Many essential reproductive health (RH) medicines and devices are off-patent and are being manufactured by suppliers throughout the world. These suppliers, including manufacturers of lower-priced generic versions of originator brand medicines, have an important role to play in meeting the need for RH supplies. Low- and middle-income (LMI) countries that procure RH supplies—particularly within their public sector programmes—also assume responsibility for ensuring product quality, even in the absence of robust regulatory authorities.

The World Health Organization (WHO) Prequalification Programme and its role in assuring quality

The Prequalification Programme was set up in 2001 by WHO to facilitate access to medicines (for HIV, AIDS, malaria and tuberculosis) that meet unified standards of quality, safety, and efficacy. From the outset, the project has been supported by the Joint United Nations Programme on HIV/AIDS (UNAIDS), the United Nations Children's Fund (UNICEF), the United Nations Population Fund (UNFPA), and the World Bank to contribute to the United Nations (UN) priority goal of addressing widespread diseases in countries with limited access to quality medicines. The list of prequalified products is used primarily by UN agencies to guide their procurement decisions. However, the list has become a vital tool for any agency or organization involved in bulk purchasing of medicines at the country or global level.

WHO's Prequalification Programme is supporting the improvement in manufacturing capacity by prequalifying products that have been assessed, inspected, and controlled to meet international norms and standards for quality, efficacy, and safety; by giving assurance that international norms and standards are applied to all the steps of the prequalification and to the process itself; and by enabling access to good quality medicines.

The WHO Programme, together with UNFPA, has recently begun to prequalify contraceptive products and is expanding into other medicines for RH. Click here to see more information on WHO's Prequalification Programme.

How the Coalition is putting Prequalification of RH medicines on the map

• The Coalition and its partners were involved in the formulation of the Interagency List of Essential Medicines for Reproductive Health (2006), the WHO Model List of Essential Medicines, and the Essential Medicines for Reproductive Health: Guiding Principles for their Inclusion on National Medicines Lists. Inclusion of a medicine on these lists is a prerequisite to review under the WHO prequalification process (click here for more information on this). 
• The Coalition reached consensus at its Bonn membership meeting in October 2006 on the principle to procure only products that have either been prequalified by WHO or approved by a stringent regulatory drug agency.
• Via its membership meetings, communication activities, and regular correspondence, the Coalition provides regular updates on the prequalification of RH medicines. For example, an update was given at the Coalition's London membership meeting in April 2007. 
• Coalition members WHO, UNFPA, and PATH collaborated on two regional workshops to acquaint national procurement and regulatory officials with the WHO Prequalification Programme. PATH, WHO, and UNFPA are also leading three workshops on prequalification aimed at condom manufacturers in 2008 and will hold a workshop for large-scale procurers and donors at the Coalition membership meeting in May 2008. The workshops are supported through a grant to PATH from the Bill & Melinda Gates Foundation.