Opinion: Misguided policies keep life-saving drugs out of reach

WASHINGTON — Malaria is a preventable and curable disease that kills nearly 1 million people, mostly children, every year.

This disease continues to kill in large part because so many poor people living in Africa lack access to safe, effective and affordable medicines. Yet in an attempt to increase access, some governments and funding agencies have promoted policies that might undermine treatment outcomes. Political interference in medicine production and procurement must end and governments must instead focus their efforts on fixing medicine distribution systems that limit access.

Some countries have imposed tariffs on imported drugs in order to protect local drug manufacturers. Such favoritism not only increases the price of drugs but it also constricts the supply of imported drugs, which are often of higher quality. Kenya and Uganda, for example, once imposed tariffs, but these were removed under pressure from local health activists who argued that this regressive tax harmed the sick and the poor. Yet both these countries have pursued policies that have harmed access to medicines in other ways.

The government of Uganda, along with Indian drug producer Cipla, has financed a state-of-the-art drug production facility near Kampala owned by Quality Chemicals Industries Ltd. (QCIL). The government has invested tens of millions of dollars and taken a 22 percent shareholding in the company. QCIL, which now lobbies for a re-introduction of import tariffs, aims to supply anti-retrovirals for the treatment of HIV/AIDS as well as anti-malarial drugs.

Yet despite the substantial investments of taxpayers’ funds over several years, there is little evidence that this company has produced a single anti-malarial drug. Furthermore, it hasn’t sought quality approval from the World Health Organization (WHO) or another stringent regulatory authority. Even if QCIL were to produce malaria drugs of acceptable quality, the high production costs in Uganda mean the drugs would be more expensive than quality-assured imported drugs.

The Ugandan government appears to have bought into the idea that locally produced goods are inherently cheaper and hence automatically improve access; however, there is no evidence to support this notion.

Kenya has pursued a different path for its drug procurement. In August 2008, the Global Fund sub-recipient Kenya Medical Supplies Agency awarded the tender for its annual supply of anti-malarial drugs to Indian generics firm, Ajanta Pharma Ltd. Ajanta’s tender price was substantially lower than competitors, which made it appear an attractive option. Yet at that time Ajanta’s malaria drug had not been approved by the WHO, an approval that has been subsequently granted. The firm had little history in delivering the large amounts required for international tenders of this sort, a fact that proved disastrous for ordinary Kenyans.

Ajanta’s drugs were delivered late, in insufficient amounts with some of the packages missing pills. As a result of this poor procurement decision, thousands of Kenyans would have gone without malaria treatment, putting their lives at risk.

Worryingly, having already invested in a local company that cannot produce, Uganda looks set to award its latest malaria treatment tender to Ajanta Pharma. The Ugandan ministry of health issued a statement saying that it was satisfied that Ajanta had taken action to improve its logistics and supply problems. Yet around this same time WHO issued a Notice of Concern against Ajanta Pharma following an inspection that revealed major deviations from WHO Good Manufacturing Practices, raising further questions about the wisdom of granting the tender to this firm. WHO did withdraw Ajanta’s Notice of Concern in September 2009.

Uganda is currently struggling with a widespread stock-out of anti-malarial drugs and in this country, as with Kenya, the U.S. government has had to step in with emergency procurements of medicines at considerable cost to U.S. taxpayers. Many of the problems seem to be grounded in poor logistics — one study found that 93 percent of deliveries from Uganda’s national medical stores didn’t even make it to their intended destination.

The Global Fund, the world’s largest financier of malaria programs, must bear some responsibility for these procurement debacles. In an effort to reduce prices, the Global Fund has increased competition allowing grant recipients to procure drugs from a wide range of manufacturers, including those with poor records of delivery or producing drugs of unknown quality.

Some donor agencies, such as Germany’s GTZ, have been promoting the idea of local production as beneficial in and of itself. Local production makes sense where the country has a comparative advantage in drug production. Most malarial countries do not have this comparative advantage and so local production simply ends up enriching local industries and costing taxpayers and ordinary individuals suffering from malaria the most.

When using taxpayer’s money to procure life-saving medicines it is incumbent on governments to seek out drugs of known and acceptable quality, from companies that are able to deliver on time at competitive prices. Unfortunately, some governments and funding agencies focus on price alone or push the nationalistic idea of domestic production ahead of other considerations, such as fixing local logistics. Both policies undermine access to medicines and can cost lives.

Richard Tren is director of the health advocacy group, Africa Fighting Malaria. James Taylor recently completed an M.A. at Makerere University, Uganda, researching local drug production, procurement and distribution.