[Ip-health] Sarah Boseley's Global Health Blog in The Guardian: Better funding call for vital drug approval programme

Thiru Balasubramaniam thiru at keionline.org
Thu Jan 16 01:45:53 PST 2014


Better funding call for vital drug approval programme

Without the prequalification programme of the World Health Organisation,
Africa could have bad drugs or no drugs for HIV and TB, but this vital
service for assessing medicine quality needs secure funds for the future,
say experts

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

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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