* African Medicines Agency blueprint modelled on EU watchdog
* Aim to harmonise rules, improve access to quality drugs
* Doubts over big ambition to cover 55 divergent countries
By Ben Hirschler
LONDON, Dec 4 (Reuters) - Last July, Ugandan officials seized fake versions of the cancer drug Avastin on sale in Kampala, revealing only the tip of an iceberg of bogus medicines found all too often in Africa.
It wasn't a very good fake. The bottles contained blue-grey tablets, whereas genuine Avastin is a liquid given by infusion, and the fraudsters labelled the manufacturer as AstraZeneca . The real thing is made by Roche.
The low bar for criminals pushing dodgy drugs in Africa is just one reason why the continent needs to up its game in medicines regulation.
The World Health Organisation (WHO) estimates one in 10 drugs sold in developing countries is fake or substandard, leading to tens of thousands of deaths, many of them of African children given ineffective treatments for pneumonia and malaria.
Sub-Saharan Africa has more than its fair share, accounting for 42 percent of reports of counterfeit and low-quality products the U.N. agency has received since 2013.
Bad drugs flourish when regulation is weak and there is a lack of access to quality treatments. At the moment, Africa has a patchwork of national agencies, many short of funds and expertise to clamp down on fakes or approve genuine drugs efficiently.
Healthcare experts, who met in Ghana last week to push the case for coordinated drug oversight in Africa, have a lofty ambition to create an African Medicines Agency (AMA) by 2018. It would be modelled on the 22-year-old European Medicines Agency (EMA) but cover twice as many countries and 1.2 billion people.
Considerable practical and legal problems must be overcome. But the case for such collaboration has been spurred on by the 2014-15 Ebola outbreak, where an African regulatory forum for vaccines played a leading role in fast-tracking clinical trials.
The prize is big. Supporters of the AMA believe it will speed approval of modern medicines and encourage local drug manufacturing. Like the EMA, it would work alongside national regulators.
"It is time we had an institution that can harmonise the requirements for market authorisation and address issues around quality," Margareth Ndomondo-Sigonda, AMA programme coordinator at the African Union's (AU) Nepad economic development agency, told Reuters.
Supporters of such harmonisation include the WHO and the Bill & Melinda Gates Foundation. Drugmakers also like the idea of simplifying access to an African market of 55 divergent countries where sales to date have been limited.
Five years ago, forecasters predicted annual African drug sales would reach $45 billion by 2020, driven by economic growth and the rise of non-communicable diseases like diabetes and cancer. Today, the same experts at research company IQVIA, previously known as IMS Health, suggest it is more likely to be around $25 billion.
The political will to make the AMA work is building, helped by the backing of the WHO's first African director-general Tedros Adhanom Ghebreyesus. The Ethiopian hit the headlines in October when he appointed Robert Mugabe as a WHO goodwill ambassador shortly before the Zimbabwean president's removal from power - a decision Tedros was quickly forced to rescind.
Suzanne Hill, the WHO's head of essential medicines, sees "potentially a huge value-add" from having a central body assess drug quality, rather than each country doing it independently.
"Collaboration amongst regulators is essential," she said.
Sceptics, however, doubt the practicality of a pan-African agency, given the lack of a common legal system or an equivalent of the European Court of Justice to arbitrate in disputes.
"The only reason the EMA exists is because the EU has binding legislation, standards and enforcement mechanisms. Africa hasn't really got anything like that," said one official at a Western drugs agency.
Harald Nusser, head of social business at Novartis, agrees it will be "much more complex" to build an African drugs regulator than the equivalent in Europe.
But Ndomondo-Sigonda, who ran Tanzania's drug regulator for seven years, believes Africa can "leap-frog", based on the experience of the EMA and the U.S. Food and Drug Administration (FDA), although she admits the AMA won't be fully up and running next year.
While a draft AMA treaty was presented to ministers in Victoria Falls in August and Ndomondo-Sigonda expects formal endorsement from AU heads of state by late 2018 or early 2019, the treaty will then still need to be signed by at least 15 member states. Only after that can operations start.
Like the EMA and FDA, the agency will be part-funded by fees paid by drugmakers as products are reviewed - a trade-off that has led to debates over conflicts of interest in Europe and the United States and will be a challenge in Africa.
"It's very important that there is transparency over how money and information flows in an organisation like the AMA. That is a significant hurdle that needs to be addressed," said Jayasree Iyer, head of the non-profit Access to Medicine Foundation.
For companies, better regulation could finally open up a market opportunity that has been constrained by bureaucratic delays and opaque supply chains.
But Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations, sees the AMA developing gradually. "There need to be realistic expectations." (Reporting by Ben Hirschler; editing by David Stamp)