title: New drug regulations in France: what are the impacts on market access? Part 2 - impacts on market access and impacts for the pharmaceutical industry.
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.
authors.affiliation: Creativ-Ceutical, Paris, France.
authors.forename: Cécile
authors.initials: C
authors.lastname: Rémuzat
authors.affiliation: Department of Decision Sciences and Health Policies, University Claude Bernard of Lyon 1, UFR d'Odontologie, Lyon, France.
authors.forename: Mondher
authors.initials: M
authors.lastname: Toumi
authors.affiliation: INSERM Unit U669 (Public Health and Mental Health), Maison de Solenn, University Paris-Sud, Paris, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Falissard
keywords: France; comparative evidence; drugs; law; market access; medico-economic assessment; pricing; reimbursement