|First-year experiences with the Interagency Guidelines for Drug Donations (WHO/EDM, 2000, 51 p.)|
After extensive consultation the Interagency Guidelines for Drug Donations were issued in May 1996 on behalf of eight cosponsoring agencies active in humanitarian emergency relief. In the same month the World Health Organization (WHO) was requested by the World Health Assembly to review the experiences with the Guidelines after one year. In the autumn of 1997 WHO therefore initiated a global review of first year experiences with the Guidelines. The results of the review form the basis of this report.
The objective of the study was to make recommendations on any need for changes in the text and any other mechanisms to further increase the benefit of drug donations. The basis of the review was a postal survey with dedicated forms being sent to donors, consolidators (intermediaries) or recipients. Approximately half the questions were closed (yes/no answers). The following underlying research questions were asked. What have been the practical benefits of the Guidelines? What are the magnitude and the beneficial effects of drug donations? Which drug donations have been hampered, delayed or cancelled? What is the experience with Article 6 (12-month minimum shelf-life)? In what ways could the Guidelines be improved? In what ways could donation practices be further improved?
Four hundred questionnaires in English were sent out and fifty in French. All individuals and organizations on file in the WHO Action Programme on Essential Drugs (WHO/DAP)* who had expressed interest in drug donations were sent questionnaires. Special efforts were made to encourage those receiving questionnaires to request others, particularly recipients, involved in the donation process to fill in and return copies.
* (Since July 1998 incorporated in the Department of Essential Drugs and Medicines Policy (EDM).
One hundred and seventy-two questionnaires were returned. Thirty-four were not included in the analysis. Those who had never seen or read the Guidelines and a number of pharmaceutical companies with their own donation policies who saw no point in filling in the questionnaire were excluded. One organization sent identical replies from different national offices; only one example was therefore entered into the analysis. The data from 138 respondents of whom 42 were donors, 17 consolidators and 79 recipients were entered in the database and analysed.
The survey found that in some 45 countries the Guidelines have been adopted or adapted by either the government or organizations involved with donations. This was undoubtedly linked to the fact that after their launch in 1996 the Guidelines were extensively disseminated. They were fully reproduced in the Essential Drugs Monitor, translated into French, Spanish and Russian, widely distributed by mail and discussed at conferences. Articles in the medical and general press highlighted the guidelines and problems related to donations of drugs. Not all respondents who filled in questionnaires replied fully to every question. This made interpretation in some cases difficult. Of the respondingdonors less than 20% of their donations were made for acute emergencies. The total value of donations reported by donors was US$ 298 million of which US$ 228 million (76%) was from industry donors, US$ 68 from nongovernmental organizations and government agencies contributed US$ 3 million. Consolidators represented in the study reported donations totalling US$ 360 million. Bilateral drug donations by governments were not included in the overview but were estimated to be in the order of US$ 300 million a year.
Eighty-four percent of donors, 92% of consolidators and only 35% of recipients indicated that over half of their donations were based on specific requests. There is a difference in perception as to what forms a specific request with many recipients believing that they received many donations without specifically asking for them.
Open questions put to all respondents indicated general benefits brought about by the Guidelines. These included comments that the Guidelines were an excellent framework for improving drug donation practices, improved documentation of consignments and perception of the Guidelines as a useful tool for curtailing inappropriate donations.
Responses to closed questions showed 53% of replying recipients found it easier to refuse, return or destroy unwanted donations. Specific benefits for recipients included an improvement in donations meeting needs (45% of replying recipients), improvement in shelf-life (45% of replying recipients) and improvement in packaging and labelling (40% of replying recipients).
Hampered, delayed or cancelled drug donations troubled consolidators disproportionately compared to donors and recipients. This was mainly related to the 12-month shelf-life requirement in which some recipient governments had given insufficient consideration to the possible exceptions (Article 6) resulting in some valid donations being delayed or cancelled.
Recommendations based on questionnaire responses proposed that the interagency group should be reconvened to update the Guidelines incorporating the exceptions to direct donations into the main body of Article 6 to prevent the guideline from simply being copied and used without proper consideration of the exception. It was also recommended that the section on drug management be expanded and that a system be installed whereby recipients and consolidators could report examples of inappropriate donations. It was considered useful to have more partners involved in the cosponsorship of the Guidelines.
At a meeting on 5 March 1999 an update of the Guidelines introduction and modification and expansion to Article 6 were agreed. New paragraphs on managing drugs with less than one year expiry, rapid customs clearance, avoidance of donations of short-dated drugs and donor coordination were added. Seven additional organizations agreed to cosponsor the Guidelines bringing the total to fifteen.
In December 1999 the Department of Essential Drugs and Medicines Policy web site introduced a list for organizations wishing to underwrite and endorse the Guidelines. The site also contains an explanation of how complaints related to unhelpful donations may be registered with WHO.