(2001; 96 pages) [French] [Spanish]
3.3 Developing drug legislation and regulations
In some countries there are opportunities to review all relevant drug laws and bring them together in one law, while in other countries drug issues are covered in different laws and regulations.
In drafting or revising drug legislation it is important, first, to make a full inventory of existing laws and regulations, and carefully decide what type of legislation is required. Then, legal experts should collaborate closely with health experts and other stakeholders in drafting the new text. After drafting, a wide consultative process is needed to inform interested parties and to enable them to comment and express their concerns. At this time it is important to ensure that there is political support for the proposed changes and that this support is maintained throughout the process.
When writing the law, the practicalities of future enforcement should be kept in mind. If there are no strategies, facilities and resources for implementation and enforcement, legislation on its own will achieve nothing. A law with modest aims and objectives that is properly enforced is preferable to a more comprehensive one that cannot be implemented.
Some practical aspects of developing or updating drug legislation
• Pharmaceutical legislation and regulations cannot be developed or updated in a vacuum, but must fit into the country’s existing legal framework. It is imperative to define clearly the objectives of drug legislation in relation to national health objectives, government policies and available resources.
• The legislation should cover the basic principles. It should also enable the issuing of lower-level legal acts and regulations covering technical and operational details, which can be changed more easily.
• Political commitment is required and all stakeholders must be consulted. Moreover, opposition may be mounted by those whose interests will be affected. This can often result in lengthy negotiations, and drafting and passing laws and regulations can therefore be time-consuming.