Jensen Donald M, Sebhatu Phoebe, Reau Nancy S
Section of Hepatology, Department of Medicine, RUSH Medical Center, Chicago, IL, USA.
Liver Int. 2016 Jul;36(7):925-8. doi: 10.1111/liv.13120.
The recent development and approval of expensive but highly effective oral agents against hepatitis C has led to restrictions and access limitations in many countries with limited healthcare budgets. Generic formulations of many of these agents are available at a fraction of the retail price in several countries because of generic licensure agreements. The discounted alternatives are only accessible in developing countries and require manufacturing and distribution regulations to ensure the quality and bioequivalence of the new drug formulations. The continued medication access limitations have driven great interest in the practice of personal drug importation of the generic formulations. This review and debate will address the medical and legal issues involved in the purchase and importation of these medicines.
近期，针对丙型肝炎的昂贵但高效的口服药物得到开发并获批，这在许多医疗保健预算有限的国家导致了限制和获取方面的局限。由于仿制药许可协议，其中许多药物的仿制药制剂在一些国家的售价仅为零售价的一小部分。这些打折的替代药物仅在发展中国家可以获取，并且需要生产和分销法规来确保新药物制剂的质量和生物等效性。持续存在的药物获取限制引发了人们对个人进口仿制药制剂做法的浓厚兴趣。本次综述和辩论将探讨购买和进口这些药物所涉及的医学和法律问题。
