Global Trends by
Monday 28 November 2005
Avian flu fear sparks chase for drugs
The warnings that
a human-to-human type of avian flu is emerging that could affect millions
worldwide have prompted many governments to stockpile a drug that can
treat the disease. However, supply cannot match demand, and there are
renewed concerns over the role of patents in restricting access to badly
The scare over the possible
emergence of an avian flu pandemic has re-ignited the controversial issue
of patents being a hindrance to access to badly needed medicines.
Although there have been less
than 200 cases of death from avian flu, all of these in Asia, the World
Health Organisation has warned that a worldwide pandemic is imminent and
that up to 7.4 million people may die from it.
Last month, at a specially
called meeting in Geneva, the WHO warned that “indredients for a pandemic
are abundantly available.” If the avian flu virus combines with the human
flu virus, a new pandemic flu virus would be formed that can be transmitted
from human to human.
The drug, Tamiflu, is now recommended
by health authorities for reducing the severity of avian flu H5N1 which
infects humans. It is now in great demand as governments are ordering
this drug to stock it in case the pandemic emerges.
However, it is produced by
only one company, Roche, which is unable to produce fast enough to meet
demand. The estimate is that it will take several years before the company
can meet the present orders.
Moreover, the drug is quite
expensive. Thus, there is a near-crisis feeling developing among health
authorities as they try to secure some stocks, in the fear that it would
be too late to start ordering if and when avian flu breaks out in their
are now considering locally producing Tamiflu. Roche says it will consider
granting voluntary licenses to local producers to produce generic versions,
but so far the terms of such licenses are not known and few, if any, companies
have been given such licenses.
The Indian generic drug company,
Cipla, has announced it is ready to produce cheap versions of Tamiflu
and sell the drug to developing countries at a “humanitarian price.”
It may however face opposition
from Roche, which has applied for a patent for the drug in India.
According to various reports,
many governments are looking at the possibility of issuing a compulsory
license enabling a local agency or company to produce generic versions
Under the rules of the World
Trade Organisation, a government can issue such licenses for local production
or importation of a drug that is patented in the country, provided that
compensation is paid to the company holding the patent. The compensation
rate can be around 4 percent of the price of the generic medicines, according
to expert reports, including one published by the UN Development Programme.
Malaysia was one of the first
developing countries to issue a type of compulsory license (known as government
user order). The license was issued last year for a local company to
import three types of drugs to treat HIV-AIDS
The cost of the drugs was drastically
reduced as a result of the use of the imported generic drugs, according
to the Health Ministry.
Last week, the Taiwan government
became the first to announce that it will issue a compulsory license to
enable local production of Tamiflu, so as to build stockpiles of the drug
to prepare for an avian flu pandemic.
“We are allowing the Department
of Health to produce Tamiflu on its own or mandate a local company to
produce the drug, but it must use up all Tamiflu which has already been
supplied or will be supplied by Roche before starting to use its own supplies,”
said Tsai Lien-sheng, director-general of the intellectual property office.
The compulsory license is limited to domestic use and limited to the end
of 2007. The Department of Health must pay Roche “appropriate” license
fees, and the compulsory license can be revoked once the two sides reach
an agreement for voluntary licensing.
However, according to a Financial
Times report, Roche had agreed to increase Tamiflu supplies to Taiwan
to a level which made it unlikely that the government would have to tap
locally-made stockpiles. Taiwan has ordered courses of the drug to cover
4% of its population of 23 million by mid-2006.
The Department of Health will nevertheless start mass production of the
drug as soon as it receives the compulsory license from the patent office.
It has documentation of already made small amounts of Tamiflu and trained
two local companies in mass-producing materials for making the drug.
The action by Taiwan is likely
to spark interest in other countries for local production of a medicine
that is much in demand for obvious reasons. The WHO has stated that
“on present trends, most developing countries will have no access to vaccines
and antiviral drugs throughout the duration of a pandemic.’
According to Sanya Smith, a
researcher based in Kuala Lumpur with the Third World Network, the owner
of the Tamiflu patent, Gilead, has licensed the right to manufacture and
market the drug to Roche.
The best price that Roche is
offering is 12 euros per course of 10 capsules to developing countries.
Averaging that out across the population at the WHO recommended level
of stocks for 25% of the population, that is 3 euros per capita. The total
government health expenditure in at least eight countries is less than
that per year.
“Furthermore, according to
the WHO, it would take Roche producing Tamiflu at full capacity for the
next 10 years and stockpiling it for there to be enough at the end of
that period for 20 percent of the world's population,” says Smith.
“Given the price and quantity
problems, developing countries need to consider sourcing generic versions
which can be 69 times cheaper. This is feasible both legally and practically.”
In light of the avian flu situation,
Consumers International (CI) has also called on members of the WTO to
review its intellectual property rules and practices to address public
This review should include an assessment of the medical threats to the
public health that an avian flu pandemic, SARS (severe acute respiratory
syndrome) or other
emerging health threats present, and an assessment of the degree to which
WTO members have prepared for such cases, including the stockpiling of
medicines for an avian flu pandemic or other important threats.
It should also look at the degree to which the WTO’s intellectual property
treaty should be modified in order to ensure that effective measures are
taken to protect the public from such emergencies, said CI.
As more cases of avian flu
are reported, and the public’s concerns increase, we can expect more demands
made on governments to ensure supply of the drug, and for local production
or importation of cheap generic versions.
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