The World Bank has come out with a comprehensive antiretroviral (ARV) procurement manual to address the specific requirements and unique features of the medicines and supplies that are part of the HIV/AIDS Care Package. The bank has given prominence to procuring generics whenever possible, and has also compiled detailed information on intellectual property rights (including information how/when to use compulsory licensing and/or parallel importation) for countries and companies that need an update on their rights under TRIPS.
The "Technical Guide for HIV/AIDS Medicines and Related Supplies: Contemporary Context and Procurement, February 2004," complements the Technical Note - Procurement of Health Sector Goods, May 2000, Revised February 2001, March 2002 and March 2003. The guide endorses the use of fixed dose combination medicines including generic FDC ARVS. It gives a detailed interpretation of Article. 39.3 of the TRIPS Agreement that permits a drug regulatory authority to establish bio-equivalence and to approve a generic medicine for marketing even when that authority uses a drug company's otherwise confidential data for purposes of comparison.
The guide recommends the countries to go for fast-track regulatory approval of WHO pre-qualified medicines. "In most cases, it is strongly recommended to purchase products already prequalified by the WHO-initiated project." It has said.
Another major highlight of the technical guide, which is to be the guide book for World Bank staffers, is the non preference for locally produced products - "Bidders supplying product manufactured locally must demonstrate that the quality of the local production meets WHO equivalent standards and their prices are competitive with international prices."
The guide contains tips on procurement processes such as tendering, pooled procurement and assistance for procurement. Suggestions on how to obtain lower drug prices and how to calculate the cost of an ARV programme are given. The guide also contains information on purchasing diagnostics, including HIV testing kits.
The guide is targeted at people responsible for making procurement decisions. The World Bank guidelines are in all material respects similar to those of the Global Fund. In contrast, they differ sharply from the US PEPFAR bilateral initiative which does not endorse FDC ARVs and WHO pre-qualification.