of Irish patients' organisations' modes of engagement with pharmaceutical corporations10. That research, which involved a survey of 112 patients' organisation, followed by more in-depth qualitative research with a small number of organisations, found evidence of a strong and growing cultural tendency in Irish patients' organisations to frame pharmaceutical corporations as allies in their quests for better health. Almost half (47%) of the organisations we surveyed had received pharmaceutical industry sponsorship. Organisations that invest considerable hope as well as material resources in the search for biomedical cures were amongst those that have friendly relations with pharmaceutical corporations, organisations such as Fighting Blindness, the Medical Research Charities Group and the Irish Platform for Patients' Organisations, Science and Industry. In a submission to the Irish government from the last of these organisations it is stated that 'research charities here are beginning to realise that it is absolutely essential to work very closely with industry... if it is seriously hoped to find solutions to the medical problems which they address'. In our study we also learnt about how certain patients' organisations in Ireland contribute to publicising the mutual benefits that such relations can entail, and have facilitated individual drug companies in communicating their desire to move beyond sponsorship relationships with patients' organisations to ‘partnerships’. In the words of a representative of Merck Sharp & Dohme who addressed a seminar organised by the Medical Research Charities Group in 2005, because the corporation now recognises the limitations of its ‘internal expertise’, it is interested in ‘interfacing’ with patients' organisations on matters such as research and educational initiatives, rather than just funding them.

A shift in the positioning vis-à-vis the industry?

124While it would appear that pharmaceutical corporations are largely succeeding in defining themselves as kind, caring and socially responsible, as well as rightful allies of patients' organisations, I should emphasise that Irish patients' organisations have varying modes of engagement with drug companies. So called partnerships with industry are becoming more common, but it also seems they are being critically questioned by actors within some organisations, are not inevitable and once formed, do not necessarily endure. In some organisations there is evidence of a strategic shift in their historical positioning vis-à-vis the industry and a move to ‘arms length’ relations. An example here is Aware - Helping to Defeat Depression, an organisation that in the past received drug company sponsorship for public education and other activities. It has become more wary of such sponsorship due to the increasing demands of sponsors, but also because of fears that it could jeopardise the organisation's credibility and public image. A minority of Irish patients' organisations shun and try to delegitimise pharmaceutical industry sponsorship as self-promotional on the industry's part. One such organisation is the Dublin AIDS Alliance that has a policy that prohibits acceptance of pharmaceutical industry funding because of the industry's pricing and other policies that have stymied access to HIV/AIDS medicines in the global south. In our study we argued these modes of engagement can be plotted along a continuum and characterised as corporatist, cautious cooperation and confrontational. In trying to explain why patients' organisations develop these varying relations with market actors, our research attempted to shed light on the organisations' 'cultures of action', key dimensions of which are their constructions of the health cause around which they are organised, the kind of patienthood they espouse, their ways of taking political action and their framings of friends and foes.

125The case of Alzheimer's disease: profit-making and social responsabilty, a fool's bargain?

  • 11 Sarah Boseley 'Drug firms and patient groups join in fight to overturn advertising ban', The Guardi (...)

126More recently, my research has focused on patients' organisations mobilised around Alzheimer's disease. Both internationally and historically, Alzheimer's disease organisations have tended to frame pharmaceutical corporations as their allies. This is manifested for example in the Alzheimer Society of Ireland's cooperation with Pfizer in its 'disease awareness' activities. Their joint campaign that uses the slogan 'keep you being you' publicises the importance of early diagnosis of the disease and the potential for antidementia medications to stave off the progression of the disease. (I should note that the effectiveness of these drugs is disputed, resulting in the restriction of public subsidies to them in certain countries). Likewise, Pfizer is one of a number of pharmaceutical corporations that funds Alzheimer Europe, the pan-European organisation established in 1990. As seems to be the trend with European level alliances, Alzheimer Europe relies to a far greater extend that its national level member organisations on industry funding. In 2005, it received 37% of its income from drug companies11. In the context of Alzheimer's disease organisations efforts to influence EU and national level pharmaceutical policy, the implications of their friendly relations with the manufacturers of antidementia medications have been called into question. For example, arising from their opposition to the reduction in Britain of public subsidies for antidementia drugs, the chairman of the National Institute for Health and Clinical Excellence has cautioned that industry sponsorship of patients' organisations could lead to excessive pressure and unfair rulings about which medicines were made available and that it undermines confidence in the organisations' independence (Mintzes, 2007). Alzheimer's disease movement organisations have also been singled out in media accounts of drug companies' efforts to enlist a major new ally in their struggle for profits (Boseley, 2007). (Alzheimer Europe is one of a number of organisations identified as supporting industry efforts to change EU legislation that restricts the advertising of medicines to members of the public). These kinds of commentaries are part of the ongoing debate about the implications of industry funding for the autonomy of patients' organisations. In another response to the BMJ feature about whether or not patients' organisations should accept money from drug companies mentioned above, Barbara Mintzes argues it undermines their independence. She argues that the conflict of interest inherent in such a relationship makes it difficult for patients' organisations to remain 'impartial' in matters such as information provision and to represent the interests of patients when those interests diverge from those of their sponsors, as in matters such as raising concerns about drug safety. For me such questioning of the implications of partnerships with industry for the pronouncements, actions and cultures of action of patients' organisations are important, but I am also interested in the conditions that are conducive or otherwise for them to be formed and to seem appropriate in the first instance.

  • 12 See Novas, C. 2006. 'The political economy of hope: Patients' organisations, science and biovalue', (...)

