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Journal of Market Access & Health Policy (JMAHP) is published by MDPI from Volume 12 Issue 1 (2024). Previous articles were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence, and they are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Taylor & Francis.
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Article

New Drug Regulations in France: What Are the Impacts on Market Access? Part 2—Impacts on Market Access and Impacts for the Pharmaceutical Industry

by
Cécile Rémuzat
1,*,
Mondher Toumi
2 and
Bruno Falissard
3
1
Creativ-Ceutical, 215 rue du Faubourg Saint-Honore, Paris, France
2
Department of Decision Sciences and Health Policies, University Claude Bernard of Lyon 1, UFR d’Odontologie, Lyon, France
3
INSERM Unit U669 (Public Health and Mental Health), Maison de Solenn, University Paris-Sud, Paris, France
*
Author to whom correspondence should be addressed.
J. Mark. Access Health Policy 2013, 1(1), 20892; https://doi.org/10.3402/jmahp.v1i0.20892
Submission received: 19 March 2013 / Revised: 17 June 2013 / Accepted: 17 June 2013 / Published: 6 August 2013

Abstract

Access to the French drug market is being impacted by an ongoing dramatic shift in practice as well as by two laws that came into force in December 2011. This new environment has been described and analyzed in two separate articles. This second article analyzes how this new environment will actually impact the access to French drug market. French drug market access will be increasingly driven by comparative-effectiveness and cost-effectiveness data, and an increased role of postmarketing studies in the years to come. This access is evolving in a more complex environment for stakeholders due to the uncertainties surrounding these changes and it will be more complex and difficult for the pharmaceutical industry to address. The main issue faced by the pharmaceutical companies will be to minimize uncertainty at the time of a drug's launch to narrow the decision window. This is a major change of paradigm for the pharmaceutical business, in which pre- and postlaunch risks are directed toward the pharmaceutical industry.
Keywords: France; market access; drugs; law; pricing; reimbursement; comparative evidence; medico-economic assessment France; market access; drugs; law; pricing; reimbursement; comparative evidence; medico-economic assessment

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MDPI and ACS Style

Rémuzat, C.; Toumi, M.; Falissard, B. New Drug Regulations in France: What Are the Impacts on Market Access? Part 2—Impacts on Market Access and Impacts for the Pharmaceutical Industry. J. Mark. Access Health Policy 2013, 1, 20892. https://doi.org/10.3402/jmahp.v1i0.20892

AMA Style

Rémuzat C, Toumi M, Falissard B. New Drug Regulations in France: What Are the Impacts on Market Access? Part 2—Impacts on Market Access and Impacts for the Pharmaceutical Industry. Journal of Market Access & Health Policy. 2013; 1(1):20892. https://doi.org/10.3402/jmahp.v1i0.20892

Chicago/Turabian Style

Rémuzat, Cécile, Mondher Toumi, and Bruno Falissard. 2013. "New Drug Regulations in France: What Are the Impacts on Market Access? Part 2—Impacts on Market Access and Impacts for the Pharmaceutical Industry" Journal of Market Access & Health Policy 1, no. 1: 20892. https://doi.org/10.3402/jmahp.v1i0.20892

APA Style

Rémuzat, C., Toumi, M., & Falissard, B. (2013). New Drug Regulations in France: What Are the Impacts on Market Access? Part 2—Impacts on Market Access and Impacts for the Pharmaceutical Industry. Journal of Market Access & Health Policy, 1(1), 20892. https://doi.org/10.3402/jmahp.v1i0.20892

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