Policy, Legislation, and Regulation

Pharmaceuticals involve many parties, including patients, doctors, other health workers, drug sellers, and manufacturers. The complexity of managing pharmaceuticals, the large number of interested stakeholders involved, and the value of the products make pharmaceutical systems vulnerable. The field also involves important risks: people can die not only from a lack of medicines, but also from medicines that are substandard or fake, wrongly prescribed, or used incorrectly. The consequences of using inferior pharmaceutical products can prolong the required therapy period, exacerbate the illness, and may cause resistance to antimicrobials. It also undermines patients’ confidence in the health care system. It is easy, therefore, to see why laws and regulations are needed.

Through the establishment of pharmaceutical laws and regulations, countries can set quality standards and pricing guidelines, require licensing of dispensers and outlets, and establish production guidelines. Medicine registration is often a major element in legislation, to ensure that individual products meet the criteria of efficacy, safety, and quality. Medicine policy guides budget allocations, research and development priorities, and education initiatives and defines the role of the public and private sectors in pharmaceutical manufacturing and distribution.

A country usually has a regulatory authority that oversees laws and regulations; however, many countries do not have sufficient regulatory infrastructure or resources to effectively monitor the quality, safety, and use of pharmaceutical products. Lack of quality assurance can result in the wide availability of substandard and counterfeit products. In addition, with consumers’ increased access to essential medicines comes a greater need to monitor and promote medicine safety and effectiveness—called pharmacovigilance. Pharmacovigilance also goes hand in hand with the availability of unbiased, evidence-based information to help guide treatment decisions and promote rational—that is, safe, effective, and cost-effective—use of medicines. 

MSH supports all levels of a country’s regulatory infrastructure, from helping implement accredited drug seller initiatives in the private sector, to developing registration software to streamline access to medicines, to providing technical assistance to countries to draft national pharmaceutical policies. In addition, we promote the development of comprehensive pharmacovigilance systems and availability of drug information.