Aids drugs arrived in Africa, in spite of the sceptics. They came at a price that the international donors felt they could pay and have saved hundreds of thousands of lives. But had it not been for a small and normally unlauded unit of the World Health Organisation, the huge effort and large sums of money could have been wasted.
The prequalification of medicines programme (PQP) of the WHO, launched in 2001, was set up to assess the quality of the generic medicines for HIV and other diseases made by companies in India, China and elsewhere. These were affordable versions of the big brand drugs. Aids drugs that cost $10,000 a year per person could and were manufactured eventually for $100. But it is no good having the drugs if they don't work. In infectious diseases, it is worse than no good. Poor quality drugs can allow bacteria, viruses or parasites to develop resistance and that can undermine the efficacy of the high-quality medicine.
The PQP has been a fantastic success story, giving a stamp of approval to good quality generics and allowing the governments of developing countries to buy effective versions of essential drugs they can afford. But, say four respected experts in the Journal of Public Health Policy, the programme is endangered by its insecure funding. It lurches from one grant to another. Two organisations keep it going - UNITAID and the Bill and Melinda Gates Foundation. The experts argue that a unit as important to public health as the PQP should not be dependent on just two sources of funds.
The article is written by Ellen 't Hoen, a regular consultant to the WHO medicines programme and former director of the Medicines Patent Pool, Hans Hogerzeil, Professor of Global Health at Groningen University in the Netherlands, Jonathan Quick, former director of the Essential Medicines programme at WHO, of which the PQP is part, and Hiiti Sillo, director general of the Tanzania Food and Drugs Authority. They have all been deeply involved in issues around the supply of good quality drugs to low income countries.
The PQP is not in danger at the current moment, 't Hoen told me when I spoke to her. Things were looking rocky towards the end of last year, until UNITAID's December board meeting, which granted it funding for three years. But their point, she said, is that such a valuable resource ought not to be worrying about where the next dollars are coming from.
It came very close. When we sent the article [for publication], they were out of money and did not know whether UNITAID was going to renew.
Having more donors would mean they could expand their activities beyond the immediate preoccupations of their current donors, 't Hoen said, to include, for instance, cancer drugs and hepatitis C treatment.
The PQP saves huge amounts of money for donor governments and others by ensuring they spend their money safely and wisely, argues the article:
The WHO PQP has become a global public good that has helped save millions of lives. Most international organizations and many governments that procure and supply medicines depend on the WHO PQP. Yet very few choose to contribute financially to its work. The Global Fund spends around $610 million per year on medicines and other pharmaceutical products... PEPFAR spent $1.2 billion on medicines procurement over 5 years. The $15 million annual budget for the WHO PQP represents less than 2 per cent of the annual amount spent on medicines by these two organizations alone. Reliance on two donors is risky. It is time a consortium of public and private global health donors create a sustainable funding base. WHO PQP is essential to assure their products' quality. It is the strongest mechanism currently in place to create sustainable regulatory systems in low- and middle-income countries. This alone justifies investment in WHO PQP.
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