I. Introduction

These Guidelines for drug donations have been developed by the World Health Organization (WHO) in cooperation with the major international agencies active in humanitarian relief.

The first version was issued in May 1996 and represented the consensus of WHO, Churches’ Action for Health of the World Council of Churches, the International Committee of the Red Cross, the International Federation of Red Cross and Red Crescent Societies, Médecins Sans Frontières, the Office of the United Nations High Commissioner for Refugees, OXFAM and the United Nations Children’s Fund. In 1999 the number of co-sponsors expanded to include Caritas Internationalis, the International Pharmaceutical Federation, Pharmaciens Sans Frontières, UNAIDS, the United Nations Development Programme, the United Nations Population Fund and the World Bank.

The Guidelines aim to improve the quality of drug donations, not to hinder them. They are not an international regulation, but are intended to serve as a basis for national or institutional guidelines, to be reviewed, adapted and implemented by governments and organizations dealing with drug donations.

The original Guidelines were based on several rounds of consultation and comments by over 100 humanitarian organizations and individual experts. In 1996 WHO was requested by the World Health Assembly, in resolution WHA49.14, to review the experiences with the guidelines after one year. In autumn 1997 WHO's Action Programme on Essential Drugs therefore initiated a global review of first-year experiences. The results of the review are presented in the forthcoming document First-year experiences with the interagency guidelines for drug donations. The evaluation formed the basis for the changes in the text. In general, experiences with the Guidelines were very positive. But there were complaints that the authorities in some recipient countries strictly adhered to the Guidelines, without regard for the exceptions specifically included, and as a result useful donations were lost. For example, problems were reported with Guideline 6: “donated drugs should have a remaining shelf-life of 12 months upon arrival in the recipient country”. However, the problems arose from misunderstanding of or failure to refer to the stated exceptions to that guideline, rather than from the text of Guideline 6 itself. In this revised edition Guideline 6 has been modified. It now allows for direct donations of drugs with a remaining shelf-life of less than one year to specific health facilities, provided assurance can be given that the drugs can be used prior to expiration.

There are many different scenarios for drug donations. They may take place in acute emergencies or as part of development aid in non-emergency situations. They may be corporate donations (direct or through private voluntary organizations), aid by governments, or donations aimed directly at single health facilities. And although there are legitimate differences between these scenarios, there are many basic rules for an appropriate donation that apply to all. The Guidelines aim to describe this common core of “Good Donation Practice”.

This document starts with a discussion on the need for guidelines, followed by a presentation of the four core principles for drug donations. The guidelines for drug donations are presented in Chapter IV. When necessary for specific situations, possible exceptions to the general guidelines are indicated. Chapter V gives some suggestions on other ways that donors may help, and Chapter VI contains practical advice on how to implement a policy on drug donations.