[e-drug] Global Fund changes quality assurance rules

["E-Drug" <e-drug@healthnet.org>]

E-DRUG: Global Fund changes quality assurance rules
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[The Board meeting of Global Fund slightly changed the rules for quality assurance; this became necessary as national DRA decisions of "non-stringent" countries were supposed to have phased out as per end 2004. Comments from users in the field? WB]


Decision of the Board of the Global Fund to Fight AIDS, Tuberculosis and Malaria.

Tenth Board Meeting, Geneva, April 21st-22nd 2005.

Quality Assurance of Limited and Single Source Pharmaceutical Products

Decision Point:

The Board decides to change its policy on quality assurance approved at the Third Board Meeting on "option (c)" by replacing the decision on Agenda Item 10(B)(4)(b)(c) with the following and eliminating the last sentence of the "option (c)" time limit:

'	Once there are two or more equivalent pharmaceutical products that meet the standards in Option (a) or Option (b), the Option (c) is not applicable. Contracts entered into on or before April 30th, 2005 with suppliers for products that qualified for purchase under Option (c) may be honoured by the Principal Recipient until they expire. No new purchase contracts or contract extensions for such products will be allowed after April 30th, 2005.

'	If the Principal Recipient determines that there is only one or no equivalent pharmaceutical product that meets the standards of Option (a) or Option (b) OR if the Principal Recipient determines that the products that meet these standards are unavailable  and represents the same to the Global Fund Secretariat, and the Secretariat does not object, then Global Fund resources may be used to procure other equivalent pharmaceutical products, provided that the products are selected in accordance with the following, in order of priority:
i.	the manufacturer who has submitted an application for product approval to the WHO Prequalification Program or a stringent regulatory authority AND is manufactured at a site that is compliant with standards of Good Manufacturing Practice (GMP), as certified after inspection by the WHO or a stringent regulatory authority;
ii.	the 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 procures under provisions (i) and (ii), after having followed the above process. In turn, 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) and Option (b) standard.

In the event that (a) the submitted application for product approval is no longer under considerations; 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 (i) and (ii) should be time limited and Principal Recipients should defer to Options (a) or (b) as soon as possible.

The Secretariat will monitor implementation of this decision and report to the Board at the Fourteenth Board Meeting.

The budgetary implications are in the amount of up to $450,000 per year for possible staffing and contracting costs associated with implementation of the decisions above. The accuracy of this estimate and the need for additional funds beyond the approved total 2005 budget will be reviewed by the Finance and Audit Committee at its next meeting.

 
Appendix 2: Countries considered to have stringent National Drug Regulatory Authorities

For the purposes of the Procurement and Supply Management policy of the Global Fund, a "stringent drug regulatory authority" is defined as a regulatory authority in one of the 28 countries that is either a PIC/S member and/or ICH member.

Pharmaceutical Inspection Cooperation Scheme (PIC/S) participating regulatory authorities
Australia	Greece	Portugal
Austria	Hungary	Romania
Belgium	Iceland	Slovak Republic
Canada	Ireland	Spain
Czech Republic	Italy	Sweden
Denmark	Liechtenstein	Switzerland
Finland	Malaysia	United Kingdom
France	Netherlands	United States
Germany	Norway	

International Conference on Harmonization (ICH) participating regulatory authorities
European Union	Japan	United States