For any pharmaceutical products to be eligible for purchase with the Global Fund resources, its compliance with quality standards must be assured.

Multi-source pharmaceutical products

Multi-source pharmaceutical products are pharmaceutically equivalent products that may or may not be therapeutically equivalent. Multi-source pharmaceutical products that are therapeutically equivalent are interchangeable. Multi-source pharmaceutical products tend to be available from a wide range of manufacturers around the world. They are off-patent products with publicly available quality assurance standards including, analytic methods and reference substances for the finished dosage form; that is, for which there is monograph for finished dosage form publicly available in one or more Pharmacopoeias (e.g., British Pharmacopoeia, United States Pharmacopoeia and International Pharmacopoeia).

Quality assurance standards are publicly available for most medicines necessary in the control of tuberculosis and malaria, and to manage opportunistic infections in HIV/AIDS.

For such multi-source products, there are no additional requirements other than (as described above) that verification of compliance with quality standards must be conducted in accordance with relevant requirements of the National Drug Regulatory Authorities in the recipient’s country.

In November 2007, at its Sixteenth Board Meeting, the Global Fund Board decided that any pharmaceutical products for the treatment of AIDS, tuberculosis and malaria for which the monograph of the finished dosage has been published in International, US or British Pharmacopeia after 10 October 2002, shall be subject to the QA Policy for Single and Limited-Source Pharmaceutical Products.

Single and limited-source pharmaceutical products

In its Quality Assurance (QA) Policy, the Global Fund defines acceptable QA standards.

Compliance with the Global Fund Quality Assurance Policy

According to the QA policy, grant funds may be used to procure pharmaceutical products provided that they meet one of the following standards:

(A) such product is acceptable under the WHO Prequalification Program or;

(B) such product has been authorized for use by a stringent regulatory authority;

If there are two or more manufacturers for which Option A or B applies AND the product is available from these manufacturers (defined as the ability to supply a sufficient quantity to the country within 90 days of the date of order), then the product must be procured from this set of manufacturers.

(C) If the Principal Recipient determines that there is only one or no equivalent pharmaceutical product that meets the standards of either (A) or (B) or if the Principal Recipient determines that the products that meet these standards are unavailable (Defined as inability of the manufacturer to supply a sufficient quantity of finished product within 90 days from date of order), then Grant funds may be used to procure another equivalent pharmaceutical product, provided that such product is selected in accordance with the following, in order of priority:

Ci - The manufacturer has submitted an application for approval of such product to the WHO Prequalification Program or a stringent regulatory authority and such product is manufactured at a site that is compliant with the standards of GMP, as certified (after inspection) by the WHO or a stringent regulatory authority; or

Cii - such product is manufactured at a GMP-compliant manufacturing site, as certified (after inspection) by the WHO or a stringent regulatory authority.

A Principal Recipient shall inform the Global Fund Secretariat if it is planning to procure under provision Ci or Cii, after having followed the above process. The notification should be addressed to  the Global Fund Portfolio Manager assigned to the grant. If the Secretariat does not object, then Global Fund resources may be used to procure the products.

The Secretariat, working with technical partners, shall contract an independent third-party to conduct random quality analysis of products being procured according to these criteria to ensure their quality in the absence of the Option A or Option B standard.

In the event that (a) the submitted application for product approval is no longer under consideration; or (b) the independent third party finds the quality of the product to be unacceptable, then the Principal Recipient shall promptly terminate the contract with the supplying manufacturer.

In all cases, products purchased with Global Fund resources are subject to the monitoring product quality standards prescribed by the Fund as specified in section 6 of the Report of the Third Board Meeting.

Procurement of products according to criteria Ci or Cii should be time limited and Principal Recipients should defer to Option A or B as soon as possible.

Please note that for the purpose of this policy a tentative product approval from the Food and Drug Administration (FDA) is considered as an Option B product that is approved by a stringent regulatory authority.

For your reference several documents are attached in order to facilitate a full understanding of the policy and its application. Special focus should be given to the power-point presentation called Explanation of the application of the C Option which will help you to understand the decision more easily. Lists of products and manufacturers classified according to The Global Fund Quality Assurance Policy is a valuable tool for those conducting procurement using Global Fund resources, as it may complement other types of information that the countries may collect.