[ci-dessous cette article récemment publié dans The Lancet. Notre traducteur
est en congés... qui peut traduire pour tous les e-mediens ? CB]
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)60687-3/fulltext
The Lancet, Volume 375, Issue 9726, Pages 1597 - 1598, 8 May 2010
doi:10.1016/S0140-6736(10)60687-3
Tide turns for drug manufacturing in Africa
Tatum Anderson
With several efforts underway to increase the local production of drugs
in developing countries, Tatum Anderson assesses the pros and cons of
manufacturing medicines in Africa.
A drugs producer in Uganda has become the first in a least developed
country (LDC)-a category reserved for the world's poorest nations-to
achieve a world-class seal of quality for its manufacturing standards.
The Quality Chemicals plant, in the Ugandan capital Kampala, is the
first to get this far along the so-called WHO pre-qualification process;
a stringent quality check imposed on manufacturers of drugs. There are
around 37 manufacturers in sub-Saharan Africa. "There has been
excitement", says George Baguma chief marketing officer at Quality
Chemicals. "We are the first in sub-Saharan Africa to get
pre-qualification of a plant outside South Africa."
The next step is to gain approval, or pre-qualification, for each
malaria and HIV/AIDS drug the firm produces, before international
agencies, such as UNICEF, are allowed to buy from the company.
It is an important milestone because of scepticism over domestic, or
local manufacturing, in such countries, says Suerie Moon, an expert on
local production at the Kennedy School of Government, Harvard
University, MA, USA. "There is a lot of doubt in the global health
community as to whether a firm in an LDC is capable of producing at WHO
pre-qualification standards", she says. "It sends a clear signal
that it's possible and is an important part of changing the way people
think about local production."
A World Bank report set the tone in 2005, concluding that in many parts
of the developing world, producing medicines domestically made little
economic sense and could even end up reducing access to medicines. The
thinking was that few developing world producers could compete with
those from India and China. And, crucially, from a public health point
of view it does not matter where the drug comes from as long as it is
safe, affordable, and of good quality.
Manufacturers, especially in poor nations, face a multitude of expenses
that push up the cost of medicines beyond those from India and China
said the report's authors, Richard Laing from WHO and Warren Kaplan,
assistant professor of international health at Boston University, MA,
USA. Difficulties include unreliable water and electricity supplies.
Companies are also often forced to import machinery, packaging, and
active pharmaceutical ingredients (APIs) because there is little
production of starting materials at home. Technical specialists are
scarce too.
By contrast, India and China are pharmaceutical powerhouses with
plentiful supplies of skilled professionals and decades of government
support. The countries' enormous populations have helped support
industries too.
Andreas Seiter, a senior health specialist at the World Bank says that
few factors have changed dramatically since 2005, particularly in
Africa. "There is still a cost disadvantage for local manufacturing in
Africa", he says. "In Ghana, for instance, with energy costs and
importing raw materials and no large volumes produced, they are not
competitive with Indian and Chinese manufacturers."
And it is not just about cost. Some say that the quality of
drugs produced can be much lower than international standards and that
countries are putting industrial agendas ahead of public health if they
buy from inefficient local facilities rather than better-quality
medicines abroad.
Others attribute Quality Chemicals' success to one of India's leading
pharmaceutical companies, Cipla, which designed the plant (it is a
carbon copy of Cipla's facility in Goa, India, say insiders). Cipla sent
its experts to train Ugandan staff and even applied for WHO
pre-qualification certification on behalf of Quality Chemicals.
Why then, is there currently a flurry of global activity aimed at
increasing local production in developing countries? WHO, several UN
agencies, the European Union and non-governmental organisations, are
looking at local production strategies; Michel Sidibé, executive
director of UNAIDS, last year called for local production of
antiretrovirals to be ramped up; and importantly, the African Union (AU)
grouping of African Governments, is currently devising a fully costed
business plan for the production of drugs for HIV/AIDS, tuberculosis,
and malaria on the continent.
