The Effects of Patent Extension and Take-Back Regulation on Green Pharmacy

Tianqin Shi, N. Petruzzi, Dilip Chhajed
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Abstract

Problem definition: The eco-toxicity arising from unused pharmaceuticals has regulators advocating the benign design concept of “green pharmacy,” but high research and development expenses can be prohibitive. We therefore examine the impacts of two regulatory mechanisms, patent extension and take-back regulation, on inducing drug manufacturers to go green. Academic/practical relevance: One incentive suggested by the European Environmental Agency is a patent extension for a company that redesigns its already patented pharmaceutical to be more environmentally friendly. This incentive can encourage both the development of degradable drugs and the disclosure of technical information. Yet, it is unclear how effective the extension would be in inducing green pharmacy and in maximizing social welfare. Methodology: We develop a game-theoretic model in which an innovative company collects monopoly profits for a patented pharmaceutical but faces competition from a generic rival after the patent expires. A social-welfare-maximizing regulator is the Stackelberg leader. The regulator leads by offering a patent extension to the innovative company while also imposing take-back regulation on the pharmaceutical industry. Then the two-profit maximizing companies respond by setting drug prices and choosing whether to invest in green pharmacy. Results: The regulator’s optimal patent extension offer can induce green pharmacy but only if the offer exceeds a threshold length that depends on the degree of product differentiation present in the pharmaceutical industry. The regulator’s correspondingly optimal take-back regulation generally prescribes a required collection rate that decreases as its optimal patent extension offer increases, and vice versa. Managerial implications: By isolating green pharmacy as a potential target to address pharmaceutical eco-toxicity at its source, the regulatory policy that we consider, which combines the incentive inherent in earning a patent extension on the one hand with the penalty inherent in complying with take-back regulation on the other hand, serves as a useful starting point for policymakers to optimally balance economic welfare considerations with environmental stewardship considerations.
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专利延长与回收监管对绿色制药的影响
问题定义:未使用药品产生的生态毒性促使监管机构倡导“绿色药房”的良性设计理念,但高昂的研发费用可能令人望而却步。因此,我们研究了两种监管机制——专利延长和回收监管——对诱导制药企业走向绿色的影响。学术/实际意义:欧洲环境署提出的一项激励措施是,对重新设计其已获得专利的药品的公司延长专利期限,使其更加环保。这种奖励既可以鼓励可降解药物的开发,也可以鼓励技术信息的披露。但是,在诱导绿色制药和最大化社会福利方面,延长期限的效果如何,目前还不清楚。方法:我们开发了一个博弈论模型,其中一家创新公司为专利药物收集垄断利润,但在专利到期后面临来自非专利对手的竞争。社会福利最大化的管理者是斯塔克尔伯格式的领导者。监管机构率先向创新公司提供专利延期,同时对制药业实施回收监管。然后,两个利润最大化的公司通过设定药品价格和选择是否投资绿色制药来应对。结果:监管机构的最优专利延长报价可以诱导绿色制药,但前提是报价超过阈值长度,该阈值长度取决于制药行业存在的产品差异化程度。监管机构相应的最优回收监管通常规定了所需的收集率,随着其最优专利延长报价的增加而降低,反之亦然。管理意义:通过将绿色药房作为潜在目标,从源头上解决药物生态毒性问题,我们考虑的监管政策,一方面结合了获得专利延期的内在激励,另一方面结合了遵守回收法规的内在惩罚,作为政策制定者最佳平衡经济福利考虑与环境管理考虑的有用起点。
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