Several respondents suggested that the minimum shelf-life required be extended to 18, 24 or even 36 months. Their main arguments were the following: the distribution channels are so slow that more time is needed; and irregular donations and drug needs are so difficult to predict that donations need to last for a long time and therefore need a long remaining shelf-life.
Several respondents advanced arguments for reducing the minimum shelf-life. The main arguments were as follows: supplies are quickly used and do not need such a long shelf-life, especially in emergency situations; expired medicines can still be used; pharmaceutical companies mainly donate drugs with a shelf-life of less than one year; and national guidelines in the donor country also allow for supplies with a minimum shelf-life of six months.
Several donors felt that the circumstances should dictate the dating - shelf-life should be determined by nature of need, distribution system, turnover, governmental restrictions, patient load, level of planning, speed of customs clearance, and other unique features. The recipient should specify the dating requirements and be held accountable.
It is clear that Article 6 is the most contentious issue of the Guidelines. From the responses and many comments received the following observations can be made.
A majority of the respondents agree with the requirement that donated drugs have a minimum shelf-life of 12 months upon arrival, and all national governments that developed their own guidelines have copied that provision. It is mainly the consolidators that have experienced problems in practice and that foresee reduced drug donations in the future.
In some cases, recipient governments have specifically decided not to allow for exceptions to the minimum shelf-life of donations. Some examples have been reported of delays in or cancellations of valuable donations which could have been used before expiry if recipient authorities had applied the exception clauses in a flexible way.
However, we should be careful not to blame the victim. Recipient governments are fully entitled to refuse certain donations on their territory if admitting them could lead to substandard therapy or double standards in quality. Relief agencies may or may not agree with a decision to refuse entry of an important drug with (sometimes slightly) less than a one-year expiry. But accepting the rule of law and the power of regulation implies accepting a government decision. And if an exception is not granted, it should perhaps be asked why it was asked for in the first place.
In this regard it would be interesting to know why some private voluntary organizations seem to continue to receive such large offers of drug donations with a shelf-life of less than one year. Have they failed to inform their donor partners, or do companies continue to donate short-dated products despite growing international resistance? However, only 21% of companies indicated that they had experienced problems with the minimum shelf-life provision.
If it is agreed that donations are a useful means of supporting health care delivery when there are chronic shortages of essential drugs, any delay in or cancellation of such donations has a negative impact on health. On the other hand, the Guidelines were specifically intended to reduce the number of donations of (nearly) expired drugs. Any report on cancellations of donations of short-dated products shows that the Guidelines have had an impact in reducing such practices. The questions remains whether short-dated donations have now been replaced with longer-dated ones.
Most of the special circumstances mentioned above are already part of the exception clause of the Guidelines. Small quantities of drugs, donated directly to health facilities where the recipient knows and agrees with the short-dated donation and can guarantee that the drugs will be used before expiry, were already foreseen in the 1996 version. The fact that there is a technical justification for an exception to a general rule, or the possibility that an unfavourable decision is taken by an uninformed civil servant or customs officer who simply follows instructions and refuses to make an exception, does not imply that the rule should be changed or scrapped. Instead, the capacity of the government to deal with such situations should be increased through information and training.