Vieira Marcela, Slovenski Iulia, Large Kaitlin, Alonso Ruiz Adrian, Moon Suerie
Global Health Centre, Geneva Graduate Institute, 1205 Geneva, Switzerland.
Trop Med Infect Dis. 2024 Oct 8;9(10):233. doi: 10.3390/tropicalmed9100233.
Alternative innovation models have emerged to address failures of the traditional pharmaceutical system, particularly for diseases where market incentives do not attract sufficient research and development efforts. However, the feasibility of such models for diseases with significant markets is not well-established. This article analyses the development of a novel drug (ravidasvir) for the treatment of hepatitis C, a highly profitable market. Data from qualitative research methods, including literature reviews and semi-structured interviews, was analyzed using a novel conceptual framework focusing on actors, resources, organizational practices, and outcomes. Dissimilar to other projects, ravidasvir did not involve any major pharmaceutical companies. Rather, it leveraged the capacities of actors less traditionally involved in the development of novel medicines by constructing a collaborative network of private and public partners from low- and middle-income countries with a shared goal. The collaboration was successful in developing a highly effective, easy-to-use, and affordable medicine and contributed significantly to capacity-strengthening. However, the case also highlighted that strategic behavior by competing for-profit firms could pose significant challenges and that changing external conditions reduced the potential public health impact of the drug. Lessons from ravidasvir can inform future efforts to develop alternative innovation models for therapeutic areas with significant commercial interest.
替代性创新模式已经出现，以应对传统制药体系的失灵问题，特别是针对那些市场激励无法吸引足够研发投入的疾病。然而，此类模式在具有重大市场的疾病领域的可行性尚未得到充分确立。本文分析了一种用于治疗丙型肝炎的新型药物（雷迪帕韦）的研发情况，丙型肝炎市场利润丰厚。使用一种聚焦于行为主体、资源、组织实践和成果的新型概念框架，对来自定性研究方法（包括文献综述和半结构化访谈）的数据进行了分析。与其他项目不同，雷迪帕韦的研发未涉及任何大型制药公司。相反，它通过构建一个由低收入和中等收入国家的公私合作伙伴组成的协作网络，利用了那些传统上较少参与新型药物研发的行为主体的能力，这些合作伙伴有着共同目标。该合作成功研发出了一种高效、易用且价格亲民的药物，并为能力建设做出了重大贡献。然而，该案例也凸显出，营利性竞争公司的战略行为可能带来重大挑战，而且外部条件的变化降低了该药物对公共卫生的潜在影响。雷迪帕韦的经验教训可为未来针对具有重大商业利益的治疗领域开发替代性创新模式的努力提供参考。
