There is no dispute over the dangers that fake medicines pose. Often
containing few or no active ingredients, they are typically ineffective -
and are sometimes actively harmful. Some contain enough of an active
ingredient to affect a disease but not enough to eliminate it,
contributing to the growth of drug-resistance. And they cost almost
nothing to manufacture but bring huge profits to their makers and
distributors.
The problem is thought to be widespread in countries with weak
regulatory oversight; in 2003, Nigerian health officials estimate that
70 percent of drugs in circulation in the country were either
counterfeit or adulterated.
But international agreement over how to deal with fake medicines has
been elusive, with discussions getting bogged down over exactly what
kinds of drugs should be targeted. The problem is that the phrase
normally used in the debate - “counterfeit medicines” - can refer to far
more than chalk pills with forged labels.
The World Health Organization (WHO) defines a counterfeit drug as “a
medicine, which is deliberately and fraudulently mislabelled with
respect to identity and/or source.
“Counterfeiting can apply to both branded and generic products, and
counterfeit products may include products with the correct ingredients
or with the wrong ingredients, without active ingredients, with
insufficient active ingredients or with fake packaging.”
Yet pharmaceutical companies consider even safe, efficacious drugs
“counterfeit” when their expensively developed and patented formulas are
copied without their permission, or even when their own drugs, licensed
and packaged for sale in one country, are diverted, repackaged and sold
elsewhere at a higher price.
A meeting at WHO in Geneva next month will try to nail down more firmly
what international control measures should cover and, just as
importantly, what they should not.
A focus on trade or health?
For Oxfam’s senior medical policy adviser, Mogha Kamal-Yanni, the
concerns of drug companies are purely a trade issue, with no relevance
to public health initiatives.
By conflating the two, “you are transferring the duty of checking and
enforcing intellectual property rights from the private owner of those
rights to governments, which have very limited resources, and you’re not
sorting out the problem; the real problem is about bad-quality
medicines,” Kamel-Yanni told a meeting at London’s Chatham House.
Despite efforts to harmonize copyright and intellectual property laws by
countries like the US and Japan, which are home to many pharmaceutical
companies, these laws vary greatly around the world.
There have been a number of cases
in which generic drugs manufactured legally in countries like India, on
their way to other countries where those drugs would also be regarded
as legal, such as Nigeria or Brazil, have been seized in transit through
Europe on the grounds that they violate patents recognized under
European legislation.
The result has been bitter opposition to attempts to reach an
international agreement on combating counterfeit medicines. Countries
like India, China and Brazil allege that big drug companies are trying
to use WHO to suppress competition from more affordable generics.
Anna George, of Chatham House’s Centre for Global Health Security, says
the pharmaceutical industry needs to stop insisting on the catch-all
term “counterfeit”.
“The industry needs to move away,” she told IRIN. “They need to drop
that word that causes so many problems, say that their own intellectual
property rights will be pursued elsewhere, and allow the debate to focus
on health issues.”
Taken from here
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