127In this research on Alzheimer's disease organisations and their struggles to influence drug reimbursement policies, I've begun to think about their broader normative effects, their contributions to shaping what is understood to be right and wrong, ethical and unethical, fair and unfair. This entails thinking about how the practices of patients'organisations impact on the norms not only of biomedical science, but also of healthcare provision and society more generally, and their potential to subvert or reinforce dominant ideas about the mechanisms of the market as the primary means to progress (as suggested by Carlos Novas12).

128The controversy about antidementia drugs is framed by Alzheimer's organisations as primarily an ethical issue concerning equity of access to medicines for low income patients. The organisations' opposition suggests that the norms of the market should not prevail in respect of access to the drugs, but instead the social value of equity should be given precedence. However, this endeavour to subvert the privatisation of the consumption market for antidementia drugs sits uncomfortably with other organisational practices and sensibilities that uphold the primacy of the market and the norms of neo-liberal consumer society.

129Firstly, part of the rationale underpinning the Alzheimer's organisations commitment to early diagnosis and treatment of Alzheimer's disease is that this enables individuals make provisions for their future healthcare needs, and thus is in line with the edicts of neoliberalism about individual responsibility. Celebration of the potentially empowering nature of early diagnosis and treatment can be tinged with the compulsion for people to take measures to minimise the extent to which they are a financial burden on others in the future. Secondly, claims that Alzheimer's disease patients have a right to antidementia drugs are presented in isolation from and as superseding those of the public more generally. Thirdly, Alzheimer's organisations' friendly relationships with pharmaceutical corporations uphold the industry's efforts define itself as socially responsible. However, the pharmaceutical industry, one of the most profitable sectors of the global capitalist economy, has been to the fore in lobbying for systems of global governance that prioritise market over social values, such as in respect of intellectual property rights. The success of the industry in securing measures, such as TRIPS (Trade-Related Aspects of Intellectual Property Rights Agreement), has led to prohibitive drug prices in many parts of the Global South that result in millions of the world's poor being denied access to medicines. In light of the industry's global record, it is difficult to see its support for the campaign for equity of access to antidementia drugs in Europe as being motivated by anything other than its own commercial interests and its attempts to promulgate the idea that it can reconcile vast profit-making with social responsibility. Finally, perhaps the most profound way in which the practices and sensibilities of Alzheimer's organisations uphold the norms of the market is through their cultivation of the idea that health is something that can be advanced through consumption, and that money (either public or private) mediates between health needs and their satisfaction. While many commentators on consumer society emphasise that individuals charged with the task of ‘self-construction’ do so primarily through consumption, in the case of antidementia medications their consumption is presented as a means of self-preservation, a way to 'keep you being you'. Such ideas foster a belief that the market will deliver ‘solutions’ to health ‘problems’, but also that in a situation where there is only one kind of product on offer then these must be chosen. As expressed in the 2007 manifesto of Alzheimer Scotland, antidementia drugs are the ‘only chance people have’. After all, an imperative of a society in which its members are primarily consumers is that they make choices between the products on display, to choose nothing is disallowed.

130Alzheimer's organisations, therefore, can be seen to both subvert and uphold a normative framework in which the market values of individual responsibility and choice are paramount, but in a manner which is undoubtedly functional for the expansion of the market for pharmaceuticals and the accumulation of profits by pharmaceutical corporations.

131In conclusion, when thinking about the relations between patients' organisations and market actors, I suggest it is necessary for us to extend the debate beyond the important discussions about how these relations are shaped by and shape organisational cultures, and their implications for the autonomy of individual organisations, to consider how such relations can entail endorsing values that resonate more broadly.


Summary of the discussion, group 1

132by Marisa Matias

133The session started with the attempt at deepening the discussion initiated at the plenary session, mainly focusing on the controversial nature of, and difficult relationships between, Patient Organizations (PO) and economic actors. Some conditions were identified as the key elements for a positive partnership between POs and industry: agreement on what good care is; agreement on what good treatment is; agreement on what care and treatment are wanted for; and, finally, existence of a solid structure which facilitates the relationships. If these dimensions were identified as key features for the possible cooperation between these two categories of actors, some other issues were raised as requirements for a better understanding of this type of relationships. First, the need to know in greater depth what types of organizations and what kinds of disease groups manage this well; secondly, what are the subjects over which the conflicts arise most often (are these conflicts over what it is to live as a person with a specific type of condition?). Fundamental concerns seem to be the needs to work well and to create an agreement on what the problem actually is.

134The debate on cooperation/conflict between POs and industry was at the core of the discussion, but other related topics were raised, namely: how to manage the different interests associated to POs and industry? How do size and main focus of POs configure different types of intervention? How to deal with information and uncertainty? And, finally, what is the role of the State? Some other questions were pointed out, although without furthering the discussion: the existence or non-existence of discussion among PO boards concerning cooperation with industry; and the need to tell stories about alternative therapies.

Cooperation and/or conflict between POs and industry

135The cooperation between patient organizations and industry was highlighted with different examples. The existing partnership between Association Française de Diabétiques (AFD) and MEDTRONIC, presented in a previous plenary session, was recovered and deepened during the discussion. As presented, the “smooth relationships established between AFD and MEDTRONIC are part of a “real partnership and differ significantly from the relationships established between MEDTRONIC and physicians, which were presented as quite conflictual. As referred by a participant, although MEDTRONIC is a profit-making company, since there's a “real demand from patients for its products its members don't feel guilty: “every one year or two, we put on the market new devices designed to improve people's lives. Disagreements on new insulin pump systems - either as the ultimate option before death or insulin as a functional therapy - were at the basis of this partnership. AFD was initially run by physicians, and patients with diabetes became “hostages” of the medical prescription of the system, since the costs were too high, as were the costs of reimbursement. Patients came to the leadership of AFD, there being no possibility of coming to an agreement with physicians, started a direct collaboration with industry. One key condition was identified by AFD as the main feature of the existing partnership: having a good structure with a good financial framework. Currently, about 40% of the funding of AFD comes from the pharmaceutical industry, but these funds are only used in areas that do not threaten the continuity of the association.

