How to Develop and Implement a National Drug Policy (Second Edition)
(2001; 96 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentContributors
View the documentAbbreviations and acronyms
View the documentPreface
Close this folderPart I: How to develop and implement a national drug policy
Open this folder and view contents1. Introduction
Open this folder and view contents2. The national drug policy process
Close this folder3. Legislation
View the document3.1 Importance of legislation and regulations
View the document3.2 Framework for drug legislation
View the document3.3 Developing drug legislation and regulations
Open this folder and view contentsPart II: Key components of a national drug policy
View the documentReferences
View the documentSelected WHO publications and documents of related interest
View the documentBack cover
 

3.2 Framework for drug legislation

What is covered by the legislation?

Pharmaceutical legislation is mostly concerned with ensuring that effective and safe drugs of good quality are made available, and that correct information is provided about them. These tasks are covered in drug laws, pharmacy acts and drug regulations. The drug regulatory authority is the enforcing body.

There are also other laws and regulations that may support the implementation of the national drug policy, such as those that support generic substitution, those relating to patents and intellectual property rights, and tax laws. In some countries there are laws and regulations that deal with prescribing and dispensing practices to ensure the appropriate use of drugs. The most important aspects of a national drug policy which need legislative and regulatory support are listed in Table 2.

Table 2. Examples of components of a national drug policy which need political and legislative support

Component

Political and legislativeb support on:

Selection of essential drugs

• Use of the national list of essential drugs

 

• Selection and use of traditional medicines

Affordability

• Removal of import taxes on essential drugs

 

• Distribution margins

 

• Pricing policy

 

• Generic policy, generic substitution

 

• Equity pricing

 

• Parallel importc

 

• Compulsory licensingc

Drug financing

• Increased government funding of drugs for priority diseases, the poor and disadvantaged

 

• User charges, cost-sharing mechanisms

 

• Support for health insurance and social security

 

• Drug donations

Supply systems

• Public drug supply based on essential drugs list

 

• Public-private mix in drug supply and distribution

 

• Support to national pharmaceutical industry

 

• Disposal of unwanted or expired drugs

Regulation and quality assurance

• Establishment and funding of the drug regulatory agency

 

• Good manufacturing practices and other quality standards

 

• Licensing of products, premises and personnel

 

• Inspection

 

• Quality control

 

• Regulation of traditional and herbal medicines

Rational use

• Scheduling of drugs (over-the-counter, prescription-only)

 

• Minimum requirements of professional training

 

• Essential drugs concept as basis for training curricula

 

• Training of informal drug sellers

 

• Use of financial incentives for prescribers

 

• Dissociation of prescribing/dispensing functions

 

• Drug promotion

Research

• Clinical trials

b Legislative support includes laws, decrees and regulations.
c In accordance with the TRIPS Agreement

Legislation framework

Legislative models and structures for drug regulation vary from country to country, but the basic elements listed below represent a reasonable common framework. The applicable legislation must be broad in its scope in order to address all the essential issues and be flexible enough to make the legislation specific to problems. The list below can be useful as the basis for planning new drug laws or for revising existing legislation.

Box 4

Elements of drug legislation

What should be regulated

• Premises, persons and practices involved in the manufacture, importation, distribution, procurement, supply and sale of drugs, as well as the promotion and advertising of drugs.

• Drug products.

Who regulates

• Governments have primary responsibility, but public and private professional associations also have a role to play.

Scope/extent of regulation

• Geographical area.

Which sanctions

• Administrative measures.
• Legal sanctions (warnings, fines, withdrawal of licences, imprisonment).

Organization of the text and general provisions

• Title or name of the law.

• Date of entry into operation of the entire law or certain parts, sections and articles.

• Area of operation (geographical) and application (state, private and public sector).

• Purposes and objective.

• Relationship to other existing laws.

• Definitions of selected terms and concepts, exclusions.

• Statutory powers, duties and responsibilities of the regulatory authority, its organization, resources and staff.

• Licensing and registration system (products, companies and individuals in the contexts of manufacture, import, export, transit, procurement, distribution, prescribing, dispensing, storage, use); statutory requirements, standards and procedures.

• Information (labelling), advertising and promotion.

• Enforcement procedures (seizures), penal provisions and administrative penalties.

• Special issues (patents, pricing, clinical trials, post-marketing surveillance, national essential drugs list and formulary, generic drugs, traditional medicines, orphan drugs).

• Regulation-making scope and power.

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