Interagency Guidelines on Drug Donations

Canadians have long been involved in supporting international development efforts. The general public in developed countries often view drug donations to developing countries as part of international assistance for development or, in times of emergency, as a helpful way to provide much-needed supplies. Particularly in situations where the absence of pharmaceutical products is a pressing problem, the donation of medicines can be seen as a pragmatic and direct response.

The donation of medicines, however, can be a complex issue. Medicines are an essential element in alleviating suffering. Development and relief efforts can greatly benefit from donations of appropriate drugs when they are delivered within a coordinated framework. The challenge is to ensure that such donations are effective and support sustainable development objectives. Where drugs are not appropriately delivered, there is a potential for drug donations to cause more harm than good. Examples of drug donations that may cause problems include: if donated drugs are unknown to local health professionals and patients, they may be dangerously administered; donated drugs may arrive unsorted and labeled in an inappropriate language; the quality of the drugs does not always comply with standards in the donor country, for example, the drugs may have expired before reaching the patient; or drugs may be donated in the wrong quantities, leading to waste and creating problems of disposal at the receiving end. Drug donations may also have a negative impact on existing markets, leading to future supply problems for the country.

As a direct result of some of the problems that have arisen through inappropriate drug donations, an interagency group was formed to develop guidelines outlining best practices in the area of drug donations. The interagency Guidelines for Drug Donations, issued by the World Health Organization (also known as the WHO Guidelines), are the result of that broad interagency collaboration. The WHO Guidelines subscribe to the principles that donations should provide maximum benefit to the recipient, donations should respect the wishes and authority of the recipient, there should be no double standards in quality; and there should be effective communication between donor and recipient. Supporting these 4 core principles for pharmaceutical donations are 12 articles. (See the table below outlining the 12 articles and rationale of the WHO Guidelines.)

Substance of the WHO Guidelines

The WHO Guidelines recognize the inherent distinction between drug donations offered in times of humanitarian emergencies versus those designed to contribute to development aid, but hold that there are basic rules for drug donations that apply in all scenarios, though the risk of non-compliance is higher in humanitarian response interventions because of the emergency nature of these situations. The WHO Guidelines are based on 4 core principles for pharmaceutical donations supported by 12 articles.

Principle 1:

The first and paramount principle is that a drug donation should benefit the recipient to the maximum extent possible. This implies that all donations should be based on an expressed need and that unsolicited drug donations are to be discouraged.

Principle 2:

The second principle is that a donation should be made with full respect for the wishes and authority of the recipient, and be supportive of existing government health policies and administrative arrangements.

Principle 3:

The third principle is that 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.

Principle 4:

The fourth principle is that there should be effective communication between the donor and the recipient: donations should be based on an expressed need, and should not be sent unannounced.

The 12 articles of the WHO Guidelines expanding on these principles are as follows:*

Guideline article	Intent
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.	This provision stresses the point that it is the prime responsibility of the recipients to specify their needs. It is intended to prevent unsolicited donations and donations which arrive unannounced and unwanted. It also empowers the recipients to refuse unwanted gifts.
2. 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.	This provision is intended to ensure that drug donations comply with national drug policies and essential drugs programs. It aims at maximizing the positive impact of the donation, and prevents the donation of drugs which are unnecessary and/or unknown in the recipient country.
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.	Most staff working at different health care levels in the recipient country have been trained to use a certain formulation and dosage schedule, and cannot constantly change their treatment practices. Moreover, they often have insufficient training in performing the necessary dosage calculations required for such changes.
4. All donated drugs should be obtained from a reliable source and comply with quality standards in both donor and recipient countries. The WHO Certification Scheme on Quality of Pharmaceutical Products Moving in International Commerce should be used.	This provision prevents double standards: drugs of unacceptable quality in the donor country should not be donated to other countries. Donated drugs should be authorized for sale in the country of origin, and manufactured in accordance with international standards of Good Manufacturing Practice (GMP).
5. No drugs should be donated that have been issued to patients and then returned to a pharmacy or elsewhere, or have been given to health professionals as free samples.	Patients return unused drugs to a pharmacy to ensure their safe disposal; the same applies to drug samples that have been received by health workers. In most countries it is not allowed to issue such drugs to other patients, because their quality cannot be guaranteed. For this reason returned drugs should not be donated either. In addition to quality issues, returned drugs are very difficult to manage at the receiving end because of broken packages and the small quantities involved.
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.	In many recipient countries, and especially under emergency situations, there are logistical problems. Very often the regular drug distribution system has limited possibilities for immediate distribution. Regular distribution through different storage levels (e.g. central store, provincial store, district hospital) may take six to nine months. This provision especially prevents the donation of drugs just before their expiry, as in most cases such drugs would only reach the patient after expiry . It is important that the recipient official responsible for acceptance of the donation is fully aware of the quantities of drugs being donated, as overstocking may lead to wastage. The argument that short-dated products can be donated in the case of acute emergencies, because they will be used rapidly, is incorrect. In emergency situations the systems for reception, storage, and distribution of drugs are very often disrupted and overloaded, and many donated drugs tend to accumulate.
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 Nonproprietary Name (INN) or generic name, batch number, dosage form, strength, name of manufacturer, quantity in the container, storage conditions, and expiry date.	All donated drugs, including those under brand name, should be labelled also with their INN or the official generic name. Most training programs are based on the use of generic names. Receiving drugs under different and often unknown brand names and without the INN is confusing for health workers and can even be dangerous for patients. In the case of injections, the route of administration should be indicated.
8. As much as possible, donated drugs should be presented in larger quantity units and in hospital packs.	Large quantity packs are cheaper, less bulky to transport and conform better with public sector supply systems in most developing countries. This provision also prevents the donation of drugs in sample packages, which are impractical to manage. In precarious situations, the donations of pediatric syrups and mixtures may be inappropriate because of logistical problems and their potential misuse.
9. All drug donations should be packed in accordance with international shipping regulations, and be accompanied by a detailed packing list that 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.	This provision is intended to facilitate the administration, storage, and distribution of donations in emergency situations, as the identification and management of unmarked boxes with mixed drugs is very time- and labour-intensive. This provision specifically discourages donations of small quantities of mixed drugs. The maximum weight of 50 kilograms ensures that each carton can be handled without special equipment.
10. Recipients should be informed of all donations that are being considered, prepared, or actually under way.	Many drug donations arrive unannounced. Detailed advance information on all drug donations is essential to enable the recipient to plan for the receipt of the donation and to coordinate the donation with other sources of supply. The information should at least include the type and quantities of donated drugs including their International Nonproprietary Name (INN) or generic name, strength, dosage form, manufacturer and expiry date; reference to earlier correspondence (for example, the letter of consent by the recipient); the expected date of arrival and port of entry; and the identity and contact address of the donor.
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 that information is not available, on the wholesale world-market price for its generic equivalent.	This provision is needed solely to prevent drug donations being valued in the recipient country according to the retail price of the product in the donor country. This may lead to elevated overhead costs for import tax, port clearance, and handling in the recipient country. It may also result in a corresponding decrease in the public sector drug budget in the recipient country.
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.	This provision prevents the recipient from being forced to spend effort and money on the clearance and transport of unannounced consignments of unwanted items, and also enables the recipient to review the list of donated items at an early stage.

* From the Interagency Guidelines for Drug Donations (PDF - 72 KB, 24 pages) issued by the WHO, page 7-10.

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