Sherkow Jacob S
Innovation Center for Law and Technology, New York Law School, New York, NY; Health Policy and Management, Columbia University Mailman School of Public Health, New York, NY.
Yale J Biol Med. 2017 Dec 19;90(4):667-672. eCollection 2017 Dec.
Patent issues surrounding CRISPR, the revolutionary genetic editing technology, may have important implications for the public health. Patents maintain high prices for novel therapies, limiting patient access. Relatedly, insurance coverage for expensive therapies is waning. Patents also misallocate research and development resources to profitable disease indications rather than those that necessarily impinge on the public health. And it is unclear how CRISPR therapies will figure into the current regulatory framework for biosimilars. Policy makers and physicians should consider these issues now, before CRISPR therapies become widely adopted-and entrenched-in the marketplace.
围绕革命性基因编辑技术CRISPR的专利问题可能对公共卫生产生重要影响。专利维持了新型疗法的高价,限制了患者的可及性。与此相关的是,昂贵疗法的保险覆盖范围正在缩小。专利还将研发资源错误地分配到有利可图的疾病适应症上,而非那些必然影响公共卫生的疾病。而且目前尚不清楚CRISPR疗法将如何融入当前生物类似药的监管框架。在CRISPR疗法在市场上被广泛采用并根深蒂固之前,政策制定者和医生现在就应该考虑这些问题。