Wilde H
Queen Saovabha Memorial Institute and Department of Medicine, Chulalongkorn University Hospital, Bangkok, Thailand.
Clin Infect Dis. 2001 Sep 1;33(5):648-50. doi: 10.1086/322705. Epub 2001 Jul 30.
Development costs for new biological agents are increasing, and the time span from laboratory research to introduction of a product on the world market is becoming ever longer. Complex regulatory requirements add barriers and additional costs to early introduction abroad. This results in reluctance by manufacturers to undertake development of a vaccine that will be used for a tropical disease in only the public sector of a poor country. The chances of recovery of huge investment costs before patents expire are not good, unless such a new vaccine can also be sold at high cost in North America and Europe. These are some of the reasons that we still do not have a modern Japanese encephalitis vaccine or products against malaria and dengue fever. Many tropical countries must find a way to develop their own vaccine production facilities. Innovative help for technology transfer will have to be forthcoming, or many new life-saving products will never bridge the gap between research unit and production.
新型生物制剂的研发成本不断攀升,从实验室研究到产品推向全球市场的时间跨度也越来越长。复杂的监管要求给产品早日推向国外市场增添了障碍和额外成本。这导致制造商不愿研发仅用于贫穷国家公共部门的热带病疫苗。除非这种新型疫苗也能在北美和欧洲以高价出售,否则在专利到期前收回巨额投资成本的可能性不大。这些就是我们仍然没有现代日本脑炎疫苗或抗疟疾和登革热疫苗产品的部分原因。许多热带国家必须找到发展自身疫苗生产设施的方法。必须提供创新的技术转让援助,否则许多新的救生产品将永远无法跨越研究单位和生产之间的差距。