136The detailed description of this particular example gave rise to a debate on the possible competition between different industries to dominate the market. This is clearly the case for glaucoma patients, for instance, as the pharmaceutical companies who produce eye drops are seen as “very jealous of each other and try to control the market. In the case of diabetes in France, there are 3 million patients, 127,000 of them associated to AFD, and there is no information on how many of these patients have pump systems, so the landscape of competition is not so visible. If the cooperation between MEDTRONIC and AFD marked the debate on cooperation, there was also room for presenting a situation of conflict between industry and patient organizations involving the same organization. Some years ago, AFD started a cooperation with Sanofi Aventis (one of the biggest French drug companies), and it went wrong. Sanofi marketed a drug called ‘Lantus’ and it was sold as prevention to complications related to diabetes. In order to publicize the drug, Sanofi Aventis tried to get the endorsement of both AFD and a physician's association. The later was paid, but that was not the case of AFD. For a second campaign, there were disagreements within the board of AFD -some defending the endorsement without payment and others taking the opposite position -, and the company decided to cut down two years of support. Now, a third campaign is being negotiated and the company asked AFD for endorsement. The existence or non-existence of discussion among the directing boards of Pos on the evaluation of drugs becomes a central question in cases like these.

137But there are very different types of situations. The case of the deaf community is exemplary of a community whose members do not see themselves as patients. A device - cochlear implant - was created and companies tried to commercialize it, but the deaf community refused it. The debate here is not about some position against technology, because other sorts of technologies were welcome, but about the way the problems are defined by the different actors. The demands of deaf communities for other types of technologies were unsuccessful because it was not at the top of the priorities of the companies. A clear example of this mismatch was the demand for the videophone before its emergence in the broader market. Some 'patient' groups are not regarded by companies as an “interesting” market. Another example from the deaf community is their position against genetic testing during pregnancy, since it is seen as a threat to their way of life. This situation also raises the debate on the difference between life-threatening diseases and other types of disease.

138As the debate has shown, cooperation between industry and POs it's not a “black and white” situation but a rather complex one. As stated by one of the participants:

“There simply are areas where collaboration works well and areas where it doesn't and what I tried to suggest just before was that everything may depend on the extent to which there's agreement around an appropriate form of intervention. If patient organizations agree that a drug or a device, whether it exists or not, is what they need, then collaboration will work. Where's there's real disagreement as to the form of intervention that's appropriate, for example in the area of mental health care, then it's likely to be a more contested or conflictual relationship.”

139The case of breast cancer is also a good example of this complexity. There are groups willing to have additional treatments and willing to work with the pharmaceutical industry; and, on the other hand, there are other groups willing to focus on environmental causes and which are very critical of the fact that the pharmaceutical industry is interested only in treatments. This situation points towards other directions:

“We need to think about patient organizations around particular diseases as spanning a range of political viewpoints, and that some of them are highly critical all the time in all this presentation today (...) wanting to say, well, actually, we need to move away from a focus on pharmaceutical treatments and think about what causes these problems, and it might be the same people that are involved.”

140The case of rare diseases was highlighted as well, since the link between POs and industry has a very particular configuration. The strategy here is frequently centred on possible ways of improving the involvement of industry, namely their involvement in research.

141It was also noticed that the discussion on cooperation/conflict between industry and POs should not mask other types of asymmetrical relationships, for example, between POs and physicians or POs and researchers. The need to focus on these relationships was seen as being located "one step before" the space of market and industry. Sometimes, patient needs are not addressed by researchers or physicians, and that is regarded as a key element to consider when talking about the empowerment of patients. The definition given by one of the participants is exemplary of this type of concerns:

“We speak a lot about environment and bounds with the patients and patients' organizations in the area of market and pharmaceutical industries. But I think there's another step before that and that's a step of patients and patient organizations working together with researchers. In the area of 'how do you get the questions of patients on what more they would like to know', 'what they know', 'what are topics of research in research?' I think this is a very big question.”

How to manage different interests?

142Parallel to the debate on cooperation/conflict between industry and POs is the one on the different interests which are at stake both for industry and POs. This is also linked to the differences between what is interesting for public research and what is interesting for private research. Breast cancer and AIDS were introduced into the debate as key examples in this field. The debate on the supply of generic drugs to treat AIDS in Africa was pointed out as an exemplary case:

“There is a difference in what is interesting for the industry, what is interesting for patient organizations and what is interesting for research, in public research or in private research. And I did not really feel, but how do you live, as a patient organization, these conflicts. And just to remind you, we have these big issues like the question of generica (generic drugs) for AIDS. We all remember, two or three years ago, the negotiations with Africa and there's a big involvement of health organizations who say: 'we need generica (generic drugs)' and the industry would never have voluntarily released. They had certain positions. On the other side, we have initiatives like the drug forum saying that the disease initiative was launched by 'Médecins sans frontières' working together with several public research institutions on diseases that affect patients mainly in Africa where there is, of course, no industry because there is no market. Who would ever pay for those drugs? So, they succeeded somehow in making industries come and in telling them: 'here, we need drugs. Nothing is done'. And it's not only that the industry is not there but there is also a lack of public research and investigation in certain fields.”

143In some cases, though, the problem is not only about the absence of industry (“not being there”) but also about the lack of public research in certain domains. The need to debate more in depth the dimensions associated to property rights and patents was one of the questions that remained open.

144The different types of POs: smaller organizations versus umbrella organizations?

