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
Open this folder and view contentsPart I: How to develop and implement a national drug policy
Close this folderPart II: Key components of a national drug policy
Open this folder and view contents4. Selection of essential drugs
Open this folder and view contents5. Affordability
Open this folder and view contents6. Drug financing
Open this folder and view contents7. Supply systems
Close this folder8. Drug regulation
View the document8.1 Need for drug regulation and quality assurance
View the document8.2 Basic requirements for drug regulation
View the document8.3 Core elements of drug regulation
View the document8.4 Stepwise approach to drug registration
View the document8.5 Quality
View the document8.6 Safety
View the document8.7 Efficacy
View the document8.8 Information and drug promotion
View the document8.9 Information exchange with WHO and with other agencies
Open this folder and view contents9. Rational use of drugs
Open this folder and view contents10. Research
Open this folder and view contents11. Human resources development
Open this folder and view contents12. Monitoring and evaluation
View the documentReferences
View the documentSelected WHO publications and documents of related interest
View the documentBack cover
 

8.2 Basic requirements for drug regulation

Drug regulation is a complex task, with many stakeholders and vested interests involved. For this reason there are a number of basic requirements.

Sound legal basis, adequate human and financial resources

A DRA can be effective only if it has a legal basis for all its functions. It must have: sufficient competent administrative and technical staff with the necessary integrity; adequate and sustainable funding; access to external experts and international contacts; access to a quality control laboratory; and a reliable system of law enforcement in the courts. The national drug policy must address all of these factors.

Independence

To maintain public confidence the DRA must operate, and be seen to operate, in an independent, authoritative and impartial manner. It must be funded by the government or by fees collected from industry and clients. However, in the latter case, the DRA must be careful that decisions to grant product registration and licences for establishments are not biased by the need to collect fees from pharmaceutical companies and other clients. Fees levied by the DRA should not be so high that they discourage applications for the registration of essential drugs, and act as a barrier to drug availability and affordability. Provisions should therefore be in place for a reduction of or exemption from registration fees in order to ensure that vital and life-saving drugs are available.

It is also important that drug regulatory functions are separated from drug supply functions and from agencies involved in supply management, in order to maintain independence and ensure that there is no conflict of interest. In some situations the DRA can authorize an independent body to perform functions such as drug evaluation and inspection of manufacturers, to ensure that they comply with GMP.

One important policy decision is where to site the DRA: whether it should be within the ministry of health, or within a technically and managerially independent organization that reports to the minister or should be totally independent. Some of the key policy issues concerning the DRA’s independence are presented in Table 3. This shows that an organization (which may include the drug quality control laboratory as well), which is technically and managerially independent but reports directly to the minister of health, can have the advantages of a fully independent agency without most of its disadvantages.

Table 3. Key policy issues on the independence of a drug regulatory agency

 

Potential advantages

Potential disadvantages

Part of ministry of health (MoH)

• MoH able to set policies

• Low salaries
• Inefficient management
• Inflexibility with funds; low fees
• Conflict of interest with executive MoH functions (e.g. supply)

Technically and managerially independent, but reports directly to the minister

• Competitive salaries
• Realistic fee structure
• Fees used to fund DRA and for drug control laboratory
• No conflict of interest with executive MoH functions
• MoH able to set policies

 

Fully independent
(privatized)

• Competitive salaries
• Realistic fee structure
• Fees used to fund DRA and drug control laboratory

• MoH cannot set policies
• Dependent on users and registration fees
• Risk of DRA being “hijacked” by other stakeholders not supporting national drug policy
• Incentive to register too many drugs

Transparency

One of the keys to an honest and accountable DRA is transparency in all its procedures and outcomes for all stakeholders. Transparency and openness help to prevent bias and corruption. Some of the means of achieving transparency in drug regulation are:

• definition, publication and dissemination of the requirements for information to be submitted to the DRA in support of various types of applications;

• publication of the criteria that the DRA uses and the procedures it follows when making decisions about applications;

• publication of the DRA’s decisions (regular comprehensive lists of drugs registered, renewals and withdrawals) and of the information upon which these are based; a DRA web site may be a convenient way to achieve this.

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