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in Conflict of Interest and Medicine Sous la direction de HAURAY Boris , BOULLIER Henri, GAUDILLÈRE Jean-Paul, MICHEL Hélène Publié en 2021-09
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The introduction of generic drugs in France is quite recent. While they represented barely 3% of all drugs sold in pharmacies in 1999, they now account for one third, still far behind the United States’ 84%, the United Kingdom’s 83%, Germany’s 80%, and the 48% average of the 19 main countries of the OECD. Generic drugs offer a particularly heuristic case for questioning conflicts of interest, because they are theoretically supposed to align all interests surrounding drug prescription: they are legally defined as “substantially similar” to the original drugs and are therefore supposed to have exactly the same benefit/risk profile for patients as their original counterpart; they are less expensive than the original drugs and therefore save money for patients and (public and private) insurers; and they do not hinder innovation, since they do not reach the market until the patent on the original drug expires, many years after it is marketed, and thus allow insurers to finance innovative drugs that reach the market. The prescription or dispensation of these copies should therefore be self-evident for physicians and pharmacists. However, the development of generic drugs has given rise to a paradoxical framing of conflict of interest in the media and in political and professional fields. Although pharmacists have strongly invested in substitution since 1999, they have been questioned on numerous occasions because of the higher margin they make when selling these copies. On the other hand, although physicians have not prescribed generics generics or have even opposed them, they have been questioned very little for possible conflicts of interest. How can this paradoxical framing of conflicts of interest around the (non-)prescription of generics be explained? To answer this question, I focus on how the prescription choices of physicians and the substitution choices of pharmacists are “framed” (or not) as conflict of interest in the relationships they establish with pharmaceutical companies, France’s (public) national health insurance scheme, patients, and other healthcare professionals. I first analyze the framing of the prescription and substitution of generic drugs from the perspective of the financial interests of healthcare professionals, pharmaceutical companies, and the National Health Insurance scheme. I turn then to the controversies surrounding the qualification of the health benefits and risks related to the prescription and substitution of generic drugs. Finally, I highlight the central role of inter- and intra-professional hierarchy and competition in the framing of professional interests and the prescription or substitution of generic drugs.

in Les marchés de la santé en France et en Europe au XXe siècle Sous la direction de VALAT Bruno Publié en 2021-03
CAROF Solenne
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Cette étude entend analyser la dynamique de formation et d’institutionnalisation des marchés d'alicaments, aux frontières du médicament et de l’aliment, en France depuis le début des années 1990. En nous appuyant sur les importants apports de l’histoire et de la sociologie économiques , nous entendons montrer en quoi la qualification de ces produits comme des médicaments, des aliments ou des compléments alimentaires et l’évaluation de leurs bénéfices et de leurs risques pour la santé a d’importantes conséquences sur l’organisation de leurs marchés et sur les valeurs qui leurs sont prêtées. Les « alicaments » constituent des objets d’étude particulièrement intéressants pour interroger ces liens entre les processus de sanitarisation du marché , visant à faire du marché le support d’une promotion de la santé publique, et de marchandisation de la santé, visant à faire de la santé publique un vecteur d’organisation et de valorisation marchandes. En effet, ces produits ont remis en cause les frontières érigées tout au long du vingtième siècle entre le marché des médicaments, dont la fonction première serait de soigner des personnes malades et celui des aliments, dont la fonction première serait de répondre aux besoins nutritionnels de personnes en bonne santé. Cette contribution entend précisément interroger ces « jeux aux frontières » auxquels se sont livrés les industriels et les autorités de régulation pour « (re)qualifier » ces produits et ainsi « (re)-structurer » les marchés sur lesquels ils circulent.

Depuis le début des années 1990, l’Europe a vu se multiplier des produits-frontières se situant explicitement entre le médicament, dont ils revendiquent les « bienfaits pour la santé », et l’aliment auquel ils sont réglementairement rattachés. Faut-il alors voir dans le développement de ces produits un signe de pharmaceuticalisation de l’alimentation ? En analysant la mise en œuvre du règlement européen de 2006 sur les allégations nutritionnelles et de santé, nous montrons que les autorités européennes de régulation se sont livrées à un véritable travail de démarcation (boundary work) visant à séparer les denrées alimentaires des médicaments, en distinguant la prévention et l’entretien de la santé du traitement des maladies ; les bénéfices des risques sanitaires ; et la médecine des preuves du marketing des promesses. Bien que la référence au médicament demeure importante, cette régulation a surtout cherché à construire un cadre original pour penser la contribution de l’alimentation à la santé publique.

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The stakes around the global and national medicines markets have been rising steadily for the last twenty years. How can one think of a market in which operate companies ranking among the most capital-intensive and profitable, states that want to provide their populations with access to essential and innovative treatments without jeopardizing their national health insurance systems, and health professionals who play a central role as market intermediaries? How can one analyse a market in which there are both innovative medicines (most often but not always) resulting from long R&D processes, protected by patents and costing up to several hundred thousand euros per patient, and generic medicines, produced on a large scale to treat "common" diseases and costing just a few euros? The purpose of this article is to present this research agenda which is both individual and collective. The first line of research is to examine the organisation and regulation of health product markets. A second line of research consists in analyzing the processes through which medicines contribution to Health and Economy is valued.

