Achieving universal health coverage in France: policy reforms and the challenge of inequalities.

Since 1945, the provision of health care in France has been grounded in a social conception promoting universalism and equality. The French health-care system is based on compulsory social insurance funded by social contributions, co-administered by workers' and employers' organisations under State control and driven by highly redistributive financial transfers. This system is described frequently as the French model. In this paper, the first in The Lancet's Series on France, we challenge conventional wisdom about health care in France. First, we focus on policy and institutional transformations that have affected deeply the governance of health care over past decades. We argue that the health system rests on a diversity of institutions, policy mechanisms, and health actors, while its governance has been marked by the reinforcement of national regulation under the aegis of the State. Second, we suggest the redistributive mechanisms of the health insurance system are impeded by social inequalities in health, which remain major hindrances to achieving objectives of justice and solidarity associated with the conception of health care in France.

Crisis and Change: The Making of a French FDA.

Policy Points: Introducing a recent special issue of The Lancet on the health system in France, Horton and Ceschia observe that "the dominance of English as the language of science and, increasingly, global health too often closes the door on the history and experiences of others."1 In that spirit, this manuscript presents a detailed case study of public health policy transformation in France in the early 1990s. It casts light on processes of policy change in a political and cultural environment very different from that of the United States, showing how the public health policy process is shaped by multiple contingencies of history, ideology, and politics. More specifically, we describe the transformation of a disease catastrophe into a political crisis and the deployment of that crisis to precipitate reform of the French public health system. CONTEXT: Until the last decade of the 20th century, France had no equivalent to the US Food and Drug Administration. In this paper we describe and interpret the complex series of events that led to the passage by the French Parliament in December 1992 of a law incorporating such an agency, the Agence du Médicament (literally, "medicines agency"). The broad aim of this project was to learn how public health policy change comes about by detailed analysis of a specific instance. More specifically, we aimed to better understand the circumstances under which public health crisis leads to significant public health policy reform. METHODS: This paper is based on detailed analysis of primary documents (eg, archived French health ministry papers, recorded parliamentary debates, government reports, newspaper articles) and oral history interviews covering a period from 1988 to 1993. Thematic analysis of these materials was initially grounded in theories of organizational change, moving to constructs that emerged from the data themselves. FINDINGS: Policy entrepreneurs positioned to frame adverse events and seize opportunities are key to public health policy reform. However, whether these entrepreneurs will have the requisite institutional power is contingent both on political structure and on the power of competing institutional actors. Health crises may catalyze institutional reform, but our analysis suggests that whether reform occurs, or even whether adverse episodes are labeled as crises, is highly contingent on circumstances of history, political structure, and political ideology and is extremely difficult to predict or control. CONCLUSIONS: Actors positioned to shape public health policy need to have a detailed understanding of the circumstances that facilitate or impede policy reform. Health crises are now more often global than not. Comparative, theoretically grounded, cross-national research that looks in detail at how different countries respond to similar health crises would be extremely valuable in informing both policymakers and researchers.

Regulatory anticipation of postmarket safety problems for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study.

PURPOSE: The aim of the study is to describe preapproval safety concerns expressed by the European Medicines Agency (EMA) following regulatory review and to compare those concerns with subsequent issuance of postmarket safety communications. METHODS: All novel medicines approved by the EMA through the centralized authorization procedure from 2001 to 2010 were included. Preapproval safety concerns were identified through examination of information related to regulatory review publicly available on the EMA's website. Relevant postmarket safety events were identified through Dear Healthcare Professional Communications (DHPCs), including those resulting in a withdrawal, issued by at least one of four leading national regulators of the European Union. RESULTS: Among the 184 novel medicines included, the EMA had expressed at least one preapproval safety concern for 110 (59.8%) of them. Then, at least one safety communication was issued for 53 (28.8%) medicines within the postmarket period of study, totaling 90 DHPCs and 5 withdrawals. Overall, these 95 DHPCs and withdrawals were pertaining to 66 different clinical safety events. The EMA had expressed a preapproval concern consistent with the postmarket safety event for 22.7% (15 of 66). The rate of issuance of a postmarket safety communication was not statistically different between medicines with or without any preapproval safety concern (31.8% vs. 24%, p = 0.25). CONCLUSIONS: Preapproval safety concerns are frequently expressed by the EMA following regulatory review. However, when comparing postmarket safety communications with prior concerns, anticipation was low. Our findings emphasize the need to systematically conduct postmarket studies dedicated to safety evaluation. Copyright © 2015 John Wiley & Sons, Ltd.

Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study.

