World Health Organisation Guidelines on Drug Donations

The full WHO Guidelines on Drug Donations (reference WHO/EDM/PAR/99.4) may be found on the WHO website.

The Guidelines state that:

1. All drug donations should be based on an expressed need and be relevant to the disease pattern in the recipient country. Drugs should not be sent without prior consent by the recipient.
2. All donated drugs or their generic equivalents should be approved for use in the recipient country and appear on the national list of essential drugs, or, if a national list is not available, on the WHO Model List of Essential Drugs, unless specifically requested otherwise by the recipient.
3. The presentation, strength and formulation of donated drugs should, as much as possible, be similar to those of drugs commonly used in the recipient country.
4. All donated drugs should be obtained from a reliable source and comply with quality standard in both donor and recipient country. The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce should be used.
5. No drugs should be donated that have been issued to patients and then returned to a pharmacy or elsewhere, or were given to health professionals as free samples.
6. After arrival in the recipient country all donated drugs should have a remaining shelf life of at least one year. An exception may be made for direct donations to specific health facilities, provided that: the responsible professional at the receiving end acknowledges that (s)he is aware of the shelf-life; and that the quantity and remaining shelf-life allow for proper administration prior to expiration. In all cases it is important that the date of arrival and the expiry dates of the drugs be communicated to the recipient well in advance.
7. All drugs should be labelled in a language that is easily understood by health professionals in the recipient country; the label on each individual container should at least contain the International Non proprietary Name (INN) or generic name, batch number, dosage form, strength, name of manufacturer, quantity in the container, storage conditions and expiry date.
8. As much as possible, donated drugs should be presented in larger quantity units and hospital packs.
9. All drug donations should be packed in accordance with international shipping regulations, and be accompanied by a detailed packing list which specifies the contents of each numbered carton by INN, dosage form, quantity, batch number, expiry date, volume, weight and any special storage conditions. The weight per carton should not exceed 50 kilograms. Drugs should not be mixed with other supplies in the same carton.
10. Recipients should be informed of all drug donations that are being considered, prepared or actually under way.
11. In the recipient country the declared value of a drug donation should be based upon the wholesale price of its generic equivalent in the recipient country, or, if such information is not available, on the wholesale world-market price for its generic equivalent.
12. Costs of international and local transport, warehousing, port clearance and appropriate storage and handling should be paid by the donor agency, unless specifically agreed otherwise with the recipient in advance.