Many governments have implemented a controlled off-label use of medicines as a tool combined with reimbursement decisions, among other policies, to avoid pharmaceutical firms gaming regulatory systems based on the requirement for marketing authorisation. This article aims to compare the drug regulations in selected European Union countries (France, Italy and Germany) in order to identify specific provisions and concrete solutions implemented by them regarding that matter. The employment of an economic analysis of the law as a theoretical framework allows for the identification of the incentives created in the long run by the referred regulations. The scholarly literature identifies a myriad of drawbacks and advantages associated with off-label practices, and a welfare analysis is ambiguous. Off-label practices are a reality; thus, it is advisable to elaborate policy measures in order to address these practices and condition them on some requirements, taking into account that off-label practices imply trade-offs among access to healthcare, protection of public health, competitiveness and innovation in the industry.

许多政府已经实施了受控的标签外使用药物作为一种工具，并结合报销决策等政策，以避免制药公司根据上市许可的要求博弈监管系统。本文旨在比较选定的欧盟国家（法国、意大利和德国）的药品法规，以确定它们在该问题上实施的具体规定和具体解决方案。将法律的经济分析用作理论框架，可以识别所提及的法规在长期内产生的激励措施。学术文献确定了与标签外做法相关的无数缺点和优点，福利分析是模棱两可的。标签外的做法是现实；因此，