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The controversy over 'counterfeit' drugs

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LONDON, 2 October 2013 (IRIN) - One of the biggest hurdles to stemming
the global tide of counterfeit medicines is disagreement over the term
itself, which drug companies are accused of hijacking for commercial
rather than public health reasons.

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

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 Organisation (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 the World Health Organization (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.

The Meeting of the Member
State Mechanism on Substandard/spurious/falsified/falsely
labelled/counterfeit medical products will focus not on drafting a
treaty - such an ambition has been abandoned for the time being - but
rather on developing a "programme of work" to curb the sale of such
products. This will look at best existing practice and can be tailored
to the situation in different regions.

Michael Deats, WHO's project manager for quality assurance and safety
of medicines, is cautiously optimistic. "This topic is mired in
controversy," he said, "because of the conflict between protection of
public health and protection of intellectual property. But we are now
getting to the stage where negotiations are starting to settle down,
and we have got a better chance of moving forward."

A focus on trade or health?

For Oxfam's senior medical policy advisor, 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
rlands.html> 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."

Shoring up supply chain

Kamal-Yanni says more lasting solutions can be found by investing in
supply chains in the developing countries worst affected by the

"As a patient," she said, "if I have access to a trained pharmacist and
a good supply chain system, the counterfeiters and the people supplying
bad-quality drugs will have limited access to the market. So investing
in the supply chain - and in stopping drug shortages in the public
sector, which force people to go to private markets with zero
regulation - this is the kind of investment that we need before we go
for an international treaty."

At the moment, the issue of a treaty is on hold, says WHO's Deats. He
told IRIN, "WHO now has a solid platform and an agreed mandate, clearly
focussing on public health. We are still at the talking stage rather
than the doing stage, but there is now a spirit of cooperation rather
than the hostility which existed a few years back.

"The pharmaceutical companies are major stakeholders in the field, so I
don't think you can exclude them, but the amount of influence they have
mustn't be disproportionate. The low-income countries, which are really
suffering badly, would do better to invest in their supply chain and
systems of oversight, but there's no 'one size fits all' solution. Our
task now is to identify priorities and then get to work with a view to
minimizing harm to patients in our member states."


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[This report does not necessarily reflect the views of the United
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