More on: WHO's new definition of counterfeit medicines

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Contributed by Chinu Sriniwasan of LOCOST, Vadodara.

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WHO's new definition of counterfeit drugs intended to hurt Indian cos: IPANovember 19, 2008, 0800 ISTIndian Pharmaceutical Alliance (IPA), which represents major Indian generic drug companies, has warned the Central government that most programmes on counterfeit drugs by the international bodies like SECURE, ACTA and IMPACT have degenerated into using them as a tool to create barrier to generic medicines. In a letter to the DCGI, the IPA said that counterfeiting medicines is a vile and serious criminal offence that needed coordinated efforts of all stakeholders at the international level to combat it. But, instead of focusing on the counterfeit medicines, most programmes of EU Council Regulation (EC) No.1383/2003 of 22 July 2003, International Medical Products Anti-Counterfeiting Taskforce (IMPACT) by WHO, Standards Employed by Customs for Uniform Rights Enforcement (SECURE) by World Customs Organization and Anti Counterfeiting Trade Agreement (ACTA) initiated by the USTR have degenerated into using them as a tool to create barrier to generic medicines.IPA's response comes in the wake of the Indian government reopening discussion, apparently under pressure from the WHO, with the Indian drug industry on the WHO proposal which Indian authorities had earlier turned down on the ground that the new definition will act against the interest of the Indian drug industry.Interestingly, IPA was not invited for a government-industry meeting on the issue called by the Union health ministry on November 14. Finding fault with the WHO definition on counterfeit drugs, IPA suggested that the WHO defines counterfeit medicines as 'medicines which are deliberately and fraudulently mislabelled with respect to identity or source. Counterfeiting occurs both with branded and generic products and counterfeit medicines may include products with the correct ingredients but fake packaging, with wrong ingredients, without active ingredients or with insufficient active ingredients'. The problem with this definition is that it clubs 'substandard' medicines with 'counterfeit' medicines.The IMPACT defines 'a medical product as counterfeit when there is a false representation in relation to its identity, history or source. This applies to the product, its container, packaging or other labelling information. Counterfeiting can apply to both branded and generic products. Counterfeits may include products with correct ingredients or components, with wrong ingredients or components, without active ingredients, with incorrect amounts of active ingredients, or with fake packaging'. The problem with this definition is that besides clubbing 'substandard' with 'counterfeit', it adds a new dimension to definition by inserting the word 'history' without being specific. This raises concerns of the public health activists and the generic industry that it may be interpreted in a manner that will create barrier to generics, IPA said. IPA also urged the DCGI to exclude infringement of patent rights, parallel importation of original goods from a third country where they have been sold by the appropriate right-holder and the diversion of supplies of authorized items from the scope and definition of counterfeit medicines, because since the focus of the issue is on public and personal health implications of use of counterfeit medicines, the new definition should not include these provisions. Calling upon the developing countries to unite at the WHO to establish one and uniform definition of counterfeits for medical products, the IPA has said that the IMPACT background document had defined its scope and stated, 'the focus of these principles is on public and personal health implications in relation to counterfeit medical products'. Therefore, it should not address infringement of aspects of intellectual property rights (IPR) related to patent rights, or parallel importation of original goods from a third country where they have been sold be the appropriate right-holder and explicitly cover other illegal activities such as diversion of supplies of authorized medical products, or theft of authorized medical products.

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Health ministry calls meet over WHO definition of counterfeit drugsNovember 13, 2008, 0800 ISTThe Union health ministry is once again convening a government-industry meeting on November 14 to discuss the World Health Organisation (WHO)'s proposal to give a new definition to counterfeit drugs which the ministry had earlier turned down on the ground that the new definition will act against the interest of the Indian drug industry.According to sources, the health ministry is under pressure from the WHO to fall in line and approve its proposal to give a new definition to counterfeit drugs. All the major pharma associations have been invited to attend the meeting on November 14 called by the Union health ministry. Some time back, the ministry had turned down the WHO's proposal due to stiff resistance from the industry. The industry pleaded with the government that the new definition will act against the Indian drug industry, especially the generic drug manufacturers as the new definition considers apparent "trademark violations" as "counterfeiting" cases. The Indian drug manufacturers, especially the small scale sector, are concerned over the WHO proposal as they fear the efforts would be another attempt by the big multinational companies to kill the Indian generic drug makers. As per the proposal by the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) of the WHO, apparent "trademark violations" will be considered as "counterfeiting" cases which the Indian drug makers said would harm exports of generic drug makers. "We are concerned over the ongoing WHO negotiations that aim to bring non-health issues, having no direct implications on the safety of a drug, within the ambit of the definition of "counterfeit medicine", the industry pleaded with the government. The current definition of WHO says counterfeit drugs are "medicines which are deliberately and fraudulently mislabeled with respect to identity or source. Counterfeiting occurs both with branded and generic products and counterfeit medicines include products with the correct ingredients but fake packaging, with the wrong ingredients, without active ingredients or with insufficient active ingredients". The definition proposed by IMPACT removes the clause 'deliberately and fraudulently' and replaces it with 'a medical product is counterfeit when there is a false representation in relation to its identity, history, or source'. It also says that 'this applies to the product, its container, packaging or other labeling information'. IMPACT also wants to see that WHO definition on counterfeiting "can apply to both branded and generic products and include products with correct ingredients/components, with wrong ingredients/components, without active ingredients, with incorrect amounts of active ingredients, or with fake packaging". But, the Indian drug manufacturers fear that if the changes go through, foreign drug firms could stall exports of low-cost versions of patent expired medicines to key markets. Today, Indian firms have several brands that sound similar to those of multinational brands. For example, global drug major Pfizer has an erectile dysfunction medicine Viagra, while Indian companies make generic versions of Viagra with similar sounding names. Currently, this would at the most be treated as a trademark violation (under Indian Patent and Trade Mark Act). However, according to the definition proposed by IMPACT, the Indian product could be rejected as counterfeit.Indian companies, increasingly dependant on exports of cheap off-patented medicines to developed markets to drive business growth, will find this a major roadblock. "The IMPACT definition refers to 'history', which is mischievous. This could lead to generics being treated as counterfeits," the Indian drug industry argues.