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
Close this folder1. Introduction
View the document1.1 Essential drugs are not used to their full potential
View the document1.2 What is a national drug policy?
View the document1.3 Key components of a national drug policy
Open this folder and view contents2. The national drug policy process
Open this folder and view contents3. Legislation
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
 

1.3 Key components of a national drug policy

A national drug policy is a comprehensive framework in which each component plays an important role in achieving one or more of the general objectives of the policy (access, quality and rational use). The policy should balance the various goals and objectives, creating a complete and consistent entity. For example, access to essential drugs can only be achieved through rational selection, affordable prices, sustainable financing and reliable health and supply systems. Each of the four components of the “access framework” is essential but not sufficient in itself to ensure access. Similarly, rational drug use depends on many factors, such as rational selection, regulatory measures, educational strategies and financial incentives.

Table 1 lists the key components of a national drug policy and shows how they relate to the three main objectives of the policy.

Table 1. Components of a national drug policy, linked to key policy objectives

Components:

Objectives:

Access

Quality

Rational use

Selection of essential drugs

 

X

(X)

X

Affordability

 

X

   

Drug financing

 

X

   

Supply systems

 

X

 

(X)

Regulation and quality assurance

   

X

X

Rational use

     

X

Research

 

X

X

X

Human resources

 

X

X

X

Monitoring and evaluation

 

X

X

X

X = direct link; (X) = indirect link

As can be seen from the Table, most components cannot be linked to one objective only. The components are briefly summarized below and are discussed in detail in Part II (Chapters 4-12).

Selection of essential drugs

Drug selection, preferably linked to national clinical guidelines, is a crucial step in ensuring access to essential drugs and in promoting rational drug use, because no public sector or health insurance system can afford to supply or reimburse all drugs that are available on the market. Key policy issues are:

• the adoption of the essential drugs concept to identify priorities for government involvement in the pharmaceutical sector, and especially for drug supply in the public sector and for reimbursement schemes;

• procedures to define and update the national list(s) of essential drugs;

• selection mechanisms for traditional and herbal medicines.

Affordability

Affordable prices are an important prerequisite for ensuring access to essential drugs in the public and private sectors. Key policy issues are:

• government commitment to ensuring access through increased affordability;

• for all drugs: reduction of drug taxes, tariffs and distribution margins; pricing policy;

• for multi-source products: promotion of competition through generic policies, generic substitution and good procurement practices;

• for single-source products: price negotiations, competition through price information and therapeutic substitution, and TRIPS-compliant measures such as compulsory licensing, “early workings” of patented drugs for generic manufacturers and parallel imports.

Drug financing

Drug financing is another essential component of policies to improve access to essential drugs. Key policy issues are:

• commitment to measures to improve efficiency and reduce waste;

• increased government funding for priority diseases, and the poor and disadvantaged;

• promotion of drug reimbursement as part of public and private health insurance schemes;

• use and scope of user charges as a (temporary) drug financing option;

• use of and limits of development loans for drug financing;

• guidelines for drug donations.

Supply systems

The fourth essential component of strategies to increase access to essential drugs is a reliable supply system. Key policy issues are:

• public-private mix in drug supply and distribution systems;

• commitment to good pharmaceutical procurement practices in the public sector;

• publication of price information on raw materials and finished products;

• drug supply systems in acute emergencies;

• inventory control, and prevention of theft and waste;

• disposal of unwanted or expired drugs.

Regulation and quality assurance

The drug regulatory authority is the agency that develops and implements most of the legislation and regulations on pharmaceuticals, to ensure the quality, safety and efficacy of drugs, and the accuracy of product information. Key policy issues are:

• government commitment to drug regulation, including the need to ensure a sound legal basis and adequate human and financial resources;

• independence and transparency of the drug regulatory agency; relations between the drug regulatory agency and the ministry of health (MoH);

• stepwise approach to drug evaluation and registration; definition of current and medium-term registration procedures;

• commitment to good manufacturing practices (GMP), inspection and law enforcement;

• access to drug control facilities;

• commitment to regulation of drug promotion;

• regulation of traditional and herbal medicines;

• need and potential for systems of adverse drug reaction monitoring;

• international exchange of information.

Rational use

The rational use of drugs means that patients receive medicines appropriate for their clinical needs, in doses that meet their individual requirements, for an adequate period of time, and at the lowest cost to them and their community. Irrational drug use by prescribers and consumers is a very complex problem, which calls for the implementation of many different interventions at the same time. Efforts to promote rational drug use should also cover the use of traditional and herbal medicines. Key policy issues are:

• development of evidence-based clinical guidelines, as the basis for training, prescribing, drug utilization review, drug supply and drug reimbursement;

• establishment and support of drugs and therapeutics committees;

• promotion of the concepts of essential drugs, rational drug use and generic prescribing in basic and in-service training of health professionals;

• the need and potential for training informal drug sellers;

• continuing education of health care providers and independent, unbiased drug information;

• consumer education, and ways to deliver it;

• financial incentives to promote rational drug use;

• regulatory and managerial strategies to promote rational drug use.

Research

Operational research facilitates the implementation, monitoring and evaluation of different aspects of drug policy. It is an essential tool in assessing the drug policy’s impact on national health service systems and delivery, in studying the economics of drug supply, in identifying problems related to prescribing and dispensing, and in understanding the sociocultural aspects of drug use. Key policy issues are:

• the need for operational research in drug access, quality and rational use;
• the need and potential for involvement in clinical drug research and development.

Human resources development

Human resources development includes the policies and strategies chosen to ensure that there are enough trained and motivated personnel available to implement the components of the national drug policy. Lack of motivation and appropriate expertise has been a decisive factor in the failure to achieve national drug policy objectives. Key policy issues are:

• government responsibility for planning and overseeing the development and training of the human resources needed for the pharmaceutical sector;

• definition of minimum education and training requirements for each category of staff;

• career planning and team building in government service;

• the need for external assistance (national and international).

Monitoring and evaluation

Monitoring and evaluation are essential components of a national drug policy, and the necessary provisions need to be included in the policy. Key policy issues are:

• explicit government commitment to the principles of monitoring and evaluation;

• monitoring of the pharmaceutical sector through regular indicator-based surveys;

• independent external evaluation of the impact of the national drug policy on all sectors of the community and the economy.

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