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Parallel imports, innovations, and generics: Competition in the German market for oral anti-diabetics

平行进口、创新和仿制药：德国口服抗糖尿病药市场的竞争

基本信息

批准号：
246492140
负责人：
Professorin Dr. Annika Herr
金额：
--
依托单位：
Abteilung Unternehmen und Märkte
依托单位国家：
德国
项目类别：
Research Grants
财政年份：
2014
资助国家：
德国
起止时间：
2013-12-31 至 2016-12-31
项目状态：
已结题

来源：
https://gepris.dfg.de/gepris/projekt/246492140?language=en
关键词：
Parallel imports innovations generics Competition

项目摘要

Pharmaceutical expenses have grown at a pace well exceeding inflation in Germany as well as other OECD countries over the last few decades. Thus, one of the major challenges for regulators and policymakers is to ensure the provision of innovative, yet affordable, pharmaceutical products to an ageing population. In the case of chronic diseases such as diabetes, epilepsy or Alzheimer`s disease, which are becoming increasingly diagnosed in western societies, it is especially important to analyze the continuously changing market dynamics, well understand the existing regulatory interventions and, ultimately, develop appropriate new policy instruments. Patents play a peculiar role in pharmaceutical markets since they grant firms temporary monopolies that incentivize investments in a particularly risky research & development (R&D) environment. Hence, on-patent markets are characterized by low competition with high price-cost margins that, in turn, imply increasing expenditures for the Statutory Health System. In Germany, competition in on-patent markets is introduced through the entry of new products based on similar active ingredients in the same therapeutic market (i.e. the so called generics) and the parallel imports of the original products from other European countries. The effectiveness of this latter policy is quite controversially discussed among policymakers and economists since parallel imports do not increase the industry`s productivity but simply allow traders to exploit price differentials across countries and generate arbitrage gains that might reduce producers' incentives to invest in R&D. Therefore, the ultimate welfare consequences of such a policy are not clear.The primary focus of our research proposal is the empirical evaluation of the competitive impact of parallel imports in on-patent drug markets. The study is based on the estimation of structural econometric models of pharmaceutical competition and the counterfactual simulation of alternative policy scenarios. To this end, we utilize a unique dataset of German and Danish monthly prices and sales in the three therapeutic markets mentioned above for the 2000 to 2010 period. Our approach allows us to investigate the impact of specific regulatory interventions -especially the effect of parallel imports- as well as other related issues such as (i) the effect of the introduction of innovative products; and (ii) the impact of market entry of generic products.

在过去的几十年里，德国和其他经合组织国家的医药费用增长速度远远超过了通胀。因此，监管机构和政策制定者面临的主要挑战之一是确保向老龄化人口提供创新但负担得起的药品。在西方社会日益被诊断为糖尿病、癫痫或阿尔茨海默氏症等慢性疾病的情况下，分析不断变化的市场动态，充分理解现有的监管干预措施，并最终开发适当的新政策工具，尤其重要。专利在制药市场上发挥着特殊的作用，因为它们授予企业临时垄断，激励投资于风险特别高的研发(R&D)环境。因此，专利市场的特点是低竞争、高价格-成本边际，这反过来又意味着法定卫生系统的支出增加。在德国，专利市场上的竞争是通过以类似活性成分为基础的新产品进入同一治疗市场(即所谓的仿制药)以及从其他欧洲国家平行进口原始产品来实现的。后一项政策的有效性在政策制定者和经济学家中引起了相当大的争议，因为平行进口不会提高行业的生产率，只是允许贸易商利用各国之间的价格差异，产生套利收益，这可能会降低生产商投资研发的动机。因此，这种政策的最终福利后果尚不清楚。我们研究建议的主要重点是对平行进口在专利药品市场上的竞争影响进行实证评估。这项研究是基于对药品竞争的结构性计量模型的估计和对替代政策情景的反事实模拟。为此，我们利用了一个独特的数据集，其中包括德国和丹麦在上述三个治疗市场2000至2010年间的月度价格和销售额。我们的方法使我们能够调查具体监管干预的影响--特别是平行进口的影响--以及其他相关问题，如(1)推出创新产品的影响；(2)非专利产品进入市场的影响。