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Le coronavirus a mis la France face à la défaillance de son système de santé publique. Centré sur l’hôpital, il tend à négliger certains facteurs sociaux et environnementaux, en amont et en aval d’une prise en charge médicalisée. En vue des crises sanitaires à venir, faut-il développer des surcapacités hospitalières ou réformer en profondeur nos politiques de santé publique ?

The popularity of labels as tools of government is growing in many policy areas. This chapter focuses on the creation and implementation of one specific kind of label, which we have defined as a “rewarding label”. These labels are granted by governments or public authorities and reward organizations for their contribution to public welfare. Governance by rewarding labels relies on the mechanisms of competition and social distinction at play within a given field, in order to orient actors towards options that governments consider to be in the public interest. Taking eco-labels and nutritional charters as case studies, this chapter shows the difficulties involved in governing through this tool. Rewarding labels are designed to satisfy a range of conflicting objectives and interests and their application has become a site of conflict among public authorities and private actors. Four limitations to this approach are highlighted: management of labels’ reputations, consumer enrolment, competition between companies, and competition between government labels and other market devices or actors.

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The popularity of labels as tools of government is growing in many policy areas. This working paper focuses on the creation and the implementation of three different public labels in the public health field. Granted by the States or other public authorities, those labels reward distinctively organizations for their contribution to a public cause. Governance by labels relies on the mechanisms of market competition and of social distinction at play within a field, to orient actors towards opinions that governments consider to be in the public interest. This working paper nevertheless shows the difficulties to implement effectively that kind of soft policy tools: for them to affect firms and consumers' behaviours, they have to integrate many conflicting objectives and interests at the same time, which is rarely the case. We actually show, in our three case studies, that governing the market through labels implies governing the labels themselves, by carefully selecting their grantee, promoting them to both consumers and companies, and struggling against other challenger labels or market intermediaries. It is not an uncommon paradox that these labels that are entrusted with such a high power of "changing the world", have been finally stripped of any power.

Les faux médicaments se comptent par centaines de millions et font des ravages dans les populations. Comment comprendre que des ONG, des gouvernements ou des mouvements activistes s’opposent à la lutte contre ce fléau ?

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Functional foods have swept across France and Europe since the late 1980s. Margarines enriched with omega 3 or phytosterols, yoghurts enriched with bifidus or vitamin-rich food supplements... these foods with health claims have reopened the boundary erected over the course of the twentieth century between the markets for medicines, whose primary function is to treat the sick, and those for foods, whose primary function is to meet the nutritional needs of healthy people. They thus raise many issues for regulators, producers, distributors and consumers. Are they health products that can usefully contribute to the prevention of chronic diseases or marketing manipulations that are not of any health interest? Should they be regulated and marketed as drugs, as food or as a separate category? Drawing on significant contributions in economic history and sociology, this article analyzes the consequences of the classification of these products as medicines, foods or dietary supplements on their valuation and the structure of their markets. It also focuses on the boundary work in which industry and regulatory actors engage in order to “(re)classify” these products, and thereby “(re)structure” the markets in which they circulate. The first part of the article describes the process that led France to establish a boundary between the previously intertwined markets for medicines and foods over the course of the twentieth century, which has been blurred by the appearance of functional foods since the beginning of the 1980s. The second part deals with the efforts of French and European regulatory authorities and industry actors to renegociate these boundaries between the markets for medicines and foods bearing nutritional and health claims. We conclude this second part with a discussion of the consequences of this reframing for the reorganization of markets and the reevaluation of the health benefits and commercial advantages of these products.

in La Vie des Idées Publié en 2019
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Since the beginning of the 2000s, the fight against counterfeit and illegal medicines has become an international cause, mobilizing the World Health Organization and the World Customs Organization. Numbers and harrowing facts are regularly cited in justification of the international agenda: one in 10 drugs in circulation in developing countries is apparently illegal, and customs intercepted 550 million doses of counterfeit medicines in 2013; these medicines have also caused many deaths, the most striking example being the 2500 deaths in Niger in 1995 after a fake vaccine was administered (pp. 7-10). In this context, the international fight that was organized from the 2000s to counter this scourge of “pharmaceutical fraud” appears not only perfectly justified, but even somewhat belated. How, then, can one explain the fact that NGOs, governments and activist movements have protested against this fight? Based on two ethnographic field works conducted in Kenya and India, and on an analysis of the press and of reports published by the World Health Organization, Mathieu Quet’s book highlights the controversies surrounding this “pharmaceutical fraud”, which involve public health, economic interests, the securing of quality medicines and the monitoring of their global circulation. (first paragraph)

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