(2001; 96 pages) [French] [Spanish]
3.1 Importance of legislation and regulations
A legislative framework is needed in order to implement and enforce the various components of a national drug policy, and to regulate the activities of the different parties in both the public and private sectors. Permitting the circulation of poor-quality, ineffective products and harmful ingredients in a country has an impact on the population’s health and on the national economy. Lack of legislation and regulations on other aspects of pharmaceuticals, such as financing, supply and the use of drugs, affects cost-effectiveness in health delivery.
Two types of legal framework cover pharmaceuticals. Laws are passed by a country’s legislative bodies, and are formulated in general terms to meet current and future needs. Regulations enable government authorities to set out in more detail how the laws should be interpreted, and how they will be implemented and enforced. Regulations can be changed more easily than laws, and create the necessary flexibility in a changing environment. In some countries, regulations require only the approval of the head of a ministry or department.
Legislation and regulations ensure that the responsibilities, qualifications, rights and roles of each party are defined and recognized (including those of medical practitioners, pharmacists and the drug regulatory authority). They also create the legal basis enabling the regulatory control of activities such as drug manufacture, import, export, marketing, prescribing, dispensing and distribution, and the enforcement of such laws and regulations.
The purpose of the legislation is therefore the same as that of the drug policy: to ensure that only safe, effective, quality drugs are produced, imported and distributed, and that these drugs are made available, as well as managed and used appropriately.