Cristina P Pinheiro1
Department of Hygiene and Epidemiology, University of Porto Medical School, Porto, Portugal
Drug donations are necessary and valued when they accurately meet the recipient's needs. However, the lack of international regulation on drug donation procedures allows some entities to take an unfair advantage of the situation.
WHO has repeatedly drawn attention to what is probably the main issue related to drug donations in the form of development aid and humanitarian assistance: "good procurement - getting quality medicines to people when and where needed".1 According to WHO, "the number of different agencies involved in procuring drugs - including ministries of health, manufacturers and donor agencies - can render the process highly complex and vulnerable to inefficiency and waste". WHO's interagency guidelines for drug donation describe four core principles that should be respected and guaranteed: (i) maximum benefit to the recipient; (ii) respect for the wishes and authority of the recipient; (iii) no double standards in quality; and (iv) effective communication between donor and recipient.2 Regrettably, these guidelines are not international regulations.
Recent accounts of emergency relief operations throughout the world reveal that all major donations of pharmaceuticals fail to meet the recipients' real needs.3 The inappropriateness of drug donations comes primarily from their origin (industry surpluses, free medical samples, drugs collected by independent organizations or returned to pharmacies for disposal). Some drugs arrive unsorted and labelled in languages unknown to the professionals in the field. Expired drugs (at the time of their arrival) and drugs close to expiry still comprise a large proportion of donations from nongovernmental organizations, corporations, pharmaceutical industries and associations.4 This practice is defended by a sad assertion that making use of expired, partially degraded drugs is better than having none at all. It obviously raises an ethical issue about the existence of first-hand/first-class drugs and second-hand/lower-class drugs and a disturbing division between the rights and worth of different populations.
Drug donations provide benefits such as tax deductions and are a very convenient way for industries to get rid of stagnant stocks without having to pay for their controlled and expensive destruction in their country of origin.5 Some entities seem to find it legitimate to send unusable drugs to nations which are not prepared to dispose of them safely and properly. The recipients receive the drugs as donations and instead are obliged to manage them as waste. Lamentably, there is no international convention to regulate the transfer of non-requested pharmaceutical products and surpluses across borders. Once received into a country, the donations cannot be returned to donors, as recommended by the guidelines, because they are considered hazardous cargo and their shipment must respect the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal.6 This legal demand involves the existence of consented protocols between exporters and importers, and time-consuming procedures that severely compromise its feasibility.
Therefore, we can clearly say that drug donations are not for free and most of the time their costs to the recipient countries surpass the very fair value of the donations. If the recipients have to pay more (for something they do not need and did not ask for) than they would by just purchasing the medicines and equipment needed, then what good are the donations?
The useless medicines remaining from the process and the consequences that result from their management are self-defeating and represent a major public health problem for the local authorities. That is why the Emergency Health Kits were created by WHO in the early 1980s.7 Each kit comprises a standard set of drugs, disposable supplies and appropriate medical equipment for basic health care, and is specially conceived to quickly respond to the needs of approximately 10 000 people for 3 months. The kits are permanently stored by major relief organizations and not-for-profit suppliers and can be made available within 48 hours.8 The WHO Action Programme on Essential Drugs determined that the sustainability of the kits depends exclusively on funding by external donors.9 Therefore, cash donations are an excellent way to support relief aid and to allow the affected governments to acquire the supplies its population needs. Another advantage of cash donations is that relief organizations can save, share and distribute funds to other recipients in later crises.10 Moreover, we should keep in mind that the arrival of international assistance to disaster areas can cause socioeconomic changes such as rising inflation, making poor people even poorer and recipients dependent on more donations.11 This is why drug donations need to be better regulated, particularly in humanitarian crises.
1. Médicaments: pour acheter mieux et moins cher. Cahiers d´études et recherches francophones/Santé. WHO; 2000;10: 4.
2. Essential drugs and medicines policy: guidelines for drug donations [Interagency Guidelines]. Geneva: WHO; 1999 (WHO/EDM/PAR/99.4).
3. Étude sur les dons demédicaments dans la province d'Aceh en Indonésie: la synthèse. Pharmaciens Sans Frontières Comité International; 2005. Available from: http://www.drugdonations.org/fr/Synthese_dons_inappropries_VF2.pdf [accessed on 7 July 2008] .
4. Snell B. Inappropriate drug donations: the need for reforms. Lancet 2001;358:578-80. PMID:11520548 doi:10.1016/S0140-6736(01)05712-9
5. Berckmans P, Dawans V, Schmets G, Vanderbergh D, Autier P. Inappropriate drug-donation practices in Bosnia and Herzegovina, 1992 to 1996. N Engl J Med 1997;337:1842-5. PMID:9400045 doi:10.1056/NEJM199712183372512
6. Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal. Secretariat of the Basel Convention No.97/012.; 1998. Available from: http://www.basel.int/ [accessed on 24 June 2008] .
7. The interagency emergency health kit 2006: medicines and medical devices for 10,000 people for approximately 3 months [An interagency document]. Geneva: WHO; 2006 (WHO/PSM/PAR/2006.4).
8. Hogerzeil HV, Couper MR, Gray R. Guidelines for drug donations. BMJ 1997;314:737. PMID:9116555
9. Drug supply by ration kits: report of an evaluation. Essent Drugs Monit 1991:12-4. PMID:12284332
10. Eggertson L. Tsunami help donations worldwide. CMAJ 2006;174:299. PMID:16379011
11. Saunders P. It's time to call a halt to poor drug donation practice. 1999. Available from: http://www.drugdonations.org [accessed on 24 June 2008] .