The Delicate Dilemma of Regulating Drug Dumping

A recent New England Journal of Medicine (NEJM) article (Berkmans, et. al 1997) has confirmed that over half the drugs donated to the Bosnian relief effort between 1992 and 1996 were "inappropriate"; that is, useless or unusable medications. In the wake of this atrocity the process of donating drugs to areas in need has undergone shifts in policy and practice which leave the situation slightly closer to equilibrium, but perhaps even more ethically convoluted.

The Bosnian conflict joins a growing list of recent world crises which have been exploited to the advantage of pharmaceutical companies, governments and non-government organizations (NGO's) seeking to unload worthless medications. Donors avoid destruction costs, generate good publicity, and in some cases net hefty tax write-offs. The World Health Organization (WHO), in response to public outcry against these practices, has offered specific guidelines for donors in the last year; and recipient governments have been enforcing them in a stringent manner. The crackdown has created a backlash among pharmaceutical companies and relief organizations who are less willing and/or able to donate under these stricter standards, and some NGO's are feeling the pinch. Those who continue their involvement in the donation chain often choose to override WHO guidelines, asserting that problems of drug donation pile-up in crisis-stricken areas are more attributable to inefficiency of distribution by recipients than the categorical quality of the parcel leaving the hands of the particular donor.

The WHO guidelines consist, broadly, of the following: 1) a drug donation should benefit the recipient to the maximum extent possible; 2) a donation should be given with full respect for the wishes and authority of the recipient; 3) There should be no double standards in quality (if the quality of an item is unacceptable in the donor country, it is also unacceptable as a donation); and 4) donations should be based on an expressed need and not sent unannounced. These standards have been repeatedly transgressed in the last decade. In response to the Armenian earthquake of 1988, 5,000 tons of drugs were donated, slightly over a third were relevant for an emergency situation. In the war in Eritrea, 1989, one settlement recieved 30,000 half-liter bottles of expired amino acid solution which could not be disposed of locally because of the smell. In Lithuania, 1993, a case was reported where 11 women temporarily lost their eyesight due to the ingestion of poorly-labelled donated drugs. One doctor relates a story of being shown a stockpile of medications in Bosnia donated by a German organization which were ten years overdue.

Organizations and companies, however, are bristling at some of the particulars of the WHO guidlines. Most contraversial, it seems, is the call for a one-year expiration window on donated drugs. According to Neil Frame, the procurement director of LA-based "Operation USA" (an intermediary organization that collects drugs from companies and distributes them internationally), this condition is unnecessarily binding on donors, and has caused a decrease in donation offers from companies. Many organizations have the ability to distribute and administer drugs within as few as a six-months, he asserts, and furthermore, "few companies are going to want to let go of medications which still have that much potential for sale". In light of this, some organizations opt to override the guidelines when expedient. Public information from pharmeceutical companies tends to reflect this ambiguity. Few are up front with any kind of official policy on donation practices.

Frame voiced a greater concern for organizations' temptation to accept anything and everything from companies in order to post the big numbers in regards to their own activities. He notes that, in recent years, NGOs have in fact been claiming higher sum totals of donations recieved and distributed than companies' and governments' own donation figures. In some situations, organizations donate to each other, resulting in circular exchanges where a bunch of NGO's get credit for the same batch of drugs, as expiration dates tick away. A policing organization has been formed between some donor NGO's, including Operation USA, which is attempting to generate greater responsibility on these matters. However, Frame admits that "standards still vary across organizations".

The issue of drug disposal in underpriviledged and disaster- stricken areas remains unresolved. The 17,000 tons of unuseable drugs stockpiled in Bosnian warehouses will cost the country approximately $34 million to dispose of. More alarming are the health and environmental problems that Bosnia, or any recipient country in similar circumstances, will be plagued by down the road as a result of disposal procedures. Berkmans, et. al., in the NEJM article, go beyond the WHO guidelines in calling for donors to take responsibility for unusable donations, taking them back and dealing with their disposal on their own turf. Frame believes this is unreasonable. He argues that recipients of donations, at the organizational or governmental level, need to be "judicious about their relations" with donors. In other words, if one asks a donor to take back a useless drug, there won't be many more donations forthcoming from that source. He does however concede that disposal of useful and useless medical supplies in crisis-stricken and impoverished areas poses a significant problem, environmentally and economically.

Popular opinion still seems to maintain that getting things out there is of primary importance. Karen Blank, of Cal State Long Beach, who is in contact with professionals in the field, comments: "Needs should be addressed first, then we can deal with the legalities." With attention to the irresponsibilities of donors becoming more acute, however, the issues surrounding the evolving nature of donations to relief efforts have outgrown in complexity the reductionist finger-pointing which has been prevalent thus far. And what needs to be dealt with, precisely, are the legalities.

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