How to Develop and Implement a National Drug Policy (Second Edition): Part I: How to develop and implement a national drug policy: 3. Legislation: 3.2 Framework for drug legislation

How to Develop and Implement a National Drug Policy (Second Edition)
(2001; 96 pages) [French] [Spanish]

Table of Contents

Contributors
Abbreviations and acronyms
Preface
Part I: How to develop and implement a national drug policy
	1. Introduction
		1.1 Essential drugs are not used to their full potential
		1.2 What is a national drug policy?
		1.3 Key components of a national drug policy
	2. The national drug policy process
		2.1 Overview of the national drug policy process
		2.2 Formulating a national drug policy
		2.3 Implementing a national drug policy
		2.4 Monitoring and evaluation
	3. Legislation
		3.1 Importance of legislation and regulations
		3.2 Framework for drug legislation
		3.3 Developing drug legislation and regulations
Part II: Key components of a national drug policy
	4. Selection of essential drugs
		4.1 Essential drugs
		4.2 Old problems and new challenges
		4.3 Strategies for the selection of essential drugs
		4.4 Traditional and herbal medicines
	5. Affordability
		5.1 Challenges
		5.2 Strategies to increase affordability
	6. Drug financing
		6.1 Challenges
		6.2 Drug financing options
	7. Supply systems
		7.1 Public or private? Or mixed?
		7.2 Drug procurement
		7.3 Local manufacture
		7.4 Distribution strategies
		7.5 Drug supply in emergency situations
	8. Drug regulation
		8.1 Need for drug regulation and quality assurance
		8.2 Basic requirements for drug regulation
		8.3 Core elements of drug regulation
		8.4 Stepwise approach to drug registration
		8.5 Quality
		8.6 Safety
		8.7 Efficacy
		8.8 Information and drug promotion
		8.9 Information exchange with WHO and with other agencies
	9. Rational use of drugs
		9.1 Why is it important to promote rational use?
		9.2 Challenges
		9.3 Planning for activities to promote rational use of drugs
		9.4 Core strategies to improve drug use
		9.5 Educational strategies
		9.6 Managerial strategies to promote rational drug use
		9.7 Regulatory strategies to promote rational drug use
		9.8 Promoting rational drug use in the private sector
	10. Research
		10.1 Introduction
		10.2 Strategies to promote research
	11. Human resources development
		11.1 Introduction
		11.2 Strategies for human resource development
	12. Monitoring and evaluation
		12.1 Monitoring and evaluation are part of a national drug policy
References
Selected WHO publications and documents of related interest
Back 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 legislative^b 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 import^c
	• Compulsory licensing^c
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.