Counterfeit medicines: relevance, consequences and strategies to combat the global crisis

Abstract Counterfeiting of medicines, also known as “falsification” or “adulteration”, is the process in which the identity, origin, or history of genuine medicines are intentionally modified. Currently, counterfeit medicines are a global crisis that affects and is mostly caused by developing countries in Asia, Africa and Latin America. These countries lack strict law enforcement against this practice and have low-income populations with medicinal needs. Lately, the crisis has escalated, impacting developed countries as well, e.g., the US and the EU, mainly via the Internet. Despite this extension, some current laws aim to control and minimize the crisis’ magnitude. Falsification of medicines maintains an illegitimate supply chain that is connected to the legitimate one, both of which are extremely complex, making such falsification difficult to control. Furthermore, political and economic causes are related to the crisis’ hasty growth, causing serious consequences for individuals and public health, as well as for the economy of different countries. Recently, organizations, technologies and initiatives have been created to overcome the situation. Nevertheless, the development of more effective measures that could aggregate all the existing strategies into a large functioning network could help prevent the acquisition of counterfeit medicines and create awareness among the general population.

摘要：药品造假（counterfeiting of medicines），亦称“伪造”（falsification）或“掺假”（adulteration），指故意篡改正版药品的身份、来源或历史的行为。当前，假药已演变为全球性公共卫生危机，受其冲击的主要为亚洲、非洲与拉丁美洲的发展中国家，且该类造假行为多源于这些地区。此类国家既缺乏针对此类造假行为的严格执法机制，其民众又多为低收入群体，存在迫切的药品需求。近年来，该危机呈升级态势，也开始波及美国、欧盟等发达国家，主要传播途径为互联网。尽管造假范围已拓展至全球，但当前已有部分法律法规旨在管控并缓解该危机的影响规模。药品造假依托一条与合法供应链相连的非法供应链，二者均极为复杂，使得此类造假行为难以被有效管控。此外，政治与经济层面的诱因推动了该危机的快速蔓延，给民众个体、公共卫生事业乃至多国经济均造成了严重后果。近期，各类相关组织、技术方案与行动倡议陆续涌现，以应对这一困局。尽管如此，若能开发出更具实效的解决方案，将现有各类防控策略整合为一套高效运作的完整体系，将有助于防范假药的流通，并提升普通民众的防范意识。