Gress Stefan, Niebuhr Dea, May Uwe, Wasem Jürgen
University of Applied Sciences, Fulda, Germany.
Pharmacoeconomics. 2007;25(6):443-54. doi: 10.2165/00019053-200725060-00001.
We review regulation of two important parameters for third-party payers and manufacturers of prescription drugs: regulation of reimbursement and pricing. We find that centralised regulation of reimbursement and pricing prevails in the 15 original EU member countries (EU-15) and in European Free Trade Association (EFTA) countries. Compared with countries such as Switzerland, The Netherlands, France and England, regulation in the German social health insurance system is rather unique. First, market approval is nearly always equivalent to reimbursement. Second, manufacturers are free to determine prices but internal reference prices restrict them from actually doing so for generics and therapeutic substitutes. In order to contain rising expenditures for prescription drugs in Germany, and to set incentives for physicians to consider the costs as well as the benefits of prescriptions, three reform scenarios are feasible. The first scenario maintains centralised reimbursement and centralised pricing; the second maintains centralised reimbursement but switches to decentralised pricing (similar to social health insurance in Israel and Medicare in the US). Third-party payers would be able to negotiate with manufacturers about discounts and market shares for genetic and therapeutic substitutes. In the third scenario, pricing and reimbursement would be decentralised (similar to private health insurance in the US). We suggest that the second scenario is a viable compromise between consumer protection and a more competitive and cost-effective market for prescription drugs in German social health insurance and other similar markets for prescription drugs.
报销监管和定价监管。我们发现，在欧盟15个原成员国（欧盟15国）以及欧洲自由贸易联盟（EFTA）国家，报销和定价的集中监管占主导地位。与瑞士、荷兰、法国和英国等国家相比，德国社会医疗保险体系中的监管相当独特。首先，市场批准几乎总是等同于报销。其次，制造商可以自由定价，但内部参考价格限制了他们对仿制药和治疗替代药实际定价。为了控制德国处方药支出的增长，并激励医生在开处方时考虑成本和收益，有三种改革方案可行。第一种方案维持集中报销和集中定价；第二种方案维持集中报销，但转向分散定价（类似于以色列的社会医疗保险和美国的医疗保险）。第三方支付方将能够与制造商就仿制药和治疗替代药的折扣及市场份额进行谈判。在第三种方案中，定价和报销将是分散的（类似于美国的私人医疗保险）。我们认为，第二种方案是德国社会医疗保险及其他类似处方药市场在消费者保护与更具竞争力和成本效益的处方药市场之间的一个可行折衷方案。
