Access to essential medicines for developing country populations is crucial to maintaining and improving health. Access to essential medicines depends on four factors: rational selection, affordable prices, sustainable financing and reliable health systems. They are best secured through development and implementation of a national drug policy and an essential drugs programme. Medicine donations and price discounts, when clearly justified, carefully planned and properly managed, can be applied as additional policy instruments to improve access. They can contribute to reducing the cost of health care, and help to reduce unnecessary suffering and save lives. However, their impact on and relation to the other factors also need to be considered.

There are several good examples of long-term donation programmes, including the ivermectin programme that has been active for over 25 years and has drastically reduced the incidence and prevalence of river blindness. Long-term agreements also exist for the donation of ivermectin and albendazole for lymphatic filariasis, for azithromycin for trachoma and for nevirapine for the prevention of mother-to-child-transmission of HIV/AIDS. Experiences with discount agreements are more recent, and more mixed. Some drugs for the treatment of multi-drug resistant tuberculosis are successfully being offered at large discounts. On the other hand, the offer by five pharmaceutical companies for discounts on medicines needed for the care of HIV/AIDS patients has not been taken up very widely. A recent discount agreement for lumefantrine-artesunate against malaria has not yet been evaluated.

Target audience

These interagency guidelines are designed to maximize the benefit of price discount arrangements. They are intended for policy-makers and technical staff in international and bilateral agencies active in international health development support, for pharmaceutical companies, and for governments and NGOs in recipient countries.

Objectives of these guidelines

• Maximize the benefit to recipients of price discounts for single-source products;

• Help prevent unnecessary misunderstandings and delays;

• Promote the integration of efforts leading to price discounts of single-source products within long-term programmes, in order to improve access to essential medicines for priority diseases.

Link between price discounts and equitable pricing

Equitable pricing is the adaptation of prices to purchasing power in different countries. This aim can be achieved in many ways, such as (1) increased competition, generic policies and bulk purchasing; (2) voluntary price agreements and discounts; (3) voluntary licensing with transfer of technology and geographic restriction; (4) non-exclusive compulsory licensing and (5) systematic patent waivers. Voluntary price discounts are therefore only one way to achieve the wider objective of equitable pricing.

Link to guidelines for drug donations, scope and review of these guidelines

This document should be read in conjunction with the interagency Guidelines for Drug Donations, which give the general principles for drug donations. The present guidelines are intended to cover the additional specific aspects of price discounts of single-source pharmaceuticals. Although generic equivalents may exist in some countries, single-source pharmaceuticals are usually patented products and the discounts are usually offered by or negotiated with one single pharmaceutical company. These guidelines are not international regulations but are intended as a checklist of important issues to consider when planning, executing, supporting or evaluating a programme of price discounts of single-source pharmaceuticals in the public and/or private sector. The guidelines will be reviewed in 2005.