Rémuzat Cécile, Toumi Mondher, Falissard Bruno
Creativ-Ceutical, Paris, France.
Department of Decision Sciences and Health Policies, University Claude Bernard of Lyon 1, UFR d'Odontologie, Lyon, France.
J Mark Access Health Policy. 2013 Aug 6;1. doi: 10.3402/jmahp.v1i0.20892. eCollection 2013.
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.
法国药品市场准入正受到实践中持续的巨大转变以及2011年12月生效的两项法律的影响。这一新环境已在两篇独立的文章中得到描述和分析。第二篇文章分析了这一新环境将如何实际影响法国药品市场的准入。未来，法国药品市场准入将越来越多地受到药物疗效对比和成本效益数据的驱动，上市后研究的作用也会增强。由于这些变化存在不确定性，对于利益相关者而言，这种准入正处于一个更为复杂的环境中不断演变，制药行业应对起来将更加复杂和困难。制药公司面临的主要问题将是在药品推出时尽量减少不确定性，以缩短决策窗口。这对制药行业来说是一个重大的范式转变，在这一转变中，上市前和上市后的风险都指向了制药行业。
