New drug regulations in France: what are the impacts on market access? Part 2 – impacts on market access and impacts for the pharmaceutical industry

New drug regulations in France: what are the impacts on market access? Part 2 – impacts on market access and impacts for the pharmaceutical industry

2013 J Mark Access Health Policy

Remuzat, C. | Toumi, M. | Falissard, B. | Volume: 1, Issue: , Pages: 20892, France, Market access,

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.