Sunday, October 06, 2013

Company Wealth Or Public Health - Counterfeit Drugs

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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