Background

In June 2001, the Bank’s Board of Executive Directors approved the first Bank-financed project to allow for provision of anti-retroviral drugs through the Caribbean Multi-country AIDS Program, specifically for provision through the Barbados national program. In February 2002, the Board endorsed the Africa Region’s Multi-country HIV/AIDS Program 2 (MAP2) allowing countries to purchase anti-retroviral drugs (ARVs) on a pilot basis. Initiatives to expand the provision of treatment, care and support must be embedded within health systems with the necessary infrastructure and adequately trained staff to assure their safe and effective delivery. There are clearly a range of technical and quality assurance issues that need to be addressed as these initiatives unfold. Likewise, there is a need for these initiatives to be consistent with international law and agreements and to respect intellectual property rights (IPR). In this regard, the adoption of the Doha Ministerial Declaration on the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and Public Health allows many developing and least-developed WTO member countries flexibility in addressing public health emergencies, including HIV-AIDS. It reaffirms the right of countries to declare national emergencies and issue compulsory licenses. Least-developed countries can extend implementation of patent laws and defer enforcement of patents already granted. Countries that are not members of WTO and have no domestic legislation or patent for drugs can either produce or import the drugs; while the countries that are not members of WTO with domestic legislation for drugs must follow the domestic legislation.

Purpose of this Note

The objective of this note is to provide guidance on the options available to project teams regarding procurement of HIV-AIDS related medicines, in particular, the methods that can be used to improve and accelerate access.

Procurement and Supply Management Issues

There are multiple stages in the pharmaceutical supply cycle, of which procurement is only one. The selection and quantification of the drugs occurs before any procurement is begun. WHO has already developed treatment guidelines for the selection and prequalification of anti-retroviral drugs and countries are encouraged to use these guidelines. WHO and other partner agencies have established a Pilot Procurement, Quality and Sourcing Project. The project has already compiled a list of prequalified products. The prequalification process is ongoing and free. Any supplier can contact WHO for review of their products to enter the prequalified list. The list can be obtained at: http://www.who.int/medicines/organization/qsm/activities/pilotproc/pilotproc.shtml.

Countries are advised to advertise a procurement notice to inform manufacturers and suppliers and to give opportunity to those that are not included in the prequalification list of WHO to apply. Procurement should be conducted among the group of prequalified suppliers to allow access to quality-assured medicines in an expedited fashion. For medicines under patent, direct contracting (sole-sourcing) from originators (research-based industry) on the basis of price negotiations can be used. Some of these originators are currently offering the ARVs at discounted prices through the Access Initiative to HIV Care, Support and Treatment, cosponsored by the UN and five pharmaceutical companies. Where the borrower lacks the capacity to conduct the procurement process, a specialized international procurement agent can be hired in accordance with Bank guidelines. Other options include purchasing from WHO or a UN agency as supplier, use of private or nonprofit specialized international supply agencies, and joint procurement arrangements with local NGOs with proven capacity. The Bank is satisfied with the capacity of WHO and UNICEF to undertake procurement of HIV-AIDS-related medicines. Engagement of other private or not-for-profit specialized supply agencies or NGOs must be subject to satisfactory results of an assessment of the agencies to carry out procurement and other key functions of the supply chain. The Bank should conduct an assessment at the time these agencies are identified by the project teams.

For new operations, the procurement arrangements should be included in the Project Appraisal Document (PAD) during project preparation. For on-going operations, procurement arrangements can be modified through the issuance of a loan amendment signed by a Director, cleared by Legal Department, and the Regional Procurement Adviser.

OPCPR jointly with the Global HIV-AIDS Program and Aids Campaign Team for Africa (ACTafrica) will prepare a more comprehensive Technical Guide intended to provide assistance to project teams and clients on the subject of procurement of HIV-AIDs commodities at the national level. We expect the completion of the initial draft by the end of the first quarter of 2003. For additional information please contact Yolanda Tayler.

Procurement Policy and Services Group
OPCPR