[Ip-health] Bangkok Post- Activists say definition of 'counterfeit' too broad

[Terri - Louise Beswick]

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Activists say definition of 'counterfeit' too broad


Public health groups say they're all for suppressing medicines that are
a threat to public safety, but they totally disagree with efforts to
lump generics into that category


Public health activists have strongly and continuously opposed the Thai
government's adoption of a broad definition of fake medicines, which
they say is spearheaded by transnational pharmaceutical companies and
developed countries such as the United States, Japan and countries of
the European Union. The intention behind including generic medicines in
the definition, say the activists, is to protect intellectual property
rights, often to the detriment of consumers.

At the international level, in February 2006, the World Health
Organization launched the International Medical Products
Anti-Counterfeiting Taskforce (Impact) as a core agency to coordinate
with countries to stop the production, trade and selling of medicines
defined as fake around the world.

Impact says a "counterfeit medicine is one 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 ingredient or with fake packaging".

Kannikar Kijtiwatchakul, coordinator of a joint project between Campaign
for Essential Medicine and Health Consumer Protection, said that these
groups support efforts by the Thai government and the international
community in suppressing fake and substandard medicines for the public
safety.

However, they totally disagree with any attempt to broaden the
definition of fake medicines which will negatively affect the production
of cheaper generics. Public health groups both national and
international disagree on a definition of "counterfeit" related to
infringement of intellectual property rights or violation of trademarks.

"Medicines are not a general consumer product. They involve public
health," said Ms Kannikar.

"The definition of fake drug given in Section 73 of the 1957 Drug Act,
which focuses on 'medicines with false label of brand names and false
production place, or those with incorrect quantities of ingredients
required by law' is appropriate. The problem is how to enforce a
suppression scheme effectively."

The groups say that the government has been persuaded to adopt a new
broader concept proposed by the multinational pharmaceutical companies,
despite a denial from the International Federation of Pharmaceutical
Manufacturers Association (IFPMA). In 2007, a drafted memorandum of
understanding from the government said that the term counterfeit
medicines refers not only to those defined in the Drug Act, but also the
Trademark Act (1967, revised in 2000) and the Patent Act (1979, revised
1992 and 1999). In the wake of strong opposition from activist groups to
any changes, as of now the definition of a counterfeit drug remains as
listed in the Drug Act.

Meanwhile, the Thai government has stepped up intellectual property
rights enforcement measures. Activist groups - which include the Aids
Access Foundation - as well as the Thai Pharmaceutical Manufacturers
Association and other organisations, have submitted letters to the
government asking it to separate issues of protection and enforcement of
intellectual property rights. They say the government should be
concerned with the safety, efficacy and quality of medical products.

"We have to closely monitor any possible change of definition since it
would potentially create entry barriers for legitimate non-patented drug
versions, or lawful generic medicines. Countries, including Thailand,
which need cheap medicines would be in difficulty," said Ms Kannikar,
adding that such situations are already happening. She cited studies by
law professors in Korea and Hong Kong which detailed how shipments of
generic medicines en route to developing countries had been seized and
held by customs officials in European countries, the justification being
that they were counterfeits. These include a shipment of a generic
blood-thinning drug made in India en route to Colombia, which was seized
by Dutch Customs officers in October 2008.

Ms Kannikar said many groups are skeptical about the independence of
Impact, and think it is influenced by lobbyists for pharmaceutical
manufacturers.

"It is a conflict of interest," she said.

http://www.bangkokpost.com/news/investigation/27927/activists-say-defini
tion-of-counterfeit-too-broad