In the early 1990s an increasing number of examples of drug donations were reported which were unnecessary, inappropriate or even dangerous. There were detailed reports on the impact of drug donations after the large earthquake in Armenia1 in 1988 and the war in Bosnia-Herzegovina2. In 1994 WHO/DAP therefore started a global consultation process to develop international guidelines for drug donations.
The Interagency Guidelines for Drug Donations were built on the practical field experience of the Christian Medical Commission of the World Council of Churches and the International Committee of the Red Cross. They represent a consensus view of eight international relief organizations. Besides WHO, these are the Churches' Action for Health of the World Council of Churches, the International Committee of the Red Cross (ICRC), the International Federation of Red Cross and Red Crescent Societies (IFRC), Médecins Sans Frontières, the Office of the United Nations High Commissioner for Refugees (UNHCR), OXFAM, and the United Nations Children's Fund (UNICEF).
The Guidelines are presented as four core principles and twelve articles on selection, quality, supply and information regarding drug donations. The core principles of good donation practice are as follows:
maximum benefit for the recipient;
respect for the wishes and authority of the recipient;
no double standards in quality;
effective communication between donor and recipient.
The extensive consultation process which preceded the issue of the Guidelines included comments from over 100 individual experts, recipient countries, donor organizations, industry representatives and others on three successive drafts of the Guidelines. At a final meeting in Geneva on 30 April 1996 the Guidelines were adopted by the eight organizations, and were issued by WHO/DAP in May 1996 as an interagency document. In the months that followed WHO/DAP issued French, Spanish and Russian translations.
A truly global discussion took place after the Guidelines were issued. Newspapers and scientific journals published articles on drug donations. A large number of national organizations, donor countries, recipients, consumer organizations, pharmaceutical industries, nongovernmental organizations (NGOs) and individuals engaged in discussions on good donation practice in general and on the Guidelines in particular. In many cases the Guidelines were adopted and published. In addition, many adaptations and translations appeared, and large numbers of copies were disseminated for comments and for use. In the first year at least 15 countries, both developed and developing, issued national guidelines, largely based on the Guidelines. Donors started to change their practices, and recipients became more vocal in refusing certain types of donations.
A number of problems emerged as well. Some recipient countries became very strict in implementing the Guidelines, and especially the requirement that donated drugs have a remaining shelf-life of 12 months upon arrival. Some pharmaceutical companies continued to offer donations of large quantities of drugs with 6-12 months' shelf-life, which nongovernmental organizations found difficult to refuse in view of the desperate needs of the poor in developing countries. A number of large consignments of valuable antibiotics with 11 months' remaining shelf-life were turned down. Some donations were kept in bond by the customs authorities while the 12-month mark passed, and were then refused entry.
Most drug donations are made with the best of intentions, and play a vital role in relieving human suffering. Yet some donations create more problems than they solve. The Guidelines are not intended to discourage drug donations, but only to improve their beneficial effect. It is in this spirit that the current review of first-year experiences was undertaken. Its ultimate objective is to further maximize the potential benefits of drug donations.