Model guidelines were prepared to enable adequate procurement of controlled substances in disaster relief. The procedures would allow suppliers to ship controlled medicines internationally in emergency situations at the request of recognized agencies providing humanitarian assistance without prior export/import authorizations. The defined procedures are acceptable to the control authorities and the INCB.
The INCB has advised control authorities that emergency humanitarian deliveries are considered as being consumed in the exporting country. This makes that no additional estimate has to be sent by the authorities of the receiving country. (As the sent amounts are usually relatively small in comparison to the domestic use of the sending country, in most cases the existing estimation is large enough to comprise the amount sent, and hence, the sending country has no additional estimations to submit to the INCB either.)
The INCB recommends to limit control obligations in emergency situations to the authorities of exporting countries.57
57 This principle was endorsed by the UN Commission on Narcotic Drugs in 1995, and was further reinforced by its resolution entitled "Timely provision of controlled medicines for emergency care" adopted at the 39th session in 1996. This and a similar resolution adopted by the 49th session of the World Health Assembly requested WHO to prepare model guidelines to assist national authorities with simplified regulatory procedures for this purpose, in consultation with the relevant UN bodies and interested governments. (Model Guidelines for the International Provision of Controlled Medicines for Emergency Medical Care, WHO/PSA/96.17).
Who should do what?
The operator58 should make a written request for emergency supplies of controlled substances to the supplier59, using the attached model form. The operator is responsible for:
♦ selection of suppliers;60
♦ information provided on the form;
♦ actual handling of controlled medicines at the receiving end or adequate delivery to the reliable recipient;
♦ reporting to the control authorities of the receiving country (whenever they are available) as soon as possible;
♦ reporting to the control authorities of the receiving country on unused quantities, if any, when the operator is the end-user or to arrange for the end-user to do so;
♦ reporting to the control authorities of the exporting country through the supplier, with copy to the INCB, any problems encountered in the working of emergency deliveries.
58 Operators: organizations engaged in the provision of humanitarian assistance in health matters recognized by the control authorities of exporting countries.
59 Suppliers: supplier of medicines for humanitarian assistance at the request of an operator (either a separate entity or a department of an operator).
60 Suppliers should be limited to those recognized by the control authorities of exporting countries. They should at least have: adequate experience as a supplier of good quality emergency medical supplies; managerial capability to assess the appropriateness of requests for the simplified procedure from operators; adequate level of stock and a responsible pharmacist; sufficient knowledge about the relevant international conventions; standard agreement with the control authorities of exporting countries (see attached document with outlines for the agreement).
Before responding to the request from the operator, the supplier should be convinced that the nature of the emergency justifies the application of the simplified procedure without export/import authorizations. The supplier is also responsible for:
♦ submitting immediately a copy of the shipment request to the control authorities of the exporting country;
♦ submitting an annual report on emergency deliveries and quantities of medicines involved as well as their destinations, with copy to the INCB;
♦ reporting to the control authorities of the exporting country, with copy to the INCB, any problems encountered in the working of emergency deliveries.
The control authorities of the exporting country should inform their counterpart in the receiving country (whenever they are available) of the emergency deliveries.
The control authorities of the receiving country have the right to refuse the importation of such deliveries.