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WHO settles long standing dispute between India and European Union - (24 Nov 2016)

Law of Medicine

The World Health Organization has settled a long standing dispute between India and the European Union (EU) by clarifying that the term ‘counterfeit’ will now be used by member States with respect to protection of Intellectual Property Rights (IPR) and has retained ‘falsified’ to describe medicines of inferior quality. This decision is infact an important move for encouraging global access to Indian made generic medicines. The terms were being used interchangeably to confiscated Indian made generic drugs exported to other countries by showing that they were in violation of intellectual property.

On earlier occasions, the European Union and Indian drug manufacturing companies had reached a deadlock and the European Union Free Trade Agreement (EU FTA) was hit after affordable, safe-to-use generic drugs made in India were confiscated as ‘illegal’ and ‘counterfeit’ and nearly 20 shipments of generic drugs, including basic antibiotics and anti- retroviral, were detained while in transit from India to several developing countries via Europe between 2008 and 2009, derailing the free trade agreement negotiations.

For past few years, genuine generic medicines were being labeled as counterfeit and this propaganda had taken away the much needed attention from the substandard medicines, which in turn a bigger public health problem for developing countries. The big pharmaceutical companies were using the term ‘counterfeit’ to describe generic medicines and disrupting trade of generic medicines.

The World Health Organization clarified that the adopted definition drops the word ‘counterfeit’ and uses the term ‘falsified’ which is much more in line with public health concerns regarding medicines, which make false claims about what they contain or where they are from, that represent a genuine problem. The said decision was taken by a technical working group on draft working definitions of substandard/spurious/falsely-labeled/falsified/counterfeit (SSFFC) medical products.

As per the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), the definition of counterfeit was clearly targeted at one particular area wherein it is stated that it is wilful infringement of trademark on a commercial scale. In reality, campaigns and legislation against counterfeit drugs often have nothing to do with concerns about drug quality. The major European and US pharmaceutical companies used these rules for vested interest by limiting competition from generic drugs and were using increased enforcement of IP laws as a tool to clamp down on the legitimate trade in high-quality generic medicines between developing countries.

However, after such decision, the definition will now use falsified instead of counterfeit which in line with public health concerns regarding medicines. Indeed, it is welcome step for Indian companies for expanding themselves at global level.


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