There are at least four ways in which provision of drugs through the private sector may conflict with the principles of national drug policies. The first two of these concerns relate to equity (availability and affordability), the third to rational drug use and the fourth to drug quality.
• Availability (geographical access): The full range of essential drugs should be available throughout the country. Are private pharmacies or other licensed drug outlets accessible to the majority of the population?
• Affordability
(financial access): Drugs that are needed should be obtainable at a price that is affordable to the majority of the population. How do the poor gain access to drugs?
• Rational use: Drugs should be prescribed, dispensed and consumed in a therapeutically rational manner. Are private health providers, pharmacists, pharmacy aides and other drug dispensers providing good advice on consumer purchases? Are patients and consumers buying therapeutic quantities of prescribed or recommended drugs?
• Drug quality, safety and efficacy: Drugs should be registered, imported, and produced according to accepted standards of quality, safety, and efficacy. Are only properly registered drugs of good quality available in the private market?
Government has a number of mechanisms by which to help promote availability, affordability and rational use of drugs in the private sector. Table 7 provides an overview of possible options.
Table 7. Measures to promote access, rational drug use and drug quality in the private sector
|
Availability |
Affordability |
Rational drug use |
Drug quality |
Affecting market structure |
|
|
|
|
• Drug registration |
|
|
|
X |
• Licensing of importers, wholesalers and retailers |
X |
|
X |
X |
• Registration of drug outlets |
X |
|
X |
X |
• Dispensing clinicians |
X |
|
X |
|
• Generic substitution |
|
X |
|
|
Providing information and education |
|
|
|
|
• Setting standards of undergraduate training |
|
|
X |
|
• Continuing education for professionals |
|
|
X |
|
• Training of drug sellers |
|
|
X |
|
• Development of standard treatment guidelines |
|
|
X |
|
• Public and patient education |
|
X |
X |
|
• Regulation of drug information and promotion |
|
X |
X |
|
• Provision of price information |
|
X |
|
|
Controlling prices |
|
|
|
|
• Regulation of producer and distribution prices |
|
X |
|
|
• Regulation of retail margins |
|
X |
|
|
Setting incentives |
|
|
|
|
• Incentives for wholesalers and retailers |
X |
|
|
|
• Accreditation schemes |
|
|
X |
|
Increasing financing |
|
|
|
|
• Community drug schemes |
X |
X |
X |
|
• Health insurance schemes |
|
X |
X |
|
Key: X denotes that this measure may be used to affect the target variable
Government supervision of the private pharmaceutical market involves complex and often contentious issues. Governments must carefully explore and understand the options open to them before acting:
• Several of the identified instruments will help achieve more than one objective: For example, regulation of drug marketing may prevent market segmentation and the development of market power, and may also promote rational drug use.
• For some mechanisms there may be conflict between different objectives: Allowing clinicians to dispense may enhance geographical accessibility but at the same time may provide an incentive to overprescribe. Price regulation may discourage some producers from entering the market, thus possibly reducing availability.
• Some mechanisms are easier to implement than others: Substantial problems may be encountered in price regulation [105]. Providing price information may be easier to do but may (arguably) be less effective in maintaining low prices.
Government may be particularly concerned about improving drug availability and affordability in the private sector in situations where government health services do not exist or are not able to provide drugs to the poor, medically needy, geographically isolated or otherwise underserved populations. In countries where a large proportion of the population is poor and government health services lack sufficient resources, ensuring universal access to drugs is particularly challenging.