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 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 labeled 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
modeled 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 harmonize the
requirements for market authorization and address issues around
quality," Margareth Ndomondo-Sigonda, AMA program coordinator at the
African Union's (AU) Nepad economic development agency, told
Reuters.
Supporters of such harmonization 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.
SLOW DRUG SALES
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.
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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.
INDUSTRY FEES
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 organization 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)
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