145Speaking about POs implies taking into account their considerable diversity and complexity. Differences of size and main focus of intervention give rise to quite different ways of intervening and to different results. The world of POs comprises both small organizations and umbrella organizations. If in some cases, smaller organizations seem to be adequate:

“For our concern, AGAT, I would prefer a smaller organization for Turner's syndrome because AGAT takes care of women with Turner's syndrome and maybe it would be better to have an organization with a group only”,

146in other cases umbrella organizations seem to play an important role:

“Eurordis was created mainly to make advocacy, lobbying to have a European orphan drug regulation. (.) This kind of action is because it was a large umbrella organization taking older, common problems of rare diseases, that it was possible to drive this regulation. That's why I think there is no competition between all these kinds or organizations.”

147Both types of POs are linked to specific losses and gains, depending on the type of intervention they want to promote.

Information and uncertainty

148One critical dimension POs have to deal with is the great amount of information which is circulated inside patient communities. How to deal with this information? How to assess it? How to know where it comes from? How to know whether it is good or not? These are key questions that POs have to ask in order to take decisions. Sometimes, big institutions like INSERM may play an intermediate role between patients and industries and between patients and researchers. Specific programs were created to join representatives from POs and scientists. This type of initiatives enables POs to discuss among themselves, to identify general questions which go beyond the specific questions each one has to deal with, and to propose research orientations.

The role of the State and public authorities

149“Who is allowed to select which diseases are reimbursed and why?, is one of the questions arising when the focus of the discussion is on the role of States and public authorities. Here, again, different groups and different types of conditions imply different configurations of relationships. Besides, we should not forget that the State and public authorities also appear as multiple entities, which adds to the complexity of this debate:

“The State is not always in a position to be the regulator between industry and the patient organizations. Sometimes, they want to defend citizens and patient organizations, so they have another role and another definition of their objective.”

150As a result, and as stated by one of the participants

“It's very difficult to have a definitive and coherent opinion on what should be the role of the State, what should be the attitude of patient organizations towards industry, and so on.”

151Triangular relations between States, patient organizations and industry thus seem to be at the origin of different alliances, depending on what is at stake. If, in some specific cases, patient organizations and industry are allies, in other cases, the allies can be the State and patient organizations.

152The examples of diabetes and rare diseases highlight two possible configurations of these alliances. In the case of diabetes, both States and industry are already convinced of their benefits: it is a visible condition, it is financed by social security, and there is a potential market; in the case of rare diseases, it seems that is still necessary to convince both States and industry.

153In addition to that, the definition of the role of the public authorities in making decisions on ethical questions is becoming increasingly important. Pre-implantation genetic diagnosis gives us a good entry point to this discussion: some people argue that if there is a continuing reduction in the number of children born with certain types of conditions, there will be less and less resources directed to treatment; some people argue that there is a need to make sure that people have access to these diagnostic tests.

Summary of the discussion, group 2

154by Angela Marques Filipe

155The three main questions for the discussion may be summarized as follows: i) the relationships between patient organizations and the industry being often described as asymmetrical, under what conditions is the cooperation between these two types of actors possible and viable?; ii) does the building of partnerships require the acquisition of detailed mutual knowledge of partners, new rules or forms of action?; iii) how are patient organizations positioned in the triangle they form with industry and public authorities?

PO and the industry: a suspicious or a fertile relationship?

156The discussion started from questions of the independence and transparency of POs in relation to their involvement with industry. In some countries, like Germany and France, strong criticisms and suspicions have been directed at POs on that particular topic, although, as one representative of a health institution said, these may be regarded, to some degree, as an extension of the lay/patient - expert/professional divide:

“Ok, patient organizations need money. So where does it come from? I was told, when I started to work there: 'be reasonable, there are dangerous patient associations. We don't know where their money comes from.' (.) And to do my work, I need patient organizations which are political partners [so] please give me a better way. The other point is that I'm very surprised sometimes by the guarantees which are asked from the associations. I'm not sure the same guarantees are asked from each physician, each professional. (.) We are talking about conflicts of interests. So, if we want to be -I could say 'cruel'- with patient organizations, let's be cruel with other professionals and you will see how terrible it will be.”

157The debate over the topic of independence - often expressed in terms like transparency or autonomy - revealed different positions associated with clusters of organizations which may be broadly described as favourable or sceptical; although these are of course extreme categories drawn upon in some analyses of the relationship between POs and the industry, it was often the case that terms like opposition, “instrumentalization” or cooperation (as they appear in the title of the session) were often used together to describe the possible configurations arising from specific organizational trajectories, or associated with the aims or the conditions/diseases defining each PO.

The self-regulation of the PO against the risks of manipulation and criticism

158Some POs are currently involved in a cooperative relationship with economic actors and the pharmaceutical industry. A first example of this was provided by a rare diseases umbrella organization, which, while admitting the unequal and sometimes instrumental relationship between industry and POs, on the one hand, and the restrictions imposed by their own constitutive principles regarding the origin of funding, on the other, managed to improve its position through a transparency policy and a peculiar model of round-table participation/funding:

«All the activist patient groups, which includes us, have seen the worst things between the industry and patient groups. We have seen patient groups destroyed by bad relationships with the industry [or] creating patient groups out of its need of a drug property. (...)Then another kind [we have been] very much involved. We've been on the forefront (...) since the implementation of the regulation, because we have two representatives at the front. It was the first time patient representatives were sitting at a committee that takes decisions. (.) For this work you need money, there's no miracle. So, we were approached by a few small pharmaceutical firms who said: 'we would like to help you because we believe in what you do on information. You have a website etc.' And we said 'yes, but we cannot take money from the pharmaceutical industry.' (.) So we started thinking and (.) we decided to create a round table of the companies and (.) you see that the money we get from the round table (.) has nothing to do with orphan drugs, it goes to training patient representatives.»

