Taxpayers supporting untested medicines

Tuesday, May 20, 2008

By Roger Bate

RogerNew field research shows that a third of anti-malaria drugs collected in six African cities fail at least one quality test–and aid agencies continue to fund untested substandard drugs: poor medicine for poor people.

The World Health Organisation suggests that one-fifth of the approximately one million children who die every year from malaria die because of substandard and poorly prescribed medicines.

In our sample of anti-malarial drugs sold in six African countries, we found 32% of those produced in Asia failed basic quality tests, as did 48% of those made in Africa, described in our paper published on 7 May in the U.S. Public Library of Science peer-reviewed medical journal PLoSONE.

Fake medicines are an increasing problem in richer nations, too. Fake Chinese heparin caused the deaths of at least 81 Americans; fake Viagra, cholesterol drugs and painkillers are also increasingly prevalent across the United States and Europe.

But while the U.S. Food and Drug Administration, the WHO, Interpol and European health and law enforcement agencies are doing their best to crack down on the major counterfeiters, taxpayer-funded aid agencies–including the Global Fund to Fights AIDS, Tuberculosis and Malaria–are still financing sales of untested and often poor, medicines to poor people.

Nirj Deva, Member of the European Parliament for the South East of England and the British Conservative Party’s spokesman for International Development, asked the European Commission in March why it was funding "medicines in the developing world that would not in any instance be approved for use on EU citizens?"

Europe’s Commissioner for Development and Humanitarian Aid, Louis Michel, provided a long-winded answer in which he admitted that "stimulating competition" to lower drug prices was the main reason–although he made no mention of the local tariffs that inflate those prices in many poor countries.

U.S. taxpayers support roughly a third of the Global Fund’s budget–close to a billion dollars a year–but no U.S. legislator has asked why U.S. tax dollars are buying untested drugs, even though these drugs can endanger the people they were purchased to help, and may not lower prices.

After all the German aid agency GTZ has reported that drugs produced locally in Ghana are often more expensive than imports from India, China, or Europe. Their effectiveness is even more debatable. The Global Fund only requires that the drugs come from facilities that can show good manufacturing practices (GMP), which means, in effect, a company that can produce aspirin is considered acceptable for producing more complex, and potentially harmful, anti-malaria drugs.

A generic drug sold to westerners must pass bio-equivalence testing, to demonstrate the drug actually mimics the original drug. But the Global Fund does not demand proof of bio-equivalence for drugs on its approve list.

Although half our sample of African-produced medicines failed quality tests, health activists continue to promote subsidised local production, and importation from under-regulated producers in Asia, to increase the availability of medicines in Africa.

Certainly some African countries and the better producers of India and China are capable of manufacturing safe medicines. And it is not clear how many of the drugs we tested in Ghana, Kenya, Nigeria, Rwanda, Tanzania and Uganda are being procured by the Global Fund, as the fund does not reveal how taxpayer money is spent.

Even if no poor quality drugs are actually procured by the Fund, simply listing them as acceptable sends a bad signal: all the drugs we tested were listed on the national registries of the countries in question, highlighting their inability to police their own lists. In India, which has no national drug regulatory authority, individual States license generic manufacturers (making copies of patented or off-patent drugs), sometimes for export only. Exporters need not even comply with weak local standards. The Global Fund denies there is a problem: the most recent Board meeting, in April, did not deal with it, which means no action until November at the earliest, at the next Board meeting.

The Global Fund’s current policy is harming the most vulnerable by endorsing substandard products but African children can’t fight back and bureaucrats and activists don’t seem interested. Patients, health workers, and governments in poor countries have to start complaining loudly against this hypocrisy.

Roger Bate is a Director of Africa Fighting Malaria, Washington, D.C. and author of Making a Killing, The Deadly Implications of the Counterfeit Drug Trade (May 2008, AEI, Washington)