Chronic conditions such as diabetes, cancers and heart disease are gradually displacing infectious diseases as the greatest health problem in lower-income countries. The long-term nature of these diseases, combined with ageing populations, will pose enormous problems for overstretched state health systems.
In responding to this challenge, there is some indication that governments may copy some of the policies which have informed the response to HIV/AIDS, including taking steps to reduce the cost of producing drugs. This paper is an attempt to see what lessons for the production of medicines for chronic disease can be drawn from the international response to HIV/AIDS.
To date, the international community has centred its response to HIV on increasing the availability and uptake of generic ARVs, particularly by encouraging manufacturers in lower-income countries. This has taken place through a mixture of voluntary licenses, compulsory licenses and unlicensed manufacture of copies of patented drugs by companies in India and certain African countries. Meanwhile, innovator companies have pursued “tiered pricing” strategies, which involve selling their patented ARVs at a discounted price in lower-income countries.
In principle, generic medicines make valid alternatives to innovator drugs providing they are bioequivalent, safe and efficacious. Many of the major government-backed procurement programmes and their advisors in the World Health Organization, however, have judged that the need to rapidly expand ARV coverage outweighs the need to rigorously test and certify all generics. Also, many of the generic ARVs being manufactured in India and certain African countries have not received any form of quality approval.
As a result, there is a possibility that many of the ARVs in circulation in sub Saharan Africa do not meet the strict bioequivalence requirements necessary to minimise drug resistance and clinical failure. An examination of the literature relating to ARV quality in lower and middle-income countries suggests wide variations in the quality of drugs available, and high levels of drug resistance in some areas. The few studies that exist for Africa also raise questions about the quality of the drug supply.
As chronic diseases become more prevalent in lowerincome countries, it is vital that public authorities do not repeat these mistakes, and sacrifice the quality of medicines in the sometimes ideological and clinically irrational promotion of generic medicines. As such, the differential pricing schemes pursued by some manufacturers seems a viable way of improving access while maintaining quality, as do properly administered voluntary licenses for generic production.
Finally, donors should not be distracted by debates on intellectual property from the major barriers to access to medicines, which are insufficient health infrastructure and trained personnel.