²³ This special pricing agreement to procure artemether/lumefan-trine (Coartem^®) has been extended to UNICEF in 2004.

How to place an order for Coartem® through WHO or UNICEF

What to bear in mind prior to placing an order:

1. National approvals

The product must either be registered for use in the country by the appropriate regulatory authority or have a legally acceptable exemption allowing its use in specific circumstances pending regulatory review of the product.

The use of the product should be consistent with changes, or foreseen changes, in pertinent treatment guidelines and/or drug formularies that guide the use of antimalarial medicines in the country.

Non-governmental and bilateral or multilateral agency purchasers must obtain written approval from the Ministry of Health (MoH) of the disease endemic developing country ascertaining that the MoH is in agreement with the planned purchase and use of the drug.

2. WHO procurement procedures (and applicable fees)

WHO shall procure the drug on behalf of disease endemic developing countries, recognized non-governmental organizations and bilateral and multilateral agencies, working by permission of, or in association with, such countries, using the following “reimbursable” procurement system:

- Before WHO makes commitment on behalf of a requesting authority or organization, funds equal to the total cost as estimated by WHO shall be deposited in US dollars or Swiss francs or other freely convertible currencies, to the credit of WHO either by cheque or bank transfer payable unconditionally to WHO at sight.

- If the amount reimbursed to WHO is in a currency other than US dollar the requesting authority will be liable to reimburse WHO for the amount of any foreign exchange loss due to exchange rate movements occurring between the date of payment by WHO and the date of re-imbursement to WHO.

- A charge of three per cent shall be levied by WHO from the public sector agency involved and shall be applied on the net cost of items of purchase. Under certain specific circumstances, i.e. in case of epidemics/emergency situations, this charge may be waived. Charges to other UN organizations are determined by independent agreements made by WHO with these organizations.

- Partial shipment may be made, and upon completion of the transaction, WHO shall send to the purchaser a statement of account with the supporting documents. The requesting authority may ask for a statement of account at the end of the transaction and require that any uncommitted balances of the advance made, be refunded to it.

- Any discount or other saving shall be passed on to the requesting authority concerned.

- Once the request for supplies has been approved, the requesting authority shall be responsible for ensuring that import permits (if required) are granted.

- The forwarding agent indicated in the purchase order shall dispatch the supplies to the WHO Offices in countries or to other UN agencies as the case may be.

- Further information can be obtained from WHO Supply (PRS), Avenue Appia 20, 1211 Geneva 27, Switzerland, telephone +41 22 791 2187 or 791 1254, or fax +41 22 791 4196.

- For procurement through UNICEF Supply Division, further information can be obtained by contacting the Pharmaceuticals & Micronutrients Team, UNICEF Supply Division, UNICEF plads, Freeport, 2100 Copenhagen, Denmark, telephone +45 3527 3527 or fax: +45 3526 9421

3. Package presentations and cost

Coartem^® packs especially designed for use in the public sector are available as of the second quarter of 2002.

4. Minimum order size per destination

The minimum size per order and per destination is 108 boxes of 30 treatment packs, corresponding to 3,240 individual treatment courses. This minimum lot size applies to each of the four «public sector» presentations described above, under paragraph 3. This implies that purchase orders should be made by multiples of 3,240 individual treatment courses for each of the individual weight-specific treatment packs.

On a case-by-case basis, WHO can provide assistance in the purchase of smaller amounts needed for implementation of clinical trials.

5. Shelf life and lead time

The company has placed considerable effort in ensuring that the product has a maximal shelf life. Notwithstanding these efforts, artemether-lumefantrine has a relatively limited shelf life of 24 months which dictates that the supply chain must be as efficient as possible to avoid stock outs, waste or improper use.

The company requires a minimum period of four months from the time it receives an order from WHO or UNICEF to when it ships product. In addition to this time, requesting parties should add a minimum of one month from the initial receipt of the funds by WHO or UNICEF to the placement of the order with the company.

Hence, for routine use, a request for purchase of the drug should be made at least 6 months prior to the time that the product is required at the port of entry within the country. To determine the proper time for purchase, the requesting agencies must also add the time needed for distribution within the country to the territories/areas where the drug is intended to be used.

For emergency use, it is recognized that these lead times are too long. Expedited procedures for review of requests have therefore been put into place. In addition, WHO and UNICEF are trying to raise the funds necessary to establish an emergency stock of the drug intended for situations where rapid availability of product is crucial.

6. Conditions for access to the ‘public sector’ price and continued use of WHO/UNICEF procurement services

All disease endemic developing countries, non-governmental organizations or other agencies potentially interested in obtaining artemether-lumefantrine through WHO/UNICEF should express this interest to WHO/UNICEF (even prior to the time that an actual purchase is planned) and agree to collaborate in providing regular and frequent forecasts of potential purchases.

In addition, according to the terms of the Agreement between the company and WHO/UNICEF, governments procuring the drug shall:

- Justify the use of the drug based on a report of the relevant malaria situation, control activities, and treatment guidelines;

- As appropriate, revise malaria treatment guidelines to include artemether-lumefantrine and other antimalarial drugs according to WHO-recommended drug regimens;

- Support the introduction of artemether-lumefantrine as first- or second-line antimalarial treatment with appropriate training of health professionals and consumer education;

- Provide assurances that the supplies will not be diverted from their agreed use;

- Take all possible steps to prevent parallel exportation of the product;

- Not unduly increase the price to the end-user due to tariffs, duties and taxes;

- Apply due diligence in onward distribution of supplies to the treatment points and in strengthening weak links in the national drug management and distribution systems; and

- Provide reports on the supply situation prior to new requests of the drug.

What to submit, to whom, and how

A Request to Purchase form that is to be submitted with each request is available on the Web http://www.rbm.who.int or http://www.unicef.org/supply, or can be obtained from either WHO Roll Back Malaria Department(WHO/RBM), telephone: +41 22 791 3720, fax: +41 22 791 4824 or UNICEF Supply Division, telephone: +45 3527 35 27, fax: +45 3526 9421.

This form should be filled completely and completion to include all appropriate signatures. Incomplete forms will returned for further information/completion and may result in undesirable delays. Should assistance or more information be required regarding the form, please contact: WHO/RBM, telephone +41 22 791 3720, fax +41 22 791 4824 or UNICEF Supply Division, telephone: +45 3527 35 27, fax: +45 3526 9421.

As official signatures are required, this form should be mailed as a hardcopy to corresponding the procuring agency, either WHO Roll Back Malaria Department, Avenue Appia 20, 1211 Geneva 27, Switzerland. To expedite review for routine procurements and in all emergency situations this form should also be faxed to WHO/RBM at the number: +41 22 791 4824; or UNICEF Supply Division, UNICEF plads, Freeport, 2100 Copenhagen, Denmark. To expedite review for routine procurements and in all emergency situations this form can also be faxed to UNICEF Supply Division at the number: +45 3526 9421.

The completed form will be reviewed by the WHO appointed group of experts who will issue a recommendation to WHO/UNICEF within 7 working days for routine use and within 24 hours for emergency use. WHO will make a final decision regarding the request, and following administrative procedures, forward it for action to WHO or UNICEF Procurement Services who will place the order with the company.

Those parties who wish to know the status of their request or orders at any time after submission can contact WHO/ RBM, telephone +41 22 791 3720, fax +41 22 791 4824 or UNICEF Supply Division, telephone: +45 3527 35 27, fax: +45 3526 9421.

For more information see: http://mosquito.who.int/cmc_upload/0/000/015/789/CoA_website5.pdf