159This situation led to a scenario of “cooperation through transparency and common rules” where the final aim is actually to facilitate the improvement of patient leverage. As stated the representative of an umbrella organization:

«We could live without the pharmaceutical industry if we decided to; it's just that it helps us to do more for our members and we did it just for that reason. (.) We ask our members every year how they are funded [and] they have to have a majority of patients and parents on the board, these are strict rules. Also, if they get too much from the pharmaceutical industry, we advise them not to do so and then we take them as associate members, which means they cannot vote as full members. That's our policy. (.) The feedback that we get is that it is good to have a transparency policy; it has improved the openness of pharmaceutical industries to behave properly towards patient groups [and helped] them to stand in front of the industry.»

Considering the possible common interests of the POs and the pharmaceutical industry with regard to all the actors involved

160A second example of cooperation was provided by an organization dealing with chronic illness with a very positive experience with cooperation, which actually allowed the PO to improve its leverage, in this case regarding doctor-patient relationships on issues of information, medical treatment and compliance:

«I have a four-year experience of patient organizations together with pharmaceutical industries, and during those four years, we achieved more than in all the years where I was active as a patient representative on an 'island', as I say now. What we try as a big organization is to change everyone's attitudes, including doctors, insurance companies, and so on. (.. ) Now we have a commission with the pharmaceutical industry and we are acting, now, not on a low level but on high level circuits. So, we reached in a few years a national debate about compliance and the government started to fear our criticism on the subject. (.) The same with medical treatment standards, that was a question of doctors, it was their work. (.) Meanwhile, there is a law in our country saying that a patient decides his treatment and not a doctor. 'So please, may I have the information to decide what sort of treatment I will get: drugs, physiotherapy, surgery or doing nothing?' And some years ago, the doctor was the one who decided what to do.»

161In this example, and considering the different actors involved in the health domain - POs, doctors, industry and State -, the collusion between PO and pharmaceutical industry is viewed as a form of partnership as would be the case of any other collaboration generating advantages for the patient and his/her condition (although apparently it seems to be easier where the patient/doctor divide is stronger). At the same time, and as in the previous case, some mechanisms of transparency and guidelines were created to avoid manipulation and criticism:

«On one side, there is all the information about, for example, drugs or other treatments and the doctor is deciding what is going through the 'tunnel' and I am sitting here and getting what he decides. No. I want to negotiate with the pharmaceutical industry on this side and I want all their information. (.) Now, as a patient organization, we reach a state of maturity: we do business with influent companies and with doctors on a national level. (.) And I want to fight, as a chronically ill patient, for the best treatment; so, I want to do business and the pharmaceutical industry is a business partner for me. Of course, it has its own interest, just like me. And we can find each other at a certain moment and we are very successful. (.) We did everything to cover criticism (... ) we made everything transparent. The companies which invested our sponsor money, the amount, when they paid it, how they paid it, what it was for and arrangements about not influencing patient organizations. (.) The pharmaceutical industry is much more promising for the quality of my life than all the doctors together. The doctors only help me to have a good ride going through this tunnel.»

Is a transparency policy sufficient to oppose the asymetry of positions?

162Following these interventions, another position emerged, one more sceptical towards industry. This was due not only to reasons already brought forward, also to actual negative experiences. This sceptical position was taken by organizations with different aims and commitments from patient or pathology-driven organizations. One of these was an organization related to public health and drug regulation activism. It had a negative view of POs funded by industry, regarded as being at risk of manipulation, particularly if they tend to turn more into consumer organizations, subjects of advertisement and, eventually, agents of industry's own agenda:

«We know that the practices in the pharmaceutical industry, as to the promotion to the physician and how that affects prescribing in a rational way some drugs, are in common knowledge square conflicts and interests. (.) But being transparent is not a substitute to being independent and, inevitably, patient organizations need to realize that there are strings attached to the fact of taking industry money because, at a given point, they will be asked or required to take certain positions. We have seen, for instance, that certain cancer organizations in the UK or in Europe have been offensive on very recent treatments and they just happened to be financed by Roche. So, we see that there is, sometimes, a very big push from certain patient organizations particularly close to certain groups, such as the health authority, to ask for the reimbursement of those drugs, newer drugs that are more expensive and might not be necessarily better. There is a need (.) for clarity. And, at the same time, what we see happening is an insidious influence of the industry trying to push for an agenda in which it is recognized (.) that there is a desert of information and that patients need more information. (.) It's pushing forward to consumer advertising and this is very dangerous.»

163Another organization's representative dealing with demedicalization of birth and related issues raised some questions about drug regulation:

«I looked at what information the drug companies gave in each country and compared the UK, Ireland, America and France. And what I discovered was disturbing: they gave completely different information in each country. (.) In the UK, it said that this drug could be used. In Ireland, it said that the drug was restricted because it had some risks; and in America, it had a long line of risks and said it should not be used in pregnant women. (.) So, this should be targeted and there should be a standardized requirement.»

164An interesting issue brought into the debate was that not only drugs but all sorts of medical devices are often adopted with no regard for adequate control or testing, as was the case of ultrasound:

«It is marketed all around the world as beneficial, having absolutely no side effects. And every time I see somebody saying that, I send them a little letter saying: 'will you kindly explain the randomized control trial of 9.000 women in which there were 20 still-births in the group that had ultrasound and none in the controls. Now, will you kindly explain the other study of Doppler-ultrasound where there were four times as many near-natal deaths in the babies that had ultrasound compared with the ones that didn't?' And I get total silence every time. (.) In the UK, they are not allowed to advertise ultrasound in journals and magazines but they can do it on the web and it says: 'ultrasound is absolutely safe', so we have that problem with the industry.»

