Kesselheim Aaron S, Choudhry Niteesh K
Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Ann Intern Med. 2008 Apr 15;148(8):614-9. doi: 10.7326/0003-4819-148-8-200804150-00006.
In response to increasing prescription drug costs, more U.S. patients and policymakers are importing less-expensive pharmaceutical products from other countries. Large-scale prescription drug importation is currently illegal, but the U.S. Food and Drug Administration permits individuals to bring in 90-day supplies of drugs for personal use. As patient use of foreign-bought drugs has increased, federal legislators have continued to debate the full legalization of importation. Three factors help guide whether U.S. patients and policymakers can rely on other countries as sources of imported prescription drugs: whether the safety of the product can be ensured, how the import price compares with domestic prices, and how importation might affect the exporting country's pharmaceutical market. In wealthier countries with active regulatory systems, drug safety can be adequately ensured, and brand-name products are usually less expensive than in the United States (although generic drugs may be more expensive). However, implementing large-scale importation can negatively impact the originating country's market and can diminish the long-term cost savings for U.S. consumers. In low- and middle-income countries, prices may be reduced for both brand-name and generic drugs, but the prevalence of unauthorized products on the market makes ensuring drug safety more difficult. It may be reasonable for individual U.S. consumers to purchase essential medicines from certain international markets, but the most effective way to decrease drug costs overall is the appropriate use of domestic generic drugs, which are available for almost every major therapeutic class.
为应对处方药成本不断上涨的情况,越来越多的美国患者和政策制定者开始从其他国家进口价格较低的药品。目前,大规模进口处方药是非法的,但美国食品药品监督管理局允许个人携带90天用量的药品供个人使用。随着患者对国外购买药品的使用增加,联邦立法者继续就进口合法化展开辩论。有三个因素有助于指导美国患者和政策制定者是否可以将其他国家作为进口处方药的来源:产品安全能否得到保证、进口价格与国内价格相比如何,以及进口可能对出口国药品市场产生何种影响。在拥有活跃监管体系的富裕国家,药品安全能够得到充分保证,名牌产品通常比在美国便宜(尽管仿制药可能更贵)。然而,实施大规模进口可能会对原产国市场产生负面影响,并可能减少美国消费者的长期成本节省。在低收入和中等收入国家,名牌药和仿制药的价格可能都会降低,但市场上未经授权产品的普遍存在使得确保药品安全更加困难。美国个人消费者从某些国际市场购买基本药物可能是合理的,但总体上降低药品成本的最有效方法是合理使用国内仿制药,几乎每个主要治疗类别都有仿制药可供选择。