Activists say definition of 'counterfeit' too broad

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.

CONSUMER ADVOCATE: Kannikar Kijtiwatchakul says a close watch is needed on the government.

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.