AIMS: Regulatory review time has been associated with post-market medication safety issues in the United States. Our objective was to evaluate whether regulatory review time and near deadline approval are associated with post-market safety events (PMSEs) for novel medicines approved by the European Medicines Agency (EMA). METHODS: We performed a cross-sectional analysis of all novel medicines approved by the EMA through the centralized authorization procedure between 2001 and 2010. PMSEs were defined as withdrawals and communications identified through Dear Healthcare Professional Communications (DHPCs). Regulatory review time was defined as the time that elapsed between the start of the assessment procedure and approval. Near regulatory deadline approval was defined as approval within the 30 days before the EMA's 210 day regulatory deadline. RESULTS: Among 161 eligible medicines, PMSEs were identified for 49 (30.4%), 44 of which were DHPCs, five of which were withdrawals. Median regulatory review time was 337 days (IQR 276-406) and was not associated with PMSEs (P = 0.57). However, when categorized by regulatory review speed tertile, there were differences in risk of PMSEs, with higher rates among medicines in the middle tertile (25 of 55, 45.4%; P = 0.01). Finally, 26 medicines were approved near the 210 day regulatory deadline, but were not more likely to have PMSEs (38.5% vs. 28.7%; P = 0.32). CONCLUSIONS: Neither faster EMA regulatory review speed nor approval near regulatory deadlines was associated with greater likelihood of PMSEs among recently approved novel medicines.

Construction of a policy arena: the case of public health in France.

In this article we examine the transformation over the past two decades of public health as a policy arena in France from a backwater of little interest to politicians, bureaucrats, the media, and the public into a central preoccupation of the state. Recent dramatic health crises (the scandal over HIV-contaminated blood, mad cow disease, etc.) have substantially raised the political profile of (and corresponding state investment in) public health in France, offering opportunities and incentives for political actors not traditionally associated with public health to enter the field and challenging more traditional actors to galvanize themselves and compete for this newly attractive policy terrain. We use the occasion of the passage of a public health law in 2004, labeled by its proponents as the "first" public health law in one hundred years, to show how, in a context of national struggle to contain both risks and costs, "public health" -- chameleonlike -- has taken on various meanings and forms to serve highly conflicting political interests.

[Health democracy tested]. / La démocratie sanitaire à l'épreuve.

La démocratie sanitaire à l'épreuvethis text doesn't intend to assess, from a sociological and political science standpoint, the implementation of the law of March 4, 2002, in general -as it covers many aspects difficult to discuss in such a short space, and because we lack enough empirical data for this purpose. However, based on (non-exhaustive) reviews carried out in 2007, 2013 and 2015, it is possible to formulate some hypotheses about the conditions of implementation of patient's individual rights, especially the right to information and informed consent. We also recall some findings established by the sociology Of patient movements regarding their unequal influence in politics. Finally, based on this and on some reflections stemming from a research project on the French management of the Covid crisis that we are currently conducting (financed by the French National Research Agency), we try to identify the ways in which the contemporary epidemic crisis is challenging health democracy now that this concept is celebrating its 20th anniversary.

La démocratie sanitaire à l'épreuveil n'est pas question de faire ici un bilan, du point de vue de la sociologie et de la science politique, de la mise en oeuvre de la loi du 4 mars 2002 ­ laquelle couvre de très nombreux aspects qu'il est difficile de traiter dans ce court espace ­, pour lequel les données empiriques (nous) manquent. Mais, sur la base de revues (non exhaustives) réalisées en 2007, 2013 et 2015, nous formulons quelques hypothèses concernant les conditions de réalisation des droits individuels, en particulier le droit à l'information et le consentement éclairé. Nous rappelons également certains constats qu'établit la sociologie des mouvements de patients concernant leur inégale influence en politique. Sur la base de ces rappels et à partir des quelques réflexions que nous menons actuellement dans le cadre d'une recherche financée par l'Agence nationale de la recherche sur la gestion française de la crise du Covid, nous tentons enfin de cerner les manières dont la crise épidémique contemporaine met à l'épreuve la démocratie sanitaire, qui fête aujourd'hui ses 20 ans.

Inconsistencies among European Union pharmaceutical regulator safety communications: a cross-country comparison.

BACKGROUND: The European Medicines Agency (EMA) and national regulators share the responsibility to communicate to healthcare providers postmarketing safety events but little is known about the consistency of this process. We aimed to compare public availability of safety-related communications and drug withdrawals from the EMA and European Union member countries for novel medicines. METHODS AND FINDINGS: We performed a cross-sectional analysis using public Dear Healthcare Professional Communications (DHPCs) for all novel medicines authorized between 2001 and 2010 by the EMA and available for use in France, Netherlands, Spain, and the United Kingdom. Between 2001 and 2010, the EMA approved 185 novel medicines. DHPCs could not be ascertained for the EMA. Among the 4 national regulators, as of April 30, 2013, at least one safety DHPC or withdrawal occurred for 53 (28.6%) medicines, totaling 90 DHPCs and 5 withdrawals. Among these 53 medicines, all 4 national agencies issued at least one communication for 17 (32.1%), three of the four for 25 (47.2%), two of the four for 6 (11.3%), and one of the four for 5 (9.4%). Five drugs were reported to be withdrawn, three by all four countries, one by three and one by two. Among the 95 DHPCs and withdrawals, 20 (21.1%) were issued by all 4 national regulators, 37 (38.9%) by 3 of the 4, 22 (23.2%) by 2 of the 4, and 16 (16.8%) by one. Consistency of making publicly available all identified safety DHPC or withdrawal across regulator pairs varied from 33% to 73% agreement. CONCLUSIONS: Safety communications were not made publicly available by the EMA. Among the 4 European member countries with national regulators that make DHPCs publicly available since at least 2001, there were substantial inconsistencies in safety communications for novel medicines. The impact of those inconsistencies in terms of public health remains to be determined.