165Two kinds of pharmaceutical industries

166A further issue was the acknowledgment of the fact that both POs and the industry are diverse, and so are the relationships between them. Smaller businesses are sometimes associated with products that may be used by POs for their own benefit:

«That alliance has been the first to go to the industry and say: 'you have many molecules that you don't use and are abandoned; they might be of some use for our diseases where there are no treatments.' (.) I think that there are really two kinds of pharmaceutical industries, so the big pharma that everybody fears is getting into more and more trouble. And you have a few people who got out of their game because they didn't like it (.) so there is no such thing as big pharma as a whole. (.) What I see also is those small value companies that are quite enthusiastic into going into innovation, and our hopes are, for people living with rare diseases, it's certainly not Pfizer (.) so there is less asymmetry.»

167Collaboration is possible when there is a more balanced relationship between some POs and specific industries:

«so we expect from the pharmaceutical industry that they want to listen to what we have to say because we want new and better products, but we are only interested in pharmaceutical companies which are really trying to improve in our interest, and not all the others.»

The role of POs in tracing and discussing risks and ethical dilemmas related to the use of drugs

168By the end of the session, it was acknowledged that in any political or economic relationship between actors, the possibility of manipulation is always there, but the most important question is that opposite views on the same subject may coexist, often formulated as ethical dilemmas:

169«I was talking to a patient and she has severe mental health problems. She was saying: 'No, I wouldn't belong to a patient organization that takes money from the industry because I don't believe in it'. But she also said: 'I'm also a hypocrite because, actually, the technologies enable me to function day-by-day, so I rely on industry'.*

170A similar dilemma was stated concerning drugs:

«Patients may suffer from side effects, but we have to accept some side effects if we want drugs for the diseases [chronic and lethal]. So we are ready to, maybe, accept more and we are ready to be very innovative (.) And then people could decide if they want to go on with the treatment or not».

171Finally these risks and dilemmas can only be traced and discussed effectively through the increasing engagement of POs in the health domain, something that has notoriously been changing:

«Actually, there is no medicine that doesn't carry some risk with it.' (...) Regulators feel they have to protect the public from risk 100% but they say they -well, they can't and actually, regulators were saying: 'we need to engage with the patient groups more, we need to engage with the public in our discussions a lot' (.) So, I'd say this relationship is changing. And some regulators are beginning to applaud patients' groups».

Summary of the discussion, group 3

172by Florence Paterson

173The first point of the discussion was about the reasons of the cooperation between Pos and the industry: financial, image, but also research and development of innovative medications. For some POs this relationship is unavoidable, for others to avoid. The discussion went on to the controversial point of the cooperation and conflict of interests between POs and the industry: cooperation between POs and industry is a relation at risk, where the independence and the credibility are at stake. The third point concerned the principles that shape relationships- or the formalization of the relationships: transparency, diversity of resources, agreements, charters, guidelines, and whether it is an approach in terms of policy or of experience. The question of taking into account the network of relations including the whole spectre of actors involved, and the dynamic within the network seems quite important to understand the previous points. Finally, a few tracks to be considered have been discussed, and notably the interest of a comparative approach with the relationship POs and the industry have with research institutions, or the alternative ways of funding and developing research.

Why do POs and industry seek for cooperation?

174Why do POs seek for cooperation with the industry? And why does the industry seek for cooperation with POs? The participants mentioned two main reasons. First, and this seems to be the main reason, POs seek financial resources, "where they can", and the industry is one of the possible sources. It was stressed that the need for money is particularly present

“in the early days of a PO, and the PO withdraw from the relationship with the industry when they are less reliant on money they receive from this source.”

175The situation depends also whether funding provided by the industry is only used to finance actions of support and information to patients, or if the PO seeks funding to finance research on the disease they represent (and especially fundamental research for diseases on which knowledge is very limited or nothing efficient exists in terms of cure): the need for money is quite different and in the second case the need for cooperation (with the industry or from other sources of funding) is bigger.

176Research and production of medication and drugs are the second issue at stake in the cooperation between POs and pharmaceutical industry. Universities, hospitals and research institutions do research, and many patient organizations started developing research policies, but on the particular question of drug treatments a lot of research is needed and this type of research is by far undertaken by the pharmaceutical companies.

177For some diseases, such as diabetes, where “drugs are needed to stay in life, it is important, and even unavoidable, for the POs to have a relationship with the industry as new therapeutics can bring important improvement on a medical ground as well as on the quality of life. In some other cases, such as mental illness, the experience of certain POs towards pharmaceutical products contrasts sharply and the cause they defend is quite the opposite: “the lack of services provided for people with mental illnesses makes the pharmaceutical therapy quite the only option offered to patients and helping people finding an alternative option is why patient organisations exist.

178The introduction of a new medication on the market and the development of an alterative product may be a common interest for POs and industry. For the industry seeking the support of POs, notably in the negotiations about the reimbursement of the products with government authorities, is a way to develop business and for POs a way to help the patients having access to a new treatment. Some participants to the discussion observe that pharmaceutical companies do not seek cooperation with any type of PO: POs concerned with illnesses for which there are no medication or for which there is no alternative in medication (for example the treatment of transplant patients) are not contacted. The difference between POs contacted by the industry and POs contacting the industry was stressed by some participants to the workshop.

179Financial support to PO may be a question of producing a positive image of the company whatever the business sector. For some companies, promoting a healthier life - a better life - is part of the marketing plans (food companies for example). It was not clear in the discussions whether it corresponds to actual experience or not. But the point was to stress possible conflicts on interests and the use companies may make of the image and values of POs in exchange of funding.

