Angeli Federica
Department of Health Services Research, Maastricht University, Duboisdomein 30, Postbox 6200 MD, Maastricht, The Netherlands. E-mail:
Health Policy Plan. 2014 May;29(3):280-91. doi: 10.1093/heapol/czt015. Epub 2013 Apr 4.
This article investigates the implications of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which reached full-fledged implementation in 2005, for the patenting activity of Indian biopharmaceutical companies. The Indian biopharmaceutical industry is well-known for its generic producers, whose business models capitalize on the opportunity to reverse-engineer patented compounds and produce them at low costs through process innovation. By strengthening intellectual property rights, TRIPS determined a major regulative change, which presents the characteristics of an institutional shock. The examination of the patenting and alliance activity of 123 Indian biopharmaceutical firms between 1999 and 2009 reveals two important insights. First, the innovation outcome of Indian biopharmaceuticals has sharply increased during the transition to TRIPS-compliant regulation, suggesting that Indian companies have been capable and willing to transit from an imitation-based to an innovation-based business model. Second, those biopharmaceutical firms holding cross-border alliances to foreign partners have proved significantly more successful at enhancing their innovative capability. This research delivers a multifold contribution to the policy debate surrounding the enforcement of TRIPS in emerging economies. First, it suggests that such regulatory change may have encouraged biopharmaceutical innovation in India, despite the sceptical voices who did not foresee any benefits because of inherent inertia of the industry. Second, by arguing and testing the advantages of foreign partnerships, this research highlights that the much feared return of pharmaceutical foreign companies to India could instead favour adaptation to institutional change. Implications for Indian public health are particularly critical. The impact of TRIPS on drug pricing and on the capability--and willingness--of Indian biopharmaceuticals to invest in local health conditions are two crucial points of discussion.
本文探讨了《与贸易有关的知识产权协定》(TRIPS协定)于2005年全面实施后,对印度生物制药公司专利活动的影响。印度生物制药行业以其仿制药生产商而闻名,这些生产商的商业模式利用了对专利化合物进行逆向工程并通过工艺创新以低成本生产这些化合物的机会。通过加强知识产权,TRIPS协定带来了一项重大的监管变革,呈现出制度冲击的特征。对1999年至2009年间123家印度生物制药公司的专利和联盟活动进行的考察揭示了两个重要的见解。第一,在向符合TRIPS协定的监管过渡期间,印度生物制药公司的创新成果大幅增加,这表明印度公司有能力且愿意从基于模仿的商业模式转变为基于创新的商业模式。第二,事实证明,那些与外国合作伙伴建立跨境联盟的生物制药公司在提升其创新能力方面要成功得多。这项研究为围绕TRIPS协定在新兴经济体实施的政策辩论做出了多方面的贡献。首先,它表明这种监管变革可能鼓励了印度的生物制药创新,尽管有怀疑论者认为由于该行业固有的惰性不会带来任何好处。其次,通过论证和检验外国合作伙伴关系的优势,本研究强调,人们极为担忧的制药外国公司重返印度,反而可能有利于适应制度变革。对印度公共卫生的影响尤为关键。TRIPS协定对药品定价以及印度生物制药公司投资于当地卫生状况的能力和意愿的影响,是两个至关重要的讨论要点。