4 Getting Antiretrovirals to Where They’re Needed Julian Fleet UNAIDS, Geneva, Switzerland

With some 8,000 AIDS deaths daily, lack of HIV treatment in developing countries remains a global public health emergency. The WHO and UNAIDS estimate that, of the nearly six million people in need in these countries, only 700,000 were on antiretroviral therapy (ART) at the end of 2004.  While nine out of ten people in need still cannot obtain ART, the conditions for expanding access in developing countries have improved significantly recently.  Governments and civil society in many countries, supported by the international community, today are on the verge of expanding access to HIV treatment on a mass scale. 

Pilot ART projects by NGOs, government authorities and international organizations have been the major source of access to ART in poor communities until recently.  These small programmes yielded insights into technical and management challenges and cast light on the obstacles to wider access to HIV medicines and care.  A number of these barriers are now being addressed sufficiently to set the stage for a major expansion in ART access.  Treatment advocacy by people living with HIV, their allies in civil society, clinicians and other health practitioners, and international initiatives such as three by five and PEPFAR have contributed to unprecedented political commitment to treatment access within developing countries.

A critically important challenge is the affordability of quality HIV medicines and diagnostics in many developing countries.  Since 2000, the prices of some WHO-recommended first-line ART combinations have decreased by more than 95%.  Strategies to promote greater affordability of HIV medicines have included treatment advocacy, generic competition, differential pricing by research-based companies, voluntary licensing and utilization of the flexibilities in international trade rules. While current prices of branded and generic medicines remain higher than local purchasing power in developing countries, substantially lower prices have undoubtedly been a factor in helping to secure the unprecedented financial resources becoming available for treatment access.

The World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) sets minimum international norms patent protection and offers national authorities considerable flexibility in allowing the manufacture, sale, import and export of generic versions of patented products through compulsory licensing.  The Doha Declaration provides further flexibility for countries to use generic medicines.   Both the Global Fund and the World Bank encourage the use of international trade rules to obtain quality medicines at affordable prices.  A recent US Government Accountability Office report noted that PEPFAR procurement of lower-priced generics is limited and that the price differences could translate into hundreds of millions of dollars of additional expense over the coming years.   

Access to antiretrovirals in developing countries can be strengthened through greater efforts by pharmaceutical companies – both research-based and generic – to register their products for marketing approval with national drug regulatory authorities in developing countries.  The WHO prequalification project provides an assessment of the quality which can serve as a reference point for national drug regulatory authorities in developing countries and which, in turn, can help expedite national marketing approval of quality HIV-related medicines.

Despite these important advances toward scaling up ART in developing countries, formidable barriers remain.  These include the need for stronger health systems and for far greater numbers of health care and social service workers who can provide HIV testing and counseling, diagnose, prescribe and monitor ART, and provide nutritional support and other care to those in need in developing countries.