WHO settles India, EU medicine dispute

In a significant victory for the global access to medicines campaign, the World Health Organisation (WHO) has dropped the term ‘counterfeit’ and retained ‘falsified’ to describe medicines of inferior quality.

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.

In a meeting on Thursday, the WHO settled a long standing dispute between India and the European Union (EU) by clarifying that ‘counterfeit’— will now be used by member States with respect to protection of Intellectual Property Rights (IPR).

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

Genuine medicines

“This decision by the WHO settles a long-standing battle about labelling of drugs. For far too long, genuine generic medicines have been labelled as counterfeit. The confusion had taken away the much needed attention from the substandard medicines — which is a bigger public health problem for developing countries.

Additionally, big pharmaceutical companies were using the term ‘counterfeit’ to describe generic medicines and disrupting trade of generic medicines,” said Leena Menghaney, South Asia head of humanitarian aid organisation Médecins Sans Frontières (MSF), which relies on Indian medicines to treat a wide variety of diseases, including tuberculosis, malaria, HIV/AIDS and other infections that afflict the poorest and most vulnerable populations.

Clarifying its position, the WHO said in a statement 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 decision was taken by a technical working group on draft working definitions of substandard/spurious /falsely-labelled/falsified/counterfeit (SSFFC) medical products met on November 23.

The term ‘counterfeit’ was being described substandard or falsified medicines even though, under international law, — the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) — the definition of counterfeit is clearly targeted at one particular area: 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. Major U.S. and European pharmaceutical companies have a vested interest in limiting competition from generic drugs, and are using increased enforcement of intellectual property laws as a tool to clamp down on the legitimate trade in high-quality generic medicines between developing countries,” said K.M. Gopakumar, Legal Advisor with the Third World Network (TWN), a transnational policy think tank.

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Printable version | Sep 24, 2021 8:01:49 AM |

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