Regulatory Issues
WHO Guidelines for Drug Donations
Web site: July 1998, updated February 2000
The World Health Organisation has developed guidelines (revised in 1999) to improve the quality of drug donations around the world. Donations should maximally benefit the recipient and be based on expressed need - not just sent. Donations should be made respecting the recipient government’s health policies. If a medicine is of unacceptable quality for use in New Zealand it should not be donated.
The World Health Organisation (WHO) says many donated drugs are often not relevant for the emergency situation, the disease, or level of care available. They are often unknown by local health professionals and may not comply with locally agreed medicine policies. Some may even be dangerous.
A WHO audit of humanitarian drug donations received in Albania during May 1999 revealed serious quality problems. It was estimated that 50% of the drugs coming into Albania during the Kosovo refugee crisis were inappropriate or useless and would have to be destroyed. 65% of the drugs had an inadequate expiry date (either missing or expiring < 1 year from the date of donation): and 32% were identified only by brand names, which were unfamiliar to Albanian health professionals. None of the short shelf-life donations were requested, and according to aid workers they could not be distributed and used before the end of the year.
Between 1992 and mid-1996, an estimated 17,000 metric tons of inappropriate donations were received in Bosnia and Herzegovina. The estimated disposal cost was US$34 million.
Core principles for a donation
- Maximum benefit to the recipient
- Respect for wishes and authority of the recipient
- No double standards in quality
- Effective communication between donor and recipient
WHO guidelines
- 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.
- 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.
- the presentation, strength and formulation of donated drugs should, as much as possible, be similar to those of drugs used in the recipient country.
- all donated drugs should be obtained from a reliable source and comply with quality standards in both donor and recipient country. The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce should be used (Included in: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Geneva: World Health Organization; 1992. Technical Report Series No. 823)
- 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.
- 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.
- 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 Nonproprietary Name (INN) or generic name, batch number, dosage form, strength, name of manufacturer, quantity in container, storage conditions and expiry date.
- as much as possible, donated drugs should be presented in larger quantity units and hospital packs.
- 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 50kg and drugs should not be mixed with other supplies in the same carton.
- recipients should be informed of all drug donations that are being considered, prepared or actually underway.
- in the recipient country the declared value of a drug donation should be based upon wholesale price of its generic equivalent in the recipient country, or, if such information is not available, on the wholesale world-wide price for its generic equivalent.
- 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.
To obtain a copy of these guidelines contact your local Regional Medicines Control Office.