Pharmaceutical companies from Democratic Republic of the Congo to
Ethiopia are being helped to reach international standards too. German
development agency GTZ is even sending individual inspectors from the
German regulator to Africa to do personal plant assessments. Although no
substitute for a full WHO pre-qualification, the process helps identify
improvements necessary to reach international standards.
Other African manufacturers have also applied for pre-qualification
says Lembit Rägo, coordinator of WHO's medicine quality assurance and
safety unit, who set up WHO's pre-qualification process. Local
production is gaining in popularity because, despite imports, a third of
the world's population is still without access to medicines, more than
half in parts of Africa and Asia. The view is that local production,
with other strategies, must be ramped up to fill the gap.
Many developing countries are keen because they fear supply insecurity
since their citizens' health is dependent on supplies from abroad and
they want the economic benefits of local industry. LDCs are also exempt
from some world patent rules which, in theory, enables them to legally
produce more affordable copies of drugs that would be subject to patents
elsewhere, including India.
There is disagreement as to whether employment increases substantially
or how insecure foreign supplies really are. Dilip Shah, head of the
Indian Pharmaceutical Association, argues that there are so many Indian
suppliers, insecurity is highly unlikely.
For its part, Quality Chemicals told The Lancet that Indian
manufacturers are able to sell at artificially low prices, because of
financial help from their government, and this damages the African
industry. "Our government does not subsidise us, so our products look
more expensive", says Baguma. "The environment is hostile."
Additionally, attaining pre-qualification in a poor country is a costly
business, he says. Salaries for Indian experts engaged in technology
transfer has been paid for by Quality Chemicals at five-times the cost
of local staff, and Cipla applied for pre-qualification because it can
help surmount a myriad of obstacles including important laboratory
studies that would delay pre-qualification by a lone African firm for
years.
A few other changes have also altered the case for local production
since the World Bank report. For a start, the substantial rise in global
health donor funding means there is a greater demand for drugs, and a
greater potential market for local manufacturers. And because donors
require international manufacturing standards, many local manufacturers
are now investing in improvements to compete for the funds.
There has also been a shift towards a more pragmatic approach to local
production. Agencies are working on establishing evidence for specific
cases where local manufacturing makes sense,
says Precious Malebona
Matsoso, director of public health, innovation and intellectual property
at WHO. "We want to show countries that it might be feasible for them
to import but in some instances to manufacture", she says. "We can
make the tools available to help countries make those decisions."
Manufacturing in some countries might be more viable than others, for
instance. Daniel Ayele, of GTZ Ethiopia says that Ethiopia might be able
to sustain local producers because it is Africa's second most populous
nation.
Some products, and not others, might make more sense to manufacture
locally. Not every API import is prohibitively expensive for instance
and intravenous drips, which are mostly water, are tricky to import.
That is also why the AU wants to promote regional rather than local
production. The populations of several neighbouring countries might
support one manufacturing plant located in one of them. "If the
countries that are producing can work together we could, as a continent,
have more access to the medicines", says Jane Byaruhanga, health
officer at the AU Commission in Addis Ababa.
Here too, alternatives might also be more appropriate says Byaruhanga;
several African countries might choose instead to club together and buy
drugs from abroad at a cheaper price or use flexibilities in world trade
rules to access more imports.
Improving access to good, affordable drugs, after all, is not just
about local production. More research into drugs and vaccines for
diseases that disproportionately hurt the poor is needed. Regulators
need strengthening to better spot bad drugs and manufacturers-local or
foreign. So are improved drug distribution systems to prevent drug stock
outs and hefty price mark-ups levied by the supply chain.
But for local manufacturing to work, say proponents, governments must
be prepared to coordinate, harmonise legislation of drugs within regions
and if manufacturing does not make sense from a public health viewpoint,
to step away. That might be easier said than done says WHO's Rägo.
"Local production is not a panacea. The tragedy is that it is
sometimes promoted blindly", he warns. "Of course countries want to
create industries to provide medicines for their people but the cost
should not be higher prices and lower quality. That is the irony we have
seen in many parts of the world."