Cooperation and/or conflict of interest between POs and industry

180Cooperation between POs and the industry was described as being at risk for the POs. The key words that could characterise the issues at stake are independence and credibility.

181Becoming the hostage of the funding provided by the industry is one of the risks, when an important part of the budget relies on this kind of source and especially when it relies on a single company.

182The risks of being instrumentalized or discredited were also mentioned: on one hand, discredit may derive from the use that the industry can make of the values defended by the POs, and on the other hand, it may come from a perception - especially from the media - that the message of the POs is distorted and tainted by the partnership with the industry (it can be said that PO Y belongs to company X). The threat is even greater, said some participants after their experience, that industry is not always trustful; it happened that things were done or said publicly to the media without the PO's approval. What is at stake for the POs is not only the question of their image in their relationship to the media and public opinion, but it is also the trust of their own members. Even if funding is needed, the recourse to the industry is not always easy to explain nor easy for their members to agree.

183PO are not the only ones to be at risk. Scandals, and maybe past scandals, trigger the way media and public opinion react to this issue: the example of the medications for mental illness show that the media could discredit pharmaceutical companies for funding POs.

184The heterogeneity of the industry, the diversity of the business sectors and markets, were underlined as being an important point in the controversy about the possible conflict of interests between POs and industry. The ethical standpoints may vary according to the products: POs make distinctions between different market actors (for example, “some of the Aids organisations policies consist in not accepting money from the pharmaceutical industry, but accepting it from condom manufactures). Other examples of ethical questions and the necessary awareness Pos have to keep while deciding to accept sponsorship or cooperation with the industry have been given about the food and drink companies and their marketing plans based on the promotion of a healthier life: may PO, which have a prevention activity (against diabetes or alcoholism), cooperate with companies whose products may favour obesity or metabolic diseases such a diabetes (soft drinks, crisps)? A PO concerned with mental illness was ready to receive funds from a soft drink company, but denied after discovering that it also produces alcoholpops (a mix of soft drink and alcohol intended to young customers).

185One of the social scientists participating to the workshop stressed one of the aspects of the controversy linked to the diversity of the conditions, that is: how the “collaboration with pharmaceutical corporation is a controversial point at associations with some conditions and not others (for instance with mental illness, and is not with others).

Formalising the relationships with the industry: exit or the implementation of principles, guidelines and charters

186Facing the controversy about the relationship between POs and the industry, and the series of risks mentioned above, PO have different ways of envisaging what should be done.

187Exit is one of the positions taken by POs: they adopt the principle of an opposition to any form of partnership or cooperation with the industry as the best way to keep their independence and credibility.

188Being reliant on industry funding is envisaged as a difficult situation to hold. Some PO have adopted the principle of affecting funds received specifically to a product (publication, brochure, leaflet, for instance). By giving an official affectation to the funding, POs may provide information on the disease without being linked to a firm. This kind of affectation is part of the transparency policy of certain POs. To diversify the partners (i.e. having more than one partner) is another way for the POs to protect their independence. Transparency and diversification are the two basic principles mentioned by C. Nourissier from Eurordis during the plenary session. About the principle of transparency, one of the participants stressed that

“it is not because there is a clear indication of who supports the PO that it show to what extend the PO keeps its independence or if one of the partners get influence on the other.”

189Putting a limit to the amount of funding per company (up to 5000 euros) was another example given; this “budget limit” principle has been, in this case, at the origin of misunderstandings from the media, who criticized the PO without knowing in what proportion of their budget was coming from industrial funding. But it might be an opposition to the industry's funding to POs, and so even “two euros is too much for some people.

190Some PO have elaborated guidelines or a charter to formalize their partnership with the industry. One example of charter has been given: the charter was created with the help of a professional expert. It specifies that “the company gives money without asking anything in exchange, except being mentioned in the PO's bulletin (published twice a year) and that the companies appear by alphabetical order. All the requests to provide patients or to give a talk on a treatment will be denied.

191Some companies bring their own guidelines or provide letters of agreement.

192The discussion mainly focused on whether guidelines or regulations offer protection. People mentioned different experiences. Some people consider it has been a positive experience, and others that it does not offer any protection: one example was given of a product manager whose enthusiasm has not been stopped by the guidelines and spoke publicly without the PO to have a say.

193A researcher asked if the diversity of the positions of the POs towards cooperation with the industry is about a political approach by patient organizations or is a matter of individual experience with the industry. The idea that guidelines or a common policy could be issued from a common work of POs has been debated. Would a common position offer more guarantees than individual initiatives? Is the formalization of the relationships not so much a matter of rules than a lack of enforcement?

194POs need the capacity and the skills to manage the relationship with the industry. The ignorance of the industrial world places them in a situation of asymmetry against companies. It enhances the need for professional actors within the POs to negotiate with companies. Letters of agreement provided by companies are in some cases difficult to understand and the terms of the agreement not clear enough to be read without the recourse to professional expertise; besides trying to negotiate in these cases is time consuming. POs have to seek advices before engaging in relationship with the industry (for example, not to be tied for a long period of time). Example was given where the PO did not endeavour into such agreements and preferred to loose opportunities of receiving funds.

195As concerns the development of innovative treatments, the lack of knowledge makes POs sometimes prefer the pharmaceutical laboratories to work with the researchers, instead of themselves. Researchers who conduct trials in hospital units and this institutional frame enables taking distance with the pharmaceutical industry. The issue at stake for the POs is to be careful not to advertise for a drug without sufficient knowledge about it.

Types of POs: smaller organizations versus umbrella organizations?

