The development stage: September 1994 - May 1996

In September 1994 the WHO Action Programme on Essential Drugs (WHO/DAP) started collecting information on drug donations and reviewed copies of existing drug donations guidelines. The guidelines for drug donations of the Christian Medical Commission of the World Council of Churches in particular served as a starting point. By the end of 1994 a first working draft of international guidelines had been prepared and discussed within WHO.

In February 1995 the second working draft was sent out to an interagency group which had previously been collaborating in the development of the New Emergency Health Kit. At the same time it was also sent to WHO/DAP's working partners, such as regional offices, country offices, essential drugs programmes, consumer organizations, pharmaceutical industry representatives and others.

Comments were received and incorporated into the third draft, dated November 1995, which was sent out again to all persons who had responded to the second draft, and to any other person or organization that had expressed an interest. Their comments were incorporated into the final text, which was finalized and adopted by the interagency group on 30 April 1996, and issued by WHO/DAP on 9 May 1996.

Discussion

In the course of the development process an unknown number of individual experts and organizations received the draft Guidelines; over 100 individuals and groups sent their comments to WHO. Although the Guidelines were presented as drafts, many groups and individuals immediately started using them for internal discussions, reviews, local adaptations, and so forth. In fact, the process of development of the Guidelines was an important component of their final dissemination, as most experts and organizations active in the field were already involved and had been informed before the final Guidelines were issued.

Perhaps the only exception to this were some private voluntary organizations and pharmaceutical industry donors in the United States, which entered the picture only early in 1996 after the third draft was circulated to them. Through a special meeting with industry representatives in March 1996 their comments and concerns were heard and most of them were incorporated into the final text.