Forzley Michele, Robertson Jane, Smith Anthony
O'Neill Institute for National and Global Health Law, Georgetown Law, Washington, DC, USA.
School of Medicine and Public Health, The University of Newcastle, New South Wales, Australia.
WHO South East Asia J Public Health. 2013 Jan-Mar;2(1):69-71. doi: 10.4103/2224-3151.115848.
Effective national legislation is critical to support the activities of a Medicines Regulatory Authority. However, the law is an under-recognized mechanism for managing issues in the implementation of access to medicines and other medicines policy goals. Regulations are a more flexible tool, have legal effect and the advantage that they can be created or changed without the need to go to the Parliament. Closer collaboration between the health and legal sectors is important as is political commitment for enforcement of the law. Some regional case studies illustrate the opportunities to use the law as an effective tool to implement medicine policies and to meet access to medicine challenges.
有效的国家立法对于支持药品监管机构的活动至关重要。然而，法律是一种在实现药品可及性及其他药品政策目标的实施过程中，用于管理相关问题但未得到充分认识的机制。法规是一种更为灵活的工具，具有法律效力，且其优势在于无需经过议会即可制定或修改。卫生部门与法律部门之间加强协作很重要，对法律执行的政治承诺同样重要。一些区域案例研究表明，有机会将法律用作实施药品政策和应对药品可及性挑战的有效工具。