196Is it different for an umbrella organization or for an alliance to deal with funding that comes from industry? For the representative of an umbrella organization, the situation is

“completely different because we don't ask them, they are asking us (...) because they want to use our name”,

197and speak in the name of the patients, in particular in the negotiations with the government about the reimbursement of medications. The major difference of an umbrella organization is that it represents a collective of organisations and it has more weight than a single organization.

“We sometimes have problems with our members because the relationship is different”

198said a representative of an umbrella organization.

199Within an umbrella organization, the problems of democracy and of the choice of the leaders appear also in the circumstances of the relationship with the industry. Leaders are wearing different hats, from their own organization and from the umbrella organization, which makes the use pharmaceutical industry may make of their name difficult to control.

200Another representative of an umbrella organization has had positive experiences, even if, he says,

“I would agree that there is the opportunity for words to be changed or images to be provided which we don't necessarily agree with. So, it is a difficult area and I think it has to be managed.”

201But he mentioned possible problems like the fact that umbrella organizations tend to have relationship with the

“headquarters of the companies. Then we are the European organization in conflict with the national associations who might be dealing with [the national branches of the same companies].”

202Considering the whole network of relations and the action & place of each

203actor in the network

204To consider only the relation of the PO with the industry seems too reducing to several participants:

«You probably get much more nuance and much a more diverse spectre and a different spectre from the one you would get if you just look at patient organizations versus industry."

205The whole “spectre”, means the POs and the umbrella organizations, the public and private partners, be they partners for financial purpose or for research development, companies, universities, hospitals, public authorities, etc., and the dynamics of the relationship within this whole network.

206The question of the financial independence of the PO needs to be considered as concerns both the funding from private companies - from different business markets - and public funding. Whatever the source of financing, there is a risk for the PO of being a hostage of its funding sources. Public authorities may intervene on the financial partnership of POs and industry: for instance, one of the conditions for a PO to obtain the approval by the French Ministry, is that it should not be totally dependant from the pharmaceutical industry's funding.

207Another example of this dynamic including POs, industry, public authorities and scientific and medical professions is given about the emergence of a new drug: the “drug receives approval in the US for the treatment of fibromyagia. In France, the doctors say they will not prescribe the drug”. For the POs it is “important to communicate” about this standpoint with the doctors as well as with the pharmaceutical industry, to understand what is at stake. Communication means that the PO needs information about the new product and what kind of controversy possibly exists about it. But it also means that “as patients we have something to say about our condition” and daily life with the illness and the treatments, the PO will enter into the controversy.

Tracks to be considered

208During the workshop, several participants have suggested comparative approach of the questions raised by the cooperation between PO and the industry and cooperation between other types of actors in the field of health and medical research.

209The model of exchange with the industry was described as a one way model (money against a good image). Are they other modes of exchange? Are POs trying to interact with the industry in a comparable way they do in their collaboration with physicians and researchers, which consists in modifying the research agenda, the research themes, etc? Do they try to modify the strategies of the pharmaceutical industry?

210It can be considered that the relations between researchers, universities or public research organizations and the industry raise the same kind of problems than the relations between POs, charities and foundations and the industry: they have constantly to show their independence from private interest, conflicts of interest, ect., and there is supposedly a wide body of knowledge on the rules that can help to guarantee their independence. Is there something to understand through making a parallel between the two situations? Do we have something to gain from their experience of co-existing in the public sector in relation to independence?

211New initiatives have been developed at the European level as well as at the national level to enhance the participation of the civil society organizations in research and the cooperation between researchers and communities (specific instruments at EU level; in France, in the 'Region Ile-de-France', partnerships called PICRI, Partenariat Institutions-Citoyens pour la Recherche et l'Innovation / Partnership Institutions-Citizen for Research and Innovation; in Canada, programmes of cooperation between researchers and communities called CURA, Community-University Research Alliances). Is there a potential for patient organizations to find partnerships with other civil society organizations, which would reinforce the diversity of the funding? Do these new instruments and programs favour the involvement of POs in the design of research policies and in the collaboration with research organizations?




3 The reduction is from one shot every three days instead of 15 shots for the same period of time (when the scheme is of 5 injections a day).


5 Regulation (EC) N° 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products, Official Journal of the European Communities, 22. 1. 2000, L 18/1-5.

6 Contacts: Yann Le Cam, Chief Executive Officer. Fabrizia Bignami, Therapeutic Development Officer. Anne-Mary Bodin, Project Assistant.

7 The National Organization for Rare Disorders (NORD) is a private charity that was established in the USA in 1983, dedicated to helping individuals and families affected by rare disorders through programs of education, advocacy, research, and service.

8 Mintzes, B. 2007. 'Should patient groups accept money from drug companies? No', BMJ, 334: 935 (5 May); King, S. 2004, 'Pink Ribbons Inc: breast cancer activism and the politics of philanthropy', International Journal of Qualitative Studies in Education 17: 473-492.

9 Kent, Al. 2007. 'Should patient groups accept money from drug companies? Yes', BMJ, 334: 934 (5 May).

10 O'Donovan, O. 2007. 'Corporate colonization of health activism? Irish health advocacy organizations' modes of engagement with pharmaceutical corporations', International Journal of Health Services, 37, 4 (in press).

11 Sarah Boseley 'Drug firms and patient groups join in fight to overturn advertising ban', The Guardian, 21 May 2007.

12 See Novas, C. 2006. 'The political economy of hope: Patients' organisations, science and biovalue', BioSocieties, 1, 289-305.

Table des illustrations

Fichier image/jpeg, 92k
Titre Financial ReportRevenues by origin
Légende Budget 2007 by source of revenues
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Légende Eurordis round table of companies
Fichier image/jpeg, 76k
Légende ERTC biannual workshops
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