Due to the tremendous pressure exerted by the developing countries including India and Brazil, the World Health Organisation (WHO) has dropped the controversial resolution on counterfeit drugs.
The WHO decision will prove to be a huge victory for the generic pharma industry in the developing world which has been opposing the WHO attempt on the plea that, once the resolution is passed, their products could be rejected as counterfeit products.
According to sources, the decision to shelve the resolution on implementing the IMPACT-proposed new definition on counterfeit drugs was taken at the WHO's executive board meeting held in Geneva. Top Indian health ministry officials had also attended the meeting. However, the WHO is yet to officially announce the decision in this regard.
Sources close to the development said, "Developing countries, in particular Brazil voted against the WHO Secretariat report and the attached draft counterfeit resolution (EB 124/14) presented at the WHO Executive Board meeting. Developing countries were concerned that IMPACT's focus on policy and legislation on counterfeit drugs will be counter productive and will create barriers to trade in and access to legitimate medicines.
The seizure of legitimate generic drugs in transit from India to Brazil as counterfeit by the EU on allegations of IP infringement, added to the fears of developing countries that the resolution could be misused to further the intellectual property enforcement agenda."
The International Medical Products Anti-Counterfeiting Taskforce (IMPACT), an organisation funded by WHO, has been organising meetings after meetings in different parts of the world on evolving a new definition to counterfeit drugs. As per the proposal by the IMPACT, apparent 'trademark violations' will be considered as 'counterfeiting' cases. The generic industry opposed this tooth and nail on the plea that this would harm exports of generic drug makers. Moreover, the industry was concerned over the WHO's attempt 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 current definition of WHO says counterfeit drugs are 'medicines which are deliberately and fraudulently mislabelled 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 labelling information'.
In India, all the major industry associations like IDMA, IPA, SPIC, CIPI and FOPE have been opposing the WHO move as they feared it as yet another attempt by the big multinational companies to kill the Indian generic drug makers. The Indian drug manufacturers feared that if the changes go through as proposed by the IMPACT, 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.
The lone voice of support for the WHO move came from OPPI.